Clinical Trials Register

Summary
EudraCT Number:	2009-012219-16
Sponsor's Protocol Code Number:	113060
National Competent Authority:	Germany - PEI
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-02-22
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

Germany - PEI

A.2

EudraCT number

2009-012219-16

A.3

Full title of the trial

A phase IV, open-label, non-randomised, multicentre study to assess the immunogenicity and reactogenicity of a booster dose of GSK Biologicals’ combined reduced-antigen-content diphtheria-tetanus, acellular pertussis and inactivated poliovirus vaccine dTpa-IPV (Boostrix Polio) when administered in healthy adults, 10 years after a booster vaccination in study 711866/003 (dTpa-IPV-003).

A.3.1

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

Evaluation of GSK Biologicals’ Boostrix Polio in healthy adults, 10 years after a booster vaccination.

A.3.2

Name or abbreviated title of the trial where available

DTPA-IPV (BOOSTRIX-IPV)-012 BST: 003

A.4.1

Sponsor's protocol code number

113060

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01323959

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	Rixensaert
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-Polio
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline
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-Polio
D.3.2	Product code	dTpa-IPV
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	D
D.3.9.3	Other descriptive name	diphtheria toxoid
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.3.9.2	Current sponsor code	T
D.3.9.3	Other descriptive name	tetanus toxoid
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.2	Current sponsor code	PT
D.3.9.3	Other descriptive name	pertussis toxoid
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.3.9.2	Current sponsor code	FHA
D.3.9.3	Other descriptive name	filamentous haemagglutinin
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.3.9.2	Current sponsor code	PRN
D.3.9.3	Other descriptive name	pertactin
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	Inactivated poliovirus type 1
D.3.10	Strength
D.3.10.1	Concentration unit	DAgU D antigen unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	Inactivated poliovirus type 2
D.3.10	Strength
D.3.10.1	Concentration unit	DAgU D antigen unit(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.3.9.3	Other descriptive name	Inactivated poliovirus type 3
D.3.10	Strength
D.3.10.1	Concentration unit	DAgU D antigen unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	32
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)	Information not present in EudraCT
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	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
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	Information not present in EudraCT
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

Booster immunisation of healthy adults against diphtheria, tetanus, pertussis and poliomyelitis.

E.1.1.1

Medical condition in easily understood language

Persistence of antibodies and immune response and safety against diphtheria, tetanus, whooping cough and polio diseases.

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	PT
E.1.2	Classification code	10043376
E.1.2	Term	Tetanus
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	PT
E.1.2	Classification code	10034738
E.1.2	Term	Pertussis
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	PT
E.1.2	Classification code	10013023
E.1.2	Term	Diphtheria
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	PT
E.1.2	Classification code	10036012
E.1.2	Term	Poliomyelitis
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 exhibit one month after a booster dose of dTpa-IPV vaccine, that the booster dose elicits seroprotective antibody concentrations when given 10 years after a dose of:
-dTpa-IPV vaccine or co-administered dTpa+IPV vaccines, in at least 80% of the subjects against diphtheria, the 3 polio antigens and in at least 90% of the subjects against tetanus.
-dTpa-IPV vaccine, in at least 80% of the subjects against diphtheria, the 3 polio antigens and in at least 90% of the subjects against tetanus.
-co-administered dTpa+IPV vaccines, in at least 80% of the subjects against diphtheria, the 3 polio antigens and in at least 90% of the subjects against tetanus.
-Sanofi Pasteur MSD’s Td-IPV, one in at least 80% of the subjects against diphtheria, the 3 polio antigens and in at least 90% of the subjects against tetanus.
•To assess the persistence of antibodies to diphtheria, tetanus, PT, FHA, PRN and poliovirus antigens type 1, 2 and 3, 10 years after the booster dose in dTpa-IPV-003 study.

