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 - Tabular View

Tracking Information

First Received Date ^ICMJE

August 10, 2005

Last Updated Date

October 9, 2008

Start Date ^ICMJE

March 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Evaluate antibody responses to Hib and meningococcal serogroups C and Y in 3 different Hib-MenCY-TT formulations and one Hib-MenC-TT formulation as compared to licensed Hib and meningococcal serogroup C conjugate vaccines

Original Primary Outcome Measures ^ICMJE

Evaluate antibody responses to Hib and meningococcal serogroups C an Y in 3 different Hib-MenCY-TT formulations and one Hib-MenC-TT formulation as compared to licensed Hib and meningococcal serogroup C conjugate vaccines.

Change History

Complete list of historical versions of study NCT00129116 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evaluate the safety and reactogenicity of the 3 Hib-MenCY-TT formulations and the Hib-MenC-TT formulation
Evaluate antibody persistence, immune memory, and booster vaccine responses induced by Hib-MenCY-TT and Hib-MenC-TT

Original Secondary Outcome Measures ^ICMJE

Evaluate the safety and reactogenicity of the 3 Hib-MenCY-TT formulations and the Hib-MenC-TT formulation. Evaluate antibody persistence, immune memory, and booster vaccine responses induced by Hib-MenCY-TT and Hib-MenC-TT. Evaluate immune responses to

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

See Detailed Description

Brief 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.

Detailed Description

Primary & booster vaccination study to evaluate the immuno,reacto & safety of 3 diff. formulations of GSKBio'combined Haemophilus influenzae typeb-meningococcal serogroups C & Y-conjugate vaccine & one formulation of GSKBio' Haemophilus influenzae typeb-meningococcal serogroup C conjugate vaccine each given concomitantly With Infanrix penta (DTaP-IPV-HepB vaccine), vs Meningitec meningococcal SerogroupC conj.vaccine) given concomitantly With Infanrix hexa (DTaP-IPV-HepB-Hib vaccine) in infants according a 2-3-4 mth schedule

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Meningococcal Infection
Haemophilus Infection

Intervention ^ICMJE

Biological: Hib-MenCY-TT and Hib-MenC-TT vaccines

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

400

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy infants without major congenital illness, immunosuppression, or chronic disease born at 36 to 42 weeks of gestation, between 6 and 12 weeks of age at enrollment, and vaccinated against hepatitis B at birth.

Exclusion Criteria:

Infants should not have received any investigational drug, vaccine, chronic immunosuppressants, or immunoglobulin or blood products.

Gender

Both

Ages

6 Weeks to 12 Weeks

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium, Germany

Administrative Information

NCT ID ^ICMJE

NCT00129116

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

792014/003, 100381

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP