Clinical Trials Register

Summary
EudraCT Number:	2006-006460-32
Sponsor's Protocol Code Number:	109664,109666,109668
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2007-03-09
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

UK - MHRA

A.2

EudraCT number

2006-006460-32

A.3

Full title of the trial

A phase IV, open, multicenter, multicountry study to assess the long-term antibody persistence of a booster dose of GlaxoSmithKline (GSK) Biologicals’ Haemophilus influenzae type b – meningococcal serogroup C conjugate (Hib-MenC) vaccine given at 12-15 months of age to subjects who were primed in primary study 103974 (HIB-MENC-TT-012) and boosted in study 104056 (HIB-MENC-TT-013 BST:012).

A.3.2

Name or abbreviated title of the trial where available

Hib-MenC-TT-027, 028, 029

A.4.1

Sponsor's protocol code number

109664,109666,109668

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	Infanrix IPV
D.2.1.1.2	Name of the Marketing Authorisation holder	SmithKline Beecham plc T/A GlaxoSmithKline UK
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.3.4	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.3.8	INN - Proposed INN	Diphteria toxoid
D.3.9.2	Current sponsor code	D
D.3.9.3	Other descriptive name	detoxified diphteria toxin
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	60
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	detoxified tetanus toxin
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	80
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	detoxified pertussis toxin
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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	Filamentous haemagglutinin
D.3.9.2	Current sponsor code	FHA
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
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	Pertactin
D.3.9.2	Current sponsor code	PRN
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	16
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Inactivated Polio Virus Type 1
D.3.9.2	Current sponsor code	IPV type 1
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	80 to DU/ml
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Inactivated Polio Virus Type 2
D.3.9.2	Current sponsor code	IPV type 2
D.3.10	Strength
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	16 to DU/ml
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Inactivated Polio Virus Type 3
D.3.9.2	Current sponsor code	IPV type 3
D.3.10	Strength
D.3.10.3	Concentration number	64 to DU/ml
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.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	MENITORIX
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	Menitorix
D.3.2	Product code	Hib-MenC-TT
D.3.4	Pharmaceutical form	Powder for 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.3.8	INN - Proposed INN	Haemophilus influenza type b polysaccharide (PRP) conjugated to tetanus toxoid (TT)
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	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Neisseria meningitidis serogroup C polysaccharide (PSC) conjugated to tetanus toxoid (TT)
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	5
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

Persistence of antibodies after a 3-dose primary vaccination (in infancy) with or without a booster vaccination (in the second year of life) against Haemophilus influenzae type b disease and meningococcal disease due to serogroup C

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

In all evaluable subjects of groups HibMenC and LicMenC at 12 months after the booster vaccination; in all evaluable subjects of groups HibMenC and LicMenC at 24 months after the booster vaccination; in all evaluable subjects of group NoBoost at 40-43 months of age; and in all evaluable subjects of groups HibMenC and LicMenC at 48 months after the booster vaccination:
• To evaluate the persistence of meningococcal C antibodies
• To evaluate the persistence of Haemophilus influenzae type b antibodies.
In all UK evaluable subjects* of groups HibMenC and LicMenC:
• To evaluate the persistence of anti-pertussis antibodies prior to Infanrix-IPV preschool booster and the response to Infanrix-IPV preschool booster 24 months later.
* UK pediatric vaccination schedule recommends a DTP booster at the moment of Visit 2 (24 months after study booster vaccination) of our study; the Polish pediatric vaccination schedule recommends a DTP booster before Visit 1 of our study.

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

All subjects must satisfy the following criteria at study entry:

Subjects of groups HibMenC and LicMenC at Visits 1, 2 and 3:
•Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study.
•A male or female between and including 24 and 31 months of age at the time of Visit 1, between and including 40 and 43 months of age at Visit 2 and between and including 60 and 64 months at Visit 3.
•Written informed consent obtained from the parent or guardian of the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study.
•Having completed the booster vaccination study HIB-MENC-TT-013 BST:012.

Subjects of group NoBoost at Visit 2 (UK only):
•Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
•A male or female between and including 40 and 43 months of age at Visit 2.
•Written informed consent obtained from the parent or guardian of the subject.
•Healthy subjects as established by medical history and clinical examination before entering into the study
•Having received a 3-dose primary vaccination with a MenC conjugate vaccine and a Hib containing vaccine before the age of 8 months.

