Clinical Trials Register

Summary
EudraCT Number:	2015-001656-29
Sponsor's Protocol Code Number:	V110-018
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2015-04-21
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
H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED

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A. Protocol Information

A.2

EudraCT number

2015-001656-29

A.3

Full title of the trial

A Phase III, Open-Label Clinical Trial to Study the Safety and Immunogenicity of V110 in Subjects 50 Years of Age and Older and in Subjects 2 to 49 Years of Age at Increased Risk for Pneumococcal Disease, from the Russian Population.

A.3.1

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

Russian Registration Study of PPV23

A.3.2

Name or abbreviated title of the trial where available

Russian Registration Study of PPV23

A.4.1

Sponsor's protocol code number

V110-018

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01734239

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	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
B.1.3.4	Country	United States
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	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
B.5.2	Functional name of contact point	Global Clinical Trials Operations
B.5.3	Address:
B.5.3.1	Street Address	One Merck Drive, P.O. Box 100
B.5.3.2	Town/ city	Whitehouse Station
B.5.3.3	Post code	NJ 08889-0100
B.5.3.4	Country	United States
B.5.4	Telephone number	1 267-305-7902
B.5.5	Fax number	1 267 305 6515
B.5.6	E-mail	luwy.musey@merck.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	PNEUMOVAX 23
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	PNEUMOVAX 23
D.3.2	Product code	V110
D.3.4	Pharmaceutical form	Solution 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	pneumococcal polysaccharide polyvalent – serotype 1
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1
D.3.9.4	EV Substance Code	SUB25373
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pneumococcal polysaccharide polyvalent – serotype 2
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 2
D.3.9.4	EV Substance Code	SUB25372
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pneumococcal polysaccharide polyvalent – serotype 3
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3
D.3.9.4	EV Substance Code	SUB25371
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pneumococcal polysaccharide polyvalent – serotype 4
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4
D.3.9.4	EV Substance Code	SUB20576
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pneumococcal polysaccharide polyvalent – serotype 5
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5
D.3.9.4	EV Substance Code	SUB25370
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pneumococcal polysaccharide polyvalent – serotype 6B
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B
D.3.9.4	EV Substance Code	SUB20577
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pneumococcal polysaccharide polyvalent – serotype 7F
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F
D.3.9.4	EV Substance Code	SUB25369
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pneumococcal polysaccharide polyvalent – serotype 8
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8
D.3.9.4	EV Substance Code	SUB25357
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pneumococcal polysaccharide polyvalent – serotype 9N
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9N
D.3.9.4	EV Substance Code	SUB25367
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pneumococcal polysaccharide polyvalent – serotype 9V
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V
D.3.9.4	EV Substance Code	SUB20578
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pneumococcal polysaccharide polyvalent – serotype 10A
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A
D.3.9.4	EV Substance Code	SUB25378
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pneumococcal polysaccharide polyvalent – serotype 11A
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A
D.3.9.4	EV Substance Code	SUB25365
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pneumococcal polysaccharide polyvalent – serotype 12F
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F
D.3.9.4	EV Substance Code	SUB25364
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pneumococcal polysaccharide polyvalent – serotype 14
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14
D.3.9.4	EV Substance Code	SUB20579
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pneumococcal polysaccharide polyvalent – serotype 15B
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B
D.3.9.4	EV Substance Code	SUB25363
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pneumococcal polysaccharide polyvalent – serotype 17F
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 17F
D.3.9.4	EV Substance Code	SUB25362
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pneumococcal polysaccharide polyvalent – serotype 18C
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C
D.3.9.4	EV Substance Code	SUB20580
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pneumococcal polysaccharide polyvalent – serotype 19F
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F
D.3.9.4	EV Substance Code	SUB20581
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pneumococcal polysaccharide polyvalent – serotype 19A
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A
D.3.9.4	EV Substance Code	SUB25361
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pneumococcal polysaccharide polyvalent – serotype 20
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 20
D.3.9.4	EV Substance Code	SUB25360
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pneumococcal polysaccharide polyvalent – serotype 22F
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F
D.3.9.4	EV Substance Code	SUB25359
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pneumococcal polysaccharide polyvalent – serotype 23F
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F
D.3.9.4	EV Substance Code	SUB20582
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	pneumococcal polysaccharide polyvalent – serotype 33F
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F
D.3.9.4	EV Substance Code	SUB25326
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	25
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	No
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Vaccination against pneumococcal disease caused by the 23 serotypes included in the vaccine

E.1.1.1

Medical condition in easily understood language

Infection caused by a bacterium identified as Streptococcus pneumoniae

E.1.1.2

Therapeutic area

Body processes [G] - Immune system processes [G12]

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

Safety Objective: To describe the safety and tolerability profiles of PNEUMOVAX™ 23 in subjects from the Russian population 50 years of age and older and in subjects 2 to 49 years of age who are at increased risk for pneumococcal disease. Immunogenicity Objective: To describe the immunogenicity profile of PNEUMOVAX™ 23 in subjects from the Russian population 50 years of age and older and in subjects 2 to 49 years of age who are at increased risk for pneumococcal disease.

E.2.2

Secondary objectives of the trial

Not applicable

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Merck will conduct Future Biomedical Research on DNA (blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.

