Clinical Trials Register

Summary
EudraCT Number:	2009-015791-94
Sponsor's Protocol Code Number:	113077
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2010-08-03
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Czechia - SUKL

A.2

EudraCT number

2009-015791-94

A.3

Full title of the trial

A phase III, randomized, observer-blind, placebo-controlled, multicentre, clinical vaccination trial to assess the prophylactic efficacy, safety and immunogenicity of GSK Biologicals’ gE/AS01B vaccine when administered intramuscularly on a 0, 2-month schedule in adults aged 70 years and older.

Fáze III, randomizovaná, pro pozorovatele zaslepená, placebem kontrolovaná, mezinárodní multicentrická studie hodnotící účinnost, bezpečnost a imunogenitu očkovací látky proti pásovému oparu od firmy GSK Biologicals (gE/AS01B) podané nitrosvalově ve dvou dávkách (0 – 2 měsíce) u dospělých jedinců starších 70 let.

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Study to evaluate GSK Biologicals’ Herpes Zoster vaccine GSK1437173A in adults aged ≥70 years.

Studie hodnotící očkovací látku proti pásovému oparu od firmy GSK Biologicals (GSK1437173A) u dospělých jedinců starších 70 let.

A.3.2

Name or abbreviated title of the trial where available

ZOSTER-022

A.4.1

Sponsor's protocol code number

113077

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01165229

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	GlaxoSmithKline Biologicals
B.1.3.4	Country	Belgium
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	GlaxoSmithKline Biologicals
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GlaxoSmithKline Biologicals
B.5.2	Functional name of contact point	Clinical Disclosure Advisor
B.5.3	Address:
B.5.3.1	Street Address	Rue de l'Institut, 89
B.5.3.2	Town/ city	Rixensart
B.5.3.3	Post code	1330
B.5.3.4	Country	Belgium
B.5.4	Telephone number	4420 89904466
B.5.5	Fax number	--------
B.5.6	E-mail	GSKClinicalSupportHD@gsk.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	gE recombinant protein formulated in AS01B Adjuvant System
D.3.2	Product code	gE/AS01B
D.3.4	Pharmaceutical form	Powder and solvent for suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	-
D.3.9.2	Current sponsor code	gE
D.3.9.3	Other descriptive name	gE recombinant protein
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Intramuscular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Primary immunization of subjects ≥ 70 YOA against Herpes Zoster (HZ). The study population includes males and females without severely immunocompromising conditions in the age ranges 70-79 YOA and ≥ 80 YOA.

E.1.1.1

Medical condition in easily understood language

Vaccination against shingles in elderly adults

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	LLT
E.1.2	Classification code	10019982
E.1.2	Term	Herpes zoster NOS
E.1.2	System Organ Class	100000004862

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

*Primary objective for study ZOSTER-022:
•To evaluate vaccine efficacy (VE) in the prevention of HZ compared to placebo in adults ≥70 YOA, as measured by the reduction in HZ risk;

*Primary objectives for pooled analysis of studies ZOSTER-006 (EudraCT nr 2008-000367-42; study 110390) and ZOSTER-022:
•To evaluate VE in the prevention of PHN compared to placebo in subjects ≥70 YOA across both phase III studies;
•To consolidate VE estimation in the prevention of HZ compared to placebo in subjects ≥70 YOA across both phase III studies.

E.2.2

Secondary objectives of the trial

*For ZOSTER-022:
To evaluate the following compared to placebo in subjects ≥70 YOA -
•VE in the prevention of overall PHN;
•VE in reducing the total duration of severe 'worst' HZ-associated pain over the entire pain reporting period, with confirmed HZ;
•VE in the reduction of overall and HZ-related mortality and hospitalizations;
•VE in the reduction in incidence of HZ-associated complications, with confirmed HZ;
•VE in the reduction in use of pain medications, with confirmed HZ;
•Vaccine safety and reactogenicity (all subjects).

*For the pooled analysis of ZOSTER-006 (110390) and ZOSTER-022:
To evaluate the following compared to placebo -
•VE in the prevention of overall PHN in subjects ≥50 YOA;
•VE in the prevention of PHN in subjects ≥50 YOA with confirmed HZ;
•VE in reducing the total duration of severe 'worst' HZ-associated pain over the entire pain reporting period in subjects ≥ 70 YOA, with confirmed HZ;
•Vaccine safety and reactogenicity in subjects ≥70 YOA.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Subjects who the investigator believes will comply with the requirements of the protocol (e.g. completion of the diary cards/questionnaires, return for follow-up visits, have regular contact to allow evaluation during the study);
•Written informed consent obtained from the subject;
•A male or female aged 70 years or older at the time of the first vaccination.

E.4

Principal exclusion criteria

•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use 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 (pharmaceutical product or device);
•Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, HIV infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders);
•History of HZ;
•Previous vaccination against varicella or HZ (either registered product or participation in a previous vaccine study, and including previous vaccination with childhood varicella vaccine);
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation (such as materials that may possibly contain latex -gloves, syringes, etc). Please note, the vaccine and vials in this study do not contain latex;
•Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 4 years);
•Receipt of immunoglobulins and/or any blood products within the 90 days preceding the first dose of study vaccine or planned administration during the study period;
•Administration or planned administration of any other immunizations within 30 days before the first or second study vaccination or scheduled within 30 days after study vaccination. However, licensed non-replicating vaccines (i.e., inactivated and subunit vaccines, including inactivated and subunit influenza vaccines for seasonal or pandemic flu, with or without adjuvant) may be administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine;
•Any other condition (e.g., extensive psoriasis, chronic pain syndrome, cognitive impairment, severe hearing loss) that, in the opinion of the investigator, might interfere with the evaluations required by the study;
•Acute disease and/or fever at the time of enrolment; Fever is defined as temperature ≥ 37.5°C (99.5°F) on oral, axillary or tympanic setting, or ≥ 38.0°C (100.4°F) on rectal setting. The preferred route for recording temperature in this study will be oral. Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
•Chronic administration (defined as more than 15 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, is allowed. Inhaled and topical steroids are allowed.

