Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-Pregnant Subjects.
Condition: Bacterial Infection Due to Streptococcus, Group B
MeSH terms: Bacterial Infections
Intervention: GBS Trivalent Vaccine
Intervention description: Administration of lyophilized formulation of a GBS trivalent vaccine containing 5 µg of each polysaccharide capsules from serotypes Ia, Ib, and III of Group B Streptococcus conjugated to CRM-197 .
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: Female
Minimum age: 22 Years
Maximum age: 46 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of this extension study is the initial assessment of safety and immunogenicity
      of the second dose of GBS Trivalent Vaccine following the time interval that is close to the
      inter-pregnancy interval observed in the general population.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy, non-pregnant subjects who have received a single 5 µg dose of GBS Trivalent
             Vaccine or placebo in the V98_06 study and healthy non-pregnant female subjects aged
             22-46 years inclusive on the day of informed consent who have not received any GBS
             vaccine in the past

          2. Individuals in good health as determined by the outcome of medical history, physical
             examination and clinical judgment of the investigator

          3. Females of childbearing potential who are using an effective birth control method
             which they intend to use until the end of the study (day 181 visit) or females of
             non-childbearing potential

        Exclusion Criteria:

          1. Progressive, unstable or uncontrolled clinical conditions, or clinical conditions
             representing a contraindication to intramuscular vaccination and blood draws

          2. Abnormal function of the immune system

          3. Received immunoglobulins or any blood products within 180 days prior to informed
             consent

          4. Received an investigational or non-registered medicinal product within 30 days prior
             to informed consent

          5. Any other clinical condition that, in the opinion of the investigator, might interfere
             with the results of the study or pose additional risk to the subject due to
             participation in the study

          6. Individuals who received any other vaccines within 14 days for inactivated vaccines or
             28 days for live vaccines prior to enrolment in this study or who are planning to
             receive any vaccine within 28 days from the study vaccination. Exception - an
             inactivated influenza vaccine may be administered up to 7 days prior to study
             vaccination or 7 days after study vaccination

          7. Individuals who anticipate becoming pregnant prior to the end of the study, or
             individuals who are breastfeeding

          8. Individuals who have had a previous immunization with a vaccine containing Group B
             Streptococcus antigens that was not part of V98_06 study

          9. Individuals with a fever (oral temperature ≥ 38°C) within 3 days prior to day 1 or use
             of antipyretics and/or analgesic medications within 24 hours prior to day 1

         10. Individuals with acute or chronic infection(s) that require systemic antibiotic
             treatment or antiviral therapy, within 7 days prior to day 1