Clinical Trials Register

Summary
EudraCT Number:	2011-004751-39
Sponsor's Protocol Code Number:	115115
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2012-04-12
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

2011-004751-39

A.3

Full title of the trial

A phase III, randomized, open, active-controlled study to evaluate the safety and immunogenicity of a prime-boost schedule of the H5N1 candidate vaccine adjuvanted with AS03B administered to children aged 3 to 17 years.

A.3.1

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

Safety and immunogenicity study of a prime-boost schedule of GSK Biologicals' influenza vaccine GSK1562902A in children aged 3 to 17 years.

A.3.2

Name or abbreviated title of the trial where available

FLU D-PAN H5N1=AS03-032

A.4.1

Sponsor's protocol code number

115115

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/147/2011

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	GlaxoSmithKline Biologicals
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	GlaxoSmithKline Biologicals
B.5.2	Functional name of contact point	Clinical Disclosure Advisor
B.5.3	Address:
B.5.3.1	Street Address	Rue de l’institut 89
B.5.3.2	Town/ city	Rixensart
B.5.3.3	Post code	1330
B.5.3.4	Country	Belgium
B.5.4	Telephone number	442089904466
B.5.6	E-mail	GSKClinicalSupportHD@gsk.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	H5N1 A/turkey/Turkey/01/2005 with AS03B
D.3.2	Product code	GSK1562902A
D.3.4	Pharmaceutical form	Emulsion and suspension for emulsion 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.3.9.3	Other descriptive name	A/Turkey/Turkey/01/2005 (H5N1)
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	15
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	H5N1 A/Indonesia/05/2005 with AS03B
D.3.2	Product code	GSK1562902A
D.3.4	Pharmaceutical form	Emulsion and suspension for emulsion 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.3.9.3	Other descriptive name	A/INDONESIA/05/2005 (H5N1) - LIKE STRAIN
D.3.9.4	EV Substance Code	SUB30758
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	15
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Havrix 1440 Adult
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline Biologicals
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
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	Havrix 1440 Adult
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.3.9.3	Other descriptive name	HEPATITIS A VACCINE (INACTIVATED)
D.3.9.4	EV Substance Code	SUB25550
D.3.10	Strength
D.3.10.1	Concentration unit	ELISA unit/ml enzyme-linked immunosorbent assay unit/millitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1440
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
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	Havrix 720 Junior
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline Biologicals
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
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	Havrix 720 Junior
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.3.9.3	Other descriptive name	HEPATITIS A VACCINE (INACTIVATED)
D.3.9.4	EV Substance Code	SUB25550
D.3.10	Strength
D.3.10.1	Concentration unit	ELISA unit/ml enzyme-linked immunosorbent assay unit/millitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1440
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

Prime-boost immunisation of healthy subjects aged 3 to 17 years against pandemic H5N1 influenza.

E.1.1.1

Medical condition in easily understood language

Immunisation of healthy children against pandemic influenza.

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

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

Co-primary Immunogenicity Objective
• To assess the superiority of the haemagglutination inhibition (HI) antibody response against A/turkey/Turkey/01/2005 (H5N1) 10 days following H5N1 vaccination at Day 182 [1.9 µg A/turkey/Turkey/01/2005 (H5N1) HA antigen adjuvanted with AS03B] in subjects previously primed with 2 doses of heterologous A/Indonesia/5/2005 (H5N1) vaccine (Group H5N1_H5N1) versus non primed subjects (Group Havrix_H5N1).

Co-primary Safety Objective
• To evaluate the safety of the paediatric H5N1 vaccine when administered as a 2-dose primary vaccination to subjects 3 to 17 years of age in terms of occurrence of medically attended adverse events (MAEs) from Day 0 to Day 182 and to the Day 364 visit.

