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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00127855

Purpose

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.

Condition	Intervention	Phase
Haemophilus Infection Meningococcal Infection	Biological: Hib-MenCY-TT vaccine	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	400
Study Start Date:	March 2003

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

Eligibility

Ages Eligible for Study:	6 Weeks to 12 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127855

Locations

Australia, South Australia
GSK Investigational Site
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
GSK Investigational Site
Carlton, Victoria, Australia, 3053
Australia, Western Australia
GSK Investigational Site
Subiaco, Western Australia, Australia, 6018

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Publications indexed to this study:

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.

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	792014/001, 792014/002
Study First Received:	August 8, 2005
Last Updated:	October 30, 2008
ClinicalTrials.gov Identifier:	NCT00127855
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:

Invasive bacterial disease caused by Hib
Neisseria meningitidis serogroups C & Y

Study placed in the following topic categories:

Haemophilus Infections
Bacterial Infections
Haemophilus influenzae
Meningococcal Infections
Influenza, Human

Neisseria meningitidis
Meningococcal infection
Neisseriaceae Infections
Gram-Negative Bacterial Infections

Additional relevant MeSH terms:

Pasteurellaceae Infections
Communicable Diseases
Infection

ClinicalTrials.gov processed this record on January 16, 2009