Meningococcal Disease
Conditions
Keywords
Meningitis
Brief summary
In this extension study, V59P20E1, the sponsor was planning to assess 5-year antibody persistence in subjects who received one or two doses of MenACWY conjugate vaccine at 2 to 10 years of age, and to evaluate response to a booster dose administered 5 years after primary vaccination in the parent study V59P20 (NCT00616421).
Interventions
BIOLOGICALMeningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
Subjects received at day 1 a single dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.
Sponsors
Novartis Vaccines
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 15 Years
Healthy volunteers
Yes
Inclusion criteria
In order to participate in this study, all subjects must meet ALL of the inclusion criteria described. 1. Subject has (a) parent(s) or legal guardian(s) who has/have given written consent after the nature of the study has been explained according to local regulatory requirements. 2. If the subject is of an age where, according to local regulations, informed assent is required, that subject has provided assent to participate in the study. 3. Subject is in good health as determined by the outcome of medical history, physical examination, and clinical judgment of the investigator. 4. A negative urine pregnancy test is required before female subjects of childbearing potential will be enrolled. Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy. 5. For subjects who participated in study V59P20 (Groups MenACWYCRM\_ 2 (≥7-≤10 Years), MenACWYCRM\_1 (≥7-≤10 Years) and MenACWYCRM\_ 1 (≥11-≤15 Years) only): * subject who enrolled in Groups MenACWYCRM\_2 (≥7-≤10 Years), MenACWYCRM\_1 (≥7-≤10 Years) and MenACWYCRM\_1 (≥11-≤15 Years) of study V59P20, has completed this study and included in per protocol immunogenicity analysis; * the date of first vaccination in study V59P20 occurred 54 to 66 months prior to the collection of the blood sample at Visit 1. 6. For vaccine-naive subjects (Groups Vaccine Naive(≥7-≤10Years) and Vaccine Naive (≥11-≤15 Years) only): * Individual is a male or female 7 to 10 years of age (group Vaccine Naive(≥7-≤10Years)) or 11 to 15 years of age (Group Vaccine Naive (≥11-≤15 Years)).
Exclusion criteria
In order to participate in this study, all subjects must meet NONE of the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine | 5 years post-vaccination | The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported. The serum bactericidal antibodies directed against N.meningitidis serogroups, are measured by human complement Serum Bactericidal Assay (hSBA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects | 5 years post-vaccination; baseline for naive | The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine five years earlier in the parent study, are compared with the hSBA response in age matched vaccine-naive subjects. |
| Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Day 28 post-vaccination | The antibody response against N.meningitidis serogroups A, C, W and Y, at one month after one injection of Men ACWY-CRM vaccine was administered in the present study to subjects who had received either one or two doses of MenACWY-CRM vaccine 5 years earlier and to age matched naive subjects, is evaluated in terms of the percentages of subjects with hSBA titers ≥1:8. |
| Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine. | 5 years post-vaccination | The persistence of geometric mean titers (GMTs) against N.meningitidis serogroups A, C, W and Y in subjects who had received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported. |
| Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Day 1 to day 7 post-vaccination | The number of subjects reporting solicited local and systemic adverse events after one injection of MenACWY-CRM vaccine was administered in the present study to, 1. Subjects, who had 5 years earlier received either one or two doses of MenACWY-CRM vaccine 2. Vaccine-naive subjects. |
| Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Day 1 to day 28 | The safety and tolerability of one injection of MenACWY-CRM vaccine, administered in the present study, was evaluated in terms of the number of subjects reporting unsolicited adverse events, serious adverse events and adverse events leading to premature withdrawal. |
| Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Day 28 post-vaccination | The antibody response against N.meningitidis serogroups A, C, W and Y, at one month after one injection of Men ACWY-CRM vaccine was administered in the present study to subjects who had received either one or two doses of MenACWY-CRM vaccine 5 years earlier and to age matched naive subjects, is evaluated in terms of GMTs. |
Countries
Ukraine, United States
Participant flow
Recruitment details
Subjects were recruited from 22 study sites.