E.2.2

Secondary objectives of the trial

•To assess the immune response to the pertussis component of the study vaccine in terms of seropositivity rates and booster response, one month after vaccination.
•To assess the immune response to the study vaccine in terms of antibody concentrations/titres against all vaccine antigens, one month after vaccination.
•To evaluate the safety and reactogenicity of GSK Biologicals’ dTpa-IPV vaccine in terms of solicited symptoms (local and general), unsolicited symptoms and serious adverse events (SAEs).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

•Subjects who the investigator believes can and will comply with the requirements of the protocol.
•Male or female subjects who have received a dTpa-IPV, dTpa + IPV or Td-IPV vaccine in study NCT01277705.
•Written informed consent obtained from the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Female subjects of non-childbearing potential may be enrolled in the study.
–Non-childbearing potential is defined as pre-menarcheal, current tubal ligation, hysterectomy, ovariectomy or post-menopausal.
•Female subjects of childbearing potential may be enrolled in the study and receive the booster vaccine, if the subject:
–practices/has practiced adequate contraception for 30 days prior to vaccination, and
–has a negative pregnancy test on the day of vaccination, and
–agrees to continue adequate contraception during the entire booster epoch.

E.4

Principal exclusion criteria

•Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of the study vaccine, or planned use during the study period.
•Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
•Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination, or planned administration during the active study period.
•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 product.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
•Previous booster vaccination against diphtheria, tetanus, pertussis or poliovirus since the dose received in study NCT01277705. In Germany, previous dose of a monovalent vaccine against pertussis is allowed for subjects in the Td-IPV group.
•History of diphtheria, tetanus, pertussis or poliomyelitis diseases following the receipt of booster dose in study NCT01277705.
•Any confirmed or suspected immunosuppressive or immunodeficiency condition based on medical history and physical examination.
•Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
•Occurrence of any of the following adverse event (AE) after a previous administration of a DTP vaccine:
–Hypersensitivity reaction to any component of the vaccine,
–encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine,
–fever ≥ 40°C within 48 hours of vaccination not due to another identifiable cause,
–collapse or shock-like state within 48 hours of vaccination,
–convulsions with or without fever, occurring within 3 days of vaccination.
•Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
•Acute disease and/or fever at the time of enrolment.
•Pregnant or lactating female.
•Female planning to become pregnant or planning to discontinue contraceptive precautions.

E.5 End points

E.5.1

Primary end point(s)

•Immunogenicity with respect to booster vaccination.
-Seroprotection rates against diphtheria, tetanus and poliovirus types 1, 2 and 3.
•Immune persistence after the booster dose given in the study NCT01277705.
-Seroprotection rates against diphtheria, tetanus and poliovirus types 1, 2 and 3.
-Anti-PT, anti-FHA and anti-PRN seropositivity rates.
-Geometric mean concentrations/titres (GMCs/ GMTs) to all vaccine antigens.

E.5.1.1

Timepoint(s) of evaluation of this end point

Immunogenicity with respect to booster vaccination: One month (Month 1) after a booster dose of Boostrix-Polio vaccine
Immune persistence after the booster dose given in the study NCT01277705: Before (Day 0) a booster dose of Boostrix-Polio vaccine

E.5.2

Secondary end point(s)

•Immunogenicity with respect to booster vaccination, one month after booster vaccination in all subjects.
-Booster response to the PT, FHA and PRN antigens.
-Anti-PT, anti-FHA and anti-PRN seropositivity rates.
-GMCs/GMTs to all vaccine antigens.
•Solicited local and general symptoms.
-Occurrence of solicited local and general symptoms during the 4-day (Day 0–Day 3) follow-up period after booster vaccination.
•Unsolicited adverse events.
-Occurrence of unsolicited symptoms during the 31-day (Day 0–Day 30) follow-up period after booster vaccination.
•Serious adverse events
-Occurrence of serious adverse events (SAEs) from the booster dose up to study end.

E.5.2.1

Timepoint(s) of evaluation of this end point

Immunogenicity with respect to booster vaccination: One month (Month 1) after the booster dose of Boostrix-Polio vaccine
Occurrence of solicited local and general symptoms: During the 4-day (Day 0-3) follow-up period after booster vaccination
Occurrence of unsolicited adverse events: During the 31-day (Day 0-30) follow-up period after booster vaccination
Occurrence of serious adverse events: From the booster dose (Day 0) up to study end (Month 1)

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

Yes

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)

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

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

Information not present in EudraCT

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

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

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

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 subject last visit

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:

300

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

150

F.4.2

For a multinational trial

F.4.2.1

In the EEA

300

F.4.2.2

In the whole clinical trial

300

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)

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. However, subjects presenting with a suboptimal immunological response may be offered an additional dose of the most appropriate licensed vaccine at the discretion of the investigator outside the scope 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

2011-03-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-04-18

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-03-01

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