Clinical Trials Register

Summary
EudraCT Number:	2019-003306-27
Sponsor's Protocol Code Number:	B7471012
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-06-15
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2019-003306-27

A.3

Full title of the trial

A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN AS A SERIES OF 2 INFANT DOSES AND 1 TODDLER DOSE IN HEALTHY INFANTS

SPERIMENTAZIONE DI FASE 3, RANDOMIZZATA, IN DOPPIO CIECO PER VALUTARE LA SICUREZZA E L’IMMUNOGENICITÀ DI UN VACCINO PNEUMOCOCCICO CONIUGATO 20-VALENTE, SOMMINISTRATO COME SERIE DI 2 DOSI PER IL LATTANTE E 1 DOSE PER IL BIMBO AI PRIMI PASSI, IN NEONATI SANI

A.3.1

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

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 3-Dose Series in Healthy Infants

STUDIO SULLA SICUREZZA E L’IMMUNOGENICITÀ DI UN VACCINO PNEUMOCOCCICO CONIUGATO 20-VALENTE DI UNA SERIE DI 3 DOSI IN NEONATI SANI

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

B7471012

A.5.4

Other Identifiers

Name:

US IND number

Number:

17980

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/159/2020

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	PFIZER 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	Pfizer Inc., 235 East 42nd Street, New York, NY 10017
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	Pfizer Inc.
B.5.2	Functional name of contact point	Clinical Trials.gov Call Centre
B.5.3	Address:
B.5.3.1	Street Address	235 East 42nd Street
B.5.3.2	Town/ city	New York
B.5.3.3	Post code	10017
B.5.3.4	Country	United States
B.5.4	Telephone number	+18007181021
B.5.6	E-mail	ClinicalTrials.gov_Inquiries@pfizer.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	20-valent Pneumococcal Conjugate Vaccine (20vPnC)
D.3.2	Product code	[PF-06482077]
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.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB25373
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 3
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB25371
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 4
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB20576
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 5
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB25370
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 6A
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB126381
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 6B
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB20577
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB25369
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 8
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB25357
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 9V
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB20578
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 10A
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB25378
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 11A
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB25365
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 12F
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB25364
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 14
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB20579
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 15B
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB25363
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 18C
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB20580
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 19A
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB25361
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 19F
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB20581
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 22F
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB25359
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 23F
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB20582
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 33F
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB25326
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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 - SOSPENSIONE INIETTABILE-USO INTRAMUSCOLARE-SIRINGA PRERIEMPITA (VETRO) 0.5 ML 1 SIRINGA PRERIEMPITA
D.2.1.1.2	Name of the Marketing Authorisation holder	WYETH-LEDERLE VACCINES S.A.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	-
D.3.2	Product code	[-]
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.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB25373
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 3
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB25371
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 4
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB20576
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 5
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB25370
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 6A
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB126381
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 6B
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB20577
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB25369
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 9V
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB20578
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 14
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB20579
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 18C
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB20580
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 19A
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB25361
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 19F
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB20581
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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 23F
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB20582
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	INFANRIX HEXA - POLVERE E SOSPENSIONE PER SOSPENSIONE INIETTABILE 10 FLACONCINI + 10 SIRINGHE PRERIEMPITE 0.5 ML + 20 AGHI USO INTRAMUSCOLARE
D.2.1.1.2	Name of the Marketing Authorisation holder	GLAXOSMITHKLINE BIOLOGICALS S.A.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	-
D.3.2	Product code	[-]
D.3.4	Pharmaceutical form	Powder and solvent for 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	DIPHTHERIA TOXOID
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB12489MIG
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	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TETANUS TOXOID
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB12608MIG
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	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PERTUSSIS TOXOID
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB14817MIG
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	FILAMENTOUS HAEMAGGLUTININ
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB38509
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	PERTUSSIS PERTACTIN
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB20527
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	8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	HEPATITIS B SURFACE ANTIGEN
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB14083MIG
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	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN)
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB25292
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	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN)
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB25266
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	8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN)
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB25264
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	32
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE (POLYRIBOSYLRIBITOL PHOSPHATE)
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB120765
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	10
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.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	M-M-RVAXPRO - 1 FLACONCINO MONODOSE DI POLVERE + 1 SIRINGA PRERIEMPITA MONODOSE SENZA AGO CON 2 AGHI SEPARATI DI SOLVENTE
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI PASTEUR MSD SNC
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	-
D.3.2	Product code	[-]
D.3.4	Pharmaceutical form	Powder and solvent for suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MEASLES VIRUS ENDERS' EDMONSTON STRAIN (LIVE, ATTENUATED)
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB21608
D.3.10	Strength
D.3.10.1	Concentration unit	CCID50 cell culture infective dose 50
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	1000
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MUMPS VIRUS JERYL LYNN (LEVEL B) STRAIN (LIVE, ATTENUATED)
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB21609
D.3.10	Strength
D.3.10.1	Concentration unit	CCID50 cell culture infective dose 50
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	12500
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	RUBELLA VIRUS WISTAR RA 27/3 STRAIN (LIVE, ATTENUATED)
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB21610
D.3.10	Strength
D.3.10.1	Concentration unit	CCID50 cell culture infective dose 50
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	1000
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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: 5
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	Varilrix 10 3.3 PFU/0.5ml, powder and solvent for solution for injection
D.2.1.1.2	Name of the Marketing Authorisation holder	SmithKline Beecham Ltd
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	-
D.3.2	Product code	[-]
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	VARICELLA VIRUS OKA/MERCK STRAIN, (LIVE, ATTENUATED) PRODUCED IN HUMAN DIPLOID (MRC-5) CELLS
D.3.9.2	Current sponsor code	-
D.3.9.4	EV Substance Code	SUB25312
D.3.10	Strength
D.3.10.1	Concentration unit	PFU plaque forming unit
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	199526231
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

Pneumococcal Infections

Infezioni pneumococciche

E.1.1.1

Medical condition in easily understood language

Prevention of disease caused by a type of bacteria called Streptococcus pneumoniae (pneumococcal disease).

Prevenzione della malattia causata da un tipo di batterio chiamato Streptococcus pneumoniae (malattia da pneumococco).

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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10069578
E.1.2	Term	Pneumococcal immunisation
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Primary Safety Objective
To describe the safety profile of 20vPnC

Primary Pneumococcal Immunogenicity Objectives
To demonstrate that the percentages of participants with predefined serotype-specific IgG concentrations for the 13 serotypes in the 20vPnC group are noninferior to the percentages of the corresponding serotypes in the 13vPnC group at 1 month after Dose 3
To demonstrate that the percentages of participants with predefined serotype-specific IgG concentrations for the 7 additional serotypes in the 20vPnC group are noninferior to the lowest percentage among the 13 serotypes in the 13vPnC group at 1 month after Dose 3
To demonstrate that the serotype-specific IgG GMCs for the 13 serotypes in the 20vPnC group are noninferior to the GMCs for the corresponding serotypes in the 13vPnC group at 1 month after Dose 3

Please refer to the protocol for a full list of primary objectives.

Obiettivo primario di sicurezza
Descrivere il profilo di sicurezza di 20vPnC

Obiettivi primari di immunogenicità anti-pneumococco
Dimostrare che le percentuali di partecipanti con concentrazioni predefinite di immunoglobuline G (IgG) specifiche per sierotipo per i 13 sierotipi nel gruppo 20vPnc sono non inferiori alle percentuali dei sierotipi corrispondenti nel gruppo 13vPnC 1 mese dopo la dose 3
Dimostrare che le percentuali di partecipanti con concentrazioni predefinite di IgG specifiche per sierotipo per i 7 sierotipi aggiuntivi nel gruppo 20vPnC sono non inferiori rispetto alla percentuale più bassa nei 13 sierotipi nel gruppo 13vPnC 1 mese dopo la dose 3
Dimostrare che le concentrazioni geometriche medie (GMC) di IgG specifiche per sierotipo per i 13 sierotipi nel gruppo 20vPnC sono non inferiori alle GMC per i sierotipi corrispondenti nel gruppo 13vPnC 1 mese dopo la dose 3

Si prega di fare riferimento al protocollo per una lista completa degli obiettivi principali.

