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

A PHASE 2B, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A HEXAVALENT GROUP B STREPTOCOCCUS VACCINE WHEN ADMINISTERED CONCOMITANTLY WITH TETANUS, DIPHTHERIA, AND ACELLULAR PERTUSSIS VACCINE (TDAP) IN HEALTHY NONPREGNANT WOMEN 18 THROUGH 49 YEARS OF AGE

Sponsors

Lead Sponsor: Pfizer

Source Pfizer
Brief Summary

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

Overall Status Not yet recruiting
Start Date March 31, 2021
Completion Date April 10, 2022
Primary Completion Date April 10, 2022
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentages of participants reporting prompted local reactions within 7 days following investigational product administration Day 7
Percentages of participants reporting prompted systemic events within 7 days following investigational product administration Day 7
Percentages of participants reporting adverse events (AEs) through 1 month following investigational product administration 1 month following administration of investigational product
Percentages of participants reporting medically attended adverse events (MAEs) and serious adverse events (SAEs) through 6 months following investigational product administration 6 months following administration of investigational product
Difference in percentages of participants with anti-tetanus toxoid antibody concentrations greater than or equal to 0.1 IU/mL measured 1 month after vaccination between the GBS6 and Tdap group and the placebo and Tdap group 1 month after investigational product administration
Difference in percentages of participants with anti-diphtheria toxoid antibody concentrations greater than or equal to 0.1 IU/mL measured 1 month after vaccination between GBS6 and Tdap group and placebo and Tdap group 1 month after investigational product administration
Geometric mean concentration (GMC) ratio, estimated by the ratio of the GMC of anti-pertussis toxin antibodies from the GBS6 and Tdap group to the placebo and Tdap group measured 1 month after vaccination. 1 month after investigational product administration
GMC ratio, estimated by the ratio of the GMC of anti-filamentous hemagglutinin (anti-FHA) antibodies from the GBS6 and Tdap group to the placebo and Tdap group measured 1 month after vaccination. 1 month after investigational product administration
GMC ratio, estimated by the ratio of the GMC of antipertactin (anti-PRN) antibodies from the GBS6 and Tdap group to the placebo and Tdap group measured 1 month after vaccination. 1 month after investigational product administration
GBS capsular polysaccharide (CPS) serotype-specific IgG GMC ratio, estimated by the ratio of the GMC of GBS CPS serotype-specific IgG antibodies from the GBS6 and Tdap group to the GBS6 and placebo group measured 1 month after vaccination. 1 month after investigational product administration
Enrollment 1740
Condition
Intervention

Intervention Type: Biological

Intervention Name: Hexavalent Group B streptococcus vaccine

Description: Hexavalent Group B streptococcus vaccine

Intervention Type: Biological

Intervention Name: Tetanus, diphtheria, and acellular pertussis vaccine

Description: Tetanus, diphtheria, and acellular pertussis vaccine

Other Name: Tdap

Intervention Type: Biological

Intervention Name: Placebo

Description: Saline control

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. - 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 6-month follow-up visit [Visit 3]). - Vaccination within 5 years with tetanus and diphtheria toxoids and acellular pertussis-containing vaccines (Tdap) before investigational product administration.

Gender: Female

Gender Based: Yes

Gender Description: Healthy women ≥18 and ≤49 years of age.

Minimum Age: 18 Years

Maximum Age: 49 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Pfizer CT.gov Call Center Study Director Pfizer
Overall Contact

Last Name: Pfizer CT.gov Call Center

Phone: 1-800-718-1021

Email: [email protected]

Verification Date

February 2021

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: GBS6 and Tdap

Type: Experimental

Description: Hexavalent group B streptococcus vaccine and Tetanus, diphtheria, and acellular pertussis vaccine (Tdap)

Label: GBS6 and Placebo

Type: Experimental

Description: Hexavalent group B streptococcus vaccine and Placebo

Label: Placebo and Tdap

Type: Experimental

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

Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Double (Participant, Investigator)

Masking Description: This is an observer-blinded study. Study staff dispensing and administering the vaccine will be unblinded, but all other study personnel, including the principal investigator, and the subject, will be blinded.

Source: ClinicalTrials.gov