Bacterial Meningitis
Conditions
Keywords
Meningococcal,, ACWY,, bacterial meningitis,, conjugate vaccine,, healthy, children,, adolescents,, adults,, India
Brief summary
This study will evaluate the immunogenicity of a single injection of Novartis Meningococcal ACWY conjugate vaccine in healthy subjects from the age of 2 years and above in India.
Interventions
BIOLOGICALMeningococcal ACWY conjugate vaccine
All subjects received a single dose of Meningococcal ACWY conjugate vaccine
Sponsors
Novartis Vaccines
Novartis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
Individuals eligible for enrollment in this study are those: 1. who are of any gender, from the age of 2 to 75 years at the time of visit 1, and to whom the nature of the study has been explained and: * the parent/legal representative has provided written informed consent (greater than or equal to 2 - less than 18 years of age). * have provided written assent (greater than or equal to 7-less than or equal to 18 years) * have provided written informed consent (greater than or equal to 18 to 75 years of age). 2. who the investigator believes that they or their parents/legal representatives can and will comply with the requirements of the protocol (e.g., completion of the Diary Card, return for follow-up visit). 3. who are in good health as determined by medical history, physical exam, clinical judgment of the investigator 4. who have a negative urine pregnancy test for female subjects of childbearing potential.
Exclusion criteria
Individuals not eligible to be enrolled in the study are those: 1. who are unwilling or unable to give written informed assent or consent to participate in the study. 2. who are perceived to be unreliable or unavailable for the duration of the study period. 3. who had a previous or suspected disease caused by N. meningitidis. 4. who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment. 5. who have previously been immunized with a meningococcal vaccine. 6. who have received any investigational or non-registered product (drug or vaccine)within 28 days prior to enrollment or who expect to receive an investigational drug or vaccine prior to the completion of the study. 7. who have received any vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 30 days from the study vaccines. (Exception: Influenza vaccine may be administered up to 15 days prior to study vaccination and at least 15 days after study vaccination) 8. who have experienced within the 7 days prior to enrollment significant acute infection (for example requiring systemic antibiotic treatment or antiviral therapy) or have experienced fever (defined as body temperature greater than or equal to 38°C) within 3 days prior to enrollment. 9. who have any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV infection or AIDS, or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition). 10. who have epilepsy or any progressive neurological disease. 11. who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components. 12. who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example): * receipt of immunosuppressive therapy within 28 days prior to enrollment (any systemic corticosteroid administered for more than 5 days, or in a daily dose greater than 1 mg/kg/day prednisone or equivalent during any of 28 days prior to enrollment, or cancer chemotherapy) * receipt of immunostimulants * receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study. 13. who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. 14. who have any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup A. | Day 29 (1 month post vaccination) | The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup A. Seroresponse is defined as: * For subjects with a pre-vaccination hSBA titer \<1:4, a postvaccination hSBA titer≥1:8 * For subjects with a pre-vaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the pre-vaccination titer. |
| Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup C | Day 29 (1 month post vaccination) | The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup C. |
| Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup W. | Day 29 (1 month post vaccination) | The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup W. |
| Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup Y. | Day 29 (1 month post vaccination) | The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup Y. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 1. | Day 1 | To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup W at day 1. |
| Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 29. | Day 29 | To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup W. |
| Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 1 | Day 1 | To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup Y at day 1. |
| Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 29 | Day 29 (ie, 1 month post vaccination) | To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup Y at day 29. |
| hSBA Geometric Mean Titers (GMTs) Directed Against N.Meningitidis Serogroup A at Day 1 | Day 1 | To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup A at day 1. |
| hSBA GMTs Directed Against N.Meningitidis Serogroup A at Day 29 | Day 29 ( ie, 1 month post vaccination) | To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup A at day 29. |
| hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 1 | Day 1 | To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup C at day 1. |
| Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 1. | Day 1 | To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup A at day 1. |
| hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 1 | Day 1 | To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup W at day 1. |
| hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 29 | Day 29 (ie, 1 month post vaccination) | To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup W at day 29. |
| hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 1 | Day 1 | To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup Y at day 1. |
| hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 29 | Day 29 (ie, 1 month post vaccination) | To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup Y at day 29. |
| Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination | From day 1 to Day 7 post vaccination | The safety of one dose of MenACWY - CRM was assessed in terms of the number of subjects reporting any solicited local and systemic reactions. |
| Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | From day 1 to Day 7 post vaccination | The safety of one dose of MenACWY - CRM was assessed in terms of the number of subjects reporting solicited local and systemic reactions. |
| Number of Subjects With Unsolicited Adverse Events | Day 1 through day 29 | The safety of one dose of MenACWY -CRM was assessed in terms of the number of subjects reporting unsolicited adverse events. All AEs were recorded from day 1 to day 7; SAE, medically attended AEs and AEs Leading to premature withdrawal were recorded throughout the entire study period. |
| hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 29 | Day 29 (ie, 1 month post vaccination) | To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup C at day 29. |
| Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 29. | Day 29 (ie, 1 month post vaccination) | To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup A at day 29. |
| Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 1. | Day 1 | To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup C at day 1. |
| Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 29. | Day 29 (ie, 1 month post vaccination) | To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup C at day 29. |
Countries
India
Participant flow
Recruitment details
Subjects were enrolled from 3 study sites.
