Immuno & Safety Study With 2 Formulations of DTPw-HBV/HIB When Given at Birth With Hepatitis B at 2, 4 and 6 Mths.Age.
This study has been terminated.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00316680
First received: April 20, 2006
Last updated: September 29, 2011
Last verified: September 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Haemophilus Influenzae Type b Disease Hepatitis B Prophylaxis for Diphtheria Pertussis Tetanus |
Biological: Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Study to Assess Immunogenicity & Safety of GSK Bio Kft's DTPw-HBV/Hib vs DTPwCSL-HBV/Hib Kft & vs Concomitant Administration of CSL's Triple Antigen & Hiberix (GSK Bio), to Infants 2,4,6 Mths of Age, After a Birth Dose of Hep B |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- GMC of anti-BPT Ab
Secondary Outcome Measures:
- "anti-HBs, anti-diphtheria, anti-tetanus, anti-BPT & anti-PRP conc. & GMCs; vaccine response to BPT
- Solicited & unsolicited symptoms, SAEs "
| Estimated Enrollment: | 288 |
| Study Start Date: | March 2006 |
Intervention Details:
Detailed Description:
-
Biological: Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine
- Diphtheria
- tetanus
- pertussis
- hepatitis B
- Hib vaccine
Other Names:
"The study will be carried out in a partially double blind manner (i.e. double blind with respect to DTPwGöd-HBV/Hib Kft and DTPwCSL-HBV/Hib Kft groups and open with respect to CSL's Triple Antigen & Hib group). Subjects will be randomly allocated to one of the three following groups to receive:
- GSK Biologicals Kft's combined DTPwGöd-HBV/Hib Kft vaccine.
- GSK Biologicals Kft's combined DTPwCSL-HBV/Hib Kft vaccine.
- CSL's Triple Antigen + GSK Biologicals' Hib vaccines. There will be a specific follow-up of solicited local and general symptoms during 4 days after each vaccination and of unsolicited symptoms for 31 days after each vaccination. Serious adverse events reported during the study period will be recorded.
"
Eligibility| Ages Eligible for Study: | 6 Weeks to 12 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00316680 History of Changes |
| Other Study ID Numbers: | 104489 |
| Study First Received: | April 20, 2006 |
| Last Updated: | September 29, 2011 |
| Health Authority: | Dominican Republic: Secretaría del Estado de Salud Pública y Asistencia Social (SESPAS) |
Additional relevant MeSH terms:
|
Diphtheria Hepatitis Hepatitis A Hepatitis B Influenza, Human Whooping Cough Tetanus Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Orthomyxoviridae Infections Respiratory Tract Infections Respiratory Tract Diseases Bordetella Infections Gram-Negative Bacterial Infections Infection Clostridium Infections |
ClinicalTrials.gov processed this record on May 23, 2013