The MenQuadfi® Pregnancy Registry: A Surveillance Registry to Assess the Safety of MenQuadfi® Among Exposed Pregnant Women and Their Offspring

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Healthy Volunteers: t
View:

⁃ 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).

Locations
United States
Pennsylvania
Pennsylvania Locations
RECRUITING
Swiftwater
Contact Information
Primary
Trial Transparency email recommended (Toll free number for US & Canada)
Contact-Us@sanofi.com
800-633-1610
Time Frame
Start Date: 2021-03-05
Estimated Completion Date: 2028-05-18
Participants
Target number of participants: 50
Treatments
Pregnant women and their offspring(s)
Pregnant women and their offspring(s) exposed to MenQuadfi® during their pregnancy or within 30 days prior to their LMP
Related Therapeutic Areas
Sponsors
Leads: Sanofi Pasteur, a Sanofi Company

This content was sourced from clinicaltrials.gov