Meningococcal Disease
Conditions
Keywords
Meningitis, children, vaccine, safety, efficacy
Brief summary
Safety and immunogenicity of meningococcal ACWY conjugate versus polysaccharide vaccine in children 2 to 10 years of age
Interventions
BIOLOGICALMeningococcal ACWY-CRM conjugate vaccine
MenACWY-CRM vaccine was obtained by extemporaneous mixing of the lyophilized MenA component to be resuspended with the liquid MenCWY component. One dose (0.5 mL) was administered by IM injection in the deltoid area of the arm without a BCG scar.
BIOLOGICALMeningococcal ACWY-PS polysaccharide vaccine
MenACWY-PS vaccine was supplied as a single dose (one vial of vaccine and one vial of diluent). One dose (0.5 mL) of MenACWY-PS vaccine was administered by SC injection in the deltoid area of the arm without a BCG scar.
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy children 2 to 10 years of age inclusive whose parents or legal guardians gave written informed consent at the time of enrollment; * Available for all visits and telephone calls (parents or legal guardians) scheduled for the study; * Good health as determined by the clinical judgment of the investigator.
Exclusion criteria
Individuals not eligible to be enrolled into the study were those: * whose parent or legal guardian was unwilling or unable to give written informed consent to participate in the study; * whose parent or legal guardian were perceived as unreliable or unavailable for the duration of the study period; * who had a previous or suspected disease caused by N meningitidis; * who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment; * who had previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational); * who had received any investigational agents or vaccines within 90 days prior to enrollment or who expected to receive an investigational agent or vaccine prior to the completion of the study; * who had received any licensed vaccines within one month prior to enrollment or for whom receipt of a licensed vaccine was anticipated within one month after vaccination (Exception: influenza vaccine could be administered up to 15 days prior to study vaccination and no less than 15 days after study vaccination); * who had received a live viral vaccine within 60 days prior to enrollment; * who had experienced, within the 7 days prior to enrollment, significant acute or chronic infection (for example requiring systemic antibiotic treatment or antiviral therapy) or had experienced fever (defined as axillary temperature ≥38°C) within 3 days prior to enrollment; * who had any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS), or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition). (Exception: subjects with mild asthma were eligible for enrollment; subjects with moderate or severe asthma requiring routine use of inhaled or systemic corticosteroids were not eligible for enrollment); * who had epilepsy or any progressive neurological disease; * who had a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component; * who had a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example): * receipt of immunosuppressive therapy within 30 days prior to enrollment (any systemic corticosteroid administered for more than 5 days, or in a daily dose \>1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy); * receipt of immunostimulants; * receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study; * common childhood exanthematous diseases (varicella, mumps, measles, rubella) occurring 6 weeks prior to vaccination; * who were known to have a bleeding diathesis or any condition that could be associated with a prolonged bleeding time; * who had Down syndrome or other known cytogenic disorders; * whose families were planning to leave the area of the study site before the end of the study period; * who had any condition that, in the opinion of the investigator, could interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | 1 month after vaccination (day 29) | Immunogenicity was measured as the percentage of subjects with hSBA seroresponse, directed against each of meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), one month after vaccination (day 29)with MenACWY-CRM or MenACWY-PS vaccine. Seroresponse was defined as: 1. for subjects with a prevaccination hSBA titer \<1:4, a postvaccination hSBA titer ≥1:8; 2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer. |
| Number of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination | Day 1 to 7 postvaccination | Safety was assessed in terms of the number of subjects who reported at least one severe systemic reaction after vaccination with MenACWY-CRM or MenACWY-PS from day 1 to day 7 after vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Day 181 | The persistence of immune response was measured as the percentage of subjects with hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at day 181 after vaccination with MenACWY-CRM or MenACWY-PS. |
| Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Day 1 and 29 | Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month (day 29)after one vaccination with MenACWY-CRM or MenACWY-PS. |
| Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Day 1 to 7 postvaccination | Safety was assessed as the number of subjects who reported local and systemic reactions and axillary temperature during day 1 to day 7 after vaccination with MenACWY-CRM or MenACWY-PS. |
| The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Day 181 | The persistence of immune response was measured in terms of the hSBA GMTs persisting at day 181 against each of four meningococcal serogroups A, C, W and Y after vaccination with MenACWY-CRM or MenACWY-PS |
| The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Day 1 and 29 | The immune response was measured as the hSBA geometric mean titers (GMTs) directed against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month(day 29) after one vaccination with MenACWY-CRM or MenACWY-PS. |
Countries
Argentina
Participant flow
Recruitment details
Subjects were enrolled at 3 study centers in Argentina.
