MedTrace Logo

Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants

NCT01000974 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4003

Last updated 2018-07-12

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate safety, to demonstrate lot-to-lot consistency of the vaccine, to address the relevant concomitant vaccine administrations and to provide a comparison between GSK Biologicals' Hib conjugate vaccine and the licensed monovalent Hib vaccine ActHIB as well as the licensed combination product Pentacel in infants at 2, 4, 6 and 15-18 months of age. This study is designed with a primary and a booster phase.

Conditions

  • Haemophilus Influenzae Type b

Interventions

BIOLOGICAL

GSK Biologicals' Haemophilus influenzae type b vaccine (GSK 208108)

Three doses of 3 different manufacturing lots in primary study at 2, 4 and 6 months of age as intramuscular injection and one dose as booster vaccination.

BIOLOGICAL

ActHIB™

Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination

BIOLOGICAL

Pentacel™

Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection and one dose as a booster vaccination

BIOLOGICAL

Pediarix™

Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection

BIOLOGICAL

Prevnar 13™

Three doses in primary epoch at 2, 4 and 6 months of age as intramuscular injection

BIOLOGICAL

Rotarix™

Two oral doses in primary epoch at 2 and 4 months of age

BIOLOGICAL

Engerix™-B

Two or three doses in primary epoch at 2,( 4) and 6 months of age as intramuscular injection

BIOLOGICAL

Infanrix™

One dose in the booster epoch at 15-18 months of age as intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-06-18
Primary Completion
2011-11-18
Completion
2013-07-17

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01000974 on ClinicalTrials.gov