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
Condition: Group B Streptococcal Infections
MeSH terms: Streptococcal Infections
Intervention: Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6)
Intervention description: 2 formulations at 1 dose level
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: There are two arms in the study however based on the prior formulation received participants can only be enrolled into one predetermined arm in the study. Participants are assigned by an interactive response technology (IRT) based on prior formulation received.
Masking: None (Open Label)
Enrollment: 151.0
Sex: All
Minimum age: 20 Years
Maximum age: 51 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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.

          2. Participants who were enrolled in the C1091001 study, received GBS6, and completed the
             1-month blood draw.

        Exclusion Criteria:

          1. 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.

          2. 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.

          3. History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis)
             to any vaccine.

          4. History of microbiologically proven invasive disease caused by group B streptococcus
             (Streptococcus agalactiae).

          5. 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).