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| MenACWY-CRM Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM) | 950 |
| MenACWY-PS Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS) | 550 |
| Total | 1,500 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 6 | 4 |
Baseline characteristics
| Characteristic | MenACWY-CRM | MenACWY-PS | Total |
|---|---|---|---|
| Age, Continuous | 5.8 Years STANDARD_DEVIATION 2.5 | 5.7 Years STANDARD_DEVIATION 2.5 | 5.8 Years STANDARD_DEVIATION 2.5 |
| Sex: Female, Male Female | 482 Participants | 288 Participants | 770 Participants |
| Sex: Female, Male Male | 468 Participants | 262 Participants | 730 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 409 / 950 | 271 / 550 |
| serious Total, serious adverse events | 9 / 950 | 1 / 550 |
Outcome results
Primary
Number of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination
Safety was assessed in terms of the number of subjects who reported at least one severe systemic reaction after vaccination with MenACWY-CRM or MenACWY-PS from day 1 to day 7 after vaccination.
Time frame: Day 1 to 7 postvaccination
Population: Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MenACWY-CRM | Number of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination | 11 Number of subjects |
| MenACWY-PS | Number of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination | 1 Number of subjects |
95% CI: [0.82, 49.2]Risk ratio(MenACWY-CRM/MenACWY-PS)
Primary
Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Immunogenicity was measured as the percentage of subjects with hSBA seroresponse, directed against each of meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), one month after vaccination (day 29)with MenACWY-CRM or MenACWY-PS vaccine. Seroresponse was defined as: 1. for subjects with a prevaccination hSBA titer \<1:4, a postvaccination hSBA titer ≥1:8; 2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
Time frame: 1 month after vaccination (day 29)
Population: Analysis was done on the per-protocol (PP) dataset of primary vaccination, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at one month after vaccination; and had no major protocol violations as defined in the analysis plan.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM | Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A | 93 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (N=147,144) | 82 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (N=143,142) | 74 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (N=146,146) | 82 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (N=146,146) | 63 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A | 55 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (N=143,142) | 46 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (N=147,144) | 52 Percentage of subjects |
Comparison: Comparison of hSBA seroresponse for the serogroup A one month after vaccination of MenACWY-CRM and MenACWY-PS95% CI: [29, 47]Chi-squared
Comparison: Comparison of hSBA seroresponse for the serogroup C one month after vaccination of MenACWY-CRM and MenACWY-PS95% CI: [19, 40]Chi-squared
Comparison: Comparison of hSBA seroresponse for the serogroup W one month after vaccination of MenACWY-CRM and MenACWY-PS95% CI: [17, 39]Chi-squared
Comparison: Comparison of hSBA seroresponse for the serogroup Y one month after vaccination of MenACWY-CRM and MenACWY-PS95% CI: [8, 28]Chi-squared
Secondary
Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
Safety was assessed as the number of subjects who reported local and systemic reactions and axillary temperature during day 1 to day 7 after vaccination with MenACWY-CRM or MenACWY-PS.
