PMID- 36053721
OWN - NLM
STAT- MEDLINE
DCOM- 20221219
LR  - 20221222
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 18
IP  - 6
DP  - 2022 Nov 30
TI  - Immunogenicity, reactogenicity and safety of an inactivated quadrivalent 
      influenza vaccine in children and adolescents 6 months through 17 years of age in 
      India.
PG  - 2104527
LID - 10.1080/21645515.2022.2104527 [doi]
LID - 2104527
AB  - 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/2018/05/014191Registry Name: Clinical Trials Registry - IndiaDate of Trial 
      Registration: May 29, 2018Study 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.
FAU - Kalappanavar, Nijalingappa K
AU  - Kalappanavar NK
AD  - Department of Pediatrics, S.S Institute of Medical Sciences and Research Center, 
      Davangere, India.
FAU - Ghosh, Apurba
AU  - Ghosh A
AD  - Department of Pediatrics, Institute of Child Health, Kolkata, India.
FAU - Sharma, Monika
AU  - Sharma M
AD  - Department of Pediatric Medicine, Christian Medical College & Hospital, Ludhiana, 
      India.
FAU - Ravichandran, Latha
AU  - Ravichandran L
AD  - Department of Pediatric Medicine, Sri Ramachandra Hospital, Chennai, India.
FAU - Choraria, Nirmal
AU  - Choraria N
AD  - Department of Pediatrics, Nirmal Hospital Pvt. Ltd, Surat, India.
FAU - P, Saravanan
AU  - P S
AD  - Department of Paediatrics, Sapthagiri Institute of Medical Sciences & Research 
      Centre, Bangalore, India.
FAU - Pandey, Madhukar
AU  - Pandey M
AD  - Department of Pediatrics, Oriana Hospital, Varanasi, India.
FAU - N, Pradeep
AU  - N P
AD  - Department of Immunology, Cheluvamba Hospital, Opposite Mysore Medical College 
      and Research Institute, Mysore, India.
FAU - Shah, Prachee
AU  - Shah P
AD  - Department of Pediatrics, Panchshil Hospital, Ahmedabad, India.
FAU - Nair, Sneha
AU  - Nair S
AD  - Established Pharmaceuticals Division, Abbott India Ltd, Mumbai, India.
FAU - Shaikh, Ashfaque
AU  - Shaikh A
AD  - Established Pharmaceuticals Division, Abbott India Ltd, Mumbai, India.
FAU - van de Witte, Serge
AU  - van de Witte S
AD  - Established Pharmaceuticals Division, Abbott Healthcare Products B.V., Weesp, The 
      Netherlands.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
DEP - 20220902
PL  - United States
TA  - Hum Vaccin Immunother
JT  - Human vaccines & immunotherapeutics
JID - 101572652
RN  - 0 (Antibodies, Viral)
RN  - 0 (Influenza Vaccines)
RN  - 0 (Vaccines, Combined)
RN  - 0 (Vaccines, Inactivated)
SB  - IM
MH  - Adolescent
MH  - Child
MH  - Humans
MH  - Infant
MH  - Antibodies, Viral
MH  - Hemagglutination Inhibition Tests
MH  - HIV Seropositivity
MH  - Immunogenicity, Vaccine
MH  - Influenza A Virus, H1N1 Subtype
MH  - Influenza A Virus, H3N2 Subtype
MH  - Influenza B virus
MH  - *Influenza Vaccines/adverse effects
MH  - *Influenza, Human/prevention & control
MH  - Vaccines, Combined/adverse effects
MH  - Vaccines, Inactivated/adverse effects
MH  - Child, Preschool
MH  - India
PMC - PMC9746468
OTO - NOTNLM
OT  - Adolescents
OT  - children
OT  - hemagglutination
OT  - immunogenicity
OT  - influenza
OT  - quadrivalent influenza vaccine
OT  - reactogenicity
COIS- 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.
EDAT- 2022/09/03 06:00
MHDA- 2022/12/15 06:00
PMCR- 2022/09/02
CRDT- 2022/09/02 12:12
PHST- 2022/09/03 06:00 [pubmed]
PHST- 2022/12/15 06:00 [medline]
PHST- 2022/09/02 12:12 [entrez]
PHST- 2022/09/02 00:00 [pmc-release]
AID - 2104527 [pii]
AID - 10.1080/21645515.2022.2104527 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2022 Nov 30;18(6):2104527. doi: 
      10.1080/21645515.2022.2104527. Epub 2022 Sep 2.