Meningococcal Immunisation, Healthy Volunteers
Conditions
Brief summary
This study evaluated the immunogenicity and safety of a single dose of MenQuadfi® administered as a booster vaccine in toddlers 12 - 23 months of age in Argentina who had been primed with at least 1 dose of the quadrivalent meningococcal conjugate vaccines Nimenrix® or Menveo® during infancy to protect against invasive meningococcal disease (IMD). Participants received a single dose of MenQuadfi® at Visit 1. Participants provided 2 blood samples, one at D01 (Visit 1) pre-vaccination and another at D31 (Visit 2) post-vaccination for the immunogenicity assessments. Study included 2 visits at D01 (Visit 1) and at D31 (Visit 2), and 1 Telephone call (TC) for safety follow-up at D09 post-study vaccination.
Detailed description
Study duration was approximately 30 days (+14 days) per participant
Interventions
BIOLOGICALMenACYW conjugate vaccine
Pharmaceutical form: Liquid solution Route of administration: Intramuscular (IM) injection
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 23 Months
Healthy volunteers
Yes
Inclusion criteria
* Aged 12 to 23 months on the day of inclusion * Participants who are healthy as determined by medical evaluation including medical history, physical examination, and judgement of the Investigator * Received at least one priming dose of licensed Nimenrix® or Menveo® vaccine during infancy before 12 months of age with an interval of at least 2 months between the last vaccination with Nimenrix® or Menveo® and the MenQuadfi® booster dose
Exclusion criteria
* 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 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. 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 vaccines) in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine (including COVID-19 vaccines) in the 4 weeks following the study intervention administration except for influenza vaccination, which may be received at least 2 weeks before or 2 weeks after the study intervention. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines. * Previous vaccination with a Meningococcal C vaccine or Meningococcal B (MenB) vaccine * Receipt of immunoglobulins, blood or blood-derived products in the past 3 months * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw NOTE: The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Assay Using Human Complement | Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1) | Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). |
| Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 Against Meningococcal Serogroups A, C, Y, and W | Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1) | Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). Percentages are rounded to the nearest tenth. |
| Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1) | Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). Percentages are rounded to the nearest tenth. |
| Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination | Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1) | Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). Percentages are rounded to the nearest tenth. |
| Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Assay Using Human Complement | Day 1 (pre-vaccination) and Day 31 (30 days post vaccination on Day 1) | Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). hSBA vaccine seroresponse was defined for a participant with a pre-vaccination titer \<1:8 as a post-vaccination titer of \>=1:16 and for a participant with a pre-vaccination titer \>=1:8 as a post-vaccination titer that is at least 4-fold greater than the pre-vaccination titer. Percentages are rounded to the nearest tenth. |
| Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (rSBA) | Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1) | Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using baby rabbit complement (rSBA). |
| Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W | Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1) | Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using baby rabbit complement (rSBA). Percentages are rounded to the nearest tenth. |
| Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination | Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1) | Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using baby rabbit complement (rSBA). Percentages are rounded to the nearest tenth. |
| Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement | Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1) | Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using baby rabbit complement (rSBA). rSBA vaccine seroresponse was defined for a participant with a pre-vaccination titer \<1:8 as a post-vaccination titer of \>=1:32 and for a participant with a pre-vaccination titer \>=1:8 as a post-vaccination titer that is at least 4-fold greater than the pre-vaccination titer. Percentages are rounded to the nearest tenth. |
| Geometric Mean Concentrations (GMCs) of Antibodies Against Tetanus Toxoid | Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1) | Geometric Mean Concentrations (GMCs) of anti-tetanus toxoid antibodies was measured by diphtheria, tetanus, pertussis multiplexed electrochemiluminescent assay. |
| Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | Up to 30 minutes post-vaccination on Day 1 | 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 onset window post-vaccination. |
| Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Up to 7 days post-vaccination on Day 1 | 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 injection site reactions included injection site tenderness, injection site erythema and injection site swelling. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss and irritability. |
| Number of Participants With Unsolicited Adverse Events | Up to 30 days post-vaccination on Day 1 | 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 vaccination (Day 1) up to 30 days post vaccination, 31 days | 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
Argentina
Participant flow
Recruitment details
This study was conducted at 2 investigational sites in Argentina between 07 September 2023 to 09 September 2024.
