Invasive Meningococcal Disease, Meningitis, Meningococcal Infections, Meningococcal Meningitis
Conditions
Keywords
Meningitis, Meningococcal Meningitis, Menactra®, Menomune® A/C/Y/W 135
Brief summary
Primary objectives: * To describe the antibody responses to meningococcal serogroups A, C, Y, and W 135, measured by serum bactericidal assay using human complement (hSBA) and baby rabbit complement (rSBA), induced by a single dose of Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein (MenACYW) Conjugate vaccine or Menomune® - A/C/Y/W 135. * To describe the safety profile of a single dose of MenACYW Conjugate vaccine or Menomune® - A/C/Y/W 135.
Detailed description
All participants received a single dose of their assigned vaccine on Day 0. They were assessed for immunogenicity on Day 0 and Day 30, and monitored for safety throughout the study.
Interventions
BIOLOGICALMeningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate Vaccine
0.5 milliliter (mL), Intramuscular (IM)
BIOLOGICALMeningococcal Polysaccharide Vaccine, Groups A, C, Y, W 135 Combined
0.5 mL, Subcutaneous (SC)
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
56 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged 56 or older on the day of inclusion. * Informed consent form had been signed and dated. * Able to attend all scheduled visits and complied with all trial procedures.
Exclusion criteria
* Participant was pregnant, or lactating, or of childbearing potential (were considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or used an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination). * Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. * Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination except for influenza vaccination, which might be received at least 2 weeks before or after the study vaccines. * Previous vaccination against meningococcal disease with either a trial vaccine or another vaccine. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * 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 trial. * Known systemic hypersensitivity to latex or any of the vaccine components, or history of a severe reaction to the vaccines used in the trial or to a vaccine containing any of the same substances. * Personal history of Guillain-Barré syndrome. * Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within at least 10 years of the proposed study vaccination. * Self-reported thrombocytopenia, contraindicating IM vaccination. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination. * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. * Current alcohol abuse or drug addiction. * Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion. * Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4°Fahrenheit \[≥ 38.0°Celsius\]). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided. * Receipt of oral or injectable antibiotic therapy within 3 days prior to any blood draw. Should a participant receive oral or injectable antibiotic therapy within 3 days prior to any blood draw, the Investigator would postpone the blood draw until it had been 3 days since the participant last received oral or injectable antibiotic therapy. Postponement must still be within the timeframe for blood draw indicated in the Table of Study Procedures, when possible. * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Day 0 (pre-vaccination) | Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method. |
| Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Day 30 (post-vaccination) | Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method. |
| Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Day 30 (post-vaccination) | Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by hSBA assay method. Seroresponse was defined as post-vaccination hSBA titers ≥1:8 for participants with pre-vaccination hSBA titers less than (\<) 1:8, or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers ≥1:8. |
| Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Day 0 (pre-vaccination) | GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method. |
| Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Day 30 (post-vaccination) | GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method. |
| Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® | Day 0 (pre-vaccination) | Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method. |
| Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® | Day 30 (post-vaccination) | Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method. |
| Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Day 30 (post-vaccination) | Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by rSBA assay method. Seroresponse was defined as post-vaccination rSBA titers ≥1:8 for participants with pre-vaccination rSBA titers \<1:8, or at least a 4-fold increase in rSBA titers from pre- to post-vaccination for participants with pre-vaccination rSBA titers ≥1:8. |
| Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Day 0 (pre-vaccination) | GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method. |
| Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Day 30 (post-vaccination) | GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method. |
| Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Vaccination | Within 30 minutes after vaccination | An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event (SAE) was any untoward medical occurrence 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. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF. |
| Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination | Within 7 days after vaccination | A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (symptom and onset) prelisted in the CRF. Solicited injection site reactions included: pain, erythema, and swelling. Solicited systemic reactions included: fever, headache, malaise and, myalgia. |
| Number of Participants With Unsolicited Adverse Events After Vaccination | Within 30 days after vaccination | An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRF in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. An SAE was any untoward medical occurrence 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. Non-serious AE (AE excluding SAE) which was significant and prevented daily activity was considered as Grade 3 unsolicited non-serious AE. |
Countries
United States
Participant flow
Recruitment details
Study was conducted from 12-November-2012 to 17-January-2013 at 12 sites in the United States.
