Evidence map›Paper›PMID 33914729›Full record

Trial reportPLoS medicine2021

Efficacy of live attenuated and inactivated influenza vaccines among children in rural India: A 2-year, randomized, triple-blind, placebo-controlled trial.

Anand Krishnan, Lalit Dar, Siddhartha Saha, Venkatesh Vinayak Narayan, Rakesh Kumar, Ramesh Kumar, Ritvik Amarchand, Shivram Dhakad, Reshmi Chokker, Avinash Choudekar and 8 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PLoS medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 3 pooled it
2.0field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 3 syntheses or guidelines pooled it, 22 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 4 institutions in 2 countries.

Anand KrishnanCentre for Community Medicine, All India Institute of Medical Sciences, Delhi, India.ORCID 0000-0002-9173-7811
Lalit DarMicrobiology Department, All India Institute of Medical Sciences, Delhi, India.
Siddhartha SahaInfluenza Program, Centers for Disease Control and Prevention, New Delhi, India.ORCID 0000-0002-7494-267X
Venkatesh Vinayak NarayanInfluenza Program, Centers for Disease Control and Prevention, New Delhi, India.ORCID 0000-0001-7529-7804
Rakesh KumarCentre for Community Medicine, All India Institute of Medical Sciences, Delhi, India.
Ramesh KumarMicrobiology Department, All India Institute of Medical Sciences, Delhi, India.ORCID 0000-0001-5202-7668
Ritvik AmarchandCentre for Community Medicine, All India Institute of Medical Sciences, Delhi, India.ORCID 0000-0001-8300-3829
Shivram DhakadMicrobiology Department, All India Institute of Medical Sciences, Delhi, India.
Reshmi ChokkerCentre for Community Medicine, All India Institute of Medical Sciences, Delhi, India.
Avinash ChoudekarMicrobiology Department, All India Institute of Medical Sciences, Delhi, India.ORCID 0000-0002-0427-7301
Giridara GopalCentre for Community Medicine, All India Institute of Medical Sciences, Delhi, India.ORCID 0000-0002-2238-6843
Aashish ChoudharyMicrobiology Department, All India Institute of Medical Sciences, Delhi, India.
Varsha PotdarNational Institute of Virology, Pune, India.
Mandeep ChadhaNational Institute of Virology, Pune, India.
Kathryn E LafondInfluenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.ORCID 0000-0001-5018-9591
Stephen LindstromInfluenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
Marc-Alain WiddowsonInfluenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.ORCID 0000-0002-0682-6933
Seema JainInfluenza Division, Centers for Disease Control and Prevention, Atlanta, Georgia, United States of America.
All India Institute of Medical Sciences · INCenters for Disease Control and Prevention · USICMR-National Institute of Virology · INNational Center for Disease Control · IN

Funding

Epidemiological study of Respiratory Pathogens in Acute Respiratory Tract InfectiU01IP000492 · IP · ALL-INDIA INSTITUTE OF MEDICAL SCIENCES · PI KRISHNAN, ANAND · 2011 to 2015
$5.0M
NCIRD CDC HHS U01 IP000492
6 · The paper itself

Abstract

backgroundInfluenza is a cause of febrile acute respiratory infection (FARI) in India; however, few influenza vaccine trials have been conducted in India. We assessed absolute and relative efficacy of live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) among children aged 2 to 10 years in rural India through a randomized, triple-blind, placebo-controlled trial conducted over 2 years. METHODS AND

findingsIn June 2015, children were randomly allocated to LAIV, IIV, intranasal placebo, or inactivated polio vaccine (IPV) in a 2:2:1:1 ratio. In June 2016, vaccination was repeated per original allocation. Overall, 3,041 children received LAIV (n = 1,015), IIV (n = 1,010), nasal placebo (n = 507), or IPV (n = 509). Mean age of children was 6.5 years with 20% aged 9 to 10 years. Through weekly home visits, nasal and throat swabs were collected from children with FARI and tested for influenza virus by polymerase chain reaction. The primary outcome was laboratory-confirmed influenza-associated FARI; vaccine efficacy (VE) was calculated using modified intention-to-treat (mITT) analysis by Cox proportional hazards model (PH) for each year. In Year 1, VE was 40.0% (95% confidence interval (CI) 25.2 to 51.9) for LAIV and 59.0% (95% CI 47.8 to 67.9) for IIV compared with controls; relative efficacy of LAIV compared with IIV was -46.2% (95% CI -88.9 to -13.1). In Year 2, VE was 51.9% (95% CI 42.0 to 60.1) for LAIV and 49.9% (95% CI 39.2 to 58.7) for IIV; relative efficacy of LAIV compared with IIV was 4.2% (95% CI -19.9 to 23.5). No serious adverse vaccine-attributable events were reported. Study limitations include differing dosage requirements for children between nasal and injectable vaccines (single dose of LAIV versus 2 doses of IIV) in Year 1 and the fact that immunogenicity studies were not conducted.

conclusionsIn this study, we found that LAIV and IIV vaccines were safe and moderately efficacious against influenza virus infection among Indian children.

trial registrationClinical Trials Registry of India CTRI/2015/06/005902.

Indexed as

Administration, IntranasalChildChild, PreschoolFemaleHumansIndiaInfluenza, HumanInfluenza VaccinesMaleRural PopulationVaccinationVaccines, AttenuatedVaccines, InactivatedInfluenza VaccinesVaccines, AttenuatedVaccines, Inactivated

Identifiers

PMID33914729
PMCPMC8118535
OpenAlexW3159759495

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.