Clinical Trials Register

Summary
EudraCT Number:	2008-003648-12
Sponsor's Protocol Code Number:	B1851009(6096A1-3010)
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2012-02-20
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

2008-003648-12

A.3

Full title of the trial

A Phase 3, Open Label Trial Evaluating the Safety, Immunogenicity, and Impact of 13-valent Pneumococcal Conjugate Vaccine in Alaskan Native Children

A.3.1

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

Clinical Study with Prevenar 13 vaccine in Alaskan Native Children

A.4.1

Sponsor's protocol code number

B1851009(6096A1-3010)

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT00743652

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/73/2011

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Wyeth Pharmaceuticals Inc. (a Pfizer company)
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	Wyeth Pharmaceuticals Inc. (a Pfizer Company)
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 E 42nd Street
B.5.3.2	Town/ city	New York
B.5.3.3	Post code	NY 10017
B.5.3.4	Country	United States
B.5.4	Telephone number	0018007181021
B.5.5	Fax number	0013037391119
B.5.6	E-mail	ClinicalTrials.govCallCenter@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	13-valent pneumococcal conjugate vaccine
D.3.2	Product code	13vPnC
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.3.9.4	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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pneumococcal Polysaccharide conjugate Serotype 3
D.3.9.4	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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pneumococcal Polysaccharide conjugate Serotype 4
D.3.9.4	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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pneumococcal Polysaccharide conjugate Serotype 5
D.3.9.4	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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pneumococcal Polysaccharide conjugate Serotype 6B
D.3.9.4	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	8.8
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pneumococcal Polysaccharide conjugate Serotype 7F
D.3.9.4	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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pneumococcal Polysaccharide conjugate Serotype 9V
D.3.9.4	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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pneumococcal Polysaccharide conjugate Serotype 18C
D.3.9.4	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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pneumococcal Polysaccharide conjugate Serotype 19A
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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pneumococcal Polysaccharide Serotype conjugate 19F
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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pneumococcal Polysaccharide conjugate Serotype 23F
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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pneumococcal Polysaccharide conjugate Serotype 6A
D.3.9.4	EV Substance Code	SUB30928
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	4.4
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	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 invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks to 5 years of age.

E.1.1.1

Medical condition in easily understood language

prevention of 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	14.1
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 assess the impact of 13vPnC on the incidence of IPD in the YK Delta region due to the 13 vaccine S pneumoniae serotypes.

E.2.2

Secondary objectives of the trial

- To assess the overall impact of 13v PnC on the incidence of IPD in the YK Delta region due to any S. pneumoniae serotypes.
- To assess the impact of 13vPnC on the incidence of IPD due to S pneumoniae serotypes 1, 3, 5, 6A, 7F, and 19A in the YK Delta region.
- To assess the impact of 13vPnC on the incidence of IPD due to S pneumoniae serotype 19A in the YK Delta region.
- To assess the impact of 13vPnC on the incidence of IPD due to nonvaccine S pneumoniae serotypes in the YK Delta region.
- To assess the impact of 13vPnC on NP colonization in the YK Delta region.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

All Participants
1. Male or female infants and children between the ages of ≥ 42 days (6 weeks) and <5 years of age at the time of enrollment.
2. Must be available for the entire study period and the parent/legal guardian can be reached by telephone.
3. Must be determined to be in good health by medical history, physical examination, and the judgment of the investigator or a medically qualified designee.
4. Parent/legal guardian must be able to complete all relevant study procedures during study participation.
Immunogenicity Study Participants
1. Parent/legal guardian is willing to complete a supplemental informed consent form permitting blood to be taken from the subject.
2. Subject lives in the Bethel, Alaska area.

E.4

Principal exclusion criteria

All Participants
1. A previous anaphylactic reaction to any vaccine or vaccine-related component.
2. Contraindication to vaccination with pneumococcal vaccine.
3. Bleeding diathesis or condition associated with prolonged bleeding time that would
contraindicate intramuscular injection.
4. Major known congenital malformation.
5. Significant neurological disorder or significant evolving disorders such as
encephalopathy, hydrocephalus, a history of seizures including uncontrolled
epilepsy/infantile or other significant disorders. Does not include resolving syndromes
due to birth trauma such as Erb palsy or simple febrile seizures.
6. Participation in another investigational or interventional trial. Participation in purely
observational studies is acceptable.
Immunogenicity Study Participants
1. Receipt of blood products or gamma globulin within the last 3 months.
2. Known or suspected immune deficiency or suppression.

E.5 End points

E.5.1

Primary end point(s)

The primary immunogenicity endpoints for each of the pneumococcal serotypes are the proportions of subjects achieving a serotype-specific IgG antibody concentration ≥0.35 μg/mL measured 1 month after the infant series (groups 1, 2, and 3), 1 month after the toddler dose (groups 1, 2, and 3), and 1 month after completion of the relevant catch-up dose(s) (groups 4 and 5). In addition, for catch-up groups 4 and 5, the proportion of subjects achieving a serum IgG antibody concentration ≥0.35 μg/mL prior to vaccination with 13vPnC will be calculated.

safety endpoints are AEs and SAEs.

E.5.1.1

Timepoint(s) of evaluation of this end point

Immunogenicity – one month after the infant series of doses or other relevant dose
Safety – ongoing through study

E.5.2

Secondary end point(s)

for each of the pneumococcal serotypes: the proportions of subjects achieving a serotype-specific IgG antibody concentration ≥1.0 μg/mL measured 1 month after
the infant series (groups 1, 2, and 3), 1 month after the toddler dose (groups 1, 2, and 3), and 1 month after completion of the relevant catch-up dose(s) (groups 4 and 5).

E.5.2.1

Timepoint(s) of evaluation of this end point

Immunogenicity – one month after the infant series of doses or other relevant dose

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

E.8.1.1

Randomised

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

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)

E.8.2.2

Placebo

E.8.2.3

Other

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

United States

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

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:

373

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:

294

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

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

subjects aged 6 weeks to <5 years

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

373

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)

All children will be followed through completion of the 6-month safety follow-up. Following this there are no plans for treatment of subjects specified in the protocol after their participation has ended.

G. Investigator Networks to be involved in the Trial

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

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