Pre-assignment details
A total of 71 participants were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| MenACYW Conjugate Vaccine Participants who had received at least 1 of 2 priming doses of either Nimenrix® or Menveo® vaccine during infancy as part of their routine immunization before 12 months of age received a single booster dose (0.5 mL) of MenACYW conjugate vaccine as an IM injection at Day 1. | 71 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Deviation | 1 |
| Overall Study | Withdrawal by participant's parents/legally acceptable representatives | 2 |
Baseline characteristics
| Characteristic | MenACYW Conjugate Vaccine | — |
|---|---|---|
| Age, Continuous | 14.3 months STANDARD_DEVIATION 1.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 34 Participants | — |
| Sex: Female, Male Male | 37 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 69 |
| other Total, other adverse events | 45 / 69 |
| serious Total, serious adverse events | 1 / 69 |
Outcome results
Primary
Geometric Mean Concentrations (GMCs) of Antibodies Against Tetanus Toxoid
Geometric Mean Concentrations (GMCs) of anti-tetanus toxoid antibodies was measured by diphtheria, tetanus, pertussis multiplexed electrochemiluminescent assay.
Time frame: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Population: The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Only participants with data collected for each specified serogroup are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACYW Conjugate Vaccine | Geometric Mean Concentrations (GMCs) of Antibodies Against Tetanus Toxoid | Day 1 | 0.642 International units/milliliter |
| MenACYW Conjugate Vaccine | Geometric Mean Concentrations (GMCs) of Antibodies Against Tetanus Toxoid | Day 31 | 8.56 International units/milliliter |
Primary
Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (rSBA)
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using baby rabbit complement (rSBA).
Time frame: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Population: The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Only participants with data collected for each specified serogroup are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACYW Conjugate Vaccine | Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (rSBA) | Serogroup A: Day 1 | 82.3 Titer |
| MenACYW Conjugate Vaccine | Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (rSBA) | Serogroup A: Day 31 | 4715 Titer |
| MenACYW Conjugate Vaccine | Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (rSBA) | Serogroup C: Day 1 | 11.6 Titer |
| MenACYW Conjugate Vaccine | Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (rSBA) | Serogroup C: Day 31 | 3676 Titer |
| MenACYW Conjugate Vaccine | Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (rSBA) | Serogroup Y: Day 1 | 30.9 Titer |
| MenACYW Conjugate Vaccine | Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (rSBA) | Serogroup Y: Day 31 | 5198 Titer |
| MenACYW Conjugate Vaccine | Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (rSBA) | Serogroup W: Day 1 | 28.0 Titer |
| MenACYW Conjugate Vaccine | Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (rSBA) | Serogroup W: Day 31 | 9329 Titer |
Primary
Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Assay Using Human Complement
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA).
Time frame: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Population: The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Only participants with data collected for each specified serogroup are reported.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Assay Using Human Complement | Serogroup A: Day 1 | 14.0 Titer |
| MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Assay Using Human Complement | Serogroup A: Day 31 | 244 Titer |
| MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Assay Using Human Complement | Serogroup C: Day 1 | 12.3 Titer |
| MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Assay Using Human Complement | Serogroup C: Day 31 | 1072 Titer |
| MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Assay Using Human Complement | Serogroup W: Day 1 | 16.9 Titer |
| MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Assay Using Human Complement | Serogroup W: Day 31 | 953 Titer |
| MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Assay Using Human Complement | Serogroup Y: Day 1 | 14.0 Titer |
| MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) Against Meningococcal Serogroups A, C, Y, and W as Measured by Serum Bactericidal Assay Using Human Complement | Serogroup Y: Day 31 | 945 Titer |
Primary
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
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 onset window post-vaccination.
Time frame: Up to 30 minutes post-vaccination on Day 1
Population: The SafAS included participants who received the study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenACYW Conjugate Vaccine | Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) | 0 Participants |
Primary
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
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.
Time frame: From vaccination (Day 1) up to 30 days post vaccination, 31 days
Population: The SafAS included participants who received the study vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenACYW Conjugate Vaccine | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | SAEs | 1 Participants |
| MenACYW Conjugate Vaccine | Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | AESIs | 1 Participants |
Primary
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
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 injection site reactions included injection site tenderness, injection site erythema and injection site swelling. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss and irritability.
Time frame: Up to 7 days post-vaccination on Day 1
Population: The SafAS included participants who received the study vaccine.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenACYW Conjugate Vaccine | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Solicited injection site reaction | 24 Participants |
| MenACYW Conjugate Vaccine | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | Solicited systemic reaction | 35 Participants |
Primary
Number of Participants With Unsolicited Adverse Events
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.
