Pertussis VaccineGriCoVaxNCT04494581
GriCoVax Study in 4 Maternity Wards in the Ile-de-France Region
An observational study of Pertussis Vaccine and Healthcare Worker Patient Transmission, run by Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux at 4 sites in France.
Trial summary
Implementation of organizational adjustments can enhance involvement of healthcare teams in carrying out flu and pertussis vaccinations, and optimizing access to vaccines for women and their families. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pertussis Vaccine, Healthcare Worker Patient Transmission, Pregnant Women
- What is being tested?
- questionnaire
- How many people
- 480 participants
- Where
- 4 sitesFrance
- Study dates
- 3 May 2019to 30 Mar 2020
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteer women and staff.
Who may be able to join
- Pregnant and postpartum women over 18 medically followed in maternity wards included. Femmes enceintes ou en post-partum :
- Health professionals over 18 working in maternity wards included.
Who cannot join
- Women under the protection of a conservator Temporary Health staff
Trial locations and contacts
4 sites in 1 country.
France4 sites
Maternité Hôpital privé
Antony, 92160
Maternité Hôpital Jean Verdier
Bondy, 93143
Maternité Notre Dame de Bon Secours - GH Paris St Joseph
Paris, 75014
Maternité Port Royal
Paris, 75014
About this study
Official title: Assessment of Practices and of Immunization Programs Against Flu and Pertussis in Maternity Hospitals
Implementation of organizational adjustments can enhance involvement of healthcare teams in carrying out flu and pertussis vaccinations, and optimizing access to vaccines for women and their families. Pertussis vaccination of pregnant women is envisaged by the French Health Autority, considering that, given international experiences, vaccination during the second trimester of pregnancy is safe, effective, and would aim to protect babies during the first months of their life. Before considering such a recommendation in France, the acceptability of this strategy by pregnant women and health professionals must be considered.
Read the detailed description
Multicentre, descriptive study conducted in a declarative manner and supplemented by direct observation by an investigator.
Main objectives:
- Assess existing practices of the various actors involved in flu and pertussis vaccination of pregnant or postpartum women medically followed in maternity wards.
- Assess acceptability of pertussis and flu vaccination during pregnancy by women medically followed in maternity wards, and by health professionals of theses facilities.
Secondary objectives:
- Assess flu and pertussis immunization coverage of pregnant and postpartum women and of health professionals working in maternity wards.
- Assess the links between immunization coverage of health professionals and their current practices in promoting flu and pertussis vaccination of women in maternity wards.
Main outcome measures:
- Identify in each maternity hospital facilitators of flu and pertussis vaccination.
- Proportion of women willing to be vaccinated against pertussis and flu during pregnancy.
- Proportion of health professionals agreeing to vaccinate pregnant women against flu and pertussis.
Secondary endpoints:
- Flu and pertussis immunization coverage of pregnant and postpartum women.
- Flu and pertussis immunization coverage of health professionals.
- Proportion of patient records with vaccination trace.
- Link between understanding of vaccines and vaccine-preventable diseases, and immunization coverage of health professionals.
- Link between attitudes and practices of health professionals, and immunization coverage of patients.
- Link between immunization coverage of patients and health professionals.
- Conditions
- Pertussis Vaccine, Healthcare Worker Patient Transmission, Pregnant Women, Influenza Vaccination
- Being tested
- questionnaire
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Questionnaire survey
| Study group | Role | What they receive |
|---|---|---|
| Pregnant and postpartum women | Pregnant and postpartum women over 18, meeting inclusion and exclusion criteria. Receives: Other: questionnaire | |
| healthcare workers | Health professionals over 18, working in maternity wards included. Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify in each maternity hospital facilitators of flu and pertussis vaccination
Qualitative interviews
Measured: May 2019 - July 2019
Proportion of women willing to be vaccinated against pertussis and flu during pregnancy
Questionnaire survey
Measured: September 2019-December 2019
Proportion of health professionals agreeing to vaccinate pregnant women against flu and pertussis.
