| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Healthy volunteers (active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y or W) |
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| E.1.1.1 | Medical condition in easily understood language |
| Healthy volunteers (active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y or W) |
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| E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10027274 |
| E.1.2 | Term | Meningococcal infection |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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| 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 |
| This Phase III, open-label, randomized, parallel-group, active-controlled, multicenter study is conducted to assess the immunogenicity and safety of a single dose of MenACYW conjugate vaccine when administered alone and in combination with other pediatric vaccines in healthy toddlers in South Korea, the Russian Federation, and Mexico. |
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| E.2.2 | Secondary objectives of the trial |
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| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
•For South Korea: Korean males and females aged 12 to 23 months on the day of the first study visit
•For Mexico: Males and females aged 12 to 23 months on the day of the first study visit
•For the Russian Federation: Males and females aged 12 to 14 months or 16 to 23 months on the day of the first study visit (eligible for enrollment to MenACYW conjugate vaccine group) or 15 to 23 months on the day of the first study visit (eligible for enrollment to the MenACYW conjugate vaccine+PCV13 group or the PCV13 group)
•Participants had received all recommended standard of care vaccinations according to their age as per local regulations*.
•For the Russian Federation only, participants aged 15 to 23 months on the day of the first study visit (eligible for enrollment to MenACYW conjugate vaccine+PCV13 group or the PCV13 group) must not have received the third PCV13 vaccination corresponding to his or her age as per the country's National Immunization Program (NIP). The 2nd dose of PCV13 must have been administered at least 4 weeks before the 3rd dose of PCV13 is administered in the study.
•For South Korea, participants must not have received the MMR or Varicella vaccination corresponding to his or her age at inclusion.
•For Mexico, participants must not have received the DTaP-IPV-HB-Hib vaccination corresponding to his or her age at inclusion.
•Informed consent form has been signed and dated by the parent(s) or guardian if allowed by local regulations (and by independent witnesses if required by local regulations)†.
•Participant and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.
•*Participants must have received the total number of doses expected for each vaccine recommended for his/her age in the respective NIPs, but inclusion of participants with variations in the vaccine administration timeframes is considered acceptable if the total number of doses for the corresponding vaccines have been completed (e.g., in Mexico, 3 infant doses of the pentavalent vaccine must have been administered but the 4th dose due in the 2nd year of life should not have been administered for participants to be included in the trial). For the Russian Federation only, participants that have not received a seasonal flu vaccination from 6 months of age according to the Russian NIP are still eligible to participate in this study.
•†In the Russian Federation, as per local regulations, only the participant's parent(s) are entitled to sign an informed consent form. A child under the responsibility of a guardian will not be included in the study.
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| E.4 | Principal exclusion criteria |
•Participation in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
•Receipt of any vaccine in the 4 weeks (28 days) preceding the first trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which may be received at least 2 weeks before or after the study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
•Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B vaccine).
•For participants enrolled at sites in the Russian Federation: previous vaccination with the third dose of PCV13 in participants 15 to 23 months of age (eligible for MenACYW conjugate vaccine+PCV13 group or the PCV13)
•For participants enrolled at sites in Mexico: known history of seizures, or uncontrolled neurologic disorder (including epilepsy); or encephalopathy of unknown etiology occurring within 7 days following previous vaccination with pertussis containing vaccine; previous vaccination with DTaP-IPV-HB-Hib or DTaP-containing vaccine at 12 to 23 months of age
•For participants enrolled at sites in South Korea: known history of seizures, cerebral injury, or encephalopathy; previous vaccination with MMR or Varicella at 12 to 23 months of age
•Receipt of immune globulins, blood or blood-derived products in the past 3 months
•Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
•History of meningococcal infection, confirmed either clinically, serologically, or microbiologically
•At high risk for meningococcal infection during the trial, according to the Investigator's judgment (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or subjects traveling to countries with high endemic or epidemic disease)
•Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
•Verbal report of thrombocytopenia, as reported by the parent/guardian, contraindicating intramuscular vaccination by the Investigator's judgment
•Known bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination by the Investigator's judgment
•Personal history of Guillain-Barré syndrome (GBS)
•Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine
•Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
•For participants enrolled at sites in South Korea or Mexico: Moderate or severe acute illness/infection (according to investigator's judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
•For participants enrolled at sites in the Russian Federation: Acute disease of any severity on the day of vaccination or febrile illness (axillary temperature ≥ 37.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
•Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
•Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
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| E.5 End points |
| E.5.1 | Primary end point(s) |
1.Antibody titers against meningococcal serogroups A, C, Y, and W measured by serum bactericidal assay using human complement in participants receiving MenACYW conjugate vaccine alone or in combination with other pediatric vaccines.
Antibody titers against meningococcal serogroups A, C, Y, and W are assessed on Day 0 and Day 30 post vaccination with either MenACYW conjugate vaccine alone in combination with other pediatric vaccines. |
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Day 0 and Day 30 post-vaccination |
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| E.5.2 | Secondary end point(s) |
1.Antibody responses to antigens in the MMR (measles, mumps, and rubella) vaccine
Antibodies to antigens in the MMR vaccine are assessed on Day 0 and Day 30 post-vaccination with either MenACYW conjugate vaccine alone in combination with MMR vaccine.
2.Anti-Varicella antibody concentrations following vaccination with the Varicella vaccine
Anti-Varicella antibody concentrations are assessed on Day 0 and Day 30 post-vaccination with either MenACYW conjugate vaccine alone in combination with Varicella vaccine.
3.Antibody responses to antigens (tetanus and acellular pertussis [pertussis toxoid {PT} and filamentous hemagglutinin {FHA}) in the DTaP-IPV-HB-Hib vaccine
Antibody responses to antigens (tetanus and acellular pertussis) are assessed on Day 0 and Day 30 post-vaccination with either MenACYW conjugate vaccine alone in combination with DTaP-IPV-HB-HiB vaccine.
4.Antibody responses to diphtheria, inactivated poliomyelitis, hepatitis B, and Haemophilus influenzae antigens in the DTaP-IPV-HB-Hib vaccine
Antibody responses to diphtheria, inactivated poliomyelitis, hepatitis B, and Haemophilus influenzae antigens are assessed on Day 0 and Day 30 post-vaccination with either MenACYW conjugate vaccine alone in combination with DTaP-IPV-HB-Hib vaccine.
5.Anti-pneumococcal antibody concentrations for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F in the PCV13 vaccine [
Anti-pneumococcal antibody concentrations for serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F are assessed on Day 0 and Day 30 post-vaccination with either MenACYW conjugate vaccine alone in combination with PCV13 vaccine.
6.Solicited injection site and systemic reactions, unsolicited adverse events, and serious events in participants receiving MenACYW conjugate vaccine alone or in combination with other pediatric vaccines
Solicited injection site and systemic reactions (Day 0 up to Day 7), unsolicited adverse events and serious adverse events (Day 0 up to Day 30 post-vaccination) are reported.
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Day 0 and Day 30 post-vaccination
2. Day 0 and Day 30 post-vaccination
3. Day 0 and Day 30 post-vaccination
4. Day 0 and Day 30 post-vaccination
5. Day 0 and Day 30 post-vaccination
6. Day 0 up to Day 30 post-vaccination |
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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 | Yes |
| E.8.1.1 | Randomised | Yes |
| 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 | Yes |
| 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 | 9 |
| 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 |
| Korea, Republic of |
| Mexico |
| Russian Federation |
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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 | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 7 |
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