Clinical Trials Register

Summary
EudraCT Number:	2017-002941-31
Sponsor's Protocol Code Number:	207759
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	GB - no longer in EU/EEA
Date on which this record was first entered in the EudraCT database:	2017-10-16
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

UK - MHRA

A.2

EudraCT number

2017-002941-31

A.3

Full title of the trial

A Phase 2, randomised, observer-blind, multi-centre study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' GSK3277511A investigational vaccine when administered intramuscularly according to two different vaccine schedules in adults aged 40 to 80 years old.

A.3.1

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

A study to test if a third dose of the vaccine is safe in current and former smokers aged 40 to 80 years old and to gather information on the immune response following the third dose of the vaccine.

A.3.2

Name or abbreviated title of the trial where available

NTHI MCAT-008

A.4.1

Sponsor's protocol code number

207759

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	44208990 4466
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	NTHi-Mcat 10-10-3.3
D.3.2	Product code	GSK3277511A
D.3.4	Pharmaceutical form	Powder and solvent for 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.3.9.2	Current sponsor code	PD
D.3.9.3	Other descriptive name	Recombinant Non-typeable Haemophilus influenzae Protein D (PD)
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	PE-PilA
D.3.9.3	Other descriptive name	Recombinant Non-typeable Haemophilus influenzae PE and PilA fusion 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	UspA2
D.3.9.3	Other descriptive name	Ubiquitous Surface Protein A2 (UspA2) from Moraxella catarrhalis
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	3.3
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Solution for injection
D.8.4	Route of administration of the placebo	Intramuscular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Chronic Obstructive Pulmonary Disease (COPD)

E.1.1.1

Medical condition in easily understood language

COPD is a lung disease that makes it hard to breathe. It is caused by damage to the lungs over many years, usually from smoking

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10009033
E.1.2	Term	Chronic obstructive pulmonary disease
E.1.2	System Organ Class	10038738 - Respiratory, thoracic and mediastinal disorders

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 profile of the NTHi-Mcat vaccine administered according to two vaccination schedules

E.2.2

Secondary objectives of the trial

• To evaluate the long term safety profile.
• To evaluate the humoral immunogenicity of the NTHi-Mcat investigational vaccine.
• To evaluate the cellular immunogenicity of the NTHi-Mcat investigational vaccine.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject prior to performing any study specific procedure.
• A male or female between, and including, 40 and 80 years of age at the time of the first vaccination.
• Current or former smoker with a cigarette smoking history of ≥ 10 pack-years.
• Female subjects of non-childbearing potential may be enrolled in the study.
- Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
• 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

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day -29 to Day 1), or planned use during the study period.
• Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
• Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
• Administration of long-acting immune-modifying drugs at any time during the study period.
• Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first and ending 30 days after the last dose of vaccine administration, with the exception of any influenza or pneumococcal vaccine which may be administered ≥ 15 days preceding or following any study vaccine dose.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
• Previous vaccination with any vaccine containing NTHi and/or Mcat antigens.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• History of or current autoimmune disease.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
•Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥37.5°C. The preferred location for measuring temperature in this study will be the oral cavity or the axilla.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
• Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.
• Pregnant or lactating female.
• Current alcoholism and/or drug abuse.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.
• Diagnosed with a respiratory disorder.
• Has significant disease, in the opinion of the investigator, likely to interfere with the study and/or likely to cause death within the study duration.
• Malignancies within previous 5 years or lymphoproliferative disorders.
• Any other condition that the investigator judges may interfere with study findings.

E.5 End points

E.5.1

Primary end point(s)

1. Number of subjects reported with each solicited local adverse event (AE) (any and grade 3) within each vaccination schedule.
2. Number of subjects reported with each solicited general adverse event (AE) (any and grade 3) within each vaccination schedule.
3. Number of subjects reported with any unsolicited adverse event (AE) within each vaccination schedule.
4. Number of subjects reported with any serious adverse event (SAE) within each vaccination schedule.
5. Number of subjects reported with any Potential Immune-mediated diseases (pIMDs) within each vaccination schedule.

E.5.1.1

Timepoint(s) of evaluation of this end point

1-2: During the 7-day follow-up period (Days 1-7) after each vaccination.
3: During the 30-day follow-up period (Days 1-30) after each vaccination.
4-5: From first vaccination (Day 1) up to and including Visit 9, at Day 541.

E.5.2

Secondary end point(s)

1. Number of subjects reported with any serious adverse event (SAE) within each vaccination schedule.
2. Number of subjects reported with any Potential Immune-mediated diseases (pIMDs) within each vaccination schedule.
3. Anti–Protein D (PD) antibody concentrations, as measured by ELISA, within each vaccination schedule.
4. Anti–Protein E (PE) antibody concentrations, as measured by ELISA, within each vaccination schedule.
5. Anti–type IV pili subunit (PilA) antibody concentrations, as measured by ELISA, within each vaccination schedule.
6. Anti–ubiquitous surface protein A2 of Moraxella catarrhalis (UspA2) antibody concentrations, as measured by ELISA, within each vaccination schedule.
7. Number of seropositive subjects for anti-PD antibody, as measured by ELISA, within each vaccination schedule.
8. Number of seropositive subjects for anti-PE antibody, as measured by ELISA, within each vaccination schedule.
9. Number of seropositive subjects for anti-PilA antibody, as measured by ELISA, within each vaccination schedule.
10. Number of seropositive subjects for anti-UspA2 antibody, as measured by ELISA, within each vaccination schedule.
11. NTHi-specific and Mcat-specific cell-mediated immune responses as measured by flow cytometry Intracellular Cytokine Staining (ICS) (frequency of specific CD4+ T-cells), in a sub-cohort of subjects and within each vaccination schedule.
12. NTHi-specific and Mcat-specific cell-mediated immune responses as measured by flow cytometry Intracellular Cytokine Staining (ICS) (frequency of specific CD8+ T-cells), in a sub-cohort of subjects and within each vaccination schedule.

E.5.2.1

Timepoint(s) of evaluation of this end point

1-2: From Visit 9 (Day 541) up to and including Visit 10 (Day 721).
3-10: At Day 1, Day 91, Day 181, Day 211, Day 361, Day 391, Day 541 and Day 721.
11-12: At Day 1, Day 91, Day 181, Day 211, day 361 and Day 391.

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

observer-blind

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

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

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

Canada

Germany

United Kingdom

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 testing results released of samples collected at Visit 10 (Day 721)

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

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:

100

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

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

F.4.2

For a multinational trial

F.4.2.1

In the EEA

100

F.4.2.2

In the whole clinical trial

200

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. A plan for treatment or care after the subject has ended the participation in the trial is not provided for prophylactic vaccine studies, as the subjects are healthy and do not need any treatment or care after end of the study.

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

2017-11-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2018-01-16

P. End of Trial
P.	End of Trial Status	GB - no longer in EU/EEA

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