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3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age

NCT00129116 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 388

Last updated 2018-08-27

Study results available
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Summary

This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine and 1 formulation of Hib-MenC-TT vaccine compared to a control group receiving licensed meningococcal serogroup C conjugate vaccine, each administered at 2, 3, and 4 months of age. Antibody persistence and immune responses to booster vaccinations were additionally assessed at 12 to 18 months of age.

Conditions

  • Haemophilus Influenzae Type b
  • Neisseria Meningitidis

Interventions

BIOLOGICAL

Hib-MenCY-TT vaccine

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.

BIOLOGICAL

Hib-MenC-TT vaccine

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.

BIOLOGICAL

Menjugate ®

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in left thigh.

BIOLOGICAL

Infanrix penta ®

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.

BIOLOGICAL

Infanrix hexa ®

Three doses during the primary vaccination and one booster dose administered intramuscularly (IM) in right thigh.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2003-03-01
Primary Completion
2003-12-01
Completion
2003-12-16

Countries

  • Belgium
  • Germany

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 NCT00129116 on ClinicalTrials.gov