Clinical Trials Register

Summary
EudraCT Number:	2022-000090-15
Sponsor's Protocol Code Number:	213749
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2022-07-21
Trial 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

France - ANSM

A.2

EudraCT number

2022-000090-15

A.3

Full title of the trial

A Phase 1/2 randomized, observer-blinded, multi-country study to
evaluate safety and immunogenicity of investigational adjuvanted human papillomavirus vaccine in females (16 to 26 years of age)

A.3.1

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

A study on the immune response and safety of an adjuvanted human papillomavirus vaccine when given to healthy women 16 to 26 years of age

A.3.2

Name or abbreviated title of the trial where available

HPV9-AS04-001

A.4.1

Sponsor's protocol code number

213749

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 SA
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 SA
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 SA
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.3.2	Product code	GSKVx000000031164
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	N/A
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB22591
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
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	N/A
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB22592
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
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	N/A
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	not less then
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	N/A
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	not less then
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	N/A
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB130868
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
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	N/A
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB130869
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
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	N/A
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 45 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB130870
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
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	N/A
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 52 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB130871
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
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	N/A
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 58 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB130872
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
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: 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.3.2	Product code	GSKVx000000031166
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	N/A
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB22591
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB22592
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
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	not less then
D.3.10.3	Concentration number	15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
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	not less then
D.3.10.3	Concentration number	15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB130868
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB130869
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 45 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB130870
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 52 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB130871
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	N/A
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 58 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB130872
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
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	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.3.2	Product code	GSKVx000000031168
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	N/A
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 6 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB22591
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
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	N/A
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 11 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB22592
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
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	N/A
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	not less then
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	N/A
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	not less then
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	N/A
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 31 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB130868
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
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	N/A
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 33 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB130869
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
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	N/A
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 45 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB130870
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
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	N/A
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 52 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB130871
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
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	N/A
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS TYPE 58 L1 PROTEIN
D.3.9.4	EV Substance Code	SUB130872
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	not less then
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.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	Gardasil 9
D.2.1.1.2	Name of the Marketing Authorisation holder	MSD VACCINS
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Gardasil 9 suspension for injection
D.3.4	Pharmaceutical form	Suspension for injection in pre-filled syringe
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	HUMAN PAPILLOMAVIRUS VACCINE [TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58] (RECOMBINANT, ADSORBED)
D.3.9.3	Other descriptive name	HUMAN PAPILLOMAVIRUS VACCINE [TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58] (RECOMBINANT, ADSORBED)
D.3.9.4	EV Substance Code	SUB130921
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	20 to 60
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

Active immunisation for the prevention of human papillomavirus infection

E.1.1.1

Medical condition in easily understood language

Prevention of human papillomavirus infection

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10071146
E.1.2	Term	Human papilloma virus immunisation
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

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 evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals SA (GSK)’s investigational adjuvanted human papillomavirus (HPV) vaccine formulations.

• To evaluate the immune response to GSK’s investigational adjuvanted HPV vaccine formulations.

E.2.2

Secondary objectives of the trial

• To evaluate the safety and reactogenicity of GSK’s investigational adjuvanted HPV vaccine formulations.

• To evaluate the immune response for all HPV vaccine types for all vaccines.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Healthy participants as established by medical history and clinical examination before entering into the study
2. For Step 1 only (US only): Female between and including 18 and 26 years of age at the time of the first study intervention administration
3. For Step 2: Female between and including 16 and 26 years of age at the time of the first study intervention administration
4. Written informed consent obtained from the participant and/or participant's parent(s)/legally acceptable representative(s) (LAR[s]) prior to performance of any study-specific procedure
5. Participants and/or participants’ parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol
6. Female participant with no more than 4 lifetime sexual partners prior to enrollment.
7. Female participants of non-childbearing potential may be enrolled in the study. Female participants of childbearing potential may be enrolled in the study if the participant:
− has practiced adequate highly effective contraception for at least 1 month prior to study intervention administration, and
− has a negative pregnancy test on the day of study intervention administration, and
− has agreed to continue adequate contraception during the entire intervention period and for 2 months after completion of the study intervention administration series.

