Meningococcal Meningitis
Conditions
Keywords
meningitis, children, vaccine
Brief summary
To compare the functional immune response 28 days after administration of one dose of Men ACWY-CRM conjugate vaccine without adjuvant (MenACWY-CRM(Ad-)) with that of a Men ACWY polysaccharide (PS) vaccine
Interventions
BIOLOGICALMenACWY polysaccharide vaccine
Sponsors
Novartis
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Months to 59 Months
Healthy volunteers
Yes
Inclusion criteria
* healthy 12-\<60 month old children;
Exclusion criteria
* subjects who have previously received any meningococcal vaccine * subjects with any serious acute or chronic progressive disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | 28 days after first vaccination. | Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | 28 days after first vaccination | Immune response of one dose of MenACWY-CRM(Ad-) vaccine compared with that of one dose of MenACWY-PS vaccine, 28 days after administration in subjects 36-59 months of age, as measured by hSBA geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W, and Y. |
| hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | 6 months after first vaccination and 12 months after first vaccination | Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y. |
| Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | 6 months after first vaccination and 12 months after first vaccination | Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by the percentage of hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y. |
| Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | 6 months after first vaccination and 12 months after first vaccination | Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y. |
| hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | 21 days after second vaccination | Booster effect of a second dose of MenACWY-CRM(Ad-) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured 21 days after the booster dose by hSBA GMT against N. meningitidis serogroups A, C, W, and Y. |
| Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | 21 days after second vaccination | Booster effect of a second dose of MenACWY-CRM(-Ad) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS in children aged 36 to 59 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y. |
| Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | 21 days after the second vaccination | Booster effect of a second dose of MenACWY-CRM(Ad-) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS in children aged 36 to 59 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y. |
| Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | 28 days after first vaccination. | Immune response of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y. |
| hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | 28 days after first vaccination | Immune response of one dose of MenACWY-CRM vaccine with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y. |
| Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | 28 days after first vaccination. | Immune response of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by the percentage of subjects with human complement serum bactericidal antibody (hSBA) titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y. |
| Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | 21 days after second vaccination | Immune response to a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y. |
| Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | 28 days after first vaccination | Immune response of one dose of MenACWY-CRM(Ad-) compared to that of a MenACWY-PS vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentages of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y. |
| hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | 21 days after second vaccination | Immune response to a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after the initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y. |
| hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | 6 months after first vaccination and 12 months after first vaccination | Persistence of immune response at 6 or 12 months following administration of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y. |
| Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | 6 months after first vaccination and 12 months after first vaccination | Persistence of immune response at 6 or 12 months after one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y. |
| hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | 21 days after the second vaccination | Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y. |
| Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | 21 days after second vaccination | Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered either at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y. |
| hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | 12 months after second vaccination | Persistence of immune response at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y. |
| Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | 12 months after second vaccination | Persistence of immune response, at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y. |
| Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | 12 months after second vaccination | Persistence of immune response, at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y. |
| Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | From day 1 through day 7 after first or second vaccination(s) | Safety was assessed as the number of subjects 12 to 59 months of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the first or second vaccination(s) with MenACWY-CRM vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine. |
| Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | 28 days after first vaccination and 21 days after second vaccination | Safety was assessed as the number of subjects 12 to 59 months of age who reported serious adverse events (SAE), AEs necessitating a physician's visit and/or resulting in premature withdrawal from the study, AEs were to be collected between day 7 and the subsequent visit (approximately 1 month later) after the first or second vaccination(s) of MenACWY-CRM vaccine, with or without adjuvant, or MenACWY-PS vaccine. Any SAE were to be collected throughout the study. |
| Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | 21 days after second vaccination | Immune response to a second dose of either MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after the initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y. |
Countries
Finland, Poland
Participant flow
Recruitment details
Subjects were enrolled at one center in Finland and in two centers in Poland.
