ClinicalTrials.Veeva

Menu

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

GlaxoSmithKline (GSK) logo

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)

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

Trial documents
1

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems