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Launay, Odile ; Duval, Xavier ; Fitoussi, Serge ; Jilg, Wolfgang ; Kerdpanich, Angkool ; Montellano, May ; Schwarz, Tino F. ; Watanveerade, Veerachai ; Wenzel, Jürgen J. ; Zalcman, Gerard ; Bambure, Vinod ; Li, Ping ; Caplanusi, Adrian ; Madan, Anuradha ; Gillard, Paul ; Vaughn, David W.

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

Article

Launay, Odile, Duval, Xavier, Fitoussi, Serge, Jilg, Wolfgang, Kerdpanich, Angkool, Montellano, May, Schwarz, Tino F., Watanveerade, Veerachai, Wenzel, Jürgen J. , Zalcman, Gerard, Bambure, Vinod, Li, Ping, Caplanusi, Adrian, Madan, Anuradha, Gillard, Paul and Vaughn, David W. (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. BMC Infectious Diseases 13 (1).

DOI to cite this document: 10.5283/epub.37520


Abstract

Background: Pandemic influenza vaccine manufacturing capacity and distribution agility is enhanced through the availability of 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 ...

Background: Pandemic influenza vaccine manufacturing capacity and distribution agility is enhanced through the availability of 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 mu g haemagglutinin antigen (HA) adjuvanted with AS03(A) administered 21 days apart, and 209 children 3-9 years of age received 1 reduced dose of D-Panor Q-Pan (0.9 mu g HA) or Q-Pan (1.9 mu g HA) with AS03(B). 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 sites and 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.



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Details

Item typeArticle
Journal or Publication TitleBMC Infectious Diseases
PublisherBIOMED CENTRAL LTD
Open Access TypeGold (mit APC - nicht UR)
Place of PublicationLONDON
Volume13
Number of Issue or Book Chapter1
Date2013
Date of publication13 Aug 2018 13:04
InstitutionsMedicine > Lehrstuhl für Medizinische Mikrobiologie und Hygiene
Identification Number
ValueType
10.1186/1471-2334-13-435DOI
KeywordsINFLUENZA VACCINE; AS03 ADJUVANT; IMMUNOGENICITY; SAFETY; ADULTS; AGE; H1N1; Pandemic influenza vaccine; Influenza virus; Children; Adults; Persistence; Immunogenicity; Manufacturing capacity; Antigen dose reduction
Dewey Decimal Classification600 Technology > 610 Medical sciences Medicine
StatusPublished
RefereedYes, this version has been refereed
Created at the University of RegensburgPartially
URN of the UB Regensburgurn:nbn:de:bvb:355-epub-375200
Item ID37520

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