Meningococcal Immunisation, Healthy Volunteers
Conditions
Brief summary
This study was conducted to support a 2-dose series (1+1 vaccination schedule) for immunization of individuals from 6 months of age. The study was 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 also described additional immunogenicity parameters and safety of MenACYW conjugate vaccine and Nimenrix® in the same population of participants.
Detailed description
The study duration would 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 was performed in a modified double-blind fashion: * Investigators and study staff who conducted the safety assessment, and the participants parent/ legally acceptable representative would not know which study intervention is administered * Only the study staff who prepared and administered the study intervention and were not involved with the safety evaluation would know which study intervention was 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 were healthy as determined by medical evaluation including medical history, physical examination and judgment of the Investigator
Exclusion criteria
Participants were 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) Against Meningococcal Serogroups A, C, W, and Y as Measured by Serum Bactericidal Assays Using Human Complement (hSBA) 30 Days After Dose 2 (Booster Dose) | At Month 7 (30 days post-dose 2) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers. |
| Percentage of Participants With Vaccine Seroresponse as Measured By Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups A, C, W and Y 30 Days After Dose 2 (Booster Dose) Compared to Pre-Dose 1 (Priming Dose) | Day 1 (pre-dose 1) and Month 7 (30 days post-dose 2) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse was defined for a participant with a pre-vaccination (pre-dose 1: priming dose) titer \<1:8, as a post-vaccination (post-dose 2: booster dose) titer of \>=1:16 and for a participant with a pre-vaccination (pre-dose 1: priming dose) titer \>=1:8, as a post-vaccination (post-dose 2: booster dose) titer that is at least 4-fold greater than the pre-vaccination (pre-dose 1: priming dose) titer. Percentages are rounded to the nearest tenth. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, W, and Y 30 Days After Dose 1 (Priming Dose) | Day 31 (30 days post-dose 1) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the hSBA. The percentage of participants with antibody titers \>=1:8 were assessed. Percentages are rounded to the nearest tenth. |
| Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y as Measured by Serum Bactericidal Assay Using Human Complement Before Dose 1 and 30 Days After Dose 1 (Priming Dose) | Day 1 (pre-dose 1) and Day 31 (30 days post-dose 1) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers. |
| Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 and >=1:8 Before Dose 1 (Pre-dose) and 30 Days After Dose 1 (Priming Dose) | Day 1 (pre-dose 1) and Day 31 (30 days post-dose 1) | Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers \>= 1:4 and \>= 1:8 were analyzed. Percentages are rounded to the nearest tenth. |
| Percentage of Participants With >=4-Fold Rise in Serum Bactericidal Assay Using Human Complement Antibody Titers From Before Dose 1 and 30 Days After Dose 1 (Priming Dose) | Day 1 (pre-dose 1) and Day 31 (30 days post-dose 1) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers \>= 4-fold increase from baseline (pre-vaccination) were analyzed. Percentages are rounded to the nearest tenth. |
| Percentage of Participants With Vaccine Seroresponse as Measured by Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups A, C, W and Y 30 Days After Dose 1 Compared to Pre-Dose 1 (Priming Dose) | Day 1 (pre-dose 1) and Day 31 (30 days post-dose 1) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse was defined for a participant with a pre-vaccination (pre-dose 1: priming dose) titer \<1:8, as a post-vaccination (post-dose 1: priming dose) titer of \>=1:16 and for a participant with a pre-vaccination (pre-dose 1: priming dose) titer \>=1:8, as a post-vaccination (post-dose 1: priming dose) titer that is at least 4-fold greater than the pre-vaccination (pre-dose 1: priming dose) titer. Percentages are rounded to the nearest tenth. |
| Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y as Measured by Serum Bactericidal Assay Using Human Complement Before Dose 2 and 30 Days After Dose 2 (Booster Dose) | Month 6 (pre-dose 2) and Month 7 (30 days post-dose 2) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers. |
| Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 and >=1:8 Before Dose 2 and 30 Days After Dose 2 (Booster Dose) | Month 6 (pre-dose 2) and Month 7 (30 days post-dose 2) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers \>= 1:4 and \>= 1:8 were analyzed. Percentages are rounded to the nearest tenth. |
| Percentage of Participants With >=4-Fold Rise in Serum Bactericidal Assay Using Human Complement Antibody Titers From Before Dose 2 and 30 Days After Dose 2 (Booster Dose) | Month 6 (pre-dose 2) and Month 7 (30 days post-dose 2) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay that utilized hSBA. Participants with hSBA titers \>= 4-fold increase from dose 2 (pre-booster dose) were analyzed. Percentages are rounded to the nearest tenth. |
