observational study describing the immune profile induced by pertussis vaccines

Conditions: Whooping Cough; Pertussis

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.


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

Keywords: whooping cough pertussis