Pre-assignment details
All the enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| 2 - 10 Years Subjects between 2 and 10 years of age received one injection of MenACWY -CRM vaccine on day 1 | 60 |
| 11 - 18 Years Subjects between 11 and 18 years of age received one injection of MenACWY -CRM vaccine on day 1 | 60 |
| 19 - 75 Years Subjects between 19 and 75 years of age received one injection of MenACWY -CRM vaccine on day 1. | 60 |
| Total | 180 |
Baseline characteristics
| Characteristic | 2 - 10 Years | 11 - 18 Years | 19 - 75 Years | Total |
|---|---|---|---|---|
| Age, Continuous | 5.77 YEARS STANDARD_DEVIATION 2.5 | 14.03 YEARS STANDARD_DEVIATION 1.931 | 32.67 YEARS STANDARD_DEVIATION 12.297 | 17.49 YEARS STANDARD_DEVIATION 13.432 |
| Sex: Female, Male FEMALE | 33 Participants | 33 Participants | 21 Participants | 87 Participants |
| Sex: Female, Male MALE | 27 Participants | 27 Participants | 39 Participants | 93 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 | 10 / 60 | 21 / 60 | 10 / 60 | 41 / 180 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 | 1 / 60 | 1 / 180 |
Outcome results
Primary
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup A.
The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup A. Seroresponse is defined as: * For subjects with a pre-vaccination hSBA titer \<1:4, a postvaccination hSBA titer≥1:8 * For subjects with a pre-vaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.
Time frame: Day 29 (1 month post vaccination)
Population: Analysis was done on the Full Analysis Set (FAS), ie, all subjects in the exposed population who provided at least one evaluable serum sample whose assay result is available for at least one serogroup.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2 - 10 Years | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup A. | 75 Percentages of subjects |
| 11 - 18 Years | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup A. | 76 Percentages of subjects |
| 19 - 75 Years | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup A. | 66 Percentages of subjects |
| Overall (≥2 Years) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup A. | 72 Percentages of subjects |
Primary
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup C
The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup C.
Time frame: Day 29 (1 month post vaccination)
Population: Analysis was done on the FAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2 - 10 Years | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup C | 84 Percentages of subjects |
| 11 - 18 Years | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup C | 90 Percentages of subjects |
| 19 - 75 Years | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup C | 90 Percentages of subjects |
| Overall (≥2 Years) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup C | 88 Percentages of subjects |
Primary
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup W.
The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup W.
Time frame: Day 29 (1 month post vaccination)
Population: Analysis was done on the FAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2 - 10 Years | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup W. | 58 Percentages of subjects |
| 11 - 18 Years | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup W. | 51 Percentages of subjects |
| 19 - 75 Years | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup W. | 54 Percentages of subjects |
| Overall (≥2 Years) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup W. | 55 Percentages of subjects |
Primary
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup Y.
The immunogenicity of a single injection of MenACWY-CRM vaccine is assessed in terms of percentage of subjects with hSBA seroresponse directed against N.meningitidis serogroup Y.
Time frame: Day 29 (1 month post vaccination)
Population: Analysis was done on the FAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2 - 10 Years | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup Y. | 69 Percentages of subjects |
| 11 - 18 Years | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup Y. | 69 Percentages of subjects |
| 19 - 75 Years | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup Y. | 75 Percentages of subjects |
| Overall (≥2 Years) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Seroresponse Against N.Meningitidis Serogroup Y. | 71 Percentages of subjects |
Secondary
hSBA Geometric Mean Titers (GMTs) Directed Against N.Meningitidis Serogroup A at Day 1
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup A at day 1.
Time frame: Day 1
Population: Analysis was done on the FAS.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 2 - 10 Years | hSBA Geometric Mean Titers (GMTs) Directed Against N.Meningitidis Serogroup A at Day 1 | 2.08 Titer |
| 11 - 18 Years | hSBA Geometric Mean Titers (GMTs) Directed Against N.Meningitidis Serogroup A at Day 1 | 2.05 Titer |
| 19 - 75 Years | hSBA Geometric Mean Titers (GMTs) Directed Against N.Meningitidis Serogroup A at Day 1 | 2.07 Titer |
| Overall (≥2 Years) | hSBA Geometric Mean Titers (GMTs) Directed Against N.Meningitidis Serogroup A at Day 1 | 2.07 Titer |
Secondary
hSBA GMTs Directed Against N.Meningitidis Serogroup A at Day 29
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup A at day 29.
Time frame: Day 29 ( ie, 1 month post vaccination)
Population: Analysis was done on the FAS.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 2 - 10 Years | hSBA GMTs Directed Against N.Meningitidis Serogroup A at Day 29 | 30 Titer |
| 11 - 18 Years | hSBA GMTs Directed Against N.Meningitidis Serogroup A at Day 29 | 50 Titer |
| 19 - 75 Years | hSBA GMTs Directed Against N.Meningitidis Serogroup A at Day 29 | 29 Titer |
| Overall (≥2 Years) | hSBA GMTs Directed Against N.Meningitidis Serogroup A at Day 29 | 35 Titer |
Secondary
hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 1
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup C at day 1.
Time frame: Day 1
Population: Analysis was done on the FAS.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 2 - 10 Years | hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 1 | 2.88 Titer |
| 11 - 18 Years | hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 1 | 4.01 Titer |
| 19 - 75 Years | hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 1 | 4.14 Titer |
| Overall (≥2 Years) | hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 1 | 3.63 Titer |
Secondary
hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 29
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup C at day 29.
Time frame: Day 29 (ie, 1 month post vaccination)
Population: Analysis was done on the FAS.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 2 - 10 Years | hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 29 | 67 Titer |
| 11 - 18 Years | hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 29 | 191 Titer |
| 19 - 75 Years | hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 29 | 287 Titer |
| Overall (≥2 Years) | hSBA GMTs Directed Against N.Meningitidis Serogroups C at Day 29 | 153 Titer |
Secondary
hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 1
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup W at day 1.
Time frame: Day 1
Population: Analysis was done on the FAS.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 2 - 10 Years | hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 1 | 9.27 Titer |
| 11 - 18 Years | hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 1 | 14 Titer |
| 19 - 75 Years | hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 1 | 12 Titer |
| Overall (≥2 Years) | hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 1 | 11 Titer |
Secondary
hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 29
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup W at day 29.
Time frame: Day 29 (ie, 1 month post vaccination)
Population: Analysis was done on the FAS.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 2 - 10 Years | hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 29 | 60 Titer |
| 11 - 18 Years | hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 29 | 75 Titer |
| 19 - 75 Years | hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 29 | 116 Titer |
| Overall (≥2 Years) | hSBA GMTs Directed Against N.Meningitidis Serogroup W at Day 29 | 80 Titer |
Secondary
hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 1
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup Y at day 1.
Time frame: Day 1
Population: Analysis was done on the FAS.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 2 - 10 Years | hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 1 | 3.59 Titer |
| 11 - 18 Years | hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 1 | 7.87 Titer |
| 19 - 75 Years | hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 1 | 8.69 Titer |
| Overall (≥2 Years) | hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 1 | 6.26 Titer |
Secondary
hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 29
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by hSBA GMTs directed against N. meningitidis serogroup Y at day 29.
Time frame: Day 29 (ie, 1 month post vaccination)
Population: Analysis was done on the FAS.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 2 - 10 Years | hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 29 | 45 Titer |
| 11 - 18 Years | hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 29 | 105 Titer |
| 19 - 75 Years | hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 29 | 173 Titer |
| Overall (≥2 Years) | hSBA GMTs Directed Against N.Meningitidis Serogroup Y at Day 29 | 93 Titer |
Secondary
Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination
The safety of one dose of MenACWY - CRM was assessed in terms of the number of subjects reporting any solicited local and systemic reactions.
