PMID- 33957854
OWN - NLM
STAT- MEDLINE
DCOM- 20220418
LR  - 20220418
IS  - 2164-554X (Electronic)
IS  - 2164-5515 (Print)
IS  - 2164-5515 (Linking)
VI  - 18
IP  - 1
DP  - 2022 Dec 31
TI  - Immunogenicity and safety of two quadrivalent influenza vaccines in healthy adult 
      and elderly participants in India - A phase III, active-controlled, randomized 
      clinical study.
PG  - 1-10
LID - 10.1080/21645515.2021.1885278 [doi]
AB  - BACKGROUND: This study was conducted to compare the immunogenicity and safety 
      profile of two quadrivalent influenza vaccines (QIVs) in healthy adults 
      (18-60 years) and elderly (>61 years) participants. METHOD: This phase III study 
      was conducted from March 2018 to April 2018 across 12 sites in India. In this 
      randomized, observer-blind, active-controlled study, 480 participants were 
      randomized to receive a single dose of test vaccine (subunit, inactivated 
      influenza vaccine; Influvac(R) Tetra, Abbott) (n = 240) or reference vaccine (split 
      virion, inactivated influenza vaccine; VaxiFlu-4, Zydus Cadilla Healthcare) 
      (n = 240). The primary objective was to describe and compare the immunogenicity 
      of each vaccination group based on hemagglutination inhibition (HI) assay 
      seroprotection and seroconversion rates, and geometric mean fold increase (GMFI) 
      against four vaccine strains in two age groups. Safety and reactogenicity were 
      also compared for the vaccines in both the age groups. RESULTS: The pre- and 
      post-vaccination HI titers for both the vaccines were comparable. The GMFI varied 
      from 4.3 - 22.7 in the test and 3.7-21.6 in the reference vaccine group. The 
      seroprotection rates were >90% for the A-strains and ranged between >43% and <60% 
      for B-strains for both the vaccines. Seroconversion rates varied between 41.4% 
      and 78.8%. Overall, the reported adverse events (AEs) for both the vaccines were 
      <1% and comparable. Reported local and systemic reactions were comparable. 
      CONCLUSION: Influvac(R) Tetra elicited an adequate immune response with a favorable 
      safety profile which was comparable with the reference vaccine. (Clinical trial 
      registry number: CTRI/2018/02/012222).
FAU - Basu, Indraneel
AU  - Basu I
AD  - Department of Medicine, Popular Hospital, Varanasi, Uttar Pradesh, India.
FAU - Agarwal, Manish
AU  - Agarwal M
AD  - Department of Medicine, Medilink Hospital Research Centre, Ahmedabad, Gujrat, 
      India.
FAU - Shah, Viral
AU  - Shah V
AD  - Department of Medicine, Panchshil Hospital, Ahmedabad, Gujarat, India.
FAU - Shukla, Vijay
AU  - Shukla V
AD  - Department of Ear, Nose and Throat, Ajanta Research Centre, Lucknow, Uttar 
      Pradesh, India.
FAU - Naik, Sunil
AU  - Naik S
AD  - Department of Medicine, Rajiv Gandhi Institute of Medical Sciences, Adilabad, 
      Andhra Pradesh, India.
FAU - Supe, Pravin Dinkar
AU  - Supe PD
AD  - Department of Medicine, Supe Heart and Diabetes Hospital and Research Center, 
      Nasik, Maharashtra, India.
FAU - Srivastava, Manoj Kumar
AU  - Srivastava MK
AD  - Department of Medicine, OM Research Centre, Varanasi, Uttar Pradesh, India.
FAU - Giriraja, Kanakapura Vrushabaiah
AU  - Giriraja KV
AD  - Department of General Medicine, Sapthagiri Institute of Medical Science & 
      Research Centre, Bangalore, Karnataka, India.
FAU - Pinjar, Peersab
AU  - Pinjar P
AD  - Department of General Medicine, S.S Institute of Medical Sciences and Research 
      Center, Davangere, Karnataka, India.
FAU - Mishra, Pradeep Kumar
AU  - Mishra PK
AD  - Department of General Medicine, Yashoda Hospital, Secunderabad, Andhra Pradesh, 
      India.
FAU - Joshi, Shishir
AU  - Joshi S
AD  - Department of Medicine, Sahyadri Hospital, Pune, Maharashtra, India.
FAU - Vijayakumar, Ranjit
AU  - Vijayakumar R
AD  - Department of General Medicine, Krishna Rajendra Hospital, Mysuru, Karnataka, 
      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
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210506
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  - Adult
MH  - Aged
MH  - Antibodies, Viral
MH  - Double-Blind Method
MH  - Hemagglutination Inhibition Tests
MH  - Humans
MH  - Immunogenicity, Vaccine
MH  - India
MH  - *Influenza Vaccines/adverse effects
MH  - *Influenza, Human/prevention & control
MH  - Vaccines, Combined
MH  - Vaccines, Inactivated/adverse effects
PMC - PMC8920161
OTO - NOTNLM
OT  - Immunogenicity
OT  - immunosenescence
OT  - quadrivalent influenza vaccine
OT  - reactogenicity
OT  - safety
COIS- Serge van de Witte is an employee of Abbott Healthcare Products B.V. All other 
      authors were the 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- 2021/05/08 06:00
MHDA- 2022/04/19 06:00
PMCR- 2021/05/06
CRDT- 2021/05/07 06:14
PHST- 2021/05/08 06:00 [pubmed]
PHST- 2022/04/19 06:00 [medline]
PHST- 2021/05/07 06:14 [entrez]
PHST- 2021/05/06 00:00 [pmc-release]
AID - 1885278 [pii]
AID - 10.1080/21645515.2021.1885278 [doi]
PST - ppublish
SO  - Hum Vaccin Immunother. 2022 Dec 31;18(1):1-10. doi: 
      10.1080/21645515.2021.1885278. Epub 2021 May 6.