Pertussis/Whooping CoughCOVAGRIPNCT05234229
Influenza and Pertussis Vaccination Status of Women in Immediate Postpartum and Caregivers
An observational study of Pertussis/Whooping Cough and Influenza Viral Infections, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Pertussis is a bacterial respiratory infection caused by Bordetella pertussis. Highly contagious, it is potentially serious and even fatal in infants under 6 months of age. The immunity acquired through vaccination is very limited in time, requiring regular booster shots. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pertussis/Whooping Cough, Influenza Viral Infections
- What is being tested?
- Survey
- Type of treatment
- Vaccines
- How many people
- 254 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2022to 30 Oct 2023
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women over 18 years old, delivery after 35GA and healthcare staff of the University Maternity Hospital of Nancy in 2022. Person having received complete information about the research and not opposed to the study.
Who may be able to join
- Person having received complete information about the research and not opposed to the study.
- Hospitalization in the post-partum service and within the last 5 days of delivery.
- women. caregivers
Who cannot join
- Female under 18 years of age,
- Woman under legal protection,
- Delivery of a stillborn child,
- Premature delivery < 35GA,
- Hospitalized newborn,
- Women who doesn't speak french.
Trial locations and contacts
1 site in 1 country.
France1 site
Maternite Regionale Universitaire CHRU NANCY
Nancy, Lorraine, 54035
About this study
Official title: Influenza and Pertussis Vaccination Status of Women in Immediate Postpartum and Caregivers in the Maternity Hospital of Nancy
Pertussis is a bacterial respiratory infection caused by Bordetella pertussis. Highly contagious, it is potentially serious and even fatal in infants under 6 months of age. The immunity acquired through vaccination is very limited in time, requiring regular booster shots. There is a passive protection of the newborn by the maternal-fetal transmission of maternal antibodies, but it is brief. The infant's first vaccination is given at 2 months of age and immunity is not acquired until the second injection at 4 months of age. The booster at 11 months of age is essential to prolong this immunity.
In order to protect infants under 6 months of age, France has recommended since 2004 the cocooning strategy, which consists of vaccinating people likely to be in close contact with the infant during this period. This vaccination is therefore proposed to adults who are planning to have children, to the entourage of pregnant women, and in the immediate post-partum period for the mother (and people who were not vaccinated during pregnancy). This strategy was put in place following the international recommendation of a forum of scientific experts, the Global Pertussis Initiative.
Read more
In France, vaccination against pertussis is not currently recommended during pregnancy. There is no contraindication to vaccination during pregnancy and it is recommended in many countries.
Influenza is a viral respiratory infection caused by Myxovirus influenzae, which is highly contagious.
In France, vaccination against influenza is recommended for pregnant women, regardless of the trimester of pregnancy. It is also recommended for the entourage of infants under 6 months of age with risk factors for severe influenza.
There are few recent data in the scientific literature regarding influenza and pertussis vaccination coverage among pregnant or postpartum women in France. In addition, the COVID19 pandemic has recently reopened the debate on vaccination of the general population and caregivers. Knowing the current status of vaccination coverage among pregnant women and caregivers, their knowledge and fears regarding vaccination could help improve the information provided by healthcare staff.
- Being tested
- Survey
- Keywords
- immunization, cocooning
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Collection of immunization status by questionnaire
| Study group | Role | What they receive |
|---|---|---|
| covagrip women in immediate post partum | women in immediate post partum Receives: Other: Survey | |
| Caregivers | health care personnel Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of influenza vaccination
To determine the rate of influenza immunization in immediate postpartum women and caregivers at the Nancy University Maternity Hospital in 2022 .
Measured: 4 months
Prevalence of pertussis vaccination
To determine the rate of pertussis immunization in immediate postpartum and caregivers at the Nancy University Maternity Hospital in 2022
Measured: 4 months
Secondary outcomes (4)
awareness of own vaccination status
To determine the awareness of own vaccination status (yes; no; unknown) in immediate postpartum women regarding their influenza and pertussis immunization
Measured: 4 months
Knowledge about vaccination
To determine the rate of right answers to a questionnaire about knowledge of influenza and pertussis vaccination, and the possibility of vaccination during pregnancy.
Measured: 4 months
opinion on vaccination during pregnancy
To determine the rate of differences in vaccination coverage and knowledge among postpartum women and healthcare staff.
