E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prophylaxis against Neisseria meningitidis serogroups A, C, W, and Y |
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E.1.1.1 | Medical condition in easily understood language |
Prophylaxis against 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 assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects with hSBA seroresponse1, directed against N meningitidis serogroups A, C, W, and Y. |
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E.2.2 | Secondary objectives of the trial |
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects with hSBA seroresponse1, directed against N meningitidis serogroups A, C, W, and Y by age group (2-10, 11-17, and 18 years and above).
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA geometric mean titers (GMTs) and by the percentage of subjects with hSBA titer ≥ 1:8, directed against N meningitidis serogroups A, C, W, and Y, overall and by age group.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Individuals eligible for enrolment in this study were those
1. who were of any gender, from the age of 2 years and above at the time of visit 1, and to whom the nature of the study was described and:
the parent/legal representative had provided written informed consent (≥2 to <18years of age);
had provided written assent (≥11 to <18 years of age);
had provided written informed consent (≥18 years of age onwards).
2. who the investigator believed that the subject and/or his or her parent/legal representative could and would comply with the requirements of the protocol (eg, completion of the diary card, return for follow-up visit).
3. who were in good health as determined by:
medical history;
physical exam;
clinical judgment of the investigator.
4. who had a negative urine pregnancy test for female subjects from 11 years of age.
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E.4 | Principal exclusion criteria |
Individuals not eligible to be enrolled in the study were those:
1. who were unwilling or unable to give written informed assent or consent to participate
in the study;
2. who were perceived to be unreliable or unavailable for the duration of the study
period;
3. who had a previous confirmed 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 enrolment;
5. who had previously been immunized with a meningococcal vaccine or vaccine
containing meningococcal antigen(s) (licensed or investigational);
6. who were pregnant or breast feeding (female subjects);
7. who had received any investigational or nonregistered product (drug or vaccine)
within 28 days prior to enrolment or who expected to receive an investigational drug
or vaccine prior to the completion of the study;
8. who had received any vaccines within 14 days (for inactivated vaccines) or 28 days
(for live vaccines) prior to enrolment in this study or who were planning to receive
any vaccine within 30 days from the study vaccines (exception: Influenza vaccine may
be administered up to 15 days prior to study vaccination and at least 15 days after
study vaccination);
9. who had experienced within the 7 days prior to enrolment, a significant acute
infection (for example requiring systemic antibiotic treatment or antiviral therapy) or
had experienced fever (defined as body temperature 38°C) within 3 days prior to
enrolment;
10. who had any serious acute, chronic or progressive disease (eg, any history of
neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV infection or
AIDS, or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition) and who had epilepsy or any progressive neurological disease or history
of Guillain-Barre syndrome;
11. who had a history of any anaphylaxis, serious vaccine reactions, or allergy to any
vaccine components including diphtheria toxin (CRM-197) and latex in the syringe;
12. who had 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 enrolment (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
enrolment, or cancer chemotherapy);
- receipt of immunostimulants;
- receipt of parenteral immunoglobulin preparation, blood products, and/or plasma
derivatives within 90 days prior to enrolment and for the full length of the study.
13. who were known to have a bleeding diathesis, or any condition that may be associated
with a prolonged bleeding time. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of subjects with hSBA seroresponse to N meningitidis serogroups A, C, W, and Y. Seroresponse was defined as a postvaccination hSBA ≥ 1:8 in subjects with a prevaccination hSBA < 1:4 and at least a 4-fold increase in postvaccination hSBA in subjects with prevaccination hSBA ≥ 1:4. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Percentage of subjects with hSBA seroresponse to N meningitidis serogroups A, C,
W, and Y stratified by age group (≥2 to ≤10 years, ≥11-≤17 years, 18 years and
above) (seroresponse defined above).
- hSBA GMTs to N meningitidis serogroups A,C,W, and Y, overall and stratified by
age group (≥2-≤10 years, ≥11-≤17 years, 18 years and above).
- Percentage of subjects with hSBA ≥ 1:8 to N meningitidis serogroups A, C, W, and Y,
overall and stratified by age group (≥2-≤10 years, ≥11-≤17 years, 18 years and
above). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
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 | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 29 |