Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine.
- Who it may be relevant to
- Registry conditions: Meningococcal Infection. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The MenQuadfi® Pregnancy Registry: A Surveillance Registry to Assess the Safety of MenQuadfi® Among Exposed Pregnant Women and Their Offspring
Overview
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.
Interventions
- Biological Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine
Pharmaceutical form: Solution for injection Route of administration: Intramuscular
Primary outcome measures
- Percentage of pregnant women with maternal adverse events (AEs) [Time frame: From vaccination to end of follow-up (i.e.,up to 22 months after cohort entry)]
- Percentage of pregnant women with obstetrical AEs [Time frame: From vaccination to 28 days after delivery]
- Percentage of pregnant women with pregnancy AEs [Time frame: On day of birth]
Secondary outcome measures (2)
- Percentage of offsprings with adverse neonatal AEs [Time frame: From day of birth to 28 days post-birth]
- Percentage of offsprings with adverse infant AEs [Time frame: From day 29 post-birth to 365 days post-birth]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Pennsylvania Locations — Swiftwater
Identifiers
NCT: NCT04843111 · MEQ00070 · U1111-1250-2672 · MEQ00070