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| MenACWY-CRM(Ad+) 12 to 35 Months Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination. | 207 |
| MenACWY-CRM(Ad-) 12 to 35 Months Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination. | 206 |
| MenACWY-CRM(Ad-) 36 to 59 Months Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337. | 128 |
| MenACWY-PS (36 to 59 Months) Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337. | 82 |
| Total | 623 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | AE or Death | 3 | 1 | 0 | 0 |
| Overall Study | Inappropriate Enrollment | 1 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 1 | 1 |
| Overall Study | Unable to classify | 3 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 4 | 6 | 7 |
Baseline characteristics
| Characteristic | MenACWY-CRM(Ad+) 12 to 35 Months | MenACWY-CRM(Ad-) 12 to 35 Months | MenACWY-CRM(Ad-) 36 to 59 Months | MenACWY-PS (36 to 59 Months) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 24.1 Months STANDARD_DEVIATION 6.4 | 23.7 Months STANDARD_DEVIATION 6.2 | 45.1 Months STANDARD_DEVIATION 6.7 | 44.7 Months STANDARD_DEVIATION 6.4 | 31.0 Months STANDARD_DEVIATION 11.8 |
| Sex: Female, Male Female | 110 Participants | 107 Participants | 68 Participants | 44 Participants | 329 Participants |
| Sex: Female, Male Male | 97 Participants | 99 Participants | 60 Participants | 38 Participants | 294 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 155 / 205 | 158 / 206 | 97 / 125 | 58 / 81 |
| serious Total, serious adverse events | 13 / 205 | 12 / 206 | 11 / 125 | 9 / 81 |
Outcome results
Primary
Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age
Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
Time frame: 28 days after first vaccination.
Population: Analysis was done on per protocol (PP) dataset -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenA (Baseline; N=101,80) | 2 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenA (28 days after 1st vaccination; N=101,80) | 75 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenC (Baseline; N=99,79) | 14 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenC (28 days after 1st vaccination; N=99,79) | 60 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenW (Baseline; N=100,81) | 17 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenW (28 days after 1st vaccination; N=100,81) | 91 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenY (Baseline; N=100,79) | 10 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenY (28 days after 1st vaccination; N=100,79) | 77 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenY (28 days after 1st vaccination; N=100,79) | 67 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenA (Baseline; N=101,80) | 1 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenW (Baseline; N=100,81) | 19 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenA (28 days after 1st vaccination; N=101,80) | 55 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenY (Baseline; N=100,79) | 11 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenC (Baseline; N=99,79) | 10 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenW (28 days after 1st vaccination; N=100,81) | 67 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenC (28 days after 1st vaccination; N=99,79) | 52 percentages of subjects |
Secondary
hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age
Immune response of one dose of MenACWY-CRM(Ad-) vaccine compared with that of one dose of MenACWY-PS vaccine, 28 days after administration in subjects 36-59 months of age, as measured by hSBA geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W, and Y.
Time frame: 28 days after first vaccination
Population: Analysis was done on per protocol (PP) dataset -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenA (Baseline; N=101,80) | 2.06 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenC (Baseline; N=99,79) | 2.42 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenW (28 days after 1st vaccination; N=100,81) | 24 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenA (28 days after 1st vaccination; N=101,80) | 15 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenY (Baseline; N=100,79) | 2.42 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenC (28 days after 1st vaccination; N=99,79) | 7.12 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenY (28 days after 1st vaccination; N=100,79) | 21 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenW (Baseline; N=100,81) | 3.05 titers |
| MenACWY-PS (36 to 59 Months) | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenY (28 days after 1st vaccination; N=100,79) | 14 titers |
| MenACWY-PS (36 to 59 Months) | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenA (Baseline; N=101,80) | 2.03 titers |
| MenACWY-PS (36 to 59 Months) | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenA (28 days after 1st vaccination; N=101,80) | 6.82 titers |
| MenACWY-PS (36 to 59 Months) | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenC (Baseline; N=99,79) | 2.54 titers |
| MenACWY-PS (36 to 59 Months) | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenC (28 days after 1st vaccination; N=99,79) | 7.16 titers |
| MenACWY-PS (36 to 59 Months) | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenW (Baseline; N=100,81) | 3.14 titers |
| MenACWY-PS (36 to 59 Months) | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenW (28 days after 1st vaccination; N=100,81) | 12 titers |
| MenACWY-PS (36 to 59 Months) | hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenY (Baseline; N=100,79) | 2.46 titers |
Secondary
hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Immune response of one dose of MenACWY-CRM vaccine with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.
