Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)

NCT04843111 | Recruiting FDA Drug

• 2 other identifiers: MEQ00070U1111-1250-2672
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Meningococcal Infection

Outcome Measures

Primary Outcomes (3)

• Percentage of pregnant women with maternal adverse events (AEs)

  Maternal adverse events defined as any reported adverse event (AE), following vaccination of a pregnant woman, occurring independent of the pregnancy (e.g., injection site reactions)

  From vaccination to end of follow-up (i.e.,up to 22 months after cohort entry)

• Percentage of pregnant women with obstetrical AEs

  Obstetrical adverse events defined as any reported AE, following vaccination of a pregnant woman, related directly to the pregnancy (e.g., complications of pregnancy, labor and delivery, and puerperium)

  From vaccination to 28 days after delivery

• Percentage of pregnant women with pregnancy AEs

  Pregnancy adverse events defined as any reported AE, following vaccination of a pregnant woman, related to birth outcomes (e.g., live birth, spontaneous abortion/miscarriage, stillbirth/fetal death)

  On day of birth

Secondary Outcomes (2)

• Percentage of offsprings with adverse neonatal AEs

  From day of birth to 28 days post-birth

• Percentage of offsprings with adverse infant AEs

  From day 29 post-birth to 365 days post-birth

Study Arms (1)

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

Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine

Interventions

Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine BIOLOGICAL

Pharmaceutical form: Solution for injection Route of administration: Intramuscular

Also known as: Meningococcal A-C-Y-W135 (T CONJ) vaccine

Pregnant women and their offspring(s)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 last menstrual period (LMP), for whom the exposure is reported to the pregnancy registry.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (1)

Pennsylvania Locations

Swiftwater, Pennsylvania, 18370-0187, United States

RECRUITING

MeSH Terms

Conditions

Meningococcal Infections

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Central Study Contacts

Trial Transparency email recommended (Toll free number for US & Canada)

CONTACT

800-633-1610; Contact-Us@sanofi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 22 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 13, 2021
• Study Start: March 5, 2021
• Primary Completion (Estimated): May 18, 2028
• Study Completion (Estimated): May 18, 2028
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)