A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.
Recruiting at608 trial locations
Age: < 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Pfizer
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?
This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of maternal immunization with RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) in infants.
Research Team
PC
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Eligibility Criteria
Inclusion Criteria
The participant is willing to allow her infant to participate in the study and has given informed consent.
The woman had negative HIV, syphilis, and HBV tests during her pregnancy and before she was chosen for the study.
Women who are pregnant with only one baby, are younger than 49 years old, and are between 24 and 36 weeks pregnant. They should also not have any known complications that could increase the risk of problems.
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Treatment Details
Interventions
- Placebo (Other)
- RSVpreF (Virus Therapy)
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RSVpreF vaccineExperimental Treatment1 Intervention
RSVpreF
Group II: Placebo dosePlacebo Group1 Intervention
Placebo
RSVpreF is already approved in Canada, Japan for the following indications:
Approved in Canada as Abrysvo for:
- LRTD caused by RSV in adults 60 years of age and older
- LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age
Approved in Japan as Abrysvo for:
- LRTD caused by RSV in adults 60 years of age and older
- LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University