E.2.2

Secondary objectives of the trial

Immunogenicity
• To assess the HI antibody response in terms of seropositivity rates, GMTs, SCR, SPR and MGI, against A/Indonesia/5/2005 and A/turkey/Turkey/01/2005 (H5N1) strains: at Days 0, 42 and 182 (all subjects), at Day 192 (Groups H5N1_H5N1 and Havrix_H5N1) and Day 364 (Groups H5N1_H5N1, H5N1_Havrix and Havrix_H5N1).
• To further describe the humoral immune responses in terms of the age strata used for enrolment in this study.
• To describe the H5N1 neutralising antibody responses against the A/Indonesia/5/2005 and A/turkey/Turkey/01/2005 strains at Days 0, 42, 182 (all subjects), 192 (groups H5N1_H5N1 and H5N1_Havrix) and 364 (Groups H5N1_H5N1, H5N1_Havrix and Havrix_H5N1).
Safety
• To evaluate, after each vaccination, safety and reactogenicity in terms of 7-day solicited local and general symptoms, unsolicited adverse events (AEs) for 21 days after each dose and Day 0 to Day 84 overall, and pIMDs and SAEs during the entire study.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

All subjects must satisfy ALL the following criteria at study entry:
• Subjects for whom the investigator believes that the parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol .
• A male or female child 3 to 17 years of age inclusive, at the time of the first vaccination.
• Written informed consent obtained from the subject’s parent or guardian. Assent obtained from the subject when applicable.
• Good general health as established by medical history and clinical examination before entering into the study.
• Comprehension by the subject’s parent or guardian of the study requirements, ability to comprehend and comply with procedures for collection of short- and long-term safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits.
• Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device (i.e., a common-use phone serving multiple rooms or apartments).
• Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

E.4

Principal exclusion criteria

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
• Child in care
• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
• Planned administration of any vaccine 30 days prior and 21 days after any study vaccine administration.
• Active participation in other clinical trials.
• Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
• Acute disease and/or fever at the time of enrolment:
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
• Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
• An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
• Receipt of any immunoglobulins and/or any blood products within 9 months of study enrolment or planned administration of any of these products during the study period.
• Any known or suspected allergy to any constituent of influenza vaccines ; a history of anaphylactic-type reaction to vaccine components or a history of severe adverse reaction to a previous influenza vaccine.
• History of seizures or progressive neurological disease.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.
• Diagnosed with cancer or any chronic severe disease.
• Previous administration of any H5N1 vaccine.

E.5 End points

E.5.1

Primary end point(s)

Primary immunogenicity endpoint
• Humoral immune response in terms of H5N1 HI antibodies against the A/turkey/Turkey/01/2005 (H5N1) strain:
Observed variables:
 H5N1 HI antibody titres against the A/turkey/Turkey/01/2005 (H5N1) strain at Day 192.
Derived variables:
 GMTs of H5N1 HI antibody titres at Day 192.
 GMT ratio at Day 192 of Group H5N1_H5N1 over Group Havrix_H5N1.

Primary safety endpoint
• The occurrence of MAEs during the period from Day 0 to Day 182 and to the Day 364 visit.

E.5.1.1

Timepoint(s) of evaluation of this end point

Immunogenicity: Day 192

Safety: From Day 0 to Day 182 and to the Day 364 visit.

E.5.2

Secondary end point(s)

