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

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 Infections Meningococcal Infections	Biological: Hib-MenCY-TT vaccine	Phase II

MedlinePlus related topics:

Flu Memory

ChemIDplus related topics:

Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	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

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:

This study evaluated the safety and immunogenicity of 3 formulations of Hib-MenCY-TT vaccine compared to ActHIB® (a Hib conjugate vaccine licensed in Australia) and Menjugate® (although use of Meningitec® was planned, Menjugate® was actually used due to vaccine availability. Both are MenC vaccines licensed in Australia). All vaccines were administered at 2, 4, and 6 months of age. The non-inferiority of immune responses to Hib and MenC in subjects receiving Hib-MenCY-TT vaccine was compared to the immune responses in recipients of the active control vaccines. In addition, the immunogenicity to MenY in recipients of Hib-MenCY-TT vaccine was summarized. Immune memory was assessed at 11 to 14 months of age via the adminstration of plain polysaccharide PRP and Men ACWY vaccines.

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
	GSK Clinical Trials Call Center
	Victoria, Australia

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	Clinical Trial	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.

Study ID Numbers:	792014/001, 792014/002
First Received:	August 8, 2005
Last Updated:	October 10, 2006
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 October 10, 2008

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