Pre-assignment details
A total of 301 participants were enrolled and vaccinated in the study.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: MenACYW Conjugate Vaccine Adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0. | 201 |
| Group 2: Menomune® A/C/Y/W 135 Vaccine Adult participants aged ≥56 years received a single dose of Menomune® vaccine on Day 0. | 100 |
| Total | 301 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Group 2: Menomune® A/C/Y/W 135 Vaccine | Total | Group 1: MenACYW Conjugate Vaccine |
|---|---|---|---|
| Age, Continuous | 65.8 years STANDARD_DEVIATION 6.58 | 65.9 years STANDARD_DEVIATION 6.96 | 66.0 years STANDARD_DEVIATION 7.15 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 9 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 97 Participants | 287 Participants | 190 Participants |
| Sex: Female, Male Female | 55 Participants | 176 Participants | 121 Participants |
| Sex: Female, Male Male | 45 Participants | 125 Participants | 80 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 199 | 0 / 100 |
| other Total, other adverse events | 114 / 199 | 54 / 100 |
| serious Total, serious adverse events | 0 / 199 | 0 / 100 |
Outcome results
Primary
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Time frame: Day 0 (pre-vaccination)
Population: Analysis was performed on PPAS population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup A | 9.73 titers (1/dilution) |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup C | 3.32 titers (1/dilution) |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup Y | 3.02 titers (1/dilution) |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup W 135 | 2.83 titers (1/dilution) |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup W 135 | 2.83 titers (1/dilution) |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup A | 10.4 titers (1/dilution) |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup Y | 3.53 titers (1/dilution) |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup C | 2.87 titers (1/dilution) |
Primary
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Time frame: Day 30 (post-vaccination)
Population: Analysis was performed on PPAS population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup A | 51.0 titers (1/dilution) |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup Y | 41.9 titers (1/dilution) |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup C | 48.3 titers (1/dilution) |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup W 135 | 29.0 titers (1/dilution) |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup W 135 | 17.1 titers (1/dilution) |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup A | 31.8 titers (1/dilution) |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup C | 18.5 titers (1/dilution) |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup Y | 16.6 titers (1/dilution) |
Primary
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.
Time frame: Day 0 (pre-vaccination)
Population: Analysis was performed on PPAS population. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup A | 7.75 titers (1/dilution) |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup C | 3.40 titers (1/dilution) |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup Y | 15.3 titers (1/dilution) |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup W 135 | 4.74 titers (1/dilution) |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup W 135 | 6.05 titers (1/dilution) |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup A | 7.32 titers (1/dilution) |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup Y | 13.1 titers (1/dilution) |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup C | 2.93 titers (1/dilution) |
Primary
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.
Time frame: Day 30 (post-vaccination)
Population: Analysis was performed on PPAS population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup Y | 591 titers (1/dilution) |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup C | 1559 titers (1/dilution) |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup W 135 | 910 titers (1/dilution) |
| Group 1: MenACYW Conjugate Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup A | 1054 titers (1/dilution) |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup W 135 | 493 titers (1/dilution) |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup Y | 260 titers (1/dilution) |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup A | 746 titers (1/dilution) |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup C | 445 titers (1/dilution) |
Primary
Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Vaccination
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event (SAE) was any untoward medical occurrence 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. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF.
Time frame: Within 30 minutes after vaccination
Population: Analysis was performed on SafAS population which included participants who received at least one dose of the study or control vaccine and had safety data available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Vaccination | 0 Participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Vaccination | 0 Participants |
Primary
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination
A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (symptom and onset) prelisted in the CRF. Solicited injection site reactions included: pain, erythema, and swelling. Solicited systemic reactions included: fever, headache, malaise and, myalgia.
Time frame: Within 7 days after vaccination
Population: Analysis was performed on SafAS population. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination | Swelling | 15 Participants |
| Group 1: MenACYW Conjugate Vaccine | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination | Fever | 3 Participants |
| Group 1: MenACYW Conjugate Vaccine | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination | Headache | 47 Participants |
| Group 1: MenACYW Conjugate Vaccine | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination | Malaise | 44 Participants |
| Group 1: MenACYW Conjugate Vaccine | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination | Erythema | 23 Participants |
| Group 1: MenACYW Conjugate Vaccine | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination | Myalgia | 70 Participants |
| Group 1: MenACYW Conjugate Vaccine | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination | Pain | 61 Participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination | Myalgia | 26 Participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination | Fever | 1 Participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination | Pain | 32 Participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination | Erythema | 5 Participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination | Headache | 28 Participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination | Malaise | 15 Participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination | Swelling | 2 Participants |
Primary
Number of Participants With Unsolicited Adverse Events After Vaccination
An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRF in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. An SAE was any untoward medical occurrence 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. Non-serious AE (AE excluding SAE) which was significant and prevented daily activity was considered as Grade 3 unsolicited non-serious AE.
