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

ConditionMeningococcal Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSanofi Pasteur, a Sanofi Company

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

None

Trial population

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 last menstrual period (LMP), for whom the exposure is reported to the pregnancy registry.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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

    Biological/Vaccine

    Pharmaceutical form: Solution for injection Route of administration: Intramuscular

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Pregnant women and their offspring(s)1 intervention

Trial outcomes

Primary outcomes

1

Percentage of pregnant women with maternal adverse events (AEs)

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)

Time frame
From vaccination to end of follow-up (i.e.,up to 22 months after cohort entry)
2

Percentage of pregnant women with obstetrical AEs

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)

Time frame
From vaccination to 28 days after delivery
3

Percentage of pregnant women with pregnancy AEs

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)

Time frame
On day of birth

Secondary outcomes

1

Percentage of offsprings with adverse neonatal AEs

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)

Time frame
From day of birth to 28 days post-birth
2

Percentage of offsprings with adverse infant AEs

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sanofi Pasteur, a Sanofi Company

Lead sponsor

Source ClinicalTrials.gov
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