Evidence map›Paper›PMID 23966556›Full record

Trial reportClinical and vaccine immunology : CVI2013

Randomized, controlled, multicenter study of the immunogenicity and safety of a fully liquid combination diphtheria-tetanus toxoid-five-component acellular pertussis (DTaP5), inactivated poliovirus (IPV), and haemophilus influenzae type b (Hib) vaccine compared with a DTaP3-IPV/Hib vaccine administered at 3, 5, and 12 months of age.

Timo Vesikari, Sven Arne Silfverdal, Florence Boisnard, Stéphane Thomas, Grace Mwawasi, Donna Reynolds

Registry-linked trialOpen access · diamondAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical and vaccine immunology : CVI, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00287092 (A Randomised, Controlled, Double-Blind Study of the Immunogenicity and Safety of PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conjugate Vaccine), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.4field-weighted citation impact, top 21% 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.

NCT00287092 phase3completednot on this map

A Randomised, Controlled, Double-Blind Study of the Immunogenicity and Safety of PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed) Compared To Infanrix®-IPV+Hib When Both Vaccines Are Given to Infants Using a Three Dose Immunisation Schedule ("Nordic Schedule" 3-5-12 Months)

TypeinterventionalSponsorSanofi Pasteur, a Sanofi CompanyRan2006 to 2008Enrolled807ConditionsPertussis, Diphtheria, Tetanus, PoliomyelitisArmsDT5aP-IPV-Hib 5-component Pertussis vaccine, Infanrix® -IPV+Hib
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 10 citations in OpenAlex.

  1. Article
  2. Article
  3. Combination vaccines against diarrheal diseases.Human vaccines & immunotherapeutics · 2015
    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

6 authors at 2 institutions in 3 countries.

Timo VesikariUniversity of Tampere Medical School, Vaccine Research Centre, Tampere, Finland.
Sven Arne Silfverdal
Florence Boisnard
Stéphane Thomas
Grace Mwawasi
Donna Reynolds
Sanofi (Canada) · CAUmeå University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study compared the levels of immunogenicity and safety of diphtheria-tetanus toxoid-five-component acellular pertussis (DTaP(5)), inactivated poliovirus (IPV), and Haemophilus influenzae type b (Hib) (DTaP(5)-IPV-Hib) and DTaP(3)-IPV/Hib vaccines for study participants 3, 5, and 12 months of age. Post-dose 3 noninferiority criteria comparing DTaP(5)-IPV-Hib to DTaP(3)-IPV/Hib using rates of seroprotection were demonstrated against diphtheria, tetanus, and polio types 1 to 3, but not for polyribosylribitol phosphate (PRP). While PRP did not meet noninferiority criteria, the seroprotection rate and geometric mean concentration (GMC) were high, indicating a clinically robust immune response. GMCs or titers for other antigens (including pertussis) and the safety profiles were generally similar between groups. Fully liquid DTaP(5)-IPV-Hib can be administered using the 3-, 5-, and 12-month vaccination schedule. (This study has been registered at ClinicalTrials.gov under registration no. NCT00287092.).

Indexed as

Antibodies, BacterialAntibodies, ViralDiphtheria-Tetanus-Pertussis VaccineDrug-Related Side Effects and Adverse ReactionsFemaleHaemophilus VaccinesHumansInfantMalePoliovirus Vaccine, InactivatedVaccinationVaccines, CombinedAntibodies, BacterialAntibodies, ViralDiphtheria-Tetanus-Pertussis VaccineDTP-IPV-Hib vaccineHaemophilus VaccinesPoliovirus Vaccine, InactivatedVaccines, Combined

Identifiers

PMID23966556
PMCPMC3807208
OpenAlexW1969308586

What OpenQuestion holds

Textmetadata
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.