Immuno & Safety Study With 2 Formulations of DTPw-HBV/HIB When Given at Birth With Hepatitis B at 2, 4 and 6 Mths.Age.

NCT00316680 | Terminated Phase 3

• 1 other identifier: 104489
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Haemophilus Influenzae Type b; Diphtheria; Tetanus; Hepatitis B; Whole Cell Pertussis

Outcome Measures

Primary Outcomes (1)

• GMC of anti-BPT Ab

Secondary Outcomes (2)

• anti-HBs, anti-diphtheria, anti-tetanus, anti-BPT & anti-PRP conc. & GMCs; vaccine response to BPT

• Solicited & unsolicited symptoms, SAEs "

Interventions

Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine BIOLOGICAL

Also known as: Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Santo Domingo, Dominican Republic

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Haemophilus Infections; Diphtheria; Tetanus; Hepatitis B

Interventions

Tetanus Toxoid; Hepatitis B Vaccines; HibTITER protein, Haemophilus influenzae

Condition Hierarchy (Ancestors)

Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Clostridium Infections; Blood-Borne Infections; Communicable Diseases; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures; Viral Hepatitis Vaccines; Viral Vaccines

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2006
• First Posted: April 21, 2006
• Study Start: March 1, 2006
• Study Completion: November 1, 2006
• Last Updated: October 7, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

DO (1)