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

Brief description of study

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).

Detailed description of 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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Meningococcal Infection
  • Gender: Male or Female

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.

Updated on 31 Jan 2023 . Study ID: NCT04843111

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