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Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery

NCT02853929 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 551

Last updated 2020-01-14

Study results available
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Summary

The purpose of this study is to assess the immunogenicity and safety of the Infanrix hexa booster dose given at 11-18 months of age to infants who received primary vaccination at 6-14 weeks. All infants in this booster study were born to pregnant women who participated in the study 116945 \[DTPA (BOOSTRIX)-047\] and having received the full primary vaccination series as per protocol requirement in study 201330 \[DTPA (BOOSTRIX)-048.

Conditions

  • Diphtheria
  • Hepatitis B
  • Acellular Pertussis
  • Haemophilus Influenzae Type b
  • Tetanus
  • Poliomyelitis
  • Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines

Interventions

BIOLOGICAL

Infanrix hexa

All subjects will receive Infanrix hexa co-administered with Prevenar13 as a booster dose.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
19 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-19
Primary Completion
2019-03-19
Completion
2019-03-19

Countries

  • Australia
  • Canada
  • Czechia
  • Finland
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02853929 on ClinicalTrials.gov