Prasert ThongcharoenPrasert AuewarakulYanee HutagalungGary OngPaul GillardMamadou DrameHans L. BockMahidol UniversityGlaxoSmithKline2018-05-032018-05-032011-08-01Journal of the Medical Association of Thailand. Vol.94, No.8 (2011), 916-926012522082-s2.0-79961186873https://repository.li.mahidol.ac.th/handle/20.500.14594/12405Objective: The present study (NCT00449670) in Asian subjects (18-60 years) evaluated the manufacturing consistency of four formulations of 3.75mg AS03 A -adjuvanted H5N1 influenza vaccine, in terms of post-immunization Hemagglutination Inhibition (HI) titers against the A/Vietnam/1194/2004 and A/Indonesia/05/2005 strains. The immunogenicity and safety of the vaccine in the Thai population are reported herein. Material and Method: Subjects were randomized (2:2:2:2:1:1) between four vaccine groups and two control groups to receive two doses of either the AS03 A -adjuvanted or non-adjuvanted H5N1 vaccine formulations, 21 days apart. Sera were assayed for HI antibody titers against the two strains. Results: After the second dose of AS03 A -adjuvanted vaccine, 94.2% subjects in the H5N1-AS03 A groups seroconverted and 94.9% subjects were seroprotected against the A/Vietnam/1194/2004 strain. Cross-clade immune response against the A/Indonesia/05/2005 strain was observed. All vaccine formulations had an acceptable safety profile. Conclusion: This antigen-sparing AS03 A -adjuvanted influenza vaccine could be a suitable candidate for combating and mitigating future influenza pandemics.Mahidol UniversityMedicineArticleSCOPUS