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NCT Number: NCT04843111

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

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).

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Key information

Conditions

Meningococcal Infection Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Meningococcal Infections Neisseriaceae Infections

Sex eligibility

All sexes

Study type

Observational

Primary location

Pennsylvania Locations

Swiftwater, Pennsylvania, 18370-0187, United States

Location status: Recruiting

About this study

This study is a prospective pregnancy registry to collect and analyze the outcome of exposure to MenQuadfi™ during pregnancy or within 30 days prior to their LMP. The registry will encourage prospective registration, which is defined as registration of a pregnancy exposure prior to knowledge or perceived knowledge of the pregnancy outcome.

Exposed pregnant women will be followed up to the end of their pregnancy, and the offspring(s) will be followed up to 1 year of age.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Biological

Pharmaceutical form: Solution for injection Route of administration: Intramuscular

Other names: Meningococcal A-C-Y-W135 (T CONJ) vaccine

Primary outcomes

  1. 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)

    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)

  2. Percentage of pregnant women with obstetrical AEs

    Time frame: From vaccination to 28 days after delivery

    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)

  3. Percentage of pregnant women with pregnancy AEs

    Time frame: On day of birth

    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)

Secondary outcomes

  1. Percentage of offsprings with adverse neonatal AEs

    Time frame: From day of birth to 28 days post-birth

    Neonatal events defined as any reported AE, following vaccination of a pregnant woman, directly related to the infant and assessed immediately after birth or within the first 28 days of life (e.g., congenital anomalies)

  2. Percentage of offsprings with adverse infant AEs

    Time frame: From day 29 post-birth to 365 days post-birth

    Infant events defined as any reported AE, following vaccination of a pregnant woman, directly related to the infant occurring / diagnosed between days 29 and 365 post-birth

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

800-633-1610 ext. option 6

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Apr 13, 2021
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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