Clinical Trials Register

Summary
EudraCT Number:	2015-003405-42
Sponsor's Protocol Code Number:	201532
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2018-01-16
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
H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED

Expand All Collapse All

A. Protocol Information

A.2

EudraCT number

2015-003405-42

A.3

Full title of the trial

A phase III, open-label, single-group, multi-centre study to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ combined reduced antigen content diphtheria, tetanus and acellular pertussis (dTpa) vaccine, Boostrix, administered as a booster dose in healthy Russian subjects aged four years and older.

A.3.1

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

Evaluation of immunogenicity, safety and reactogenicity of GSK Biologicals’ dTpa booster vaccine (263855) (Boostrix) administered as a booster dose in healthy Russian subjects.

A.3.2

Name or abbreviated title of the trial where available

DTPA (BOOSTRIX)-050

A.4.1

Sponsor's protocol code number

201532

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	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	Yes
D.2.1.1.1	Trade name	Boostrix
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline Biologicals
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Boostrix
D.3.2	Product code	dtPa
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.3.9.2	Current sponsor code	DT
D.3.9.3	Other descriptive name	DIPHTHERIA TOXOID
D.3.9.4	EV Substance Code	SUB12489MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	2
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	TT
D.3.9.3	Other descriptive name	TETANUS TOXOID
D.3.9.4	EV Substance Code	SUB12608MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	2
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	PT
D.3.9.3	Other descriptive name	PERTUSSIS TOXOID
D.3.9.4	EV Substance Code	SUB14817MIG
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	8
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	FHA
D.3.9.3	Other descriptive name	FILAMENTOUS HAEMAGGLUTININ
D.3.9.4	EV Substance Code	SUB38509
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	8
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	PRN
D.3.9.3	Other descriptive name	PERTUSSIS PERTACTIN
D.3.9.4	EV Substance Code	SUB20527
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	2.5
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

Healthy volunteers [Booster immunisation against diphtheria, tetanus and pertussis diseases of individuals from age of four years onwards. The study population for this study will include individuals aged four years and above.

E.1.1.1

Medical condition in easily understood language

Diphtheria
Lock jaw
Whopping cough

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	SOC
E.1.2	Classification code	10021881
E.1.2	Term	Infections and infestations
E.1.2	System Organ Class	10021881 - Infections and infestations

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 immune response to the dTpa vaccine in terms of seroprotection status for antibodies against diphtheria and tetanus antigens and in terms of seropositivity status for anti-bodies against the pertussis antigens [pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN)], one month after vaccination.

E.2.2

Secondary objectives of the trial

• To assess the immune response in terms of booster response to diphtheria, tetanus, PT, FHA, and PRN antigens, one month after vaccination.
• To assess the immune response in terms of antibody concentrations to diphtheria, tetanus, PT, FHA, and PRN antigens, one month after vaccination.
• To assess the reactogenicity and safety of Boostrix in terms of solicited symptoms (local and general), unsolicited adverse events (AEs) and serious adverse events (SAEs)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Subjects or subjects’ parent(s)/adoptive parent(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• A male or female four years of age and older.
• Written informed consent obtained from the subject/from the parent(s)/ adoptive parent(s) of the subject prior to performing any study specific procedure.
• Written informed assent obtained from subjects aged 14 years to <18 years.
• Healthy subjects as established by medical history and physical examination before entering into the study.
• Children four to seven years of age who have received diphtheria, tetanus and pertussis vaccination prior to study enrolment as per local recommendations.
• Subjects eight years of age and older who have received diphtheria, tetanus and pertussis vaccination to the best of their/subjects’ parent(s)/subjects’ adoptive parent(s) knowledge and did not receive an additional diphtheria, tetanus or pertussis vaccination within 5 years prior to enrolment in the study will be enrolled.
•Female subjects of non-childbearing potential may be enrolled in the study.
Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
•Female subjects of childbearing potential may be enrolled in the study, if the subject:
-has practiced adequate contraception within 30 days prior to vaccination, and
-has a negative pregnancy test on the day of vacci-nation, and
-has agreed to continue adequate contraception during the entire treatment period and for 1 month after completion of the vaccination.

