Clinical Trials Register

Summary
EudraCT Number:	2016-000744-34
Sponsor's Protocol Code Number:	204939
National Competent Authority:	Finland - Fimea
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-06-04
Trial 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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Finland - Fimea

A.2

EudraCT number

2016-000744-34

A.3

Full title of the trial

A phase III, randomized, observer-blind, placebo controlled, multicenter clinical trial to assess Herpes Zoster recurrence and the reactogenicity, safety and immunogenicity of GSK Biologicals’ Herpes Zoster vaccine (HZ/su) when administered intra-muscularly on a 0 and 2 month schedule to adults ≥ 50 years of age with a prior episode of Herpes Zoster

III vaiheen satunnaistettu, lumekontrolloitu, havainnoitsijan suhteen sokkoutettu monikeskustutkimus, jossa arvioidaan vyöruusun uusiutumista ja vyöruusurokotteen (HZ/su) reaktogeenisuutta, turvallisuutta ja immunogeenisuutta vyöruusun aiemmin sairastaneilla vähintään 50-vuotiailla aikuisilla, jotka saavat rokotteen lihakseen kahtena annoksena 2 kuukauden välein

A.3.1

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

A study to evaluate the safety and immunogenicity of GlaxoSmithKline’s Shingrix vaccine when given on a two-dose schedule to adults at least 50 years of age (YOA) who had prior episode of shingles

A.3.2

Name or abbreviated title of the trial where available

ZOSTER-062

A.4.1

Sponsor's protocol code number

204939

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	442089904466
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	Yes
D.2.1.1.1	Trade name	SHINGRIX
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline Biologicals SA
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Herpes Zoster subunit vaccine (GSK1437173A)
D.3.2	Product code	HZ/su
D.3.4	Pharmaceutical form	Powder and suspension 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	Varicella Zoster Virus Glycoprotein E antigen
D.3.9.2	Current sponsor code	gE Antigen
D.3.9.3	Other descriptive name	RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E
D.3.9.4	EV Substance Code	SUB31416
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	Powder and solution for 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

Healthy volunteers (Prevention of Herpes Zoster)

E.1.1.1

Medical condition in easily understood language

Shingles

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare the incidence of HZ recurrence in the HZ/su group to the placebo group
A formal non-inferiority analysis will be performed.
Criterion: The objective is met if the upper limit (UL) of the 95% CI of the ratio of the incidence of HZ recurrence (HZ/su versus placebo) is below 5.

E.2.2

Secondary objectives of the trial

•To evaluate the rate of HZ recurrence in HZ/su and placebo groups during the entire study period.
•To evaluate safety and reactogenicity following administration of HZ/su vaccine or placebo within 30 days after each dose.
•To evaluate safety following administration of HZ/su vaccine or placebo during the entire study period.
•To characterize anti-gE humoral immunogenicity response prior to the first vaccination (Day 1), at two months post first vaccination (Month 2) and at one month post last vaccination (Month 3) in both groups.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Subjects and/or subject’s LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol
•Written informed consent obtained from the subject/subject’s LAR(s) prior to performance of any study specific procedure.
•A male or female ≥ 50 YOA at the time of the first vaccination.
•Subjects with a history of HZ. Confirmation of the prior HZ diagnosis can be done by one of the following three methods:
Clinically diagnosed HZ OR Laboratory diagnosed HZ OR HZ diagnosed by an adjudication committee
Female subjects of non-childbearing potential may be enrolled in the study.
(Non-childbearing potential is defined as current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy, bilateral salpingectomy 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 for 2 months after completion of the vaccination series.

E.4

Principal exclusion criteria

•Subjects who at time of study entry or during the maximum period of anticipated study participation are/will become part of the population recommended to receive a zoster vaccine per existing local or national immunization practices will be excluded from study participation.
•Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine, or planned use during the study period.
•Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
•Onset of HZ in the past 6 months or any ongoing symptoms from a prior HZ episode.
•Chronic antiviral use for HZ prophylaxis.
•History of >1 prior episode of HZ.
•A history of disseminated HZ, cutaneous or associated with visceral disease or associated with neurologic disease caused by VZV infection.
•Use or anticipated use of immunosuppressants or immune-modifying drugs during the period starting six months prior to study start and during the whole study period. This includes chronic administration of corticosteroids, long-acting immune-modifying agents or immunosuppressive/cytotoxic therapy
•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 and ending 30 days after the last dose of study vaccine. However, licensed pneumococcal vaccines and non-replicating vaccines may be administered up until 8 days prior to dose 1 and/or dose 2 and/or at least 14 days after any dose of study vaccine.
•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
•Previous vaccination against VZV or HZ.
•Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
•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.
•Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
•Pregnant or lactating female.
•Female planning to become pregnant or planning to discontinue contraceptive precautions in the period up to 2 months after completion of the vaccination series.

E.5 End points

E.5.1

Primary end point(s)

Number of confirmed Herpes Zoster (HZ) cases.

A suspected case of HZ is defined as a new unilateral rash accompanied by pain and no alternative diagnosis.
A suspected case of HZ is confirmed by 2 ways:
• By PCR (Polymerase Chain Reaction)
• By the HZ Ascertainment Committee (HZAC)
The incidence of HZ recurrence in the HZ/su group versus placebo group is compared by performing a non-inferiority analysis.

E.5.1.1

Timepoint(s) of evaluation of this end point

From one-month post-dose 2 to study end (Month 26)

E.5.2

Secondary end point(s)

Number of confirmed HZ cases
Number of subjects with any solicited local adverse events (AEs)
Number of subjects with any solicited general AEs
Number of subjects with any unsolicited AEs
Number of subjects with any serious adverse events (SAEs)
Number of subjects with any serious adverse events (SAEs)
Number of subjects with any related SAEs
Number of subjects with any potential immune-mediated diseases (pIMDs)
Number of subjects with any pIMDs
Vaccine response rate (VRR) for anti-glycoprotein E (Anti-gE) antibodies as determined by Enzyme Linked Immuno-sorbent Assay (ELISA)
Anti-gE antibody concentrations in terms of Geometric Mean Concentrations (GMCs) as determined by ELISA

E.5.2.1

Timepoint(s) of evaluation of this end point

From Visit Day 1 till study end (Month 26)
Within 7 days (Days 1-7) after each vaccination
Within 7 days (Days 1-7) after each vaccination
Within 30 days (Days 1-30) after each vaccination
From Visit Day 1 up to 30 days post last vaccination
From 30 days post last vaccination to 1 year post last vaccination.
During the entire study period (Visit day 1 to Month 26)
From Visit Day 1 up to 30 days post last vaccination
From 30 days post last vaccination to 1 year post last vaccination
At Month 2 and Month 3
At Day 1, Month 2 and Month 3

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

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

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

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

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

Hong Kong

Mexico

Panama

Russian Federation

E.8.7

Trial has a data monitoring committee

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

After all the subjects complete their study conclusion contact, occurring within 30 days of the projected study conclusion date of the late enrolled subject, that is, 26 months (790 days) from the enrolment date of the last subject AND the release of all polymerase chain reaction (PCR) test results for the HZ rash lesion samples

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

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)

Yes

F.1.2.1

Number of subjects for this age range:

580

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

870

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

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

252

F.4.2

For a multinational trial

F.4.2.1

In the EEA

793

F.4.2.2

In the whole clinical trial

1426

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)

After study conclusion, placebo recipients may be offered cross-over vaccination with HZ/su, if supported by study results.

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

2019-06-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-06-28

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2024-03-15

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials