Clinical Trials Register

Summary
EudraCT Number:	2018-001151-12
Sponsor's Protocol Code Number:	V114-027
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2018-11-07
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

2018-001151-12

A.3

Full title of the trial

A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the
Interchangeability of V114 and Prevnar 13™ with Respect to Safety, Tolerability, and Immunogenicity in Healthy Infants (PNEU-DIRECTION)

A.3.1

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

Safety and Immunogenicity of the Interchangeability between V114 and Prevnar 13™ in Healthy Infants

A.4.1

Sponsor's protocol code number

V114-027

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT03620162

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/339/2017

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	Kara Bickham
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	+17325941884
B.5.6	E-mail	kara.bickham@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	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	15-Valent Pneumococcal Conjugate Vaccine
D.3.2	Product code	V114
D.3.4	Pharmaceutical form	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	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB30925
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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB30926
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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB25336
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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB30927
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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB30928
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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB25356
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	4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB30929
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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB25343
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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB25341
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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB28209
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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB30930
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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB25337
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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB188146
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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB25368
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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB188110
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	2
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	Comparator
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	Prevenar 13
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Limited
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	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	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB30925
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB30926
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB25336
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB30927
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB30928
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB25356
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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB30929
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB25343
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB25341
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB28209
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB30930
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB25337
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO CRM197
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB25368
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	2.2
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: 3
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 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS
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	IU international unit(s)
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 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS
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	IU international unit(s)
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 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS
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	IU international unit(s)
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 HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS
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	IU international unit(s)
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 P1A[8] HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS
D.3.9.3	Other descriptive name	ROTAVIRUS SEROTYPE P1A[8] HUMAN-BOVINE ROTAVIRUS REASSORTANTS (LIVE) PRODUCED ON VERO CELLS
D.3.9.4	EV Substance Code	SUB89281
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
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: 4
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	HBVaxPro (RECOMBIVAX HB®)
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	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	HEPATITIS B VACCINE (recombinant)
D.3.9.3	Other descriptive name	HEPATITIS B VACCINE (RDNA)
D.3.9.4	EV Substance Code	SUB12020MIG
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.5
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

prevention of pneumococcal disease

E.1.1.1

Medical condition in easily understood language

pneumococcal disease

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10061353
E.1.2	Term	Pneumococcal infection
E.1.2	System Organ Class	10021881 - Infections and infestations

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 evaluate the safety and tolerability of complete V114 (Group 5) and mixed Prevnar 13™/V114 dosing schedules (Groups 2, 3, and 4) compared with a complete dosing schedule of Prevnar 13™ (Group 1) with respect to the proportion of participants with adverse events (AEs).
-To evaluate the anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days following Dose 4 for participants administered mixed dosing schedules of Prevnar 13™/V114 (Groups 2, 3, and 4) compared with participants administered a complete dosing schedule of Prevnar 13™ (Group 1).

E.2.2

Secondary objectives of the trial

-Compare the proportion of participants with anti-HBsAg ≥10 mIU/mL at 30 days post Dose 3 for participants administered a complete primary infant series dosing schedule of V114 (Group 5) + RECOMBIVAX HB™ vs participants administered a complete primary infant series dosing schedule of Prevnar 13™ (Groups 1, 2) + RECOMBIVAX HB™.
-Compare the anti-rotavirus IgA GMT at 30 days post Dose 3 for participants administered a complete primary infant series dosing schedule of V114 (Group 5) + RotaTeq™ vs participants administered a complete primary infant series dosing schedule of Prevnar 13™ (Groups 1, 2) + RotaTeq™.
-Evaluate the anti-PnPs serotype-specific IgG GMCs and IgG response rates at 30 days post Dose 3 for each vaccination group (Groups 1, 2, 3, 4, 5).
-Evaluate the anti-PnPs serotype-specific IgG GMCs at 30 days post Dose 4 for participants administered a complete dosing schedule of V114 (Group 5) vs participants administered a complete dosing schedule of Prevnar 13™ (Group 1).

