Clinical Trials Register

Summary
EudraCT Number:	2019-002585-12
Sponsor's Protocol Code Number:	A3L00057
National Competent Authority:	Finland - Fimea
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2022-03-16
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

Finland - Fimea

A.2

EudraCT number

2019-002585-12

A.3

Full title of the trial

Immunogenicity and Safety of DTaP-IPV-HB-PRP~T Combined Vaccine Given at 3, 5, and 12 Monhs of Age Concomitantly or Sequentially 4CMenB Vaccine in Italian and Finnish Infants

A.3.1

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

Study to Assess the Immune Response and the Safety Profile of DTaP-IPV-HB-PRP~T Combined Vaccine Given Concomitantly or Sequentially with 4CMenB Vaccine in Italian and Finnish Infants

A.4.1

Sponsor's protocol code number

A3L00057

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1239-0365

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	Sanofi Pasteur
B.1.3.4	Country	France
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	Sanofi Pasteur
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	Sanofi AB
B.5.2	Functional name of contact point	Clinical Study Unit
B.5.3	Address:
B.5.3.1	Street Address	Box 30052
B.5.3.2	Town/ city	Stockholm
B.5.3.3	Post code	10425
B.5.3.4	Country	Sweden
B.5.4	Telephone number	+46 86345000
B.5.6	E-mail	clinicaltrials.sweden@sanofi.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	Hexyon suspension for injection Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi Pasteur Europe
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.4	Pharmaceutical form	Suspension for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	Yes
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	DIPHTHERIA TOXOID
D.3.9.2	Current sponsor code	D
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	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TETANUS TOXOID
D.3.9.2	Current sponsor code	T
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	40
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PERTUSSIS TOXOID
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PERTUSSIS FILAMENTOUS HAEMAGGLUTININ
D.3.9.2	Current sponsor code	FHA
D.3.9.3	Other descriptive name	PERTUSSIS FILAMENTOUS HAEMAGGLUTININ
D.3.9.4	EV Substance Code	SUB20298
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	25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	POLIOVIRUS (INACTIVATED) TYPE 1
D.3.9.2	Current sponsor code	IPV
D.3.9.3	Other descriptive name	POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) PRODUCED ON VERO CELLS
D.3.9.4	EV Substance Code	SUB25669
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.3.8	INN - Proposed INN	POLIOVIRUS (INACTIVATED) TYPE 2
D.3.9.2	Current sponsor code	IPV
D.3.9.3	Other descriptive name	POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) PRODUCED ON VERO CELLS
D.3.9.4	EV Substance Code	SUB25670
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.3.8	INN - Proposed INN	POLIOVIRUS (INACTIVATED) TYPE 3
D.3.9.2	Current sponsor code	IPV
D.3.9.3	Other descriptive name	POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) PRODUCED ON VERO CELLS
D.3.9.4	EV Substance Code	SUB25671
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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	HEPATITIS B SURFACE ANTIGEN
D.3.9.2	Current sponsor code	Hep B
D.3.9.3	Other descriptive name	HEPATITIS B SURFACE ANTIGEN
D.3.9.4	EV Substance Code	SUB14083MIG
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	HAEMOPHILUS TYPE B POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID
D.3.9.2	Current sponsor code	PRP-T
D.3.9.3	Other descriptive name	HAEMOPHILUS TYPE B POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID ADSORBED ON ALUMINIUM PHOSPHATE
D.3.9.4	EV Substance Code	SUB25305
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	22 to 36
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	Bexsero suspension for injection in pre-filled syringe Meningococcal group B Vaccine (rDNA, component, adsorbed)
D.2.1.1.2	Name of the Marketing Authorisation holder	GSK Vaccines S.r.l
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.4	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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Recombinant Neisseria meningitidis group B NHBA fusion protein
D.3.9.3	Other descriptive name	RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE
D.3.9.4	EV Substance Code	SUB96088
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	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Recombinant Neisseria meningitidis group B NadA protein
D.3.9.3	Other descriptive name	RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE
D.3.9.4	EV Substance Code	SUB96089
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	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Recombinant Neisseria meningitidis group B fHbp fusion protein
D.3.9.3	Other descriptive name	RECOMBINANT NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE
D.3.9.4	EV Substance Code	SUB96090
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	50
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254
D.3.9.3	Other descriptive name	OUTER MEMBRANE VESICLES (OMV) FROM NEISSERIA MENINGITIDIS GROUP B STRAIN NZ98/254 MEASURED AS AMOUNT OF TOTAL PROTEIN CONTAINING THE PORA P1.4 ADSORBED ON ALUMINIUM HYDROXIDE
D.3.9.4	EV Substance Code	SUB96091
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	25
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.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	Prevenar 13 suspension for injection Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Europe MA EEIG
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.4	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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pneumococcal polysaccharide serotype 1
D.3.9.3	Other descriptive name	Pneumococcal polysaccharide serotype 1 conjugated to CRM197 adsorbed on aluminium phosphate
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pneumococcal polysaccharide serotype 3
D.3.9.3	Other descriptive name	Pneumococcal polysaccharide serotype 3 conjugated to CRM197 adsorbed on aluminium phosphate
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pneumococcal polysaccharide serotype 4
D.3.9.3	Other descriptive name	Pneumococcal polysaccharide serotype 4 conjugated to CRM197 adsorbed on aluminium phosphate
D.3.9.4	EV Substance Code	SUB25261
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pneumococcal polysaccharide serotype 5
D.3.9.3	Other descriptive name	Pneumococcal polysaccharide serotype 5 conjugated to CRM197 adsorbed on aluminium phosphate
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pneumococcal polysaccharide serotype 6A
D.3.9.3	Other descriptive name	Pneumococcal polysaccharide serotype 6A conjugated to CRM197 adsorbed on aluminium phosphate
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pneumococcal polysaccharide serotype 6B
D.3.9.3	Other descriptive name	Pneumococcal polysaccharide serotype 6B conjugated to CRM197 adsorbed on aluminium phosphate
D.3.9.4	EV Substance Code	SUB25344
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	4.4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pneumococcal polysaccharide serotype 7F
D.3.9.3	Other descriptive name	Pneumococcal polysaccharide serotype 7F conjugated to CRM197 adsorbed on aluminium phosphate
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pneumococcal polysaccharide serotype 9V
D.3.9.3	Other descriptive name	Pneumococcal polysaccharide serotype 9V conjugated to CRM197 adsorbed on aluminium phosphate
D.3.9.4	EV Substance Code	SUB25342
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pneumococcal polysaccharide serotype 14
D.3.9.3	Other descriptive name	Pneumococcal polysaccharide serotype 14 conjugated to CRM197 adsorbed on aluminium phosphate
D.3.9.4	EV Substance Code	SUB25340
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pneumococcal polysaccharide serotype 18C
D.3.9.3	Other descriptive name	Pneumococcal polysaccharide serotype 18C conjugated to CRM197 adsorbed on aluminium phosphate
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pneumococcal polysaccharide serotype 19A
D.3.9.3	Other descriptive name	Pneumococcal polysaccharide serotype 19A conjugated to CRM197 adsorbed on aluminium phosphate
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pneumococcal polysaccharide serotype 19F
D.3.9.3	Other descriptive name	Pneumococcal polysaccharide serotype 19F conjugated to CRM197 adsorbed on aluminium phosphate
D.3.9.4	EV Substance Code	SUB25366
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	2.2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pneumococcal polysaccharide serotype 23F
D.3.9.3	Other descriptive name	Pneumococcal polysaccharide serotype 23F conjugated to CRM197 adsorbed on aluminium phosphate
D.3.9.4	EV Substance Code	SUB25347
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	2.2
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

