Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings

Novartis

Status and phase: Completed; Phase 2

Conditions: Bacterial Infection; Streptococcal Infection; Gram-positive Bacterial Infection

Treatments: Biological: Placebo; Biological: Group B Streptococcus Trivalent Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01446289

2010-020840-36

V98_04

Details and patient eligibility

About

The study investigated the immune response induced by the Group B streptococcus vaccine in healthy pregnant women. In addition, the study investigated the amount of vaccine induced antibodies which were transferred to the newborn.

Enrollment: 86 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy pregnant women 18-40 years of age at 24-35 weeks of gestation at screening.
2. Individuals who have given a 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 will be available for all scheduled visits (ie, not planning to leave the area before the end of the study period).

Exclusion criteria

1. Individuals who were unwilling and/or unable to give written informed consent to participate in the study.

2. Individuals with a history of severe allergic reactions after previous vaccinations such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component.

3. Individuals with any known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from:

   • receipt of immunosuppressive therapy within 30 days prior to enrollment (any systemic corticosteroid administered for more than 5 days, or in a daily dose > 15 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy).
   • receipt of immunostimulants.
   • receipt of parenteral immunoglobulin preparation, blood products, and /or plasma derivatives within 12 weeks prior to enrollment and for the full length of the study.

   Note: Anti-D (Rho) Immunoglobulins (anti-RhD) given for Anti-D prophylaxis were to be allowed.

4. Individuals characterized as "high risk" pregnancies at investigator discretion, such as those who have:

   • gestational diabetes
   • preeclampsia/eclampsia
   • women at risk of preterm labor (except positivity for vaginal GBS)
   • History of previous pregnancy complications including delivery of preterm infant.
   • History of still-birth, late abortions and children with congenital anomalies.

5. Individuals who had received any other investigational agent or investigational intervention during the course of the study.

6. Individuals with acute infection including oral temperature ≥ 38°C were to be temporarily excluded. They could be enrolled once the infection had resolved (as judged by investigator).

7. HIV positive by history.

8. Individuals reporting any known or suspected serious acute, chronic or progressive disease (eg, any history of neoplasm, malignancy, including lymphoproliferative disorder, diabetes, cardiac disease, malnutrition, renal failure, autoimmune disease, HBV or HCV, blood disorders).

   Note: Malignancies, highly likely to having been cured at the investigators discretion are allowed. (eg, no relapse since 5 years post last malignancy specific treatment).

9. Individuals with bleeding diathesis, or any condition that might have been associated with a prolonged bleeding time.

10. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, might have interfered with the subject's ability to participate in the study (eg, who were not able to comprehend or to follow all required study procedures for the whole period of the study).

11. Individuals with any progressive or severe neurologic disorder, seizure disorder, epilepsy or Guillain-Barré syndrome.

12. Individuals with history or any illness that, in the opinion of the investigator, might have posed additional risk to subjects due to participation in the study.

13. Individuals who were part of study personnel or close family members conducting this study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 2 patient groups, including a placebo group

Group B Streptococcus Trivalent Vaccine

Experimental group

Description:

Pregnant women who received one injection of Group B Streptococcus Trivalent Vaccine.

Treatment:

Biological: Group B Streptococcus Trivalent Vaccine

Placebo

Placebo Comparator group

Description:

Pregnant women who received one injection of saline solution.

Treatment:

Biological: Placebo