| Percentage of Participants With Vaccine Seroresponse as Measured by Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups A, C, W, and Y 30 Days After Dose 2 Compared to Pre-Dose 2 (Booster Dose) | Month 6 (pre-dose 2) and Month 7 (30 days post-dose 2) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the hSBA. hSBA vaccine seroresponse was defined for a participant with a pre-vaccination (pre-dose 2: booster dose) titer \<1:8, as a post-vaccination (post-dose 2: booster dose) titer of \>=1:16 and for a participant with a pre-vaccination titer (pre-dose 2: booster dose) \>=1:8, as a post-vaccination titer (post-dose 2: booster dose) that is at least 4-fold greater than the pre-vaccination titer (pre-dose 2: booster dose). Percentages are rounded to the nearest tenth. Percentages are rounded to the nearest tenth. |
| Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y as Measured by Serum Bactericidal Assay Using Human Complement Before Dose 1 (Priming Dose) and 30 Days After Dose 2 (Booster Dose) | Day 1 (pre-dose 1) and Month 7 (30 days post-dose 2) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers. |
| Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 and >=1:8 Before Dose 1 (Priming Dose) and 30 Days After Dose 2 (Booster Dose) | Day 1 (pre-dose 1) and Month 7 (30 days post-dose 2) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers \>= 1:4 and \>= 1:8 were analyzed. Percentages are rounded to the nearest tenth. |
| Percentage of Participants With >=4-Fold Rise in Serum Bactericidal Assay Using Human Complement Antibody Titers From Before Dose (Priming Dose) and 30 Days After Dose 2 (Booster Dose) | Day 1 (pre-dose 1) and Month 7 (30 days post-dose 2) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the hSBA. Participants with hSBA titers \>= 4-fold increase from baseline (pre-vaccination) were analyzed. Percentages are rounded to the nearest tenth. |
| Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y as Measured by Serum Bactericidal Assays Using Baby Rabbit Complement (rSBA) Before Dose 1 and 30 Days After Dose 1 (Priming Dose) | Day 1 (pre-dose 1) and Day 31 (30 days post-dose 1) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the rSBA and the results were expressed as geometric mean titers. |
| Percentage of Participants With Serum Bactericidal Assays Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, W, and Y Before Dose 1 and 30 Days After Dose 1 (Priming Dose) | Day 1 (pre-dose 1) and Day 31 (30 days post-dose 1) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the rSBA. Participants with rSBA titers \>= 1:8 and \>= 1:128 were analyzed. Percentages are rounded to the nearest tenth. |
| Percentage of Participants With >=4-Fold Rise in Serum Bactericidal Assays Using Baby Rabbit Complement Titers From Before Dose 1 and 30 Days After Dose 1 (Priming Dose) | Day 1 (pre-dose 1) and Day 31 (30 days post-dose 1) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the rSBA. Participants with rSBA titers \>= 4-fold increase from baseline (pre-vaccination) were analyzed. Percentages are rounded to the nearest tenth. |
| Percentage of Participants With Vaccine Seroresponse as Measured by Serum Bactericidal Assays Using Baby Rabbit Complement 30 Days After Dose 1 Compared and Pre-Dose 1 (Priming Dose) | Day 1 (pre-dose 1) and Day 31 (30 days post-dose 1) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the rSBA. rSBA vaccine seroresponse was defined for a participant with a pre-vaccination (pre-dose 1: priming dose) titer \<1:8, as a post-vaccination titer (post-dose 2: priming dose) of \>=1:32 and for a participant with a pre-vaccination titer (pre-dose 1: priming dose) \>=1:8, as a post-vaccination (post-dose 2: priming dose) titer that is at least 4-fold greater than the pre-vaccination (pre-dose 1: priming dose) titer. Percentages are rounded to the nearest tenth. Percentages are rounded to the nearest tenth. |
| Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Measured by Serum Bactericidal Assays Using Baby Rabbit Complement Before Dose 2 and 30 Days After Dose 2 (Booster Dose) | Month 6 (pre-dose 2) and Month 7 (30 days post-dose 2) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the rSBA and the results were expressed as geometric mean titers. |
| Percentage of Participants With Serum Bactericidal Assays Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Before Dose 2 and 30 Days After Dose 2 (Booster Dose) | Month 6 (pre-dose 2) and Month 7 (30 days post-dose 2) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the rSBA. Participants with rSBA titers \>= 1:8 and \>= 1:128 were analyzed. Percentages are rounded to the nearest tenth. |
| Percentage of Participants With >=4-Fold Rise in Serum Bactericidal Assays Using Baby Rabbit Complement Titers From Before Dose 2 and 30 Days After Dose 2 (Booster Dose) | Month 6 (pre-dose 2) and Month 7 (30 days post-dose 2) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the rSBA. Participants with rSBA titers \>= 4-fold increase from dose 2 (pre-booster dose) were analyzed. Percentages are rounded to the nearest tenth. |
