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

Meningococcal Infection Clinical Trial

Official title:

The MenQuadfi® Pregnancy Registry: A Surveillance Registry to Assess the Safety of MenQuadfi® Among Exposed Pregnant Women and Their Offspring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04843111
• Other study ID #: MEQ00070
• Secondary ID: U1111-1250-2672
• Status: Recruiting
• Start date: March 5, 2021
• Est. completion date: May 18, 2028

Study information

• Verified date: August 2023
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free number for US &
• Phone: 800-633-1610
• Email: Contact-Us[@]sanofi.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 18, 2028
• Est. primary completion date: May 18, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Meningococcal Infection
• Meningococcal Infections

Intervention

Biological:
• Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine
Pharmaceutical form: Solution for injection Route of administration: Intramuscular

Locations

Country	Name	City	State
United States	Investigational site	Swiftwater	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	From vaccination to end of follow-up (i.e.,up to 22 months after cohort entry)
Primary	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)	From vaccination to 28 days after delivery
Primary	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)	On day of birth
Secondary	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)	From day of birth to 28 days post-birth
Secondary	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	From day 29 post-birth to 365 days post-birth