Clinical Trials Register

Summary
EudraCT Number:	2020-003329-49
Sponsor's Protocol Code Number:	V260-074
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2021-08-16
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

2020-003329-49

A.3

Full title of the trial

A Phase 3 Randomized, Open-Label, Clinical Trial to Study the Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of V260 and Inactivated Poliomyelitis Vaccine (IPV) in Chinese Healthy Infants

A.3.1

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

Immunogenicity and safety assessment of concomitant administration of V260 and IPV in Chinese healthy infants

A.4.1

Sponsor's protocol code number

V260-074

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT04481191

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	Minghuan Zheng
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, New Jersey
B.5.3.3	Post code	08889-0100
B.5.3.4	Country	United States
B.5.4	Telephone number	+86(10) 58609375
B.5.6	E-mail	ming.huan.zheng@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	Rotateq®
D.2.1.1.2	Name of the Marketing Authorisation holder	MSD VACCINS
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.3.4	Pharmaceutical form	Oral solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ROTAVIRUS SEROTYPE G1
D.3.9.3	Other descriptive name	ROTAVIRUS SEROTYPE G1 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS
D.3.9.4	EV Substance Code	SUB25315
D.3.10	Strength
D.3.10.1	Concentration unit	Infectious unit
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	2200000
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ROTAVIRUS SEROTYPE G2
D.3.9.3	Other descriptive name	ROTAVIRUS SEROTYPE G2 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS
D.3.9.4	EV Substance Code	SUB25325
D.3.10	Strength
D.3.10.1	Concentration unit	Infectious unit
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	2800000
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ROTAVIRUS SEROTYPE G3
D.3.9.3	Other descriptive name	ROTAVIRUS SEROTYPE G3 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS
D.3.9.4	EV Substance Code	SUB25335
D.3.10	Strength
D.3.10.1	Concentration unit	Infectious unit
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	2200000
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ROTAVIRUS SEROTYPE G4
D.3.9.3	Other descriptive name	ROTAVIRUS SEROTYPE G4 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS
D.3.9.4	EV Substance Code	SUB25323
D.3.10	Strength
D.3.10.1	Concentration unit	Infectious unit
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	2000000
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ROTAVIRUS SEROTYPE P1[8]
D.3.9.3	Other descriptive name	ROTAVIRUS SEROTYPE P1[8] HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS
D.3.9.4	EV Substance Code	SUB25322
D.3.10	Strength
D.3.10.1	Concentration unit	Infectious unit
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	2300000
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.IMP: 2
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	Inactivated Poliomyelitis Vaccine Made From Sabin Strains (Vero Cell)
D.2.1.1.2	Name of the Marketing Authorisation holder	Beijing Biological Products Institute Co.,Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	China
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.3.4	Pharmaceutical form	Solution for injection in vial
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	POLIOVIRUS TYPE 1
D.3.9.3	Other descriptive name	POLIOVIRUS TYPE 1 (INACTIVATED)
D.3.9.4	EV Substance Code	SUB20462
D.3.10	Strength
D.3.10.1	Concentration unit	DAgU D antigen unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	POLIOVIRUS TYPE 2
D.3.9.3	Other descriptive name	POLIOVIRUS TYPE 2 (INACTIVATED)
D.3.9.4	EV Substance Code	SUB20463
D.3.10	Strength
D.3.10.1	Concentration unit	DAgU D antigen unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	45
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	POLIOVIRUS TYPE 3
D.3.9.3	Other descriptive name	POLIOVIRUS TYPE 3 (INACTIVATED)
D.3.9.4	EV Substance Code	SUB20464
D.3.10	Strength
D.3.10.1	Concentration unit	DAgU D antigen unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	45
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

Immunogenicity and safety assessment of concomitant administration of RotaTeq (V260) and IPV in Chinese healthy infants.

E.1.1.1

Medical condition in easily understood language

Immunogenicity and safety assessment of concomitant administration of RotaTeq (V260) and IPV in Chinese healthy infants.

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	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10076887
E.1.2	Term	Rotavirus immunization
E.1.2	System Organ Class	100000004865

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10054187
E.1.2	Term	Polio immunization
E.1.2	System Organ Class	100000004865

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 demonstrate that the immunogenicity of IPV in the concomitant-use group is non-inferior to that in the staggered-use group.

