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Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women

NCT04766086

CompletedPhase 2

Sponsor: Pfizer

Conditions: Group B Streptococcus Infections

Interventions: Multivalent Group B streptococcus vaccine, Tetanus, diphtheria, and acellular pertussis vaccine, Placebo

Countries: United States

This phase 2B, placebo-controlled, randomized, observer-blinded trial will evaluate the safety, tolerability, and immunogenicity of the investigational multivalent group B streptococcus vaccine administered concomitantly with Tdap in healthy nonpregnant women 18 through 49 years of age.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 49 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Locations (12)

Newton, Kansas, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Raleigh, North Carolina, United States
Wilmington, North Carolina, United States
Dayton, Ohio, United States
Dayton, Ohio, United States
Oklahoma City, Oklahoma, United States
Knoxville, Tennessee, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States