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  • 51.
    Silfverdal, Sven Arne
    et al.
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Flodmark, Carl-Erik
    Rombo, Lars
    Tansey, Susan P.
    Sidhu, Mohinder
    Trammel, James
    Emini, Emilio A.
    Gruber, William C.
    Scott, Daniel A.
    Gurtman, Alejandra
    13-Valent pneumococcal conjugate vaccine (PCV13) in children partially immunized with 7-valent pneumococcal conjugate vaccine (PCV7): A phase 3, open-label trial2013In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 31, no 9, p. 1284-1292Article in journal (Refereed)
    Abstract [en]

    Background: As 13-valent pneumococcal conjugate vaccine (PCV13) is introduced, children who began vaccination with 7-valent pneumococcal conjugate vaccine (PCV7) may complete their vaccination with PCV13. This open-label phase 3 study evaluated immunogenicity and safety of PCV13 in Swedish infants and toddlers previously given 1 or 2 doses of PCV7 during infancy. Methods: Healthy infants previously given PCV7 at ages 3 months (group 1; n = 118) or 3 and 5 months (group 2; n = 116) received PCV13 at ages 5 (group 1) and 12 months (both groups). IgG responses were assessed 1 month after each PCV13 dose and before the 12-month dose. Local reactions and systemic events were collected for 7 days postvaccination. Other adverse events were also collected. Results: Post-5-month dose, IgG geometric mean concentrations (GMCs) in group 1 were 1.56-4.70 mu g/ml for most PCV7 serotypes except 6B (0.40 mu g/ml) and 23F (0.57 mu g/ml) and 0.72-1.88 mu g/ml for most of the 6 additional serotypes, except 6A (0.28 mu g/ml). Post-12-month dose, IgG GMCs for the PCV7 serotypes were 2.93-9.63 mu g/ml (group 1) and 3.33-9.30 mu g/ml (group 2); and for the 6 additional serotypes, 1.85-14.65 mu g/ml (group 1) and 1.34-13.16 mu g/ml (group 2). GMCs increased by >4-fold in both groups from pre- to post-12-month dose. Proportions of subjects in group 1 with pneumococcal serotype-specific IgG concentrations >= 0.35 mu g/ml (WHO-designated postprimary reference antibody level) post-5-month dose were 92.2-99.1% for most PCV7 serotypes except 6B (53.0%) and 23F (62.6%) and 80.9-100.0% for most of the 6 additional serotypes except 6A (36.8%). Local reactions and fever were mostly mild or moderate. Conclusions: PCV13 was immunogenic and safe in infants and toddlers previously partially immunized with PCV7. Even a single dose in an infant or toddler induces an immune response to the 6 additional serotypes. (C) 2013 Published by Elsevier Ltd.

  • 52.
    Silfverdal, Sven Arne
    et al.
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Gothefors, Leif
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    [Time to vaccinate infants and small children against pneumococci]2006In: Lakartidningen, ISSN 0023-7205, Vol. 103, no 7, p. 477-8Article in journal (Other academic)
    Abstract [sv]

    Article in Swedish

  • 53.
    Silfverdal, Sven Arne
    et al.
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Hernell, Olle
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Livsmedelstillsatser kan ökahyperaktivitet hos barn: Resultat från brittisk studie stärker sambandet2008In: Läkartidningen, ISSN 0023-7205, E-ISSN 1652-7518, Vol. 105, no 6, p. 354-355Article in journal (Other academic)
  • 54.
    Silfverdal, Sven Arne
    et al.
    Umeå University, Faculty of Medicine, Clinical Sciences, Paediatrics.
    Hernell, Olle
    Umeå University, Faculty of Medicine, Clinical Sciences, Paediatrics.
    [Who is responsible for dietary advice for our children?]2008In: Lakartidningen, ISSN 0023-7205, Vol. 105, no 24-25, p. 1863-4Article in journal (Other academic)
  • 55.
    Silfverdal, Sven Arne
    et al.
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Hogh, Birthe
    Department of Pediatrics, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.
    Bergsaker, Marianne Riise
    Division of Infectious Disease Control, Norwegian Institute of Public Health, Oslo, Norway.
    Skerlikova, Helena
    GPP Practice, Dolny Kubin, Slovakia.
    Lommel, Patricia
    Global Clinical Development Center, GlaxoSmithKline Biologicals, Rixensart, Belgium.
    Borys, Dorota
    Global Clinical Development Center, GlaxoSmithKline Biologicals, Rixensart, Belgium.
    Schuerman, Lode
    Global Clinical Development Center, GlaxoSmithKline Biologicals, Rixensart, Belgium.
    Immunogenicity of a 2-dose priming and booster vaccination with the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine2009In: The Pediatric Infectious Disease Journal, ISSN 0891-3668, E-ISSN 1532-0987, Vol. 28, no 10, p. e276-282Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: The immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) was determined following a simplified 2-dose priming and the more commonly employed 3-dose priming both followed by a booster dose. METHODS: A total of 351 healthy subjects were primed with PHiD-CV at either 3 and 5 or 3, 4 and 5 months of age followed in all subjects by a booster dose at 11 to 12 months of age. Serotype-specific pneumococcal responses were measured by 22F-inhibition ELISA and opsonophagocytic assays 1 month following primary and booster vaccinations. RESULTS: Depending on the serotype, the percentages of subjects reaching the ELISA antibody threshold of 0.2 microg/mL were 92.8% to 98.0% following 2 primary doses and 96.1% to 100% following 3 primary doses except for serotype 6B (55.7% and 63.1%, respectively) and serotype 23F (69.3% and 77.6%, respectively). Opsonophagocytic activity (OPA) could be measured in 74.4% to 100% and 88.9% to 100% of the subjects after the 2-dose or 3-dose priming, respectively, except for serotype 1 (60.8% and 62.9%, respectively). In both groups, robust increases in ELISA antibodies and OPA titers were observed for all serotypes after the booster dose. Higher postprimary and postbooster ELISA antibody levels and OPA titers were observed for most serotypes following the 3+1 schedule. CONCLUSION: PHiD-CV was immunogenic in both schedules, but further effectiveness data are needed to fully understand the public health benefit to be expected from these schedules in terms of prevention against invasive and mucosal infections.

