Tags

Type your tag names separated by a space and hit enter

Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccines in participants >/=3 years of age: a double-blind, randomized, parallel-controlled phase III clinical trial in China.
Expert Rev Vaccines. 2017 11; 16(11):1155-1169.ER

Abstract

BACKGROUND

Viruses from two antigenically distinct influenza B strains have co-circulated since the mid-1980s, yet inactivated trivalent influenza vaccines (TIVs) with either the Victoria or Yamagata lineage could only provide limited protection from influenza B strain. Quadrivalent influenza vaccine (QIV) including both influenza B lineages can improve protection against circulating influenza B viruses.

METHODS

Participants >/ = 3 years of age were recruited, stratified by age, and then randomly allocated at a ratio of 2:1:1 to receive one-injection of the experimental QIV, TIV-Victoria (Vic) or TIV-Yamagata (Yam). The primary objective of this study was to demonstrate that the hemagglutination-inhibition (HI) antibodies induced by the QIV candidate are not inferior to the licensed TIVs.

RESULTS

First, 3661 participants received the inoculation. The QIV was found to be non-inferior to TIVs in terms of the geometric mean titers (GMTs) and seroconversion rates (SCRs) of the HI antibodies against shared strains 28 days after completion of inoculation, and was superior to the TIVs against the alternate B strain, which is absent from the TIVs. The occurrences of adverse events (AEs) post-vaccination were similar across the treatment groups.

CONCLUSION

The experimental QIV showed good immunogenicity and an acceptable safety profile.

Authors+Show Affiliations

a Department of Public Health , Southeast University , Nanjing , PR China.b Department of Respiratory Virus Vaccine , National Institutes for Food and Drug Control , Beijing , PR China.c Vaccine Clinical Evaluation Department , Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , PR China.d Corporate Representative , Jiangsu GDK Biotechnology Co., Ltd , Taizhou , PR China.c Vaccine Clinical Evaluation Department , Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , PR China.c Vaccine Clinical Evaluation Department , Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , PR China.c Vaccine Clinical Evaluation Department , Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , PR China.c Vaccine Clinical Evaluation Department , Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , PR China.a Department of Public Health , Southeast University , Nanjing , PR China.a Department of Public Health , Southeast University , Nanjing , PR China.a Department of Public Health , Southeast University , Nanjing , PR China.d Corporate Representative , Jiangsu GDK Biotechnology Co., Ltd , Taizhou , PR China.

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

28870140

Citation

Wang, Shi-Yuan, et al. "Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine Candidate Versus Inactivated Trivalent Influenza Vaccines in Participants >/=3 Years of Age: a Double-blind, Randomized, Parallel-controlled Phase III Clinical Trial in China." Expert Review of Vaccines, vol. 16, no. 11, 2017, pp. 1155-1169.
Wang SY, Liu SZ, Chu K, et al. Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccines in participants >/=3 years of age: a double-blind, randomized, parallel-controlled phase III clinical trial in China. Expert Rev Vaccines. 2017;16(11):1155-1169.
Wang, S. Y., Liu, S. Z., Chu, K., Zhao, Y., Zhu, F. C., Hu, Y. M., Meng, F. Y., Li, J. X., Luo, L., Yang, J. Y., Liu, P., & Yu, J. (2017). Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccines in participants >/=3 years of age: a double-blind, randomized, parallel-controlled phase III clinical trial in China. Expert Review of Vaccines, 16(11), 1155-1169. https://doi.org/10.1080/14760584.2017.1374181
Wang SY, et al. Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine Candidate Versus Inactivated Trivalent Influenza Vaccines in Participants >/=3 Years of Age: a Double-blind, Randomized, Parallel-controlled Phase III Clinical Trial in China. Expert Rev Vaccines. 2017;16(11):1155-1169. PubMed PMID: 28870140.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccines in participants >/=3 years of age: a double-blind, randomized, parallel-controlled phase III clinical trial in China. AU - Wang,Shi-Yuan, AU - Liu,Shu-Zhen, AU - Chu,Kai, AU - Zhao,Yue, AU - Zhu,Feng-Cai, AU - Hu,Yue-Mei, AU - Meng,Fan-Yue, AU - Li,Jing-Xin, AU - Luo,Li, AU - Yang,Jia-Ying, AU - Liu,Pei, AU - Yu,Jun, Y1 - 2017/09/18/ PY - 2017/9/6/pubmed PY - 2018/5/31/medline PY - 2017/9/6/entrez KW - Quadrivalent influenza vaccine KW - Victoria lineage KW - Yamagata lineage KW - clinical trial KW - immunogenicity KW - safety KW - seasonal influenza SP - 1155 EP - 1169 JF - Expert review of vaccines JO - Expert Rev Vaccines VL - 16 IS - 11 N2 - BACKGROUND: Viruses from two antigenically distinct influenza B strains have co-circulated since the mid-1980s, yet inactivated trivalent influenza vaccines (TIVs) with either the Victoria or Yamagata lineage could only provide limited protection from influenza B strain. Quadrivalent influenza vaccine (QIV) including both influenza B lineages can improve protection against circulating influenza B viruses. METHODS: Participants >/ = 3 years of age were recruited, stratified by age, and then randomly allocated at a ratio of 2:1:1 to receive one-injection of the experimental QIV, TIV-Victoria (Vic) or TIV-Yamagata (Yam). The primary objective of this study was to demonstrate that the hemagglutination-inhibition (HI) antibodies induced by the QIV candidate are not inferior to the licensed TIVs. RESULTS: First, 3661 participants received the inoculation. The QIV was found to be non-inferior to TIVs in terms of the geometric mean titers (GMTs) and seroconversion rates (SCRs) of the HI antibodies against shared strains 28 days after completion of inoculation, and was superior to the TIVs against the alternate B strain, which is absent from the TIVs. The occurrences of adverse events (AEs) post-vaccination were similar across the treatment groups. CONCLUSION: The experimental QIV showed good immunogenicity and an acceptable safety profile. SN - 1744-8395 UR - https://www.unboundmedicine.com/medline/citation/28870140/Immunogenicity_and_safety_of_an_inactivated_quadrivalent_influenza_vaccine_candidate_versus_inactivated_trivalent_influenza_vaccines_in_participants_>/=3_years_of_age:_a_double_blind_randomized_parallel_controlled_phase_III_clinical_trial_in_China_ L2 - http://www.tandfonline.com/doi/full/10.1080/14760584.2017.1374181 DB - PRIME DP - Unbound Medicine ER -