Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine
Condition: Infections, Streptococcal; Streptococcal Infections
MeSH terms: Infections; Communicable Diseases; Streptococcal Infections
Intervention: GBS Vaccine; GBS Vaccine
Intervention description: Liquid formulation of a vaccine containing polysaccharide capsules from serotypes Ia, Ib, and III of the Group B Streptococcus; Lyophilized formulation of a vaccine containing polysaccharide capsules from serotypes Ia, Ib, and III of the Group B Streptococcus
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1053.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: GBS; vaccine comparability; Group B Strep

Summary:

      The purpose of the present study is to assess and compare in healthy non-pregnant women 18 to
      40 years of age the safety and immunogenicity of a liquid formulation of Group B
      Streptococcus (GBS) Trivalent Vaccine (not requiring reconstitution prior to administration),
      and of the lyophilized formulation of GBS Trivalent Vaccine, administered in non-pregnant and
      pregnant women in the clinical development program to date.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy females 18-40 years of age, inclusive.

          2. Individuals who have given written consent after the nature of the study has been
             explained according to local regulatory requirements.

          3. Individuals in good health as determined by the outcome of medical history, physical
             examination and clinical judgment of the investigator.

          4. Individuals who can comply with all study procedures and are available for follow-up.

        Exclusion Criteria:

          1. Individuals who are pregnant (urine pregnancy test at Study Day 1) or who anticipate
             becoming pregnant prior to the end of the study, Day 181 Visit.

          2. Individuals "of childbearing potential", heterosexually active, and has not used any
             of the "acceptable contraceptive methods" for at least 2 months prior to study entry
             and who will not continue to use acceptable contraceptive methods through to the end
             of the study, Day 181 Visit.

               -  Of childbearing potential is defined as status post onset of menarche and not
                  meeting any of the following conditions: menopausal for at least 2 years, status
                  after bilateral tubal ligation for at least 1 year, status after bilateral
                  oophorectomy, or status after hysterectomy.

               -  Acceptable birth control methods are defined as one or more of the following:

             hormonal contraceptive (such as oral, injection, transdermal patch, implant, cervical
             ring); barrier (condom with spermicide or diaphragm with spermicide) each and every
             time during intercourse; intrauterine device (IUD); monogamous relationship with
             vasectomized partner who was vasectomized for at least six months prior to the
             subject's study entry; or abstinence/no sexual intercourse.

          3. Individuals who are nursing (breastfeeding).

          4. Individuals who have participated in any clinical trial with another investigational
             product 30 days prior to first study visit or who intend to participate in another
             trial prior to the end of the study, Day 181 Visit.

          5. Individuals who have had a previous immunization with a vaccine containing Group B
             Streptococcus antigens.

          6. Individuals who receive:

               -  live vaccine 30 days prior to study vaccination

               -  inactivated vaccines 15 days prior to study vaccination

               -  any vaccines within 30 days after 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 with a fever (oral temperature ≥ 38°C) within 3 days prior to Study Day 1.

          8. Individuals with acute or chronic infection(s) (e.g. requiring systemic antibiotic
             treatment or antiviral therapy) within 7 days prior to Study Day 1.

          9. Individuals with a history of severe allergic reactions after previous vaccination or
             medication such as anaphylactic shock, asthma, urticaria, or other allergic reaction
             or hypersensitivity to any vaccine component.

         10. Individuals with known or suspected impairment of the immune system including known or
             suspected HIV infection or HIV-related disease, a history of or an active autoimmune
             disorder and receipt of immunosuppressive therapy.

         11. Long term use of glucocorticoids, including oral or parenteral prednisone ≥ 20 mg/day
             or equivalent for more than 2 consecutive weeks (or 2 weeks total) within 30 days
             prior to enrollment. Use of inhaled, intranasal, intra-articular, or topical
             corticosteroids is allowed.

         12. Individuals who have received blood, blood products and/or plasma derivatives or any
             parenteral immunoglobulin preparation in the past 12 weeks.

         13. Individuals with any progressive or severe neurologic disorder, seizure disorder,
             epilepsy or Guillain-Barré syndrome.

         14. Individuals with behavioral or cognitive impairment or psychiatric disease that, in
             the opinion of the investigator, may interfere with the subject's ability to
             participate in the study.

         15. Individuals who are not able to comprehend and to follow all required study procedures
             for the whole period of the study.

         16. Individuals with history or any illness that, in the opinion of the investigator,
             might interfere with results of the study or pose additional risk to subjects due to
             participation.