Back to resultsStudy to Assess Safety & Immunogenicity of GSK Biologicals' Boostrix (dTpa) Vaccine vs. Chinese DT Vaccine
Primary Purpose
Diphtheria, Acellular Pertussis, Tetanus
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Boostrix
Chinese DT vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Diphtheria focused on measuring Chinese DT vaccin
Eligibility Criteria
Inclusion Criteria:
- A male or female between, and including, 6-8 years of age at the time of vaccination,
- Written informed consent obtained from the parent or guardian of the subject,
Exclusion Criteria:
- Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life, subjects who have received previous DTP booster vaccination since administration of the fourth dose of vaccine in second year of life can not participate.
- Subjects with history of diphtheria, pertussis or tetanus diseases can not participate.
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
Anti-diphtheria, anti-tetanus, anti-PT, anti-PRN & anti-FHA antibody concentration.
Secondary Outcome Measures
Solicited symptoms (Day 0-3), unsolicited AEs (Day 0-30) & SAEs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00452686
Brief Title
Study to Assess Safety & Immunogenicity of GSK Biologicals' Boostrix (dTpa) Vaccine vs. Chinese DT Vaccine
Official Title
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Boostrix (dTpa) Vaccine and the Chinese DT Vaccine, When Administered as Booster Vaccination in Healthy Children Aged 6-8 Years
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (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
This study will evaluate the safety and immunogenicity of a booster dose of GSK Biologicals' reduced antigen content diphtheria, tetanus, acellular pertussis (dTpa) vaccine - Boostrix in comparison with Chinese DT vaccine, in children 6-8 years of age.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diphtheria, Acellular Pertussis, Tetanus
Keywords
Chinese DT vaccin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
660 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Boostrix
Intervention Type
Biological
Intervention Name(s)
Chinese DT vaccine
Other Intervention Name(s)
Boostrix
Primary Outcome Measure Information:
Title
Anti-diphtheria, anti-tetanus, anti-PT, anti-PRN & anti-FHA antibody concentration.
Secondary Outcome Measure Information:
Title
Solicited symptoms (Day 0-3), unsolicited AEs (Day 0-30) & SAEs
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
A male or female between, and including, 6-8 years of age at the time of vaccination,
Written informed consent obtained from the parent or guardian of the subject,
Exclusion Criteria:
Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life, subjects who have received previous DTP booster vaccination since administration of the fourth dose of vaccine in second year of life can not participate.
Subjects with history of diphtheria, pertussis or tetanus diseases can not participate.
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
Suining
Country
China
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.
Citations:
PubMed Identifier
20215881
Citation
Zhu F, Zhang S, Hou Q, Zhang Y, Xu Y, Ma X, Lu X, Pan H, Chen D, Ramakrishnan G, Zhao R, Tang H, Van Der Meeren O, Bock HL. Booster vaccination against pertussis in Chinese children at six years of age using reduced antigen content diphtheria-tetanus-acellular pertussis vaccine (Boostrix()). Hum Vaccin. 2010 Mar 3;6(3):10503. doi: 10.4161/hv.6.3.10503. Epub 2010 Mar 3.
Results Reference
background
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
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
108638
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
108638
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
108638
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
108638
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
108638
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
108638
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
108638
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Study to Assess Safety & Immunogenicity of GSK Biologicals' Boostrix (dTpa) Vaccine vs. Chinese DT Vaccine
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