Clinical trial NCT04843111: Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)
Official title: The MenQuadfi® Pregnancy Registry: A Surveillance Registry to Assess the Safety of MenQuadfi® Among Exposed Pregnant Women and Their Offspring
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Meningococcal Infection
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2021-04-13
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief 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).

Detailed 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.

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 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.

Primary outcomes:
measure: Percentage of pregnant women with maternal adverse events (AEs)
timeFrame: From vaccination to end of follow-up (i.e.,up to 22 months after cohort entry)
measure: Percentage of pregnant women with obstetrical AEs
timeFrame: From vaccination to 28 days after delivery
measure: Percentage of pregnant women with pregnancy AEs
timeFrame: On day of birth
Secondary outcomes:
measure: Percentage of offsprings with adverse neonatal AEs
timeFrame: From day of birth to 28 days post-birth
measure: Percentage of offsprings with adverse infant AEs
timeFrame: From day 29 post-birth to 365 days post-birth
Other outcomes:
Locations:
city: Swiftwater
country: United States
facility: Pennsylvania Locations
state: Pennsylvania
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: