Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Immunogenicity and Safety of ADACEL™ (TdcP Vaccine) as Fifth Dose in Children 6-8 Years of Age.

Conditions
-----------------
Diphtheria, Tetanus, Pertussis

Intervention / Treatment
-----------------
* Biological: Diphteria, tetanus, and Acellular Pertussis vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged from 6 to 8 years on the day of inclusion Informed consent form (ICF) signed by parent(s)/legal representative Able to attend all scheduled visits and to comply with all trial procedures Written documentation of complete primary series and fourth dose of Diphtheria, Tetanus toxoids and whole cell Pertussis vaccine (DTP) Parent(s)/legal representative present or fully completed pre-inclusion medical questionnaire Exclusion Criteria: Participation in another clinical trial in the 4 weeks preceding the trial vaccination Planned participation in another clinical trial during the present trial period Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long term systemic corticosteroids therapy Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances with specific focus on subjects who had, after previous administration of DTP or diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine, one of the following adverse events encephalopathy not attributable to another identifiable cause within 7 days of administration of a previous dose temperature of > 40.5 °C within 48 hours not due to another identifiable cause collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours persistent, inconsolable crying lasting > 3 hours, occurring within 48 hours seizure with or without fever occurring within 3 days Chronic illness at a stage that could interfere with trial conduct or completion. Blood or blood-derived products received in the past 3 months Any vaccination in the 4 weeks preceding the trial vaccination (except Oral Poliomyelitis Vaccine [OPV]) Any vaccination planned during the present trial period (except OPV) History of diphtheria and/or tetanus and/or pertussis infection (confirmed either clinically, serologically or microbiologically) Previous fifth vaccination against diphtheria and/or tetanus and/or pertussis infection with the trial vaccine or another vaccine Clinical or serological evidence of systemic illness including Hepatitis B, C or Human Immunodeficiency Virus (HIV) Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination History of/current seizures Febrile illness (axillary temperature ≥ 37.4 °C) or acute illness on the day of inclusion

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 8 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Diphteria, tetanus, and Acellular Pertussis vaccine|0.5 mL, Intramuscular|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and 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. | Day 0 and Day 28 Post-vaccination | 
| Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and 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. | Day 0 and Day 28 post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-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 | Within 8 days of vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADACEL™, Tetanus, Diphteria, Acellular pertussis