Questionnaire survey
Measured: October 2019-February 2020
Secondary outcomes (3)
Flu and pertussis immunization coverage of pregnant and postpartum women
Questionnaire survey
Measured: September 2019-December 2019
Flu and pertussis immunization coverage of health professionals
Two survey Questionnaires: one distributed to health professionals, one addressed to Occupational Health services
Measured: October 2019-February 2020
Proportion of patient records with vaccination trace
Review of sample of patient records
Measured: October-December 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2020
- Study start3 May 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pertussis VaccineStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux
- Sponsor type
- Research network
- Collaborators
- Agence Regionale de Sante d'Ile de France, National Agency of Public Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04494581
- Sponsor's protocol ID
- GriCoVax - GERES
- Other IDs
- 2019-A00346-51
- Acronym
- GriCoVax
- Status last verified
- Jul 2020
- First submitted
- 22 Jul 2020
- Last updated
- 31 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Practices and of Immunization Programs Against Flu and Pertussis in Maternity Hospitals
- ClinicalTrials.gov ID
- NCT04494581
- Acronym / sponsor ID
- GriCoVax / GriCoVax - GERES
- Conditions
- Pertussis Vaccine, Healthcare Worker Patient Transmission, Pregnant Women, Influenza Vaccination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents InfectieuxResearch network
- Collaborators
- Agence Regionale de Sante d'Ile de France, National Agency of Public Health
- Study start
- 3 May 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 31 Jul 2020 (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.
Implementation of organizational adjustments can enhance involvement of healthcare teams in carrying out flu and pertussis vaccinations, and optimizing access to vaccines for women and their families. Pertussis vaccination of pregnant women is envisaged by the French Health Autority, considering that, given international experiences, vaccination during the second trimester of pregnancy is safe, effective, and would aim to protect babies during the first months of their life. Before considering such a recommendation in France, the acceptability of this strategy by pregnant women and health professionals must be considered.
Detailed description
Multicentre, descriptive study conducted in a declarative manner and supplemented by direct observation by an investigator.
Main objectives:
- Assess existing practices of the various actors involved in flu and pertussis vaccination of pregnant or postpartum women medically followed in maternity wards.
- Assess acceptability of pertussis and flu vaccination during pregnancy by women medically followed in maternity wards, and by health professionals of theses facilities.
Secondary objectives:
- Assess flu and pertussis immunization coverage of pregnant and postpartum women and of health professionals working in maternity wards.
- Assess the links between immunization coverage of health professionals and their current practices in promoting flu and pertussis vaccination of women in maternity wards.
Main outcome measures:
- Identify in each maternity hospital facilitators of flu and pertussis vaccination.
- Proportion of women willing to be vaccinated against pertussis and flu during pregnancy.
- Proportion of health professionals agreeing to vaccinate pregnant women against flu and pertussis.
Secondary endpoints:
- Flu and pertussis immunization coverage of pregnant and postpartum women.
- Flu and pertussis immunization coverage of health professionals.
- Proportion of patient records with vaccination trace.
- Link between understanding of vaccines and vaccine-preventable diseases, and immunization coverage of health professionals.
- Link between attitudes and practices of health professionals, and immunization coverage of patients.
- Link between immunization coverage of patients and health professionals.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant and postpartum women | – | Other: questionnairePregnant and postpartum women over 18, meeting inclusion and exclusion criteria. |
| healthcare workers | – | Other: questionnaireHealth professionals over 18, working in maternity wards included. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteer women and staff.
Key inclusion criteria (2 listed)
- Pregnant and postpartum women over 18 medically followed in maternity wards included. Femmes enceintes ou en post-partum :
- Health professionals over 18 working in maternity wards included.
Key exclusion criteria (1 listed)
- Women under the protection of a conservator Temporary Health staff
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaireQuestionnaire survey | Other | Pregnant and postpartum women, healthcare workers |
Primary outcome
Identify in each maternity hospital facilitators of flu and pertussis vaccination
Time frame: May 2019 - July 2019
Qualitative interviews
Proportion of women willing to be vaccinated against pertussis and flu during pregnancy
Time frame: September 2019-December 2019
Questionnaire survey
Proportion of health professionals agreeing to vaccinate pregnant women against flu and pertussis.
Time frame: October 2019-February 2020
Questionnaire survey
3 secondary outcomes
Flu and pertussis immunization coverage of pregnant and postpartum women
Time frame: September 2019-December 2019
Flu and pertussis immunization coverage of health professionals
Time frame: October 2019-February 2020
Proportion of patient records with vaccination trace
Time frame: October-December 2019
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 31 Jul 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pertussis Vaccine and Healthcare Worker Patient Transmission, run by Groupe d'Etude sur le Risque d'Exposition des Soignants aux Agents Infectieux at 4 sites in France.
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 2 inclusion and 1 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 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
Identify in each maternity hospital facilitators of flu and pertussis vaccination (time frame: May 2019 - July 2019). The study lists 3 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 31 Jul 2020.