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 - Full Text View

Purpose

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.

Condition	Intervention	Phase
Meningococcal Infections Haemophilus Infections	Biological: Hib-MenCY-TT and Hib-MenC-TT vaccines	Phase II

MedlinePlus related topics:

Flu

ChemIDplus related topics:

Infanrix hexa

U.S. FDA Resources

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

Official Title:	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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

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 and 1 formulation of Hib-MenC-TT vaccine compared to Infanrix hexa® (a pediatric combination vaccine containing a Hib conjugate antigen licensed in Belgium and Germany) and Menjugate® (although use of Meningitec® was planned, Menjugate® was actually used due to vaccine availability. Both are MenC vaccines licensed in Belgium and Germany). All vaccines were administered at 2, 3, 4, and 12 to 18 months of age. The non-inferiority of immune responses and antibody persistence 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.

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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129116

Locations


Germany

	Munich, Germany

Sponsors and Collaborators

GlaxoSmithKline

Investigators


Study Director:	Clinical Trials	GlaxoSmithKline

More Information

Study ID Numbers:	792014/003, 100381
First Received:	August 10, 2005
Last Updated:	October 10, 2006
ClinicalTrials.gov Identifier:	NCT00129116
Health Authority:	Germany: Paul-Ehrlich-Institut

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 September 23, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00129116