Overview

This trial is active, not recruiting.

Condition bacterial infection due to streptococcus, group b
Treatments gbs trivalent vaccine
Phase phase 2
Sponsor GlaxoSmithKline
Start date March 2016
End date November 2016
Trial size 80 participants
Trial identifier NCT02690181, 2015-003094-15, 205421, V98_06E1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Subjects who received GBS Trivalent Vaccine with no adjuvant in parent study V98_06 and received a single dose of unadjuvanted GBS Trivalent Vaccine.
gbs trivalent vaccine
Administration of lyophilized formulation of a GBS trivalent vaccine containing 5 µg of each polysaccharide capsules from serotypes Ia, Ib, and III of Group B Streptococcus conjugated to CRM-197 in subjects who received GBS No Adj in parent study.
(Experimental)
Subjects who received GBS Trivalent Vaccine with alum adjuvant in parent study V98_06 and received a single dose of unadjuvanted GBS Trivalent Vaccine.
gbs trivalent vaccine
Administration of lyophilized formulation of a GBS trivalent vaccine containing 5 µg of each polysaccharide capsules from serotypes Ia, Ib, and III of Group B Streptococcus conjugated to CRM-197 in subjects who received GBS Alum in parent study.
(Experimental)
Subjects who received GBS Trivalent Vaccine with full dose of MF59 in parent study V98_06 and received a single dose of unadjuvanted GBS Trivalent Vaccine.
gbs trivalent vaccine
Administration of lyophilized formulation of a GBS trivalent vaccine containing 5 µg of each polysaccharide capsules from serotypes Ia, Ib, and III of Group B Streptococcus conjugated to CRM-197 in subjects who received GBS MF59 Full in parent study.
(Experimental)
Subjects who received GBS Trivalent Vaccine with half dose of MF59 in parent study V98_06 and received a single dose of unadjuvanted GBS Trivalent Vaccine.
gbs trivalent vaccine
Administration of lyophilized formulation of a GBS trivalent vaccine containing 5 µg of each polysaccharide capsules from serotypes Ia, Ib, and III of Group B Streptococcus conjugated to CRM-197 in subjects who received GBS MF59 Half in parent study.
(Experimental)
Subjects who received placebo in parent study V98_06 and received a single dose of unadjuvanted GBS Trivalent Vaccine.
gbs trivalent vaccine
Administration of lyophilized formulation of a GBS trivalent vaccine containing 5 µg of each polysaccharide capsules from serotypes Ia, Ib, and III of Group B Streptococcus conjugated to CRM-197 in subjects who received Placebo in parent study.
(Experimental)
Subjects who are naive and were not vaccinated as a part of V98_06 and received a single dose of unadjuvanted GBS Trivalent Vaccine.
gbs trivalent vaccine
Administration of lyophilized formulation of a GBS trivalent vaccine containing 5 µg of each polysaccharide capsules from serotypes Ia, Ib, and III of Group B Streptococcus conjugated to CRM-197 in subjects who were not part of parent study.

Primary Outcomes

Measure
Numbers of subjects reaching predefined sequential serotype-specific serum antibody levels for serotypes Ia, Ib and III at day 61 postvaccination, as measured by ELISA
time frame: Day 61
Numbers of subjects with solicited local and systemic AEs
time frame: Day 1-7
Number of subjects with any unsolicited AEs
time frame: Day 1-31
Number of subjects with SAEs, medically attended AEs, and AEs leading to study withdrawal
time frame: Day 1-181

Secondary Outcomes

Measure
Serotype-specific (Ia, Ib, and III) geometric mean antibody titers as measured by ELISA in all subjects and by pre-vaccination serotype-specific GBS antibody LLQ status
time frame: Day 31, 61
Percentage of subjects reaching predefined sequential serotype-specific serum antibody levels for serotypes Ia, Ib and III as measured by ELISA
time frame: Day 31
Percentage of subjects reaching serotype-specific serum antibody levels for serotypes Ia, Ib and III as measured by ELISA according to pre-vaccination serotype-specific GBS antibody LLQ status
time frame: Day 31, 61
Within subject geometric mean ratio (GMR) of serotype-specific (Ia, Ib & III) serum antibody levels as measured by ELISA for all subjects and by pre-vaccination serotype-specific GBS antibody LLQ status.
time frame: Day 31, 61
Reverse cumulative distribution function (RCDF) curves of serotype-specific (Ia, Ib and III) serum antibody levels measured by ELISA at pre-vaccination and by pre-vaccination serotype-specific GBS antibody LLQ status.
time frame: Day 31, 61
Anti-diphtheria geometric mean antibody concentrations measured by ELISA
time frame: Day 1, 61

Eligibility Criteria

Female participants from 22 years up to 46 years old.

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

Additional Information

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 information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by GlaxoSmithKline.