Consistency, immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ Herpes Zoster (HZ) vaccine GSK1437173A in adults = 50 years of age.

• Register: EUCTR
• Last refreshed on: 13 June 2016
• Main ID: EUCTR2013-000373-76-BE
• Date of registration: 19/12/2013
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline Biologicals
• Public title: Consistency, immunogenicity and safety study of GlaxoSmithKline (GSK) Biologicals’ Herpes Zoster (HZ) vaccine GSK1437173A in adults = 50 years of age.
• Scientific title: A phase III, randomized, double blind multicenter study, to evaluate consistency, immunogenicity, safety and reactogenicity of 3 lots of GSK Biologicals’ herpes zoster HZ/su candidate vaccine when administered intramuscularly on a 0 and 2 month schedule to adults =50 years of age. - ZOSTER-007
• Date of first enrolment: 16/01/2014
• Target sample size: 651
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000373-76
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: lot-to-lot consistency Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Belgium, Panama, United States

Contacts

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

• Name: Clinical Disclosure Advisor
• Affiliation: GlaxoSmithKline Biologicals

Key inclusion & exclusion 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.
- 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.


• Female subjects of childbearing potential may be enrolled in the study, if the subject:
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 434
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 217

Exclusion criteria:
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. A prednisone dose of <20 mg/day is allowed. Inhaled, topical and intra-articular corticosteroids are allowed.
- Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine (E.g. inactivated and subunit vaccines) within 8 days prior to or within 14 days after either dose of study vaccine.
- Administration of long-acting immune-modifying drugs 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 product.
- Previous vaccination against HZ or varicella.
- Planned administration during the study of an HZ or varicella vaccine other than the study vaccine.
- History of HZ.
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- Acute disease and/or fever at the time of enrolment.
* Fever is defined as temperature = 37.5°C (99.5°F) by oral route. The preferred route for recording temperature in this study will be oral.
* Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- Administration of immunoglobulins and/or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
- Pregnant or lactating females.
- Females planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 4
- Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
- Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study
- Any condition which, in the judgment of the investigator would make intramuscular injection unsafe.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Herpes Zoster (HZ) and its related complications.
MedDRA version: 17.0 Level: PT Classification code 10019974 Term: Herpes zoster System Organ Class: 10021881 - Infections and infestations

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Intervention(s)

Product Name: Herpes zoster vaccine GSK1437173A
Product Code: HZ/su or gE/AS01B
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: NA
Current Sponsor code: gE
Other descriptive name: gE antigen
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Primary end point(s): Anti-gE humoral immunogenicity.
* Anti-gE antibody concentrations, as determined by enzyme-linked immunosorbent assay (ELISA).

Main Objective: - To demonstrate lot-to-lot consistency in terms of anti-gE humoral immunogenicity between three production lots of the HZ/su vaccine one month after the second dose (Month 3).

Secondary Objective: - To demonstrate the consistency of three manufacturing lots of HZ/su vaccine in terms of vaccine response rates one month after the second vaccine dose.
Criteria:
For each pair-wise comparison, the two-sided 95% confidence interval (CI) on the lot difference in vaccine response rate (VRR) to the HZ/su vaccine (in terms of the humoral anti-gE immune response) one month after the second vaccine dose is within the [-10%; +10%] margin.
This secondary objective will be assessed in a hierarchical manner i.e. it can only be met if the statistical criteria for this objective are met as well as the statistical criteria for the primary objective.
- To characterize anti-gE humoral immune responses for all study groups at Month 0 and Month 3.
- To evaluate the safety and reactogenicity following administration of HZ/su vaccine up to one month post last vaccination and until study end (Month 14).

Timepoint(s) of evaluation of this end point: Anti-gE antibody concentrations at Month 3.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: - Anti-gE antibody concentrations at Month 0 and Month 3.
- Vaccine response for anti-gE humoral immunogenicity at Month 3.
- Solicited local and general symptoms: Within 7 days (Days 0-6) after each vaccination.
- Unsolicited symptoms: During 30 days (Days 0-29) after each vaccination.
- SAEs:
* From first vaccination up to 30 days post last vaccination (Month 0-Month 3).
* From 30 days post last vaccination until study end (Month 4 - Month 14).
- pIMDs:
* From first vaccination up to 30 days post last vaccination. (Month 0-Month 3)
* During the period starting after 30 days post last vaccination until study end. (Month 4 –Month 14)

Secondary end point(s): - Anti-gE humoral immunogenicity.
* Anti-gE antibody concentrations, as determined by ELISA.
* Vaccine response for anti-gE humoral immunogenicity, as determine by ELISA.
- Occurrence of solicited local and general symptoms.
* Occurrence, intensity and duration of each solicited local symptom.
*Occurrence, intensity, duration and relationship to vaccination of each solicited general symptom.
- Occurrence of unsolicited symptoms
* Occurrence, intensity and relationship to vaccination of unsolicited adverse events (AEs) according to the Medical Dictionary for Regulatory Activities (MedDRA) classification.
- Occurrene of Serious Adverse Events (SAEs)
* Occurrence and relationship to vaccination of all SAEs.
- Occurrence of AEs of specific interest.
* Occurrence of any potential Immune Mediated Diseases (pIMDs).

Secondary ID(s)

117177

Source(s) of Monetary Support

GlaxoSmithKline Biologicals