Meningococcal Immunisation, Healthy Volunteers
Conditions
Brief summary
This study is conducted to support a 2-dose series (1+1 vaccination schedule) for immunization of individuals from 6 months of age. The study is designed to evaluate the non-inferiority of the immunological response of MenACYW conjugate vaccine to Nimenrix® after the completion of the 2-dose series (1+1 vaccination schedule), with the first dose (priming dose) being given at 6-7 months of age to MenACWY- naïve healthy infants and the second dose (booster dose) given at 12-13 months of age. This study will also describe additional immunogenicity parameters and safety of MenACYW conjugate vaccine and Nimenrix® in the same population of participants.
Detailed description
The study duration will be approximately 7 to 8.5 months (at least 7 months per participant).
Interventions
BIOLOGICALMenACYW conjugate vaccine
Pharmaceutical form:Solution for injection (in a single-dose vial)-Route of administration:Intramuscular (IM) injection
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The study will be performed in a modified double-blind fashion: * Investigators and study staff who conduct the safety assessment, and the participants parent/ legally acceptable representative 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
6 Months to 14 Months
Healthy volunteers
Yes
Inclusion criteria
* Aged 6 to 7 months on the day of inclusion * Participants who are healthy as determined by medical evaluation including medical history, physical examination and judgment of the Investigator
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, 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 study (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease) * Personal history of Guillain-Barré syndrome * Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine * Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study intervention(s) used in the study or to a product containing any of the same substances * Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided * Receipt of any vaccine (including COVID-19) and Meningococcal B vaccines) in the 4 weeks preceding the first and second study intervention administration or planned receipt of any vaccine (including COVID-19 and Meningococcal B vaccines) in the 4 weeks following any study intervention administration except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after the study interventions. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines. * Previous vaccination against meningococcal A, C, W, or Y disease with either the trial vaccine or another vaccine (i.e., mono- or quadrivalent meningococcal conjugate vaccine) containing serogroups A, C, Y, or W.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric mean titers (GMTs) of Antibodies against meningococcal serogroups A, C, W and Y | 30 days after dose 2 (booster dose) (+14 days) | Geometric mean titers after a 2-dose serie measured by serum bactericidal assays using human complement (hSBA) |
| Vaccine Seroresponse to meningococcal serogroups A, C, W and Y assessed by hSBA | 30 days after dose 2 (booster dose) (+14 days) | Vaccine seroresponse after a 2-dose serie measured by hSBA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, W and Y | For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days | Antibody titers are measured by hSBA and summarized as % of participants achieving antibody titers ≥ predefined thresholds |
| Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by hSBA | For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers 12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days | — |
| hSBA meningococcal serogroups A, C, W and Y vaccine seroresponse | For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days | Vaccine seroresponse defined as follows: For a participant with a pre-vaccination titer \< 1:8, a post vaccination titer ≥ 1:16 and for a participant with a pre-vaccination titer ≥ 1:8, a post vaccination titer at least 4-fold greater than the pre vaccination titer |
| Rabbit complement (rSBA) antibody titers against meningococcal serogroups A, C, W, and Y | For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days | — |
| rSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, W and Y | For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers 12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days | — |
| hSBA antibody titers ≥ 1:8 against meningococcal serogroups A, C, W and Y | 30 days after dose 1 (priming dose) (+14 days) | % of participants achieving antibody titers measured by hSBA ≥ predefined threshold of 1:8 |
| rSBA meningococcal serogroups A, C, W and Y vaccine seroresponse | For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers 12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days) | Vaccine seroresponse defined as follows: For a participant with a pre-vaccination titer \< 1:8, a post vaccination titer ≥ 1:32 and for a participant with a pre-vaccination titer ≥ 1:8, a post vaccination titer at least 4-fold greater than the pre vaccination titer |
| Number of participants with immediate adverse events (AEs) | Within 30 minutes after each vaccination | Unsolicited systemic AEs that occur within 30 minutes after vaccination |
| Number of participants with solicited injection site reactions or systemic reactions | Within 7 days after each vaccination | Pre-defined solicited injection site reactions and systemic reactions that are pre-listed in the diary cards and CRF |
| Number of participants with unsolicited AEs | Up to 30 days after each vaccination | AEs other than solicited reactions |
| Number of participants with serious adverse events (SAEs) | From baseline to up to 7 months | SAEs (including adverse events of special interest \[AESIs\]) reported throughout the study |
| Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by rSBA | For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days | — |
| hSBA antibody titers against meningococcal serogroups A, C, W and Y | For infants 6-7 months old: Before and 30 days after dose 1 (priming dose) (+14 days) For toddlers12-13 months old: Before and 30 days after dose 2 (booster dose) (+14 days) | Antibody titers are measured by hSBA and summarized as geometric mean titers (GMTs) |
Countries
Czechia, Denmark, Finland, Germany, Poland, Romania
Outcome results
None listed