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AS03(A)-Adjuvanted influenza A (H1N1) 2009 vaccine for adults up to 85 years of age.
Clin Infect Dis. 2010 Sep 15; 51(6):668-77.CI

Abstract

BACKGROUND

Vaccination of high-risk groups was started shortly after the emergence of the influenza A (H1N1)2009 pandemic virus.

METHODS

Healthy adults were enrolled into 2 age strata: 18-60 years and 160 years, and received monovalent influenza vaccine containing 3.75 microg of A/California/2009 (H1N1) hemagglutinin antigen, adjuvanted with AS03A. Hemagglutination inhibition assay-based antibody titers against H1N1 vaccine were assessed after 1 vaccine dose(primary endpoint), after which subjects were randomized 1:1 to receive no further vaccination or a second dose.Immunogenicity endpoints were European licensure criteria for influenza vaccines. Exploratory analyses assessed the effect of previous seasonal influenza vaccination on responses to the H1N1 vaccine.

RESULTS

Licensure criteria for immunogenicity were fulfilled after 1 dose of H1N1 vaccine (N=240). For subjects 18-60 years of age, previous vaccination against seasonal influenza within the preceding 2 seasons resulted in significantly lower geometric mean titers (adjusted for baseline antibody titer) after 1 or 2 doses of H1N1 vaccine (P <.001 and P=.003, respectively). Transient mild or moderate injection-site pain was reported by 87.5%and 65.0% of subjects 18-60 years of age and >60 years of age, respectively, after the first dose, and in 63% of subjects overall after the second dose.

CONCLUSIONS

A single dose of 3.75 microg hemagglutinin antigen, AS03A-adjuvanted H1N1 2009 vaccine was immunogenic and well tolerated in adults. In exploratory analyses (of subjects 18-60 years of age), postvaccination antibody titers were lower in subjects who had previously received seasonal influenza vaccination, compared with those who had not. This phenomenon warrants further investigation.

CLINICAL TRIALS REGISTRATION

NCT00968526.

Authors+Show Affiliations

GlaxoSmithKline Biologicals, Wavre.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

20687838

Citation

Roman, François, et al. "AS03(A)-Adjuvanted Influenza a (H1N1) 2009 Vaccine for Adults Up to 85 Years of Age." Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, vol. 51, no. 6, 2010, pp. 668-77.
Roman F, Vaman T, Kafeja F, et al. AS03(A)-Adjuvanted influenza A (H1N1) 2009 vaccine for adults up to 85 years of age. Clin Infect Dis. 2010;51(6):668-77.
Roman, F., Vaman, T., Kafeja, F., Hanon, E., & Van Damme, P. (2010). AS03(A)-Adjuvanted influenza A (H1N1) 2009 vaccine for adults up to 85 years of age. Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, 51(6), 668-77. https://doi.org/10.1086/655830
Roman F, et al. AS03(A)-Adjuvanted Influenza a (H1N1) 2009 Vaccine for Adults Up to 85 Years of Age. Clin Infect Dis. 2010 Sep 15;51(6):668-77. PubMed PMID: 20687838.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - AS03(A)-Adjuvanted influenza A (H1N1) 2009 vaccine for adults up to 85 years of age. AU - Roman,François, AU - Vaman,Tejaswini, AU - Kafeja,Froukje, AU - Hanon,Emmanuel, AU - Van Damme,Pierre, PY - 2010/8/7/entrez PY - 2010/8/7/pubmed PY - 2010/12/14/medline SP - 668 EP - 77 JF - Clinical infectious diseases : an official publication of the Infectious Diseases Society of America JO - Clin Infect Dis VL - 51 IS - 6 N2 - BACKGROUND: Vaccination of high-risk groups was started shortly after the emergence of the influenza A (H1N1)2009 pandemic virus. METHODS: Healthy adults were enrolled into 2 age strata: 18-60 years and 160 years, and received monovalent influenza vaccine containing 3.75 microg of A/California/2009 (H1N1) hemagglutinin antigen, adjuvanted with AS03A. Hemagglutination inhibition assay-based antibody titers against H1N1 vaccine were assessed after 1 vaccine dose(primary endpoint), after which subjects were randomized 1:1 to receive no further vaccination or a second dose.Immunogenicity endpoints were European licensure criteria for influenza vaccines. Exploratory analyses assessed the effect of previous seasonal influenza vaccination on responses to the H1N1 vaccine. RESULTS: Licensure criteria for immunogenicity were fulfilled after 1 dose of H1N1 vaccine (N=240). For subjects 18-60 years of age, previous vaccination against seasonal influenza within the preceding 2 seasons resulted in significantly lower geometric mean titers (adjusted for baseline antibody titer) after 1 or 2 doses of H1N1 vaccine (P <.001 and P=.003, respectively). Transient mild or moderate injection-site pain was reported by 87.5%and 65.0% of subjects 18-60 years of age and >60 years of age, respectively, after the first dose, and in 63% of subjects overall after the second dose. CONCLUSIONS: A single dose of 3.75 microg hemagglutinin antigen, AS03A-adjuvanted H1N1 2009 vaccine was immunogenic and well tolerated in adults. In exploratory analyses (of subjects 18-60 years of age), postvaccination antibody titers were lower in subjects who had previously received seasonal influenza vaccination, compared with those who had not. This phenomenon warrants further investigation. CLINICAL TRIALS REGISTRATION: NCT00968526. SN - 1537-6591 UR - https://www.unboundmedicine.com/medline/citation/20687838/AS03_A__Adjuvanted_influenza_A__H1N1__2009_vaccine_for_adults_up_to_85_years_of_age_ L2 - https://academic.oup.com/cid/article-lookup/doi/10.1086/655830 DB - PRIME DP - Unbound Medicine ER -