Monitoring outcomes of women and their babies after MenQuadfi® vaccination during pregnancy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational program aims to collect and analyze data on maternal, obstetrical, pregnancy, and neonatal outcomes for women who received the MenQuadfi® vaccine during pregnancy or within 30 days before their last menstrual period. The study will create a prospective pregnancy registry, encouraging early registration of pregnancies exposed to the vaccine. Participants will be followed throughout their pregnancy and their offspring will be monitored up to one year of age to assess any potential impacts of the vaccination.

Why it matters

Who can join: the full rules

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.

Where it's running

• Pennsylvania Locations
  Swiftwater, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free number for US & Canada)
• Email: Contact-Us@sanofi.com
• Phone: 800-633-1610

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Is its immune response and safety in babies and toddlers when given a meningococcal vaccine in China

  This study tests whether the MenACYW conjugate vaccine safely produces an immune response in healthy infants and toddlers in China, compared with locally licensed vaccines.

  Recruiting at 8 sites Phase 3 Sanofi · Huanggang and 7 other locations · NCT07710872

• Meningococcal vaccine for children 12–23 months old (Group ACYW135)

  This study tests whether the new Group ACYW135 meningococcal vaccine in healthy children aged 12 to 23 months can provoke a similar immune response and has an acceptable safety profile compared with a licensed vaccine.

  Recruiting at 2 sites Phase 3 Sinovac Biotech Co., Ltd · Nanning, Guangxi and 1 other locations · NCT07505836

• Group ACYW135 meningococcal vaccine in children 6-11 months

  This trial tests whether the investigational meningococcal vaccine in healthy infants aged 6 to 11 months can provoke a strong immune response with good safety compared with a licensed vaccine.

  Recruiting at 2 sites Phase 3 Sinovac Biotech Co., Ltd · Nanning, Guangxi and 1 other locations · NCT07505823

• Meningococcal vaccine in infants aged 3-5 months

  This trial tests a new group ACYW135 meningococcal vaccine in healthy babies aged 3 to 5 months to see if it triggers a strong immune response and how safe it is, with a booster given at 12 months.

  Recruiting at 2 sites Phase 3 Sinovac Biotech Co., Ltd · Nanning, Guangxi and 1 other locations · NCT07505810

• National survey on bacterial meningitis in children

  This study is trying to learn more about bacterial meningitis in children by looking at which bacteria are causing it and how things have changed since the introduction of vaccines.

  Recruiting Association Clinique Thérapeutique Infantile du val de Marne · Créteil · NCT04664569

• Meningococcal conjugate vaccine for healthy adults aged 19–55

  This will test a single dose of the EG-MCV4 meningococcal conjugate vaccine to see if it produces protective antibodies and is safe in healthy adults aged 19 to 55.

  Recruiting Phase 2/3 EyeGene Inc. · Seoul · NCT07204457

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.