Recruiting

MenQuadfi

Sponsor:

Sanofi Pasteur, a Sanofi Company

Code:

NCT04843111

Conditions

Meningococcal Infection

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

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

Study Details

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

Study ID

NCT04843111

Start date

Mar 5, 2021

Status verified date

Nov, 2025

Completion date

May 18, 2028

Anticipated

Primary completion date

May 18, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

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

Pharmaceutical form: Solution for injection Route of administration: Intramuscular

Primary outcome measure

  • Percentage of pregnant women with maternal adverse events (AEs) [ Time Frame: From vaccination to end of follow-up (i.e.,up to 22 months after cohort entry) ]
  • Percentage of pregnant women with obstetrical AEs [ Time Frame: From vaccination to 28 days after delivery ]
  • Percentage of pregnant women with pregnancy AEs [ Time Frame: On day of birth ]

Central Contacts and Locations

Central contacts

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

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

Locations

Pennsylvania Locations

Recruiting

Swiftwater, Pennsylvania, United States, 18370-0187

More Information

Sponsor

Sanofi Pasteur, a Sanofi Company

Last update posted

Dec 1, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sanofi Pasteur, a Sanofi Company on 2025-12-01.