Clinical Trials Register

Summary
EudraCT Number:	2016-003678-42
Sponsor's Protocol Code Number:	IIV-316
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-06-07
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Netherlands - Competent Authority

A.2

EudraCT number

2016-003678-42

A.3

Full title of the trial

Immunological effects of an acellular pertussis booster vaccination in children, young adults and elderly with different immunisation background.
An international study in Finland, the Netherlands and the United Kingdom

Immunologische effecten van een boostervaccinatie met acellulaire kinkhoest vaccin bij kinderen, jonge volwassenen en ouderen met een verschillende immunisatie achtergrond. Een internationaal onderzoek in Finland, Nederland en het Verenigd Koninkrijk

A.3.1

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

Immunological effects of an acellular pertussis booster vaccination in children, young adults and the elderly with different immunisation background.
An international study in Finland, the Netherlands and the United Kingdom

A.3.2

Name or abbreviated title of the trial where available

Booster against pertussis (Bert)

A.4.1

Sponsor's protocol code number

IIV-316

A.5.4

Other Identifiers

Name:

ABR

Number:

NL60807.100.17

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	RIVM
B.1.3.4	Country	Netherlands
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	Horizon 2020/IMI
B.4.2	Country	European Union
B.4.1	Name of organisation providing support	GSK Vaccines
B.4.2	Country	Belgium
B.4.1	Name of organisation providing support	Sanofi Pasteur SA
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	RIVM
B.5.2	Functional name of contact point	Periscope-Booster Information
B.5.3	Address:
B.5.3.1	Street Address	Antonie van Leeuwenhoeklaan 9
B.5.3.2	Town/ city	Bilthoven
B.5.3.3	Post code	3720 MA
B.5.3.4	Country	Netherlands
B.5.6	E-mail	Periscope@rivm.nl
B.Sponsor: 2
B.1.1	Name of Sponsor	Clinical Trials and Research Governance
B.1.3.4	Country	United Kingdom
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	Horizon 2020/IMI
B.4.2	Country	European Union
B.4.1	Name of organisation providing support	GSK Vaccines
B.4.2	Country	Belgium
B.4.1	Name of organisation providing support	Sanofi Pasteur SA
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Clinical Trials and Research Governance
B.5.2	Functional name of contact point	Churchill Hospital
B.5.3	Address:
B.5.3.1	Street Address	Old Road
B.5.3.2	Town/ city	Oxford
B.5.3.4	Country	United Kingdom
B.5.6	E-mail	Dominic.kelly@paediatrics.ox.ac.uk
B.Sponsor: 3
B.1.1	Name of Sponsor	Turun Yliopisto
B.1.3.4	Country	Finland
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	Horizon 2020/IMI
B.4.2	Country	European Union
B.4.1	Name of organisation providing support	GSK Vaccines
B.4.2	Country	Belgium
B.4.1	Name of organisation providing support	Sanofi Pasteur SA
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Turun Yliopisto
B.5.2	Functional name of contact point	Turku University
B.5.3	Address:
B.5.3.1	Street Address	Kiinamyllynkatu 13
B.5.3.2	Town/ city	20520 Turku
B.5.3.4	Country	Finland
B.5.6	E-mail	Jussi.mertsola@tyks.fi

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 or Boostrix-IPV
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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.3.4	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.3.11 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

Pertussis infection

Kinkhoest infectie

E.1.1.1

Medical condition in easily understood language

Whooping Cough

Kinkhoest

E.1.1.2

Therapeutic area

Body processes [G] - Immune system processes [G12]

MedDRA Classification

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 magnitude and changes in pertussis toxin (PT) specific IgG antibody levels just before (T0) and 28 days (T4) after the booster vaccination in 2 cohorts of children (7-10 and 11-15 years of age), 1 cohort of young adults (20-34 years of age) and 1 cohort of elderly (60-70 years of age) in three different countries.

