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

Tracking Information

First Received Date ^ICMJE

August 8, 2005

Last Updated Date

October 30, 2008

Start Date ^ICMJE

March 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00127855 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evaluate the safety and reactogenicity of the 3 Hib-MenCY-TT formulations
Evaluate antibody persistence and immune memory induced by Hib-MenCY-TT
Evaluate immune responses to co-administered Diptheria, Tetanus and Pertussis-Inactivated Polio Vaccine-Hepatitis B (DTaP-IPV-HepB) and 7-valent pneumococcal vaccines

Original Secondary Outcome Measures ^ICMJE

Evaluate the safety and reactogenicity of the 3 Hib-MenCY-TT formulations. Evaluate antibody persistence and immune memory induced by Hib-MenCY-TT. Evaluate immune responses to co-administered DTaP-IPV-HepB and 7-valent pneumococcal vaccines.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

See Detailed Description

Brief 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.

Detailed Description

Evaluate immuno. (incl. immune memory),reacto & safety of 3 diff. formul. of GSKBio combined Haemophilus influenzae typeb-meningococcal serogroups CY conjugate vaccine given concomitantly with Infanrix®penta DTaP-IPV-HepB vaccine) & Prevenar® (7-valent pneumo. vaccine) vs ActHIB® (Hibvaccine) & Meningitec® (meningococcal serogroupC vaccine) given concomitantly with Infanrix®penta (DTaP-IPV-HepB vaccine) & Prevenar® (7-valent pneumococcal vaccine)in infants according to a 2-4-6 mth schedule

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Haemophilus Infection
Meningococcal Infection

Intervention ^ICMJE

Biological: Hib-MenCY-TT vaccine

Study Arms / Comparison Groups

Publications *

Nolan T, Lambert S, Roberton D, Marshall H, Richmond P, Streeton C, Poolman J, Boutriau D. A novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus-toxoid conjugate vaccine is immunogenic and induces immune memory when co-administered with DTPa-HBV-IPV and conjugate pneumococcal vaccines in infants. Vaccine. 2007 Dec 12;25(51):8487-99. Epub 2007 Oct 25.

* 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 enrolment, 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

Australia

Administrative Information

NCT ID ^ICMJE

NCT00127855

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

792014/001, 792014/002

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