Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan
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|ClinicalTrials.gov Identifier: NCT00258908|
Recruitment Status : Completed
First Posted : November 28, 2005
Results First Posted : June 8, 2009
Last Update Posted : April 14, 2016
To assess the immunogenicity profile of ADACEL™, Tetanus and Diphtheria Toxoids Adsorbed combined with Component Pertussis Vaccine (TdcP Vaccine) one month after administration.
To describe the safety profile of ADACEL™ (TdcP Vaccine) when given as a fifth dose.
|Condition or disease||Intervention/treatment||Phase|
|Diphtheria Tetanus Pertussis||Biological: Diphteria, tetanus, and Acellular Pertussis vaccine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunogenicity and Safety of ADACEL™ (TdcP Vaccine) as Fifth Dose in Children 6-8 Years of Age.|
|Study Start Date :||November 2005|
|Actual Primary Completion Date :||August 2006|
|Actual Study Completion Date :||August 2006|
- Biological: Diphteria, tetanus, and Acellular Pertussis vaccine
0.5 mL, IntramuscularOther Name: ADACEL™
- Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination [ Time Frame: Day 0 and Day 28 Post-vaccination ]Immunogenicity profile of ADACEL™ (TdcP vaccine) antibody (anti-diphtheria, anti-tetanus, and anti-pertussis) responses at Day 0 and Day 28 Post-vaccination.
- Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination [ Time Frame: Day 0 and Day 28 post-vaccination ]GMTs and 95% confidence intervals of anti-diphtheria, anti-tetanus, and anti-pertussis toxoids responses at Day 0 and Day 28 Post-vaccination.
- Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination [ Time Frame: Within 8 days of vaccination ]The percentage of participants reporting solicited injection site and systemic reactions within 8 days after vaccination with ADACEL™ (TdcP vaccine) when given as a fifth dose
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): NCT00258908
|Study Director:||Medical Director||Sanofi Pasteur Inc|