Clinical Trials Register

Summary
EudraCT Number:	2007-000164-24
Sponsor's Protocol Code Number:	109836
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2016-10-21
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

Belgium - FPS Health-DGM

A.2

EudraCT number

2007-000164-24

A.3

Full title of the trial

A phase I/II, partially-blind, randomized multicentre study to assess the safety and immunogenicity of an HPV-16/18/33/58 L1 VLP vaccine formulated with different adjuvant systems when administered intramuscularly according to a 3-dose (0, 1, 6-month) or 2-dose schedules (0, 3-month or 0, 6-month) in healthy adult females (18-25 years of age).

A.3.1

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

Safety and immunogenicity study of GlaxoSmithKline Biologicals’ HPV-16/18/33/58 L1 VLP vaccine in healthy female subjects aged 18–25 years

A.3.2

Name or abbreviated title of the trial where available

HPV-NG-001 PRI

A.4.1

Sponsor's protocol code number

109836

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	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	44208994466
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	HPV-16/18/33/58 L1 VLP AS04 vaccine
D.3.2	Product code	HPV-16/18/33/58 L1 VLP AS04 vaccine
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	-
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB22593
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	-
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB22594
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	-
D.3.9.2	Current sponsor code	HPV-33 L1 VLP
D.3.9.3	Other descriptive name	Human papillomavirus 33 L1 protein
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	-
D.3.9.2	Current sponsor code	HPV-58 L1 VLP
D.3.9.3	Other descriptive name	Human papillomavirus 58 L1 protein
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	20
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	Yes
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	HPV-16/18/33/58 L1 VLP AS01E vaccine
D.3.2	Product code	HPV-16/18/33/58 L1 VLP AS01E vaccine
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	-
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB22593
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	-
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB22594
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	-
D.3.9.2	Current sponsor code	HPV-33 L1 VLP
D.3.9.3	Other descriptive name	Human papillomavirus Type 33 L1 protein
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	-
D.3.9.2	Current sponsor code	HPV-58 L1 VLP
D.3.9.3	Other descriptive name	Human papillomavirus Type 58 L1 protein
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	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	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: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	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	HPV-16/18/33/58 L1 VLP AS01E vaccine
D.3.2	Product code	HPV-16/18/33/58 L1 VLP AS01E vaccine
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	-
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB22593
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	-
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB22594
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	-
D.3.9.2	Current sponsor code	HPV-33 L1 VLP
D.3.9.3	Other descriptive name	Human papillomavirus Type 33 L1 protein
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	-
D.3.9.2	Current sponsor code	HPV-58 L1 VLP
D.3.9.3	Other descriptive name	Human papillomavirus Type 58 L1 protein
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	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	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	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	HPV-16/18/33/58 L1 VLP AS02W vaccine
D.3.2	Product code	HPV-16/18/33/58 L1 VLP AS02W vaccine
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	-
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB22593
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	-
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB22594
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	-
D.3.9.2	Current sponsor code	HPV-33 L1 VLP
D.3.9.3	Other descriptive name	Human papillomavirus Type 33 L1 protein
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	-
D.3.9.2	Current sponsor code	HPV-58 L1 VLP
D.3.9.3	Other descriptive name	Human papillomavirus Type 58 L1 protein
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	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	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: 5
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	Cervarix
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline Biologicals
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.3.4	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	-
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB22593
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	-
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB22594
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	20
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	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

Healthy volunteers

E.1.1.1

Medical condition in easily understood language

Cervical cancer

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

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 assess the safety of the HPV-16/18/33/58 L1 VLP vaccine with respect to the incidence, intensity and relationship to vaccination of solicited local and general symptoms reported during the 7-day period (Day 0-6) following each dose of vaccine, when administered as different formulations and different schedules.
•To assess the immune response (by enzyme-linked immunosorbent assay [ELISA]) to the HPV-16 and HPV-18 components of the HPV-16/18/33/58 L1 VLP vaccine at one month after the last dose of vaccine (Month 7 or Month 4 depending on the schedule) when administered as different formulations and different schedules.

