RecruitmentNCT06511635
Multicenter Quantitative and Qualitative Study of the Determinants of Participation in a Cytomegalovirus Preventive Vaccine Study in France in Women Aged 18 to 40 Years Old.
An observational study of Recruitment, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
During a vaccine clinical trial of Cytomegalovirus (CMV) vaccine, one of the participants' motivations was to prevent an infection responsible for malformations in a future child. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recruitment
- What is being tested?
- Qualitative interview and Quantitative questionnaire
- Type of treatment
- Vaccines
- How many people
- 306 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2024to Nov 2024
- 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 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: All french participants of the CMVCTORY vaccine trial.
Who may be able to join
- Womens between 18 to 40 included in CMVCTORY vaccine trial
Who cannot join
- Refusal
Trial locations and contacts
1 site in 1 country.
Nelly JACQUEMET, nurse contact
France1 site
Centre Hospitalier Universitaire de St Etienne
Saint-Etienne, 42055
Nelly JACQUEMET, Nurse
Amandine GAGNEUX-BRUNON, MD PhD
About this study
During a vaccine clinical trial of Cytomegalovirus (CMV) vaccine, one of the participants' motivations was to prevent an infection responsible for malformations in a future child. Would their attitude towards a vaccine trial be the same in the context of a vaccine designed to protect them individually? By improving the knowledge of clinical research and determinants in women aged 18 to 40, this study could improve recruitment methods in this specific population for future vaccine trials within the CIC1408 infectious diseases and vaccinology area at Saint-Etienne University Hospital.
- Conditions
- Recruitment
- Being tested
- Qualitative interview, Quantitative questionnaire
- Keywords
- Recruitment methods, Determinants, CMVCTORY vaccine trial, women's participation, vaccine trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative interviewOther
Interview between participant and a researcher, in order to identity the determinants of participation in a clinical trial among participants in the CMVictory vaccine trial.
Quantitative questionnaireOther
Anonymous online survey using a 3-part questionnaire, studying knowledge of clinical research and the determinants of participation in a preventive vaccine study in a population of young women (aged 18-40).
| Study group | Role | What they receive |
|---|---|---|
| Women between 18 to 40 included in CMVCTORY vaccine trial | Women between 18 to 40 included in CMVCTORY vaccine trial will be included. Receives: Other: Qualitative interview; Other: Quantitative questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
qualitative interview
To identify the motivations and the obstacles of participation in an experimental trial in women of childbearing age in Phase 3 trial.
Measured: Day : 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study startSep 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RecruitmentStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Retrospective
- Enrolment
- 306 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nelly JACQUEMET, nurse, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06511635
- Sponsor's protocol ID
- IRBN432024/CHUSTE
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 22 Jul 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 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Quantitative and Qualitative Study of the Determinants of Participation in a Cytomegalovirus Preventive Vaccine Study in France in Women Aged 18 to 40 Years Old.
- ClinicalTrials.gov ID
- NCT06511635
- Acronym / sponsor ID
- IRBN432024/CHUSTE
- Conditions
- Recruitment
- Keywords
- Recruitment methods, Determinants, CMVCTORY vaccine trial, women's participation, vaccine trial
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 22 Jul 2024 (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.
During a vaccine clinical trial of Cytomegalovirus (CMV) vaccine, one of the participants' motivations was to prevent an infection responsible for malformations in a future child. Would their attitude towards a vaccine trial be the same in the context of a vaccine designed to protect them individually? By improving the knowledge of clinical research and determinants in women aged 18 to 40, this study could improve recruitment methods in this specific population for future vaccine trials within the CIC1408 infectious diseases and vaccinology area at Saint-Etienne University Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women between 18 to 40 included in CMVCTORY vaccine trial | – | Other: Qualitative interview, Other: Quantitative questionnaireWomen between 18 to 40 included in CMVCTORY vaccine trial will be included. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All french participants of the CMVCTORY vaccine trial.
Key inclusion criteria (1 listed)
- Womens between 18 to 40 included in CMVCTORY vaccine trial
Key exclusion criteria (1 listed)
- Refusal
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 |
|---|---|---|
| Qualitative interviewInterview between participant and a researcher, in order to identity the determinants of participation in a clinical trial among participants in the CMVictory vaccine trial. | Other | Women between 18 to 40 included in CMVCTORY vaccine trial |
| Quantitative questionnaireAnonymous online survey using a 3-part questionnaire, studying knowledge of clinical research and the determinants of participation in a preventive vaccine study in a population of young women (aged 18-40). | Other | Women between 18 to 40 included in CMVCTORY vaccine trial |
Primary outcome
qualitative interview
Time frame: Day : 1
To identify the motivations and the obstacles of participation in an experimental trial in women of childbearing age in Phase 3 trial.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 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.
Nelly JACQUEMET, nurse contact
Nelly JACQUEMET, nurse principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 Recruitment, run by Centre Hospitalier Universitaire de Saint Etienne 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 1 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: status not confirmed, as of the sponsor's last update on 22 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nelly JACQUEMET, nurse ((0)477829658 ext. +33, rechercheclinique.infectiologie.IDE@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
qualitative interview (time frame: Day : 1). 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 22 Jul 2024.