| Percentage of Participants With Vaccine Seroresponse as Measured by Serum Bactericidal Assays Using Baby Rabbit Complement 30 Days After Dose 2 Compared to Pre-Dose 2 (Booster Dose) | Month 6 (pre-dose 2) and Month 7 (30 days post-dose 2) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the rSBA. rSBA vaccine seroresponse was defined for a participant with a pre-vaccination (pre-dose 2: booster dose) titer \<1:8 as a post-vaccination (post-dose 2: booster dose) titer of \>=1:32 and for a participant with a pre-vaccination (pre-dose 2: booster dose) titer \>=1:8 as a post-vaccination (post-dose 2: booster dose) titer that is at least 4-fold greater than the pre-vaccination (pre-dose 2: booster dose) titer. Percentages are rounded to the nearest tenth. |
| Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Measured by Serum Bactericidal Assays Using Baby Rabbit Complement Before Dose 1 (Priming Dose) and 30 Days After Dose 2 (Booster Dose) | Day 1 (pre-dose 1) and Month 7 (30 days post-dose 2) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the rSBA and the results were expressed as geometric mean titers. |
| Percentage of Participants With Serum Bactericidal Assays Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Before Dose 1 (Priming Dose) and 30 Days After Dose 2 (Booster Dose) | Day 1 (pre-dose 1) and Month 7 (30 days post-dose 2) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the rSBA. Participants with rSBA titers \>= 1:8 and \>= 1:128 were analyzed. Percentages are rounded to the nearest tenth. |
| Percentage of Participants With >=4-Fold Rise in Serum Bactericidal Assays Using Baby Rabbit Complement Titers From Before Dose (Priming Dose) and 30 Days After Dose 2 (Booster Dose) | Day 1 (pre-dose 1) and Month 7 (30 days post-dose 2) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the rSBA. Participants with rSBA titers \>= 4-fold increase from baseline (pre-vaccination) were analyzed. Percentages are rounded to the nearest tenth. |
| Percentage of Participants With Vaccine Seroresponse as Measured by Serum Bactericidal Assays Using Baby Rabbit Complement 30 Days After Dose 2 (Booster Dose) Compared to Pre-Dose 1 (Priming Dose) | Day 1 (pre-dose 1) and Month 7 (30 days post-dose 2) | Functional meningococcal antibody activity against serogroups A, C, W, and Y was measured in a serum bactericidal assay utilizing the rSBA. rSBA vaccine seroresponse was defined for a participant with a pre-vaccination (pre-dose 1: priming dose) titer \<1:8, as a post-vaccination (post-dose 2: booster dose) titer of \>=1:32 and for a participant with a pre-vaccination (pre-dose 1: priming dose) titer \>=1:8, as a post-vaccination (post-dose 2: booster dose) titer that is at least 4-fold greater than the pre-vaccination (pre-dose 1: priming dose) titer. Percentages are rounded to the nearest tenth. |
| Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | Up to 30 minutes after each vaccination (Dose 1 on Day 1 and Dose 2 on Month 6) | An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. |
| Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Up to 7 days after each vaccination (Dose 1 on Day 1 and Dose 2 on Month 6) | A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. An injection site reaction was an AR at and around the injection site. Solicited systemic reactions were systemic AEs observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. |
| Number of Participants With Unsolicited Adverse Events | Up to 30 days after each vaccination (Dose 1 on Day 1 and Dose 2 on Month 6) | An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and/or onset window post-vaccination. |
| Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | From first vaccination (Day 1) up to 30 days post last vaccination, approximately 7 months | An SAE was any AE that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's study intervention or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor could be appropriate. |
Countries
Czechia, Denmark, Finland, Germany, Poland, Romania
Participant flow
Recruitment details
This study was conducted at 47 centers in 6 countries from 19 March 2024 to 14 November 2025.
Pre-assignment details
A total of 840 participants were enrolled in this study. Participants were randomized in a 1:1 ratio to receive meningococcal polysaccharide (serogroups A, C, W, and Y) tetanus toxoid (MenACYW conjugate vaccine) or meningococcal group A, C, W-135, and Y conjugate vaccine (Nimenrix®vaccine).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 6.5 months STANDARD_DEVIATION 0.5 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 7 Participants |
| Race/Ethnicity, Customized Black or African American | 1 Participants |
| Race/Ethnicity, Customized Multiple | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Not Reported | 0 Participants |
| Race/Ethnicity, Customized Unknown | 2 Participants |
| Race/Ethnicity, Customized White | 417 Participants |
| Sex: Female, Male Female | 382 Participants |
| Sex: Female, Male Male | 222 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 417 | 1 / 412 |
| other Total, other adverse events | 347 / 417 | 370 / 412 |
| serious Total, serious adverse events | 21 / 417 | 20 / 412 |
Outcome results
None listed