Evidence map›Paper›PMID 26337197›Full record

Trial reportHuman vaccines & immunotherapeutics2016

Safety and reactogenicity of the combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b (DTPa-IPV/Hib) vaccine in healthy Vietnamese toddlers: An open-label, phase III study.

Dang Duc Anh, Olivier Van Der Meeren, Naveen Karkada, Deepak Assudani, Ta-Wen Yu, Htay Htay Han

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01577732 (Safety and Reactogenicity of GlaxoSmithKline Biologicals' DTPa-IPV/Hib), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
0.5field-weighted citation impact, top 35% 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.

NCT01577732 phase3completednot on this map

Safety and Reactogenicity of GlaxoSmithKline Biologicals' DTPa-IPV/Hib (Infanrix-IPV+HibTM) in Healthy Vietnamese Toddlers

TypeinterventionalSponsorGlaxoSmithKlineRan2012 to 2013Enrolled321ConditionsAcellular Pertussis, Haemophilus Influenzae Type b, Tetanus, PoliomyelitisArmsInfanrix-IPV+Hib™
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
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  5. Observational
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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

6 authors at 3 institutions in 3 countries.

Dang Duc Anha National Institute of Hygiene and Epidemiology , Hanoi , Vietnam.
Olivier Van Der Meerenb GSK Vaccines , Wavre , Belgium.
Naveen Karkadac GSK Pharmaceuticals , Bangalore , India.
Deepak Assudanic GSK Pharmaceuticals , Bangalore , India.
Ta-Wen Yud GSK , Singapore.
Htay Htay Hane GSK Vaccines , King of Prussia , PA , USA.
GlaxoSmithKline (India) · INGlaxoSmithKline (Belgium) · BENational Institute Of Hygiene And Epidemiology · VN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The introduction of combination vaccines plays a significant role in increasing vaccine acceptance and widening vaccine coverage. Primary vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenza type b (Hib) diseases has been implemented in Vietnam. In this study we evaluated the safety and reactogenicity of combined diphtheria-tetanus-pertussis-inactivated polio (DTPa-IPV)/Hib vaccine when administered as a booster dose in 300 healthy Vietnamese children <2 years of age (mean age: 15.8 months). During the 4-day follow-up period, pain (31.7%) and redness (27.3%) were the most frequent solicited local symptoms. Pain (2%) was also the most frequent grade 3 local symptom. One subject reported 2 serious adverse events that were not causally related to the study vaccine. DTPa-IPV/Hib conjugate vaccine was well tolerated as a booster dose in healthy Vietnamese children aged <2 years.

Indexed as

Asian PeopleDiphtheria-Tetanus-Pertussis VaccineDrug-Related Side Effects and Adverse ReactionsFemaleHaemophilus VaccinesHealthy VolunteersHumansHyperemiaImmunization, SecondaryInfantMalePainPoliovirus Vaccine, InactivatedVaccines, Conjugatediphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccineDiphtheria-Tetanus-Pertussis VaccineHaemophilus VaccinesPoliovirus Vaccine, InactivatedVaccines, ConjugateDTPaHaemophilus influenzapoliomyelitissafetyvaccinationVietnam

Identifiers

PMID26337197
PMCPMC4964705
OpenAlexW1658079230

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.