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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-508177-85 | Registry Identifier | CTIS | |
| U1111-1280-6981 | Registry Identifier | ICTRP |
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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.
The study duration will be approximately 7 to 8.5 months (at least 7 months per participant).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: MenACYW conjugate vaccine | Experimental | Participants will receive MenACYW Conjugate Vaccine (MenQuadfi®): 2-dose schedule (1+1); dose 1 (priming dose) at 6-7 months of age and dose 2 (booster dose) at 12-13 months of age (MenQuadfi®) |
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| Group 2: Nimenrix® | Active Comparator | Participants will receive Nimenrix®: 2-dose schedule (1+1); dose 1 (priming dose) at 6-7 months of age and dose 2 (booster dose) at 12-13 months of age |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MenACYW conjugate vaccine | Biological | Pharmaceutical form:Solution for injection (in a single-dose vial)-Route of administration:Intramuscular (IM) injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titers (GMTs) of Antibodies against meningococcal serogroups A, C, W and Y | Geometric mean titers after a 2-dose serie measured by serum bactericidal assays using human complement (hSBA) | 30 days after dose 2 (booster dose) (+14 days) |
| Vaccine Seroresponse to meningococcal serogroups A, C, W and Y assessed by hSBA | Vaccine seroresponse after a 2-dose serie measured by hSBA | 30 days after dose 2 (booster dose) (+14 days) |
| Measure | Description | Time Frame |
|---|---|---|
| hSBA antibody titers ≥ 1:8 against meningococcal serogroups A, C, W and Y | % of participants achieving antibody titers measured by hSBA ≥ predefined threshold of 1:8 | 30 days after dose 1 (priming dose) (+14 days) |
| hSBA antibody titers against meningococcal serogroups A, C, W and Y |
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Inclusion Criteria:
Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site Number : 2030002 | České Budějovice | 370 06 | Czechia | |||
| Investigational Site Number: 2030001 |
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| Label | URL |
|---|---|
| MEQ00089 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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The study will be performed in a modified double-blind fashion:
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| MenACYW conjugate vaccine | Biological | Pharmaceutical form:Solution for injection (powder or cake in a single dose glass vial and a clear and colourless solvent in a pre filled syringe for reconstitution-Route of administration:Intramuscular (IM) injection |
|
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Antibody titers are measured by hSBA and summarized as geometric mean titers (GMTs) |
| 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 ≥ several pre-defined thresholds against meningococcal serogroups A, C, W and Y | Antibody titers are measured by hSBA and summarized as % of participants achieving antibody titers ≥ predefined thresholds | 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 |
| 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 | 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 | 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 |
| 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 |
| 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 |
| rSBA meningococcal serogroups A, C, W and Y vaccine seroresponse | 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 | 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) |
| Number of participants with immediate adverse events (AEs) | Unsolicited systemic AEs that occur within 30 minutes after vaccination | Within 30 minutes after each vaccination |
| Number of participants with solicited injection site reactions or systemic reactions | Pre-defined solicited injection site reactions and systemic reactions that are pre-listed in the diary cards and CRF | Within 7 days after each vaccination |
| Number of participants with unsolicited AEs | AEs other than solicited reactions | Up to 30 days after each vaccination |
| Number of participants with serious adverse events (SAEs) | SAEs (including adverse events of special interest [AESIs]) reported throughout the study | From baseline to up to 7 months |
| České Budějovice |
| Czechia |
| Investigational Site Number: 2030005 | Prague | Czechia |
| Investigational Site Number: 2080007 | Aalborg | Denmark |
| Investigational Site Number: 2080004 | Aarhus | Denmark |
| Investigational Site Number: 2080006 | Herlev | Denmark |
| Investigational Site Number : 2080005 | Hjørring | 9800 | Denmark |
| Investigational Site Number: 2080002 | Odense | Denmark |
| Investigational Site Number: 2080001 | Zeeland | Denmark |
| Investigational Site Number: 2460005 | Espoo | Finland |
| Investigational Site Number: 2460002 | Helsinki | Finland |
| Investigational Site Number: 2460011 | Helsinki | Finland |
| Investigational Site Number: 2460006 | Jaarvenpa | Finland |
| Investigational Site Number : 2460003 | Kokkola | 67100 | Finland |
| Investigational Site Number: 2460007 | Oulu | Finland |
| Investigational Site Number: 2460004 | Tampere | Finland |
| Investigational Site Number: 2460012 | Turku | Finland |
| Investigational Site Number: 2760007 | Erfurt | Germany |
| Investigational Site Number: 2760004 | Herxheim | Germany |
| Investigational Site Number: 2760003 | Hürth | Germany |
| Investigational Site Number: 2760001 | Mönchengladbach | Germany |
| Investigational Site Number: 2760011 | Mönchengladbach | Germany |
| Investigational Site Number: 2760005 | Schönau am Königssee | Germany |
| Investigational Site Number: 2760008 | Schweigen-Rechtenbach | Germany |
| Investigational Site Number: 2760010 | Wolfsburg | Germany |
| Investigational Site Number : 2760009 | Worms | 67550 | Germany |
| Investigational Site Number : 6160001 | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-079 | Poland |
| Investigational Site Number: 6160003 | Bydgoszcz | Poland |
| Investigational Site Number: 6160008 | Bydgoszcz | Poland |
| Investigational Site Number: 6160017 | Bydgoszcz | Poland |
| Investigational Site Number: 6160015 | Krakow | Poland |
| Investigational Site Number: 6160021 | Krakow | Poland |
| Investigational Site Number: 6160012 | Luboń | Poland |
| Investigational Site Number: 6160011 | Siemianowice Śląskie | Poland |
| Investigational Site Number: 6160007 | Torun | Poland |
| Investigational Site Number: 6160014 | Trzebnica | Poland |
| Investigational Site Number: 6160022 | Warsaw | Poland |
| Investigational Site Number: 6160010 | Wroclav | Poland |
| Investigational Site Number: 6160002 | Wroclaw | Poland |
| Investigational Site Number: 6160016 | Łęczna | Poland |
| Investigational Site Number: 6160004 | Łomianki | Poland |
| Investigational Site Number : 6420001 | Bucharest | 011025 | Romania |
| Investigational Site Number : 6420003 | Bucharest | 021105 | Romania |
| Investigational Site Number: 6420002 | Bucharest | Romania |
| Investigational Site Number: 6420005 | Calarasi | Romania |