J Korean Med Sci.
2018 Mar;33(13):e100. 10.3346/jkms.2018.33.e100.
Safety and Immunogenicity of an Egg-Cultivated Quadrivalent Inactivated Split-virion Influenza Vaccine (GC3110A) in Healthy Korean Children: a Randomized, Double-blinded, Active-controlled Phase III Study
- Affiliations
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- 1Department of Pediatrics, Hanil General Hospital, Seoul, Korea.
- 2Department of Pediatrics, Daejeon St. Mary's Hospital, The Catholic University of Korea, Daejeon, Korea.
- 3Department of Pediatrics, St. Vincent's Hospital, The Catholic University of Korea, Suwon, Korea.
- 4Department of Pediatrics, Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Korea.
- 5Department of Pediatrics, Nowon Eulji Medical Center, Eulji University School of Medicine, Seoul, Korea.
- 6Department of Pediatrics, Yonsei University Wonju College of Medicine, Wonju, Korea.
- 7Department of Pediatrics, Korea Cancer Center Hospital, Seoul, Korea.
- 8Department of Pediatrics, Inha University Hospital, Inha University School of Medicine, Incheon, Korea.
- 9Department of Pediatrics, Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, Korea.
- 10Department of Pediatrics, Chonbuk National University Children's Hospital, Jeonju, Korea.
- 11Department of Pediatrics, Changwon Fatima Hospital, Changwon, Korea.
- 12Department of Pediatrics, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea. kjhan@catholic.ac.kr
- KMID: 2409210
- DOI: http://doi.org/10.3346/jkms.2018.33.e100
Abstract
- BACKGROUND
The frequency with which the 2 B lineages have been found to cocirculate in a season has been on the rise, which has spurred the need for a quadrivalent influenza vaccine (QIV) to protect against both B lineages. The World Health Organization (WHO) recommended that QIV include both B lineages beginning in the 2013-2014 flu season. This study was conducted to evaluate the immunogenicity and safety of an egg-cultivated QIV in healthy Korean children and adolescents aged ≥ 6 months to < 19 years.
METHODS
A total of 528 subjects were randomized 4:1 to receive either a QIV (GC3110A) or a trivalent influenza vaccine. Hemagglutination inhibition antibody responses were assessed 28 days after the last dose. Safety was also evaluated.
RESULTS
The proportion of subjects in the GC3110A group who achieved seroconversion was confirmed to exceed 40% across all age groups. The proportion of subjects aged ≥ 6 months to < 3 years in the GC3110A group who achieved seroprotection failed to meet the Ministry of Food and Drug Safety (MFDS) standard of 70%. Potential causes may include the small number of subjects, as well as the small dosage. However, results pertaining to the other age groups satisfied the MFDS standard. The safety profile was also comparable to that of the control.
CONCLUSION
The new quadrivalent split influenza vaccine may offer broader protection to children and adolescents aged ≥ 3 years to < 19 years of age against both influenza B lineages than the existing trivalent influenza vaccines (Registered at the ClinicalTrials.gov NCT02541253).
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