Measured: 4 months
readiness to receive pertussis and influenzae immunization
to answer the readiness (yes; no; already vaccinated) to receive immunization after answering the questionnaire
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Mar 2022
- Primary completion31 Aug 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pertussis/Whooping CoughStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Michel HASCOET, Central Hospital, Nancy, France
- Investigators
- Jean Michel HASCOET, Study director, Maternité Régionale Universitaire CHRU NANCY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234229
- Sponsor's protocol ID
- 2021PI087
- Acronym
- COVAGRIP
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2022
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza and Pertussis Vaccination Status of Women in Immediate Postpartum and Caregivers in the Maternity Hospital of Nancy
- ClinicalTrials.gov ID
- NCT05234229
- Acronym / sponsor ID
- COVAGRIP / 2021PI087
- Keywords
- immunization, cocooning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 10 Feb 2022 (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.
Pertussis is a bacterial respiratory infection caused by Bordetella pertussis. Highly contagious, it is potentially serious and even fatal in infants under 6 months of age. The immunity acquired through vaccination is very limited in time, requiring regular booster shots. There is a passive protection of the newborn by the maternal-fetal transmission of maternal antibodies, but it is brief. The infant's first vaccination is given at 2 months of age and immunity is not acquired until the second injection at 4 months of age. The booster at 11 months of age is essential to prolong this immunity.
In order to protect infants under 6 months of age, France has recommended since 2004 the cocooning strategy, which consists of vaccinating people likely to be in close contact with the infant during this period. This vaccination is therefore proposed to adults who are planning to have children, to the entourage of pregnant women, and in the immediate post-partum period for the mother (and people who were not vaccinated during pregnancy). This strategy was put in place following the international recommendation of a forum of scientific experts, the Global Pertussis Initiative.
In France, vaccination against pertussis is not currently recommended during pregnancy. There is no contraindication to vaccination during pregnancy and it is recommended in many countries.
Influenza is a viral respiratory infection caused by Myxovirus influenzae, which is highly contagious.
In France, vaccination against influenza is recommended for pregnant women, regardless of the trimester of pregnancy. It is also recommended for the entourage of infants under 6 months of age with risk factors for severe influenza.
There are few recent data in the scientific literature regarding influenza and pertussis vaccination coverage among pregnant or postpartum women in France. In addition, the COVID19 pandemic has recently reopened the debate on vaccination of the general population and caregivers. Knowing the current status of vaccination coverage among pregnant women and caregivers, their knowledge and fears regarding vaccination could help improve the information provided by healthcare staff.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| covagrip women in immediate post partum | – | Other: Surveywomen in immediate post partum |
| Caregivers | – | Other: Surveyhealth care personnel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women over 18 years old, delivery after 35GA and healthcare staff of the University Maternity Hospital of Nancy in 2022. Person having received complete information about the research and not opposed to the study.
Key inclusion criteria (3 listed)
- Person having received complete information about the research and not opposed to the study.
- Hospitalization in the post-partum service and within the last 5 days of delivery.
- women. caregivers
Key exclusion criteria (6 listed)
- Female under 18 years of age,
- Woman under legal protection,
- Delivery of a stillborn child,
- Premature delivery < 35GA,
- Hospitalized newborn,
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 |
|---|---|---|
| SurveyCollection of immunization status by questionnaire | Other | Caregivers, covagrip women in immediate post partum |
Primary outcome
Prevalence of influenza vaccination
Time frame: 4 months
To determine the rate of influenza immunization in immediate postpartum women and caregivers at the Nancy University Maternity Hospital in 2022 .
Prevalence of pertussis vaccination
Time frame: 4 months
To determine the rate of pertussis immunization in immediate postpartum and caregivers at the Nancy University Maternity Hospital in 2022
4 secondary outcomes
awareness of own vaccination status
Time frame: 4 months
Knowledge about vaccination
Time frame: 4 months
opinion on vaccination during pregnancy
Time frame: 4 months
readiness to receive pertussis and influenzae immunization
Time frame: 4 months
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 8 Feb 2024.
- 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.
Jean Michel HASCOET study director
Maternité Régionale Universitaire CHRU NANCY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pertussis/Whooping Cough and Influenza Viral Infections, run by Central Hospital, Nancy, France at 1 site 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 3 inclusion and 6 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 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Prevalence of influenza vaccination (time frame: 4 months). 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 8 Feb 2024.