E.4

Principal exclusion criteria

• Child in care
• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
• History of previous or intercurrent diphtheria, tetanus or pertussis diseases since birth in subjects four to seven years of age.
• History of previous or intercurrent diphtheria, tetanus or pertussis diseases within 5 years prior to enrolment in subjects aged eight years and above.
• Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. For corticosteroids, this will mean prednisone ≥ 20 mg/day (for adult subjects, ≥18 years of age) or ≥ 0.5 mg/kg/day (for paediatric subjects, aged 4-17 years), 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 within the period starting 30 days before and ending 30 days after the dose of vaccine with the exception of inactivated influenza vaccine which can be given at any time during the study conduct as per the Summary of Product Characteristics (SPC) or PI and according to the local governmental recommendations.
• 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 (pharmaceutical product or device).
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Family history of congenital or hereditary immunodeficiency.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• Hypersensitivity to latex.
• History of encephalopathy after administration of a previous dose of pertussis vaccine that could not be attributed to another identifiable cause, progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy: pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and the condition has stabilized.
• Acute disease and/or fever at the time of enrolment.
Fever is defined as temperature >= 38.0°C / 100.4°F. The preferred location for measuring temperature in this study will be 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.
• Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions during the study conduct.
• Any medical condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
• Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.

E.5 End points

E.5.1

Primary end point(s)

• Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T).
A seroprotected subject is a subject whose anti-D and anti-T concentrations are ≥ 0.1 IU/ml.

• Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN).
A seropositive subject is a subject whose antibody concentration is greater than or equal to the assay cut-off value.

E.5.1.1

Timepoint(s) of evaluation of this end point

At Day 31

E.5.2

Secondary end point(s)

• Booster response to the D, T, PT, FHA and PRN antigens
Booster response to D and T antigens is defined as:
- for initially seronegative subjects (pre-vaccination concentration below cut-off:
< 0.1 IU/ml): antibody concentrations at least four times the cut-off (post-vaccination concentration >= 0.4 IU/ml), and
- for initially seropositive subjects (pre-vaccination concentration >= 0.1 IU/ml): an increase in antibody concentrations of at least 4 times the pre-vaccination concentration.
Booster response to PT, FHA and PRN antigens is defined as:
- for subjects with pre-vaccination antibody concentration < 5 EL.U/ml: antibody concentration >= 20 EL.U/m;
- for subjects with pre-vaccination antibody concentration >= 5 EL.U/ml and
< 20 EL.U/ml: antibody concentration at least 4 times the pre-vaccination concentration; and
- for subjects with pre-vaccination antibody concentration 20 EL.U/ml: antibody concentration at least two times the pre-vaccination concentration.
• Anti-diphtheria, anti-tetanus, anti-PT, anti-FHA and anti-PRN antibody concentrations
Concentrations are expressed as geometric mean concentra-tions (GMCs).
• Number of subjects with solicited local and general symptoms
Occurrence of each solicited local and general symptom and occurrence of large swelling reactions.
• Number of subjects with unsolicited adverse events (AEs)
An unsolicited AE was defined as Any AE reported in addition to those solicited during the clinical study. Also any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
• Number of subjects with serious adverse events (SAEs)
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.

E.5.2.1

Timepoint(s) of evaluation of this end point

Day 31
Day 31
During the 4-day (Day 1–4) follow-up period after vaccination
During the 31-day (Day 1–31) follow-up period after vaccination
From Day 1 to Day 31

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

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

Will this trial be conducted at a single site globally?

E.8.4

Will this trial be conducted at multiple sites globally?

Yes

E.8.6 Trial involving sites outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Yes

E.8.6.3

Specify the countries outside of the EEA in which trial sites are planned

Russian Federation

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 2

E.8.9 Initial estimate of the duration of the trial

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

224

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

112

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

112

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

112

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

112

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

Yes

F.3.2

Patients

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

448

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
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	GlaxoSmithKline Biologicals
G.4.3.4	Network Country	Belgium

H.4 Third Country in which the Trial was first authorised
H.4.1	Third Country in which the trial was first authorised:	Russian Federation

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

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials