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Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine

NCT00127855 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 409

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 compared to 2 control groups receiving licensed meningococcal serogroup C conjugate vaccine and/or licensed Hib conjugate vaccine administered at 2, 4, and 6 months of age. Antibody persistence and immune responses to polysaccharide vaccine boosters were additionally assessed at 11 to 14 months of age.

Conditions

  • Haemophilus Influenzae Type b
  • Neisseria Meningitidis

Interventions

BIOLOGICAL

Hib-MenCY-TT vaccine (MenHibrix)

Three doses were administered intramuscularly (IM) in left thigh at Months 0,2 and 4 respectively

BIOLOGICAL

Meningitec®

Three doses were administered IM in right lower thigh at Months 0,2 and 4.

BIOLOGICAL

ActHIB®

Three doses were administered IM in left thigh at Months 0,2 and 4.

BIOLOGICAL

Infanrix® Penta

Three doses were administered IM in right upper thigh at Months 0,2 and 4 respectively.

BIOLOGICAL

Prevenar®

Three doses were administered IM in right lower thigh at Months 0,2 and 4 respectively.

BIOLOGICAL

Mencevax® ACWY

One fifth of one dose was administered IM in deltoid region of right arm at Month 10 as booster.

BIOLOGICAL

PRP (Polyribosyl Ribitol Phosphate)

One dose was administered IM in deltoid region of left arm at Month 10 as booster.

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
2004-02-01
Completion
2004-02-12

Countries

  • Australia

Study Locations

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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 NCT00127855 on ClinicalTrials.gov