  • 56.
    Silfverdal, Sven Arne
    et al.
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Skerlikova, Helena
    Zanova, Maria
    Papúchová, Danica
    Traskine, Magali
    Borys, Dorota
    Schuerman, Lode
    Anamnestic Immune Response in 3- to 4-year-old Children Previously Immunized With 10-valent Pneumococcal Nontypeable Haemophilus influenzae Protein D Conjugate Vaccine as 2 Dose or 3 Dose Priming and a Booster Dose in the First Year of Life.2011In: The Pediatric Infectious Disease Journal, ISSN 0891-3668, E-ISSN 1532-0987, Vol. 30, no 9, p. e155-e163Article in journal (Refereed)
    Abstract [en]

    BACKGROUND:: Immunogenicity of 10-valent pneumococcal nontypeable Haemophilus influenzae proteind conjugate vaccine (PHiD-CV), administered as 2 dose or 3 dose priming followed by a booster dose, has been described previously. The present study evaluated immunologic memory following PHiD-CV vaccination according to these vaccination schedules. METHODS:: A dose of PHiD-CV (to test anamnestic responses) was administered to 172 children at 36 to 46 months of age; 110 of them had previously been vaccinated with PHiD-CV according to 2 + 1 or 3 + 1 schedules (PHiD-CV [2 + 1] and PHiD-CV [3 + 1] groups) and 62 were unprimed age-matched controls. To measure immune responses before and 7 to 10 days after the PHiD-CV dose, 22F-inhibition enzyme-linked immunosorbent assay and opsonophagocytic activity (OPA) assay were used. RESULTS:: Serotype-specific IgG geometric mean concentrations (GMCs) and OPA geometric mean titers (GMTs) increased substantially (from before to 7 to 10 days after the additional PHiD-CV dose) for all 10 vaccines and 2 cross-reactive serotypes (6A and 19A) in the children previously vaccinated with PHiD-CV, regardless of the vaccination schedule used. Antibody GMCs and OPA GMTs after the administration of the PHiD-CV dose were markedly higher in both previously PHiD-CV-vaccinated groups than in the unprimed control group, clearly demonstrating prior induction of immunologic memory. Antiprotein D antibody GMCs had also increased substantially from before to 7 to 10 days after vaccination in all 3 groups, with higher antibody GMCs in the previously vaccinated groups than in the control group. CONCLUSION:: PHiD-CV vaccination according to 2 + 1 or 3 + 1 schedules resulted in comparable anamnestic immune responses. These findings suggest that similar protective efficacy may be achieved with both the schedules.

  • 57.
    Silfverdal, Sven-Arne
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Important to overcome barriers in translating evidence based breast-feeding information into practice2011In: Acta Paediatrica, ISSN 0803-5253, E-ISSN 1651-2227, Vol. 100, no 4, p. 482-483Article in journal (Refereed)
  • 58. Silfverdal, Sven-Arne
    et al.
    Bodin, Lennart
    Ulanova, Marina
    Hahn-Zoric, Mirjana
    Hanson, Lars A
    Olcen, Per
    Long term enhancement of the IgG2 antibody response to Haemophilus influenzae type b by breast-feeding.2002In: The Pediatric Infectious Disease Journal, ISSN 0891-3668, E-ISSN 1532-0987, Vol. 21, no 9, p. 816-21Article in journal (Refereed)
    Abstract [en]

    SUBJECTS: Sets of sera were obtained from 30 children <6 years of age with invasive type b (Hib) infection and their mothers. Duration and mode of breast-feeding were monitored. Titers of IgG1, IgG2, IgA and IgM antibodies against Hib capsular polysaccharide were determined in sera taken during the acute illness and during early and late convalescence. RESULTS: Children 18 months or older with longer durations of exclusive breast-feeding (13 weeks or more; mean, 19.3 weeks) had higher Hib antibody concentrations of the IgG1, IgG2, IgA and IgM isotypes than those with a shorter duration of exclusive breast-feeding (<13 weeks; mean, 5.4 weeks). The difference was greatest for the IgG2 isotype. In regression analyses the association between the duration of exclusive breast-feeding and the anti-Hib IgG2 concentration was significant when breast-feeding, type of Hib infection, maternal Hib antibody titer and age were used as explanatory factors. In the group of 14 children <18 months of age no significant differences were noted. DISCUSSION: This study indicates the presence of a long lasting enhancing effect of breast-feeding on the antibody response to Hib in children, in particular on IgG2 Hib antibody production. This may result from the content in the milk of IFN-gamma and IFN-gamma-producing cells and possibly other factors, which can support IgG2 antibody production.

