title: 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.
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 of age received 2 doses of D-Pan or Q-Pan containing 3.75 μg haemagglutinin antigen (HA) adjuvanted with AS03A administered 21 days apart, and 209 children 3-9 years of age received 1 reduced dose of D-Panor Q-Pan (0.9 μg HA) or Q-Pan (1.9 μg 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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT00979407 and NCT01161160.
authors.affiliation: Inserm, CIC BT505; Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Cochin Broca Hôtel-Dieu, CIC de vaccinologie Cochin Pasteur; Université Paris Descartes, Paris, France. odile.launay@cch.aphp.fr.
authors.forename: Odile
authors.initials: O
authors.lastname: Launay
authors.forename: Xavier
authors.initials: X
authors.lastname: Duval
authors.forename: Serge
authors.initials: S
authors.lastname: Fitoussi
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Jilg
authors.forename: Angkool
authors.initials: A
authors.lastname: Kerdpanich
authors.forename: May
authors.initials: M
authors.lastname: Montellano
authors.forename: Tino F
authors.initials: TF
authors.lastname: Schwarz
authors.forename: Veerachai
authors.initials: V
authors.lastname: Watanveerade
authors.forename: Jürgen J
authors.initials: JJ
authors.lastname: Wenzel
authors.forename: Gerard
authors.initials: G
authors.lastname: Zalcman
authors.forename: Vinod
authors.initials: V
authors.lastname: Bambure
authors.forename: Ping
authors.initials: P
authors.lastname: Li
authors.forename: Adrian
authors.initials: A
authors.lastname: Caplanusi
authors.forename: Anuradha
authors.initials: A
authors.lastname: Madan
authors.forename: Paul
authors.initials: P
authors.lastname: Gillard
authors.forename: David W
authors.initials: DW
authors.lastname: Vaughn
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000276:immunology; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000235:genetics / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000235:genetics / Q000276:immunology*; D007251:Influenza, Human / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007252:Influenza Vaccines
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