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Study to Determine the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals; Infanrix Hexa at 2, 4 and 6 Months of Age in Healthy Infants

NCT02096263 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 585

Last updated 2019-11-27

Study results available
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Summary

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' Infanrix hexa vaccine when administered to healthy infants as primary vaccination at 2, 4 and 6 months of age, co-administered with Prevnar and Rotarix with a booster dose of GSK Biologicals' Infanrix and Hiberix vaccines at 15-18 months of age.

Conditions

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

Interventions

BIOLOGICAL

Infanrix hexa

3 doses administered intramuscularly in the right thigh.

BIOLOGICAL

Pediarix

3 doses administered intramuscularly in the right thigh

BIOLOGICAL

ActHIB

4 doses administered intramuscularly in the upper left thigh

BIOLOGICAL

Pentacel

4 doses administered intramuscularly in the right thigh

BIOLOGICAL

Engerix-B

2 or 3 doses administered intramuscularly in the upper left thigh

BIOLOGICAL

Infanrix

1 dose administered intramuscularly in the right thigh

BIOLOGICAL

Hiberix

1 dose administered intramuscularly in the left thigh

BIOLOGICAL

Prevnar13

3 doses administered intramuscularly in the lower left thigh

BIOLOGICAL

Rotarix

2 doses administered orally

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-16
Primary Completion
2015-02-06
Completion
2015-11-13

Countries

  • United States

Study Locations

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Diseases
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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 NCT02096263 on ClinicalTrials.gov