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

  • STATUS
    Recruiting
  • End date
    May 16, 2028
  • participants needed
    50
  • sponsor
    Sanofi Pasteur, a Sanofi Company
Updated on 16 May 2022
Accepts healthy volunteers

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).

Description

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.

Details
Condition Meningococcal Infection
Treatment Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Clinical Study IdentifierNCT04843111
SponsorSanofi Pasteur, a Sanofi Company
Last Modified on16 May 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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