Observational Study Describing the Immune Profile Induced By Pertussis Vaccines

• Register: ClinicalTrials.gov
• Last refreshed on: 2 May 2022
• Main ID: NCT03147898
• Date of registration: 08/05/2017
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Observational Study Describing the Immune Profile Induced By Pertussis Vaccines
• Scientific title: Characterization of Humoral and Cell-Mediated Immune Responses Following a Booster Dose of Pertussis Vaccine
• Date of first enrolment: April 12, 2017
• Target sample size: 90
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03147898
• Study type: Observational

Countries of recruitment

Mexico, Panama

Contacts

• Name: Medical Officer
• Affiliation: Sanofi Pasteur Inc.

Key inclusion & exclusion 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



Age minimum: 15 Months
Age maximum: 59 Months
Gender: All

Health Condition(s) or Problem(s) studied

Pertussis

Whooping Cough

Primary Outcome(s)

Change in magnitude of T-cell responses to pertussis-containing combination vaccines over time [Time Frame: Day 30 post vaccination]

Anti Pertussis antibody concentrations pre and post vaccination [Time Frame: Day 30 post vaccination]

Secondary ID(s)

U1111 1183 5461

NGB00001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors