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Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women
This study has been completed.
Sponsor:
GlaxoSmithKline
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02046148
First received: January 21, 2014
Last updated: April 20, 2017
Last verified: February 2017
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Results First Received: January 31, 2017
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Participant, Care Provider, Investigator, Outcomes Assessor; Primary Purpose: Prevention |
| Condition: |
GBS Disease |
| Interventions: |
Biological: GBS trivalent vaccine Biological: Placebo |
Participant Flow
Hide Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
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| Subjects were enrolled in United States. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| GBS Group | Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum). |
| Placebo Group | Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum). |
Participant Flow: Overall Study
| GBS Group | Placebo Group | |
|---|---|---|
| STARTED | 49 | 26 |
| COMPLETED | 48 | 23 |
| NOT COMPLETED | 1 | 3 |
| Lost to Follow-up | 1 | 1 |
| Withdrawal by Subject | 0 | 2 |
Show Baseline Characteristics
Outcome Measures
| 1. Primary: | Concentration of Serotype Ia GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age [ Time Frame: At Birth, Day 42 and Day 90 ] |
| 2. Primary: | 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 [ Time Frame: At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum) ] |
| 3. Primary: | 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 [ Time Frame: At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum) ] |
| 4. Secondary: | Ratio of GBS IgG Antibody Levels – Serotype Ia in Infant Serum Relative to Maternal Serum at the Time of Delivery [ Time Frame: At Delivery ] |
| 5. Secondary: | Percentage of Maternal Subjects With Solicited Local and Solicited Systemic Adverse Events (AEs) up to 30 Minutes [ Time Frame: Up to 30 minutes post-vaccination ] |
| 6. Secondary: | Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-3 [ Time Frame: During Study Days 1-3 (from 6 hours through Day 3 post-vaccination) ] |
| 7. Secondary: | Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 4-7 [ Time Frame: During Study Days 4-7 ] |
| 8. Secondary: | Percentage of Maternal Subjects With Solicited Local and Solicited Systemic AEs - Study Days 1-7 [ Time Frame: During Study Days 1-7 (from 6 hours through Day 7 post-vaccination) ] |
| 9. Secondary: | Percentage of Maternal Subjects With Any Unsolicited AEs [ Time Frame: From Study Day 1 through Study Day 31 ] |
| 10. Secondary: | Percentage of Maternal Subjects With Serious Adverse Events (SAEs), Unsolicited Medically Attended AEs (MAEs) and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal) [ Time Frame: From Study Day 1 through Study Day 31 ] |
| 11. Secondary: | Percentage of Maternal Subjects With SAEs, Unsolicited MAEs and Unsolicited AEs Leading to Study Withdrawal (AEs Lead. Wthwal) [ Time Frame: From Study Day 32 through Day 180 postpartum ] |
| 12. Secondary: | Percentage of Infants With SAEs, Unsolicited MAEs and AEs Leading to Study Withdrawal [ Time Frame: From Birth through Day 180 of age ] |
| 13. Secondary: | Birth Weight of Infants (Mean-Standard Deviation) [ Time Frame: At Birth ] |
| 14. Secondary: | Birth Weight of Infants (Median, Minimum and Maximum) [ Time Frame: At Birth ] |
| 15. Secondary: | Birth Length and Head Circumference of Infants (Mean - Standard Deviation) [ Time Frame: At Birth ] |
| 16. Secondary: | Birth Length and Head Circumference of Infants (Median - Minimum and Maximum) [ Time Frame: At birth ] |
| 17. Secondary: | Infants Apgar Scores (Mean - Standard Deviation) [ Time Frame: At 1, 5 and 10 minutes ] |
| 18. Secondary: | Infants Apgar Scores (Median, Minimum and Maximum) [ Time Frame: At 1, 5 and 10 minutes ] |
| 19. Secondary: | Descriptive Statistics for the Score for the Long-term Developmental Outcome Assessed by Bayley Scales of Infant and Toddler Development 3rd Edition Screening Test (PsychCorp) in Infants (Mean - Standard Deviation) [ Time Frame: At Day 180 of age ] |
| 20. Secondary: | Descriptive Statistics for the Score for the Long-term Developmental Outcome Assessed by Bayley Scales of Infant and Toddler Development 3rd Edition Screening Test (PsychCorp) in Infants (Median, Minimum and Maximum) [ Time Frame: At Day 180 of age ] |
| 21. Primary: | Concentration of Serotype Ib GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age [ Time Frame: At Birth, Day 42 and Day 90 ] |
Results not yet reported. Anticipated Reporting Date:
12/2019
| 22. Primary: | Concentration of Serotype III GBS IgG Levels in Infant Serum at Delivery and at Days 42 and 90 of Age [ Time Frame: At Birth, Day 42 and Day 90 ] |
Results not yet reported. Anticipated Reporting Date:
12/2019
| 23. Primary: | 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 [ Time Frame: At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum) ] |
Results not yet reported. Anticipated Reporting Date:
12/2019
| 24. Primary: | 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 [ Time Frame: At Day 1 (pre-vaccination), Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum) ] |
Results not yet reported. Anticipated Reporting Date:
12/2019
| 25. Primary: | 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 [ Time Frame: At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum) ] |
Results not yet reported. Anticipated Reporting Date:
12/2019
| 26. Primary: | 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 [ Time Frame: At Day 31 (post-vaccination), Delivery, Days 42 and 90 (postpartum) ] |
Results not yet reported. Anticipated Reporting Date:
12/2019
| 27. Secondary: | Ratio of GBS IgG Antibody Levels – Serotype Ib in Infant Serum Relative to Maternal Serum at the Time of Delivery [ Time Frame: At Delivery ] |
Results not yet reported. Anticipated Reporting Date:
12/2019
| 28. Secondary: | Ratio of GBS IgG Antibody Levels – Serotype III in Infant Serum Relative to Maternal Serum at the Time of Delivery [ Time Frame: At Delivery ] |
Results not yet reported. Anticipated Reporting Date:
12/2019
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
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| No text entered. |
More Information
Certain Agreements:
Results Point of Contact:
| Principal Investigators are NOT employed by the organization sponsoring the study. | ||||||
| There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. | ||||||
The agreement is:
|
Results Point of Contact:
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343
Organization: GlaxoSmithKline
phone: 866-435-7343
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT02046148 History of Changes |
| Other Study ID Numbers: |
205235 V98_12 ( Other Identifier: Novartis ) |
| Study First Received: | January 21, 2014 |
| Results First Received: | January 31, 2017 |
| Last Updated: | April 20, 2017 |