Healthy person immune response to a second dose of Group B Streptococcus polysaccharide capsule antigens MedDRA version: 18.1 Level: PT Classification code 10053588 Term: Group B streptococcus neonatal sepsis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Lyophilized GBS Trivalent Vaccine
Pharmaceutical Form: Powder for injection
INN or Proposed INN: Not Applicable
Other descriptive name: GBS CPSIa-CRM
Concentration unit: µg microgram(s)
Sponsors
GlaxoSmithKline Biologicals S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to participate in this study, all subjects must meet ALL of the inclusion criteria described. 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 who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. 3. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator. 4. Individuals who can comply with study procedures including follow-up. 5. 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 nonchildbearing potential Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 220 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. Progressive, unstable or uncontrolled clinical conditions. 2. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. 3. Abnormal function of the immune system resulting from: a. Clinical conditions, including but not limited to known or suspected HIV infection or HIV-related disease, a history of or an active autoimmune disorder (as per the judgment of the Investigator) b. Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to informed consent. c. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent. d. Receipt of immunosuppressive therapy within 90 days prior to informed consent 4. Received immunoglobulins or any blood products within 180 days prior to informed consent. 5. Received an investigational or non-registered medicinal product within 30 days prior to informed consent. 6. Study personnel as an immediate family or household member. 7. 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. 8. 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. 9. Individuals who anticipate becoming pregnant prior to the end of the study, Day 181 Visit.10. Individuals who are nursing (breastfeeding). 11. Individuals who have had a previous immunization with a vaccine containing Group B Streptococcus antigens that was not part of V98_06 study. 12. 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. 13. Individuals with acute or chronic infection(s) that require systemic antibiotic treatment or antiviral therapy, within 7 days prior to day 1. 14. Individuals with a history of severe allergic reactions after previous vaccinations or medications, such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component or medical equipment including latex used in this study. 15. Individuals with any progressive or severe neurologic disorder, seizure disorder, epilepsy or Guillain-Barré syndrome. 16. Individuals with history of substance or alcohol abuse within the past 2 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Immunogenicity Objective To evaluate the immunogenicity of a second dose of GBS Trivalent Vaccine (5 µg without adjuvant) administered approximately 4-6 years after the initial GBS vaccination, measured by ELISA. Safety Objective To assess the safety and tolerability of a second dose of GBS Trivalent Vaccine (5 µg without adjuvant) administered approximately 4-6 years after the initial dose.;Secondary Objective: To further characterize the immune response following a dose of GBS Trivalent Vaccine (5 µg without adjuvant) in study subjects and in subgroups of subjects defined by prevaccination serotype-specific GBS antibody LLQ status in the V98_06 study or V98_06E1 for the naïve subjects. To assess the impact of a dose of the GBS Trivalent Vaccine (5 µg without adjuvant) on the serum level of anti diphtheria antibodies in subjects who received study vaccination (active or placebo) as part of the V98_06 and naïve subjects from V98_06E1;Primary end point(s): Primary Safety Endpoint(s) The frequency and percentage of subjects with solicited local and systemic AEs from vaccination to day 7 in study V98_06E1. Time intervals after vaccination that will be summarized are: the first 30 minutes after vaccination, days 1-3 (excluding the first 30 min), days 4-7 and days 1-7 (excluding the first 30 min). The frequency and percentage of subjects with any unsolicited AEs from the day of vaccination (day 1 in study V98_06E1) to day 31. The frequency and percentage of subjects with SAEs, medically attended AEs, and AEs leading to study withdrawal from vaccination in study V98_06E1 to day 181. Primary Immunogenicity Endpoint(s) The primary immunogenicity endpoints are the percentages of subjects who reach predefined sequential serotype-specific (Ia, Ib and III) serum antibody levels at day 61 post vaccination, as measured by ELISA.;Timepoint(s) of evaluation of this end point: See E.5.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary immunogenicity endpoints are: The percentage of subjects reaching pre-defined sequential serotype-specific (Ia, Ib and III) serum antibody levels as measured by ELISA at other time points and in subgroups of subjects defined by their pre-vaccination serotype-specific GBS antibody LLQ status in the V98_06 study (or the V98_06E1 study for the naive group). The serotype-specific (Ia, Ib, and III) geometric mean concentrations (GMCs) as measured by ELISA at days 31 and 61 post-vaccination in study V98_06E1 and in the subgroups of subjects defined according to their pre-vaccination serotype-specific GBS antibody LLQ status in the V98_06 study (or V98_06E1 study for the naive group). The within subject geometric mean ratio (GMR) of serotype-specific (Ia, Ib & III) serum antibody levels as measured by ELISA at day 31 and 61. The GMRs will be determined relative to pre-vaccination in V98_06E1 and separately relative to pre-vaccination in V98_06 for all groups except the naive group. The GMRs will also be determined for subgroups of subjects defined according to their pre-vaccination serotype-specific GBS antibody LLQ status in the V98_06 study or V98_06E1 study for the naive group. Reverse cumulative distribution function (RCDF) curves of serotype-specific (Ia, Ib and III) serum antibody levels, as measured by ELISA, at pre-vaccination in V98_06 study or V98_06E1 study for the naive group, vaccination, day 31 and day 61 post-vaccination in all subjects and by pre-vaccination serotype-specific GBS antibody LLQ status in the V98_06 study or V98_06E1 study for the naive group. The anti-diphtheria geometric mean antibody concentrations measured by ELISA for samples collected before the first vaccination with GBS Trivalent Vaccine in the V98_06 study or V98_06E1 study for the naive group and on day 61 post-vaccination in V98_06E1.;Timepoint(s) of evaluation of this end point: See E.5.2 | — |
Countries
Belgium
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals S.A.
Outcome results
None listed