Clinical Trials Register

Summary
EudraCT Number:	2015-003324-32
Sponsor's Protocol Code Number:	UAT1
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:	2015-08-25
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

2015-003324-32

A.3

Full title of the trial

A Phase 4 study to evaluate the safety and immunogenicity of trivalent oral polio vaccine in adults previously vaccinated with oral polio vaccine

A.3.1

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

A vaccine study in healthy adults to evaluate the safety and immune response of a licensed oral polio vaccine containing 3 polio vaccine strains.

A.4.1

Sponsor's protocol code number

UAT1

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	University of Antwerp
B.1.3.4	Country	Belgium
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Bill and Melinda Gates Foundation
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	University of Antwerp
B.5.2	Functional name of contact point	Prof. Dr. PhD.
B.5.3	Address:
B.5.3.1	Street Address	Universiteitsplein 1, Campus Drie Eiken
B.5.3.2	Town/ city	Antwerp
B.5.3.3	Post code	2610
B.5.3.4	Country	Belgium
B.5.4	Telephone number	+32(0)3265 26 58
B.5.5	Fax number	+32(0)3265 26 40
B.5.6	E-mail	philippe.beutels@uantwerpen.be

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	Yes
D.2.1.1.1	Trade name	Polio Sabin™ Trivalent
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline
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	SABIN trivalent Oral Polio Vaccine
D.3.2	Product code	tOPV
D.3.4	Pharmaceutical form	Oral drops, suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Poliomyelitits vaccine type 1 (live)
D.3.9.3	Other descriptive name	POLIOVIRUS (LIVE, ATTENUATED) TYPE 1 (SABIN STRAIN)
D.3.9.4	EV Substance Code	SUB27074
D.3.10	Strength
D.3.10.1	Concentration unit	CCID50/dose cell culture infective dose 50/dose
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	10^6.0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Poliomyelitis vaccine type 2 (live)
D.3.9.3	Other descriptive name	POLIOVIRUS (LIVE, ATTENUATED) TYPE 2 (SABIN STRAIN)
D.3.9.4	EV Substance Code	SUB27075
D.3.10	Strength
D.3.10.1	Concentration unit	CCID50/dose cell culture infective dose 50/dose
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	10^5.0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Poliomyelitis vaccine type 3 (live)
D.3.9.3	Other descriptive name	POLIOVIRUS (LIVE, ATTENUATED) TYPE 3 (SABIN STRAIN)
D.3.9.4	EV Substance Code	SUB27076
D.3.10	Strength
D.3.10.1	Concentration unit	CCID50/dose cell culture infective dose 50/dose
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	10^5.8
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

Historic tOPV can result in the emergence of circulating vaccine-derived polioviruses (cVDPVs): the attenuated strains of poliovirus from the vaccine infect un-immunized individuals, replicate, circulate in the population, and may eventually mutate enough to become virulent and effect vaccine-associated paralytic poliomyelitis (VAPP).

E.1.1.1

Medical condition in easily understood language

Polio disease

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	18.0
E.1.2	Level	HLT
E.1.2	Classification code	10036017
E.1.2	Term	Poliomyelitis viral infections
E.1.2	System Organ Class	100000004862

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objectives of the study are to assess the safety (serious adverse events [SAEs] and severe adverse events [AEs]) and immunogenicity (seroprotection rate) of SABIN tOPV in healthy OPV-vaccinated adults.

E.2.2

Secondary objectives of the trial

Secondary objectives are to assess:
- the safety (solicited and unsolicited AEs, important medical events [IMEs], laboratory assessments) of SABIN tOPV in healthy OPV-vaccinated adults;
- the immunogenicity (seroconversion rate, median antibody titer) of SABIN tOPV in healthy OPV-vaccinated adults.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Healthy male or female, between 18 and 50 years old, extremes included
2. Received at least 4 doses of OPV in the past (more than 12 months before the start of the study)
3. In good physical and mental health as determined on the basis of medical history and general physical examination performed at Day 0
4. Female subjects of childbearing potential must agree to the use of an effective method of birth control throughout the study and up to 3 months after last vaccine dose
5. Willing to adhere to the prohibitions and restrictions specified in this protocol
6. Informed Consent Form (ICF) signed voluntarily by the subject before any study-related procedure is performed, indicating that the subject understands the purpose of and procedures required for the study and is willing to participate in the study.