Time frame: From day 1 to Day 7 post vaccination
Population: The analysis was performed on the safety analysis set, ie, all subjects in the exposed population who provided any post-baseline safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 - 10 Years | Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination | INJECTION SITE REACTIONS | 5 Participants |
| 2 - 10 Years | Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination | SYSTEMIC REACTIONS | 3 Participants |
| 11 - 18 Years | Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination | INJECTION SITE REACTIONS | 17 Participants |
| 11 - 18 Years | Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination | SYSTEMIC REACTIONS | 7 Participants |
| 19 - 75 Years | Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination | INJECTION SITE REACTIONS | 5 Participants |
| 19 - 75 Years | Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination | SYSTEMIC REACTIONS | 9 Participants |
| Overall (≥2 Years) | Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination | SYSTEMIC REACTIONS | 19 Participants |
| Overall (≥2 Years) | Number of Subjects Who Reported Any Solicited Local and Systemic Reactions Post Vaccination | INJECTION SITE REACTIONS | 27 Participants |
Secondary
Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination
The safety of one dose of MenACWY - CRM was assessed in terms of the number of subjects reporting solicited local and systemic reactions.
Time frame: From day 1 to Day 7 post vaccination
Population: The analysis was performed on the safety analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 - 10 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | IRRITABILITY | 0 Participants |
| 2 - 10 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | DIARRHEA | 0 Participants |
| 2 - 10 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | ARTHRALGIA | 1 Participants |
| 2 - 10 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | TENDERNESS | 1 Participants |
| 2 - 10 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | MYALGIA | 1 Participants |
| 2 - 10 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | MALAISE | 2 Participants |
| 2 - 10 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | INDURATION (mm) | 0 Participants |
| 2 - 10 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | HEADACHE | 2 Participants |
| 2 - 10 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | RASH | 0 Participants |
| 2 - 10 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | BODY TEMPERATURE >=38C | 1 Participants |
| 2 - 10 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | ANALGESIC ANTIPYRETIC | 2 Participants |
| 2 - 10 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | Body Temperature >=40C | 0 Participants |
| 2 - 10 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | SLEEPINESS | 0 Participants |
| 2 - 10 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | CHANGE IN EATING HABITS | 0 Participants |
| 2 - 10 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | PAIN | 4 Participants |
| 2 - 10 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | VOMITING | 0 Participants |
| 2 - 10 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | NAUSEA | 0 Participants |
| 2 - 10 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | CHILLS | 0 Participants |
| 2 - 10 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | ERYTHEMA (mm) | 0 Participants |
| 11 - 18 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | CHILLS | 4 Participants |
| 11 - 18 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | MYALGIA | 0 Participants |
| 11 - 18 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | DIARRHEA | 0 Participants |
| 11 - 18 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | ERYTHEMA (mm) | 0 Participants |
| 11 - 18 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | HEADACHE | 5 Participants |
| 11 - 18 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | ARTHRALGIA | 1 Participants |
| 11 - 18 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | MALAISE | 2 Participants |
| 11 - 18 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | IRRITABILITY | 0 Participants |
| 11 - 18 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | SLEEPINESS | 0 Participants |
| 11 - 18 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | INDURATION (mm) | 0 Participants |
| 11 - 18 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | PAIN | 17 Participants |
| 11 - 18 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | ANALGESIC ANTIPYRETIC | 5 Participants |
| 11 - 18 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | TENDERNESS | 0 Participants |
| 11 - 18 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | Body Temperature >=40C | 0 Participants |
| 11 - 18 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | RASH | 0 Participants |
| 11 - 18 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | VOMITING | 0 Participants |
| 11 - 18 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | BODY TEMPERATURE >=38C | 1 Participants |
| 11 - 18 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | NAUSEA | 1 Participants |
| 11 - 18 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | CHANGE IN EATING HABITS | 0 Participants |
| 19 - 75 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | RASH | 0 Participants |
| 19 - 75 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | Body Temperature >=40C | 0 Participants |
| 19 - 75 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | ANALGESIC ANTIPYRETIC | 2 Participants |