E.2.2

Secondary objectives of the trial

•To assess the safety of the HPV-16/18/33/58 L1 VLP vaccine up to one month after the last dose of vaccine.
•To assess the safety of the HPV-16/18/33/58 L1 VLP vaccine during an extended safety follow-up period (from one month up to six months after the last dose of vaccine.
•To assess the immune response to the HPV-16 and HPV-18 components of the HPV-16/18/33/58 L1 VLP vaccine before the second dose of vaccine, at one month after the second dose of vaccine, and at six months after the last dose of vaccine.
•To assess the immune response to the HPV-33 and HPV-58 components of the HPV-16/18/33/58 L1 VLP vaccine before the second dose of vaccine, at one month after the second dose of vaccine, and at one month and six months after the last dose of vaccine

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•A woman whom the investigator believes can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
•A woman between, and including, 18 and 25 years of age at the time of the first vaccination.
•Written informed consent must be obtained from the subject prior to enrolment.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Subject must be of non-childbearing potential, i.e., have a current tubal ligation, hysterectomy, ovariectomy, or be pre-menarcheal; or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccina-tion, have a negative pregnancy test and must agree to con-tinue such precautions for two months after completion of the vaccination series.
•Subject who has had no more than 6 lifetime sexual partners prior to enrolment

E.4

Principal exclusion criteria

•Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use up to six months after last dose of vaccine.
•Concurrently participating in another clinical study, at any time during the study period (up to six months after last dose of vaccine), in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
•Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose or planned during the study period up to one month after last dose of vaccine (for corticosteroids, this will mean prednisone, or equivalent, > 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
•Planned administration/administration of a vaccine not fore-seen by the study protocol within 30 days before and 30 days after (i.e. days 0–29) the first dose of study vaccine. Planned administration/administration of routine meningococcal, hepatitis A or B, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
•Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy and not breastfeeding to enter the study.
•A woman planning to become pregnant or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose.
•Previous vaccination against HPV or planned administration of any HPV vaccine other than that foreseen by the study protocol during the study period.
•Previous administration of MPL, QS21, AS04, AS01E or AS02W adjuvants.
•Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination (no laboratory testing required).
•History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccines (e.g. Aluminum, MPL, QS21, AS04, AS01E or AS02W).
•Hypersensitivity to latex (found in syringe-tip cap and plunger).
•Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional ab-normality, as determined by previous physical examination or laboratory tests.
•Cancer or autoimmune disease under treatment.
•History of having had colposcopy or has planned a colposcopy to evaluate an abnormal cervical cytology (Pap smear) test.
•Received immunoglobulins and/or blood product within 90 days preceding enrolment or planned administration during the study period up to one month after the last dose of vaccine. Enrolment will be deferred until the subject is outside of specified window.
•Acute disease at the time of enrolment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Enrolment will be deferred until condition is resolved. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral/axillary temperature <37.5°C.
•Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a cervical sample cannot be collected. Enrolment will be deferred until condition is resolved according to investigators medical judgement.

E.5 End points

E.5.1

Primary end point(s)

Occurrence, intensity and relationship to vaccination of any solicited local or general symptoms
HPV-16 and –18 seropositivity rates and geometric mean titres (GMTs) (ELISA).

E.5.1.1

Timepoint(s) of evaluation of this end point

Solicited symptoms: Within 7 days (days 0-6) after each vaccine
Seropositivity: One month after the last dose of vaccine

E.5.2

Secondary end point(s)

Occurrence of serious adverse events (SAEs)
Occurrence, intensity and relationship to vaccination of any unsolicited symptom
Occurrence of clinically relevant abnormalities in biochemical and hematological parameters
Occurrence of pregnancy and pregnancy outcomes, new onset chronic diseases (NOCDs e.g., diabetes, autoimmune disease, asthma, allergies, etc.) or medically significant conditions (i.e., AEs prompting emergency room or physician visits that are not related to common diseases, or SAEs that are not related to common diseases) throughout the study period, regardless of causal relationship to vaccination, and intensity will be collected.
HPV-16 and HPV-18 seropositivity rates and GMTs before the second dose of vaccine
HPV-33 and HPV-58 seropositivity rates and GMTs before the second dose of vaccine

E.5.2.1

Timepoint(s) of evaluation of this end point

SAEs: Up to one month after the last dose of vaccine and during the extended safety follow-up (up to six months after the last dose of vaccine
Unsolicited symtpoms: Within 30 days (days 0-29) after each vaccine dose
Clinically relevant abnormalities: Month 0, one month and six months after the last dose of vaccine
Pregnancies, NOCDs, MSCs: Throughout the entire study period (Month 0 up to six months after the last dose of vaccine)
HPV-16 and HPV-18 seropositivity: At one month after the second dose of vaccine (for groups with the 3-dose schedule), and at six months after the last dose of vaccine
HPV-33 and HPV-58 seropositivity: At one month after the second dose of vaccine (for groups with the 3-dose schedule) and at one month and six months after the last dose of vaccine.

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)

Yes

E.7.1.1

First administration to humans

Yes

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

Yes

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

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

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.8.9.1

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

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)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

540

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

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.4.1

In the member state

540

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

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2007-04-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-05-21

P. End of Trial
P.	End of Trial Status	Completed

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