Evidence map›Paper›PMID 38327239›Full record

Trial reportHuman vaccines & immunotherapeutics2024

A phase 4, open-label study to evaluate the safety and immunogenicity of DTaP5-HBV-IPV-Hib in children previously vaccinated with DTaP2-HBV-IPV-Hib or DTaP5-HBV-IPV-Hib (V419-016).

Andrea Guerra, Claudio Costantino, Federico Martinon-Torres, Soeren Westerholt, Courtney Lambeth, Ziqiang Chen, Jessie Lumley, Tomas Marcek, David Johnson, Marissa Wilck

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

Trial report in Human vaccines & immunotherapeutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05289271 (A Phase 4, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of Vaxelis™ in Healthy Children Previously Vaccinated With a 2-Dose Primary Infant Series of Either Vaxelis™ or Hexyon™), 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 22% 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.

NCT05289271 phase4completednot on this map

A Phase 4, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of Vaxelis™ in Healthy Children Previously Vaccinated With a 2-Dose Primary Infant Series of Either Vaxelis™ or Hexyon™

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2022 to 2022Enrolled168ConditionsVaccines, Combined, Hexavalent VaccineArmsVaxelis™
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Harnessing Nanocarriers to Advance Vaccine Development.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
    Review
  2. Infant protection from invasiveHuman vaccines & immunotherapeutics · 2025
    Review
  3. 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

10 authors at 7 institutions in 8 countries.

Andrea GuerraResearch, MSD (UK) Limited, London, UK.
Claudio CostantinoDepartment of Health Promotion Sciences, Maternal and Infant Care, Internal Medicine and Excellence Specialties, University of Palermo, Palermo, Italy.
Federico Martinon-TorresTranslational Pediatrics and Infectious Diseases, Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain.
Soeren WesterholtPediatrics, Praxis für Kinder- und Jugendmedizin, Wolfsburg, Germany.
Courtney LambethResearch, Merck & Co., Inc., Rahway, USA.
Ziqiang ChenResearch, Merck & Co., Inc., Rahway, USA.
Jessie LumleyResearch, Merck & Co., Inc., Rahway, USA.
Tomas MarcekVaccine, MCM Vaccine B.V, Leiden, Netherlands.
David JohnsonVaccine, Sanofi Vaccines, Swiftwater, USA.
Marissa WilckResearch, Merck & Co., Inc., Rahway, USA.ORCID 0000-0002-6890-1118
Merck & Co., Inc., Rahway, NJ, USA (United States) · USKlinik und Poliklinik für Kinder- und Jugendmedizin · DEMSD (UK) Limited (United Kingdom) · GBSanofi (United States) · USTuBerculosis Vaccine Initiative · NLUniversidade de Santiago de Compostela · ESUniversity of Palermo · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

DTaP5-HBV-IPV-Hib (Vaxelis®) is a hexavalent combination vaccine (HV) indicated in infants and toddlers for the prevention of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive disease due to

Indexed as

DiphtheriaHaemophilus influenzae type bHaemophilus VaccinesTetanusWhooping CoughAntibodies, BacterialDiphtheria-Tetanus-Pertussis VaccineHepatitis B VaccinesHepatitis B virusHumansImmunization ScheduleInfantPoliovirus Vaccine, InactivatedVaccines, CombinedAntibodies, BacterialDiphtheria-Tetanus-Pertussis VaccineHaemophilus VaccinesHepatitis B VaccinesPoliovirus Vaccine, InactivatedVaccines, Combinedhexavalent combination vaccineimmunogenicityinterchangeabilitypediatricsafetyV419vaccineVaxelis

Identifiers

PMID38327239
PMCPMC10857551
OpenAlexW4391647514

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.