Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-Pregnant Subjects.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Bacterial Infection Due to Streptococcus, Group B; Streptococcus Agalactiae

Treatments: Biological: GBS Trivalent Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02690181

205421

2015-003094-15 (EudraCT Number)

V98_06E1 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Female

Ages: 22 to 46 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 6 patient groups

GBS NoAdj/GBS NoAdj

Experimental group

Description:

Subjects who had received unadjuvanted GBS Trivalent Vaccine in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).

Treatment:

Biological: GBS Trivalent Vaccine

GBS Alum/GBS NoAdj

Experimental group

Description:

Subjects who had received GBS Trivalent Vaccine with alum adjuvant in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).

Treatment:

Biological: GBS Trivalent Vaccine

GBS MF59 Full/GBS NoAdj

Experimental group

Description:

Subjects who had received GBS Trivalent Vaccine with full dose of MF59 in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).

Treatment:

Biological: GBS Trivalent Vaccine

GBS MF59 Half/GBS NoAdj

Experimental group

Description:

Subjects who had received GBS Trivalent Vaccine with half dose of MF59 in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).

Treatment:

Biological: GBS Trivalent Vaccine

Placebo/GBS NoAdj

Experimental group

Description:

Subjects who had received placebo in parent study V98_06 (205468 - NCT01150123) and received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).

Treatment:

Biological: GBS Trivalent Vaccine

Naive/GBS NoAdj

Experimental group

Description:

Healthy non-pregnant female subjects aged 22 through 46 years inclusive on the day of informed consent who had not received any GBS vaccine in the past and who received a single dose of unadjuvanted GBS Trivalent Vaccine in V98_06E1 (205421 - NCT02690181).

Treatment:

Biological: GBS Trivalent Vaccine