  • 59.
    Silfverdal, Sven-Arne
    et al.
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Icardi, Giancarlo
    Vesikari, Timo
    Flores, Sheryl A.
    Pagnoni, Marco F.
    Xu, Jin
    Liu, Frank
    Stek, Jon E.
    Boisnard, Florence
    Thomas, Stephane
    Ziani, Eddy
    Lee, Andrew W.
    A Phase III randomized, double-blind, clinical trial of an investigational hexavalent vaccine given at 2, 4, and 11-12 months2016In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 34, no 33, p. 3810-3816Article in journal (Refereed)
    Abstract [en]

    Background: Combination vaccines simplify vaccination visits and improve coverage and timeliness. DTaP5-HB-IPV-Hib is a new investigational, fully-liquid, combination vaccine designed to protect against 6 infectious diseases, including 5 pertussis antigens and OMPC instead of PT as conjugated protein for Hib component.

    Methods: In this multicenter, double-blind, comparator-controlled, Phase III study (NCT01480258) conducted in Sweden, Italy, and Finland, healthy infants were randomized 1:1 to receive one two immunization regimens. The DTaP5-HB-IPV-Hib Group received the investigational hexavalent vaccine (DTaP5-HB-IPV-Hib) and the Control Group received Infanrix-hexa (DTPa3-HBV-IPV/Hib) at 2, 4 and 11-12 months of age. Both groups received concomitantly Prevnar 13 (PCV13) and Rotateq (RV5) or Rotarix (RV1) at 2, 4 months of age and PCV13 at 11-12 months. Subjects administered RV5 received a 3rd dose at 5 months of age.

    Results: A total of 656 subjects were randomized to the DTaP5-HB-IPV-Hib Group and 659 subjects to Control Group. Immune responses to all vaccine antigens post-toddler dose were non-inferior in the DTaP5-HB-IPV-Hib Group as compared to the Control Group. Additionally, the post-dose 2 and pre-toddler DTaP5-HB-IPV-Hib anti-PRP responses were superior. The DTaP5-HB-IPV-Hib Group responses to concomitant RV1 were non-inferior compared to the Control Group. Solicited adverse event rates after any dose were similar in both groups, except for higher rates of pyrexia (6.4% difference; 95% CI: 1.5,11.3) and somnolence (5.8% difference; 95% CI: 1.7,9.8) in the DTaP5-HB-IPV-Hib Group. Vaccine-related serious adverse events occurred infrequently in the DTaP5-HB-IPV-Hib Group (0.3%) and the Control Group (0.5%).

    Conclusions: The safety and immunogenicity of DTaP5-HB-IPV-Hib is generally comparable to Control when administered in the 2, 4, 11-12 month schedule. Early Hib responses were superior versus Control. DTaP5-HB-IPV-Hib could provide a new hexavalent option for pediatric combination vaccines, aligned with recommended immunizations in Europe.

  • 60.
    Silfverdal, Sven-Arne
    et al.
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Nilsson, Lennart
    Blennow, Margareta
    Carlsson, Rose-Marie
    Hanson, Lars Å
    Lindberg, Anders
    Lindquist, Lars
    Magnusson, Margaretha
    Norlund, Anders
    Nyrén, Olof
    Olcén, Per
    Olin, Patrick
    Säwe, Juliette
    Söderström, Ann
    Trollfors, Birger
    Örtqvist, Åke
    Vaccination of children: summary and conclusions from a systematic review2010In: Acta Paediatrica, ISSN 0803-5253, E-ISSN 1651-2227, Vol. 99, no 9, p. 1287-1289Article in journal (Refereed)
  • 61.
    Stecksén-Blicks, Christina
    et al.
    Umeå University, Faculty of Medicine, Department of Odontology.
    Granström, Elisabeth
    Umeå University, Faculty of Medicine, Department of Odontology.
    Silfverdal, Sven Arne
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    West, Christina
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Prevalence of oral Candida in the first year of life2015In: Mycoses (Berlin), ISSN 0933-7407, E-ISSN 1439-0507, Vol. 58, no 9, p. 550-556Article in journal (Refereed)
    Abstract [en]

