NCT04843111 Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)
| NCT ID | NCT04843111 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sanofi Pasteur, a Sanofi Company |
| Condition | Meningococcal Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-03-05 |
| Primary Completion | 2028-05-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2021-03-05 with a primary completion date of 2028-05-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Primary Objective: To assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women vaccinated with MenQuadfi® during pregnancy or in the 30 days preceding their Last Menstrual Period (LMP).
Eligibility Criteria
Inclusion Criteria: The eligible population will include pregnant women and their offspring residing in the US and its territories who are exposed to MenQuadfi® during their pregnancy or within 30 days prior to their LMP, for whom the exposure is reported to the pregnancy registry. Reports of MenQuadfi® pregnancy exposure must contain the following information: * Sufficient evidence to confirm that vaccination occurred during the pregnancy or in the 30 days preceding the LMP; * Vaccine name (brand or generic) is provided (i.e., MenQuadfi®, Meningococcal vaccine, MenACWY conjugate vaccine), or not specified (eg, meningococcal vaccine from an unknown manufacturer). Exclusion Criteria: Only post-marketing spontaneous case reports will be included; reports from clinical trials will not be part of the registry. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contact & Investigator
Trial Transparency email recommended (Toll free number for US & Canada)
✉ Contact-Us@sanofi.com📞 800-633-1610
Clinical Sciences & Operations
STUDY DIRECTOR
Sanofi
Frequently Asked Questions
Who can join the NCT04843111 clinical trial?
This trial is open to participants of all sexes, studying Meningococcal Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04843111 currently recruiting?
Yes, NCT04843111 is actively recruiting participants. Contact the research team at Contact-Us@sanofi.com for enrollment information.
Where is the NCT04843111 trial being conducted?
This trial is being conducted at Swiftwater, United States.
Who is sponsoring the NCT04843111 clinical trial?
NCT04843111 is sponsored by Sanofi Pasteur, a Sanofi Company. The principal investigator is Clinical Sciences & Operations at Sanofi. The trial plans to enroll 50 participants.