Evidence map›Paper›PMID 28183326›Full record

Trial reportTrials2017

The immune response to 6-monthly versus annual standard dose inactivated trivalent influenza vaccination in older people: study protocol for a randomised clinical trial.

Barnaby Young, Sapna Sadarangani, Haur Sen Yew, Chee Fu Yung, Yee Sin Leo, Mark I-Cheng Chen, Annelies Wilder-Smith

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IVComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02655874 (A Single-centre, Randomised, Observer-blind, Active Comparator-controlled, Superiority Trial of the Immune Response to Six-monthly Versus Annual Standard Dose Inactivated Trivalent Influenza Vaccination in the Elderly), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 33% 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.

NCT02655874 phase4completednot on this map

A Single-centre, Randomised, Observer-blind, Active Comparator-controlled, Superiority Trial of the Immune Response to Six-monthly Versus Annual Standard Dose Inactivated Trivalent Influenza Vaccination in the Elderly

TypeinterventionalSponsorTan Tock Seng HospitalRan2016 to 2017Enrolled200ConditionsInfluenza, HumanArmsInfluenza vaccine, Tetanus-diphtheria-pertussis vaccine
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
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 4 institutions in 1 country.

Barnaby YoungInstitute of Infectious Diseases and Epidemiology (IIDE), Tan Tock Seng Hospital, 11 Jalan, Singapore, 308433, Singapore. Barnaby_young@ttsh.com.sg.ORCID 0000-0003-1010-2230
Sapna SadaranganiInstitute of Infectious Diseases and Epidemiology (IIDE), Tan Tock Seng Hospital, 11 Jalan, Singapore, 308433, Singapore.
Haur Sen YewInstitute of Infectious Diseases and Epidemiology (IIDE), Tan Tock Seng Hospital, 11 Jalan, Singapore, 308433, Singapore.
Chee Fu YungInfectious Diseases Service, KK Women's and Children's Hospital, 100 Bukit Timah Road, Singapore, 229899, Singapore.
Yee Sin LeoInstitute of Infectious Diseases and Epidemiology (IIDE), Tan Tock Seng Hospital, 11 Jalan, Singapore, 308433, Singapore.
Mark I-Cheng ChenInstitute of Infectious Diseases and Epidemiology (IIDE), Tan Tock Seng Hospital, 11 Jalan, Singapore, 308433, Singapore.
Annelies Wilder-SmithInstitute of Infectious Diseases and Epidemiology (IIDE), Tan Tock Seng Hospital, 11 Jalan, Singapore, 308433, Singapore.
Nanyang Technological University · SGNational University of Singapore · SGKK Women's and Children's Hospital · SGTan Tock Seng Hospital · SG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe seasonal influenza vaccine is less effective in older people and a single dose is unlikely to provide the year-round protection necessary for tropical climates which have year-round influenza virus activity. This study aims to assess the effect of a trivalent inactivated influenza vaccine (IIV3) booster at 180 days on haemagglutination-inhibition (HI) antibody titres for each of the influenza strains present in the administered vaccine in older people aged 65 years or above in Singapore. METHODS/

designThis is a single-centre, randomised, observer-blind, active-comparator controlled, parallel-group, phase IV trial in 200 adults aged 65 years or older. Study participants will be assigned to one of two groups in a 1:1 ratio and followed for 1 year, with five scheduled visits. The control group will receive IIV3 at day 1, and an active comparator (Tetanus-diphtheria-pertussis vaccine) at day 180. Participants in the experimental group will receive IIV3 containing the same strains at day 1 and day 180. Endpoints are immunological, and include measures of HI titres, microneutralisation titres (MN) and cell-mediated immunity from first vaccination up to day 360. DISCUSSION: If superiority of 6-monthly influenza vaccination is demonstrated, this study could form the basis for a larger clinical trial with influenza infection as the primary endpoint.

trial registrationClinicalTrials.gov, ID: NCT02655874 . Registered on 12 January 2016.

Indexed as

Immunization ScheduleImmunogenicity, VaccineVaccinationAgedAge FactorsAntibodies, ViralClinical ProtocolsFemaleHemagglutination Inhibition TestsHumansImmunity, CellularInfluenza, HumanInfluenza VaccinesMaleResearch DesignSingaporeAntibodies, ViralInfluenza VaccinesAntibody persistenceHaemagglutination inhibitionInfluenzaOlder peopleTropicsVaccine

Identifiers

PMID28183326
PMCPMC5301431
OpenAlexW2587237386

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.