Status:
COMPLETED
Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women
Lead Sponsor:
Pfizer
Conditions:
Group B Streptococcus Infections
Eligibility:
FEMALE
18-49 years
Phase:
PHASE2
Brief Summary
This phase 2B, placebo-controlled, randomized, observer-blinded trial will evaluate the safety, tolerability, and immunogenicity of the investigational multivalent group B streptococcus vaccine admini...
Eligibility Criteria
Inclusion
- Healthy women ≥18 and ≤49 years of age.
- Participants who are willing and able to comply with scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures, including completion of the e-diary from Day 1 to Day 7 following administration of investigational product.
- Healthy females at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
- Expected to be available for the duration of the study and who can be contacted by telephone during study participation.
- Capable of giving personal signed informed consent.
Exclusion
- Pregnant female participants; breastfeeding female participants; positive urine pregnancy test for women of childbearing potential (WOCBP) at Visit 1 (prior to vaccination)
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any diphtheria toxoid-containing or CRM197-containing vaccine.
- History of microbiologically proven invasive disease caused by group B streptococcus.
- Immunocompromised participants with known or suspected immunodeficiency.
- Bleeding diathesis or condition associated with prolonged bleeding that would in the opinion of the investigator contraindicate intramuscular injection.
- Other acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Previous vaccination with any licensed or investigational GBS vaccine, or planned receipt during the participant's participation in the study (through the 1-month follow-up visit \[Visit 2\]).
- Vaccination within 5 years with tetanus and diphtheria toxoids and acellular pertussis-containing vaccines (Tdap) before investigational product administration.
- Participants who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids
- Vaccination with diphtheria- or CRM197-containing vaccine(s) from 6 months before investigational product administration, or planned receipt through the 1-month follow-up visit.
- Receipt or planned receipt of blood/plasma products or immunoglobulin, from 60 days before investigational product administration through the 1-month follow-up visit
- Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation
Key Trial Info
Start Date :
August 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2023
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT04766086
Start Date
August 12 2022
End Date
April 27 2023
Last Update
May 24 2024
Active Locations (12)
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1
Alliance for Multispecialty Research, LLC
Newton, Kansas, United States, 67114
2
Quality Clinical Research, Inc
Omaha, Nebraska, United States, 68114
3
Alliance for Multispecialty Research, LLC
Las Vegas, Nevada, United States, 89119
4
Accellacare - Raleigh
Raleigh, North Carolina, United States, 27609