Time frame: 28 days after first vaccination
Population: Analysis was done on per protocol (PP) dataset -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA (Baseline) | 2 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW (Baseline) | 2.38 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW (28 days after 1st vaccination) | 17 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC (Baseline; N=198,190) | 2.16 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (Baseline; N=199,188) | 2.18 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA (28 days after 1st vaccination) | 18 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (28 days after 1st vaccination; N=199,188) | 12 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC (28 days after 1st vaccination; N=198,190) | 7.43 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (28 days after 1st vaccination; N=199,188) | 12 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA (Baseline) | 2 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA (28 days after 1st vaccination) | 13 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC (Baseline; N=198,190) | 2.05 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC (28 days after 1st vaccination; N=198,190) | 5.9 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW (28 days after 1st vaccination) | 16 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (Baseline; N=199,188) | 2.12 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMT After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW (Baseline) | 2.26 titers |
Secondary
hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.
Time frame: 21 days after the second vaccination
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA (N=54,56,57,56) | 168 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC (N=54,56,56,57) | 575 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW (N=57,55,57,56) | 1238 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=52,56,57,55) | 915 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC (N=54,56,56,57) | 586 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW (N=57,55,57,56) | 1263 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=52,56,57,55) | 983 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA (N=54,56,57,56) | 328 titers |
| MenACWY-PS (36-59 M6PS) | hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW (N=57,55,57,56) | 687 titers |
| MenACWY-PS (36-59 M6PS) | hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC (N=54,56,56,57) | 252 titers |
| MenACWY-PS (36-59 M6PS) | hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=52,56,57,55) | 489 titers |
| MenACWY-PS (36-59 M6PS) | hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA (N=54,56,57,56) | 141 titers |
| MenACWY-PS (36-59 M12PS) | hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=52,56,57,55) | 302 titers |
| MenACWY-PS (36-59 M12PS) | hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC (N=54,56,56,57) | 297 titers |
| MenACWY-PS (36-59 M12PS) | hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA (N=54,56,57,56) | 66 titers |
| MenACWY-PS (36-59 M12PS) | hSBA GMT After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW (N=57,55,57,56) | 518 titers |
Secondary
hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age
Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.
Time frame: 6 months after first vaccination and 12 months after first vaccination
Population: Analysis was done on PP dataset -subset of subjects in the MITT population for the evaluation of immunogenicity after the 1st dose of either MenACWY Ad+/PS vaccine, provided evaluable serum samples at day 169 day 358 and had no major protocol deviation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenA | 2.84 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenC (N=47,45,32,36) | 5.06 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenW (N=47,45,32,35) | 22 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenY (N=47,45,32,36) | 11 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenC (N=47,45,32,36) | 4.3 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenW (N=47,45,32,35) | 20 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenY (N=47,45,32,36) | 18 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenA | 2.51 titers |
| MenACWY-PS (36-59 M6PS) | hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenW (N=47,45,32,35) | 9.98 titers |
| MenACWY-PS (36-59 M6PS) | hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenC (N=47,45,32,36) | 3.33 titers |
| MenACWY-PS (36-59 M6PS) | hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenY (N=47,45,32,36) | 6.44 titers |
| MenACWY-PS (36-59 M6PS) | hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenA | 2.96 titers |
| MenACWY-PS (36-59 M12PS) | hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenY (N=47,45,32,36) | 5.29 titers |
| MenACWY-PS (36-59 M12PS) | hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenC (N=47,45,32,36) | 3.89 titers |
| MenACWY-PS (36-59 M12PS) | hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenA | 2.78 titers |
| MenACWY-PS (36-59 M12PS) | hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenW (N=47,45,32,35) | 13 titers |
Secondary
hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age
Persistence of immune response at 6 or 12 months following administration of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.
Time frame: 6 months after first vaccination and 12 months after first vaccination
Population: Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenA | 3.54 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenC | 10 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenW (N=57,54,56,54) | 21 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenY (N=57,55,55,52) | 12 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenC | 4.02 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenW (N=57,54,56,54) | 19 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenY (N=57,55,55,52) | 8.69 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenA | 2.54 titers |
| MenACWY-PS (36-59 M6PS) | hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenW (N=57,54,56,54) | 14 titers |
| MenACWY-PS (36-59 M6PS) | hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenC | 9.07 titers |
| MenACWY-PS (36-59 M6PS) | hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenY (N=57,55,55,52) | 10 titers |
| MenACWY-PS (36-59 M6PS) | hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenA | 2.66 titers |
| MenACWY-PS (36-59 M12PS) | hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenY (N=57,55,55,52) | 10 titers |
| MenACWY-PS (36-59 M12PS) | hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenC | 4.79 titers |
| MenACWY-PS (36-59 M12PS) | hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenA | 2.41 titers |
| MenACWY-PS (36-59 M12PS) | hSBA GMTs After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenW (N=57,54,56,54) | 8.19 titers |
Secondary
hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age
Booster effect of a second dose of MenACWY-CRM(Ad-) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured 21 days after the booster dose by hSBA GMT against N. meningitidis serogroups A, C, W, and Y.