Haemophilus influenzae type b immunisation

E.1.1.1

Medical condition in easily understood language

Active immunization against diphtheriae, tetanus, pertussis, hepatitis B, poliomyelitis & invasive infections caused by Haemophilus influenzae type b

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10054181
E.1.2	Term	Hepatitis B immunization
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10069533
E.1.2	Term	Haemophilus influenzae type b immunisation
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

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 demonstrate the non-inferiority of the co-administration of DTaP-IPV-HB-PRP~T combined vaccine with 4CMenB vaccine in terms of seroprotection rates for anti-hepatitis B surface antigen (HBsAg) and anti-Haemophilus influenzae type b (Hib) polyribosyl ribitol phosphate (PRP) antibodies (Abs), compared to the sequential administration of the same vaccines.

E.2.2

Secondary objectives of the trial

- To describe the immune responses against all antigens of the DTaP-IPV-HB-PRP~T combined vaccine and to the 4CMenB vaccine before the first and after the third dose of each vaccine for each of the study groups.
- To describe the immune responses against all antigens of the PCV13 vaccine (with the different anti-polysaccharide responses described following a pre-defined priority list and driven by the amount of sera available) after the third dose for each of the study groups.
- To describe the safety profile after each and any injection of DTaP-IPV-HB-PRP~T combined vaccine and the other co-administered vaccines (4CMenB and PCV13 vaccines) for each of the study groups.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Aged 76 to 110 days on the day of the first study visit (depending on local practices as per National Immunization Program (NIP))
- Born to an adult mother (≥ 18 years of age) (including mothers vaccinated and not vaccinated with Tdap during pregnancy)
- Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period of 32 through 37 weeks with a birth weight ≥ 2.0 kg and under stable condition defined as: infant who does not require significant medical support or ongoing management for debilitating disease and who have demonstrated a sustained recovery growth curve by the time he/she receives the first dose of the vaccination series
- Participant and parent(s)/legally acceptable representative(s) are able to attend all scheduled visits and to comply with all trial procedures

