CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,441 enrolled
Drug / intervention
GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine +6 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00289783
NCT00289783Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Multinational Study, Double-blinded for the Immunogenicity and Consistency Evaluation of 3 Hib-MenCY-TT Vaccine Lots and Single-blinded and Controlled for the Evaluation of Safety and Immunogenicity of GSK Biologicals' Haemophilus Influenzae Type b and Neisseria Meningitidis Serogroups C and Y-tetanus Toxoid Conjugate Vaccine Combined (Hib-MenCY-TT) Compared to Monovalent Hib Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.

GlaxoSmithKline·interventional·Posted Feb 10, 2006·Updated Aug 24, 2018

In Brief

A Phase 3 clinical trial evaluating GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine, ActHIB, and 5 other interventions for Haemophilus Influenzae Type b and Neisseria Meningitidis. Completed, enrolled 4,441 participants across 93 sites in 3 countries.

Detailed Summary

This study evaluates the immunogenicity and consistency of 3 Hib-MenCY-TT vaccine lots and the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age. The study will also evaluate the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with M-M-R® II and Varivax® at 12 to 15 months of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHaemophilus Influenzae Type b, Neisseria Meningitidis
CountriesAustralia, Mexico, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 10, 2006
Enrollment StartFeb 22, 2006
Primary CompletionAug 27, 2007
Study CompletionFeb 26, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 20.4 years ago

Interventions

GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccinebiological

3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.

ActHIBbiological

3-dose intramuscular injection at 2, 4 and 6 months of age.

PedvaxHIBbiological

1 booster dose by intramuscular injection at 12 to 15 months of age.

Pediarixbiological

3-dose intramuscular injection at 2, 4 and 6 months of age.

Prevnarbiological

3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.

M-M-R IIbiological

1 booster dose by subcutaneous injection at 12 to 15 months of age.

Varivaxbiological

1 booster dose by subcutaneous injection at 12 to 15 months of age