E.4

Principal exclusion criteria

The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study:

Subjects of groups HibMenC and LicMenC at Visits 1, 2 and 3:
•Previous administration of a booster dose of Hib or meningococcal serogroup C except booster study vaccines during the study HIB-MENC-TT-013 BST:012.
•History of H. influenzae type b or meningococcal diseases.
•UK subjects only: previous administration of a booster dose of a pertussis-containing vaccine, except booster study vaccines during the study HIB-MENC-TT-013 BST:012 (104056)

Subjects of group NoBoost at Visit 2 (UK only):
•Previous administration of a booster dose of Hib or meningococcal serogroup C vaccine
•History of H. influenzae type b or meningococcal diseases

The following criteria should be checked at each visit subsequent to the first visit for subjects in groups HibMenC and LicMenC:
•History of H. influenzae type b, meningococcal or pertussis diseases* since the previous long-term persistence visit [for the Visit1 - since the last visit of the booster vaccination study 104056 (HIB-MENC-TT-013 BST:012)].
* Subjects with a history of pertussis disease will be eliminated from the pertussis analyses only. See Section 9.3.
•Previous administration of a booster dose of Hib or meningococcal serogroup C vaccines since the previous long-term persistence visit.
•UK subjects only: Prior to Visit 2: previous administration of pertussis containing vaccine as booster vaccination.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since the last visit. (For corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed.).
•Administration of immunoglobulins and/or any blood products since the last visit.

E.5 End points

E.5.1

Primary end point(s)

Immunogenicity endpoints:
In all subjects of groups HibMenC and LicMenC, at Visit 1, Visit 2 and Visit 3 (i.e. at 12, 24 and 48 months, respectively, after the Hib-MenC booster) and in all subjects of group NoBoost at 40-43 months of age (Visit 2):
• SBA-MenC titre >= 1:8 (seroprotection) and >= 1:128 and titres.
• Anti-PRP concentration >= 0.15 microg/ml (seroprotection) and >= 1.0 microg/ml and concentrations.
• Anti-PSC concentration >= 0.30 microg/ml (seropositivity) and >= 2.0 microg/ml and concentrations.
In all UK subjects of groups HibMenC and LicMenC at Visit 2 (24 months after Hib-MenC booster and prior to Infanrix-IPV booster) and at Visit 3 (48 months after Hib-MenC booster and 24 months after Infanrix-IPV booster):
• Anti-FHA, anti-PRN and anti-PT antibodies concentration >= 5EL.U/ml and concentrations.
Safety endpoints:
In all subjects of groups HibMenC and LicMenC:
• Serious adverse events (SAEs) occurring from the last study contact of the booster study HIB-MENC-TT-013 BST:012 to the end of this persistence study*.
* Note on retrospective recording of SAEs after the booster vaccinations in study HIB-MENC-TT-013 BST:012: at each visit of this long-term persistence study (i.e. at 1 year up to 4 years after booster vaccination) the subject’s parents/guardian will be asked if any SAEs, as defined hereafter, had occurred since the last visit (including since the last visit of the booster vaccination study HIB-MENC-TT-013 BST:012). Only those SAEs that are determined by the investigator to have a causal relationship to the booster vaccination will be recorded and described individually, along with the nature of the SAEs and the outcomes. Any event related to lack of vaccine efficacy (meningococcal, Hib or pertussis medical/vaccine history will be recorded) will be recorded during the long-term persistence phase or related to study participation will be described in detail.
In UK subjects:
• Serious adverse events (SAEs) occurring within 30 days of administration of the Infanrix-IPV and Menitorix vaccines*.
* Note on recording of SAEs after the Infanrix-IPV and Menitorix vaccine: SAEs occurring within 30 days following the administration of the Infanrix-IPV and Menitorix vaccines, whether related or not, will be recorded. Thirty days after Visit 2, the investigator will contact the subject’s parents/guardians, by phone, to ask if any SAE had occurred since the vaccination.

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

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

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

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 (Month 36)

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

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.1.1.6

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

Informed consent obtained from parents/legally acceptable representatives

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

267

F.4.2

For a multinational trial

F.4.2.1

In the EEA

553

F.4.2.2

In the whole clinical trial

553

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 - healthy subjects

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

2007-03-26

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2007-03-15

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2010-05-18

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