Last updated: 04/02/2024 12:10:11
Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-Pregnant Subjects.
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase 2, Non-Randomized, Controlled, Open-Label, Parallel-Group, Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-pregnant Subjects.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Percentage of Subjects with ELISA Antibody Concentrations of GBS Serotype Ia above pre-specified thresholds - Day 61
Timeframe: At Day 61
Percentage of Subjects with Antibody Concentrations of GBS Serotype Ib above pre-specified thresholds - Day 61
Timeframe: At Day 61
Percentage of All Subjects with Antibody Concentrations of GBS Serotype III above pre-specified thresholds - Day 61
Timeframe: At Day 61
Numbers of subjects with solicited local and systemic Adverse Events (AEs)
Timeframe: Day 1 to Day 7
Number of subjects with any unsolicited Adverse Events (AEs)
Timeframe: Day 1 to Day 31
Number of subjects with Serious Adverse Events (SAEs), medically attended AEs, and AEs leading to study withdrawal
Timeframe: Day 1 to Day 181
Secondary outcomes:
Percentage of Subjects with ELISA Antibody Concentrations of GBS Serotype Ia above pre-specified thresholds - Day 31
Timeframe: At Day 31
Percentage of Subjects with Antibody Concentrations of GBS Serotype Ib above pre-specified thresholds - Day 31
Timeframe: At Day 31
Percentage of Subjects with Antibody Concentrations of GBS Serotype III above pre-specified thresholds - Day 31
Timeframe: At Day 31
Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia
Timeframe: At Day 1, Day 31 and Day 61.
Geometric Mean Antibody Concentrations of GBS Serotype Ib
Timeframe: At Day 1, Day 31 and Day 61
Geometric Mean Antibody Concentrations of GBS Serotype III
Timeframe: At Day 1, Day 31 and Day 61
Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in subjects with < LLQ
Timeframe: At Day 1, Day 31 and Day 61
Geometric Mean Antibody Concentrations of GBS Serotype Ib in subjects with < LLQ
Timeframe: At Day 1, Day 31 and Day 61
Geometric Mean Antibody Concentrations of GBS Serotype III in subjects with < LLQ
Timeframe: At Day 1, Day 31 and Day 61
Geometric Mean ELISA Antibody Concentrations of GBS Serotype Ia in subjects with ≥ LLQ
Timeframe: At Day 1, Day 31 and Day 61
Geometric Mean Antibody Concentrations of GBS Serotype Ib in subjects with ≥ LLQ
Timeframe: At Day 1, Day 31 and Day 61
Geometric Mean Antibody Concentrations of GBS Serotype III in subjects with ≥ LLQ
Timeframe: At Day 1, Day 31 and Day 61
Geometric Mean ELISA Anti-Diphtheria Antibody Concentrations in All Subjects
Timeframe: At Day 1 (V98_06 or V98_06E1) and Day 61
Interventions:
Enrollment:
80
Primary completion date:
2016-02-11
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Leroux-Roels G et al. (2019) Safety and immunogenicity of a second dose of an investigational maternal trivalent Group B streptococcus vaccine in non-pregnant women 4-6 years after a first dose: results from a phase 2 trial. Clin Infect Dis. pii: ciz737. doi: 10.1093/cid/ciz737.
Medical condition
Bacterial Infection Due to Streptococcus, Group B
Product
GSK3536855A
Collaborators
Not applicable
Study date(s)
March 2016 to November 2016
Type
Interventional
Phase
2
Participation criteria
Sex
Female
Age
22 - 46 years
Accepts healthy volunteers
Yes
- 1. 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
- 2. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator
- 1. Progressive, unstable or uncontrolled clinical conditions, or clinical conditions representing a contraindication to intramuscular vaccination and blood draws
- 2. Abnormal function of the immune system
Inclusion and exclusion criteria
Inclusion criteria:
- 1. 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 2. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator 3. 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:
- 1. Progressive, unstable or uncontrolled clinical conditions, or clinical conditions representing a contraindication to intramuscular vaccination and blood draws 2. Abnormal function of the immune system 3. Received immunoglobulins or any blood products within 180 days prior to informed consent 4. Received an investigational or non-registered medicinal product within 30 days prior to informed consent 5. 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 6. 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 7. Individuals who anticipate becoming pregnant prior to the end of the study, or individuals who are breastfeeding 8. Individuals who have had a previous immunization with a vaccine containing Group B Streptococcus antigens that was not part of V98_06 study 9. 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 10. Individuals with acute or chronic infection(s) that require systemic antibiotic treatment or antiviral therapy, within 7 days prior to day 1
Trial location(s)
Study documents
Protocol and statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2016-02-11
Actual study completion date
2016-02-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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