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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00291967

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 II

MedlinePlus related topics: Diphtheria Hepatitis Hepatitis B Tetanus Whooping Cough

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

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

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

Study placed in the following topic categories:

Bacterial Infections
Liver Diseases
Hepatitis, Viral, Human
Whooping Cough
Cough
Neisseria meningitidis
Diphtheria
Tetanus
Whooping cough

Gram-Negative Bacterial Infections
Virus Diseases
Hepatitis
Gram-Positive Bacterial Infections
Digestive System Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Hepatitis B
DNA Virus Infections

Additional relevant MeSH terms:

Bordetella Infections
Corynebacterium Infections
Infection
Hepadnaviridae Infections
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 16, 2009