Whooping CoughNCT03147898
Observational Study Describing the Immune Profile Induced By Pertussis Vaccines
An observational study of Whooping Cough and Pertussis, run by Sanofi at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 15 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Whooping Cough, Pertussis
- Type of treatment
- Vaccines
- How many people
- 90 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Apr 2017to 9 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy subjects aged 15 to 59 months
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
- Conditions
- Whooping Cough, Pertussis
- Keywords
- Whooping cough, Pertussis
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Anti Pertussis antibody concentrations pre and post vaccination
The change in antibody concentrations will be measured from pre to post vaccination
Measured: 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
Measured: Day 30 post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start12 Apr 2017
- Primary completion9 Jul 2018
- Study completion9 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whooping CoughStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Officer, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147898
- Sponsor's protocol ID
- NGB00001
- Other IDs
- U1111 1183 5461
- Status last verified
- Apr 2022
- First submitted
- 8 May 2017
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Humoral and Cell-Mediated Immune Responses Following a Booster Dose of Pertussis Vaccine
- ClinicalTrials.gov ID
- NCT03147898
- Acronym / sponsor ID
- NGB00001
- Conditions
- Whooping Cough, Pertussis
- Keywords
- Whooping cough, Pertussis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 9 Jul 2018 (actual)
- Study completion
- 9 Jul 2018 (actual)
- First posted
- 10 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 15 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy subjects aged 15 to 59 months
Key inclusion criteria (11 listed)
- An individual must fulfill all of the following criteria in order to be eligible for study enrollment:
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Officer study director
Sanofi Pasteur Inc.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Whooping Cough and Pertussis, run by Sanofi at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico, Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti Pertussis antibody concentrations pre and post vaccination (time frame: Day 30 post vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.