Observational Study Describing the Immune Profile Induced By Pertussis Vaccines

April 21, 2022 updated by: Sanofi

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Ciudad de México, Mexico
        • Investigational Site
  • Panama
      • Panama City, Panama
        • Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 4 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Healthy subjects aged 15 to 59 months

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Day 30 post vaccination
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
Day 30 post vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Officer, Sanofi Pasteur Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 9, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 9, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NGB00001
  • U1111 1183 5461 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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