NCT01446289CompletedPhase 2
A Phase II Randomized, Observer-Blind, Multi-Center, Controlled Study of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 86
- Locations
- 10
- Primary Endpoint
- Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy pregnant women 18-40 years of age at 24-35 weeks of gestation at screening.
- •Individuals who have given a written consent after the nature of the study has been explained according to local regulatory requirements.
- •Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
- •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
- •Individuals who were unwilling and/or unable to give written informed consent to participate in the study.
- •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.
- •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.
- •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.
- •Individuals who had received any other investigational agent or investigational intervention during the course of the study.
- •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).
- •HIV positive by history.
- •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).
- •Individuals with bleeding diathesis, or any condition that might have been associated with a prolonged bleeding time.
- •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).
- •Individuals with any progressive or severe neurologic disorder, seizure disorder, epilepsy or Guillain-Barré syndrome.
- •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.
- •Individuals who were part of study personnel or close family members conducting this study.
Arms & Interventions
Placebo
Placebo Comparator
Pregnant women who received one injection of saline solution.
Intervention: Placebo (Biological)
Group B Streptococcus Trivalent Vaccine
Experimental
Pregnant women who received one injection of Group B Streptococcus Trivalent Vaccine.
Intervention: Group B Streptococcus Trivalent Vaccine (Biological)
Outcomes
Primary Outcomes
Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery
Time Frame: Day of delivery/birth
The Geometric mean transfer ratio of anti-GBS CPS antibodies against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery.
Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth
Time Frame: Day of delivery/birth
GMCs of anti-Group B Streptococcus (GBS) capsular polysaccharide (CPS) antibodies against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.
Secondary Outcomes
- GMRs of Anti-GBS CPS Antibody GMCs (ELISA) in Infants at 3 Months of Age Versus GMCs at Birth(Day 91 after birth)
- Percentages of Infants Reporting SAEs(From birth until study termination)
- GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects(Day 1, day 31 and day 91 post-delivery)
- Percentages of Infant Subjects Showing Anti-diphtheria Antibodies GMCs (ELISA) Over 0.1 IU/mL at 1 Month After the Last Routine Infant Immunization(1 month after the last routine infant immunization)
- Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)(From day 1 to 7 after vaccination)
- Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects(Day 31, day of delivery, day 91 post-delivery)
- GMC (ELISA) of Anti-GBS CPS Antibodies in Infants(Day of birth and day 91 after birth)
- Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs)(All AEs were recorded until delivery, after delivery all AEs requiring a non-routine physician's visit and AEs leading to withdrawal from the study. SAEs were collected for the duration of the trial.)
Investigators
Study Sites (10)
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