Time frame: 21 days after second vaccination
Population: Analysis was done on per protocol (PP) dataset, Immunogenicity after one dose of vaccine -subjects in the modified intention to treat population who received two doses of the study vaccine, provided an evaluable serum sample at baseline and 28 days after the second dose and had no major protocol deviation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenY | 247 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenC | 129 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenA | 51 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenW | 371 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenC | 472 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenW | 1120 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenA | 149 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenY | 911 titers |
| MenACWY-PS (36-59 M6PS) | hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenA | 72 titers |
| MenACWY-PS (36-59 M6PS) | hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenC | 7.33 titers |
| MenACWY-PS (36-59 M6PS) | hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenW | 38 titers |
| MenACWY-PS (36-59 M6PS) | hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenY | 22 titers |
| MenACWY-PS (36-59 M12PS) | hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenC | 17 titers |
| MenACWY-PS (36-59 M12PS) | hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenA | 116 titers |
| MenACWY-PS (36-59 M12PS) | hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenY | 24 titers |
| MenACWY-PS (36-59 M12PS) | hSBA GMTs After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenW | 82 titers |
Secondary
hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Immune response to a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after the initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.
Time frame: 21 days after second vaccination
Population: Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA (N=61,47) | 107 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC | 117 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW | 84 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=61,47) | 74 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=61,47) | 41 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA (N=61,47) | 39 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW | 61 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMTs After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC | 104 titers |
Secondary
hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age
Persistence of immune response at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by hSBA GMTs against N. meningitidis serogroups A, C, W, and Y.
Time frame: 12 months after second vaccination
Population: Analysis was done on PP dataset Immunogenicity of a booster dose - subset of subjects in the MITT population who received a booster dose of either MenACWY Ad+/Ad- conjugate vaccine, and provided evaluable serum samples at day 169, 358 \& had no major protocol deviation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenA (N=61,48) | 5.24 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenC | 13 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenW (N=61,47) | 29 titers |
| MenACWY-CRM(Ad-) (36 to 59 Months) | hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenY (N=61,48) | 19 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenY (N=61,48) | 19 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenA (N=61,48) | 4.15 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenW (N=61,47) | 25 titers |
| MenACWY-PS (36 to 59 Months) | hSBA GMTs After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenC | 18 titers |
Secondary
Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Safety was assessed as the number of subjects 12 to 59 months of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the first or second vaccination(s) with MenACWY-CRM vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine.
Time frame: From day 1 through day 7 after first or second vaccination(s)
Population: Analysis was done on Safety dataset - all subjects who received at least one dose of vaccine and with some post-baseline safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site tenderness | 73 Subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Irritability | 68 Subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea | 22 Subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomiting | 17 Subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Other | 44 Subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Analgesic/Antipyretic Med Used | 39 Subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema | 60 Subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Any Local | 100 Subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injetion site induration | 37 Subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Any systemic | 98 Subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fever (≥ 38°C) | 18 Subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Change in Eating Habits | 31 Subjects |
| MenACWY-PS (36 to 59 Months) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Any systemic | 103 Subjects |
| MenACWY-PS (36 to 59 Months) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea | 24 Subjects |
| MenACWY-PS (36 to 59 Months) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Other | 38 Subjects |
| MenACWY-PS (36 to 59 Months) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Irritability | 74 Subjects |
| MenACWY-PS (36 to 59 Months) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site tenderness | 79 Subjects |
| MenACWY-PS (36 to 59 Months) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Analgesic/Antipyretic Med Used | 35 Subjects |
| MenACWY-PS (36 to 59 Months) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injetion site induration | 38 Subjects |
| MenACWY-PS (36 to 59 Months) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomiting | 15 Subjects |
| MenACWY-PS (36 to 59 Months) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Any Local | 109 Subjects |
| MenACWY-PS (36 to 59 Months) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fever (≥ 38°C) | 23 Subjects |
| MenACWY-PS (36 to 59 Months) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Change in Eating Habits | 46 Subjects |
| MenACWY-PS (36 to 59 Months) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema | 63 Subjects |
| MenACWY-PS (36-59 M6PS) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Analgesic/Antipyretic Med Used | 20 Subjects |
| MenACWY-PS (36-59 M6PS) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Any Local | 70 Subjects |
| MenACWY-PS (36-59 M6PS) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site tenderness | 57 Subjects |
| MenACWY-PS (36-59 M6PS) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema | 37 Subjects |
| MenACWY-PS (36-59 M6PS) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injetion site induration | 25 Subjects |
| MenACWY-PS (36-59 M6PS) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Any systemic | 53 Subjects |
| MenACWY-PS (36-59 M6PS) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Change in Eating Habits | 20 Subjects |
