Assess Immune Response Following Primary Vaccination With Tritanrix™-HepB Vaccine Mixed With 3 Formulations of Hib-MenAC Vaccine to Infants
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
1 other identifier
interventional
525
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2002
CompletedFirst Submitted
Initial submission to the registry
February 14, 2006
CompletedFirst Posted
Study publicly available on registry
February 15, 2006
CompletedDecember 8, 2006
December 1, 2006
February 14, 2006
December 7, 2006
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
Unknown Facility
Manila, Philippines
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 14, 2006
First Posted
February 15, 2006
Study Start
November 1, 2002
Last Updated
December 8, 2006
Record last verified: 2006-12