Clinical Trials Register

Summary
EudraCT Number:	2014-004953-14
Sponsor's Protocol Code Number:	B1851015
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2015-04-09
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

2014-004953-14

A.3

Full title of the trial

A Phase 3, Randomized, Active-Controlled Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-Valent Pneumococcal Conjugate Vaccine Compared with a 7-Valent Pneumococcal Conjugate Vaccine in Healthy Infants in China

A.3.1

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

A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China

A.4.1

Sponsor's protocol code number

B1851015

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01692886

A.5.4

Other Identifiers

Name:

Alias

Number:

6096A1-3019-CN

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	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.
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 Center
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	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.3.1	Product name	Prevenar 13
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 conjugate Serotype 1
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 conjugate Serotype 3
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 conjugate Serotype 4
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 conjugate Serotype 5
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 conjugate Serotype 6A
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 conjugate Serotype 6B
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 conjugate Serotype 7F
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 conjugate Serotype 9V
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 conjugate Serotype 14
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 conjugate Serotype 18C
D.3.9.3	Other descriptive name	PNEUMOCOCCAL OLIGOSACCHARIDE SEROTYPE 18C CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB25338
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 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
D.3.9.3	Other descriptive name	PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO DIPHTHERIA TOXOID CARRIER PROTEIN
D.3.9.4	EV Substance Code	SUB38414
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 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	Yes
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: 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
D.2.1.1.2	Name of the Marketing Authorisation holder	Wyeth Pharmaceuticals
D.2.1.2	Country which granted the Marketing Authorisation	China
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Prevenar
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	Yes
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 4
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 6B
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 9V
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
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
D.3.9.3	Other descriptive name	PNEUMOCOCCAL OLIGOSACCHARIDE SEROTYPE 18C CONJUGATED TO CRM197
D.3.9.4	EV Substance Code	SUB25338
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 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
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	Yes
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

Pneumococcal Infection

E.1.1.1

Medical condition in easily understood language

Disease caused by a type of bacteria called Streptococcus pneumoniae (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	17.1
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 demonstrate that the immune responses to the 13 pneumococcal serotypes induced by 13vPnC in a 3-, 4-, 5-, and 12-month schedule (Group 2) are noninferior to the immune responses induced by 7vPnC in a 3-, 4-, 5-, and 12-month schedule (Group 1) when measured 1 month after the infant series.
To demonstrate that the immune responses to the 13 pneumococcal serotypes induced by 13vPnC in a 2-, 4-, 6-, and 12-month schedule (Group 3) are noninferior to the immune responses induced by 7vPnC in a 3-, 4-, 5-, and 12-month schedule (Group 1) when measured 1 month after the infant series.
To evaluate the acceptability of the safety profile of 13vPnC as measured by the incidence rates of local reactions, systemic events, and adverse events (AEs).

E.2.2

Secondary objectives of the trial

To evaluate the immune responses (IRs) to:
1) 13 pneumococcal serotypes induced by 13vPnC in a 3, 4, 5, and 12 month (mo) schedule (Group 2) compared to the IRs induced by 7vPnC in a 3, 4, 5, and 12 mo (Group 1) schedule when measured 1 mo after the toddler dose (td).
2) 13 pneumococcal serotypes induced by 13vPnC in a 2, 4, 6 and 12 mo schedule (Group 3) compared to the IRs induced by 7vPnC in a 3, 4, 5, and 12 mo schedule (Group 1) when measured 1 mo after the td.
3) 13 pneumococcal serotypes induced by 13vPnC in a 3, 5, and 12 mo schedule (Group 4) compared with the IRs induced by 7vPnC in a 3, 4, 5, and 12 mo schedule (Group 1) when measured 1 mo after the infant series and 1 mo after the td.
4) To describe the IRs to the 13 pneumococcal serotypes induced by 13vPnC in a 3, 4, 5, and 12 mo schedule (Group 2), 13vPnC in a 2, 4, 6, and 12 mo schedule (Group 3), and 13vPnC in a 3, 5, and 12 mo schedule (Group 4) when measured 1 mo after the infant series and 1 mo after the td.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Evidence of a personally signed and dated informed consent document indicating that the subject’s parent/legal guardian has been informed of all pertinent aspects of the study.
2. Subject’s caregiver willing and able to comply with scheduled visits, laboratory tests, and other study procedures. The subject’s caregiver must be able to be reached by telephone for the duration of the study.
3. Male or female subject aged 42 to 77 days (approximately 2 months) at the time of enrollment.
4. Healthy infant as determined by medical history, physical examination, and judgment of the investigator.