E.4

Principal exclusion criteria

- Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following any trial vaccination, except in case of routine vaccines to be administered as per the NIP and for influenza vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
- Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B (Hep B), pneumococcal, meningococcal, or Hib infections or diseases with the study vaccine or another vaccine
- Receipt of immunoglobulins, blood or blood-derived products since birth
- Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
- Known personal or maternal history of Hep B (HBsAg) or Hep C seropositivity
- History of diphtheria, tetanus, pertussis, poliomyelitis, Hep B, Hib infection, meningococcal infection, or pneumococcal infection, confirmed either clinically, serologically or microbiologically
- Known systemic hypersensitivity to latex or to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
- Known thrombocytopenia, as reported by the parent(s)/legally acceptable representative(s) contraindicating intramuscular (IM) vaccination as assessed by the investigator
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
- History of seizures
- Participants in an emergency setting or hospitalized involuntarily
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature ≥ 38.0°C [≥ 100.4°F]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
- Identified as a natural or adopted child of the investigator or employee with direct involvement in the proposed study

E.5 End points

E.5.1

Primary end point(s)

1. Number of participants with anti-HBsAg antibody (Ab) above predefined threshold. The Ab against HBsAg will be measured, threshold values will be considered.
2. Number of participants with anti-PRP Ab above predefined threshold. The Ab against PRP will be measured, threshold values will be considered.

E.5.1.1

Timepoint(s) of evaluation of this end point

1. 1 month post third dose of DTaP-IPV-HB-PRP~T combined vaccine (Months 10)
2. 1 month post third dose of DTaP-IPV-HB-PRP~T combined vaccine (Month 10)

E.5.2

Secondary end point(s)

1. Geometric Mean Concentrations (GMCs)/Geometric Mean Titers (GMTs) of Ab against all antigens of the DTaP-IPV-HB-PRP~T combined vaccine. The Ab against the antigens: diphtheria (D), tetanus (T), poliovirus types 1, 2, and 3, pertussis toxoid (PT), filamentous hemagglutinin (FHA), PRP, and HBsAg will be measured.
2. Geometric Mean Concentrations Ratio/ Titers Ratio (GMCR/GMTR) of Ab against all antigens of the DTaP-IPV-HB-PRP~T combined vaccine. The Ab against the antigens: D, T, poliovirus types 1, 2, and 3, PT, FHA, PRP, and HBsAg will be measured. The ratio calculated will be: (post dose 3/pre-dose 1).
3. Number of participants with Ab against all antigens of the DTaP-IPV-HB-PRP~T combined vaccine above predefined thresholds. The Ab against the antigens: D, T, poliovirus types 1, 2, and 3, PT, FHA, PRP, and HBsAg will be measured. Threshold values will be considered for each Ab: anti-D and anti-T Ab; anti-poliovirus 1, 2, and 3 Ab; anti-PT and anti-FHA Ab; anti-PRP Ab; anti-HBsAg Ab.
4. Seroconversion for anti-PT and anti-FHA. The Ab against PT and FHA will be measured.
5. Number of participants with a vaccine response to PT and FHA. The Ab against PT and FHA will be measured. Vaccine response to PT and FHA, threshold values will be considered.
6. GMCs/GMTs of Ab against antigens of the 4CMenB vaccine. The Ab against antigens of the 4CMenB vaccine will be measured.
7. GMCR/GMTR of Ab against antigens of the 4CMenB vaccine. The Ab against antigens of the 4CMenB vaccine will be measured. The ratio calculated will be: (post dose 3/pre-dose 1).
8. Number of participants with Ab against antigens of the 4CMenB vaccine above predefined thresholds. The Ab against antigens of the 4CMenB vaccine will be measured. Threshold values will be considered.
9. GMCs of Ab against pneumococcal capsular polysaccharide (PnPS) antigens of the PCV13 vaccine. The Ab against PnPS antigens will be measured.
10. Number of participants with a vaccine response to PnPS antigens. The Ab against PnPS antigens will be measured. Threshold values will be considered.
11. Number of participants reporting immediate adverse events (AEs). Unsolicited (spontaneously reported) systemic AEs.
12. Number of participants reporting solicited injection site and systemic reactions. Solicited injection site reactions: tenderness, erythema, and swelling. Solicited systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite loss and irritability.
13. Number of participants reporting unsolicited non-serious AEs.
14. Number of participants reporting serious adverse events (SAEs). SAEs, including adverse event of special interest (AESIs).

E.5.2.1

Timepoint(s) of evaluation of this end point

1, 2, 3, 4, 5. Day 0 and 1 month post third dose of DTaP-IPV-HB-PRP~T combined vaccine (Month 10)
6, 7, 8. Day 0 and 1 month post third dose of 4CMenB vaccine (Month 10 for group 1; Month 11 for group 2)
9, 10. 1 month post third dose of PCV13 vaccine (Month 10)
11. Within 30 minutes post-vaccination
12. Within 7 days post-vaccination
13. Up to 30 days after each vaccination
14. Up to Month 11

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)

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

Yes

E.8.1.1

Randomised

Yes

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

Yes

E.8.1.7.1

Other trial design description

Complex design (vaccine administrated concomitantly or sequentially)

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

Yes

E.8.2.3.1

Comparator description

Comparaison of two dose regimens

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

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

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:

396

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)

Yes

F.1.1.4.1

Number of subjects for this age range:

396

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

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

F.3.3.4

Nursing women

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

200

F.4.2

For a multinational trial

F.4.2.1

In the EEA

396

F.4.2.2

In the whole clinical trial

396

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

2022-04-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2022-05-04

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2023-12-13

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