Immunogenicity & Safety Study of a Vaccine Against Meningitis in Infants (2,4,6 Months) After a Hepatitis B Birth Dose. - Tabular View

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Descriptive Information Fields

Brief Title ^†

Immunogenicity & Safety Study of a Vaccine Against Meningitis in Infants (2,4,6 Months) After a Hepatitis B Birth Dose.

Official Title ^†

Study to Show Consistency Hib-MenAC(3 Lots) Mixed With Tritanrix™-HBV, Non-Inferiority of Study Vaccine to Tritanrix™-HBV/Hiberix™ (+/-) Meningitec™ & MenA Response in Infants (2,4,6M) With Hepatitis B Birth Dose

Brief Summary

The purpose of the study is to demonstrate consistent results in 3 production lots of Hib-MenAC vaccine when extemporaneously mixed with Tritanrix™-HepB and administered as a single injection, with respect to immunogenicity, safety and reactogenicity. Tritanrix™-HepB/Hiberix™ given alone and Wyeth Lederle's meningococcal C conjugate vaccine (Meningitec™), given concomitantly with Tritanrix™-HepB/Hiberix™ will be used as benchmark vaccines for all antigens except for MenA. The immunogenicity of MenA will also be evaluated.

Detailed Description

Randomized study with five groups to receive one of the following vaccination regimens after a birth dose of hepatitis B vaccine: One of the 3 lots of GSK Biologicals' Hib-MenAC mixed with GSK Biologicals' Tritanrix™-HBV (3 different groups) GSK Biologicals' Tritanrix™-HBV/Hiberix™ GSK Biologicals' Tritanrix™-HBV/Hiberix™ +Meningitec™

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Post-dose 3, bactericidal titers & antibody levels to meningococcal serogroups A & C; & PRP; & antibody levels to HBs, diphtheria, tetanus & BPT (subset of subjects).

Secondary Outcome Measure ^†

Solicited events (day 0-3); unsolicited events (day 0-30); serious adverse events (entire study). Pre-dose 1, antibody levels to Men(A&C) & PRP; & in some subjects anti-BPT antibody levels Seropositivity/seroprotection/vaccine response & antibody levels

Condition ^†

Diphtheria
Tetanus
Pertussis
Hepatitis B
Hib Disease
Neisseria Meningitidis Serogroup Diseases

Intervention ^†

Biological: DTPw-HBV/Hib-MenAC conjugate vaccine

MEDLINE PMIDs

Links

Booster studies This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

1000

Start Date ^†

August 2004

Completion Date

Eligibility Criteria ^†

Inclusion criteria:

• Healthy infants 56-83 days of age, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks and received a birth dose of hepatitis B vaccine within the first 72 hours of life.

Exclusion criteria:

Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history & physical examination.
Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of study vaccine, or planned administration during the study period with the exception of oral polio vaccine (OPV).
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration (>14 days) of immunosuppressants or other immune-modifying drugs since birth.
Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and/or meningococcal disease.

Gender

Both

Ages

56 Days to 83 Days

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Thailand

Administrative Information Fields

NCT ID ^†

NCT00317161

Organization ID

100480

Secondary IDs ^††

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Director:

GSK Clinical Trials

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

First Received Date ^†

February 15, 2006

Last Updated Date

October 9, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.