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

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: February 15, 2006
Last updated: September 29, 2011
Last verified: September 2011
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.

Condition Intervention Phase
Hib Disease
Hepatitis B
Neisseria Meningitidis Serogroup Diseases
Biological: DTPw-HBV/Hib-MenAC conjugate vaccine
Phase 3

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

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 Measures:
  • 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

Estimated Enrollment: 1000
Study Start Date: August 2004
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™

Ages Eligible for Study:   56 Days to 83 Days   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
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Please refer to this study by its identifier: NCT00317161

GSK Investigational Site
Bangkok, Thailand, 10400
GSK Investigational Site
Khon Kaen, Thailand, 40002
GSK Investigational Site
Songkla, Thailand, 90110
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure Identifier: NCT00317161     History of Changes
Other Study ID Numbers: 100480 
Study First Received: February 15, 2006
Last Updated: September 29, 2011
Health Authority: Thailand: Ministry of Public Health

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Immunologic Factors
Physiological Effects of Drugs processed this record on August 25, 2016