E.4

Principal exclusion criteria

1. A condition that, in the opinion of the Investigator, could compromise the well being of the subject or course of the study, or prevent the subject from meeting or performing any study requirements
2. Having Crohn’s disease or ulcerative colitis or having had major surgery of the gastrointestinal tract involving significant loss or resection of the bowel
3. A known allergy, hypersensitivity, or intolerance to the study vaccine, or to any of its components or to any antibiotics
4. Any confirmed or suspected immunosuppressive or immunodeficiency condition (including human immunodeficiency virus [HIV] infection)
5. Will have household or professional contact with known immunosuppressed people or people without full polio vaccination (i.e. complete priming) within 28 days after vaccination
6. Neonatal nurses or others having professional contact with children under 6 months old within 28 days after vaccination
7. Chronic administration (i.e., longer than 14 days) of immunosuppressant drugs or other immune-modifying drugs within 6 months prior to the first vaccine dose or planned use during the study. For instance, for corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg/day (inhaled and topical steroids are allowed whereas intra-articular and epidural injection/administration of steroids are not allowed)
8. Presence of contraindications to administration of the study vaccine on Day 0: acute severe febrile illness deemed by the Investigator to be a contraindication for vaccination or persistent diarrhea or vomiting
9. Indications of drug abuse or excessive use of alcohol at Day 0
10. Being pregnant or breastfeeding. Women of childbearing potential will undergo a urine pregnancy test at Day 0. Subjects with a positive pregnancy test will be excluded
11. Participation in another clinical study within 28 days prior to entry in this study or receipt of any investigational product (drug or vaccine) other than the study vaccine within 28 days prior to the first administration of study vaccine, or planned use during the study period
12. Planned administration or administration of any vaccine other than the study vaccine within 28 days of the first dose of study vaccine and up to 28 days after administration of each study vaccine dose
13. Administration of polio vaccine within 12 months before the start of the study
14. Having had a transfusion of any blood product or application of immunoglobulins within the 4 weeks prior to the first administration of study vaccine or during the study
15. Subject is an employee of the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site, or is a family member of an employee or the Investigator.

E.5 End points

E.5.1

Primary end point(s)

The following endpoints will be evaluated by group and overall:
- Safety: incidence of SAEs and severe§ AEs considered related or possibly related to study vaccine throughout the study period.
- Immunogenicity: seroprotection rate of type-specific polio antibodies at Day 28, following a single dose of tOPV (combined Groups 1 and 2). Seroprotection is defined as type-specific antibody titers ≥1:8.

E.5.1.1

Timepoint(s) of evaluation of this end point

- Safety: throughout the study period
- Immunogenicity: at Day 28

E.5.2

Secondary end point(s)

The following safety and immunogenicity endpoints will be evaluated by group and overall.
Safety:
1) The incidence of any SAEs and important medical events (IMEs) throughout the study period. The following will be considered IMEs: medically significant events that do not meet any of the SAE criteria, but may require medical or surgical consultation or intervention to prevent one of the other serious outcomes listed in the SAE definition.
2) The incidence and severity of solicited adverse events for Days 0-7 in both groups and days 28-35 and 56-63 in Group 2
3) The incidence and severity of unsolicited adverse events throughout the study period
4) Incidence and description of deviations from normal of safety chemistry at Day 0 (both groups), Day 7 (both groups), Day 28 (both groups), Day 35 (Group 2), Day 56 (Group 2), Day 63 (Group 2) and Day 84 (Group 2).

Immunogenicity:
5) Median titers of type-specific polio antibodies at Day 28 in Group 1
6) Seroprotection rate and median titers of type-specific polio antibodies at Days 56 and 84 in Group 2
7) Seroconversion rate of type-specific polio antibodies at Day 28 in both groups and at Day 84 in Group 2. Seroconversion is defined as a change from seronegative to seropositive and antibody titers of ≥1:8, and in seropositive subjects, as an antibody titer increase of ≥ 4 fold over baseline titers.

E.5.2.1

Timepoint(s) of evaluation of this end point

Safety:
1) Throughout the study period
2) Day 0-7 (both groups) and Day 28-35 & 56-63 (Group 2)
3) Throughout the study period
4) Day 0 (both groups), Day 7 (both groups), Day 28 (both groups), Day
35 (Group 2), Day 56 (Group 2), Day 63 (Group 2) and Day 84 (Group 2)

Immunogenicity:
5) Day 28 (Group 1)
6) Day 56 & 84 (Group 2)
7) Day 28 (both groups) and Day 84 (Group 2)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

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 (seroprotection rate)

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)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

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)

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

Yes

E.8.4

The trial involves multiple sites in the 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

A subject will be considered to have completed the study if he or she has completed all study related procedures 42 days after the last study vaccination.

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:

128

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.4.1

In the member state

128

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

128

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

2015-09-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-08-31

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

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