Pre-assignment details
All subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| MenACWY-CRM_2 (≥7-≤10 Years) Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age. | 73 |
| MenACWY-CRM_1 (≥7-≤10 Years) Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age. | 103 |
| Vaccine Naive (≥7-≤10 Years) Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine. | 120 |
| MenACWY-CRM_1 (≥11-≤15 Years) Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age. | 66 |
| Vaccine Naive (≥11-≤15 Years) Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine. | 101 |
| Not Assigned Two subjects 2-5 years of age were randomized to receive another meningococcal ACWY vaccine (not the investigational product in the extension study) in the parent study and therefore not eligible for enrolment into the extension study. These subjects were inadvertently enrolled and completed the extension study. During analysis, these two subjects were included in a separate not assigned group in the FAS and excluded from the PPS. However, one of these subjects actually received the investigational vaccine (due to a randomization error) in the parent study and was included in the safety analyses under MenACWY-CRM\_1 (≥7-≤10 Years) group in the extension study. | 2 |
| Total | 465 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 | 1 | 1 | 0 |
| Overall Study | Met exclusion criterion No 6 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Subject moved out of the state | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Visit 1 delayed, unable to reschedule | 0 | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | MenACWY-CRM_2 (≥7-≤10 Years) | MenACWY-CRM_1 (≥7-≤10 Years) | Vaccine Naive (≥7-≤10 Years) | MenACWY-CRM_1 (≥11-≤15 Years) | Vaccine Naive (≥11-≤15 Years) | Not Assigned | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 8.3 years STANDARD_DEVIATION 1.1 | 8.1 years STANDARD_DEVIATION 1.2 | 8.5 years STANDARD_DEVIATION 1.1 | 13.0 years STANDARD_DEVIATION 1.6 | 11.8 years STANDARD_DEVIATION 1 | 8.0 years STANDARD_DEVIATION 1.4 | 9.7 years STANDARD_DEVIATION 2.3 |
| Sex: Female, Male Female | 35 Participants | 49 Participants | 63 Participants | 28 Participants | 46 Participants | 1 Participants | 222 Participants |
| Sex: Female, Male Male | 38 Participants | 54 Participants | 57 Participants | 38 Participants | 55 Participants | 1 Participants | 243 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 48 / 73 | 70 / 102 | 77 / 120 | 46 / 65 | 66 / 100 |
| serious Total, serious adverse events | 0 / 73 | 0 / 102 | 1 / 120 | 0 / 65 | 1 / 100 |
Outcome results
Primary
Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine
The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported. The serum bactericidal antibodies directed against N.meningitidis serogroups, are measured by human complement Serum Bactericidal Assay (hSBA).
Time frame: 5 years post-vaccination
Population: The analysis was done on per-protocol population i.e all subjects who provided immunogenicity data; had no major protocol deviations and who were not excluded due to other reasons defined prior to analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM_2 (≥7-≤10 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine | Serogroup A (N=68, 96, 64) | 7 Percentages of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine | Serogroup C (N= 69, 96, 64) | 48 Percentages of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine | Serogroup W (N= 69, 96, 64) | 83 Percentages of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine | Serogroup Y | 50 Percentages of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine | Serogroup Y | 48 Percentages of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine | Serogroup A (N=68, 96, 64) | 14 Percentages of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine | Serogroup W (N= 69, 96, 64) | 74 Percentages of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine | Serogroup C (N= 69, 96, 64) | 32 Percentages of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine | Serogroup Y | 53 Percentages of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine | Serogroup C (N= 69, 96, 64) | 56 Percentages of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine | Serogroup W (N= 69, 96, 64) | 80 Percentages of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine | Serogroup A (N=68, 96, 64) | 22 Percentages of subjects |
Secondary
Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.
The antibody response against N.meningitidis serogroups A, C, W and Y, at one month after one injection of Men ACWY-CRM vaccine was administered in the present study to subjects who had received either one or two doses of MenACWY-CRM vaccine 5 years earlier and to age matched naive subjects, is evaluated in terms of GMTs.