Time frame: Day 1 to 7 postvaccination
Population: Analysis was performed on safety dataset. Groups were sub-divided into 2 to 5 years of age and 6 to 10 years of age.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Diarrhea | 31 participants |
| MenACWY-CRM | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Injection site erythema | 75 participants |
| MenACWY-CRM | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Arthralgia | 26 participants |
| MenACWY-CRM | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Malaise | NA participants |
| MenACWY-CRM | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Headache | 46 participants |
| MenACWY-CRM | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Chills | NA participants |
| MenACWY-CRM | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Nausea | NA participants |
| MenACWY-CRM | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Injection site induration | 59 participants |
| MenACWY-CRM | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Axillary Temperature ≥38 °C | 35 participants |
| MenACWY-CRM | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Any systemic reaction | 130 participants |
| MenACWY-CRM | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Change in Eating Habits | 36 participants |
| MenACWY-CRM | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Any local reaction | 138 participants |
| MenACWY-CRM | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Sleepiness | 29 participants |
| MenACWY-CRM | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Any other AE | 69 participants |
| MenACWY-CRM | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Irritability | 36 participants |
| MenACWY-CRM | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Injection site pain | 89 participants |
| MenACWY-CRM | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Vomiting | 21 participants |
| MenACWY-CRM | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Analgesic/Antipyretic medicine used | 69 participants |
| MenACWY-CRM | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Myalgia | NA participants |
| MenACWY-PS | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Myalgia | NA participants |
| MenACWY-PS | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Any systemic reaction | 73 participants |
| MenACWY-PS | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Malaise | NA participants |
| MenACWY-PS | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Diarrhea | 20 participants |
| MenACWY-PS | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Arthralgia | 11 participants |
| MenACWY-PS | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Injection site erythema | 34 participants |
| MenACWY-PS | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Change in Eating Habits | 24 participants |
| MenACWY-PS | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Irritability | 18 participants |
| MenACWY-PS | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Headache | 22 participants |
| MenACWY-PS | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Any local reaction | 99 participants |
| MenACWY-PS | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Nausea | NA participants |
| MenACWY-PS | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Any other AE | 42 participants |
| MenACWY-PS | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Chills | NA participants |
| MenACWY-PS | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Axillary Temperature ≥38 °C | 18 participants |
| MenACWY-PS | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Vomiting | 9 participants |
| MenACWY-PS | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Sleepiness | 13 participants |
| MenACWY-PS | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Injection site induration | 23 participants |
| MenACWY-PS | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Analgesic/Antipyretic medicine used | 42 participants |
| MenACWY-PS | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Injection site pain | 68 participants |
| MenACWY-CRM_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Any other AE | 69 participants |
| MenACWY-CRM_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Any systemic reaction | 119 participants |
| MenACWY-CRM_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Myalgia | 35 participants |
| MenACWY-CRM_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Any local reaction | 189 participants |
| MenACWY-CRM_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Injection site pain | 132 participants |
| MenACWY-CRM_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Injection site erythema | 91 participants |
| MenACWY-CRM_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Injection site induration | 84 participants |
| MenACWY-CRM_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Change in Eating Habits | NA participants |
| MenACWY-CRM_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Sleepiness | NA participants |
| MenACWY-CRM_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Irritability | NA participants |
| MenACWY-CRM_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Vomiting | NA participants |
| MenACWY-CRM_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Diarrhea | NA participants |
| MenACWY-CRM_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Arthralgia | 18 participants |
| MenACWY-CRM_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Headache | 74 participants |
| MenACWY-CRM_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Chills | 18 participants |
| MenACWY-CRM_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Nausea | 16 participants |
| MenACWY-CRM_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Malaise | 50 participants |
| MenACWY-CRM_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Axillary Temperature ≥38 °C | 20 participants |
| MenACWY-CRM_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Analgesic/Antipyretic medicine used | 69 participants |
| MenACWY-PS_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Arthralgia | 15 participants |
| MenACWY-PS_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Diarrhea | NA participants |
| MenACWY-PS_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Any systemic reaction | 69 participants |
| MenACWY-PS_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Malaise | 28 participants |
| MenACWY-PS_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Vomiting | NA participants |
| MenACWY-PS_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Irritability | NA participants |
| MenACWY-PS_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Myalgia | 25 participants |
| MenACWY-PS_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Sleepiness | NA participants |
| MenACWY-PS_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Change in Eating Habits | NA participants |
| MenACWY-PS_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Any local reaction | 125 participants |
| MenACWY-PS_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Any other AE | 47 participants |
| MenACWY-PS_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Injection site induration | 38 participants |
| MenACWY-PS_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Injection site erythema | 37 participants |
| MenACWY-PS_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Analgesic/Antipyretic medicine used | 47 participants |
| MenACWY-PS_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Axillary Temperature ≥38 °C | 16 participants |
| MenACWY-PS_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Chills | 17 participants |
| MenACWY-PS_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Headache | 46 participants |
| MenACWY-PS_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Injection site pain | 100 participants |
| MenACWY-PS_6 to 10 Years | Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS | Nausea | 11 participants |
Secondary
Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month (day 29)after one vaccination with MenACWY-CRM or MenACWY-PS.
