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 serogroups A, C, W and Y. |
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E.1.1.1 | Medical condition in easily understood language |
Novartis Meningococcal ACWY conjugate vaccine is intended for prevention of meningitis and septicemia caused by Neisseria meningitidis serogroups A, C, W and Y. |
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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 evaluate the immunity against meningococcal serogroups A, C, W-135 and Y at
21 months, 3 years, and 5 years after vaccination with either Novartis MenACWY
Conjugate Vaccine or Menactra® in study V59P13 in terms of percentage of subjects
with human SBA (hSBA) titers ≥ 1:8 directed against N meningitidis serogroups A,
C, W-135, and Y. |
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E.2.2 | Secondary objectives of the trial |
1. To evaluate the immunity against meningococcal serogroups A, C, W-135 and Y at
21 months, 3 years, and 5 years after vaccination with either MenACWY Vaccine or Menactra in study V59P13 in terms of percentage of subjects
with hSBA titers ≥ 1:4 and hSBA GMTs directed against N
meningitidis serogroups A, C, W-135, and Y.
2. To evaluate the immunity against meningococcal serogroups A, C, W-135, Y of
age-matched adolescents with no previous meningococcal vaccination in terms of
percentage of subjects with hSBA titer ≥ 1:4, percentage of subjects with hSBA
titer ≥ 1:8 and hSBA GMTs directed against N meningitidis serogroups A, C, W-135,
and Y.
3. To evaluate the antibody response at 1 month after one dose of MenACWY in
subjects who had previously received one dose of Menactra or MenACWY vaccine.
4. To evaluate the persistence of the antibody response at 2 years after one dose of
MenACWY in subjects who had previously received one dose of Menactra or
MenACWY vaccine. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy naive male and female individuals were recruited from the local communities and
were age-matched with those who previously participated in V59P13 study.
Healthy follow-on male and female subjects who previously completed the V59P13 study
protocol and were 11 through 18 years of age inclusive at the time of the enrollment into
the V59P13 study were recruited into this extension study. |
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E.4 | Principal exclusion criteria |
Naive individuals not eligible to be enrolled in the study were those:
▫ Who were unwilling or unable to give written informed assent or consent to participate in the study;
▫ Who had a previous or suspected disease caused by N meningitidis;
▫ Who had household contact with and/or intimate exposure to an individual with
culture-proven N meningitidis infection within 60 days prior to enrollment;
▫ Who had previously been immunized with a meningococcal vaccine or
vaccine containing meningococcal antigen(s) (licensed or investigational)
(Exception: Receipt of Outer Membrane Particle (OMP)-containing Hemophilus influenza B (Hib) vaccines was permitted);
▫ Who had prior military service;
▫ Who had received any investigational agents or vaccines within 90 days prior to
enrollment or who expected to receive an investigational agent or vaccine prior to the
completion of the study;
▫ Who had received any licensed vaccines within one month prior to enrollment
(Exception: Influenza vaccine may have been administered up to 15 days prior to
enrollment);
▫ Who had received a live viral vaccine within 60 days prior to enrollment;
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. 21 months, 3 years and 5 years postvaccination |
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E.5.2 | Secondary end point(s) |
1. Percentages of Subjects With hSBA Titers≥ 1:4 (persistence analyses)
2. Percentages of Subjects With hSBA Titers≥ 1:8 (persistence analyses)
3. hSBA Geometric Mean Titers (GMTs) (persistence analyses)
4. Percentages of Subjects With hSBA Titers≥ 1:4 (booster analyses)
5. Percentages of Subjects With hSBA Titers≥ 1:8 (booster analyses)
6. hSBA Geometric Mean Titers (GMTs) (booster analyses)
7. Number of Subjects Reporting Solicited Local and Systemic Adverse
8. Number of Subjects With New Medical Diagnoses of Chronic Dieases
9. Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. 21 months, 3 years and 5 years postvaccination; prior to vaccination for naive subjects
2. 21 months, 3 years and 5 years postvaccination; prior to vaccination for naive subjects
3. 21 months, 3 years and 5 years postvaccination; prior to vaccination for naive subjects
4. before and 1 month after booster dose
5. before and 1 month after booster dose
6. before and 1 month after booster dose
7. Day 1 to 7 after vaccination
8. End of parent study V59P13 (Day 180) to 5 years after primary vaccination
9. 28 days postvaccination
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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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Licensed meningococcal vaccine (Menactra) |
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E.8.2.4 | Number of treatment arms in the trial | 5 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
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 |
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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 | 45 |