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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00291967
Other study ID # 759346
Secondary ID
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
Est. completion date
Est. primary completion date
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


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)
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