E.2.2

Secondary objectives of the trial

• Assess the PT specific IgG antibody levels 1 year (T5) after vaccination.
• Assess the specific IgG antibody levels against other pertussis vaccine antigens (e.g. FHA, Prn and Fim2,3), as well as non-pertussis vaccine antigens (e.g. diphtheria toxoid, tetanus toxoid) at T0, T4 and T5.
• Determine pertussis-specific IgG-subclasses and -avidity at T0, T4 and T5.
• Determine functional pertussis-specific antibody levels at T0, T4 and T5.
• Assess magnitude and longevity of memory B cell responses against the various B. pertussis vaccine proteins at T0, 7 days post vaccination (T2), T4 and T5, to determine the effects of an aP booster vaccination in children, young adults and elderly on memory and effector cell populations.
• Compare pertussis antigen-specific T helper responses and their ratio’s at T0, 14 days post vaccination (T3), T4 and T5.
• Collection and biobanking of biological samples for identifying biomarkers of lasting memory or waning of immunity to Pertussis.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• normal general health;
• within the right age group for the cohort;
• received all regular vaccines for their age group according to the Dutch NIP, UK NIP or Finnish NIP; a copy of the vaccination booklet will be included in the participant’s documents. If booklet is not available for cohorts A, B and C, vaccination status will be checked with regulatory agencies / GP. For cohort D this booklet might not be available due to their age;
• provision of written informed consent (see section 11.2 for details);
• willing to adhere to the protocol and be available during the study period.

E.4

Principal exclusion criteria

• present evidence of serious disease(s) within the last 3 months before inclusion requiring immunosuppressive or immune modulating medical treatment, such as systemic corticosteroids, that might interfere with the results of the study ;
• chronic infection
• known or suspected immune deficiency;
• history of any neurologic disorder, including epilepsy;
• previous administration of serum products (including immunoglobulins) within 6 months before vaccination and blood sampling;
• known or suspected allergy to any of the vaccine components (by medical history);
• occurrence of serious adverse events (SAEs) after primary DTwP-IPV vaccination, DTaP-IPV vaccination or any other vaccination (by medical history);
• vaccination with any other pertussis vaccine than those described in the inclusion criteria (i.e. only according to NIP);
• vaccination with any other DT-IPV vaccine in the last 5 years, DT-IPV vaccination according to NIP in cohort B is no exclusion;
• children between 8 and 10 years of age eligible for cohort A in the Netherlands who have already received the diphtheria and tetanus toxoid vaccine (DT)-IPV booster vaccination according to the Dutch NIP around 9 years of age;
• mixed wP and aP priming within a participant, cohort B;

E.5 End points

E.5.1

Primary end point(s)

Anti-PT specific IgG-antibodies in serum and their avidity will be determined for all samples in a PERISCOPE serological core assay, comparing T0, T4 and T5.

E.5.1.1

Timepoint(s) of evaluation of this end point

before vaccination (T0)
1 month after vaccination (T4)
1 year after vaccination (T5)

E.5.2

Secondary end point(s)

-Specific IgG-levels to other pertussis vaccine antigens (FHA; Prn and Fim2,3), as well as to non-pertussis antigens (diphtheria toxoid and tetanus toxoid) will be determined at T0, T4 and T5, using a PERISCOPE serological multiplex immunoassay.
-Functional pertussis-specific antibody levels will be determined in serum samples at T0, T4 and T5, using PERISCOPE core assays as described in section 8.3.4. Differences in levels of functional antibodies will be measured before and after vaccination. Functional antibody assays include bacterial adherence inhibition (BAI), PT neutralisation (PTNA), serum bactericidal activity (SBA), and bacterial opsonophagocytosis assay (OPA). Other serological parameters such as avidity, subclass distribution (IgA, IgM) are optional in serum samples .
-Antigen-specific memory B cell responses at time points T0, T2, T4 and T5 will be measured to determine the effects of aP booster vaccination in children, young adults and elderly, using PERISCOPE B cell core assay.
-Characterisation of the effect of an aP booster on the specific T cell immune response, both early after the boost and later on, in different age groups, vaccinated initially either with a whole cell or an acellular vaccine.
-Collection and biobanking of biological samples to be used for testing in novel exploratory immunoassays and for possible bridging to other pertussis vaccine studies.

E.5.2.1

Timepoint(s) of evaluation of this end point

before vaccination (T0)
1 day after vaccination (T1)
7 days after vaccination (T2)
14 days after vaccination (T3)
1 month after vaccination (T4)
1 year after vaccination (T5)

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

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

immune responses

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

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

longitudinal intervention study

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.8.3

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

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

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

LVLS

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:

216

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:

108

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

108

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2017-06-07.

Yes

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

122

F.4.2

For a multinational trial

F.4.2.1

In the EEA

366

F.4.2.2

In the whole clinical trial

366

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

2017-06-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-09-01

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

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