Time frame: Day 28 post-vaccination
Population: The analysis was done on per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-CRM_2 (≥7-≤10 Years) | Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup A (N= 63, 95, 109, 60, 85) | 321 Titers |
| MenACWY-CRM_2 (≥7-≤10 Years) | Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup C (N= 65, 94, 109, 60, 85) | 760 Titers |
| MenACWY-CRM_2 (≥7-≤10 Years) | Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup W (N= 63, 95, 110, 60, 85) | 1571 Titers |
| MenACWY-CRM_2 (≥7-≤10 Years) | Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup Y (N= 65, 94, 110, 59, 85) | 1286 Titers |
| MenACWY-CRM_1 (≥7-≤10 Years) | Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup A (N= 63, 95, 109, 60, 85) | 361 Titers |
| MenACWY-CRM_1 (≥7-≤10 Years) | Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup Y (N= 65, 94, 110, 59, 85) | 1693 Titers |
| MenACWY-CRM_1 (≥7-≤10 Years) | Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup C (N= 65, 94, 109, 60, 85) | 498 Titers |
| MenACWY-CRM_1 (≥7-≤10 Years) | Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup W (N= 63, 95, 110, 60, 85) | 1534 Titers |
| MenACWY-CRM_1 (≥11-≤15 Years) | Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup Y (N= 65, 94, 110, 59, 85) | 48 Titers |
| MenACWY-CRM_1 (≥11-≤15 Years) | Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup C (N= 65, 94, 109, 60, 85) | 48 Titers |
| MenACWY-CRM_1 (≥11-≤15 Years) | Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup W (N= 63, 95, 110, 60, 85) | 55 Titers |
| MenACWY-CRM_1 (≥11-≤15 Years) | Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup A (N= 63, 95, 109, 60, 85) | 28 Titers |
| MenACWY-CRM_1 (≥11-≤15 Years) | Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup A (N= 63, 95, 109, 60, 85) | 350 Titers |
| MenACWY-CRM_1 (≥11-≤15 Years) | Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup C (N= 65, 94, 109, 60, 85) | 712 Titers |
| MenACWY-CRM_1 (≥11-≤15 Years) | Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup Y (N= 65, 94, 110, 59, 85) | 1442 Titers |
| MenACWY-CRM_1 (≥11-≤15 Years) | Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup W (N= 63, 95, 110, 60, 85) | 1556 Titers |
| Vaccine Naive (≥11-≤15 Years) | Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup Y (N= 65, 94, 110, 59, 85) | 45 Titers |
| Vaccine Naive (≥11-≤15 Years) | Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup W (N= 63, 95, 110, 60, 85) | 69 Titers |
| Vaccine Naive (≥11-≤15 Years) | Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup C (N= 65, 94, 109, 60, 85) | 102 Titers |
| Vaccine Naive (≥11-≤15 Years) | Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup A (N= 63, 95, 109, 60, 85) | 31 Titers |
Secondary
Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.
The number of subjects reporting solicited local and systemic adverse events after one injection of MenACWY-CRM vaccine was administered in the present study to, 1. Subjects, who had 5 years earlier received either one or two doses of MenACWY-CRM vaccine 2. Vaccine-naive subjects.
Time frame: Day 1 to day 7 post-vaccination
Population: The analysis was done on solicited safety set, ie, all subjects in the exposed set who provided post vaccination solicited reactogenicity data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM_2 (≥7-≤10 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Injection site induration (N= 68, 99, 119, 64, 98) | 12 Number of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Thera. use anal/antipyret (N= 69, 99, 118, 64, 97) | 14 Number of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Prophyl. use analg/antip (N= 68, 99, 118, 63, 97) | 0 Number of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Malaise (N= 69, 99, 117, 64, 98) | 15 Number of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Chills (N= 68, 99, 117, 64, 98) | 5 Number of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Fever (≥38°C; N= 66, 99, 115, 64, 96) | 1 Number of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Nausea (N= 68, 99, 117, 64, 97) | 10 Number of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Injection site erythema (N= 68, 99, 117, 64, 98) | 10 Number of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Injection site pain (N= 68, 99, 117, 64, 98) | 39 Number of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Headache (N= 69, 99, 117, 64, 97) | 13 Number of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Arthralgia (N= 69, 99, 117, 64, 98) | 8 Number of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Myalgia (N= 69, 99, 117, 64, 98) | 9 Number of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Malaise (N= 69, 99, 117, 64, 98) | 14 Number of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Prophyl. use analg/antip (N= 68, 99, 118, 63, 97) | 1 Number of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Injection site pain (N= 68, 99, 117, 64, 98) | 52 Number of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Injection site erythema (N= 68, 99, 117, 64, 98) | 13 Number of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Injection