    Colonisation of the gastrointestinal tract is influenced by primary microbial exposure and bioactive factors in breastmilk. The aim was to explore the prevalence of oral Candida in the first year of life in relation to selected exposures. Oral Candida was studied in 100 healthy infants at 4 and 8 weeks, 3, 6 and 12 months of age and related to delivery mode, birth weight, infant health and feeding, antibiotics, antimycotics, steroids and probiotics in mother and infant, living conditions, maternal smoking and infections The association between lactoferrin and antisecretory factor in breastmilk and maternal serum haemoglobin, transferrin, and ferritin levels in relation to oral Candida was also explored. About 11% to 15% of the infants had oral Candida at the respective age. Colonisation was fairly stable until 6 months of age. There was no conclusive impact of the investigated exposures at entry. Infants with a furry pet at home had a lower frequency of Candida at 3 months, (P < 0.05) whereas all but one colonised infant had older siblings at 12 months (P < 0.01). Lactoferrin in breastmilk was negatively associated with colonisation at 6 months of age. It is concluded that 11 to 15% had oral Candida. Exposure to furry pets and siblings impacted oral Candida.

  • 62.
    Thorén, Annelie
    et al.
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Werner, Bo
    Lundholm, Cecilia
    Bråbäck, Lennart
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Occupational and Environmental Medicine.
    Silfverdal, Sven-Arne
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    A rapid growth rate in early childhood is a risk factor for becoming overweight in late adolescence.2015In: Acta Paediatrica, ISSN 0803-5253, E-ISSN 1651-2227, Vol. 104, no 11Article in journal (Refereed)
    Abstract [en]

    AIM: We evaluated whether body mass index (BMI) and rapid growth in early life were associated with an increased risk of becoming overweight at 16 and 18 years of age.

    METHODS: The study population comprised all children born in Sweden on the 15th of each month in 1981. Individuals born on the 5th, 10th and 20th of every month were added for counties with low population densities. Information on weight and height was collected from birth up to 18 years of age for 98.6% of the 3537 children identified.

    RESULTS: Weight at 12 months of age was associated with being overweight at both 16 and 18 years of age. Rapid weight gain from birth to 12 months was associated with higher odds for being overweight later in life, and the weight gain between 18 months and four years of age was the strongest risk factor for being overweight in late adolescence in both sexes. There was no association between a birthweight of <2500 g or >4500 g and being overweight at 16 or 18 years of age.

    CONCLUSION: Fast growth during early childhood was associated with an increased risk of being overweight later in life, emphasising the importance of early prevention.

  • 63.
    Vaezghasemi, Masoud
    et al.
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Epidemiology and Global Health.
    Sundberg, Linda
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Epidemiology and Global Health.
    Ivarsson, Anneli
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Epidemiology and Global Health.
    Eurenius, Eva
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine, Epidemiology and Global Health.
    Silfverdal, Sven Arne
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Lindkvist, Marie
    Umeå University, Faculty of Medicine, Department of Public Health and Clinical Medicine.
    Psychometric analysis of Age and Stages Questionnaire: Social-Emotional (ASQ:SE) among 3-year-olds2017In: European Journal of Public Health, ISSN 1101-1262, E-ISSN 1464-360X, Vol. 27, no Suppl_3, p. 173-174Article in journal (Other academic)
    Abstract [en]

    Background: Mental health is an urgent public health challenge, and for some individuals the problem starts already in pre-school age. Increased knowledge is needed to guide evidence-based health-promoting interventions and early identification for adequate parental support. Valid and reliable instruments to measure children’s mental health are called for. Our aim is to analyze psychometric properties of the Ages and Stages Questionnaire: Social-Emotional (ASQ:SE) among 3-year-olds.

    Methods: Within Child Health Care (CHC) in Västerbotten (Sweden) the 3-year-olds’ health check-up includes parent-rated socio-emotional health by scoring the ASQ:SE. This instrument has seven psychological domains (self-regulation, compliance, communication, adaptive functioning, autonomy, affect, and interaction); built up by 31 items, responded on a 3-point Likert scale with total scores 0-465. Item scores are combined into a total score with high values indicating social-emotional vulnerability. Most parents give informed consent for research and the study has ethical approval.

    Results: During 2014-2016 we have ASQ:SE responses for 5434 children having had their 3-year health check-up (boys=2802, girls=2632), with total scores 0-215. Generally, boys scored higher (mean 31, SD 24; median 25) than girls (mean 25, SD 21; median 20), and 12% of boys, compared to 6% of girls, scored above the cut-off value (59). The internal consistency based on Cronbach’s alpha was 0.78. Confirmatory factor analysis was done and normative values were also reported for the ASQ:SE.

    Conclusions: Our psychometric analyses of ASQ:SE among 3-year-olds indicates the relevance of an instrument for screening pre-school children’s social and emotional health. This is promising for future use of the instrument within ordinary CHC in Västerbotten and elsewhere.