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 and buccal swab) 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

1. Participant is healthy (based on a review of medical history and physical examination) based on the clinical judgement of the investigator.
2. Participant is male or female infant approximately 2 months of age, from 42 days to 90 days inclusive, at the time of obtaining the informed consent.
3. Participant has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent. The legally acceptable representative may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.

E.4

Principal exclusion criteria

1. Has a history of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
2. Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV), any component of the licensed pediatric vaccines to be administered concomitantly in the study, or any diphtheria toxoid-containing vaccine.
3. Has any contraindication to the concomitant study vaccines being administered in the study.
4. *Had a recent febrile illness (rectal temperature ≥38.1°C [≥100.5°F] or axillary temperature ≥37.8°C [≥100.0°F]) occurring within 72 hours prior to receipt of study vaccine.
5. Has a known or suspected impairment of immunological function.
6. Has a history of congenital or acquired immunodeficiency.
7. Has or his/her mother has a documented human immunodeficiency virus (HIV) infection.
8. Has or his/her mother has a documented hepatitis B surface antigen – positive test.
9. Has known or history of functional or anatomic asplenia.
10. Has failure to thrive based on the clinical judgement of the investigator.
11. Has a known coagulation disorder contraindicating intramuscular vaccination.
12. Has a history of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet’s disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders).
13. Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders.
14. Has received a dose of any pneumococcal vaccine prior to study entry.
15. Has received >1 dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry.
16. Has received a dose of rotavirus vaccine prior to study entry.
17. *Meets one or more of the systemic corticosteroid exclusion criteria described in the protocol.
18. *Has received other licensed non-live vaccines within the 14 days before receipt of first dose of study vaccine.
19. *Has received a licensed live virus vaccine within the 30 days prior to receipt of first dose of study vaccine.
20. Has received a blood transfusion or blood products, including immunoglobulins.
21. Has participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included; these will be reviewed on a case-by-case basis for approval by the Sponsor.
22. Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study. Reasons may include, but are not limited to, being unable to keep appointments or planning to relocate during the study.
23. Is or has an immediate family member (eg, parent/legal guardian or sibling) who is investigational site or Sponsor staff directly involved with this study.

For items with an asterisk (*), if the participant meets these exclusion criteria, Visit 1 may be rescheduled for a time when these criteria are not met.

E.5 End points

E.5.1

Primary end point(s)

Immunogenicity:
Anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for the 13 shared serotypes contained in V114 and Prevnar 13™

Safety:
1. Proportion of participants with solicited injection-site AEs (swelling, redness/erythema, tenderness/pain, and hard lump/induration)
2. Proportion of participants with solicited systemic AEs (irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticarial)
3. Proportion of participants with vaccine-related SAEs

E.5.1.1

Timepoint(s) of evaluation of this end point

Immunogenicity:
At 30 days postdose 4 (PD4)

Safety:
1. and 2. From Day 1 through Day 14 following any vaccination with V114 or Prevnar 13™ from Day 1 through Day 14 following any vaccination with V114 or Prevnar 13™
3. From Day 1 through completion of study participation

E.5.2

Secondary end point(s)

1. Proportion of participants with anti-hepatitis B surface antigen (HBsAg) concentration ≥10 mIU/mL
2. Anti-rotavirus Immunoglobulin A (IgA) Geometric Mean Titer (GMT)
3. Anti-PnPs serotype-specific IgG GMCs and serotype-specific IgG response rates (proportion of participants meeting serotype-specific IgG threshold value of ≥0.35 μg/mL)

E.5.2.1

Timepoint(s) of evaluation of this end point

1. and 2. At 30 days PD3 of V114 or Prevnar 13™
3. At 30 days following Dose 3 for the 15 serotypes contained in V114

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

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Interchangeability, Tolerability and 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

Yes

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)

Yes

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

Puerto Rico

Thailand

Turkey

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

The overall study ends when the last participant completes the last study-related telephonecall or visit, withdraws from the study, or is lost to follow-up (ie, the participant is unable to be contacted by the investigator).
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 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

Yes

F.1.1

Number of subjects for this age range:

900

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:

900

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

900

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

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

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Orphan Designation Number:
Results Status:
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