Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)
Recruiting
Observational Study
Meningococcal Infection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Sex
Any
Study type
Observational
Participants needed
50 (estimated)
Sponsor
Sanofi Pasteur, a Sanofi Company · Industry
Who this trial is looking for
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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).
Trial Locations
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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 MenQ…
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.
Contacts
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