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

Primary Purpose

Haemophilus Influenzae Type b, Diphtheria, Tetanus

Status
Terminated
Phase
Phase 3
Locations
Dominican Republic
Study Type
Interventional
Intervention
Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Haemophilus Influenzae Type b

Eligibility Criteria

6 Weeks - 12 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GSK Investigational Site

Outcomes

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 "

Full Information

First Posted
April 20, 2006
Last Updated
October 6, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00316680
Brief Title
Immuno & Safety Study With 2 Formulations of DTPw-HBV/HIB When Given at Birth With Hepatitis B at 2, 4 and 6 Mths.Age.
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Study Start Date
March 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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.
Detailed Description
"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. "

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haemophilus Influenzae Type b, Diphtheria, Tetanus, Hepatitis B, Whole Cell Pertussis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
288 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine
Other Intervention Name(s)
Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine
Primary Outcome Measure Information:
Title
GMC of anti-BPT Ab
Secondary Outcome Measure Information:
Title
anti-HBs, anti-diphtheria, anti-tetanus, anti-BPT & anti-PRP conc. & GMCs; vaccine response to BPT
Title
Solicited & unsolicited symptoms, SAEs "

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Santo Domingo
Country
Dominican Republic

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104489
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104489
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104489
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104489
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104489
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
104489
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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