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

Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291967
• Other study ID #: 759346
• Status: Completed
• Phase: Phase 2
• First received: February 14, 2006
• Last updated: December 7, 2006
• Start date: November 2002

Study information

• Verified date: December 2006
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Bureau of Food and Drugs
• Study type: Interventional

Clinical Trial Summary

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.

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™

Recruitment information / eligibility

• Status: Completed
• Enrollment: 525
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Weeks to 10 Weeks

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Hepatitis B
• Hib Diseases
• Neisseria Meningitidis Serogroups A & C Diseases
• Pertussis
• Tetanus

Intervention

Biological:
• DTPw-HBV/Hib-MenAC conjugate vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Philippines, 

Outcome

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