Clinical trial NCT06284915: Study on Immunogenicity and Safety of a Meningococcal ACYW Conjugate Vaccine in Healthy Infants and Toddlers
Official title: A Parallel-group, Prevention, Phase III, Modified Double-blind, 2-arm, Study to Investigate the Immunogenicity and Describe the Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared With Nimenrix® When Administered in a 1+1 Schedule in Healthy Infants and Toddlers at 6 and 12 Months of Age
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Meningococcal Immunisation
Healthy Volunteers
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-02-29
Enrollment: 840
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Geometric mean titers (GMTs) of Antibodies against meningococcal serogroups A, C, W and Y
timeFrame: 30 days after dose 2 (booster dose) (+14 days)
Secondary outcomes:
measure: hSBA antibody titers ≥ 1:8 against meningococcal serogroups A, C, W and Y
timeFrame: 30 days after dose 1 (priming dose) (+14 days)
measure: hSBA antibody titers against meningococcal serogroups A, C, W and Y
timeFrame: 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)
measure: hSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, W and Y
timeFrame: 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
measure: Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by hSBA
timeFrame: 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
measure: hSBA meningococcal serogroups A, C, W and Y vaccine seroresponse
timeFrame: 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
measure: Rabbit complement (rSBA) antibody titers against meningococcal serogroups A, C, W, and Y
timeFrame: 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
measure: rSBA antibody titers ≥ several pre-defined thresholds against meningococcal serogroups A, C, W and Y
timeFrame: 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
measure: Percentage of Participants who achieved ≥4-fold rise in antibody titers over baseline measured by rSBA
timeFrame: 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
measure: rSBA meningococcal serogroups A, C, W and Y vaccine seroresponse
timeFrame: 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)
measure: Number of participants with immediate adverse events (AEs)
timeFrame: Within 30 minutes after each vaccination
measure: Number of participants with solicited injection site reactions or systemic reactions
timeFrame: Within 7 days after each vaccination
measure: Number of participants with unsolicited AEs
timeFrame: Up to 30 days after each vaccination
measure: Number of participants with serious adverse events (SAEs)
timeFrame: From baseline to up to 7 months
Other outcomes:
Locations:
city: Ceske Budejovice
country: Czechia
facility: Investigational Site Number : 2030002
city: Ceske Budejovice
country: Czechia
facility: Investigational Site Number: 2030001
city: Prague
country: Czechia
facility: Investigational Site Number: 2030005
city: Aalborg
country: Denmark
facility: Investigational Site Number: 2080007
city: Aarhus
country: Denmark
facility: Investigational Site Number: 2080004
city: Herlev
country: Denmark
facility: Investigational Site Number: 2080006
city: Hjørring
country: Denmark
facility: Investigational Site Number : 2080005
city: Odense
country: Denmark
facility: Investigational Site Number: 2080002
city: Zeeland
country: Denmark
facility: Investigational Site Number: 2080001
city: Espoo
country: Finland
facility: Investigational Site Number: 2460005
city: Helsinki
country: Finland
facility: Investigational Site Number: 2460002
city: Helsinki
country: Finland
facility: Investigational Site Number: 2460011
city: Jaarvenpa
country: Finland
facility: Investigational Site Number: 2460006
city: Kokkola
country: Finland
facility: Investigational Site Number : 2460003
city: Oulu
country: Finland
facility: Investigational Site Number: 2460007
city: Tampere
country: Finland
facility: Investigational Site Number: 2460004
city: Turku
country: Finland
facility: Investigational Site Number: 2460012
city: Erfurt
country: Germany
facility: Investigational Site Number: 2760007
city: Herxheim
country: Germany
facility: Investigational Site Number: 2760004
city: Huerth
country: Germany
facility: Investigational Site Number: 2760003
city: Moenchengladbach
country: Germany
facility: Investigational Site Number: 2760001
city: Moenchengladbach
country: Germany
facility: Investigational Site Number: 2760011
city: Schoenau Am Koenigssee
country: Germany
facility: Investigational Site Number: 2760005
city: Schweigen- Rechtenbach
country: Germany
facility: Investigational Site Number: 2760008
city: Wolfsburg
country: Germany
facility: Investigational Site Number: 2760010
city: Worms
country: Germany
facility: Investigational Site Number : 2760009
city: Bydgoszcz
country: Poland
facility: Investigational Site Number : 6160001
state: Kujawsko-pomorskie
city: Bydgoszcz
country: Poland
facility: Investigational Site Number: 6160003
city: Bydgoszcz
country: Poland
facility: Investigational Site Number: 6160008
city: Bydgoszcz
country: Poland
facility: Investigational Site Number: 6160017
city: Krakow
country: Poland
facility: Investigational Site Number: 6160015
city: Krakow
country: Poland
facility: Investigational Site Number: 6160021
city: Leczna
country: Poland
facility: Investigational Site Number: 6160016
city: Lomianki
country: Poland
facility: Investigational Site Number: 6160004
city: Lubon
country: Poland
facility: Investigational Site Number: 6160012
city: Siemianowice
country: Poland
facility: Investigational Site Number: 6160011
city: Torun
country: Poland
facility: Investigational Site Number: 6160007
city: Trzebnica
country: Poland
facility: Investigational Site Number: 6160014
city: Warszawa
country: Poland
facility: Investigational Site Number: 6160022
city: Wroclav
country: Poland
facility: Investigational Site Number: 6160010
city: Wroclaw
country: Poland
facility: Investigational Site Number: 6160002
city: Bucuresti
country: Romania
facility: Investigational Site Number : 6420001
city: Bucuresti
country: Romania
facility: Investigational Site Number : 6420003
city: Bucuresti
country: Romania
facility: Investigational Site Number: 6420002
city: Calarasi
country: Romania
facility: Investigational Site Number: 6420005
Study officials:
References: