Study of the Tdap Combined Vaccine (ADACEL™) as a Booster Dose in Healthy Adults and Children in China
Condition: Diphtheria; Tetanus; Pertussis
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Intervention: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap; Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap
Intervention description: 0.5 mL, Intramuscular (IM); 0.5 mL, Intramuscular (IM)
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 4 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Diphtheria; Tetanus; Pertussis; ADACEL®; Tdap vaccine

Summary:

      The aim of the study is to assess the safety profile of ADACEL vaccine in a small number of
      participants in China.

      Primary objective:

        -  To describe the safety in terms of occurrence of serious adverse reactions and grade 3
           adverse reactions after administration of Sanofi Pasteur's Tdap vaccine (ADACEL) given
           as a single dose in 20 adults and 20 children.

      Secondary objective:

        -  To describe the full reactogenicity profile after administration of sanofi pasteur's
           Tdap vaccine (ADACEL) given as a single dose in 20 adults and 20 children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Group 1: Aged 18 through 64 years on the day of inclusion Group 2: Aged 4 through 8
             years on the day of inclusion

          -  Informed consent form signed by the subject (Group 1) or by the parent(s) or legal
             representative (Group 2)

          -  Subject (Group 1 and 2) and parent/legal representative (Group 2 only) able to attend
             all scheduled visits and to comply with all trial procedures

          -  Group 1 only: For a woman of child-bearing potential, avoid becoming pregnant (use of
             an effective method of contraception or abstinence) from at least 4 weeks prior to
             vaccination, until at least 4 weeks after vaccination

          -  Group 2 only: Written documentation of complete primary series and fourth dose of
             Diphtheria, Tetanus, Pertussis (DTP) vaccine as per China National Immunization
             Recommendations

        Exclusion Criteria:

          -  Group 1 only: For a woman of child-bearing potential, known pregnancy or positive
             serum or urine pregnancy test

          -  Group 1 only: Currently breast-feeding a child

          -  Participation in another clinical trial investigating a vaccine, drug, medical device,
             or a medical procedure in the 4 weeks preceding the trial vaccination

          -  Planned participation in another clinical trial during the present trial period

          -  Known or suspected congenital or acquired immunodeficiency; or receipt of
             immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within
             the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or
             equivalent for more than 2 consecutive weeks within the past 3 months)

          -  Known systemic hypersensitivity to any of the vaccine components, or history of a
             life-threatening reaction to the vaccine or to a vaccine containing any of the same
             substances

          -  Chronic illness that, in the opinion of the Investigator, is at a stage that could
             interfere with trial conduct or completion

          -  Group 1 only: Current alcohol abuse or drug addiction that may interfere with the
             ability to comply with trial procedures

          -  Receipt or planned receipt of any vaccine in the 4 weeks preceding or following trial
             vaccination, except for influenza vaccination, which may be received at least two
             weeks before the study vaccine

          -  Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B or
             Hepatitis C

          -  History of diphtheria, tetanus, or pertussis infection (confirmed either clinically,
             serologically or microbiologically)

          -  Previous fifth vaccination against pertussis disease and/or previous sixth vaccination
             against diphtheria and tetanus disease with either the trial vaccine or another
             vaccine (except Tetanus-prone wound management in Group 1)

          -  Subject at high risk for diphtheria, tetanus, or pertussis infection during the trial,
             including persons who have exposure (e.g., member of a household with another infected
             member, travelers to or residents of areas where one of this disease is hyperendemic
             or epidemic, or microbiologists routinely working with one of these pathogens,)

          -  Self-reported thrombocytopenia, bleeding disorder or receipt of anticoagulants in the
             3 weeks preceding inclusion, contraindicating IM vaccination

          -  Group 1 only: Subjects deprived of freedom by an administrative or court order, or in
             an emergency setting, or hospitalized involuntarily

          -  History of contra-indication to vaccination with pertussis containing vaccine,
             including:

          -  Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within
             7 days of a previous dose of a pertussis containing vaccine that is not attributable
             to another identifiable cause

          -  Identified as employees of the Investigator or study center, with direct involvement
             in the proposed study or other studies under the direction of that Investigator or
             study center, as well as immediate family members (i.e. husband, wife and their
             children, adopted or natural) of the employees or the Investigator.