E.2.2

Secondary objectives of the trial

Secondary Pneumococcal Immunogenicity Objective
To further describe the immune responses induced by 20vPnC

Secondary Concomitant Immunogenicity Objective
To further describe the immune responses induced by specific concomitant vaccine antigens given with 20vPnC or 13vPnC

Obiettivo secondario di immunogenicità anti-pneumococco
Descrivere ulteriormente le risposte immunitarie indotte da 20vPnC

Obiettivo secondario concomitante di immunogenicità
Descrivere ulteriormente le risposte immunitarie indotte dagli antigeni vaccinali specifici somministrati in concomitanza con 20vPnC o 13vPnC

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Age and Sex:
1. Male or female infants born at >36 weeks of gestation and 2 months of age (=42 to =112 days) at the time of consent (the day of birth is considered day of life 1).
Type of Participant and Disease Characteristics:
2. Participants whose parent(s)/legal guardian(s) are willing and able to comply with all scheduled visits, treatment plan, and other study procedures.
3. Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
4. Expected to be available for the duration of the study and whose parents(s)/legal guardian can be contacted by telephone during study participation.
Informed Consent:
5. Participants whose parent(s)/legal guardian(s) is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in the protocol.

Età e sesso:
1. Neonati di sesso maschile o femminile nati a > 36 settimane di gestazione e di età pari a 2 mesi (da = 42 a = 112 giorni) al momento del consenso (si considera come giorno di vita 1 il giorno della nascita).
Tipo di partecipante e caratteristiche della malattia:
2. Partecipanti il/i cui genitore/i/tutore/i legale/i è/sono disposto/i a e in grado di rispettare tutte le visite programmate, attenersi al piano di trattamento e aderire ad altre procedure previste dallo studio.
3. Neonati sani considerati eleggibili per lo studio in base alla valutazione clinica, compresa la raccolta dell’anamnesi medica e il giudizio clinico.
4. Partecipanti con disponibilità prevista per tutta la durata dello studio e il/i cui genitore/i/tutore/i legale/i sia/siano raggiungibile/i telefonicamente durante la partecipazione allo studio.
Consenso informato:
5. Partecipanti il/i cui genitore/i/tutore/i legale/i sia/siano in grado di fornire consenso informato firmato, come descritto nell’Appendice 1 del protocollo; la firma del consenso informato implica la conformità ai requisiti e alle restrizioni elencati nel DCI e in questo protocollo.

E.4

Principal exclusion criteria

Medical Conditions:
1. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of investigational product or any diphtheria toxoid–containing vaccine.
2. Significant neurological disorder or history of seizure including febrile seizure or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Does not include resolving syndromes due to birth trauma, such as Erb's palsy and/or hypotonic-hyporesponsive episodes.
3. Major known congenital malformation or serious chronic disorder.
4. History of microbiologically proven invasive disease caused by S pneumoniae.
5. Known or suspected immunodeficiency or other conditions associated with immunosuppression, including, but not limited to, immunoglobulin class/subclass deficiencies, DiGeorge syndrome, generalized malignancy, human immunodeficiency virus (HIV) infection, leukemia, lymphoma, or organ or bone marrow transplant.
6. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
7. Congenital, functional, or surgical asplenia.
8. Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere
with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Prior/Concomitant Therapy:
9. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
10. Prior receipt of diphtheria, tetanus, pertussis, poliomyelitis, and/or Hib vaccine.
11. Currently receives treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, or planned receipt through the last blood draw. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before investigational product administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin, eyes, or ears) corticosteroids are permitted.
12. Receipt of blood/plasma products or immunoglobulins (including hepatitis B immunoglobulin) since birth or planned receipt through the last planned blood draw in the study (Visit 5, 13-month visit).
Prior/Concurrent Clinical Study Experience:
13. Participation in other studies involving investigational drug(s), investigational vaccines, or investigational devices within 28 days prior to study entry and/or during study participation or intrauterine exposure to investigational vaccines. Participation in purely observational studies is acceptable.
Diagnostic Assessments:
Not applicable.
Other Exclusions:
14. Children or grandchildren who are direct descendants of investigator site staff members or Pfizer employees who are directly involved in the conduct of the study.

