Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women (NCT02046148) | Clinical Trial Compass
CompletedPhase 2
Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women
United States75 participantsStarted 2014-03-18
Plain-language summary
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.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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Inclusion criteria
✓. Healthy pregnant women 18-40 years of age, inclusive and at 24 0/7 through 34 6/7 weeks gestation.
✓. Individuals who intend to breastfeed for at least 90 days postpartum.
✓. Individuals who have given 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 can comprehend and comply with all study procedures and are available for follow-up.
Exclusion criteria
✕. 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.
✕. Individuals with known hypersensitivity to any component of the vaccine.
✕. 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.
✕. Individuals with an infection requiring systemic antibiotic or antiviral treatment within 7 days prior to Study Day 1.
✕. Individuals determined as high risk for serious obstetrical complication, including:
✕
What they're measuring
1
Concentration of Serotype Ia GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age
Timeframe: At Birth, Day 42 and Day 90
2
Concentration of Serotype Ib GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age
Timeframe: At Birth, Day 42 and Day 90
3
Concentration of Serotype III GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age
Timeframe: At Birth, Day 42 and Day 90
4
Concentration of Serotype Ia GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum
Timeframe: At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)
5
Concentration of Serotype Ib GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum
Timeframe: At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)
6
Concentration of Serotype III GBS IgG Levels in Maternal Serum at Pre-vaccination, at Study Day 31, at Delivery and at Days 42 and 90 Postpartum
Timeframe: At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)
. 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.
✕. Individuals who are not able to comprehend and to follow all required study procedures for the whole period of the study.
✕. 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.
Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype Ia, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum
Timeframe: At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)
8
Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype Ib, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum
Timeframe: At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)
9
Ratio Relative to Pre-vaccination Levels of Maternal Serum GBS IgG Antibody Levels - Serotype III, as Measured at Study Day 31, at Delivery and at Days 42 and 90 Postpartum
Timeframe: At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum)