Observational Study Describing the Immune Profile Induced By Pertussis Vaccines

Pertussis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03147898
• Other study ID #: NGB00001
• Secondary ID: U1111 1183 5461
• Status: Completed
• Start date: April 12, 2017
• Est. completion date: July 9, 2018

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 9, 2018
• Est. primary completion date: July 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Months to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Pertussis
• Whooping Cough

Locations

Country	Name	City	State
Mexico	Investigational Site	Ciudad de México
Panama	Investigational Site	Panama City

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Mexico,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti Pertussis antibody concentrations pre and post vaccination	The change in antibody concentrations will be measured from pre to post vaccination	Day 30 post vaccination
Primary	Change in magnitude of T-cell responses to pertussis-containing combination vaccines over time	The change in cell mediated immune responses will be evaluated from pre to post vaccination	Day 30 post vaccination

External Links

•   Related Info