E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Novartis Meningococcal ACWY Conjugate Vaccine is intended for prevention of meningitis and septicemia caused by Neisseria meningitidis A, C, W-135 and Y. |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the immunogenicity of a single injection of Novartis MenACWY conjugate vaccine with the immunogenicity of a single injection of PS vaccine (Menomune), defined as the percentage of subjects with seroresponse in human serum bactericidal assay against N meningitidis serogroups A, C, W135, and Y at 1 month after vaccination, when administered to healthy children 2 to 10 years of age.
To compare the percentage of subjects presenting at least one severe (solicited) systemic reaction to the Novartis MenACWY conjugate vaccine with the percentage presenting at least one severe systemic reaction to the licensed meningococcal ACWY polysaccharide (PS) vaccine (Menomune) during the first 7 days (day 1 to 7) following a single injection administered to healthy children 2 to 10 years of age. |
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E.2.2 | Secondary objectives of the trial |
To compare the immunogenicity of a single injection of Novartis MenACWY conjugate vaccine and the immunogenicity of a single injection of PS vaccine (Menomune), defined as: percentage of subjects with hSBA ≥ 1:4, percentage of subjects with hSBA ≥ 1:8, and hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W135, and Y at 1 month after vaccination, when administered to healthy children 2 to 10 years of age.
To compare the immunogenicity of a single injection of Novartis MenACWY conjugate vaccine and the immunogenicity of a single injection of PS vaccine (Menomune), defined as: percentage of subjects with hSBA ≥ 1:8, percentage of subjects with hSBA ≥ 1:4, and hSBA GMTs against N meningitidis serogroups A, C, W135, and Y at day 181 after vaccination, when administered to healthy children 2 to 10 years of age.
To describe and compare immediate hypersensitivity reactions; solicited adverse events (AEs), axillary temperature, AEs, and serious AEs. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. 2-10 years of age inclusive whose parents or legal guardians have given written informed consent at the time of enrollment;
2. available for all visits and telephone calls (parents or legal guardians) scheduled for the study;
3. in good health as determined by:
• medical history,
• physical assessment,
• clinical judgment of the investigator;
4. up to date with primary course and booster vaccines [BCG, and 4 doses of diphtheria-tetanus-pertussis vaccine (DTP), oral polio vaccine (OPV) or inactivated polio vaccine (IPV), H. influenzae type b vaccine (Hib), measles-mumps-rubella vaccine (MMR) and hepatitis A or B,
according to the Argentinean vaccine calendar and subject age]. |
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E.4 | Principal exclusion criteria |
1. whose parent or legal guardian is unwilling or unable to give written informed consent to participate in the study;
2. whose parent or legal guardian is perceived to be unreliable or unavailable for the duration of the study period;
3. who had a previous or suspected disease caused by N. meningitidis;
4. who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment;
5. who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational);
6. who have received any investigational agents or vaccines within 90 days prior to enrollment or who expect to receive an investigational agent or vaccine prior to the completion of the study;
7. who have received any licensed vaccines within one month prior to enrollment or for whom receipt of a licensed vaccine is anticipated within one month after vaccination (Exception: Influenza vaccine may be administered up to 15 days prior to study vaccination and no less
than 15 days after study vaccination);
8. who have received a live viral vaccine within 60 days prior to enrollment;
9. who have experienced, within the 7 days prior to enrollment, significant acute or chronic infection (for example requiring systemic antibiotic treatment or antiviral therapy) or have experienced fever (defined as axillary temperature ≥38°C) within 3 days prior to
enrollment;
10. who have any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS), or blood dyscrasias, with signs
of cardiac or renal failure or severe malnutrition). (Exception: Subjects with mild asthma are eligible for enrollment. Subjects with moderate or severe asthma requiring routine use of inhaled or systemic
corticosteroids are not eligible for enrollment);
11. who have epilepsy or any progressive neurological disease;
12. who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component;
13. who have a known or suspected impairment/alteration of immune
function, either congenital or acquired or resulting from (for example):
• receipt of immunosuppressive therapy within 30 days prior to enrollment (any systemic corticosteroid administered for more than 5 days, or in a daily dose >1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy),
• receipt of immunostimulants,
• receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study,
• Common childhood exanthematous diseases (varicella, mumps, measles, rubella) occurring 6 weeks prior to vaccination;
14. who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
15. who have Down's syndrome or other known cytogenic disorders;
16. whose families are planning to leave the area of the study site before the end of the study period;
17. who have any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
2. Percentage of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1) 1 month after vaccination
2) Day 1 to 7 post vaccination |
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E.5.2 | Secondary end point(s) |
1) Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
2) The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
3) Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
4) The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
5) Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) Day 1 and 29
2) Day 1 and 29
3) Day 181
4) Day 181
5) Day 1 to 7 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Meningococcal ACWY polysaccharide vaccine |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| Yes |
E.8.4 | Will this trial be conducted at multiple sites globally? | No |
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 |
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E.8.7 | Trial has a data monitoring committee | No |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 27 |