Meningococcal Infection, Healthy Volunteers
Conditions
Brief summary
This is a Phase 3, modified double-blind, randomized, parallel-group, active-controlled, multicenter study with 2 arms and 4 groups to evaluate the immunogenicity and safety of MenACYW conjugate vaccine in children and adolescents versus control meningococcal vaccines licensed in China. Study details include: * The study duration will be approximately 180 days. * The vaccination visit will be Visit 1. * The visit frequency will be 2 on-site visits with a 30-day interval. A safety visit/telephone call is planned on the ninth day after the vaccination for all groups; a safety follow-up telephone call is planned for all groups 180 days post the last vaccination.
Detailed description
The duration of each participant's participation will be approximately 180 days.
Interventions
BIOLOGICALMenACYW conjugate vaccine
Pharmaceutical form:Liquid solution-Route of administration:Intramuscular (IM) injection
BIOLOGICALMenACYW135 polysaccharide vaccine
Pharmaceutical form: Lyophilized powder-Route of administration:IM injection
BIOLOGICALMenAC conjugate vaccine
Pharmaceutical form:Lyophilized powder-Route of administration:IM injection
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Investigators and study staff as well as Sponsor study staff who conduct the safety assessment and the participant/parent/LAR will not know which study intervention is administered. Only the study staff who prepare and administer the study intervention and are not involved with the safety evaluation will know which study intervention is administered.
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* For Cohort I: Aged 7 to 17 years on the day of inclusion ("7 to 17 years" means from the day of the 7th birthday to the day before the 18th birthday.). For Cohort II: Aged 2 to 6 years on the day of inclusion (2 to 6 years" means from the day of the 2nd birthday to the day before the 7th birthday.) * Participants who are healthy as determined by medical evaluation including medical history and physical examination. * A female participant is eligible to participate if she is not pregnant or breastfeeding
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply: * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy; or long-term systemic corticosteroid therapy * History of meningococcal infection * History of any neurologic disorders * History of Guillain-Barré syndrome * History of an Arthus-type hypersensitivity reaction after a previous dose of tetanus toxoid-containing vaccine * At high risk for meningococcal infection during the trial * Known systemic hypersensitivity to any of the vaccine components * Self-reported thrombocytopenia, contraindicating intramuscular vaccination. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination. * Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion. * Moderate or severe acute illness/infection * Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion. * Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination. * The time since last vaccination of meningococcal vaccine was 2 years or less. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W | Day 01 (pre-vaccination) and Day 31 (post- vaccination) | 30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days postvaccination for participants with pre vaccination rSBA titer ≥1:8 |
| Participants 7 through 17 years of age (Cohort I): Geometric mean titers (GMTs) of antibodies against meningococcal serogroups A, C, Y, and W | Day 31 (post- vaccination) | Antibodies titers are expressed as geometric mean titers |
| Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups W and Y will be assessed in participants receiving MenACYW conjugate vaccine | Day 01 (pre-vaccination) and Day 31 (post- vaccination) | 30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days post-vaccination for participants with pre vaccination rSBA titer ≥1:8 |
| Participants 2 through 6 years of age (Cohort II): Vaccine seroresponse to meningococcal serogroups A and C | Day 01 (pre-vaccination) and Day 31 (post- vaccination) | 30 days postvaccination rSBA titer ≥1:8 for participants with prevaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days postvaccination for participants with pre vaccination rSBA titer ≥1:8 |
| Participants 2 through 6 years of age (Cohort II): Geometric mean titers (GMTs) of antibodies against meningococcal serogroups A and C | Day 01 (pre-vaccination) and Day 31 (post- vaccination) | Antibody titers are expressed as geometric mean titers |
| Participants 2 through 6 years of age (Cohort II): Vaccine seroresponse to meningococcal serogroups W and Y in participants receiving MenACYW conjugate vaccine | Day 01 (pre-vaccination) and Day 31 (post- vaccination) | 30 days post-vaccination rSBA titer ≥1:8 for participants with pre-vaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30◦days post-vaccination for participants with pre vaccination rSBA titer ≥1:8 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants 7 through 17 years of age (Cohort I): Vaccine seroresponse to meningococcal serogroups A, C, Y, and W (Group 1) | Day 01 (pre-vaccination) and Day 31 (post- vaccination) | 30 days post vaccination rSBA titer ≥1:8 for participants with pre vaccination rSBA titer \<1:8, or At least 4-fold increase in rSBA titer from pre- to 30 days post vaccination for participants with pre vaccination rSBA titer ≥1:8 |
| Number of participants with immediate adverse events (AEs) | Within 30 minutes post-vaccination | Unsolicited systemic AEs that occur within 30 minutes after vaccination |
| Presence of solicited injection site reactions | Within 7 days post-vaccination | Solicited injection site reactions include injection site pain, erythema and swelling |
| Presence of solicited systemic reactions | Within 7 days post-vaccination | Solicited systemic reactions include fever, headache, malaise and myalgia |
| Presence of unsolicited AEs | Within 30 days post-vaccination | — |
| Presence of SAEs | Up to Day 181 post-vaccination | SAEs, including adverse events of special interest (AESIs), reported throughout the study |
| Participants 7 through 17 years of age (Cohort I): Antibody titers against meningococcal serogroups A, C, Y, and W in Groups 1 and 2 | Day 01 (pre-vaccination) and Day 31 (post- vaccination) | Antibody titers measured by rSBA titer ≥1:8, ≥1:128 |
| Participants 2 through 6 years of age (Cohort II): Antibody titers against meningococcal serogroups A, C, Y, and W in Group 3 and against meningococcal serogroups A and C in Group 4 | Day 01 (pre-vaccination) and Day 31 (post- vaccination) | Antibody titers measured by rSBA titer ≥1:8, ≥1:128 |
| Participants 2 through 6 years of age (Cohort II): Antibody titers in terms of GMTs against meningococcal serogroups Y and W in Group 3 | Day 01 (pre-vaccination) and Day 31 (post- vaccination) | Antibodies titers are expressed as geometric mean titers |
Countries
China
Contacts
CONTACTTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed