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.

NCT06511635 | Not Yet Recruiting

• 1 other identifier: IRBN432024/CHUSTE
• Study Type: observational
• Target: 306
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Recruitment methods; Determinants; CMVCTORY vaccine trial; women's participation; vaccine trial

Outcome Measures

Primary Outcomes (1)

• qualitative interview

  To identify the motivations and the obstacles of participation in an experimental trial in women of childbearing age in Phase 3 trial.

  Day : 1

Study Arms (1)

Women between 18 to 40 included in CMVCTORY vaccine trial

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

Other: Qualitative interview; Other: Quantitative questionnaire

Interventions

Qualitative interview 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.

Women between 18 to 40 included in CMVCTORY vaccine trial

Quantitative questionnaire 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).

Women between 18 to 40 included in CMVCTORY vaccine trial

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All french participants of the CMVCTORY vaccine trial.

You may qualify if:

• Womens between 18 to 40 included in CMVCTORY vaccine trial

You may not qualify if:

• Refusal

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Centre Hospitalier Universitaire de St Etienne

Saint-Etienne, 42055, France

Location

Study Officials

• Nelly JACQUEMET, nurse

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nelly JACQUEMET, nurse

CONTACT

(0)477829658; rechercheclinique.infectiologie.IDE@chu-st-etienne.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 22, 2024
• Study Start: September 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)