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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Group B Streptococcus Infections

Treatments: Biological: Tetanus, diphtheria, and acellular pertussis vaccine; Biological: Placebo; Biological: Multivalent Group B streptococcus vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04766086

C1091005

Details and patient eligibility

About

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.

Enrollment: 306 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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306 participants in 3 patient groups

GBS6 and Tdap

Experimental group

Description:

Multivalent group B streptococcus vaccine and Tetanus, diphtheria, and acellular pertussis vaccine (Tdap)

Treatment:

Biological: Tetanus, diphtheria, and acellular pertussis vaccine

Biological: Multivalent Group B streptococcus vaccine

GBS6 and Placebo

Experimental group

Description:

Multivalent group B streptococcus vaccine and Placebo

Treatment:

Biological: Placebo

Biological: Multivalent Group B streptococcus vaccine

Placebo and Tdap

Experimental group

Description:

Placebo and Tetanus, diphtheria, and acellular pertussis vaccine (Tdap)

Treatment:

Biological: Tetanus, diphtheria, and acellular pertussis vaccine

Biological: Placebo