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.

NCT ID: NCT06511635

Last Updated: 2024-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

306 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-30

Study Completion Date

2024-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Recruitment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Women between 18 to 40 included in CMVCTORY vaccine trial

Women between 18 to 40 included in CMVCTORY vaccine trial will be included.

Qualitative interview

Intervention Type OTHER

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 questionnaire

Intervention Type OTHER

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).

Interventions

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Qualitative interview

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.

Intervention Type OTHER

Quantitative questionnaire

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).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Womens between 18 to 40 included in CMVCTORY vaccine trial

Exclusion Criteria

* Refusal
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nelly JACQUEMET, nurse

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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Centre Hospitalier Universitaire de St Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Central Contacts

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Nelly JACQUEMET, nurse

Role: CONTACT

(0)477829658 ext. +33

Other Identifiers

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IRBN432024/CHUSTE

Identifier Type: -

Identifier Source: org_study_id

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