Clinical Trials Register

Summary
EudraCT Number:	2016-001117-25
Sponsor's Protocol Code Number:	V114-008
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-03-06
Trial results	View results

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

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A. Protocol Information

A.1

Member State Concerned

Denmark - DHMA

A.2

EudraCT number

2016-001117-25

A.3

Full title of the trial

A Phase II, Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Infants

A.3.1

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

Phase IIB Clinical trial to evaluate the safety and immune effectiveness of V114 in healthy infants

A.3.2

Name or abbreviated title of the trial where available

Saftey/Immunogenicity of Different Lots of V114 vs. Prevnar 13™ in Infants

A.4.1

Sponsor's protocol code number

V114-008

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT02987972

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
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, PO Box 100
B.5.3.2	Town/ city	Whitehouse Station
B.5.3.3	Post code	08889-0100
B.5.3.4	Country	United States
B.5.4	Telephone number	+1267305 2209
B.5.5	Fax number	+1267305 6431

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 adsorbed on Aluminum Phosphate
D.3.2	Product code	V114 Lot1 (WL00067190)
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
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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A
D.3.9.4	EV Substance Code	SUB126381
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
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	4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CORYNEBACTERIUM DIPHTHERIAE CRM197 CARRIER PROTEIN
D.3.9.3	Other descriptive name	CORYNEBACTERIUM DIPHTHERIAE CRM197 CARRIER PROTEIN
D.3.9.4	EV Substance Code	SUB25296
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	32
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	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 adsorbed on Aluminum Phosphate
D.3.2	Product code	V114 Lot2 (WL00067191)
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
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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A
D.3.9.4	EV Substance Code	SUB126381
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
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	4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CORYNEBACTERIUM DIPHTHERIAE CRM197 CARRIER PROTEIN
D.3.9.3	Other descriptive name	CORYNEBACTERIUM DIPHTHERIAE CRM197 CARRIER PROTEIN
D.3.9.4	EV Substance Code	SUB25296
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	32
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	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
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A
D.3.9.4	EV Substance Code	SUB126381
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
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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE 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	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.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 pneumonia

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

In healthy infants receiving one of the 2 V114 lots or Prevnar 13™ at approximately 2, 4, 6, and 12-15 months of age:
1.To describe the safety and tolerability profiles of 2 different lots of V114 [Lot 1 (V114-1), Lot 2 (V114-2)], after each dose
2.To demonstrate that V114 (either V114-1 or V114-2) is non-inferior to Prevnar 13™ for the 13 shared serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), based on the proportion of subjects meeting serotype-specific immunoglobulin G (IgG) threshold value of ≥0.35 μg/mL at 1 month post-dose 3 (PD3)
3.To evaluate the serotype-specific IgG geometric mean concentrations (GMCs) of V114-1, V114-2, and Prevnar 13™, and the IgG GMC ratios between each of the two V114 lots and Prevnar 13™ for all 15 serotypes included in V114 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) at 1 month PD3.

E.2.2

Secondary objectives of the trial

To evaluate the serotype-specific IgG GMCs of V114-1, V114-2, and Prevnar 13™, and the IgG GMC ratios between each of the two V114 lots and Prevnar 13™ for all 15 serotypes included in V114 at pre-dose 4 and 1 month postdose 4 (PD4).

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 swabs)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.Be healthy (based on medical history and physical examination) male or female infant approximately 2 months of age (42 days to 90 days), inclusive
2.Have a parent/legal guardian who understands the trial procedures, alternate treatments available, and risks involved with the trial.
3.Have a parent/legal guardian who is able to read, understand, and complete the VRC and voluntarily agree to participate by giving written informed consent.
4.A parent/legal guardian also acknowledges that they: a) will attend all scheduled visits b) comply with the trial procedures, and c) have access to a telephone.

E.4

Principal exclusion criteria

If the subject meets criteria marked with an asterisk (*), the Day 1 Visit may be rescheduled for a time when these criteria are not met.
1.Had prior administration of any pneumococcal vaccine
2.Has a known hypersensitivity to any component of the pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine
3.* 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 trial vaccine
4.Has a known or suspected impairment of immunological function
5. Has a history of congenital or acquired immunodeficiency (e.g. splenomegaly)
6.Has or his/her mother has a documented human immunodeficiency virus (HIV) infection
7.Has or his/her mother has a documented hepatitis B surface antigen – positive test
8.Has known or history of functional or anatomic asplenia
9.Has a history of failure to thrive
10.Has known or history of a coagulation disorder contraindicating intramuscular vaccination
11.Has a history of autoimmune disease including systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, and other autoimmune disorders
12.Has a known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders
13.*Meets one or more of the following systemic corticosteroid exclusion criteria: a)Has received systemic corticosteroids (equivalent of ≥ 2 mg/kg total daily dose of prednisone or ≥ 20 mg/d for persons weighing > 10 kg) for ≥ 14 consecutive days and has not completed this course of treatment at least 30 days prior to trial randomization b)Has received systemic corticosteroids within 14 days prior to the first dose of vaccine at randomization c) Is expected to require systemic corticosteroids within 30 days after each vaccination during conduct of the trial
14.*Has received other licensed non-live vaccines within the 14 days before receipt of first dose of trial vaccine
15.*Has received a licensed live virus vaccine within the 30 days prior to receipt of first dose of trial vaccine
16.Had prior receipt of a blood transfusion or blood products, including immunoglobulins
17.Has participated in another clinical trial of an investigational product before the beginning or anytime during the duration of the current clinical trial. Subjects enrolled in observational studies may be included; these will be reviewed on a caseby- case basis for approval by the SPONSOR
18.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
19.Cannot be adequately followed for safety according to the protocol plan
20.Has a parent/legal guardian who is unlikely to adhere to trial procedures, keep appointments, or is planning to relocate during the trial
21.Has any other reason that in the opinion of the investigator may interfere with the evaluation required by the trial
22.Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial

E.5 End points

E.5.1

Primary end point(s)

1. The proportion of subjects meeting serotype-specific IgG ≥0.35 μg/mL for the 13 serotypes shared with Prevnar 13™ measured by the Pn ECL assay at 1 month post-dose 3
2. The serotype-specific IgG GMC for all 15 serotypes included in V114 measured by the Pn ECL assay at 1 month post-dose 3

E.5.1.1

Timepoint(s) of evaluation of this end point

Approximately 1 month post dose 3, For purposes of analysis and reporting, the overall trial ends when the Sponsor receives the last serological results

E.5.2

Secondary end point(s)

The serotype-specific IgG GMC for all 15 serotypes included in V114 measured by the Pn ECL assay at pre-dose 4 and 1 month post-dose 4.

E.5.2.1

Timepoint(s) of evaluation of this end point

pre-dose 4, and approximately 1 month post-dose 4

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

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Tolerability

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

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

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

Canada

Denmark

Finland

Israel

Spain

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

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

1050

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:

1050

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

Yes

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Study subjects are healthy male and female infants approximately 2 months to 15 months of age .

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

176

F.4.2.2

In the whole clinical trial

1050

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

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2017-04-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-01-20

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-11-30

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