Completed PHASE2 INTERVENTIONAL 5-arm NCT00129116

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

A Phase II, Open (Partially Double-blind), Randomised, Controlled, Multicentre, Primary Vaccination Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Three Different Formulations of GSK Biologicals' Combined Haemophilus Influenzae Type B-meningococcal Serogroups C and Y- Conjugate Vaccine and One Formulation of GSK Biologicals' Haemophilus Influenzae Type B-meningococcal Serogroup C Conjugate Vaccine Each Given Concomitantly With InfanrixTM Penta, Versus MeningitecTM, Given Concomitantly With InfanrixTM Hexa in Infants According to a 2-3-4 Month Schedule

Sponsor: GlaxoSmithKline

Conditions Haemophilus Influenzae Type b Neisseria Meningitidis

Interventions Hib-MenC-TT vaccine Hib-MenCY-TT vaccine Infanrix hexa ® Infanrix penta ® Menjugate ®

Updated 8 times since 2017 Last updated: Jul 26, 2018 Started: Mar 1, 2003 Primary completion: Dec 1, 2003 Completion: Dec 16, 2003

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00129116, this PHASE2 trial focuses on Haemophilus Influenzae Type b and Neisseria Meningitidis and remains completed. Sponsored by GlaxoSmithKline, it has been updated 8 times since 2003, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

Change History

8 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE2
Sep 2024 — Sep 2025 [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Jan 2021 — Jul 2024 [monthly]

Completed PHASE2
Sep 2018 — Jan 2021 [monthly]

Completed PHASE2

▶ Show 3 earlier versions

Jun 2018 — Sep 2018 [monthly]

Completed PHASE2
Feb 2017 — Jun 2018 [monthly]

Completed PHASE2
Jan 2017 — Feb 2017 [monthly]

Completed PHASE2

First recorded

Mar 2003

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

GlaxoSmithKline

Data source: GlaxoSmithKline

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Asse, Belgium , Berlin, Germany , Bredstedt, Germany , Cham, Germany , Detmold, Germany , Drongen, Belgium , Flensburg, Germany , Ghent, Belgium , Hamburg, Germany , Kaufering, Germany and 11 more locations