E.4

Principal exclusion criteria

1. Previous vaccination with licensed or investigational pneumococcal vaccine.
2. A previous anaphylactic reaction to any vaccine or vaccine-related component.
3. Contraindication to vaccination with pneumococcal vaccines.
4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
5. Known or suspected immune deficiency or suppression.
6. History of culture-proven invasive disease caused by Streptococcus pneumoniae.
7. Major known congenital malformation or serious chronic disorder.
8. Significant neurological disorder or history of seizure including febrile seizure, or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder. Resolving syndromes due to birth trauma such as perception before Brachial plexus birth palsy (Erb palsy) not included.
9. Receipt of blood products or gamma globulin. Hepatitis B immunoglobulin might be given.
10. Participation in another investigational trial within 28 days before the current study begins and during study participation. Participation in purely observational studies acceptable
11. Subjects whose parents or legal guardian are investigational site staff members or subjects whose parents or legal guardian are Pfizer employees directly involved in the conduct of the trial.
12. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that increased the risk associated with study participation or investigational product administration or interfered with the interpretation of study results and, in the judgment of the investigator, made the subject inappropriate for entry into this study
13. Known or suspected allergy to 13vPnC, 7vPnC, or other compounds related to these classes of medication.

E.5 End points

E.5.1

Primary end point(s)

1) Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to 0.35 microgram per millilitre (mcg/mL) 1 Month After the Infant Series: Group 1, 2 and 3 Subjects.
2) Serotype-specific IgG Geometric Mean Concentrations (GMCs) 1 Month After Infant Series: Group 1, 2 and 3 Subjects.
3) Percentage of Subjects Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination 1 - Infant Series.
4) Percentage of Subjects Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination 2 – Infant Series.
5) Percentage of Subjects Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination 3 – Infant Series.
6) Percentage of Subjects Reporting Pre-Specified Local Reactions Within 7 Days After Vaccination 4 – Toddler Dose.
7) Percentage of Subjects Reporting Pre-Specified Systemic Events Within 7 Days After Vaccination 1 – Infant Series
8) Percentage of Subjects Reporting Pre-Specified Systemic Events Within 7 Days After Vaccination 2 – Infant Series.
9) Percentage of Subjects Reporting Pre-Specified Systemic Events Within 7 Days After Vaccination 3 – Infant Series.
10) Percentage of Subjects Reporting Pre-Specified Systemic Events Within 7 Days After Vaccination 4 – Toddler Dose.
11) Percentage of Participants Reporting Adverse Events

E.5.1.1

Timepoint(s) of evaluation of this end point

1) 1 month after the infant series
2) 1 Month After Infant Series
3) Within 7 Days After Vaccination 1
4) Within 7 Days After Vaccination 2
5) Within 7 Days After Vaccination 3
6) Within 7 Days After Vaccination 4
7) Within 7 Days After Vaccination 1
8) Within 7 Days After Vaccination 2
9) Within 7 Days After Vaccination 3
10) Within 7 Days After Vaccination 4
11) Baseline up to Month 18

E.5.2

Secondary end point(s)

1) Percentage of Subjects Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series: Group 1, 2, 3 and 4 Subjects.
2) Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series: Group 1, 2, 3 and 4 Subjects.
3) Serotype-specific IgG Geometric Mean Concentrations (GMCs) 1 Month After Toddler Dose: Group 1, 2, 3 and 4 Subjects.
4) Percentage of Subjects Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer >= Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 1, 2, 3 and 4 Subjects.
5) Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 1, 2, 3 and 4 Subjects.
6) Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to 0.35 microgram per millilitre (mcg/mL) 1 Month After the Infant Series in Group 4 Subjects.
7) Percentage of Subjects Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to 0.35 microgram per millilitre (mcg/mL) 1 Month After the Infant Series: Group 4 Subjects.
8) Serotype-specific IgG Geometric Mean Concentrations (GMCs) 1 Month After Infant Series: Group 4 Subjects.

E.5.2.1

Timepoint(s) of evaluation of this end point

1) 1 Month After Infant Series.
2) 1 Month After the Infant Series
3) 1 month after the toddler dose
4) 1 Month After Toddler Dose
5) 1 Month After the Toddler Dose
6) 1 month after the infant series
7) 1 month after the infant series
8) 1 Month After Infant Series.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Immunogenicity

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

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

China

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.8.9.2

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:

1674

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:

1674

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

Male or female subject aged 42 to 77 days (approximately 2 months) at the time of enrollment

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

1674

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:	China

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Orphan Designation Number:
Results Status:
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