Observational Study Describing the Immune Profile Induced By Pertussis Vaccines

Brief Title

Observational Study Describing the Immune Profile Induced By Pertussis Vaccines

Official Title

Characterization of Humoral and Cell-Mediated Immune Responses Following a Booster Dose of Pertussis Vaccine

Brief Summary

      This is an observational study designed to describe the immune profile of toddlers and
      preschoolers with acellular priming after receiving a booster dose of pertussis vaccine.
    

Study Type

Observational

Primary Outcome

Anti Pertussis antibody concentrations pre and post vaccination

Condition

Whooping Cough

Study Arms / Comparison Groups

 Group 1: Toddlers

Description:  Non-intervention observational study. Toddlers will receive wP-containing combination vaccine as part of the national immunization schedule

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Estimated Enrollment

90

Start Date

April 12, 2017

Completion Date

July 9, 2018

Primary Completion Date

July 9, 2018

Eligibility Criteria

        Inclusion Criteria:

        An individual must fulfill all of the following criteria in order to be eligible for study
        enrollment:

        Toddler Cohort:

          -  Aged 15 to 24 months on the day of (V01)

          -  Has received 3 doses of a licensed pertussis-containing vaccine for a priming series
             during infancy in accordance with the recommendations of the NIP or his / her primary
             care physician

          -  Has written documentation (e.g., immunization record, physician's certificate,
             vaccination unit registry) available to verify the receipt of 3 doses of a licensed
             pertussis-containing infant vaccines as per national immunization schedule

          -  ICF has been signed and dated by the subject's parent(s) / legally acceptable
             representative(s) and, if required, an independent witness, in accordance with local
             regulations

          -  Planned receipt of routine pertussis booster vaccine, preferably, on same date as, and
             no more than 2 days following, V01

          -  Participant and parent / legally acceptable representative are able to attend all
             scheduled visits and to comply with all study procedures

        Preschooler Cohort:

          -  Aged 48 to 59 months on the date of V01

          -  Has received 4 doses of pertussis-containing combination vaccines as per national
             immunization schedule

        Exclusion Criteria:

        An individual fulfilling any of the following criteria is to be excluded from study
        enrollment:

          -  Participation at the time of study enrollment or planned participation during the
             present study period in another clinical study investigating a vaccine, drug, medical
             device, or medical procedure

          -  Receipt of any vaccine in the 4 weeks preceding the study or planned receipt of any
             vaccine (other than a booster pertussis vaccine) between V01 and V03a

          -  Receipt of immunoglobulins, blood, or blood-derived products in the past 3 months

          -  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 corticosteroid therapy
             (prednisone or equivalent for more than 2 consecutive weeks) within the preceding 3
             months

          -  History of clinically- or laboratory-confirmed pertussis as per the WHO recommended
             case definition

          -  Bleeding disorder, verbal report of thrombocytopenia, or receipt of anticoagulants in
             the 3 weeks preceding inclusion, contraindicating venipuncture, in the opinion of the
             investigator

          -  Chronic illness that, in the opinion of the Investigator, is at a stage where it might
             interfere with study conduct or completion

          -  Moderate or severe acute illness/infection (in the opinion of the investigator) or
             febrile illness (temperature ≥ 38.0°C) at physical examination on V01 of the study. A
             prospective participant should not be included in the study until the condition has
             resolved or the febrile event has subsided.

          -  Receipt of oral or injected antibiotics therapy within the 72 hours preceding the
             first blood draw. (Topical antibiotics and antibiotic drops are not included in this
             exclusion criterion).

          -  Identified as a natural or adopted child of the Investigator or an employee with
             direct involvement in the proposed study
      

Gender

All

Ages

15 Months - 59 Months

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Medical Officer, , 

Location Countries

Mexico

Location Countries

Mexico

NCT ID

NCT03147898

Organization ID

NGB00001

Secondary IDs

U1111 1183 5461

Responsible Party

Sponsor

Study Sponsor

Sanofi

Study Sponsor

Medical Officer, Study Director, Sanofi Pasteur Inc.

Verification Date

October 2018