Clinical Trial Page

Summary
EudraCT Number:2004-000195-13
Sponsor's Protocol Code Number:V59P5
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:2005-02-11
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
A. Protocol Information
A.1Member State ConcernedUK - MHRA
A.2EudraCT number2004-000195-13
A.3Full title of the trial
A Phase II, Randomized, Open label, Controlled, Multicenter Study to Evaluate the Safety, Immunogenicity and Induction of Immunological Memory after Two or Three Doses of Novartis Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants at 2, 3, 4 or 2, 4, 6 Months of Age
A.4.1Sponsor's protocol code numberV59P5
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorNovartis Vaccines and Diagnostics
B.1.3.4CountryItaly
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameNovartis Meningococcal ACWY Conjugate Vaccine
D.3.4Pharmaceutical form Powder and solvent for suspension for injection
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPIntramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3Other descriptive nameMeningococcal group A oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein
D.3.10 Strength
D.3.10.3Concentration number10 µg/dose- 0.5mL
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3Other descriptive nameMeningococcal group C oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein
D.3.10 Strength
D.3.10.2Concentration typeequal
D.3.10.3Concentration number5 µg/dose -0.5 mL
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3Other descriptive nameMeningococcal group W-135 oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein
D.3.10 Strength
D.3.10.2Concentration typeequal
D.3.10.3Concentration number5 µg/dose -0.5 mL
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3Other descriptive nameMeningococcal group Y oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein (Men
D.3.10 Strength
D.3.10.2Concentration typeequal
D.3.10.3Concentration number5 µg/dose -0.5 mL
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Information not present in EudraCT
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
D.3.11.3.2Gene therapy medical product Information not present in EudraCT
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
D.3.11.11Herbal medicinal product Information not present in EudraCT
D.3.11.12Homeopathic medicinal product Information not present in EudraCT
D.3.11.13Another type of medicinal product Information not present in EudraCT
D.IMP: 2
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameMenomune
D.3.4Pharmaceutical form Powder and solvent for solution for injection
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPSubcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3Other descriptive namepolysaccharide antigens from Neisseria meningitidis, Group A
D.3.10 Strength
D.3.10.2Concentration typeequal
D.3.10.3Concentration number50 µg/dose -0.5mL
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3Other descriptive namepolysaccharide antigens from Neisseria meningitidis, Group C
D.3.10 Strength
D.3.10.3Concentration number50 µg/dose-0.5 mL
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3Other descriptive namepolysaccharide antigens from Neisseria meningitidis, Group W
D.3.10 Strength
D.3.10.3Concentration number50 µg/dose-0.5 mL
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3Other descriptive namepolysaccharide antigens from Neisseria meningitidis, Group Y
D.3.10 Strength
D.3.10.3Concentration number50 µg/dose-0.5 mL
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 3
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameMenjugate
D.3.4Pharmaceutical form Powder and solvent for suspension for injection
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPIntramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3Other descriptive nameMeningococcal group C oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein
D.3.10 Strength
D.3.10.3Concentration number10 µg/dose-0.5 mL
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
D.3.11.7Plasma derived medicinal product Information not present in EudraCT
D.3.11.8Extractive medicinal product Information not present in EudraCT
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product Information not present in EudraCT
D.8 Information on Placebo
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Prevention of invasive disease caused by Neisseria Meningitidis serogroup A, C, W-135 and Y
MedDRA Classification
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
Immunogenicity Objectives
To assess the immunogenicity of three doses of Chiron Men ACWY conjugate vaccine given at 2, 3, 4 or 2, 4, 6 months of age, as measured by the percentage of subjects with hSBA greater than 1:4 (i.e., the percent response), against N. meningitidis serogroups A, C, W and Y
Safety Objectives
To evaluate the safety and tolerability of Chiron Men ACWY conjugate vaccine when given concomitantly with other licensed pediatric vaccines at 2, 3, 4 or 2, 4, 6 months of age
To evaluate the safety and tolerability of Chiron Men ACWY conjugate vaccine when given concomitantly with other licensed pediatric vaccines at 12 months of age
E.2.2Secondary objectives of the trial
·To assess the immunogenicity of three doses of Chiron Men ACWY conjugate vaccine given at 2, 3, 4 or 2, 4, 6 months of age, as measured by hSBA geometric mean titer (GMT), against N. meningitidis serogroups A, C, W and Y
To assess the immunogenicity of two doses of Chiron Men ACWY conjugate vaccine given at 2 and 4 months of age, as measured by hSBA GMT and percent response, against N. meningitidis serogroups A, C, W and Y
To assess the immunogenicity of a booster dose of Chiron Men ACWY conjugate vaccine given at 12 months of age in a subset of subjects receiving the two dose regimen, as measured by hSBA GMT and percent response, against N. meningitidis serogroups A, C, W and Y
E.2.3Trial contains a sub-study Information not present in EudraCT
E.3Principal inclusion criteria
1.healthy 2-month old infants (55-89 days, inclusive), who were born after full term pregnancy with an estimated gestational age ≥ 37 weeks and a birth weight ≥ 2.5 kg;
2.for whom a parent/legal guardian has given written informed consent after the nature of the study has been explained;
3.available for all the visits scheduled in the study;
4. in good health as determined by:·medical history,·physical examination and clinical judgment of the investigator
E.4Principal exclusion criteria
1. who previously received any meningococcal vaccine;
2.who received prior vaccination with D, T, P (acellular or whole cell), IPV or OPV, HBV, H. influenzae type b (Hib) or Pneumococcus;
3. who have a previous ascertained or suspected disease caused by N. meningitidis, C. diphtheriae, C. tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B. pertussis (history of laboratory confirmed, or clinical condition of spasmodic cough for a period longer than or equal to 2 weeks associated with apnea or whooping);
4. who have a history of any anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
5. who have experienced significant acute or chronic infection within the previous 7 days or have experienced fever (³38.0°C) within the previous 3 days;
6. who have any present or suspected serious acute (e.g. leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac, renal failure, or severe malnutrition or insulin dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down’s syndrome);
7. who have a known or suspected autoimmune disease or impairment /alteration of immune function resulting from (for example):a)receipt of any immunosuppressive therapy since birthb)receipt of immunostimulants since birthc)receipt of any sytemic corticosteroid since birth
8. who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation;
9. with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
10. who have taken systemic antibiotics (either oral or parenteral) within the previous 14 days (EXCEPTION: subjects who have received an oral or parenteral β-lactam antibiotic [examples: penicillin, amoxicillin, ceftriaxone, cefuroxime, cephalexin, etc.] may be enrolled 7 days following the last dose);
E.5 End points
E.5.1Primary end point(s)
Immunogenicity of the investigational vaccine after a full vaccination course (3 doses according to the UK vaccination schedule) as measured by the % of subject with hSBA≥1:4
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis Information not present in EudraCT
E.6.2Prophylaxis Yes
E.6.3Therapy Information not present in EudraCT
E.6.4Safety Yes
E.6.5Efficacy Information not present in EudraCT
E.6.6Pharmacokinetic Information not present in EudraCT
E.6.7Pharmacodynamic Information not present in EudraCT
E.6.8Bioequivalence Information not present in EudraCT
E.6.9Dose response Information not present in EudraCT
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic Information not present in EudraCT
E.6.12Pharmacoeconomic Information not present in EudraCT
E.6.13Others Yes
E.6.13.1Other scope of the trial description
immunogenicity as surrogate marker of efficacy
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) Information not present in EudraCT
E.7.1.1First administration to humans Information not present in EudraCT
E.7.1.2Bioequivalence study Information not present in EudraCT
E.7.1.3Other Information not present in EudraCT
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) Yes
E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group No
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Yes
E.8.2.2Placebo Information not present in EudraCT
E.8.2.3Other Information not present in EudraCT
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.5The trial involves multiple Member States No
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Yes
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
E.8.7Trial has a data monitoring committee Information not present in EudraCT
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
6 months follow up (phone contact) for serious adverse events of the last subject enrolled
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years
E.8.9.1In the Member State concerned months21
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial months21
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 Yes
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) Yes
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) No
F.1.3Elderly (>=65 years) No
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers Yes
F.3.2Patients No
F.3.3Specific vulnerable populations Information not present in EudraCT
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally Yes
F.3.3.6.1Details of subjects incapable of giving consent
infants
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state225
F.4.2 For a multinational trial
F.4.2.1In the EEA 225
F.4.2.2In the whole clinical trial 405
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)
Adverse event follow up until resolution
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2004-06-11
N.Ethics Committee Opinion of the trial application
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2006-10-02

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Medical Conditions

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