Condizioni mediche:
1. Anamnesi di reazione avversa grave associata a un vaccino e/o reazione allergica grave (ad es., anafilassi) a qualsiasi componente del prodotto sperimentale o a qualsiasi vaccino contenente il tossoide difterico.
2. Disturbo neurologico significativo o anamnesi di crisi convulsive, anche di natura febbrile, o disturbi significativi, stabili o in evoluzione, quali paralisi cerebrale, encefalopatia, idrocefalo o altri disturbi significativi. Non sono incluse sindromi in via di risoluzione dovute a un trauma alla nascita, come la paralisi di Erb e/o episodi ipotonici-iporesponsivi.
3. Malformazione congenita maggiore nota o grave disturbo cronico.
4. Anamnesi di malattia invasiva, microbiologicamente dimostrata, causata da S pneumoniae.
5. Immunodeficienza nota o sospetta o altre condizioni associate a immunodepressione, inclusi, tra gli altri, deficit di classi/sottoclassi di immunoglobuline, sindrome di DiGeorge, malignità generalizzata, infezione da virus dell’immunodeficienza umana (HIV), leucemia, linfoma o trapianto d’organo o di midollo osseo.
6. Diatesi emorragica o condizione associata a sanguinamento prolungato che, a giudizio dello sperimentatore, potrebbe controindicare l’iniezione intramuscolare.
7. Asplenia congenita, funzionale o chirurgica.
8. Altra condizione medica o psichiatrica, acuta o cronica, o anomalia di laboratorio che potrebbe aumentare il rischio associato alla partecipazione allo studio o alla somministrazione del prodotto sperimentale oppure interferire con l’interpretazione dei risultati dello studio e che, a giudizio dello sperimentatore, renda il partecipante non idoneo all’ingresso nello studio.
Terapia precedente/concomitante:
9. Pregressa vaccinazione con qualsiasi vaccino pneumococcico autorizzato o sperimentale oppure vaccinazione prevista nel corso della partecipazione allo studio.
10. Pregressa vaccinazione con vaccino per difterite, tetano, pertosse, poliomielite e/o Hib.
11. Attuale trattamento con terapia immunosoppressiva, inclusi agenti citotossici o corticosteroidi sistemici, oppure trattamento previsto entro l’ultimo prelievo di sangue. In caso di somministrazione a breve termine (< 14 giorni) di corticosteroidi sistemici per il trattamento di una malattia acuta, i partecipanti non devono essere arruolati nello studio finché non siano trascorsi almeno 28 giorni tra l’interruzione della terapia corticosteroidea e la somministrazione del prodotto sperimentale. I corticosteroidi per inalazione/nebulizzazione, iniezione intrarticolare, iniezione intrabursale o somministrazione topica (cute, occhi o orecchie) sono consentiti.
12. Trattamento con emoderivati/plasmaderivati o immunoglobuline (incluse le immunoglobuline anti-epatite B) dalla nascita oppure trattamento previsto entro l’ultimo prelievo di sangue in programma nell’ambito dello studio (Visita 5, visita del mese 13).
Partecipazione precedente/concomitante a studi clinici:
13. Partecipazione ad altri studi con uno o più farmaci sperimentali, vaccini sperimentali o dispositivi sperimentali nei 28 giorni precedenti l’ingresso nello studio e/o durante la partecipazione allo studio oppure esposizione intrauterina a vaccini sperimentali. La partecipazione a studi di natura puramente osservazionale è considerata accettabile.
Valutazioni diagnostiche:
Non applicabile.
Altri criteri di esclusione:
14. Discendenti diretti (figli o nipoti) di membri del personale del centro di sperimentazione o di dipendenti di Pfizer direttamente coinvolti nella conduzione dello studio.

E.5 End points

E.5.1

Primary end point(s)

Primary Safety Endpoints
a. Prompted local reactions (redness, swelling, and pain at the injection site)
b. Prompted systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability)
c. Adverse events (AEs)
d. Serious adverse events (SAEs)
e. Newly diagnosed chronic medical conditions (NDCMCs)

Primary Pneumococcal Immunogenicity Endpoints
f. Pneumococcal serotype-specific IgG concentrations

Primary Concomitant Immunogenicity Endpoints
g. Antibody levels to diphtheria toxoid, tetanus toxoid, and pertussis antigens (PT, FHA, PRN)
h. Antibody levels to HBsAg
i. Antibody levels to poliovirus strains (types 1, 2, and 3)
j. Antibody levels to Hib
k. Antibody levels to measles, mumps, rubella, and varicella virus

Endpoint primari di sicurezza
a. Reazioni locali sollecitate (rossore, gonfiore e dolore nel sito di iniezione)
b. Eventi sistemici sollecitati (febbre, diminuzione dell’appetito, sonnolenza/ipersonnia e irritabilità)
c. Eventi avversi (EA)
d. Eventi avversi gravi (SAE)
e. Condizioni mediche croniche di nuova diagnosi (NDCMC)

