Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women a… (NCT01446289) | Clinical Trial Compass
CompletedPhase 2
Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings
Belgium, Canada86 participantsStarted 2011-09
Plain-language 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.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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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:
✕. Individuals characterized as "high risk" pregnancies at investigator discretion, such as those who have:
✕. 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).
What they're measuring
1
Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth
Timeframe: Day of delivery/birth
2
Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery
✕. 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).