Study on Immunogenicity and Safety of a Meningococcal ACYW Conjugate Vaccine in Healthy Infants and Toddlers

Sanofi Pasteur, a Sanofi Company840 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

840

Conditions

Meningococcal Immunisation Healthy Volunteers

Interventions

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 14 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (45)

Investigational Site Number : 2030002

České Budějovice, Czechia

Investigational Site Number: 2030001

České Budějovice, Czechia

Investigational Site Number: 2030005

Prague, Czechia

Investigational Site Number: 2080007

Aalborg, Denmark

Investigational Site Number: 2080004

Aarhus, Denmark

Outcomes

Primary Outcomes

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)

Time frame: 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

Time frame: 30 days after dose 2 (booster dose) (+14 days)

Secondary Outcomes

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

Time frame: 30 days after dose 1 (priming dose) (+14 days)

hSBA antibody titers against meningococcal serogroups A, C, W and Y

Antibody titers are measured by hSBA and summarized as geometric mean titers (GMTs)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Within 7 days after each vaccination

Number of participants with unsolicited AEs

AEs other than solicited reactions

Time frame: 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

Time frame: From baseline to up to 7 months