E.4

Principal exclusion criteria

1. Pregnant or lactating female.
2. Female planning to become pregnant or planning to discontinue contraceptive precautions.
3. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
4. History or current diagnosis of autoimmune disease.
5. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
6. Hypersensitivity to latex.
7. Major congenital defects, as assessed by the investigator.
8. History of abnormal Papanicolaou test or abnormal cervical biopsy result.
9. History of external genital/vaginal warts.
10. History of positive HPV test.
11. Acute or chronic clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
12. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
13. Previous vaccination against HPV.
14. Previous exposure to monophosphoryl lipid A or AS04 adjuvant.
15. Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study intervention(s) during the period beginning 30 days before the first dose of study intervention(s) (Day -29 to Day 1), or their planned use during the study period.
16. Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after each dose of study interventions administration
17. Administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab).
18. Use of systemic cytotoxic agents within the previous 3 months prior to randomization into this study or at any time during the study period.
19. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose(s). For corticosteroids, this will mean prednisone equivalent ≥20 mg/day for adult participants or ≥0.5 mg/kg/day with maximum of 20 mg/day for participants under 18 years of age. Inhaled and topical steroids are allowed.
20. Administration of systemic immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the administration of the first dose of study interventions or planned administration during the study period.
21. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention
22. History of /current chronic alcohol consumption and/or drug abuse.
23. Any study personnel or their immediate dependants, family, or household members.
24. Child in care.

E.5 End points

E.5.1

Primary end point(s)

• Percentage of participants reporting each solicited administration site event assessed as Grade 3 in terms of intensity within 7 days (Day 1 – Day 7) after each vaccine dose.
• Percentage of participants reporting each solicited systemic event assessed as Grade 3 in terms of intensity within 7 days (Day 1 – Day 7) after each vaccine dose.
• Percentage of participants reporting unsolicited adverse event assessed as Grade 3 in terms of intensity classified by Medical Dictionary for Regulatory Activities (MedDRA) within 28 days (Day 1 – Day 28) after each vaccine dose.
• Percentage of participants reporting SAEs classified by MedDRA from first vaccination up to study end.
• Percentage of participants presenting clinically relevant abnormalities in each biochemical and hematological parameter at Day 7 post-dose 1.
• Anti-HPV immunoglobulin G (IgG) antibody geometric mean concentrations (GMCs), 1 month after the third dose (Month 7).

E.5.1.1

Timepoint(s) of evaluation of this end point

As described above

E.5.2

Secondary end point(s)

• Percentage of participants reporting each solicited administration site event within 7 days (Day 1 –Day 7) after each vaccine dose.
• Percentage of participants reporting each solicited systemic event within 7 days (Day 1 – Day 7) after each vaccine dose.
• Percentage of participants reporting unsolicited symptoms within 28 days (Day 1 – Day 28) after each vaccine dose.
• Percentage of participants reporting pIMDs from first vaccination up to study end.
• The percentage of participants who experienced pregnancy and their outcomes from Day 1 of pregnancy up to study end.
• Anti-HPV IgG antibody concentration at Day 1, Month 2, Month 3, Month 6, Month 7, and Month 12.
• Anti-HPV IgG antibody seroconversion rate at Month 2, Month 3, Month 6, Month 7, and Month 12.
• Anti-HPV neutralizing antibody titers at Day 1, Month 3 and Month 7 in all participants, Month 2 in a subset of participants.
• Anti-HPV neutralizing antibody seroconversion rate at Month 3 and Month 7.
• Correlation between anti-HPV IgG antibody concentration and anti-HPV neutralizing antibody titers at Day 1, Month 2, Month 3, and Month 7.

E.5.2.1

Timepoint(s) of evaluation of this end point

As described above

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

Yes

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)

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

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-blinded for study vs comparator vaccine; double-blinded for 3 formulations of study vaccine

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

Yes

E.8.2.3.1

Comparator description

Gardasil 9

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

United States

Estonia

France

Lithuania

Poland

Bulgaria

Czechia

Germany

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

The end of trial is defined as the date of the Last Participant Last Visit (LPLV) or date of last testing results released whichever comes last. In the latter, end of trial must be achieved no later than 8 months after LPLV.

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 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:

200

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

200

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

880

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

505

F.4.2.2

In the whole clinical trial

1080

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

2022-11-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-11-21

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

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