Evidence map›Paper›PMID 29573143›Full record

Trial reportInfluenza and other respiratory viruses2018

The safety and efficacy of quadrivalent live attenuated influenza vaccine in Japanese children aged 2-18 years: Results of two phase 3 studies.

Raburn M Mallory, Jing Yu, Sachiko Kameo, Michio Tanaka, Ki Rito, Yohji Itoh, Filip Dubovsky

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Influenza and other respiratory viruses, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05494047 (A Phase III, Randomized, Double-blind and Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Influenza Vaccine, Inactivated, Quadrivalent Developed by Sinovac Biotech Co., Ltd. Compared to a Licensed Quadrivalent Influenza Vaccine, VaxigripTetra™, in Individuals Aged 3 Years and Older in Chile), which is not on this map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
1.0field-weighted citation impact, top 24% 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.

NCT05494047 phase3unknown statusnot on this mapstarted 2022, after this paper: background citation

A Phase III, Randomized, Double-blind and Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Influenza Vaccine, Inactivated, Quadrivalent Developed by Sinovac Biotech Co., Ltd. Compared to a Licensed Quadrivalent Influenza Vaccine, VaxigripTetra™, in Individuals Aged 3 Years and Older in Chile

TypeinterventionalSponsorPontificia Universidad Catolica de ChileRan2022 to 2023Enrolled1,600ConditionsInfluenza, VaccinesArmsTetravalent influenza vaccine developed by Sinovac Biotech Co.
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 2 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. [Efficacy and safety of pediatric flu vaccination: a systematic review].Revista espanola de quimioterapia : publicacion oficial de la Sociedad Espanola de Quimioterapia · 2024
    Pooled it
  3. Trial
  4. Article
  5. Review
  6. Live Attenuated Cold-Adapted Influenza Vaccines.Cold Spring Harbor perspectives in medicine · 2021
    Review
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

7 authors at 1 institution in 1 country.

Raburn M MalloryMedImmune, Gaithersburg, MD, USA.ORCID 0000-0002-2563-9981
Jing YuMedImmune, Gaithersburg, MD, USA.
Sachiko KameoAstraZeneca Japan, Osaka, Japan.
Michio TanakaAstraZeneca Japan, Osaka, Japan.
Ki RitoFormerly of AstraZeneca Japan, Tokyo, Japan.
Yohji ItohAstraZeneca Japan, Osaka, Japan.
Filip DubovskyMedImmune, Gaithersburg, MD, USA.
AstraZeneca (Japan) · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundQuadrivalent live attenuated influenza vaccine (Q/LAIV) has not been assessed in Japanese children.

objectivesEvaluate safety and efficacy of Q/LAIV in Japanese children. PATIENTS/

methodsTwo phase 3 studies were conducted in the 2014-2015 influenza season. Study 1 was an open-label, uncontrolled single arm, multicenter study of Q/LAIV safety in subjects aged 2-6 years. Study 2 was a randomized, double-blind, placebo-controlled multicenter study of Q/LAIV safety and efficacy; subjects aged 7-18 years were randomized 2:1 to receive Q/LAIV or placebo. Primary efficacy endpoint was laboratory-confirmed symptomatic influenza infection caused by vaccine-matched strains; secondary endpoint evaluated efficacy against all strains regardless of match. Both studies reported solicited symptoms, adverse events (AEs), and serious AEs.

resultsIn Study 1, 100 subjects received Q/LAIV. In Study 2, 1301 subjects received Q/LAIV (n = 868) or placebo (n = 433). Treatment-emergent AEs occurred in 42% of subjects in Study 1, and in 24.3% of subjects in the Q/LAIV arm and in 25.9% of subjects in the placebo arm in Study 2. In Study 2, a single infection by a vaccine-matched strain was reported in the placebo arm, resulting in a vaccine efficacy estimate of 100% (95% CI: -1875.3, 100.0); efficacy for all strains regardless of match to the vaccine was 27.5% (95% CI: 7.4, 43.0).

conclusionsQuadrivalent live attenuated influenza vaccine did not meet its primary efficacy endpoint as only a single infection by a vaccine-matched strain was detected; however, efficacy for the secondary endpoint, all strains regardless of match, was achieved. Q/LAIV was generally well tolerated in the Japanese pediatric population.

Indexed as

AdolescentChildChild, PreschoolDouble-Blind MethodFemaleHumansInfluenza, HumanInfluenza VaccinesJapanMaleInfluenza VaccinesJapanLAIVpediatricseasonal influenza

Identifiers

PMID29573143
PMCPMC6005581
OpenAlexW2794060446

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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.