Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Boostrix® in Adults Aged 50 Years and Older
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Herpes Zoster
- Sponsor
- GlaxoSmithKline
- Enrollment
- 935
- Locations
- 1
- Primary Endpoint
- Number of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in GSK1437173A Group
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK Biologicals' HZ/su vaccine when its first dose is co-administered with the Boostrix® vaccine in adults aged 50 years or older compared to administration of vaccines separately.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •A male or female aged 50 years or older at the time of the first vaccination with the study vaccine(s).
- •Written informed consent obtained from the subject.
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- •Female subjects of childbearing potential may be enrolled in the study, if the subject:
- •has practiced adequate contraception for 30 days prior to vaccination, and
- •has a negative pregnancy test on the day of vaccination, and
- •has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion Criteria
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, this will mean prednisone ≥ 20 mg/day, or equivalent). A prednisone dose of \< 20 mg/day is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
- •Administration or planned administration of a vaccine not foreseen by the study protocol within the period starting 30 days before the first dose of study vaccine(s) and ending 30 days after the last dose of study vaccine. This includes any type of vaccine such as (but not limited to) live, inactivated and subunit vaccines (e.g., inactivated and subunit influenza vaccines).
- •Administration of long-acting immune-modifying drugs (e.g. infliximab) within six months prior to the first vaccine dose or expected administration at any time during the study period.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
- •Previous vaccination against VZV or HZ and/or planned administration during the study of an HZ or VZV vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
- •History of HZ.
- •Vaccination against diphtheria, or tetanus in the last five years or planned vaccination against diphtheria or tetanus during the study period, other than the study vaccine(s).
- •Administration of a combined tetanus, diphtheria and pertussis (Tdap) vaccine at any time prior to study entry.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus \[HIV\] infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
Outcomes
Primary Outcomes
Number of Subjects With a Vaccine Response for Anti-glycoprotein E (Anti-gE) in GSK1437173A Group
Time Frame: At 1 month post-Dose 2 (Month 3)
This outcome was required only for the GSK1437173A Group. Vaccine response defined as: For initially seronegative subjects, antibody concentration at post-vaccination ≥ 4 fold the cut-off for Anti-gE (4x97 mIU/mL); For initially seropositive subjects, antibody concentration at post-vaccination ≥ 4 fold the pre-vaccination antibody concentration.
Antibody Concentrations Against Glycoprotein E (Anti-gE)
Time Frame: At 1 month post-Dose 2 (Month 3 for GSK1437173A Group adn Month 5 for Control Group)
Antibody concentrations against glycoprotein E (gE) have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The reference seropositivity cut-off was an anti-gE antibody concentration greater than or equal to (≥) 97 mIU/mL.
Antibody Concentrations Against Pertussis Toxoid (Anti-PT), Filamentous Hemagglutinin (Anti-FHA) and Pertactin (Anti-PRN) Antigens
Time Frame: At 1 month post-Dose 1 (Month 1)
Anti-PT, anti-FHA and anti-PRN antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Antibody Concentrations Against Diphteria (Anti-D) and Tetanus (Anti-T) Antigens
Time Frame: At 1 month post-Dose 1 (Month 1)
Anti-PT, anti-FHA and anti-PRN antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Secondary Outcomes
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Dose(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms, by Study Vaccine(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, by Dose(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Number of Days With Solicited Symptoms(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)(From first vaccination up to study end (Day 0 to Month 14))
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(Within the 30-day (Days 0-29) post-vaccination period)
- Number of Subjects With Any Serious Adverse Events (SAEs)(From first vaccination up to study end (Day 0 to Month 14))