| MenACWY-PS (36-59 M6PS) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Irritability | 31 Subjects |
| MenACWY-PS (36-59 M6PS) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomiting | 9 Subjects |
| MenACWY-PS (36-59 M6PS) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea | 12 Subjects |
| MenACWY-PS (36-59 M6PS) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fever (≥ 38°C) | 10 Subjects |
| MenACWY-PS (36-59 M6PS) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Other | 22 Subjects |
| MenACWY-PS (36-59 M12PS) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site tenderness | 42 Subjects |
| MenACWY-PS (36-59 M12PS) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Diarrhea | 1 Subjects |
| MenACWY-PS (36-59 M12PS) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Any systemic | 26 Subjects |
| MenACWY-PS (36-59 M12PS) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injetion site induration | 15 Subjects |
| MenACWY-PS (36-59 M12PS) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Any Local | 48 Subjects |
| MenACWY-PS (36-59 M12PS) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Fever (≥ 38°C) | 5 Subjects |
| MenACWY-PS (36-59 M12PS) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Injection site erythema | 19 Subjects |
| MenACWY-PS (36-59 M12PS) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Analgesic/Antipyretic Med Used | 11 Subjects |
| MenACWY-PS (36-59 M12PS) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Other | 11 Subjects |
| MenACWY-PS (36-59 M12PS) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Vomiting | 2 Subjects |
| MenACWY-PS (36-59 M12PS) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Irritability | 12 Subjects |
| MenACWY-PS (36-59 M12PS) | Numbers of Subjects 12 to 59 Months of Age Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination | Change in Eating Habits | 10 Subjects |
Secondary
Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination
Safety was assessed as the number of subjects 12 to 59 months of age who reported serious adverse events (SAE), AEs necessitating a physician's visit and/or resulting in premature withdrawal from the study, AEs were to be collected between day 7 and the subsequent visit (approximately 1 month later) after the first or second vaccination(s) of MenACWY-CRM vaccine, with or without adjuvant, or MenACWY-PS vaccine. Any SAE were to be collected throughout the study.
Time frame: 28 days after first vaccination and 21 days after second vaccination
Population: Analysis was done on Safety dataset - all subjects who received at least one dose of vaccine and with some post-baseline safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | Possibly/probably related SAE | 0 Subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | Possibly/probably related AE | 9 Subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | Death | 0 Subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | SAE | 13 Subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | AE leading to discontinuation | 3 Subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | Any AE | 117 Subjects |
| MenACWY-PS (36 to 59 Months) | Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | SAE | 12 Subjects |
| MenACWY-PS (36 to 59 Months) | Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | Any AE | 99 Subjects |
| MenACWY-PS (36 to 59 Months) | Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | Possibly/probably related SAE | 0 Subjects |
| MenACWY-PS (36 to 59 Months) | Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | AE leading to discontinuation | 1 Subjects |
| MenACWY-PS (36 to 59 Months) | Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | Death | 0 Subjects |
| MenACWY-PS (36 to 59 Months) | Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | Possibly/probably related AE | 9 Subjects |
| MenACWY-PS (36-59 M6PS) | Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | Death | 0 Subjects |
| MenACWY-PS (36-59 M6PS) | Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | Possibly/probably related AE | 3 Subjects |
| MenACWY-PS (36-59 M6PS) | Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | AE leading to discontinuation | 0 Subjects |
| MenACWY-PS (36-59 M6PS) | Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | SAE | 11 Subjects |
| MenACWY-PS (36-59 M6PS) | Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | Any AE | 64 Subjects |
| MenACWY-PS (36-59 M6PS) | Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | Possibly/probably related SAE | 0 Subjects |
| MenACWY-PS (36-59 M12PS) | Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | SAE | 9 Subjects |
| MenACWY-PS (36-59 M12PS) | Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | Any AE | 41 Subjects |
| MenACWY-PS (36-59 M12PS) | Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | Possibly/probably related AE | 1 Subjects |
| MenACWY-PS (36-59 M12PS) | Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | Death | 0 Subjects |
| MenACWY-PS (36-59 M12PS) | Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | AE leading to discontinuation | 0 Subjects |
| MenACWY-PS (36-59 M12PS) | Numbers of Subjects 12 to 59 Months Of Age Who Reported Unsolicited Adverse Events and Serious Adverse Events After Any Vaccination | Possibly/probably related SAE | 0 Subjects |
Secondary
Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age
Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by the percentage of hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
Time frame: 6 months after first vaccination and 12 months after first vaccination
Population: Analysis was done on PP dataset- subjects who received a dose of either MenACWY-CRM(Ad+) or MenACWY(Ad-) vaccine or MenACWY-PS vaccine at either 6 or 12 months from the first vaccination, and provided evaluable serum samples at baseline, at 28 days and 50 days after the first vaccine dose and had no major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenA (Day 169) | 23 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenC (Day 169; N=47,45,32,36) | 45 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenW (Day 169; N=47,45,32,36) | 94 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenY (Day 169; N=47,45,32,36) | 70 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenC (Day 169; N=47,45,32,36) | 42 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenW (Day 169; N=47,45,32,36) | 84 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenY (Day 169; N=47,45,32,36) | 80 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenA (Day 169) | 13 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenW (Day 169; N=47,45,32,36) | 56 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenC (Day 169; N=47,45,32,36) | 28 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenY (Day 169; N=47,45,32,36) | 53 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenA (Day 169) | 19 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenY (Day 169; N=47,45,32,36) | 42 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenC (Day 169; N=47,45,32,36) | 22 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenA (Day 169) | 14 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenW (Day 169; N=47,45,32,36) | 61 percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Persistence of immune response at 6 or 12 months following administration of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
