Clinical Trials Register

Summary
EudraCT Number:	2006-000554-46
Sponsor's Protocol Code Number:	106786
National Competent Authority:	Finland - Fimea
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2006-06-05
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

Finland - Fimea

A.2

EudraCT number

2006-000554-46

A.3

Full title of the trial

A phase II, observer-blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined DSSITGDPa-HBV-IPV/Hib vaccine containing diphtheria toxoid from the Statens Serum Institute (SSI) of Denmark and tetanus toxoid from GSK Biologicals’ Kft [GD], compared to the currently licensed GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) when administered to healthy infants at 2, 3 and 4 months of age.

A.3.2

Name or abbreviated title of the trial where available

DTPa-HBV-IPV-116

A.4.1

Sponsor's protocol code number

106786

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	GlaxoSmithKline Biologicals
B.1.3.4	Country	Belgium
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	Diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis and H. influenzae type b vaccin
D.3.2	Product code	DTPa-HBV-IPV/Hib
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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
D.3.9.3	Other descriptive name	detoxified diphtheria toxin
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	60
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	T
D.3.9.3	Other descriptive name	detoxified tetanus toxin
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	80
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	PT
D.3.9.3	Other descriptive name	detoxified pertussis toxin
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	50
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	FHA
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	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pertactin
D.3.9.2	Current sponsor code	PRN
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	16
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Inactivated polio virus type 1
D.3.9.2	Current sponsor code	IPV type 1
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80 DU/ml
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Inactivated polio virus type 2
D.3.9.2	Current sponsor code	IPV type 2
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	16 DU/ml
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Inactivated polio virus type 3
D.3.9.2	Current sponsor code	IPV type 3
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	64 DU/ml
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Recombinant hepatitis B surface antigen
D.3.9.2	Current sponsor code	HBV
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Haemophilus influenzae type b conjugated to tetanus toxoid
D.3.9.2	Current sponsor code	PRP-T
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	Hib:20 to TT:40-80
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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	Diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis and H. influenzae type b vaccin
D.3.2	Product code	DTPa-HBV-IPV/Hib
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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
D.3.9.3	Other descriptive name	detoxified diphtheria toxin
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	60
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	T
D.3.9.3	Other descriptive name	detoxified tetanus toxin
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	80
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	PT
D.3.9.3	Other descriptive name	detoxified pertussis toxin
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	50
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	FHA
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	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pertactin
D.3.9.2	Current sponsor code	PRN
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	16
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Inactivated polio virus type 1
D.3.9.2	Current sponsor code	IPV type 1
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80 DU/ml
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Inactivated polio virus type 2
D.3.9.2	Current sponsor code	IPV type 2
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	16 DU/ml
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Inactivated polio virus type 3
D.3.9.2	Current sponsor code	IPV type 3
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	64 DU/ml
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Recombinant hepatitis B surface antigen
D.3.9.2	Current sponsor code	HBV
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Haemophilus influenzae type b conjugated to tetanus toxoid
D.3.9.2	Current sponsor code	PRP-T
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	Hib:20 to TT:40-80
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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	Infanrix Hexa
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline Biologicals
D.2.1.2	Country which granted the Marketing Authorisation	Finland
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	Infanrix Hexa
D.3.2	Product code	DTPa-HBV-IPV/Hib
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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
D.3.9.3	Other descriptive name	detoxified diphtheria toxin
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	60
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	T
D.3.9.3	Other descriptive name	detoxified tetanus toxin
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	80
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	PT
D.3.9.3	Other descriptive name	detoxified pertussis toxin
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	50
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	FHA
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	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pertactin
D.3.9.2	Current sponsor code	PRN
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	16
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Inactivated polio virus type 1
D.3.9.2	Current sponsor code	IPV type 1
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80 DU/ml
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Inactivated polio virus type 2
D.3.9.2	Current sponsor code	IPV type 2
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	16 DU/ml
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Inactivated polio virus type 3
D.3.9.2	Current sponsor code	IPV type 3
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	64 DU/ml
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Recombinant hepatitis B surface antigen
D.3.9.2	Current sponsor code	HBV
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Haemophilus influenzae type b conjugated to tetanus toxoid
D.3.9.2	Current sponsor code	PRP-T
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	Hib:20 to TT:40-80
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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

Primary immunization of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases.