Time frame: Day 1 and 29
Population: Analysis was performed on the PP dataset of primary vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A (hSBA ≥1:4)- Day 1 | 5 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A (hSBA ≥1:8)- Day 1 | 4 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (hSBA ≥1:4)- Day 1 (N=143,142) | 40 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A (hSBA ≥1:8)- Day 29 | 95 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (hSBA ≥1:4)- Day 1 (N=147,144) | 26 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (hSBA ≥1:8)- Day 1 (N=147,144) | 16 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (hSBA ≥1:4)- Day 29 (N=143,142) | 99 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (hSBA ≥1:8)- Day 29 (N=147,144) | 88 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A (hSBA ≥1:4)- Day 29 | 95 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (hSBA ≥1:8)- Day 1 (N=143,142) | 38 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (hSBA ≥1:4)- Day 1 (N=146,146) | 17 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (hSBA ≥1:8)- Day 29 (N=143,142) | 99 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (hSBA ≥1:8)- Day 1 (N=146,146) | 14 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (hSBA ≥1:4)- Day 29 (N=147,144) | 91 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (hSBA ≥1:8)- Day 29 (N=146,146) | 89 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (hSBA ≥1:4)- Day 29 (N=146,146) | 90 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (hSBA ≥1:8)- Day 29 (N=146,146) | 66 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A (hSBA ≥1:4)- Day 1 | 3 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A (hSBA ≥1:4)- Day 29 | 55 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (hSBA ≥1:4)- Day 1 (N=147,144) | 31 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (hSBA ≥1:4)- Day 29 (N=147,144) | 80 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (hSBA ≥1:4)- Day 1 (N=143,142) | 37 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (hSBA ≥1:4)- Day 29 (N=143,142) | 78 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (hSBA ≥1:4)- Day 1 (N=146,146) | 15 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (hSBA ≥1:4)- Day 29 (N=146,146) | 77 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A (hSBA ≥1:8)- Day 1 | 2 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A (hSBA ≥1:8)- Day 29 | 55 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (hSBA ≥1:8)- Day 1 (N=147,144) | 20 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (hSBA ≥1:8)- Day 29 (N=147,144) | 70 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (hSBA ≥1:8)- Day 1 (N=143,142) | 35 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (hSBA ≥1:8)- Day 1 (N=146,146) | 11 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (hSBA ≥1:8)- Day 29 (N=143,142) | 73 Percentage of subjects |
Secondary
Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
The persistence of immune response was measured as the percentage of subjects with hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at day 181 after vaccination with MenACWY-CRM or MenACWY-PS.
Time frame: Day 181
Population: Analysis was performed on PP dataset for persistence analysis at day 181.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A(≥1:4)-Day 29 (1 month postvaccination) | 96 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A(≥1:4)-Day 181(6 months postvaccination | 39 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (hSBA ≥1:4) - Day 29 (N=141,139) | 91 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (hSBA ≥1:4) - Day 181 (N=141,139) | 87 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (hSBA ≥1:4) - Day 29 (N=137,137) | 99 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (hSBA ≥1:4) - Day 181 (N=137,137) | 97 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (hSBA ≥1:4) - Day 29 (N=140,141) | 90 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (hSBA ≥1:4) - Day 181 (N=140,141) | 94 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A (hSBA ≥1:8) - Day 29 | 95 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A (hSBA ≥1:8) - Day 181 | 35 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (hSBA ≥1:8) - Day 29 (N=141,139) | 88 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (hSBA ≥1:8) - Day 181 (N=141,139) | 81 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (hSBA ≥1:8) - Day 29 (N=137,137) | 99 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (hSBA ≥1:8) - Day 181 (N=137,137) | 96 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (hSBA ≥1:8) - Day 29 (N=140,141) | 89 Percentage of subjects |
| MenACWY-CRM | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (hSBA ≥1:8) - Day 181 (N=140,141) | 89 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (hSBA ≥1:8) - Day 181 (N=140,141) | 59 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A(≥1:4)-Day 29 (1 month postvaccination) | 54 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A (hSBA ≥1:8) - Day 29 | 54 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A(≥1:4)-Day 181(6 months postvaccination | 41 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (hSBA ≥1:8) - Day 29 (N=137,137) | 72 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (hSBA ≥1:4) - Day 29 (N=141,139) | 79 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A (hSBA ≥1:8) - Day 181 | 38 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (hSBA ≥1:4) - Day 181 (N=141,139) | 71 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (hSBA ≥1:8) - Day 29 (N=140,141) | 67 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (hSBA ≥1:4) - Day 29 (N=137,137) | 78 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (hSBA ≥1:8) - Day 29 (N=141,139) | 70 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (hSBA ≥1:4) - Day 181 (N=137,137) | 69 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (hSBA ≥1:8) - Day 181 (N=137,137) | 66 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (hSBA ≥1:4) - Day 29 (N=140,141) | 77 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (hSBA ≥1:8) - Day 181 (N=141,139) | 55 Percentage of subjects |
| MenACWY-PS | Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (hSBA ≥1:4) - Day 181 (N=140,141) | 65 Percentage of subjects |
Secondary
The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
The immune response was measured as the hSBA geometric mean titers (GMTs) directed against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month(day 29) after one vaccination with MenACWY-CRM or MenACWY-PS.
