A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A BOOSTER DOSE OF A GROUP B STREPTOCOCCUS 6 VALENT POLYSACCHARIDE CONJUGATE VACCINE (GBS6) IN HEALTHY ADULTS

Pfizer

Status and phase

Completed

Phase 2

Conditions

Group B Streptococcal Infections

Treatments

Biological: Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04258995

C1091007

Details and patient eligibility

About

This study is an extension to the completed first-in-human C1091001 study (NCT03170609) and is to evaluate the safety and immunogenicity of a single booster vaccine dose of GBS6, administered approximately 2 years or more after a primary GBS6 dose, to healthy adult males and nonpregnant women. The study will determine whether individuals who received a primary dose of GBS6 have additional benefit following a booster dose.

Enrollment

151 patients

Sex

All

Ages

20 to 51 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy adults (male and female) at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
Participants who were enrolled in the C1091001 study, received GBS6, and completed the 1-month blood draw.

Exclusion criteria

Pregnant female participants; breastfeeding female participants; positive urine pregnancy test for women of childbearing potential (WOCBP) at Visit 1 (prior to vaccination); and WOCBP who are, in the opinion of the investigator, sexually active and at risk for pregnancy and fertile men and WOCBP who are unwilling or unable to use effective methods of contraception as outlined in this protocol from the signing of the informed consent until at least 3 months after the last dose of investigational product.
Acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. Chronic medical conditions include human immunodeficiency virus, chronic hepatitis B virus (HBV) infection (HBV surface antigen positive), and/or hepatitis C virus infection.
History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis) to any vaccine.
History of microbiologically proven invasive disease caused by group B streptococcus (Streptococcus agalactiae).
Previous vaccination with any licensed or investigational group B streptococcus vaccine (other than GBS6), or planned receipt during the participant's participation in the study (through 6-month telephone call).