E.2.2

Secondary objectives of the trial

1. To evaluate immune responses to IPV at 1 month post dose 3 in the concomitant-use and staggered-use groups as measured by geometric mean titers (GMTs) of neutralizing antibodies to poliovirus types 1, 2, and 3.
2. To evaluate immune responses to IPV at 1 month post dose 3 in the concomitant-use and staggered-use groups as measured by the proportions of participants with neutralizing antibody titer ≥1:8 and ≥1:64 for each of poliovirus types 1, 2, and 3.
3. To evaluate the safety of concomitant administration of V260 and IPV based on the proportions of participants experiencing solicited injection-site adverse events (AEs), solicited systemic AEs, and serious AEs (SAEs).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Is healthy Chinese infant.
2. Is male or female from48 days to 63 days of age (inclusive) at Visit 1. (Date of birth is 1 day of age).
3. The participant’s legally acceptable representative provides written informed consent for the study.

E.4

Principal exclusion criteria

1. Has history of rotavirus disease, congenital gastrointestinal disorders, chronic diarrhea, failure to thrive, or abdominal surgery.
2. Has history of intussusception.
3. Has history of poliomyelitis.
4. Has clinical evidence of active gastrointestinal illness.
5. Has known or suspected impairment of immunological function, including severe combined immunodeficiency disease (SCID).
6. Has a fever, with an axillary temperature ≥37.5°C (or equivalent) at the time of vaccination or within 24 hours prior to vaccination.
7. Participant who clearly has acute disease.
8. Participant who has underlying diseases such as cardiovascular, renal, liver, or blood disease.
9. Has history of known hypersensitivity to any components of rotavirus vaccine and/or IPV.
10. Participant with uncontrolled epilepsy, encephalopathy, seizure, or other progressive neurological diseases.
11. Participant with known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
12. Is residing in a household with an immunocompromised person, including individuals with congenital immunodeficiency (including SCID), human immunodeficiency virus (HIV) infection, leukemia, lymphoma, multiple myeloma, generalized malignance, chronic renal failure, organ or bone marrow transplantation, or with those receiving immunosuppressive chemotherapy including long-term systemic corticosteroids.
13. Has prior administration of any rotavirus vaccines or poliovirus vaccines.
14. Received inactivated or recombinant vaccines within 14 days prior to Visit 1 or live vaccines within 28 days prior to Visit 1.
15. Has prior receipt of investigational or non-registered product other than study vaccines or is planning to use such product during the study.
16. Has prior receipt of immunosuppressive therapies including systemic (intramuscular, oral, or intravenous) corticosteroids.
17. Has prior receipt of a blood transfusion or blood products, including immunoglobulins or is planning to receive such product during the study.
18. Participated in another interventional study prior to Visit 1 or expected anytime during the study.

E.5 End points

E.5.1

Primary end point(s)

Neutralizing antibody seroconversion to each of poliovirus types 1, 2, and 3

E.5.1.1

Timepoint(s) of evaluation of this end point

One month post Dose 3.

E.5.2

Secondary end point(s)

- Neutralizing antibody titer to each of poliovirus types 1, 2, and 3
- Neutralizing antibody responses to each of poliovirus types 1, 2, and 3
- Solicited injection-site AEs (following vaccination of IPV)
- Solicited systemic AEs
- SAEs

E.5.2.1

Timepoint(s) of evaluation of this end point

One month post Dose 3.

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

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

Yes

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

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

Yes

E.8.2.3.1

Comparator description

Active control (Staggered-use group)

E.8.2.4

Number of treatment arms in the trial

E.8.3

Will this trial be conducted at a single site globally?

Yes

E.8.4

Will this trial be conducted at multiple sites globally?

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

China

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

The overall study ends when the last participant completes the last study-related telephone-call or visit, withdraws from the study, or is lost to follow-up.
For purposes of analysis and reporting, the overall study ends when the Sponsor receives the last laboratory result or at the time of final contact with the last participant, whichever comes last.

E.8.9 Initial estimate of the duration of the trial

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

Yes

F.1.1

Number of subjects for this age range:

400

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)

Yes

F.1.1.4.1

Number of subjects for this age range:

400

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)

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.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

400

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)

None

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	Yangchun Center For Disease Control and Prevention, Guangdong Province
G.4.3.4	Network Country	China

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

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