Study to Assess the Safety & Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix) When Given at 6-8 Years of Age.
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ClinicalTrials.gov Identifier: NCT00406562 |
Recruitment Status
:
Completed
First Posted
: December 4, 2006
Last Update Posted
: October 27, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tetanus Diphtheria Acellular Pertussis | Biological: Boostrix | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Open, Booster Vaccination Study to Assess Safety and Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix) When Administered to Healthy Chinese Children 6-8 Years of Age. |
Study Start Date : | January 2007 |
Actual Study Completion Date : | February 2007 |

- Occurrence of solicited symptoms during 4 days following vaccination, unsolicited symptoms during the 31 days following vaccination and serious adverse events

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 6 Years to 8 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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,
- Subjects who have received a total of 4 doses of DTP vaccine in the first 2 years of life,
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00406562
China | |
GSK Investigational Site | |
Suining, China |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Additional Information:
Study Data/Documents: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register

For additional information about this study please refer to the GSK Clinical Study Register
Publications:
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00406562 History of Changes |
Other Study ID Numbers: |
107924 |
First Posted: | December 4, 2006 Key Record Dates |
Last Update Posted: | October 27, 2016 |
Last Verified: | October 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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. |
Keywords provided by GlaxoSmithKline:
uncontrolled |
Additional relevant MeSH terms:
Diphtheria Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |