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Randomized trial: immunogenicity and safety of coadministered human papillomavirus-16/18 AS04-adjuvanted vaccine and combined hepatitis A and B vaccine in girls.
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2012 (English)In: Journal of Adolescent Health, ISSN 1054-139X, E-ISSN 1879-1972, Vol. 50, no 1, 38-46 p.Article in journal (Refereed) Published
Abstract [en]

Purpose: This randomized, open, controlled, multicenter study (110886/NCT00578227) evaluated human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine (HPV-16/18 vaccine) coadministered with inactivated hepatitis A and B (HAB) vaccine. Coprimary objectives were to demonstrate noninferiority of hepatitis A, hepatitis B, and HPV-16/18 immune responses at month 7 when vaccines were coadministered, compared with the same vaccines administered alone.

Methods: Healthy girls (9–15 years) were age-stratified (9, 10–12, and 13–15 years) and randomized to receive HPV (n = 270), HAB (n = 271), or HPV + HAB (n = 272). Vaccines were administered at months 0, 1, and 6. Immunogenicity was evaluated at months 0 and 7.

Results: The hepatitis A immune response was noninferior for HPV + HAB, versus HAB, for seroconversion rates (100% in each group) and geometric mean antibody titers (GMTs) (95% CI) (4,504.2 [3,993.0–5,080.8] and 5,288.4 [4,713.3–5,933.7] mIU/mL, respectively). The hepatitis B immune response was noninferior for HPV + HAB, versus HAB, for anti-HBs seroprotection rates (98.3% and 100%); GMTs were 3,136.5 [2,436.0–4,038.4] and 5,646.5 [4,481.3–7,114.6] mIU/mL, respectively. The HPV-16/18 immune response was noninferior for HPV + HAB, versus HPV, for seroconversion rates (99.6% and 100% for both antigens) and GMTs (22,993.5 [20,093.4–26,312.0] and 26,981.9 [23,909.5–30,449.1] EL.U/mL for HPV-16; 8,671.2 [7,651.7–9,826.6] and 11,182.7 [9,924.8–12,600.1] EL.U/mL for HPV-18, respectively). No subject withdrew because of adverse events. No vaccine-related serious adverse events were reported. Immune responses and reactogenicity were similar in girls aged 9 years compared with the entire study population.

Conclusions: Results support coadministration of HPV-16/18 vaccine with HAB vaccine in girls aged 9–15 years. The HPV-16/18 vaccine was immunogenic and generally well tolerated in 9-year-old girls.

Place, publisher, year, edition, pages
Elsevier, 2012. Vol. 50, no 1, 38-46 p.
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URN: urn:nbn:se:umu:diva-51898DOI: 10.1016/j.jadohealth.2011.10.009PubMedID: 22188832OAI: diva2:489837
Available from: 2012-02-03 Created: 2012-02-03 Last updated: 2012-02-07Bibliographically approved

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Silfverdal, Sven Arne
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