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Primary & Booster Study in Infants to Demonstrate Non-inferiority, Persistence & Immunogenicity of Hib-MenC Vaccine

NCT00327184 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 709

Last updated 2016-10-07

No results posted yet for this study

Summary

The purpose of this primary vaccination phase is to demonstrate the non-inferiority of two doses of Biologicals' Hib-MenC conjugate vaccine when given with Infanrix™ penta to infants (at 3 \& 5m) compared to NeisVac-C™ given with Infanrix™ hexa.

The purpose of the booster vaccination phase is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of the Hib-MenC vaccine given with Infanrix™ penta at 11 m of age versus NeisVac-C™ given with Infanrix™ hexa, as well as the antibody persistence prior to the administration of the booster doses. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

  • Neisseria Meningitidis
  • Haemophilus Influenzae Type b

Interventions

BIOLOGICAL

Haemophilus influenzae type b- and meningococcal serogroup C (vaccine)

Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.

BIOLOGICAL

Infanrix Penta

Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.

BIOLOGICAL

Infanrix hexa

Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age

BIOLOGICAL

Neis-Vac-C

Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age

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
2006-04-30
Primary Completion
2006-11-30
Completion
2006-11-30

Countries

  • Finland
  • Italy

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 NCT00327184 on ClinicalTrials.gov