| 19 - 75 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | ERYTHEMA (mm) | 0 Participants |
| 19 - 75 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | INDURATION (mm) | 0 Participants |
| 19 - 75 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | PAIN | 5 Participants |
| 19 - 75 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | TENDERNESS | 0 Participants |
| 19 - 75 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | ARTHRALGIA | 0 Participants |
| 19 - 75 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | BODY TEMPERATURE >=38C | 1 Participants |
| 19 - 75 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | CHANGE IN EATING HABITS | 0 Participants |
| 19 - 75 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | CHILLS | 2 Participants |
| 19 - 75 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | DIARRHEA | 0 Participants |
| 19 - 75 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | HEADACHE | 7 Participants |
| 19 - 75 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | IRRITABILITY | 0 Participants |
| 19 - 75 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | MALAISE | 2 Participants |
| 19 - 75 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | MYALGIA | 2 Participants |
| 19 - 75 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | NAUSEA | 1 Participants |
| 19 - 75 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | SLEEPINESS | 0 Participants |
| 19 - 75 Years | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | VOMITING | 0 Participants |
| Overall (≥2 Years) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | CHILLS | 6 Participants |
| Overall (≥2 Years) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | Body Temperature >=40C | 0 Participants |
| Overall (≥2 Years) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | MYALGIA | 3 Participants |
| Overall (≥2 Years) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | CHANGE IN EATING HABITS | 0 Participants |
| Overall (≥2 Years) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | BODY TEMPERATURE >=38C | 3 Participants |
| Overall (≥2 Years) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | ANALGESIC ANTIPYRETIC | 9 Participants |
| Overall (≥2 Years) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | NAUSEA | 2 Participants |
| Overall (≥2 Years) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | ARTHRALGIA | 2 Participants |
| Overall (≥2 Years) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | TENDERNESS | 1 Participants |
| Overall (≥2 Years) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | PAIN | 26 Participants |
| Overall (≥2 Years) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | RASH | 0 Participants |
| Overall (≥2 Years) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | INDURATION (mm) | 0 Participants |
| Overall (≥2 Years) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | ERYTHEMA (mm) | 0 Participants |
| Overall (≥2 Years) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | VOMITING | 0 Participants |
| Overall (≥2 Years) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | IRRITABILITY | 0 Participants |
| Overall (≥2 Years) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | HEADACHE | 14 Participants |
| Overall (≥2 Years) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | SLEEPINESS | 0 Participants |
| Overall (≥2 Years) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | MALAISE | 6 Participants |
| Overall (≥2 Years) | Number of Subjects Who Reported Solicited Local and Systemic Reactions Post Vaccination | DIARRHEA | 0 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events
The safety of one dose of MenACWY -CRM was assessed in terms of the number of subjects reporting unsolicited adverse events. All AEs were recorded from day 1 to day 7; SAE, medically attended AEs and AEs Leading to premature withdrawal were recorded throughout the entire study period.
Time frame: Day 1 through day 29
Population: The analysis was performed on the safety analysis dataset.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2 - 10 Years | Number of Subjects With Unsolicited Adverse Events | Any Unsolicited AE | 9 participants |
| 2 - 10 Years | Number of Subjects With Unsolicited Adverse Events | Any SAE | 0 participants |
| 2 - 10 Years | Number of Subjects With Unsolicited Adverse Events | AEs Leading to premature withdrawal | 0 participants |
| 2 - 10 Years | Number of Subjects With Unsolicited Adverse Events | Medically Attended AEs | 8 participants |
| 11 - 18 Years | Number of Subjects With Unsolicited Adverse Events | Any SAE | 0 participants |
| 11 - 18 Years | Number of Subjects With Unsolicited Adverse Events | AEs Leading to premature withdrawal | 0 participants |
| 11 - 18 Years | Number of Subjects With Unsolicited Adverse Events | Medically Attended AEs | 5 participants |
| 11 - 18 Years | Number of Subjects With Unsolicited Adverse Events | Any Unsolicited AE | 6 participants |
| 19 - 75 Years | Number of Subjects With Unsolicited Adverse Events | Any Unsolicited AE | 4 participants |
| 19 - 75 Years | Number of Subjects With Unsolicited Adverse Events | AEs Leading to premature withdrawal | 0 participants |
| 19 - 75 Years | Number of Subjects With Unsolicited Adverse Events | Medically Attended AEs | 4 participants |
| 19 - 75 Years | Number of Subjects With Unsolicited Adverse Events | Any SAE | 1 participants |
| Overall (≥2 Years) | Number of Subjects With Unsolicited Adverse Events | AEs Leading to premature withdrawal | 0 participants |
| Overall (≥2 Years) | Number of Subjects With Unsolicited Adverse Events | Any Unsolicited AE | 19 participants |
| