Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings
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|ClinicalTrials.gov Identifier: NCT01446289|
Recruitment Status : Completed
First Posted : October 5, 2011
Results First Posted : September 8, 2014
Last Update Posted : September 8, 2014
|Condition or disease||Intervention/treatment||Phase|
|Streptococcal Infection Gram-positive Bacterial Infection Bacterial Infection||Biological: Group B Streptococcus Trivalent Vaccine Biological: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||86 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase II Randomized, Observer-Blind, Multi-Center, Controlled Study of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women|
|Study Start Date :||September 2011|
|Primary Completion Date :||April 2013|
|Study Completion Date :||October 2013|
Experimental: Group B Streptococcus Trivalent Vaccine
Pregnant women who received one injection of Group B Streptococcus Trivalent Vaccine.
Biological: Group B Streptococcus Trivalent Vaccine
Pregnant women who received one injection of Group B Streptococcus Trivalent Vaccine administered intramuscularly.
Placebo Comparator: Placebo
Pregnant women who received one injection of saline solution.
Pregnant women who received one injection of saline solution administered intramuscularly.
- 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.
- 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.
- GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects [ Time Frame: Day 1, day 31 and day 91 post-delivery ]GMCs (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III in maternal subjects at study day 1, study day 31 and at day 91 post-partum after one administration of GBS vaccine or placebo are reported.
- Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects [ Time Frame: Day 31, day of delivery, day 91 post-delivery ]GMRs of GMCs (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III, in maternal subjects at study day 31, at delivery and at day 91 post-partum versus day 1 (baseline) after one administration of GBS vaccine or placebo are reported.
- GMC (ELISA) of Anti-GBS CPS Antibodies in Infants [ Time Frame: Day of birth and day 91 after birth ]GMC (ELISA) of anti-GBS CPS antibodies against serotypes Ia, Ib and III in infants at birth and at 3 months of age are reported.
- GMRs of Anti-GBS CPS Antibody GMCs (ELISA) in Infants at 3 Months of Age Versus GMCs at Birth [ Time Frame: Day 91 after birth ]GMRs of anti-GBS CPS antibody GMCs (ELISA) against serotypes Ia, Ib and III in infants at 3 months of age (day 91 after birth) versus GMCs at birth are reported.
- Percentages of Infant Subjects Showing Anti-diphtheria Antibodies GMCs (ELISA) Over 0.1 IU/mL at 1 Month After the Last Routine Infant Immunization [ Time Frame: 1 month after the last routine infant immunization ]Percentages of infant subjects showing anti-diphtheria antibodies GMCs (ELISA) over 0.1 IU/mL in sera collected at 1 month after the last routine infant immunization (ie, either 5 months or 7 months after birth, depending on the vaccination schedule) are reported.
- Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) [ Time Frame: From day 1 to 7 after vaccination ]Percentage of maternal subjects reporting solicited local and systemic AEs and other indicators of reactogenicity from day 1 to 7 after vaccination are reported.
- Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs) [ Time Frame: 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. ]Percentage of maternal subjects reporting unsolicited AEs, SAEs, AEs requiring a non-routine physician's visit, AEs leading to withdrawal are reported.
- Percentages of Infants Reporting SAEs [ Time Frame: From birth until study termination ]Percentages of infants born from women who received either one injection of the study vaccine or placebo, reporting SAEs from birth until study termination are reported.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01446289
|Herestraat, Leuven, Belgium, 49-B-3000|
|Regionaal Ziekenhuis Heilig Hart,|
|Gasthuismolenstraat 31, Tienen, Belgium, 3300|
|Canada, British Columbia|
|University of British Columbia, Rm B3 25 B, 4500 Oak Street,|
|Vancouver, British Columbia, Canada, V6H3N1|
|Canada, Nova Scotia|
|Dalhousie University, IWK Health Centre, 5850/5980 University Avenue,|
|Halifax, Nova Scotia, Canada, B3K 6R8|
|Centre hospitalier universitaire de Quebec (CHUQ)- hospital CHUL, Centre de recherche en infectiologie, 2705,|
|Boulevard laurier, S-745, Quebec, Canada, G1V 4G2|
|Study Chair:||Novartis Vaccines||Novartis Vaccines|
|Principal Investigator:||Gilbert Donders, Prof.||Regional Hospital Heilig Hart, Tienen, Belgium|