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

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 on...

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Bibliographic Details
Published in:	Human vaccines & immunotherapeutics Vol. 18; no. 6; p. 2104527
Main Authors:	Kalappanavar, Nijalingappa K., Ghosh, Apurba, Sharma, Monika, Ravichandran, Latha, Choraria, Nirmal, P, Saravanan, Pandey, Madhukar, N, Pradeep, Shah, Prachee, Nair, Sneha, Shaikh, Ashfaque, van de Witte, Serge
Format:	Journal Article
Language:	English
Published:	United States Taylor & Francis 30-11-2022 Taylor & Francis Group
Subjects:	Adolescent Adolescents Antibodies, Viral Child Child, Preschool children hemagglutination Hemagglutination Inhibition Tests HIV Seropositivity Humans immunogenicity Immunogenicity, Vaccine India Infant Influenza Influenza A Virus, H1N1 Subtype Influenza A Virus, H3N2 Subtype Influenza B virus Influenza Vaccines - adverse effects Influenza, Human - prevention & control quadrivalent influenza vaccine reactogenicity Vaccines, Combined - adverse effects Vaccines, Inactivated - adverse effects India influenza children hemagglutination reactogenicity quadrivalent influenza vaccine Adolescents immunogenicity
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Summary:	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
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	2164-5515 2164-554X
DOI:	10.1080/21645515.2022.2104527