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Assess Immune Response Following Primary Vaccination With Tritanrix™-HepB Vaccine Mixed With 3 Formulations of Hib-MenAC Vaccine to Infants

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00291967
First received: February 14, 2006
Last updated: December 7, 2006
Last verified: December 2006
History of Changes
  Purpose

To compare three formulations of Hib-MenAC vaccines mixed with Tritanrix™-HepB vaccine with that of Tritanrix™-HepB vaccine concomitantly administered with GSK Biologicals’ Hiberix™ vaccine and Tritanrix™-HepB vaccine mixed with Hiberix™ vaccine and concomitantly administered with Wyeth Lederle’s meningococcal C conjugate vaccine (Meningitec™), with respect to antibody response to vaccine antigens (meningococcal serogroups A and C and PRP) after a three-dose primary vaccination course.


Condition Intervention Phase
Diphtheria
Tetanus
Pertussis
Hepatitis B
Hib Diseases
Neisseria Meningitidis Serogroups A & C Diseases
 Biological: DTPw-HBV/Hib-MenAC conjugate vaccine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluate the Feasibility of GSK Biologicals’ Tritanrix™-HepB/Hib-MenAC Vaccine Administered as a 3 Dose Primary Vaccination Course at 6, 10 & 14 Weeks of Age

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • One month after the third dose of the primary vaccination course, measurement of serum bactericidal titers against meningococcal serogroups A and C (SBA-MenA; SBA-MenC) and anti-PRP antibody concentration.

Secondary Outcome Measures:
  • Immunogenicity: Before the first dose, antibody concentrations or titres against vaccine antigens (MenA, MenC, PRP, pertussis)
  • One month after the third dose, antibody concentrations or titres against all vaccine antigens
  • Reactogenicity & safety: after each dose: solicited (d 0-7, local & general) & unsolicited (d 0-30) symptoms
  • Over the full course of the study: serious adverse events (SAEs)

Estimated Enrollment: 525
Study Start Date: November 2002
Detailed Description:

Randomized study with five groups to receive one of the following vaccination regimens: One of the three formulations of GSK Biologicals’ Hib-MenAC mixed with GSK Biologicals’ Tritanrix™-HepB (3 different groups) GSK Biologicals’ Tritanrix™-HepB + GSK Biologicals’ Hiberix™ GSK Biologicals’ Tritanrix™-HepB mixed with GSK Biologicals’ Hiberix™ + Wyeth Lederle’s Meningitec™

  Eligibility

Ages Eligible for Study:   6 Weeks to 10 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy infant between 6 and 10 weeks of age at the time of the first vaccination, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.

Exclusion criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) or planned administration/ administration of vaccine not foreseen by the study protocol within 30 days preceding the first dose of study vaccine during study period, or planned use during study period with exception of oral polio vaccine (OPV).
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
  • Hepatitis B and Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and/or meningococcal disease with the exception of a birth dose of hepatitis B vaccine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00291967

Locations
Philippines
Manila, Philippines
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: Clinical Trials GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00291967     History of Changes
Other Study ID Numbers: 759346
Study First Received: February 14, 2006
Last Updated: December 7, 2006
Health Authority: Philippines: Bureau of Food and Drugs

Additional relevant MeSH terms:
Diphtheria
Hepatitis
Hepatitis A
Hepatitis B
Whooping Cough
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections

ClinicalTrials.gov processed this record on May 22, 2013