Back to resultsImmunogenicity, Antibody Persistence and Safety of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX) Vaccines.
Primary Purpose
Acellular Pertussis, Tetanus, Diphtheria
Status
Terminated
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
INFANRIX
BOOSTRIX
HAVRIX
Sponsored by
About this trial
This is an interventional prevention trial for Acellular Pertussis focused on measuring BOOSTRIX, INFANRIX
Eligibility Criteria
Inclusion Criteria:
- Male or female children between and including 18 -20 months of age at the time of the vaccination.
- Completed a primary vaccination course with DTPa (INFANRIX) vaccine at 2, 4, and 6 months.
- Written informed consent obtained before study entry from the parents or guardians of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the administration of the study vaccine dose, or planned use during the study period.
- Evidence of previous or intercurrent diphtheria, tetanus, or pertussis disease, or of vaccination against any of these diseases since completion of the primary course of DTPa (INFANRIX) vaccine.
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Anti-diphtheria and anti-tetanus antibody concentration (1M, 15-18M & 27-29M after vacc)
Occurrence of local injection site reactions (1M after vacc).
Secondary Outcome Measures
Antibody concentration to all vaccine antigens (1M, 15-18M & 27-29M after vacc),
Solicited (Day 0-14) & Unsolicited symptoms (Day 0-30),
SAEs (full study).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00544271
Brief Title
Immunogenicity, Antibody Persistence and Safety of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX) Vaccines.
Official Title
Phase IIIb Study to Evaluate Immunogenicity, Antibody Persistency and Reactogenicity of DTPa - INFANRIX and dTpa - BOOSTRIX Vaccines Administered to Healthy Children Previously Primed With 3 Doses of DTPa Vaccine Compared to Placebo (HAVRIX®JUNIOR)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the immunogenicity, persistence of antibodies and reactogenicity of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX), when administered to subjects 18-20 months old, compared with not giving a booster DTP vaccine at 18-20 months. Study double blinded for the two DTP vaccines and single blinded for the control arm.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acellular Pertussis, Tetanus, Diphtheria
Keywords
BOOSTRIX, INFANRIX
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
720 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
INFANRIX
Intervention Type
Biological
Intervention Name(s)
BOOSTRIX
Intervention Type
Biological
Intervention Name(s)
HAVRIX
Other Intervention Name(s)
INFANRIX, BOOSTRIX
Primary Outcome Measure Information:
Title
Anti-diphtheria and anti-tetanus antibody concentration (1M, 15-18M & 27-29M after vacc)
Title
Occurrence of local injection site reactions (1M after vacc).
Secondary Outcome Measure Information:
Title
Antibody concentration to all vaccine antigens (1M, 15-18M & 27-29M after vacc),
Title
Solicited (Day 0-14) & Unsolicited symptoms (Day 0-30),
Title
SAEs (full study).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
20 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female children between and including 18 -20 months of age at the time of the vaccination.
Completed a primary vaccination course with DTPa (INFANRIX) vaccine at 2, 4, and 6 months.
Written informed consent obtained before study entry from the parents or guardians of the subject.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the administration of the study vaccine dose, or planned use during the study period.
Evidence of previous or intercurrent diphtheria, tetanus, or pertussis disease, or of vaccination against any of these diseases since completion of the primary course of DTPa (INFANRIX) vaccine.
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
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
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
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
263855/035
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
263855/035
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
263855/035
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
263855/035
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
263855/035
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
263855/035
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Immunogenicity, Antibody Persistence and Safety of GSK Biologicals' DTPa (INFANRIX) and dTpa (BOOSTRIX) Vaccines.
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