Time frame: Up to 30 days post-vaccination on Day 1
Population: The SafAS included participants who received the study vaccine.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenACYW Conjugate Vaccine | Number of Participants With Unsolicited Adverse Events | 23 Participants |
Primary
Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using baby rabbit complement (rSBA). Percentages are rounded to the nearest tenth.
Time frame: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Population: The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Only participants with data collected for each specified serogroup are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: >=1:8: Day 1 | 56.4 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: >=1:128: Day 1 | 54.5 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: >=1:8: Day 31 | 100 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: >=1:128: Day 31 | 100 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: >=1:8: Day 1 | 39.3 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: >=1:128: Day 1 | 24.6 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: >=1:8: Day 31 | 100 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: >=1:128: Day 31 | 100 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: >=1:8: Day 1 | 55.9 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: >=1:128: Day 1 | 44.1 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: >=1:8: Day 31 | 100 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: >=1:128: Day 31 | 100 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: >=1:8: Day 1 | 61.9 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: >=1:128: Day 1 | 41.3 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: >=1:8: Day 31 | 100 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: >=1:128: Day 31 | 100 Percentage of participants |
Primary
Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using baby rabbit complement (rSBA). Percentages are rounded to the nearest tenth.
Time frame: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Population: The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Only participants with data collected for each specified serogroup are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination | Serogroup A | 83.3 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination | Serogroup C | 98.3 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination | Serogroup Y | 98.3 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Antibody Assay Using Baby Rabbit Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination | Serogroup W | 100 Percentage of participants |
Primary
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 Against Meningococcal Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). Percentages are rounded to the nearest tenth.
Time frame: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Population: The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Only participants with data collected for each specified serogroup are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: Day 1 | 96.7 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: Day 31 | 100 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: Day 1 | 76.2 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: Day 31 | 100 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: Day 1 | 85.5 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: Day 31 | 100 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: Day 1 | 87.5 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=1:4 Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: Day 31 | 100 Percentage of participants |
Primary
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). Percentages are rounded to the nearest tenth.
Time frame: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Population: The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Only participants with data collected for each specified serogroup are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination | Serogroup A | 91.1 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination | Serogroup C | 100 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination | Serogroup Y | 96.1 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Assay Using Human Complement Antibody Titers >=4-Fold Rise From Pre-vaccination to Post-Vaccination | Serogroup W | 100 Percentage of participants |
Primary
Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). Percentages are rounded to the nearest tenth.
Time frame: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Population: The per-protocol analysis set (PPAS) was a subset of the full analysis set (FAS). The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Only participants with data collected for each specified serogroup are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: Day 1 | 72.1 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup A: Day 31 | 100 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: Day 1 | 60.3 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup C: Day 31 | 100 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: Day 1 | 67.7 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup Y: Day 31 | 100 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: Day 1 | 73.4 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers >=1:8 Against Meningococcal Serogroups A, C, Y, and W | Serogroup W: Day 31 | 100 Percentage of participants |
Primary
Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using baby rabbit complement (rSBA). rSBA vaccine seroresponse was defined for a participant with a pre-vaccination titer \<1:8 as a post-vaccination titer of \>=1:32 and for a participant with a pre-vaccination titer \>=1:8 as a post-vaccination titer that is at least 4-fold greater than the pre-vaccination titer. Percentages are rounded to the nearest tenth.
Time frame: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Population: The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Only participants with data collected for each specified serogroup are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement | Serogroup W | 100 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement | Serogroup A | 83.3 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement | Serogroup C | 98.3 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Antibody Assay Using Baby Rabbit Complement | Serogroup Y | 98.3 Percentage of participants |
Primary
Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Assay Using Human Complement
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay using human complement (hSBA). hSBA vaccine seroresponse was defined for a participant with a pre-vaccination titer \<1:8 as a post-vaccination titer of \>=1:16 and for a participant with a pre-vaccination titer \>=1:8 as a post-vaccination titer that is at least 4-fold greater than the pre-vaccination titer. Percentages are rounded to the nearest tenth.
Time frame: Day 1 (pre-vaccination) and Day 31 (30 days post vaccination on Day 1)
Population: The PPAS was a subset of the FAS. The FAS included participants who received the study vaccine and had a valid post-vaccination serology result. Only participants with data collected for each specified serogroup are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Assay Using Human Complement | Serogroup A | 91.1 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Assay Using Human Complement | Serogroup C | 100 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Assay Using Human Complement | Serogroup Y | 96.1 Percentage of participants |
| MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse by Serum Bactericidal Assay Using Human Complement | Serogroup W | 100 Percentage of participants |