Time frame: 6 months after first vaccination and 12 months after first vaccination
Population: Analysis was done on PP dataset -subset of subjects in the MITT population for the evaluation of immunogenicity after the 1st dose of either MenACWY Ad+ / Ad- conjugate vaccine who received a booster dose of either Novartis MenACWY Ad+/ Ad- conjugate vaccine, provided evaluable serum samples at day 169 and 358, had no major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA | 26 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC | 56 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW | 82 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=57,56,55,52) | 65 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC | 34 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW | 79 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=57,56,55,52) | 66 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA | 14 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW | 77 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC | 63 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=57,56,55,52) | 67 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA | 18 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=57,56,55,52) | 56 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC | 33 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA | 9 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW | 54 percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Immune response of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
Time frame: 28 days after first vaccination.
Population: Analysis was done on per protocol (PP) dataset - subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA (Baseline) | 0 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA (28 days after 1st vaccination) | 82 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC (Baseline; N=198,190) | 5 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC (28 days after 1st vaccination; N=198,190) | 56 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW (Baseline) | 8 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW (28 days after 1st vaccination) | 82 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (Baseline; N=199,188) | 5 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (28 days after 1st vaccination; N=199,188) | 67 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (28 days after 1st vaccination; N=199,188) | 67 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA (Baseline) | 0 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW (Baseline) | 6 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA (28 days after 1st vaccination) | 70 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (Baseline; N=199,188) | 3 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC (Baseline; N=198,190) | 1 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW (28 days after 1st vaccination) | 80 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC (28 days after 1st vaccination; N=198,190) | 49 percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age
Booster effect of a second dose of MenACWY-CRM(-Ad) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS in children aged 36 to 59 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
Time frame: 21 days after second vaccination
Population: Analysis was done on PP dataset- subjects who received a dose of either MenACWY-CRM(Ad+) or MenACWY-CRM(Ad-)vaccine or MenACWY-PS vaccine at either 6 or 12 months from the first vaccination, and provided evaluable serum samples at baseline, at 28 days and 50 days after the first vaccine dose and had no major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenA | 92 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenC (N=47,45) | 100 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenW (N=47,45) | 100 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenY (N=47,45) | 100 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenC (N=47,45) | 100 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenW (N=47,45) | 100 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenY (N=47,45) | 100 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenA | 98 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenW (N=47,45) | 97 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenC (N=47,45) | 44 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenY (N=47,45) | 75 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenA | 100 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenY (N=47,45) | 75 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenC (N=47,45) | 56 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenA | 94 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenW (N=47,45) | 92 percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
Time frame: 21 days after second vaccination
Population: Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA | 100 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC | 98 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW | 98 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=56,52,57,55) | 100 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC | 96 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW | 100 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=56,52,57,55) | 100 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA | 96 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW | 100 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC | 100 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=56,52,57,55) | 100 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA | 100 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=56,52,57,55) | 100 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC | 100 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA | 95 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW | 100 percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Immune response to a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
Time frame: 21 days after second vaccination
Population: Analysis was done on per protocol (PP) dataset, Immunogenicity after one dose of vaccine -subjects in the modified intention to treat population who received two doses of the study vaccine, provided an evaluable serum sample at baseline and 28 days after the second dose and had no major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA (N=61,47) | 98 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC | 100 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW | 97 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=61,47) | 97 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=61,47) | 91 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA (N=61,47) | 91 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW | 98 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC | 94 percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Persistence of immune response, at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.