Endpoint primari di immunogenicità anti-pneumococco
f. Concentrazioni di IgG specifiche per sierotipo di pneumococco

Endpoint primari concomitanti di immunogenicità
g. Livelli di anticorpi diretti contro gli antigeni di tossoide difterico, tossoide tetanico e pertosse (TP, FHA, PRN)
h. Livelli di anticorpi anti-HBsAg
i. Livelli di anticorpi diretti contro ceppi di poliovirus (tipi 1, 2 e 3)
j. Livelli di anticorpi anti-Hib
k. Livelli di anticorpi diretti contro i virus di morbillo, parotite, rosolia e varicella

E.5.1.1

Timepoint(s) of evaluation of this end point

a. within 7 days after each vaccination
b. within 7 days after each vaccination
c. from Dose 1 to 1 month after Dose 2 and from Dose 3 to 1 month after Dose 3
d. from visit 1 until 1 month after the last study vaccination
e. from visit 1 until 1 month after the last study vaccination
f. 1 month after Dose 3
g. 1 month after Dose 3
h. 1 month after Dose 3
i. 1 month after Dose 3
j. 1 month after Dose 3
k. 1 month after Dose 3

a. entro 7 giorni dopo ciascuna vaccinazione
b. entro 7 giorni dopo ciascuna vaccinazione
c. dalla dose 1 a 1 mese dopo la dose 2 e dalla dose 3 a 1 mese dopo la dose 3
d. dalla visita 1 fino a 1 mese dopo l'ultimo studio di vaccinazione
e. dalla visita 1 fino a 1 mese dopo l'ultimo studio di vaccinazione
f. 1 mese dopo la dose 3
g. 1 mese dopo la dose 3
h. 1 mese dopo la dose 3
io. 1 mese dopo la dose 3
j. 1 mese dopo la dose 3
K. 1 mese dopo la dose 3

E.5.2

Secondary end point(s)

Secondary Pneumococcal Immunogenicity Endpoints
a. Pneumococcal serotype specific opsonophagocytic activity (OPA) titers
b. Pneumococcal serotype specific IgG concentrations

Secondary Concomitant Immunogenicity Endpoints
c. Antibody levels to diphtheria toxoid, tetanus toxoid, and pertussis antigens (PT, FHA, PRN)
d. Antibody levels to poliovirus strains (types 1, 2, and 3)
e. Antibody levels to Hib

Endpoint secondari di immunogenicità anti-pneumococco
a. Titoli OPA specifici per sierotipo di pneumococco
b. Concentrazioni di IgG specifiche per sierotipo di pneumococco

Endpoint secondari concomitanti di immunogenicità
c. Livelli di anticorpi diretti contro gli antigeni di tossoide difterico, tossoide tetanico e pertosse (TP, FHA, PRN)
d. Livelli di anticorpi diretti contro ceppi di poliovirus (tipi 1, 2 e 3)
e. Livelli di anticorpi anti-Hib

E.5.2.1

Timepoint(s) of evaluation of this end point

a. before Dose 3 (Visit 4) and 1 month after Dose 3
b. 1 month after Dose 2 and before Dose 3 (Visit 4) to 1 month after Dose 3
c. 1 month after Dose 2
d. 1 month after Dose 2
e. 1 month after Dose 2

a. prima della dose 3 (Visita 4) e 1 mese dopo la dose 3
b. 1 mese dopo la dose 2 e prima della dose 3 (Visita 4) a 1 mese dopo la dose 3
c. 1 mese dopo la dose 2
d. 1 mese dopo la dose 2
e. 1 mese dopo la dose 2

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

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

Immunogenicity Non-inferiority

Immunogenicità Non inferiorità

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

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

Information not present in EudraCT

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

Australia

Belgium

Denmark

Estonia

Finland

Italy

Netherlands

Norway

Poland

Romania

Slovakia

Sweden

Czechia

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.1.1.1

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:

1200

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

infants and toddlers and therefore incapable of giving consent personally

neonati e bambini, pertanto incapaci di dare il consenso personalmente

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

1130

F.4.2.2

In the whole clinical trial

1200

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)

No intervention will be provided to study participants at the end of the study

Nessun intervento verrà fornito ai partencipanti in studio al termine dello studio.

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

2020-11-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-07-30

P. End of Trial
P.	End of Trial Status	Ongoing

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