Time frame: Within 30 days after vaccination
Population: Analysis was performed on the SafAS population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Number of Participants With Unsolicited Adverse Events After Vaccination | Unsolicited AE | 41 Participants |
| Group 1: MenACYW Conjugate Vaccine | Number of Participants With Unsolicited Adverse Events After Vaccination | Unsolicited non-serious AE | 41 Participants |
| Group 1: MenACYW Conjugate Vaccine | Number of Participants With Unsolicited Adverse Events After Vaccination | Grade 3 unsolicited non-serious AE | 2 Participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Number of Participants With Unsolicited Adverse Events After Vaccination | Unsolicited AE | 17 Participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Number of Participants With Unsolicited Adverse Events After Vaccination | Unsolicited non-serious AE | 17 Participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Number of Participants With Unsolicited Adverse Events After Vaccination | Grade 3 unsolicited non-serious AE | 3 Participants |
Primary
Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Time frame: Day 30 (post-vaccination)
Population: Analysis was performed on PPAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup C: ≥1:8 | 74.9 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup A: ≥1:4 | 97.4 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup A: ≥1:8 | 93.8 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup C: ≥1:4 | 85.6 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup Y: ≥1:4 | 87.2 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup Y: ≥1:8 | 80.5 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup W 135: ≥1:4 | 88.7 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup W 135: ≥1:8 | 79.5 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup W 135: ≥1:8 | 60.6 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup C: ≥1:8 | 62.8 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup Y: ≥1:4 | 73.4 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup A: ≥1:4 | 93.6 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup W 135: ≥1:4 | 77.7 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup A: ≥1:8 | 85.1 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup Y: ≥1:8 | 59.6 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup C: ≥1:4 | 79.8 percentage of participants |
Primary
Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Time frame: Day 0 (pre-vaccination)
Population: Analysis was performed on Per-Protocol Analysis Set (PPAS) population which included participants who received at least one dose of the study vaccine, had any valid serology result, and no protocol deviations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup Y: ≥1:4 | 22.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup C: ≥1:4 | 27.7 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup Y: ≥1:8 | 13.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup A: ≥1:8 | 76.4 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup W 135: ≥1:4 | 26.2 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup C: ≥1:8 | 17.4 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup W 135: ≥1:8 | 13.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup A: ≥1:4 | 95.9 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup W 135: ≥1:8 | 8.5 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup A: ≥1:8 | 79.8 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup C: ≥1:4 | 30.9 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup C: ≥1:8 | 10.6 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup Y: ≥1:4 | 26.6 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup Y: ≥1:8 | 24.5 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup W 135: ≥1:4 | 26.6 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup A: ≥1:4 | 96.8 percentage of participants |
Primary
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune®
Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.
Time frame: Day 30 (post-vaccination)
Population: Analysis was performed on PPAS population. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup W 135: ≥1:128 | 94.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup C: ≥1:128 | 93.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup A: ≥1:8 | 95.9 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup C: ≥1:8 | 95.9 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup Y: ≥1:8 | 97.4 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup Y: ≥1:128 | 88.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup W 135: ≥1:8 | 98.4 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup A: ≥1:128 | 94.3 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup W 135: ≥1:8 | 94.7 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup A: ≥1:128 | 89.4 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup C: ≥1:8 | 87.2 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup Y: ≥1:128 | 73.4 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup C: ≥1:128 | 77.7 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup W 135: ≥1:128 | 79.8 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup Y: ≥1:8 | 94.7 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup A: ≥1:8 | 94.7 percentage of participants |
Primary
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune®
Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.
Time frame: Day 0 (pre-vaccination)
Population: Analysis was performed on PPAS population. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup A: ≥1:8 | 28.2 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup C: ≥1:8 | 12.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup Y: ≥1:128 | 27.7 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup A: ≥1:128 | 22.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup W 135: ≥1:8 | 20.0 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup C: ≥1:128 | 8.2 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup W 135: ≥1:128 | 12.8 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup Y: ≥1:8 | 50.3 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup W 135: ≥1:128 | 14.9 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup A: ≥1:8 | 26.9 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup A: ≥1:128 | 22.6 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup C: ≥1:8 | 9.6 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup C: ≥1:128 | 4.3 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup Y: ≥1:8 | 50.0 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup Y: ≥1:128 | 20.2 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® | Serogroup W 135: ≥1:8 | 27.7 percentage of participants |
Primary
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by hSBA assay method. Seroresponse was defined as post-vaccination hSBA titers ≥1:8 for participants with pre-vaccination hSBA titers less than (\<) 1:8, or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers ≥1:8.
Time frame: Day 30 (post-vaccination)
Population: Analysis was performed on PPAS population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup A | 65.1 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup Y | 75.4 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup C | 70.8 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup W 135 | 74.4 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup W 135 | 55.3 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup A | 46.8 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup C | 59.6 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup Y | 48.9 percentage of participants |
Primary
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by rSBA assay method. Seroresponse was defined as post-vaccination rSBA titers ≥1:8 for participants with pre-vaccination rSBA titers \<1:8, or at least a 4-fold increase in rSBA titers from pre- to post-vaccination for participants with pre-vaccination rSBA titers ≥1:8.
Time frame: Day 30 (post-vaccination)
Population: Analysis was performed on PPAS population. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup W 135 | 95.3 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup Y | 86.5 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup A | 90.2 percentage of participants |
| Group 1: MenACYW Conjugate Vaccine | Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup C | 94.8 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup W 135 | 90.4 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup C | 86.2 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup A | 89.2 percentage of participants |
| Group 2: Menomune® A/C/Y/W 135 Vaccine | Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine | Serogroup Y | 75.5 percentage of participants |