E.5 End points

E.5.1

Primary end point(s)

*Primary endpoint in study ZOSTER-022:
•Confirmed HZ cases: Confirmed HZ cases during the study in the mTVc.

*Primary endpoints in pooled analysis of studies ZOSTER-006 and ZOSTER-022:
•Occurrence of overall PHN: Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥70 YOA;
•Occurrence of confirmed HZ: Occurrence of confirmed HZ during the entire study period in subjects ≥70 YOA.

E.5.1.1

Timepoint(s) of evaluation of this end point

3 to 5 year period following Day 0

E.5.2

Secondary end point(s)

*Secondary endpoints in study ZOSTER-022:
•1. PHN cases: PHN cases in the mTVc;
•2. Duration of severe ‘worst’ HZ-associated pain: Duration of severe ‘worst’ HZ-associated pain following the onset of a confirmed HZ rash as measured by the ZBPI in subjects with confirmed HZ;
•3. Incidence of overall and HZ-related mortality;
•4. Incidence of HZ complications in subjects with confirmed HZ;
•5. Incidence of overall and HZ-related hospitalizations;
•6. Duration of pain medication administered for HZ in subjects with confirmed HZ;
•7. Occurrence of solicited local and general symptoms in a subset of subjects;
•8. Occurrence, intensity and relationship to vaccination of unsolicited adverse events (AEs), according to the Medical Dictionary for Regulatory Activities (MedDRA) classification, in all subjects;
•9. Occurrence of Serious Adverse Events (SAEs) in all subjects;
•10. Occurrence of SAEs related to study participation or to a concurrent GSK medication/vaccine in all subjects;
•11. Occurrence of fatal SAEs in all subjects;
12. Occurrence and relationship to vaccination of any pre-defined AEs in all subjects;
•13. Occurrence and relationship to vaccination of any medically attended visits (defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits, in all subjects.

*Secondary endpoints for ZOSTER-006 and ZOSTER-022 pooled analysis:
•14. Occurrence of overall PHN: Incidence of PHN calculated using the mTVc in subjects ≥50 YOA;
•15. Occurrence of PHN in subjects ≥50 YOA with confirmed HZ;
•16. Duration of severe ‘worst’ HZ-associated pain following the onset of a confirmed HZ rash as measured by the ZBPI in subjects ≥70 YOA with confirmed HZ;
•17. Occurrence of solicited local and general symptoms in subjects ≥70 YOA included in a subset of subjects;
•18. Occurrence, intensity and relationship to vaccination of unsolicited AEs, according to the MedDRA classification, in subjects ≥70 YOA;
•19. Occurrence of SAEs in subjects ≥70 YOA;
•20. Occurrence of SAEs related to study participation or to a concurrent GSK medication/vaccine in subjects ≥70 YOA;
•21. Occurrence of fatal SAEs in subjects ≥70 YOA;
•22. Occurrence and relationship to vaccination of any pre-defined AEs in subjects ≥70 YOA;
•23. Occurrence of medically attended visits and relationship to vaccination of any of medically attended visits(defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits, in subjects ≥70 YOA.

E.5.2.1

Timepoint(s) of evaluation of this end point

Secondary endpoints numbered
•1 to •6: 3 to 5 year period following Day 0;
•7: 7 days (Days 0-6) after each vaccination;
•8: 30 days (Days 0-29) after each vaccination;
•9: From Month 0 to Month 14;
Secondary endpoints numbered
•10 to •12: 3 to 5 year period following Day 0;
•13: From Month 0 to Month 8;
Secondary endpoints numbered
•14 to •16: 3 to 5 year period following Day 0;
•17: 7 days (Days 0-6) after each vaccination;
•18: 30 days (Days 0-29) after each vaccination;
•19: From Month 0 to Month 14;
Secondary endpoints numbered
•20 to •22: 3 to 5 year period following Day 0;
•23. From Month 0 to Month 8.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

Yes

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

reactogenicity, immunogenicity

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

observer-blind

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

116

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Australia

Brazil

Canada

Czech Republic

Estonia

Finland

France

Germany

Hong Kong

Italy

Japan

Korea, Republic of

Mexico

Spain

Sweden

Taiwan

United Kingdom

United States

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last subject last contact. Study end will take place when both conditions for final analysis are met and a minimum 90 days follow-up is completed for each HZ case of confirmed or clinically diagnosed suspected HZ that occurs prior to the cut-off date for final analysis.

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

14512

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

950

F.4.2

For a multinational trial

F.4.2.1

In the EEA

7525

F.4.2.2

In the whole clinical trial

14512

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

At study conclusion, if the study vaccine demonstrates sufficient evidence of efficacy and safety such that a clinically important benefit may be reasonably expected, placebo recipients will be offered cross-over immunization with the study vaccine.

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2010-11-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-10-07

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2015-07-24

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