MedDRA Classification

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 immunogenicity of the DSSITGDPa-HBV-IPV/Hib vaccine (preservative-free formulation) in terms of antibody response to all vaccine antigens is non-inferior to DTPa-HBV-IPV/Hib vaccine (licensed formulation), 1 month after a 3-dose primary vaccination.
Criteria for non-inferiority (1 month after the third dose):
- For diphtheria (Vero-cell neutralization assay), tetanus, hepatitis B, poliovirus types 1, 2 and 3 and polyribosyl-ribitol phosphate (PRP): the upper limit of the standardized asymptotic 95% confidence interval (CI) on the group difference [DTPa-HBV-IPV/Hib (licensed formulation) minus DSSITGDPa-HBV-IPV/Hib (preservative-free formulation)] in the percentage of seroprotected subjects is =< 10%.
-For the 3 pertussis antigens the upper limit of the 95% CI on the ratio of geometric mean concentrations of antibodies [DTPa-HBV-IPV/Hib (licensed formulation) divided by DSSITGDPa-HBV-IPV/Hib (preservative-free formulation)] is =< 1.5.

E.2.2

Secondary objectives of the trial

->To demonstrate that immunogenicity of the DSSITGDPa-HBV-IPV/Hib (preservative-containing formulation) for all vaccine antigens is non-inferior to DTPa-HBV-IPV/Hib (licensed formulation), post-dose 3.
This objective will be assessed without adjustment of the type 1 error. Hence, the probability to falsely conclude non-inferiority for this objective is 5% (instead of 2.5% usually required to control for this risk).
Criteria for non-inferiority (post-dose 3):
-For D (Vero-cell neutralization assay), T, HBsAg, poliovirus types 1, 2 and 3, and PRP: the UL of the standardized asymptotic 95% CI on the group difference [DTPa-HBV-IPV/Hib (licensed formulation) minus DSSITGDPa-HBV-IPV/Hib (preservative-containing formulation)] in the % of seroprotected subjects is =<10%.
-For the 3 pertussis antigens: the upper limit of the 95% CI on the ratio of GMCs of antibodies [DTPa-HBV-IPV/Hib (licensed formulation) divided by DSSITGDPa-HBV-IPV/Hib (preservative-containing formulation)] is =< 1.5.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
-A male or female between, and including, 8 and 12 weeks of age at the time of the first vaccination.
-Written informed consent obtained from the parents/guardians of the subject.
-Healthy subjects as established by medical history and clinical examination before entering into the study.
-Born after a normal gestation period of 36 to 42 weeks.

E.4

Principal exclusion criteria

-Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
-Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth until first primary vaccination dose. (For corticosteroids, this will mean prednisone, or equivalent, >=0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
-Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
-Administration/planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first dose and ending 30 days after the last dose, with the exception of the human rotavirus (HRV) vaccine.
-Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
-Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib vaccination or disease.
-HBV vaccination at birth.
-History of seizures or progressive neurological disease.

E.5 End points

E.5.1

Primary end point(s)

Immunogenicity one month after the third dose of study vaccines:
->Seroprotection status
-Anti-diphtheria antibody concentrations >= 0.016 IU/ml (based on Vero-cell neutralization assay).
-Anti-tetanus toxoid antibody concentrations >= 0.1 IU/ml.
-Anti-HBs antibody concentrations >= 10 mIU/ml.
-Anti-poliovirus type 1 antibody titres >= 8.
-Anti-poliovirus type 2 antibody titres >= 8.
-Anti-poliovirus type 3 antibody titres >= 8.
-Anti-PRP antibody concentrations >= 0.15 µg/ml.
->Anti-PT, anti-FHA and anti-PRN antibody concentrations

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

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

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Observer-blind

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.8.3

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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

Visit 4 (Month 3)

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 months

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.1.1.5

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

Written informed consent obtained from parent or guardian of the subject.

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

450

F.4.2

For a multinational trial

F.4.2.1

In the EEA

450

F.4.2.2

In the whole clinical trial

450

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 plan for further treatment or care of study subjects once they have finalized participation.

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

2006-08-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2006-08-09

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2007-05-31

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