Monitoring outcomes of women and their babies after MenQuadfi® vaccination during pregnancy
The MenQuadfi® Pregnancy Registry: A Surveillance Registry to Assess the Safety of MenQuadfi® Among Exposed Pregnant Women and Their Offspring
This study is looking at the health of pregnant women and their babies after they receive the MenQuadfi® vaccine to see if there are any effects from the vaccination.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Sex | All |
| Sponsor | Sanofi Industry-sponsored |
| Locations | 1 site (Swiftwater, Pennsylvania) |
| Trial ID | NCT04843111 on ClinicalTrials.gov |
What this trial studies
This observational program aims to collect and analyze data on maternal, obstetrical, pregnancy, and neonatal outcomes for women who received the MenQuadfi® vaccine during pregnancy or within 30 days before their last menstrual period. The study will create a prospective pregnancy registry, encouraging early registration of pregnancies exposed to the vaccine. Participants will be followed throughout their pregnancy and their offspring will be monitored up to one year of age to assess any potential impacts of the vaccination.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women in the US who have received the MenQuadfi® vaccine during their pregnancy or within 30 days prior to their last menstrual period.
Not a fit: Patients who have not been vaccinated with MenQuadfi® or who are not pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effects of MenQuadfi® vaccination during pregnancy, potentially guiding future vaccination recommendations.
How similar studies have performed: While this study is observational and focuses on post-marketing surveillance, similar approaches in monitoring vaccine safety during pregnancy have shown success in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Swiftwater, Pennsylvania
- Pennsylvania Locations — Swiftwater, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Trial Transparency email recommended (Toll free number for US & Canada)
- Email: Contact-Us@sanofi.com
- Phone: 800-633-1610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.