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

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

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 Infection Haemophilus Infection	Biological: Hib-MenCY-TT and Hib-MenC-TT vaccines	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	See Detailed Description

Resource links provided by NLM:

MedlinePlus related topics: Meningococcal Infections

U.S. FDA Resources

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

Intervention Details:

Other Name: Hib-MenCY-TT and Hib-MenC-TT vaccines

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

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

Belgium
GSK Investigational Site
Asse, Belgium, 1730
GSK Investigational Site
Drongen, Belgium, 9031
GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
Merelbeke, Belgium, 9820
GSK Investigational Site
Oudenaerde, Belgium, 9700
GSK Investigational Site
Sint-Amandsberg, Belgium, 9040
Germany
GSK Investigational Site
Cham, Bayern, Germany, 93413
GSK Investigational Site
Kaufering, Bayern, Germany, 86916
GSK Investigational Site
Muenchen, Bayern, Germany, 81675
GSK Investigational Site
Muenchen, Bayern, Germany, 80939
GSK Investigational Site
Noerdlingen, Bayern, Germany, 86720
GSK Investigational Site
Olching, Bayern, Germany, 82140
GSK Investigational Site
Detmold, Nordrhein-Westfalen, Germany, 32756
GSK Investigational Site
Kirchlengern, Nordrhein-Westfalen, Germany, 32278
GSK Investigational Site
Loehne, Nordrhein-Westfalen, Germany, 32584
GSK Investigational Site
Leipzig, Sachsen, Germany, 04178
GSK Investigational Site
Bredstedt, Schleswig-Holstein, Germany, 25821
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24943
GSK Investigational Site
Berlin, Germany, 10315
GSK Investigational Site
Berlin, Germany, 13355
GSK Investigational Site
Berlin, Germany, 12627
GSK Investigational Site
Berlin, Germany, 14197
GSK Investigational Site
Hamburg, Germany, 22307

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Habermehl P, Leroux-Roels G, Sänger R, Mächler G, Boutriau D. Combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C (HibMenC) or serogroup C and Y-tetanus toxoid conjugate (and HibMenCY) vaccines are well-tolerated and immunogenic when administered according to the 2,3,4 months schedule with a fourth dose at 12-18 months of age. Hum Vaccin. 2010 Aug;6(8):640-51.

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00129116 History of Changes
Other Study ID Numbers:	792014/003, 100381
Study First Received:	August 10, 2005
Last Updated:	October 9, 2008
Health Authority:	Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:

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

Additional relevant MeSH terms:

Haemophilus Infections
Meningococcal Infections
Pasteurellaceae Infections

Gram-Negative Bacterial Infections
Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on February 09, 2012