E.3

Principal inclusion criteria

All subjects must be from the Russian population.
a. Subjects 50 years of age or older. Any underlying chronic illness must be documented to be in stable condition.
b. Subjects 2 to 49 years of age with an increased risk for pneumococcal disease as a result of one of the following conditions:
• Chronic cardiovascular disease (including congestive heart failure and cardiomyopathies)
• Chronic pulmonary disease (including chronic obstructive pulmonary disease & emphysema)
• Diabetes mellitus
• Alcoholism
• Chronic liver disease (including cirrhosis)
•Cerebrospinal fluid leaks
• Functional or anatomic asplenia
• Sickle cell anemia
• Persons living in special environments or social settings (Individuals living in crowded, closed communities such as shelters, military camps, or long-term care facilities).
c. Subject or parent (for minor subjects) has signed and dated informed consent/assent prior to receipt of the study vaccine. For this study, parent is defined as biological or adoptive. The subject or parent may also provide consent/assent for Future Biomedical Research (FBR) for future assay/vaccine development and/or FBR. However, the subject may participate in the main trial without participating in either future assay/vaccine development or FBR.
d. Subject is highly unlikely to become pregnant at any time from signing the informed consent through 6 weeks after receiving the study vaccine, as indicated by at least one “yes” answer to the following questions:
• Subject is male.
• Subject is a female of reproductive potential who agrees to remain abstinent or use (or have her partner use) 2 acceptable methods of contraception during the time period at any time from signing the informed consent through 6 weeks after receiving the study vaccine. Acceptable methods of birth control are: hormonal contraceptives, diaphragm with spermicide, intrauterine device (IUD), contraceptive sponge, condom, or vasectomy. Note that simultaneous use of 2 reliable forms of contraception is recommended.
• Subject is a female who is not of reproductive potential. A female subject who is not of reproductive potential is defined as: one who has either (1) Not reached Puberty (2) reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone [FSH] levels in the postmenopausal range as determined by a laboratory, or 12 months of spontaneous amenorrhea), (3) post-surgical bilateral oophorectomy and/or hysterectomy, or (4) bilateral tubal ligation.

E.4

Principal exclusion criteria

a. Hypersensitivity to any of the components of the study vaccine, including phenol. See Attachments for PNEUMOVAX™ 23 Package Labeling.
b. Prior vaccination with any pneumococcal polysaccharide or conjugate vaccine. When available, written medical records should be reviewed to verify the subject’s denial of receiving a prior pneumococcal vaccination.
c. Known or suspected immune dysfunction, including persons with congenital immunodeficiency, HIV infection, leukemia, lymphoma, Hodgkin’s disease, multiple myeloma, generalized malignancy, chronic renal failure (most recent serum creatinine values in medical record ≥3mg/dL), or other conditions associated with immunosuppression such as organ or bone marrow transplantation, or those receiving immunosuppressive chemotherapy, including long-term systemic corticosteroids. (Subjects with prostate, breast, or skin cancer who are not on chemotherapeutic drugs [other than hormone blocking drugs] and subjects with other malignancies who have been disease-free for at least 5 years will be eligible for enrollment).
d. History of autoimmune disease
e. Receipt of other licensed vaccines during the study period as follows:
• Licensed live virus vaccines received during the 3 months prior to injection with the study vaccine or scheduled within 3 months after receipt of the study vaccine.
• Inactivated licensed vaccines received during the 28 days prior to injection with the study vaccine or scheduled prior to the Day 28 postvaccination visit.
f. Receipt of investigational drugs or other investigational vaccines within 2 months prior to injection with the study vaccine, or anticipated receipt of these products prior to the final (Day 28) postvaccination visit (3 months if a live virus vaccine).
g. Receipt of any blood product or immunoglobulin preparation within the 6 months prior to injection with the study vaccine, or anticipated receipt of these products prior to the final (Day 28) postvaccination visit.
h. Recent hospitalization for acute illness within the 3 months before receipt of the study vaccine.
i. Pregnant women, nursing mothers.
j. History of IPD (positive culture from blood, cerebrospinal fluid, or other sterile site).
k. Known history of other culture-positive pneumococcal disease.
l. History of febrile illness (≥37.6°C axillary; ≥38.0°C oral or equivalent) occurring within 3 days (72 hours) before receipt of the study vaccine.
m. Subject has received antibiotic therapy for any acute illness within 7 days before receipt of study vaccine.

E.5 End points

E.5.1

Primary end point(s)

Primary immunogenicity endpoints:
• Postvaccination geometric mean concentrations (GMCs) on study Day 28 for the antibody to pneumococcal serotypes 6B, 19F, 23F, 1 and 14.
• Proportions of subjects with a 2-fold increase in IgG antibody concentration from prevaccination to postvaccination for serotypes 6B, 19F, 23F, 1 and 14.
Primary safety endpoints: Elevated body temperature (≥37.6ºC axillary; ≥38.0ºC oral or equivalent) from Days 1 through 5 postvaccination; VRC-solicited injection-site reactions (redness, swelling, pain/tenderness) Days 1 through 5 postvaccination, including the day of vaccination; all other adverse experiences, including injection-site and systemic adverse experiences reported following receipt of the study vaccine through 14 days postvaccination; and all reported serious adverse experiences during the 28-day safety follow-up period.

E.5.1.1

Timepoint(s) of evaluation of this end point

Timepoints are described in E.5.1.

E.5.2

Secondary end point(s)

Not applicable

E.5.2.1

Timepoint(s) of evaluation of this end point

Not applicable

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

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

Will this trial be conducted at a single site globally?

E.8.4

Will this trial be conducted at multiple sites globally?

Yes

E.8.6 Trial involving sites outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Yes

E.8.6.3

Specify the countries outside of the EEA in which trial sites are planned

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

LVLS

E.8.9 Initial estimate of the duration of the trial

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

Yes

F.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

children

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

102

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)

All subjects are followed for adverse experiences for 14 days postvaccination, and for serious adverse experiences for 28 days postvaccination.

G. Investigator Networks to be involved in the Trial

H.4 Third Country in which the Trial was first authorised
H.4.1	Third Country in which the trial was first authorised:	Russian Federation

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:
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