    Key messages:

    • The ASQ:SE instrument is a valuable asset within CHC to increase awareness about 3-year-olds social-emotional health.
    • The ASQ:SE instrument is a promising tool for low-cost screening of early social-emotional vulnerability.
  • 64. Vesikari, Timo
    et al.
    Richardus, Jan Hendrik
    Berglund, Johan
    Korhonen, Tiina
    Flodmark, Carl-Erik
    Lindstrand, Ann
    Silfverdal, Sven Arne
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Bambure, Vinod
    Caplanusi, Adrian
    Dieussaert, Ilse
    Roy-Ghanta, Sumita
    Vaughn, David W.
    Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine in Children 6 Months to 17 Years of Age, Previously Vaccinated with an AS03-Adjuvanted A(H1N1)Pdm09 Vaccine Two Open-label, Randomized Trials2015In: The Pediatric Infectious Disease Journal, ISSN 0891-3668, E-ISSN 1532-0987, Vol. 34, no 7, p. 774-782Article in journal (Refereed)
    Abstract [en]

    Background: During the influenza pandemic 2009-2010, an AS03-adjuvanted A(H1N1) pdm09 vaccine was used extensively in children 6 months of age and older, and during the 2010-2011 influenza season, the A(H1N1) pdm09 strain was included in the seasonal trivalent inactivated influenza vaccine (TIV) without adjuvant. We evaluated the immunogenicity and safety of TIV in children previously vaccinated with the AS03-adjuvanted A(H1N1) pdm09 vaccine. Methods: Healthy children were randomized (1:1) to receive TIV or a control vaccine. Children were aged 6 months to 9 years (n = 154) and adolescents 10-17 years (n = 77) when they received AS03-adjuvanted A(H1N1) pdm09 vaccine at least 6 months before study enrolment. Hemagglutination inhibition (HI) and neutralizing antibody responses against the A(H1N1) pdm09 strain were evaluated before (day 0) and at day 28 and month 6 after study vaccination. Reactogenicity was assessed during the 7 day postvaccination period, and safety was assessed for 6 months. Results: At day 0, >93.9% of all children had HI titers >= 1:40 for the A(H1N1) pdm09 strain, which increased to 100% at both day 28 and month 6 in the TIV group. Between days 0 and 28, HI antibody geometric mean titers against A(H1N1) pdm09 increased by 9-fold and 4-fold in children 6 months to 9 years of age and 10-17 years of age, respectively. Conclusion: AS03-adjuvanted A(H1N1) pdm09 vaccine-induced robust immune responses in children that persisted into the next season, yet were still boosted by TIV containing A(H1N1) pdm09. The reactogenicity and safety profile of TIV did not appear compromised by prior receipt of AS03adjuvanted A(H1N1) pdm09 vaccine.

  • 65. Vesikari, Timo
    et al.
    Silfverdal, Sven Arne
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Boisnard, Florence
    Thomas, Stephane
    Mwawasi, Grace
    Reynolds, Donna
    Randomized, Controlled, Multicenter Study of the Immunogenicity and Safety of a Fully Liquid Combination Diphtheria-Tetanus Toxoid-Five-Component Acellular Pertussis (DTaP5), Inactivated Poliovirus (IPV), and Haemophilus influenzae Type b (Hib) Vaccine Compared with a DTaP3-IPV/Hib Vaccine Administered at 3, 5, and 12 Months of Age2013In: Clinical and Vaccine Immunology, ISSN 1556-6811, E-ISSN 1556-679X, Vol. 20, no 10, p. 1647-1653Article in journal (Refereed)
    Abstract [en]

    This study compared the levels of immunogenicity and safety of diphtheria-tetanus toxoid-five-component acellular pertussis (DTaP5), inactivated poliovirus (IPV), and Haemophilus influenzae type b (Hib) (DTaP5-IPV-Hib) and DTaP3-IPV/Hib vaccines for study participants 3, 5, and 12 months of age. Post-dose 3 noninferiority criteria comparing DTaP5-IPV-Hib to DTaP3-IPV/Hib using rates of seroprotection were demonstrated against diphtheria, tetanus, and polio types 1 to 3, but not for polyribosylribitol phosphate (PRP). While PRP did not meet noninferiority criteria, the seroprotection rate and geometric mean concentration (GMC) were high, indicating a clinically robust immune response. GMCs or titers for other antigens (including pertussis) and the safety profiles were generally similar between groups. Fully liquid DTaP5-IPV-Hib can be administered using the 3-, 5-, and 12-month vaccination schedule. (This study has been registered at ClinicalTrials.gov under registration no. NCT00287092.)

  • 66. Vesikari, Timo
    et al.
    Silfverdal, Sven-Arne
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Jordanov, Emilia
    Feroldi, Emmanuel
    A Randomized, Controlled Study of DTaP-IPV-HB-PRP-T, a Fully Liquid Hexavalent Vaccine, Administered in a 3-,5-and 11-to 12-month Schedule2017In: The Pediatric Infectious Disease Journal, ISSN 0891-3668, E-ISSN 1532-0987, Vol. 36, no 1, p. 87-93Article in journal (Refereed)
    Abstract [en]

    Background: To assess the immunogenicity and safety of a fully liquid, ready-to-use hexavalent DTaP-IPV-HB-PRP-T vaccine when administered in a 2 + 1 schedule at 3, 5 and 11-12 months of age.

    Methods: Phase III, randomized, active-controlled, observer-blind, multi-center study. Infants were randomized to receive DTaP-IPV-HB-PRP-T (N = 275) or a licensed control hexavalent vaccine (DTaP-IPV-HB//PRPNT: N = 275), both given in coadministration with Prevenar 13. Serum was analyzed for immune responses to all vaccine antigens. Noninferiority of DTaP-IPV-HB-PRP-T to the control vaccine was tested at completion of the primary series using predefined seroprotection (SP) rate and vaccine response (VR) rates. Safety was assessed using parental reports.

    Results: Noninferiority of DTaP-IPV-HB-PRP-T to the control vaccine was demonstrated postdose 3 for each antigen, and the SP (for D, T, poliovirus 1, 2 and 3, hepatitis B and polyribosylribitol phosphate) and VR rates (for pertussis toxin and filamentous hemagglutinin) were high in each group. SP rates for D, T, polio 1, 2, 3 and VR rates for pertussis toxin and filamentous hemagglutinin were similar in each group. For hepatitis B, SP rate was slightly higher for DTaP-IPV-HB//PRP similar to T (99.6%) than DTaP-IPV-HB-PRP-T (96.4%), and for PRP, SP rate was higher for DTaP-IPV-HB-PRP-T (93.5%) than DTaP-IPV-HB//PRP similar to T (85.2%). For Prevenar 13, the SP rate was high for each serotype and similar for both groups. All vaccines were well tolerated.

    Conclusions: These study findings confirm the safety and immunogenicity and thus the suitability of this fully liquid hexavalent vaccine for administration in a 2 + 1 schedule.

  • 67. Vetter, Volker
    et al.
    Baxter, Roger
    Denizer, Gülhan
    Sáfadi, Marco A P
    Silfverdal, Sven-Arne
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Vyse, Andrew
    Borrow, Ray
    Routinely vaccinating adolescents against meningococcus: targeting transmission & disease.2016In: Expert Review of Vaccines, ISSN 1476-0584, E-ISSN 1744-8395, Vol. 15, no 5, p. 641-658Article in journal (Refereed)
    Abstract [en]

    Adolescents have the highest rates of meningococcal carriage and transmission. Interrupting the adolescent habitat in order to reduce carriage and transmission within adolescents and to other age groups could help to control meningococcal disease at a population level. Compared to immunization strategies restricted to young children, a strategy focused on adolescents may have more profound and long-lasting indirect impacts, and may be more cost effective. Despite challenges in reaching this age-group, experience with other vaccines show that high vaccine coverage of adolescents is attainable.

  • 68.
    Videholm, Samuel
    et al.
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics. Unit of Research, Development, and Education, Östersund Hospital, Östersund, Sweden.
    Silfverdal, Sven-Arne
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Reniers, Georges
    Maternal weight and infections in early childhood: a cohort study2019In: Archives of Disease in Childhood, ISSN 0003-9888, E-ISSN 1468-2044, Vol. 104, no 1, p. 58-63Article in journal (Refereed)
    Abstract [en]

    Objective The aim of this study was to examine this association between maternal weight during pregnancy and the incidence of hospitalisations for infectious diseases during early childhood. Design A population-based cohort study. Setting A national cohort was created by combining data from the Swedish Medical Birth Register, the National Inpatient Register, the Cause of Death Register, the Total Population Register and the Longitudinal integration database for health insurance and labour market studies. Patients 693 007 children born in Sweden between 1998 and 2006. Main outcome measures Number of hospitalisations for infectious diseases during the first 5 years of life, overall and for categories of infectious diseases (lower respiratory, enteric, upper respiratory, genitourinary, perinatal, skin and soft tissue, neurological and eye, digestive tract, bloodstream and other infections). Results Overweight (body mass index (BMI) 25.0-29.9) and obesity (BMI >= 30) during pregnancy were associated with a higher overall incidence of hospitalisations for infectious diseases, adjusted incidence rate ratio (IRR) 1.05 (95% CI 1.03 to 1.06) and adjusted IRR 1.18 (95% CI 1.16 to 1.21). Overweight and obesity during pregnancy were strongly associated with perinatal infections, adjusted IRR 1.34 (95% CI 1.25 to 1.44) and adjusted IRR 1.72 (95% CI 1.57 to 1.88). In contrast, we found no association between maternal weight during pregnancy and infections of skin and soft tissue, the nervous system, the digestive tract or the bloodstream. Conclusions We observed an association between overweight and obesity during pregnancy, and hospitalisations for infectious diseases during early childhood.

  • 69. Zaman, S.
    et al.
    Lange, S.
    Jennische, E.
    Aamir, K.
    Silfverdal, Sven Arne
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Hanson, L. A.
    The antisecretory factor - an efficient tool for rapid recovery from early childhood diarrhoea2013In: Acta Paediatrica, ISSN 0803-5253, E-ISSN 1651-2227, Vol. 102, no 9, p. E391-E391Article in journal (Refereed)
  • 70. Zaman, Shakila
    et al.
    Aamir, Khalida
    Lange, Stefan
    Jennische, Eva
    Silfverdal, Sven-Arne
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Hanson, Lars A.
    Antisecretory factor effectively and safely stops childhood diarrhoea: a placebo-controlled, randomised study2014In: Acta Paediatrica, ISSN 0803-5253, E-ISSN 1651-2227, Vol. 103, no 6, p. 659-664Article in journal (Refereed)
    Abstract [en]

    Aim

    We studied the response to high doses of egg yolk containing antisecretory factor (B221((R)), Salovum((R))) in young children with acute diarrhoea, presenting to the Children's Hospital, Lahore, Pakistan.

