Clinical trial NCT03147898: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Whooping Cough
Pertussis
Keywords: Whooping cough
Pertussis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2017-05-10
Enrollment: 90
Sex: ALL
Minimum age (years): 15
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy subjects aged 15 to 59 months

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.


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

Primary outcomes:
measure: Anti Pertussis antibody concentrations pre and post vaccination
timeFrame: Day 30 post vaccination
measure: Change in magnitude of T-cell responses to pertussis-containing combination vaccines over time
timeFrame: Day 30 post vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Ciudad de México
country: Mexico
facility: Investigational Site
city: Panama City
country: Panama
facility: Investigational Site
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Officer
role: STUDY_DIRECTOR
References: