Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 115

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
1. encephalopathy not attributable to another identifiable cause within 7 days of administration of a previous dose
2. temperature of > 40.5 °C within 48 hours not due to another identifiable cause
3. collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours
4. persistent, inconsolable crying lasting > 3 hours, occurring within 48 hours
5. 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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Responses Pre- and Post-vaccination	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	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination	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