Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan
Condition: Diphtheria; Tetanus; Pertussis
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Intervention: Diphteria, tetanus, and Acellular Pertussis vaccine
Intervention description: 0.5 mL, Intramuscular
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 115.0
Sex: All
Minimum age: 6 Years
Maximum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ADACEL™; Tetanus; Diphteria; Acellular pertussis

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.
    

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

               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