Clinical Trials Register

Summary
EudraCT Number:	2009-015743-16
Sponsor's Protocol Code Number:	NA
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:	2009-10-23
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

2009-015743-16

A.3

Full title of the trial

A randomised, partially observer-blind, multi-centre, head-to-head comparison of a two dose regimen of Baxter and GSK H1N1 pandemic vaccines, administered 21 days apart

A.3.2

Name or abbreviated title of the trial where available

Head to head study of influenza H1N1 vaccines in adults

A.4.1

Sponsor's protocol code number

A.5.1

ISRCTN (International Standard Randomised Controlled Trial) Number

ISRCTN92328241

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	University Hospitals of Leicester NHS Trust
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
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	No
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	Celvapan
D.3.2	Product code	Celvapan
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.3.11 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	No
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	Pandemrix
D.3.2	Product code	Pandemrix
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.3.11 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

Pandemic H1N1 influenza.

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 evaluate the immunogenicity of Baxter cell-culture, non-adjuvanted, whole virus H1N1 vaccine, and GSK AS03-adjuvanted, split H1N1 vaccine with respect to Committee of Human Medicinal Products (CHMP) and FDA licensing criteria.

E.2.2

Secondary objectives of the trial

To identify whether one or two doses of vaccine are required to satisfy the licensing criteria,
To examine the short term reactogenicity of the vaccines,
To examine the kinetics of the antibody responses to vaccination,
To examine persistence of antibody at 6 months,
AND if appropriate (i.e., an antigenic drift variant emerges prior to the 2010-2011 influenza season),
To evaluate the breadth of the antibody response to the antigenic variant.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Mentally competent adults, who have signed an informed consent form after having received a detailed explanation of the study protocol.
Clinically healthy, male or female volunteers aged 18 years of age and older, including the over 65’s, and those with stable high-risk medical conditions. (NOTE: ‘Stable’ is defined as having no medical consultations for an exacerbation or worsening of any chronic medical condition during the preceding 8 weeks, AND have been maintained on a stable drug regimen for at least 2 weeks prior to study entry as assessed by the medical history).
Are able to understand and comply with all study procedures and to complete study diaries,
Individuals who can be contacted and are available for all study visits.
Females should either be using secure contraceptive precautions including a) the oral contraceptive pill, b) condom/barrier contraception c) partner has had a vasectomy, d) be surgically sterilised, or e) post-menopausal (defined as at least two years since the last menstrual period).

E.4

Principal exclusion criteria

1 Subjects who are unable to lead an independent life either physically or mentally;
2 Women should not be pregnant or lactating;
3 Women who refuse to use a reliable contraceptive method Days 0 to 42 of the study;
4 Confirmed H1N1 infection, as determined by laboratory tests;
5 Have received Oseltamivir or Zanamivir for influenza-like illness since May 2009;
6 Have a household member who had confirmed H1N1 infection, as determined by laboratory tests, and/or received Oseltamivir or Zanamivir for influenza-like illness since May 2009;
7 Receipt of another investigational agent (vaccine or medicinal product) in the preceding 4 weeks;
8 Unwilling to refuse participation in another study during Days 0 to 42 of the study;
9 Any clinically significant concurrent illness or unstable medical condition including: malignant tumours, acute or progressive renal or hepatic pathology, chronic obstructive pulmonary disease requiring oxygen therapy, and any active neurological disorder;
10 Individuals who have had acute respiratory pathology or infections requiring systemic antibiotic or antiviral therapy during the preceding 7 days (chronic antibiotic therapy for prevention of urinary tract infections is acceptable);
11 Subjects who had a temperature >38oC within 3 days of vaccination;
12 Any acute illness at the time of vaccination. Note: minor infections without fever or systemic upset are not contraindications/exclusion criteria;
13 Subjects with known or suspected impairment/alteration of immune function, including:
• receipt of oral immunosuppressive drugs or other drugs listed in section 8 of the British National Formulary (BNF) or chloroquine, gold or penicillamine or other drugs listed in section 10.1.3 of the BNF to suppress a chronic disease process (Note: long-term, inhaled steroids for asthma management is acceptable),
• receipt of immunostimulants or interferon,
• receipt of an immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months of the study;
• Anyone at high risk of developing immunocompromising condition;
• Received radiotherapy or chemotherapy during the 6 months preceding the study;
14 Subjects for whom surgery is planned during Days 0 to 42 of the study;
15 Regularly drink more than 40 units of alcohol weekly;
16 Known or suspected drug abuse (recreational or prescribed);
17 Individuals who, in the opinion of the investigator, have conditions that might complicate interpretation of the study results;
18 Subjects with a history of anaphylaxis or serious reactions to vaccines; known hypersensitivity (other than anaphylactic reaction) to influenza viral protein, to any component of the study vaccines, to products containing mercury and to residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate, sodium deoxycholate, and benzonase).
19 Subjects with a history of any neurological symptoms and signs, or anaphylactic shock following administration of any vaccine;
20 Actual or planned receipt of another vaccine, including seasonal influenza vaccine, during the period 3 weeks before to 3 weeks after vaccination on Days 0 and 21.

E.5 End points

E.5.1

Primary end point(s)

MEASURES OF IMMUNOGENICITY
Immunogenicity will be measured by haemagglutination inhibition (HI), neutralizing antibody (MN) and possibly single radial haemolysis (SRH) antibody responses to influenza H1N1 at each visit.

The principal objective of the study is to evaluate the immunogenicity of each dose of Baxter cell-culture, non-adjuvanted, whole virus H1N1 vaccine, and GSK AS03-adjuvanted, split H1N1 vaccine with respect to Committee of Human Medicinal Products (CHMP) and FDA licensing criteria, i.e., 21 days after the first and second doses.

Immunogenicity will be assessed in terms of the ‘magnitude’ and ‘kinetics’ of the antibody response, and, when appropriate, the ‘breadth’ of the antibody response:

• MAGNITUDE: i.e., measurement of the antibody titres (to the vaccine strain) to one and two 0.5mL intramuscular (IM) doses of Baxter and GSK vaccines (i.e., by comparing (i) mean geometric increases [ratio of day 21 GMT/day 0 GMT and ratio of day 42 GMT/day 0 GMT, by age group and all age groups combined ]; (ii) the seroconversion rate, or significant increases in titre; and (iii) the seroprotection rate;
• KINETICS: i.e., application of the above immunogenicity criteria 7 and 14 days after each dose, after each vaccine type, in each age group, and in all age groups combined;
and
• BREADTH: i.e., application of the above immunogenicity criteria 21 days after each dose, after each vaccine type, in each age group, and in all age groups combined, to any antigenic drift variant that emerges prior to the 2010-2011 influenza season.

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)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

E.8.1.1

Randomised

E.8.1.2

Open

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)

E.8.2.2

Placebo

E.8.2.3

Other

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

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 for completion of the clinical phase of the study, BUT the study will be completed when the laboratory analyses are done.

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

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)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

Yes

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

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

360

F.4.2

For a multinational trial

F.4.2.1

In the EEA

360

F.4.2.2

In the whole clinical trial

360

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)

This is NOT a treatment study, it is a vaccine immnogenicity study. We are not altering treatment or care of anyone who is receiving any medication.

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

2009-10-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-09-21

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2010-10-01

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