Immunogenicity, reactogenicity and safety of an inactivated quadrivalent influenza vaccine in children and adolescents 6 months through 17 years of age in India

ABSTRACT

Efficacy and safety data on quadrivalent influenza vaccines (QIVs) for immunization of Indian children are scarce. This phase 3, registration study evaluated the immunogenicity, safety, and tolerability of a QIV in Indian children aged 6–35 months (Group 1) and 3–17 y (Group 2). Subjects received one or two doses (0.5 mL each) of the study vaccine based on their priming status. Immunogenicity (post-vaccination geometric mean fold increase in hemagglutination inhibition [HI] titers and proportion of patients with seroprotection and seroconversion against the four influenza strains), unsolicited adverse events (AEs), and tolerability were analyzed. Among 118 subjects enrolled in each group, the geometric mean(standard deviation) fold increase in HI titers against A(H3N2), A(H1N1), B(Victoria), and B(Yamagata) strains were 31.7(5.33), 10.5(6.06), 4.1(5.70), and 8.6(5.34) in Group 1 and 14.0(4.37), 9.2(4.26), 14.3(6.73), and 14.4(5.41) in Group 2, respectively. Seroprotection was achieved by 91.2%, 83.3%, 41.2%, and 68.4% subjects in Group 1 and 100%, 95.8%, 73.7%, and 89.8% subjects in Group 2, respectively. Seroconversion was achieved by 87.7%, 66.7%, 41.2%, and 64.9% subjects in Group 1 and 89.0%, 78.8%, 69.5%, and 75.4% subjects in Group 2, respectively. Vaccination site pain and fever were the most common local and systemic reactions, respectively. Systemic reactions were more frequent in Group 1 (16.9% vs 7.6%). Most subjects (>90%) did not experience inconvenience within 7 d of vaccination; <10% in both groups reported unsolicited AEs. Thus, the QIV had a positive benefit/risk profile in Indian children/adolescents aged 6 months to 17 y.

CTRI Registry No: CTRI/2018/05/014191

Registry Name: Clinical Trials Registry – India

Date of Trial Registration: May 29, 2018

Study Dates: August 03, 2018 (first subject first visit) to January 31, 2019 (last subject last visit)

Drugs Controller General of India [DCGI] permission letter number: CT-03/2018

KEYWORDS:

• Adolescents
• children
• hemagglutination
• immunogenicity
• influenza
• quadrivalent influenza vaccine
• reactogenicity

Acknowledgments

The authors would like to thank the participating study volunteers, and the research staff at the centers involved in the study. The authors also thank the medical writing team of Data Sciences, Safety, and Regulatory, IQVIA (India) for providing their support in developing this manuscript.

Disclosure statement

Serge van de Witte is an employee of Abbott Healthcare Products B.V. Sneha Nair and Ashfaque Shaikh are employees of Abbott India Ltd. All other authors were investigators in the study and received grant support from Abbott to conduct this study. No other conflict of interest is declared for the work presented in this article.

Author’s contributions

All authors met the International Council of Medical Journal Editors’ criteria for authorship and all those who met those criteria are listed as authors. All authors participated in the design, implementation, analysis, and/or interpretation of the study. All the authors were involved in drafting the manuscript or revising it critically for important intellectual content and provided final approval of the manuscript. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.

Data availability statement

Data that support the findings of this study will be made available upon reasonable request.

Additional information

Funding

This study was funded by Abbott India Ltd. Influvac® Tetra is manufactured by Abbott Biologicals B.V. Abbott was involved in the study design,data collection, data analysis, and preparation of the manuscript.