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Trial record 3 of 303 for:    "Whooping cough"

Observational Study Describing the Immune Profile Induced By Pertussis Vaccines

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ClinicalTrials.gov Identifier: NCT03147898
Recruitment Status : Active, not recruiting
First Posted : May 10, 2017
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.

Condition or disease
Whooping Cough Pertussis

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Humoral and Cell-Mediated Immune Responses Following a Booster Dose of Pertussis Vaccine
Actual Study Start Date : April 12, 2017
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Anti Pertussis antibody concentrations pre and post vaccination [ Time Frame: Day 30 post vaccination ]
    The change in antibody concentrations will be measured from pre to post vaccination

  2. Change in magnitude of T-cell responses to pertussis-containing combination vaccines over time [ Time Frame: Day 30 post vaccination ]
    The change in cell mediated immune responses will be evaluated from pre to post vaccination


Biospecimen Retention:   Samples Without DNA
blood draw


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Ages Eligible for Study:   15 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Healthy subjects aged 15 to 59 months
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03147898


Locations
Mexico
Investigational Site
Ciudad de México, Mexico
Panama
Investigational Site
Panama City, Panama
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Officer Sanofi Pasteur Inc.

Additional Information:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03147898     History of Changes
Other Study ID Numbers: NGB00001
U1111 1183 5461 ( Other Identifier: WHO )
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at clinicalstudydatarequest.com. While making information available at Sanofi continues to protect the privacy of the participants in clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: clinicalstudydatarequest.com

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sanofi:
Whooping cough
Pertussis

Additional relevant MeSH terms:
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs