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.

July 15, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

306

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Saint-Étienne, France, 42055
        • Centre hospitalier universitaire de St Etienne
        • Principal Investigator:
          • Nelly JACQUEMET, Nurse
        • Sub-Investigator:
          • Amandine GAGNEUX-BRUNON, MD PhD
        • Sub-Investigator:
          • Maëlle DETOC, CRA
        • Sub-Investigator:
          • Elisabeth NOTELHO-NEVERS, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All french participants of the CMVCTORY vaccine trial.

Description

Inclusion Criteria:

  • Womens between 18 to 40 included in CMVCTORY vaccine trial

Exclusion Criteria:

  • Refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day : 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Nelly JACQUEMET, nurse, CHU Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

July 9, 2024

First Submitted That Met QC Criteria

July 15, 2024

First Posted (Actual)

July 22, 2024

Study Record Updates

Last Update Posted (Actual)

July 22, 2024

Last Update Submitted That Met QC Criteria

July 15, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRBN432024/CHUSTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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