Study to Evaluate GlaxoSmithKline (GSK) Biologicals’ MenC-TT Vaccine and Hib-MenC-TT Vaccine in Infants - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00135486

Purpose

The purpose of this primary vaccination study is to evaluate the immunogenicity, safety and reactogenicity of three doses of GSK Biologicals' MenC-TT (Neisseria meningitidis group C polysaccharide-tetanus toxoid) vaccine (2 different formulations) and of three doses of GSK Biologicals' Hib-MenC-TT (Haemophilus influenzae type b-MenC-TT) vaccine (2 different formulations) when given to infants in their 3rd, 4th, and 5th months of life. Concomitant vaccines were given to all children to complete the vaccination agenda.

Condition	Intervention	Phase
Meningitis, Haemophilus	Biological: MenC-TT Biological: Hib-MenC-TT	Phase II

MedlinePlus related topics: Meningitis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluate Immunogenicity, Reactogenicity, Safety of GSK Biologicals’ MenC-TT Vaccine (2 Formulations) Given With Infanrix Hexa® + GSK Biologicals’ Hib MenC-TT Vaccine (2 Formulations) Given With Infanrix Penta® to Infants in Mths 3,4,5 of Life

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Prior to dose 1, 1 month (m) post doses 2, 3: antibody levels to SBA-MenC, anti-polysaccharide C (PSC) in all groups

Secondary Outcome Measures:

Prior to dose 1, 1 m post doses 2, 3: anti-PRP
Prior to dose 1, 1 m post dose 3: anti-diphtheria, T, HBs, polio, PT, FHA, PRN
Solicited (days [d] 0–7), unsolicited (up to 30 d) adverse events (AEs) after each dose
Serious adverse events (SAEs)

Estimated Enrollment:	500
Study Start Date:	March 2002

Detailed Description:

Five parallel treatment groups receiving a 3-dose primary vaccination course: MenC-TT vaccine (2 formulations, double-blind) + Infanrix hexa® OR Hib-MenC-TT (2 formulations double-blind) + Infanrix penta® OR Meningitec™ + Infanrix hexa® (control). Three blood samples taken, before dose 1 and one month after dose 2 and dose 3.

Eligibility

Ages Eligible for Study:	8 Weeks to 16 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male or female infants, 8 to 16 weeks of age at the time of the first vaccination.

Exclusion Criteria:

Previous vaccination against OR history of OR exposure since birth to diphtheria, pertussis, tetanus, polio, hepatitis B, Hib and/or meningococcal disease.
Planned administration/administration of a vaccine not foreseen in the study since birth.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
A family history of congenital or hereditary immunodeficiency.
History of any neurologic disorders or seizures, allergic disease or reactions likely to be exacerbated by any component of the vaccine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135486

Locations

Germany
GSK Clinical Trials Call Center
Mainz, Germany

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

Clinical Trials

GlaxoSmithKline

More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Schmitt HJ, Maechler G, Habermehl P, Knuf M, Saenger R, Begg N, Boutriau D. Immunogenicity, reactogenicity, and immune memory after primary vaccination with a novel Haemophilus influenzae-Neisseria meningitidis serogroup C conjugate vaccine. Clin Vaccine Immunol. 2007 Apr;14(4):426-34. Epub 2007 Feb 7.

Study ID Numbers:	711202/001
Study First Received:	August 25, 2005
Last Updated:	November 23, 2006
ClinicalTrials.gov Identifier:	NCT00135486 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by GlaxoSmithKline:

Prophylaxis meningococcal serogroup C disease, Hib diseases
Haemophilus Influenzae type b/Meningococcal vaccine

Study placed in the following topic categories:

Haemophilus Infections
Bacterial Infections
Central Nervous System Infections
Meningitis, Bacterial
Haemophilus Influenzae
Influenza, Human

Central Nervous System Diseases
Fondaparinux
Meningitis, Haemophilus
Org 31540
Gram-Negative Bacterial Infections
Meningitis

Additional relevant MeSH terms:

Haemophilus Infections
Bacterial Infections
Pasteurellaceae Infections
Central Nervous System Infections
Meningitis, Bacterial
Nervous System Diseases

Central Nervous System Bacterial Infections
Central Nervous System Diseases
Meningitis, Haemophilus
Gram-Negative Bacterial Infections
Meningitis

ClinicalTrials.gov processed this record on May 07, 2009