Persistency Study After aP / Tdap Booster Vaccines in Adult Subjects (V113_01 Extension 1)
Condition: Pertussis
MeSH terms: Whooping Cough
Intervention: aP booster; TdaP booster; Licensed TdaP booster (Boostrix®)
Intervention description: Acellular pertussis vaccine:
Acellular pertussis (aP) vaccine was administered with different antigen doses intramuscularly in the upper deltoid region of the subject's non-dominant arm.
Biological: Diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany) To ensure all subjects receive a tetanus and diphtheria booster vaccination, an injection was administered on Study Day 30, one month after the administration of the investigational vaccine.; Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) Tetanus, reduced diphtheria, and acellular pertussis (TdaP) vaccine was administered with different antigen doses intramuscularly in the upper deltoid region of the subject's non-dominant arm.
Other: Saline solution Subjects received one injection of saline solution at one month after vaccination.; Licensed TdaP booster vaccine Licenced TdaP booster vaccine was administered intramuscularly in the upper deltoid region of the subject's non-dominant arm.
Other: Saline solution Subjects received one injection of saline solution at one month after vaccination.
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 315.0
Sex: All
Minimum age: 18 Years
Maximum age: 43 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the persistence of immune response against the three
      pertussis antigens (anti- pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA) and
      anti-pertactin (PRN)) in subjects who received a booster dose of either aP or Tdap study
      vaccines or Boostrix® during V113_01 study.

      There was only one Clinic Visit at day 1. Eligible subjects went undergo a single blood draw
      after which they were observed for approximately 15 minutes. Approximately 10.0 mL of blood
      was withdrawn.

      No vaccine was administered and no safety data was collected in this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy individuals previously enrolled in V113_01 trial, who completed the study
             following study protocol and who received the appropriate booster vaccine per group
             assignment

          -  Individuals who voluntarily gave written informed consent after the nature of the
             study was explained according to local regulatory requirements, prior to study entry

          -  Individuals who could comply with study procedures including follow-up

        Exclusion Criteria:

          1. Clinical conditions representing a contraindication to blood draw.

          2. Abnormal function of the immune system resulting from:

               -  Clinical conditions

               -  Systemic administration of corticosteroids per oral (PO)/ intravenous (IV)/
                  intramuscular (IM) for more than 14 consecutive days within 90 days prior to
                  informed consent.

               -  Administration of antineoplastic and immunomodulating agents or radiotherapy
                  within 90 days prior to informed consent.

          3. Received immunoglobulins or any blood products within 180 days prior to informed
             consent.

          4. Received an investigational or non-registered medicinal product within 30 days prior
             to informed consent

          5. Study personnel as an immediate family or household member

          6. Any other clinical condition that, in the opinion of the investigator, could interfere
             with the results of the study or pose additional risk to the subject due to
             participation in the study