Hepatitis B Clinical Trial
Official title:
Study to Assess Immunogenicity and Safety of GlaxoSmithKline Biologicals' Kft's DTPw-HBV/Hib vs DTPwCSL-HBV/Hib Kft and vs Concomitant Administration of CSL's Triple Antigen and GlaxoSmithKline Biologicals' Hiberix, to Infants at 2, 4, 6 Months of Age, After a Birth Dose of Hepatitis B
A trial to characterize the immunogenicity of 2 different formulations of a vaccine from GSK Biologicals, including the following five antigens: diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b. A vaccine from Commonwealth Serum Laboratories (diphtheria, tetanus, pertussis) which is co-administered with Haemophilus influenzae type b vaccine will also be used as a comparator. Reactogenicity and safety of all vaccines will be assessed as well.
Status | Terminated |
Enrollment | 288 |
Est. completion date | November 2006 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Weeks to 12 Weeks |
Eligibility |
Inclusion criteria - Administration of one dose of hepatitis B vaccine at birth. - A healthy male or female between, and including, 6 and 12 weeks of age at the time of the first DTPw vaccination. Exclusion criteria - Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. - Chronic administration of immunosuppressants or other immune-modifying drugs since birth. - Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine hepatitis B vaccine for the Triple Antigen + Hib group. - Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required) - Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. - Bacille Calmette-Guérin (BCG) vaccine given after the first 2 weeks of life. - Previous vaccination against diphtheria, tetanus, pertussis and/or Hib/History of diphteria, tetanus, pertussis, hepatitis B and/ or hib disease. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Dominican Republic | GSK Investigational Site | Santo Domingo |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Dominican Republic,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | GMC of anti-BPT Ab | |||
Secondary | anti-HBs, anti-diphtheria, anti-tetanus, anti-BPT & anti-PRP conc. & GMCs; vaccine response to BPT | |||
Secondary | Solicited & unsolicited symptoms, SAEs " |
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