site induration (N= 68, 99, 119, 64, 98) | 12 Number of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Chills (N= 68, 99, 117, 64, 98) | 3 Number of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Myalgia (N= 69, 99, 117, 64, 98) | 8 Number of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Arthralgia (N= 69, 99, 117, 64, 98) | 4 Number of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Headache (N= 69, 99, 117, 64, 97) | 9 Number of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Nausea (N= 68, 99, 117, 64, 97) | 11 Number of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Fever (≥38°C; N= 66, 99, 115, 64, 96) | 0 Number of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Thera. use anal/antipyret (N= 69, 99, 118, 64, 97) | 12 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Malaise (N= 69, 99, 117, 64, 98) | 13 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Myalgia (N= 69, 99, 117, 64, 98) | 8 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Injection site pain (N= 68, 99, 117, 64, 98) | 42 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Arthralgia (N= 69, 99, 117, 64, 98) | 5 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Injection site erythema (N= 68, 99, 117, 64, 98) | 10 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Headache (N= 69, 99, 117, 64, 97) | 22 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Thera. use anal/antipyret (N= 69, 99, 118, 64, 97) | 11 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Nausea (N= 68, 99, 117, 64, 97) | 12 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Fever (≥38°C; N= 66, 99, 115, 64, 96) | 3 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Prophyl. use analg/antip (N= 68, 99, 118, 63, 97) | 2 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Chills (N= 68, 99, 117, 64, 98) | 6 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Injection site induration (N= 68, 99, 119, 64, 98) | 7 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Arthralgia (N= 69, 99, 117, 64, 98) | 4 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Headache (N= 69, 99, 117, 64, 97) | 12 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Prophyl. use analg/antip (N= 68, 99, 118, 63, 97) | 1 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Injection site induration (N= 68, 99, 119, 64, 98) | 7 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Nausea (N= 68, 99, 117, 64, 97) | 7 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Injection site pain (N= 68, 99, 117, 64, 98) | 31 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Thera. use anal/antipyret (N= 69, 99, 118, 64, 97) | 11 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Malaise (N= 69, 99, 117, 64, 98) | 11 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Chills (N= 68, 99, 117, 64, 98) | 1 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Myalgia (N= 69, 99, 117, 64, 98) | 4 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Injection site erythema (N= 68, 99, 117, 64, 98) | 10 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Fever (≥38°C; N= 66, 99, 115, 64, 96) | 1 Number of subjects |
| Vaccine Naive (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Arthralgia (N= 69, 99, 117, 64, 98) | 8 Number of subjects |
| Vaccine Naive (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Chills (N= 68, 99, 117, 64, 98) | 2 Number of subjects |
| Vaccine Naive (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Thera. use anal/antipyret (N= 69, 99, 118, 64, 97) | 6 Number of subjects |
| Vaccine Naive (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Injection site induration (N= 68, 99, 119, 64, 98) | 8 Number of subjects |
| Vaccine Naive (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Myalgia (N= 69, 99, 117, 64, 98) | 8 Number of subjects |
| Vaccine Naive (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Headache (N= 69, 99, 117, 64, 97) | 21 Number of subjects |
| Vaccine Naive (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Injection site pain (N= 68, 99, 117, 64, 98) | 47 Number of subjects |
| Vaccine Naive (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Malaise (N= 69, 99, 117, 64, 98) | 19 Number of subjects |
| Vaccine Naive (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Injection site erythema (N= 68, 99, 117, 64, 98) | 6 Number of subjects |
| Vaccine Naive (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Prophyl. use analg/antip (N= 68, 99, 118, 63, 97) | 1 Number of subjects |
| Vaccine Naive (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Nausea (N= 68, 99, 117, 64, 97) | 8 Number of subjects |
| Vaccine Naive (≥11-≤15 Years) | Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Fever (≥38°C; N= 66, 99, 115, 64, 96) | 0 Number of subjects |
Secondary
Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.
The safety and tolerability of one injection of MenACWY-CRM vaccine, administered in the present study, was evaluated in terms of the number of subjects reporting unsolicited adverse events, serious adverse events and adverse events leading to premature withdrawal.
