| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Healthy volunteers (meningococcal infection) |
|
| E.1.1.1 | Medical condition in easily understood language |
| Invasive meningococcal disease (IMD) |
|
| 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 |
|
| 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 |
1 - To describe the antibody titers to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW conjugate vaccine or Menveo® measured by serum bactericidal assay using human complement (hSBA), for Groups 1 and 2 when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico
2 - To describe the antibody titers to the antigens (meningococcal serogroups A, C, Y, and W) present in MenACYW conjugate vaccine measured by hSBA, for Group 3, when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in the Russian Federation |
|
| E.2.2 | Secondary objectives of the trial |
1 - To describe the hSBA vaccine seroresponse to the antigens (meningococcal serogroups A, C, Y, and W) for Groups 1 and 2, 30 days after the last vaccination of the infant series (Dose 2 of MenACYW conjugate vaccine and Dose 3 of Menveo®), when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in Mexico
2 - To describe the hSBA vaccine seroresponse to the antigens (meningococcal serogroups A, C, Y, and W) for Group 3, 30 days after the last vaccination of the infant series (Dose 2 of MenACYW conjugate vaccine), when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in the Russian Federation |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
- Infants 2 months of age (60 to 89 days of age) on the day of the first study visit.*
- Born after a full-term pregnancy, with an estimated gestation age ≥ 37 weeks and a birth weight ≥ 2.5 kg.
- Informed consent form has been signed and dated by the parent(s) or guardian(s), as required by local regulations.†
- Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.
- In good health as determined by medical history and physical assessment.
- For the Russian Federation: The subject’s parents are able to verbally report or provide written documentation that the subject’s mother was hepatitis B antigennegative during pregnancy with the subject.
* "2 months” means from the 2nd month after birth to the day before the 3rd month after birth (2 months to 2 months 29 days); “60 days” means from the 60th day after birth to the day before the 90th day after birth (60 to 89 days).
†In the Russian Federation, as per local regulations, only the subject’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 |
|
| E.4 | Principal exclusion criteria |
An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
- Participation at the time of study enrollment or 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 preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks before and/or following any trial vaccination except for influenza vaccination, which may be received at a gap of at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
- Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (ie, meningitis polysaccharide or meningitis conjugate vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine).
- Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b (Hib), poliovirus, rotavirus, Streptococcus pneumoniae, measles, mumps, rubella, and / or varicella.
- For Mexico: More than 1 previous dose of hepatitis B vaccine.
- Receipt of immune globulins, blood or blood-derived products since birth.
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth.
- Family history of congenital or hereditary immunodeficiency until the immune competence of the potential vaccine recipient is demonstrated.
- Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
- Individuals with active tuberculosis.
- History of any Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically.
- History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, hepatitis A, measles, mumps, rubella, Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection / disease.
- At high risk for meningococcal infection during the trial (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects traveling to countries with high endemic or epidemic disease)
- History of intussusception.
- History of any neurologic disorders, including seizures (febrile and non-febrile) and progressive neurologic disorders.
- History of Guillain-Barré syndrome.
- Known systemic hypersensitivity to any of the vaccine components or to latex, or history of a lifethreatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances, including neomycin, gelatin, and yeast.
- Verbal report of thrombocytopenia contraindicating intramuscular vaccination in the Investigator’s opinion.
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator’s opinion.
- Receipt of oral or injectable antibiotic therapy within 72 hours of the first blood draw.
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
- Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
- Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C*). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
*For the Russian Federation, febrile illness is defined as temperature ≥ 37°C. A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided. |
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| E.5 End points |
| E.5.1 | Primary end point(s) |
Antibody titers against meningococcal serogroups A, C, Y, and W ; Titers are measured by serum bactericidal assay using human complement (hSBA),and expressed as geometric mean titers (GMTs) :
1 - Meningococcal serogroups A, C, Y, and W antibody titers ≥1:8 measured by hSBA, assessed at 30 days after the last vaccination in the second year of life with MenACYW conjugate vaccine or Menveo® in Mexico (Group 1 versus [vs] Group 2)
2 - Meningococcal serogroups A, C, Y, and W antibody titers ≥1:8 measured by hSBA assessed at 30 days after the last vaccination in the second year of life with MenACYW conjugate vaccine in the Russian Federation (Group 3) |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Before the first vaccination and 30 days after the last vaccination in second year of life (Dose 3 of MenACYW conjugate vaccine and Dose 4 of Menveo®) |
|
| E.5.2 | Secondary end point(s) |
1 - Antibody titers against meningococcal serogroups A, C, Y, and W after infant series vaccination :
- Meningococcal serogroups A, C, Y, and W antibody titers measured by hSBA, before the first vaccination (Visit 1) and 30 days after the last vaccination of the
infant series with MenACYW conjugate vaccine or Menveo® (Dose 2 of MenACYW conjugate vaccine and Dose 3 of Menveo®) in Mexico (Group 1 vs Group
2)
-Meningococcal serogroups A, C, Y, and W antibody titers measured by hSBA, before the first vaccination (Visit 1) and 30 days after the last vaccination of the
infant series with MenACYW conj
2 - Solicited injection site reactions and systemic reactions ; Injection site reactions: pain, erythema, and swelling; Systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 : Before the first vaccination and 30 days after the last vaccination of the infant series (Dose 2 of MenACYW conjugate vaccine and Dose 3 of Menveo®)
2 : Within 7 days after any injection |
|
| 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) | 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 | 4 |
| 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 |
| Mexico |
| Russian Federation |
|
| 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 | 3 |
| E.8.9.2 | In all countries concerned by the trial months | 5 |
| E.8.9.2 | In all countries concerned by the trial days | 20 |
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