Clinical Trials Register

Summary
EudraCT Number:	2014-005282-78
Sponsor's Protocol Code Number:	114720
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2016-08-17
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

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A. Protocol Information

A.2

EudraCT number

2014-005282-78

A.3

Full title of the trial

A phase IV, randomised, open-label, controlled study to assess the immunogenicity and safety of the diphtheria, tetanus, pertussis and inactivated poliovirus (DPT-IPV) vaccine Squarekids™ when co-administered with GSK Biologicals' oral live attenuated HRV liquid vaccine Rotarix™ in healthy Japanese infants aged 6 - 12 weeks at the time of the first dose of HRV vaccination.

A.3.1

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

Immunogenicity and safety of the diphtheria, tetanus, pertussis and inactivated poliovirus (DPT-IPV) vaccine Squarekids™ co-administered with GSK Biologicals’ human rotavirus (HRV) vaccine Rotarix™ (444563) in healthy infants.

A.3.2

Name or abbreviated title of the trial where available

ROTA-079

A.4.1

Sponsor's protocol code number

114720

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	Rotarix
D.2.1.1.2	Name of the Marketing Authorisation holder	GlaxoSmithKline Biologicals K. K. Japan
D.2.1.2	Country which granted the Marketing Authorisation	Japan
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	Rotarix
D.3.4	Pharmaceutical form	Oral suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	-
D.3.9.3	Other descriptive name	HUMAN ROTAVIRUS RIX4414 STRAIN (LIVE ATTENUATED)
D.3.9.4	EV Substance Code	SUB22357
D.3.10	Strength
D.3.10.1	Concentration unit	log10 CCID50/dose log10 cell culture infective dose 50/dose
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	6
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	Squarekids
D.2.1.1.2	Name of the Marketing Authorisation holder	Kitasato Daiichi Sankyo Vaccine Co., Ltd
D.2.1.2	Country which granted the Marketing Authorisation	Japan
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	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous 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	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	equal
D.3.10.3	Concentration number	14
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	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	9
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	U unit(s)
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	4
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	-
D.3.9.3	Other descriptive name	POLIOVIRUS TYPE 1 (INACTIVATED)
D.3.9.4	EV Substance Code	SUB20462
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	-
D.3.9.3	Other descriptive name	POLIOVIRUS TYPE 2 (INACTIVATED)
D.3.9.4	EV Substance Code	SUB20463
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	-
D.3.9.3	Other descriptive name	POLIOVIRUS TYPE 3 (INACTIVATED)
D.3.9.4	EV Substance Code	SUB20464
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)	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

Active immunisation of infants against gastroenteritis (GE) due to rotavirus (RV).

E.1.1.1

Medical condition in easily understood language

Irritation and inflammation of the stomach and intestines (diarrhoea) or stomach flu caused by Human Rota virus.

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	19.0
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 demonstrate that the immunogenicity to the antigens contained in DPT-IPV vaccine is not impaired by the co-administration with GSK Biologicals' liquid HRV vaccine.

E.2.2

Secondary objectives of the trial

• To assess the immunogenicity of the liquid HRV vaccine in terms of serum anti-RV IgA antibody seropositivity and GMCs in a sub-cohort of subjects, 1 month after the sec-ond dose of the liquid HRV vaccine.
• To assess the immunogenicity to all the antigens contained in the DPT-IPV vaccine in terms of GMCs/ geometric mean antibody titres (GMTs), 1 month after the third dose of the DPT-IPV vaccine.
• To assess reactogenicity and safety after each dose of liquid HRV vaccine and first dose of DPT-IPV vaccine in terms of solicited symptoms during the 8-day follow-up period and unsolicited symptoms during the 31-day follow-up period.
• To assess safety in terms of serious adverse events (SAEs) from the first dose of study vaccine up to study end.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Subjects’ parent(s)/ Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator can and will comply with the requirements of the protocol.
• A male or female between, and including, 6 and 12 weeks of age at the time of the first dose of HRV vaccination.
• Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Born full-term as per the delivery records.

E.4

Principal exclusion criteria

• Child in care.
• Use of any investigational or non-registered product other than the study vaccines within 30 days before the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone (>= 0.5 mg/kg/day, or equivalent). Inhaled and topical steroids are allowed.
• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
• Administration of long-acting immune-modifying drugs at any time during the study period.
• Planned administration/administration of a vaccine not fore-seen by the study protocol within the period starting 30 days before the first dose of HRV vaccine administration and ending at Visit 7, with the exception of other routinely administered vaccines like PCV, Hib, BCG, hepatitis B, meningococcal vaccine and inactivated influenza vaccines, which are allowed at any time during the study, if administered at sites different from the sites used to administer the DPT-IPV vaccine.
• 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.
• Uncorrected congenital malformation of the gastrointestinal tract that would predispose for Intussusception (IS).
• History of IS.
• Family history of congenital or hereditary immunodeficiency.
• Any confirmed or suspected immunosuppressive or immu-nodeficient condition, based on medical history and physical examination.
• Major congenital defects or serious chronic illness.
• Previous vaccination against rotavirus, diphtheria, tetanus, pertussis and/ or poliovirus.
• Previous confirmed occurrence of RV GE, diphtheria, tetanus, pertussis, and/ or polio disease.
• GE within 7 days preceding the HRV vaccine administration.
• History of any reaction or hypersensitivity likely to be exac-erbated by any component of the HRV or DPT-IPV vaccines.
• Hypersensitivity to latex.
• History of any neurological disorders or seizures.
• History of SCID.
• Acute disease and/or fever at the time of enrollment.
- Fever is defined as temperature ≥ 37.5°C /99.5°F on oral, axillary or tympanic setting, or ≥ 38.0°C /100.4°F on rectal setting.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.

E.5 End points

E.5.1

Primary end point(s)

Immunogenicity with respect to components of the DPT-IPV vaccine.
• anti-diphtheria antibody concentrations ≥ 0.1 IU/mL,
• anti-tetanus antibody concentrations ≥ 0.1 IU/mL,
• anti-PT and anti-FHA antibody concentrations ≥ 10 EU/mL,
• anti-poliovirus serotypes 1, 2 and 3 antibody titre ≥ 8 ED50

E.5.1.1

Timepoint(s) of evaluation of this end point

One month after administration of the third dose of the DPT-IPV vaccine (Visit 7).

E.5.2

Secondary end point(s)

• Serum anti-RV IgA antibody concentration greater and equal to 20 U/mL and seropositivity in a sub-cohort of subjects.
• Serum GMCs/GMTs for anti-diphtheria, anti-tetanus, anti-poliovirus serotypes 1, 2 and 3, anti-PT and anti-FHA antibodies.
• Occurrence of solicited general symptoms.
• Occurrence of solicited local and general symptoms.
• Occurrence of unsolicited AEs.
• Occurrence of SAEs.

E.5.2.1

Timepoint(s) of evaluation of this end point

• One month after the second dose of the liquid HRV vaccine.
• One month after the third dose of the DPT-IPV vaccine.
• During the 8-day (Days 0-7) follow-up period after each dose of liquid HRV vaccine.
• During the 8-day (Days 0-7) follow-up period after the first dose of DPT-IPV vaccine.
• During the 31-day (Days 0-30) follow-up period after each dose of the liquid HRV vaccine and the first dose of DPT-IPV vaccine.
• From the first dose of the study vaccine up to study end (Visit 7).

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)

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

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)

Yes

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

Japan

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 7.

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:

262

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:

262

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

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

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

262

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

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

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