Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women

A Phase II, Multicenter, Randomized, Observer-Blind, Controlled Study to Evaluate Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women

Evaluate the safety and immunogenicity of the trivalent group B streptococcus vaccine in healthy pregnant women. The study will also evaluate the levels of GBS serotype-specific antibodies in infants, placental transfer from the pregnant women to the infant and levels of antibodies in the breast milk.

Inclusion Criteria:

1. Healthy pregnant women 18-40 years of age, inclusive and at 24 0/7 through 34 6/7 weeks gestation.
2. Individuals who intend to breastfeed for at least 90 days postpartum.
3. Individuals who have given written consent after the nature of the study has been explained according to local regulatory requirements.
4. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
5. Individuals who can comprehend and comply with all study procedures and are available for follow-up.

Exclusion Criteria:

1. Individuals with history of illness or an ongoing illness that, in the opinion of the investigator, may pose additional risk to the subject if she participates in the study.

2. Individuals with known hypersensitivity to any component of the vaccine.

3. Individuals who received or plan to receive any licensed vaccine within 14 days before or after the study vaccine with the exception of inactivated influenza vaccine which may be administered up to 7 days before or after study vaccine.

4. Individuals with an infection requiring systemic antibiotic or antiviral treatment within 7 days prior to Study Day 1.

5. Individuals determined as high risk for serious obstetrical complication, including:

   • Gestational hypertension, as defined by American College of Obstetricians and Gynecologists guidelines (ACOG Practice Bulletin 2012)
   • Gestational diabetes which is not controlled by diet and exercise as per American College of Obstetricians and Gynecologists guidelines (ACOG Practice Bulletin 2013)
   • Pre-eclampsia or eclampsia as defined by American College of Obstetricians and Gynecologists guidelines (ACOG practice bulletin, 2002)
   • HIV infection
   • Obesity class II or greater (pre-pregnancy BMI≥35.0)
   • multiple pregnancy

6. 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.

7. Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study.

8. 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.

9. 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, or topical corticosteroids is allowed.

10. Individuals participating in any clinical trial with another investigational product during the pregnancy or intent to participate in another clinical study at any time during the conduct of this study.

11. Pregnant with a fetus with a known or suspected congenital anomaly

12. Individuals who are acting as study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel.

13. Individuals with a fever (oral temperature ≥ 38°C/100.4 °F) within 3 days prior to intended study vaccination.

14. Individuals with a history of culture confirmed GBS case in the infant(s) previously born to her.