Meningococcal InfectionNCT04843111
Observational, Passive Surveillance Program to Collect Information on Women and Their Offspring Exposed to MenQuadfi® During Pregnancy, in United States (US)
An observational study of Meningococcal Infection, run by Sanofi Pasteur, a Sanofi Company at 1 site in United States.
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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Infection
- What is being tested?
- Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2021to 18 May 2028
- How long will I take part?
- 22 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free number for US & Canada) contact
United States1 site, 1 recruiting
- Recruiting
Pennsylvania Locations
Swiftwater, Pennsylvania, 18370-0187
About this study
Official title: The MenQuadfi® Pregnancy Registry: A Surveillance Registry to Assess the Safety of MenQuadfi® Among Exposed Pregnant Women and Their Offspring
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).
Read the 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.
- Conditions
- Meningococcal Infection
- Being tested
- Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccineBiological
Also called Meningococcal A-C-Y-W135 (T CONJ) vaccine
Pharmaceutical form: Solution for injection Route of administration: Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women and their offspring(s) | Pregnant women and their offspring(s) exposed to MenQuadfi® during their pregnancy or within 30 days prior to their LMP Receives: Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: From vaccination to end of follow-up (i.e.,up to 22 months after cohort entry)
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)
Measured: From vaccination to 28 days after delivery
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)
Measured: On day of birth
Secondary outcomes (2)
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)
Measured: From day of birth to 28 days post-birth
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
Measured: From day 29 post-birth to 365 days post-birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start5 Mar 2021
- Primary completion18 May 2028 (estimated)
- Study completion18 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meningococcal InfectionStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 22 Months
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04843111
- Sponsor's protocol ID
- MEQ00070
- Other IDs
- U1111-1250-2672, MEQ00070
- Status last verified
- Nov 2025
- First submitted
- 8 Apr 2021
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org