Phase 2
N=80
Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-Pregnant Subjects.
Bacterial Infection Due to Streptococcus, Group B · Streptococcus Agalactiae
Bottom Line
View on ClinicalTrials.gov: NCT02690181 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 — 100; 100; 100; 100 Percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GBS Trivalent Vaccine (Biological)
- Age
- Adult · 22+ yrs
- Sex
- Female
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 61 |
100; 100; 100; 100; 100; 100 | — |
| PRIMARY Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 61 |
100; 100; 100; 100; 100; 85 | — |
| PRIMARY Percentage of All Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 61 |
100; 100; 100; 100; 100; 100 | — |
| PRIMARY Numbers of Subjects With Solicited Local and Systemic Adverse Events (AEs) |
11; 12; 10; 6; 3; 11 | — |
| PRIMARY Number of Subjects With Any Unsolicited Adverse Events (AEs) |
4; 5; 4; 4; 4; 9 | — |
| PRIMARY Number of Subjects With Serious Adverse Events (SAEs), Medically Attended AEs, and AEs Leading to Study Withdrawal |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Subjects With ELISA Antibody Concentrations of GBS Serotype Ia Above Pre-specified Thresholds - Day 31 |
100; 100; 100; 100; 100; 100 | — |
| SECONDARY Percentage of Subjects With Antibody Concentrations of GBS Serotype Ib Above Pre-specified Thresholds - Day 31 |
100; 100; 100; 100; 100; 75 | — |
| SECONDARY Percentage of Subjects With Antibody Concentrations of GBS Serotype III Above Pre-specified Thresholds - Day 31 |
100; 100; 100; 100; 100; 100 | — |
| SECONDARY Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia |
9.32; 5.50; 3.44; 2.18; 1.05; 0.32 | — |
| SECONDARY Geometric Mean Antibody Concentrations of GBS Serotype Ib |
0.19; 0.15; 0.10; 0.16; 0.14; 0.17 | — |
| SECONDARY Geometric Mean Antibody Concentrations of GBS Serotype III |
0.41; 0.17; 0.25; 0.17; 0.15; 0.31 | — |
| SECONDARY Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than the Lower Limit of Quantitation (LLQ) |
1.36; 2.59; 0.81; 1.12; 0.45; 0.16 | — |
| SECONDARY Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ |
0.078; 0.078; 0.078; 0.078; 0.078; 0.078 | — |
| SECONDARY Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Less Than LLQ |
0.15; 0.15; 0.15; 0.15; 0.15; 0.15 | — |
| SECONDARY Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ |
64.06; 98.43; 29.83; 39.57; 5.76; 2.54 | — |
| SECONDARY Geometric Mean Antibody Concentrations of GBS Serotype Ib in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ |
1.96; 0.52; 3.42; 3.12; 0.82; 1.92 | — |
| SECONDARY Geometric Mean Antibody Concentrations of GBS Serotype III in Subjects With Prevaccination Serotype-specific GBS Antibody Equal or Greater Than LLQ |
5.33; 1.41; 1.07; 0.74; 2.79; 171.67 | — |
| SECONDARY Geometric Mean ELISA Anti-Diphtheria Antibody Concentrations in All Subjects |
— | — |
Summary
The objective of this extension study is the initial assessment of safety and immunogenicity of the second dose of GBS Trivalent Vaccine following the time interval that is close to the inter-pregnancy interval observed in the general population.
Eligibility Criteria
Inclusion Criteria
- Healthy, non-pregnant subjects who have received a single 5 µg dose of GBS Trivalent Vaccine or placebo in the V98\_06 study and healthy non-pregnant female subjects aged 22-46 years inclusive on the day of informed consent who have not received any GBS vaccine in the past
- Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator
- Females of childbearing potential who are using an effective birth control method which they intend to use until the end of the study (day 181 visit) or females of non-childbearing potential
Exclusion Criteria
- Progressive, unstable or uncontrolled clinical conditions, or clinical conditions representing a contraindication to intramuscular vaccination and blood draws
- Abnormal function of the immune system
- Received immunoglobulins or any blood products within 180 days prior to informed consent
- Received an investigational or non-registered medicinal product within 30 days prior to informed consent
- Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study
- Individuals who received any other vaccines within 14 days for inactivated vaccines or 28 days for live vaccines prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccination. Exception - an inactivated influenza vaccine may be administered up to 7 days prior to study vaccination or 7 days after study vaccination
- Individuals who anticipate becoming pregnant prior to the end of the study, or individuals who are breastfeeding
- Individuals who have had a previous immunization with a vaccine containing Group B Streptococcus antigens that was not part of V98\_06 study
- Individuals with a fever (oral temperature ≥ 38°C) within 3 days prior to day 1 or use of antipyretics and/or analgesic medications within 24 hours prior to day 1
- Individuals with acute or chronic infection(s) that require systemic antibiotic treatment or antiviral therapy, within 7 days prior to day 1
Data sourced from ClinicalTrials.gov (NCT02690181). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.