E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To prevent Meningococcal meningitis and sepsis caused by Neisseria meningitidis.
|
|
E.1.1.1 | Medical condition in easily understood language |
|
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 antibody response to the third dose of one of the four different MenABCWY vaccine formulations or rMenB vaccine alone in subjects who previously received the same study vaccine in study V102_02. |
|
E.2.2 | Secondary objectives of the trial |
1.To evaluate the antibody response to three doses of one of the four different MenABCWY vaccine formulations or rMenB vaccine alone in subjects who participated in study V102_02.
2. To evaluate the antibody persistence at 4 (Month 6), 5 (Month 7) and 10 (Month 12) months after two doses of one of the four different MenABCWY vaccine formulations, rMenB vaccine alone, or MenACWY vaccine alone in subjects who participated in study V102_02.
3. To evaluate the antibody persistence at 6 months after a third dose of one of the four different MenABCWY vaccine formulations or rMenB vaccine alone in subjects whoparticipated in study V102_02.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.who were 11 to 18 years at the time of enrollment in primary study
2. who had given their written consent at the time of enrollment
3. who were available for all the visits scheduled in the study (ie, not planning to leave the area before the end of the study period)
4. who were in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
|
|
E.4 | Principal exclusion criteria |
1.History of any meningococcal vaccine administration
2. Current or previous, confirmed or suspected disease caused by N meningitidis
3. Household contact with and/or intimate exposure to an individual with any laboratory confirmed N.meningitidis infection within 60 days of enrollment
4. Significant acute or chronic infection within the previous 7 days or fever within the previous 3 days
5. Antibiotics within 7 days prior to enrollment or blood draw
6. Pregnancy or nursing (breastfeeding) mothers
7. Females of childbearing age who had not used or did not plan to use acceptable birth control measures, for the duration of the study. Oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide); intrauterine device or sexual abstinence was considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control
methods at least two months prior to study entry
8. Any serious chronic or progressive disease (eg, neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, human immunodeficiency virus infection or acquired immunodeficiency syndrome, blood dyscrasias, bleeding diathesis, signs of cardiac or renal failure or severe malnutrition).
9. Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, including use of corticosteroids in immunosuppressive doses or chronic use of inhaled high-potency corticosteroids or immunostimulants within the previous 60 days. Use of topical corticosteroids administered during the
study in limited areas (ie, eczema on knees or face or elbows) of the body was allowed
10. Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days
11. History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component
12. Individuals who received any other vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study or who were planning to receive any vaccine within 4 weeks from the study vaccines.
13. Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or had intent to participate in another clinical study at any time during the conduct of this study.
14. Individuals who were part of study personnel or close family members conducting this study.
15. Individuals with medical history or any illness that, in the opinion of the investigator, might interfere with the results of the study or posed additional risk to the subjects due to participation in the study. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Percentages of Subjects With hSBA ≥1:8 Against Serogroups A, C, W and Y at One Month After the Third Vaccination With Either One of Four MenABCWY Formulations, rMenB or MenACWY/Placebo |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1.Percentages of Subjects With hSBA ≥1:5 Against Serogroup B Test Strains
2.Geometric Mean Titers (GMT) at One Month After the Third Vaccination
3.Geometric Mean Ratio (GMR) for (95%CI) at One Month After the Third Vaccination
4.Antibody response was measured as Geometric Mean hSBA Titers and one month after third vaccination
5.Antibody response was measured as Geometric Mean Ratio (95% CI), One Month After the Third Vaccination
6.Antibody response was measured as the percentage of subjects after pre and post vaccination at month 6 and after the third vaccination
7.Antibody response was measured as the percentage of subjects with 4-fold Increase in hSBA titers at One Month After Third Vaccination
8.Antibody response was measured as Geometric Mean hSBA Titers after the third vaccination (month 7) and 6 month after the third vaccination (month 12)
9.Antibody response was measured as Geometric Mean Ratios (95%CI) Against N meningitidis Serogroups A, C, W and Y after the third vaccination (month 7) and 6 month after the third vaccination (month 12)
10.Antibody response was measured as Geometric Mean hSBA Titers after Third Vaccination (month 7) and 6 month after the third vaccination (month 12)
11.Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup B Test Strains after the third vaccination (month 7) and 6 month after the third vaccination (month 12)
12.Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup A, C, W, Y Test Strains after the third vaccination (month 7) and 6 month after the third vaccination (month 12)
13.Antibody response was measured as Geometric Mean Ratios (95%CI) Against Serogroup A, C, W, Y Test Strains after the third vaccination (month 7) and 6 month after the third vaccination (month 12)
14.Antibody response was measured as Geometric Mean hSBA Titers Against Serogroup B Test Strains after the third vaccination (month 7) and 6 month after the third vaccination (month 12)
15.GMR Against Serogroup B Test Strains at Month 0 Through Month 12 Following Vaccination at Month 0, 2 and 6
16.Unsolicited AEs were collected with onset from Day 1 through Day 7 After Vaccination
17.Unsolicited AEs were collected from Day 8 After vaccination Through Study Termination
18.Solicited local and systemic AEs were collected daily for 7 days (day 1 through day 7) after vaccination
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
hSBA Titers:At month 6 and month 7
GMR and GMT:At month 1, 3, 6, 7 and 12
Unsolicated AE:Day 8 After vaccination Through Study Termination, up to 6 months
Solicated AE:Day 1 to Day 7 after vaccination
|
|
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 | Yes |
E.6.13.1 | Other scope of the trial description |
|
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.1.4 | Double blind | Yes |
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 | No |
E.8.2.4 | Number of treatment arms in the trial | 11 |
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 |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 1 |
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 | 13 |