Time frame: Day 1 and 29
Population: Analysis was performed on the PP dataset of primary vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-CRM | The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A - Day 1 | 2.25 Geometric Mean Titers |
| MenACWY-CRM | The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A - Day 29 | 65 Geometric Mean Titers |
| MenACWY-CRM | The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (N=147,144) - Day 1 | 3.09 Geometric Mean Titers |
| MenACWY-CRM | The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (N=147,144) - Day 29 | 42 Geometric Mean Titers |
| MenACWY-CRM | The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (N=143,142) - Day 1 | 6.22 Geometric Mean Titers |
| MenACWY-CRM | The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (N=143,142) - Day 29 | 72 Geometric Mean Titers |
| MenACWY-CRM | The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (N=146,146) - Day 1 | 2.81 Geometric Mean Titers |
| MenACWY-CRM | The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (N=146,146) - Day 29 | 47 Geometric Mean Titers |
| MenACWY-PS | The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (N=146,146) - Day 29 | 25 Geometric Mean Titers |
| MenACWY-PS | The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A - Day 1 | 2.09 Geometric Mean Titers |
| MenACWY-PS | The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (N=143,142) - Day 1 | 5.40 Geometric Mean Titers |
| MenACWY-PS | The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A - Day 29 | 11 Geometric Mean Titers |
| MenACWY-PS | The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (N=146,146) - Day 1 | 2.64 Geometric Mean Titers |
| MenACWY-PS | The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (N=147,144) - Day 1 | 3.27 Geometric Mean Titers |
| MenACWY-PS | The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (N=143,142) - Day 29 | 20 Geometric Mean Titers |
| MenACWY-PS | The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (N=147,144) - Day 29 | 20 Geometric Mean Titers |
Secondary
The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
The persistence of immune response was measured in terms of the hSBA GMTs persisting at day 181 against each of four meningococcal serogroups A, C, W and Y after vaccination with MenACWY-CRM or MenACWY-PS
Time frame: Day 181
Population: Analysis was performed on the PP dataset for persistence analysis at day 181.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-CRM | The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A - Day 29 (1 month post vaccination) | 66 Geometric Mean Titers |
| MenACWY-CRM | The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A - Day 181 (6 months post vaccination) | 5.06 Geometric Mean Titers |
| MenACWY-CRM | The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (N=141,139) - Day 29 | 41 Geometric Mean Titers |
| MenACWY-CRM | The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (N=141,139) - Day 181 | 22 Geometric Mean Titers |
| MenACWY-CRM | The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (N=137,137) - Day 29 | 74 Geometric Mean Titers |
| MenACWY-CRM | The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (N=137,137) - Day 181 | 69 Geometric Mean Titers |
| MenACWY-CRM | The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (N=140,141) - Day 29 | 47 Geometric Mean Titers |
| MenACWY-CRM | The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (N=140,141) - Day 181 | 39 Geometric Mean Titers |
| MenACWY-PS | The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (N=140,141) - Day 181 | 14 Geometric Mean Titers |
| MenACWY-PS | The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A - Day 29 (1 month post vaccination) | 11 Geometric Mean Titers |
| MenACWY-PS | The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (N=137,137) - Day 29 | 21 Geometric Mean Titers |
| MenACWY-PS | The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup A - Day 181 (6 months post vaccination) | 5.85 Geometric Mean Titers |
| MenACWY-PS | The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup Y (N=140,141) - Day 29 | 26 Geometric Mean Titers |
| MenACWY-PS | The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (N=141,139) - Day 29 | 20 Geometric Mean Titers |
| MenACWY-PS | The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup W (N=137,137) - Day 181 | 16 Geometric Mean Titers |
| MenACWY-PS | The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS | Serogroup C (N=141,139) - Day 181 | 11 Geometric Mean Titers |