Extended antigen sparing potential of AS03-adjuvanted pandemic H1N1 vaccines in children, and immunological equivalence of two formulations of AS03-adjuvanted H1N1 vaccines: results from two randomised trials. - Inserm - Institut national de la santé et de la recherche médicale Access content directly
Journal Articles BMC Infectious Diseases Year : 2013

Extended antigen sparing potential of AS03-adjuvanted pandemic H1N1 vaccines in children, and immunological equivalence of two formulations of AS03-adjuvanted H1N1 vaccines: results from two randomised trials.

Xavier Duval
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  • PersonId : 857490
Serge Fitoussi
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  • PersonId : 946322
Wolfgang Jilg
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  • PersonId : 946323
Angkool Kerdpanich
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  • PersonId : 946324
May Montellano
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  • PersonId : 946325
Tino Schwarz
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  • PersonId : 946326
Veerachai Watanveerade
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Gerard Zalcman
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  • PersonId : 946329
Vinod Bambure
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  • PersonId : 946330
Ping Li
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  • PersonId : 946331
Adrian Caplanusi
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  • PersonId : 946332
Anuradha Madan
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  • PersonId : 946333
Paul Gillard
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  • PersonId : 946334
David Vaughn
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  • PersonId : 946335

Abstract

BACKGROUND: Pandemicinfluenza vaccinemanufacturing capacity and distribution agility is enhanced through the availabilityof equivalent antigen-sparing vaccines. We evaluated equivalence in terms of immunogenicity between GlaxoSmithKline Vaccines' A/California/7/2009(H1N1)v-like-AS03 vaccines manufactured in Dresden (D-Pan), and Quebec (Q-Pan). METHODS: In two studies,334 adults 18-60 years of age received 2 doses of D-Pan or Q-Pan containing 3.75 mug haemagglutinin antigen (HA) adjuvanted with AS03Aadministered21 days apart, and 209 children 3-9 years of age received 1reduced dose of D-Panor Q-Pan (0.9 mug HA) or Q-Pan (1.9 mug HA) with AS03B. Haemagglutination inhibition (HI)titres were assessed before and 21 days post-vaccination. HI persistence was assessed after 12 months in adults and 6 months in children. RESULTS: Pre-defined criteria for immunological equivalence of Q-Pan versus D-Pan were achieved in both populations. After one vaccine dose, >=97.6% of adults and children had HI titres >=1:40, with increases in titre>=25.7-fold. CHMP and CBER regulatory acceptance criteria for influenza vaccines were exceeded by all groups in both studies at Day 21. In adults,the percentage with HI titres >=1:40 at Month 12 was 82.9% (Q-Pan) and 84.0% (D-Pan). In children, the percentages at Month 6 were 75.3.3% (Q-Pan0.9), 85.1% (D-Pan0.9) and 79.3% (Q-Pan1.9). Safety profile of the study vaccines was consistent with previously published data. CONCLUSION: Two studies indicate that A/California/7/2009 (H1N1)v-like HA manufactured at two sitesand combined with AS03 are equivalent in terms of immunogenicity in adults and children and highly immunogenic. Different HA doses elicited an adequate immune response through 180 days post-vaccination in children 3-9 years of age.Trial registrationClinicalTrials.gov: NCT00979407 and NCT01161160.
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inserm-00868824 , version 1 (02-10-2013)

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Odile Launay, Xavier Duval, Serge Fitoussi, Wolfgang Jilg, Angkool Kerdpanich, et al.. Extended antigen sparing potential of AS03-adjuvanted pandemic H1N1 vaccines in children, and immunological equivalence of two formulations of AS03-adjuvanted H1N1 vaccines: results from two randomised trials.. BMC Infectious Diseases, 2013, 13 (1), pp.435. ⟨10.1186/1471-2334-13-435⟩. ⟨inserm-00868824⟩
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