Clinical Trials Register

Summary
EudraCT Number:	2019-001986-34
Sponsor's Protocol Code Number:	T151/2019
National Competent Authority:	Finland - Fimea
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2019-08-29
Trial 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

Finland - Fimea

A.2

EudraCT number

2019-001986-34

A.3

Full title of the trial

Exploring the impact of pertussis immunization during pregnancy on the
differences in immune response of infants after primary immunization with
an acellular pertussis containing vaccine: an open label study

A.3.1

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

Maternal pertussis Immunization in FInland Study - MIFI Study

A.4.1

Sponsor's protocol code number

T151/2019

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	Turku University Hospital
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	The Foundation for Paediatric Research
B.4.2	Country	Finland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Turku University Hospital
B.5.2	Functional name of contact point	Pediatric clinic
B.5.3	Address:
B.5.3.1	Street Address	Kiinamyllynkatu 4-8
B.5.3.2	Town/ city	Turku
B.5.3.3	Post code	20521
B.5.3.4	Country	Finland
B.5.6	E-mail	lauri.ivaska@utu.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
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
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.IMP: 2
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	Infanrix hexa
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline Biologicals s.a.
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	Infanrix hexa
D.3.4	Pharmaceutical form	Powder and suspension for suspension for injection
D.3.4.1	Specific paediatric formulation	Yes
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.IMP: 3
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	RotaTeq
D.2.1.1.2	Name of the Marketing Authorisation holder	MSD VACCINS
D.2.1.2	Country which granted the Marketing Authorisation	France
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	RotaTeq
D.3.4	Pharmaceutical form	Oral solution
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Oral 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	Yes
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.IMP: 4
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	Synflorix
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline Biologicals S.A.
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	Synflorix
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

E.1.1.1

Medical condition in easily understood language

Whooping Cough

E.1.1.2

Therapeutic area

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

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	10034738
E.1.2	Term	Pertussis
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 investigate Pertussis Toxin (PT) specific antibody responses, 1 month
following the second aP vaccine given at 5 months of age to infants
whose mothers have (Arm 1) or have not (Arm 2) received a pertussis
booster vaccine during pregnancy

E.2.2

Secondary objectives of the trial

1. To assess the effect of baseline PT, FHA and PRN specific IgG antibody responses on the PT, FHA and PRN antibody responses in
infants in Arm 1 vs Arm 2.
2. To compare pertussis antigen-specific plasma B-cell frequencies at 5 months + 7 days of age in infants from Arm 1 vs Arm 2
3. To compare pertussis antigen-specific memory B-cell frequencies at 6 months of age in infants from Arm 1 vs Arm 2.
4. To compare pertussis antigen specific T-cell responses at 6 months of age, in infants primed in Arm 1 vs Arm 2 groups
5. To compare serological responses to the non-pertussis vaccines (Hib, diphtheria, tetanus, pneumococcus, polio) in infants in Arm 1 vs Arm 2
groups.
6. Assessment of pertussis specific functional antibodies in infants in Arm 1 vs Arm 2.
7. To compare humoral, cellular, and functional immunity against pertussis, diphtheria and tetanus in children and in mothers between
Arm 1 and Arm 2 when children are 3 years old.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Mothers
• Only adult mothers who are generally healthy and with no chronic disease with regular therapy will be offered to be included.

Infants
• Infants born with ≥ 37 weeks of gestational age
• Written informed consent given by parent(s) or legal guardian(s) who is aged ≥18 years
• Parent(s) or legal guardian(s) willing and able to comply with the requirements of the protocol for the duration of the study.
• Infants due to receive their primary aP immunizations, aged up to 3 months (+- 4 days)
• Maternal immunization:
Exclusively for Arm 1: Received dTap vaccine during the current pregnancy
Exclusively for Arm 2: Not received dTap during the current pregnancy

E.4

Principal exclusion criteria

Mothers
• Mothers who have received dTap vaccine during the last 2 years are excluded.
• Mothers will be excluded if there is any condition which in the opinion of the investigator may interfere with the ability to fulfill study
requirements (this may include plans to move house and language comprehension).
• Receipt of immunosuppressive treatment during pregnancy or known HIV positivity are also reasons for exclusion.

Infats
• Birth weight < 2500 g
• Child in care (with safeguarding in place)
• Children of parents who are on the delegation log for this study
• Prior or planned receipt of any other investigational vaccine/drug or if current participation in other research study, at investigator discretion
• Major congenital defects or serious chronic illness
• Bleeding disorder
• Confirmed or suspected immunodeficiency
• A family history of congenital or hereditary immunodeficiency
• Receipt of more than 1 week of immune-suppressants or immune modifying drugs (e.g. oral prednisolone > 0.5 ml/kg/day or intravenous
glucocorticoid steroid). Nasal, topical or inhaled steroids are allowed.
• Administration of immunoglobulin and/or any blood products since birth or planned administration during the study period
• History of allergy to any component of the vaccine
• History of pertussis disease/whooping cough confirmed by laboratory analysis (serology, culture or other available methods)

E.5 End points

E.5.1

Primary end point(s)

PT-specific IgG antibody GMC at 6 months in infants from Arm 1 versus Arm 2 groups.

E.5.1.1

Timepoint(s) of evaluation of this end point

6 months

E.5.2

Secondary end point(s)

1.The difference in PT, FHA and PRN IgG antibody GMC in cord blood (Finland) and at 3 and 6 months of age in Arm 1 vs Arm 2 groups. (*)
2. Pertussis antigen-specific plasma B-cell frequencies at 5 month + 7 days of age measured by ELISpot in the Arm 1 vs Arm 2 infants. (*)
3. Pertussis antigen-specific memory B-cell frequencies at 6 months of age measured by ELISpot in the Arm 1 vs Arm 2 infants. (*)
4. Pertussis antigen-specific T-cell responses determined by cytokine analysis either from pertussis antigen stimulated whole blood
samples/PBMC's and/or supernatants. (*)
5.Hib, diphtheria, tetanus, pneumococcal and polio-specific antibody responses at baseline and 6 months in Arm 1 vs Arm 2 infants. (*)
6. Assays of pertussis specific functional antibodies may include: PT neutralization; adherence inhibition; bacterial agglutination; bactericidal
activity; bacterial opsonization and phagocytosis undertaken on plasma samples taken at 3 (prior to immunisation) and 6 months of age (1
month after the second dose). (*)
7. Same methods as above measured when children are 36 months old.

E.5.2.1

Timepoint(s) of evaluation of this end point

1. at 3 and 6 months of age
2. at 5 month + 7 days of age
3. at 6 months of age
4. at 3 months and 6 months
5. at 3 months and 6 months
6. at 3 (prior to immunisation) and 6 months of age (1 month after the second dose
7. at 36 months of age

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

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

Yes

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

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:

F.1.1.1

In Utero

Yes

F.1.1.1.1

Number of subjects for this age range:

F.1.1.2

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

F.1.1.3

Newborns (0-27 days)

Yes

F.1.1.3.1

Number of subjects for this age range:

F.1.1.4

Infants and toddlers (28 days-23 months)

Yes

F.1.1.4.1

Number of subjects for this age range:

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

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:

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

F.3.3.3

Pregnant women

Yes

F.3.3.4

Nursing women

Yes

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

infants

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

160

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)

subjets are not patients

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

2019-11-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-11-19

P. End of Trial
P.	End of Trial Status	Ongoing

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