Time frame: Day 1 to day 28
Population: The analysis was done on unsolicited safety set, ie, all exposed subjects who provided unsolicited adverse events (AE) data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM_2 (≥7-≤10 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Possibly/Probably related unsolicited AE | 4 Number of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Death | 0 Number of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Any SAE | 0 Number of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | AE leading to withdrawal | 0 Number of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Possibly/Probably related SAE | 0 Number of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Any adverse event (AE) | 18 Number of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Any SAE | 0 Number of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Death | 0 Number of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Possibly/Probably related unsolicited AE | 3 Number of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Any adverse event (AE) | 23 Number of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Possibly/Probably related SAE | 0 Number of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | AE leading to withdrawal | 0 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Possibly/Probably related unsolicited AE | 4 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Any SAE | 1 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Any adverse event (AE) | 19 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Possibly/Probably related SAE | 0 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Death | 0 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | AE leading to withdrawal | 0 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Possibly/Probably related unsolicited AE | 7 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Possibly/Probably related SAE | 0 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Any SAE | 0 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Any adverse event (AE) | 18 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Death | 0 Number of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | AE leading to withdrawal | 0 Number of subjects |
| Vaccine Naive (≥11-≤15 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Death | 0 Number of subjects |
| Vaccine Naive (≥11-≤15 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Any adverse event (AE) | 11 Number of subjects |
| Vaccine Naive (≥11-≤15 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Possibly/Probably related unsolicited AE | 5 Number of subjects |
| Vaccine Naive (≥11-≤15 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Any SAE | 1 Number of subjects |
| Vaccine Naive (≥11-≤15 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Possibly/Probably related SAE | 0 Number of subjects |
| Vaccine Naive (≥11-≤15 Years) | Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | AE leading to withdrawal | 0 Number of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.
The antibody response against N.meningitidis serogroups A, C, W and Y, at one month after one injection of Men ACWY-CRM vaccine was administered in the present study to subjects who had received either one or two doses of MenACWY-CRM vaccine 5 years earlier and to age matched naive subjects, is evaluated in terms of the percentages of subjects with hSBA titers ≥1:8.
Time frame: Day 28 post-vaccination
Population: The analysis was done on per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM_2 (≥7-≤10 Years) | Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup A (N= 63, 95, 109, 60, 85) | 98 Percentages of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup C (N= 65, 94, 109, 60, 85) | 100 Percentages of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup W (N= 63, 95, 110, 60, 85) | 100 Percentages of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup Y (N= 65, 94, 110, 59, 85) | 100 Percentages of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup A (N= 63, 95, 109, 60, 85) | 100 Percentages of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup Y (N= 65, 94, 110, 59, 85) | 100 Percentages of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup C (N= 65, 94, 109, 60, 85) | 100 Percentages of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup W (N= 63, 95, 110, 60, 85) | 100 Percentages of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup Y (N= 65, 94, 110, 59, 85) | 85 Percentages of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup C (N= 65, 94, 109, 60, 85) | 82 Percentages of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup W (N= 63, 95, 110, 60, 85) | 94 Percentages of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup A (N= 63, 95, 109, 60, 85) | 75 Percentages of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup A (N= 63, 95, 109, 60, 85) | 100 Percentages of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup C (N= 65, 94, 109, 60, 85) | 100 Percentages of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup Y (N= 65, 94, 110, 59, 85) | 100 Percentages of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup W (N= 63, 95, 110, 60, 85) | 100 Percentages of subjects |
| Vaccine Naive (≥11-≤15 Years) | Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup Y (N= 65, 94, 110, 59, 85) | 82 Percentages of subjects |
| Vaccine Naive (≥11-≤15 Years) | Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup W (N= 63, 95, 110, 60, 85) | 92 Percentages of subjects |
| Vaccine Naive (≥11-≤15 Years) | Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup C (N= 65, 94, 109, 60, 85) | 86 Percentages of subjects |
| Vaccine Naive (≥11-≤15 Years) | Percentages of Subjects With hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. | Serogroup A (N= 63, 95, 109, 60, 85) | 80 Percentages of subjects |
Secondary
Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects
The percentages of subjects with persisting serum bactericidal antibody ≥1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine five years earlier in the parent study, are compared with the hSBA response in age matched vaccine-naive subjects.