Secondary immunogenicity endpoints
• Humoral immune response in terms of H5N1 HI antibodies against the A/Indonesia/5/2005 and A/turkey /Turkey/01/2005 (H5N1 virus) strains.
Observed variable:
 H5N1 HI antibody titres at Day 0 (all subjects), Day 42 (all subjects), Day 182 (all subjects), Day 192 (Groups H5N1_H5N1 and Havrix_H5N1), Day 364 (Groups H5N1_H5N1, H5N1_Havrix and Havrix_H5N1).
Derived variables:
 Geometric means titres (GMTs) and seropositivity rates of H5N1 HI antibody titres at Day 0 (all subjects), Day 42 (all subjects), Day 182 (all subjects), Day 192 (Groups H5N1_H5N1 and Havrix_H5N1) and Day 364 (Groups H5N1_H5N1, H5N1_Havrix and Havrix_H5N1).
 Seroconversion rate (SCR) at Day 42 (all subjects), Day 182 (all subjects), Day 192 (Groups H5N1_H5N1 and Havrix_H5N1), Day 364 (Groups H5N1_H5N1, H5N1_Havrix and Havrix_H5N1).
 Seroprotection rates (SPR) at Day 0 (all subjects), Day 42 (all subjects), Day 182 (all subjects), Day 192 (Groups H5N1_H5N1 and Havrix_H5N1), Day 364 (Groups H5N1_H5N1, H5N1_Havrix and Havrix_H5N1).
 Mean Geometric Increase (MGI) at Day 42 (all subjects), Day 182 (all subjects), Day 192 (Groups H5N1_H5N1 and Havrix_H5N1), Day 364 (Groups H5N1_H5N1, H5N1_Havrix and Havrix_H5N1).
 Booster-Seroconversion rates (Booster SCR) at Day 192 (Groups H5N1_H5N1 and Havrix_H5N1), Day 364 (Groups H5N1_H5N1, H5N1_Havrix and Havrix_H5N1).
 Booster factor (BF) at Day 192 (Groups H5N1_H5N1 and Havrix_H5N1), Day 364 (Groups H5N1_H5N1, H5N1_Havrix and Havrix_H5N1).
 The same analyses as above will be performed in each age stratum with each study group that will include Day 192.
SCR for H5N1 HI antibody response is defined as the percentage of vaccinees who have either a prevaccination (Day 0) titre < 1:10 and a post-vaccination titre 1:40 or a prevaccination titre 1:10 and at least a 4-fold increase in post-vaccination titre.
SPR is defined as the percentage of vaccinees with a serum H5N1 HI antibody titre 1:40 that usually is accepted as indicating protection.
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.
Booster SCR: For seronegative subjects at pre-booster (Day 182), antibody titre  40 1/DIL at post- booster timepoints; For seropositive subjects at pre-booster (Day 182) antibody titre at post-booster timepoints 4-fold the pre-booster antibody titre
Booster Factor (BF) is defined as the geometric mean of the within-subject ratios of the post-booster vaccination reciprocal HI titre to the pre-booster vaccination (Day 182) reciprocal titre.
• Humoral immune response evaluation in terms of neutralising antibodies against A/Indonesia/5/2005 and A/turkey/Turkey/01/2005 (H5N1 virus) strains (in all subjects).:
Observed variable:
 Serum neutralising antibody titres at Days 0, 42, 182 (all subjects), 192 (Groups H5N1_H5N1 and Havrix_H5N1) and 364 (Groups H5N1_H5N1, H5N1_Havrix and Havrix_H5N1).
Derived variables:
 Geometric mean titres (GMTs) of serum neutralising antibody at Day 0 (all subjects), Day 42 (all subjects), Day 182 (all subjects), Day 192 (Groups H5N1_H5N1 and Havrix_H5N1), Day 364 (Groups H5N1_H5N1, H5N1_Havrix and Havrix_H5N1).
 Vaccine response rates (VRRs) at Day 42, Day 182, Day 192 and Day 364.
 Booster vaccine response rates at Day 192 (Groups H5N1_H5N1 and Havrix_H5N1), Day 364 (Groups H5N1_H5N1, H5N1_Havrix and Havrix_H5N1).
VRR: Percentage of vaccinees who have at least a 4-fold increase in post-vaccination titre relative to pre-vaccination titre (Day 0).
Booster VRR is defined as the percentage of vaccinees with at least a 4-fold increase in post-booster vaccination titre relative to pre-booster vaccination (Day 182).
For the safety and reactogenicity evaluation
• Percentage, intensity and relationship to vaccination of solicited local and general signs and symptoms during a 7-day follow-up period, i.e. day of vaccination and 6 subsequent days after each vaccination.
• Percentage, intensity and relationship to vaccination of unsolicited local and general signs and symptoms during a 21-day follow-up period after each vaccination and during Day 0 to TC Day 84 overall.
• Occurrence of pIMDs during the entire study period.
• Occurrence of serious adverse events during the entire study period.

E.5.2.1

Timepoint(s) of evaluation of this end point

Immunogenicity: Days 0, 42, 182, 192, 364

Safety
Solicited Local and general symptoms: During a 7-day (Day 0-6) follow-up period after each vaccination.

Unsolicited local and general symptoms: During a 21-day (Day 0-20) follow-up period after each vaccination and from Day 0 to Day 84.

Potential Immune-mediated Diseases: During the entire study period (Day 0 to 364).

Serious Adverse events: During the entire study period (Day 0 to 364).

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

Yes

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

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

Philippines

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

Last subject last visit.

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:

520

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)

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

312

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

208

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

Yes

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

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

520

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)

In the group H5N1_H5N1, the second Havrix or Havrix Junior dose will be given following at least a 6 months interval after the first dose, outside the study setting.

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:	Philippines

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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