Time frame: 12 months after second vaccination
Population: Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA (N=61,48) | 43 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC | 66 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW (N=61,47) | 89 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY | 80 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY | 81 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA (N=61,48) | 29 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW (N=61,47) | 87 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:4 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC | 73 percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age
Persistence of functional immune response at 6 or 12 months following administration of one dose of either MenACWY-CRM(Ad-) or MenACWY-PS vaccine in children aged 36 to 59 months, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.
Time frame: 6 months after first vaccination and 12 months after first vaccination
Population: Analysis was done on PP dataset -subjects in the MITT who received a dose of either MenACWY-CRM(Ad+) or MenACWY-CRM(Ad-) or MenACWY-PS vaccine at either 6 or 12 months from the 1st vaccination, and provided evaluable serum samples at baseline, at 28 days and 50 days after the 1st vaccine dose and had no major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenA | 10 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenC (N=47,45) | 32 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenW (N=47,45) | 77 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | Men Y (N=47,45) | 60 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenC (N=47,45) | 24 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenW (N=47,45) | 76 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | Men Y (N=47,45) | 64 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenA | 9 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenW (N=47,45) | 53 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenC (N=47,45) | 19 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | Men Y (N=47,45) | 38 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenA | 16 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | Men Y (N=47,45) | 36 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenC (N=47,45) | 19 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenA | 14 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenW (N=47,45) | 56 percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age
Immune response of one dose of MenACWY-CRM(Ad-) compared to that of a MenACWY-PS vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentages of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.
Time frame: 28 days after first vaccination
Population: Analysis was done on per protocol (PP) dataset, Immunogenicity after one dose of vaccine -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenA (Baseline) | 2 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenA (28 days after 1st vaccination) | 61 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenC (Baseline; N=99,79) | 5 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenC (28 days after 1st vaccination; N=99,79) | 54 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenW (Baseline; N=100,81) | 15 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenW (28 days after 1st vaccination; N=100,81) | 84 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenY (Baseline; N=100,79) | 7 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenY (28 days after 1st vaccination; N=100,79) | 67 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenY (28 days after 1st vaccination; N=100,79) | 57 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenA (Baseline) | 0 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenW (Baseline; N=100,81) | 14 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenA (28 days after 1st vaccination) | 39 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenY (Baseline; N=100,79) | 6 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenC (Baseline; N=99,79) | 8 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenW (28 days after 1st vaccination; N=100,81) | 59 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age | MenC (28 days after 1st vaccination; N=99,79) | 39 percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Immune response of one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, 28 days after administration to subjects aged 12 to 35 months, as measured by the percentage of subjects with human complement serum bactericidal antibody (hSBA) titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.
Time frame: 28 days after first vaccination.
