Observational Study Describing the Immune Profile Induced By Pertussis Vaccines

NCT03147898 | Completed

• 2 other identifiers: NGB00001U1111 1183 5461
• Study Type: observational
• Target: 90
• Locations: 2 countries
• Sites: 2

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.

Conditions

Whooping Cough; Pertussis

Keywords

Whooping cough; Pertussis

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (4)

Group 1: Toddlers

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

Group 2: Toddlers

Non-intervention observational study. Toddlers will receive an aP-containing combination vaccine as part of the national immunization schedule.

Group 3: Preschooler

Non-intervention observational study. Preschoolers will receive a wP-containing combination vaccine as part of the national immunization schedule.

Group 4: Preschooler

Non-intervention observational study. Preschoolers will receive an aP-containing combination vaccine as part of the national immunization schedule.

Eligibility Criteria

• Age: 15 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Healthy subjects aged 15 to 59 months

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (2)

Investigational Site

Mexico City, Mexico

Location

Investigational Site

Panama City, Panama

Location

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood draw

MeSH Terms

Conditions

Whooping Cough

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Medical Officer

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 10, 2017
• Study Start: April 12, 2017
• Primary Completion: July 9, 2018
• Study Completion: July 9, 2018
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

PA (1); ME (1)