    Methods

    In a randomised, placebo-controlled trial, 36 children aged 7 to 60months with acute diarrhoea of unknown aetiology, with mild-to-moderate dehydration, were randomised to the Salovum((R)) or placebo groups. Initially, 16 grams of Salovum((R)) or ordinary egg yolk (placebo) mixed in oral rehydration salts was given, followed by 8g every 5h until recovery. The number and consistency of stools were recorded.

    Results

    The two groups were comparable in age, gender, duration of diarrhoea, hydration and nutritional status, although the proportion with watery stools was higher in the Salovum((R)) group (p=0.04). Reduction in the frequency of stools was seen at 7 versus 18h (p<0.0001) and normalising of stool consistency was 10 versus 18h, p<0.03) in the Salovum((R)) and placebo groups. The overall effect was 35 versus 70h in the two groups (p=0.001). No side effects were reported.

    Conclusion

    High doses of AF in the form of Salovum((R)) effectively and safely reduce childhood diarrhoea of a likely broad aetiology.

  • 71. Åkeson, Pia Karlsland
    et al.
    Åkesson, Kristina E
    Lind, Torbjörn
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Hernell, Olle
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Silfverdal, Sven-Arne
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Öhlund, Inger
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Vitamin D Intervention and Bone: A Randomized Clinical Trial in Fair- and Dark-skinned Children at Northern Latitudes2018In: Journal of Pediatric Gastroenterology and Nutrition - JPGN, ISSN 0277-2116, E-ISSN 1536-4801, Vol. 67, no 3, p. 388-394Article in journal (Refereed)
    Abstract [en]

    Objectives: The aim of the study was to evaluate vitamin D status and effects of vitamin D intervention on bone mineral density (BMD) and content (BMC) in children with fair and dark skin in Sweden during winter.

    Methods: In a 2-center prospective double-blinded randomized intervention study 5- to 7-year-old children (n = 206) with fair and dark skin in Sweden (55 degrees N-63 degrees N) received daily vitamin D supplements of 25 mu g, 10 mu g, or placebo (2 mu g) during 3 winter months. We measured BMD and BMC for total body (TB), total body less head (TBLH), femoral neck (FN), and spine at baseline and 4 months later. Intake of vitamin D and calcium, serum 25-hydroxy vitamin D (S-25 [OH]D), and related parameters were analyzed.

    Results: Despite lower S-25(OH)D in dark than fair-skinned children, BMD of TB (P = 0.012) and TBLH (P = 0.002) and BMC of TBLH (P = 0.04) were higher at baseline and follow-up in those with dark skin. Delta (Delta) BMD and BMC of TB and TBLH did not differ between intervention and placebo groups, but FN-BMC increased more among dark-skinned children in the 25 mu g (P = 0.038) and 10 mu g (P = 0.027) groups compared to placebo. We found no associations between Delta S-25(OH)D, P-parathyroid hormone, P-alkaline phosphatase, and Delta BMD and BMC, respectively.

    Conclusions: BMD and BMC remained higher in dark- than fair-skinned children despite lower vitamin D status. Even though no difference in general was found in BMD or BMC after vitamin D intervention, the increase in FN-BMC in dark-skinned children may suggest an influence on bone in those with initially insufficient vitamin D status.

  • 72.
    Öhlund, Inger
    et al.
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Lind, Torbjörn
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Hernell, Olle
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Silfverdal, Sven-Arne
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Karlsland Åkeson, Pia
    Increased vitamin D intake differentiated according to skin color is needed to meet requirements in young Swedish children during winter: a double-blind randomized clinical trial2017In: American Journal of Clinical Nutrition, ISSN 0002-9165, E-ISSN 1938-3207, Vol. 106, no 1, p. 105-112Article in journal (Refereed)
    Abstract [en]

    Background: Dark skin and low exposure to sunlight increase the risk of vitamin D insufficiency in children. Objective: The aim of the study was to evaluate the amount of vitamin D needed to ascertain that most children >4 y of age attain sufficient serum25-hydroxyvitamin D [S-25(OH) D; i.e., >= 50 nmol/L] during winter regardless of latitude and skin color. Design: In a longitudinal, double-blind, randomized, food-based intervention study, 5- to 7-y-old children from northern (638 degrees N) and southern (558 degrees N) Sweden with fair (n = 108) and dark (n = 98) skin were included. Children, stratified by skin color by using Fitzpa-trick's definition, were randomly assigned to receive milk-based vitamin D-3 supplements that provided 2 (placebo), 10, or 25 mu g/d during 3 winter months. Results: Mean daily vitamin D intake increased from 6 to 17 mu g and 26 mu g in the intervention groups supplemented with 10 and 25 mu g, respectively. In the intention-to-treat analysis, 90.2% (95% CI: 81.1%, 99.3%) of fair-skinned children randomly assigned to supplementation of 10 mu g/d attained sufficient concentrations, whereas 25 mu g/d was needed in dark-skinned children to reach sufficiency in 95.1% (95% CI: 88.5%, 100%). In children adherent to the study product, 97% (95% CI: 91.3%, 100%) and 87.9% (95% CI: 76.8%, 99%) of fair-and dark-skinned children, respectively, achieved sufficient concentrations if supplemented with 10 mu g/d. By using 95% prediction intervals for 30 and 50 nmol S-25(OH) D/L, intakes of 6 and 20 mu g/d are required in fair-skinned children, whereas 14 and 28 mu g/d are required in children with dark skin. Conclusion: Children with fair and dark skin require vitamin D intakes of 20 and 28 mu g/d, respectively, to maintain S-25(OH) D >= 50 nmol/L, whereas intakes of 6 and 14 mu g/d, respectively, are required to maintain concentrations >= 30 nmol/L during winter.

  • 73.
    Öhlund, Inger
    et al.
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Silfverdal, Sven-Arne
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Hernell, Olle
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Lind, Torbjörn
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Serum 25-Hydroxyvitamin D Levels in Preschool-Age Children in Northern Sweden Are Inadequate After Summer and Diminish Further During Winter2013In: Journal of Pediatric Gastroenterology and Nutrition - JPGN, ISSN 0277-2116, E-ISSN 1536-4801, Vol. 56, no 5, p. 551-555Article in journal (Refereed)
    Abstract [en]

    Background and Objective: Despite studies indicating that vitamin D intake among Swedish children does not meet the recommendation, little is known of their vitamin D status. The aim of the present study was to examine vitamin D status in preschool-age children in relation to vitamin D intake, season, body mass index, and skin color. Methods: Preschool-age children (n = 90; mean age 54 +/- 7.1 months), all living in northern Sweden (latitude 63 degrees north), half of them with fair skin, half with darker complexion, were recruited from well-baby clinics. The study group was examined first in August-September (late summer) and then the following January-February (winter). Skin type, vitamin D intake, anthropometrics, serum 25-hydroxyvitamin D (S-25[OH] D), and serum parathyroid hormone were assessed. Results: Mean +/- SD S-25(OH) Din summer and winter were 60 +/- 15 nmol/L and 55 +/- 16 nmol/L, respectively (P < 0.001). Fifteen percent and 10% had S-25(OH) D >= 75 nmol/L, and 25% and 40% had S-25(OH) D < 50 nmol/L, respectively. The mean vitamin D intake was higher in dark-skinned compared with fair-skinned children. In spite of this, S-25(OH) D in dark-skinned children was lower compared with fair-skinned children during both seasons. The dietary intake of vitamin D was positively associated with S-25(OH) D levels. Conclusions: Vitamin D status is inadequate in preschool-age children living in northern Sweden, especially in dark-skinned children and during the winter despite vitamin D intakes meeting the recommendations, prompting strategies to improve intake of vitamin D in this population.

  • 74. Örtqvist, Å
    et al.
    Blennow, M
    Carlsson, R-M
    Hansson, LÅ
    Lindberg, A
    Lindqvist, I
    Magnusson, M
    Nilsson, L
    Norlund, A
    Nyrén, O
    Olcén, P
    Olin, P
    Silfverdal, Sven Arne
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Säwe, J
    Söderström, A
    Trollfors, B
    Vaccination of children: a children systematic review2010In: Acta Paediatrica. Supplement, ISSN 0803-5326, Vol. 99, no s461, p. 1-192Article in journal (Refereed)
  • 75. Østergaard, Lars
    et al.
    Silfverdal, Sven-Arne
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Berglund, Johan
    Flodmark, Carl-Erik
    West, Christina
    Umeå University, Faculty of Medicine, Department of Clinical Sciences, Paediatrics.
    Bianco, Veronique
    Baine, Yaela
    Miller, Jacqueline M.
    A tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when co-administered with Twinrix(®) in subjects aged 11-17 years: An open, randomised, controlled trial.2012In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 30, no 4, p. 774-783Article in journal (Refereed)
    Abstract [en]

    The co-administration of the tetravalent meningococcal conjugate vaccine, MenACWY-TT, with a licensed hepatitis A and B vaccine, HepA/B (Twinrix(®)), was compared to their separate administration in this open, randomised, controlled study. Healthy subjects 11-17 years of age (n=611) were randomised (3:1:1) to receive both vaccines, MenACWY-TT alone or HepA/B alone. The co-administration of both vaccines was shown to be non-inferior to their individual administration. At seven months after the first vaccination, 99.4-100% of the subjects who received both vaccines co-administered showed seroprotection against all meningococcal serogroups and at least 99.1% of them were seropositive for hepatitis A and seroprotected against hepatitis B. This study suggests that MenACWY-TT vaccine could be co-administered with HepA/B without adversely impacting the immunogenicity, safety and reactogenicity of either of the vaccines.

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