Population: Analysis was done on per protocol (PP) dataset -subjects in the modified intention to treat population who received one dose of the study vaccine, and provided an evaluable serum sample at baseline and 28 days after the vaccine dose and had no major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA (Baseline) | 0 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW (Baseline) | 6 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC (Baseline; N=198,190) | 3 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA (28 days after 1st vaccination) | 72 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (Baseline; N=199,188) | 4 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC (28 days after 1st vaccination; N=198,190) | 47 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (28 days after 1st vaccination; N=199,188) | 60 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW (28 days after 1st vaccination) | 72 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (28 days after 1st vaccination; N=199,188) | 57 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA (Baseline) | 0 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA (28 days after 1st vaccination) | 61 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC (Baseline; N=198,190) | 1 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC (28 days after 1st vaccination; N=198,190) | 36 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW (Baseline) | 4 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW (28 days after 1st vaccination) | 69 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (Baseline; N=199,188) | 2 percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age
Persistence of immune response at 6 or 12 months after one dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.
Time frame: 6 months after first vaccination and 12 months after first vaccination
Population: Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA | 21 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC | 51 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW | 72 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=57,56,55,52) | 58 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC | 25 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW | 73 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=57,56,55,52) | 50 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA | 13 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW | 70 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC | 57 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=57,56,55,52) | 55 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA | 11 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=57,56,55,52) | 46 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC | 26 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA | 7 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW | 50 percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age
Booster effect of a second dose of MenACWY-CRM(Ad-) vaccine administered either 6 or 12 months after an initial dose of MenACWY-CRM(Ad-) or MenACWY-PS in children aged 36 to 59 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.
Time frame: 21 days after the second vaccination
Population: Analysis was done on per protocol (PP) dataset - subjects in the modified intention to treat population who received two doses of the study vaccine, provided an evaluable serum sample at baseline and 28 days after the second dose and had no major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenA | 90 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenC (N=47,45) | 96 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenW (N=47,45) | 100 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenY (N=47,45) | 100 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenC (N=47,45) | 100 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenW (N=47,45) | 100 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenY (N=47,45) | 100 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenA | 98 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenW (N=47,45) | 78 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenC (N=47,45) | 34 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenY (N=47,45) | 66 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenA | 97 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenY (N=47,45) | 58 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenC (N=47,45) | 47 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenA | 94 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM(Ad-) Vaccine In Subjects 36-59 Months Of Age | MenW (N=47,45) | 89 percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age
Immune response to a second dose of either MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered 28 days after the initial dose to subjects aged 12 to 35 months, as measured 21 days after the second dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.
Time frame: 21 days after second vaccination
Population: Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA (N=61,47) | 98 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC | 98 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW | 97 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=61,47) | 97 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=61,47) | 83 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA (N=61,47) | 85 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW | 90 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC | 90 percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age
Booster effect of a second dose of MenACWY-CRM vaccine, with adjuvant or without adjuvant, administered either at 6 or 12 months after an initial dose in children aged 12 to 35 months, as measured 21 days after the booster dose by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.
Time frame: 21 days after second vaccination
Population: Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA | 100 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC | 98 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW | 98 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=56,52,57,55) | 100 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC | 96 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW | 100 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=56,52,57,55) | 100 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA | 96 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW | 100 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC | 100 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=56,52,57,55) | 100 percentages of subjects |
| MenACWY-PS (36-59 M6PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA | 100 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenY (N=56,52,57,55) | 100 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenC | 100 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenA | 91 percentages of subjects |
| MenACWY-PS (36-59 M12PS) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Second Dose Of MenACWY-CRM Vaccine, With or Without Adjuvant, In Subjects 12-35 Months Of Age | MenW | 100 percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age
Persistence of immune response, at 12 months following administration of two doses of MenACWY-CRM vaccine, with adjuvant or without adjuvant, in subjects aged 12 to 35 months of age, as measured by the percentage of subjects with hSBA titers ≥ 1:8 against N. meningitidis serogroups A, C, W, and Y.
Time frame: 12 months after second vaccination
Population: Analysis was done on per protocol dataset - subjects in the Modified Intention to treat population who received the two doses of vaccine correctly, and provided evaluable serum samples at the relevant time points, and had no major protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenA (N=61,48) | 38 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenC | 59 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenW (N=61,47) | 87 percentages of subjects |
| MenACWY-CRM(Ad-) (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenY (N=61,48) | 69 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenY (N=61,48) | 71 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenA (N=61,48) | 23 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenW (N=61,47) | 85 percentages of subjects |
| MenACWY-PS (36 to 59 Months) | Percentages of Subjects With hSBA Titers ≥ 1:8 After Two Doses Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, In Subject 12-35 Months Of Age | MenC | 63 percentages of subjects |