NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT04843111

RecruitingN/A

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions: Meningococcal Infection

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

Countries: United States

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 overview

Sex: ALL

Healthy volunteers: Yes

Study type: OBSERVATIONAL

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.

Locations (1)

Swiftwater, Pennsylvania, United States