Time frame: 5 years post-vaccination; baseline for naive
Population: The analysis was done on per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM_2 (≥7-≤10 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects | Serogroup A (N= 68, 96, 118, 64, 100) | 7 Percentages of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects | Serogroup C (N= 69, 96, 118, 64, 99) | 48 Percentages of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects | Serogroup W (N= 69, 96, 118, 64, 100) | 83 Percentages of subjects |
| MenACWY-CRM_2 (≥7-≤10 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects | Serogroup Y | 50 Percentages of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects | Serogroup A (N= 68, 96, 118, 64, 100) | 14 Percentages of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects | Serogroup Y | 48 Percentages of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects | Serogroup C (N= 69, 96, 118, 64, 99) | 32 Percentages of subjects |
| MenACWY-CRM_1 (≥7-≤10 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects | Serogroup W (N= 69, 96, 118, 64, 100) | 74 Percentages of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects | Serogroup Y | 23 Percentages of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects | Serogroup C (N= 69, 96, 118, 64, 99) | 21 Percentages of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects | Serogroup W (N= 69, 96, 118, 64, 100) | 52 Percentages of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects | Serogroup A (N= 68, 96, 118, 64, 100) | 0 Percentages of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects | Serogroup A (N= 68, 96, 118, 64, 100) | 22 Percentages of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects | Serogroup C (N= 69, 96, 118, 64, 99) | 56 Percentages of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects | Serogroup Y | 53 Percentages of subjects |
| MenACWY-CRM_1 (≥11-≤15 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects | Serogroup W (N= 69, 96, 118, 64, 100) | 80 Percentages of subjects |
| Vaccine Naive (≥11-≤15 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects | Serogroup Y | 37 Percentages of subjects |
| Vaccine Naive (≥11-≤15 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects | Serogroup W (N= 69, 96, 118, 64, 100) | 54 Percentages of subjects |
| Vaccine Naive (≥11-≤15 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects | Serogroup C (N= 69, 96, 118, 64, 99) | 21 Percentages of subjects |
| Vaccine Naive (≥11-≤15 Years) | Percentages of Subjects With Persisting hSBA Titers ≥1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects | Serogroup A (N= 68, 96, 118, 64, 100) | 5 Percentages of subjects |
Secondary
Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine.
The persistence of geometric mean titers (GMTs) against N.meningitidis serogroups A, C, W and Y in subjects who had received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported.
Time frame: 5 years post-vaccination
Population: The analysis was done on per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-CRM_2 (≥7-≤10 Years) | Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine. | Serogroup A (N=68, 96, 64) | 2.41 Titers |
| MenACWY-CRM_2 (≥7-≤10 Years) | Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine. | Serogroup C (N= 69, 96, 64) | 7.55 Titers |
| MenACWY-CRM_2 (≥7-≤10 Years) | Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine. | Serogroup W (N= 69, 96, 64) | 23 Titers |
| MenACWY-CRM_2 (≥7-≤10 Years) | Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine. | Serogroup Y | 8.57 Titers |
| MenACWY-CRM_1 (≥7-≤10 Years) | Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine. | Serogroup Y | 8.13 Titers |
| MenACWY-CRM_1 (≥7-≤10 Years) | Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine. | Serogroup A (N=68, 96, 64) | 2.95 Titers |
| MenACWY-CRM_1 (≥7-≤10 Years) | Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine. | Serogroup W (N= 69, 96, 64) | 19 Titers |
| MenACWY-CRM_1 (≥7-≤10 Years) | Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine. | Serogroup C (N= 69, 96, 64) | 6.5 Titers |
| MenACWY-CRM_1 (≥11-≤15 Years) | Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine. | Serogroup Y | 10 Titers |
| MenACWY-CRM_1 (≥11-≤15 Years) | Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine. | Serogroup C (N= 69, 96, 64) | 12 Titers |
| MenACWY-CRM_1 (≥11-≤15 Years) | Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine. | Serogroup W (N= 69, 96, 64) | 26 Titers |
| MenACWY-CRM_1 (≥11-≤15 Years) | Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine. | Serogroup A (N=68, 96, 64) | 3.73 Titers |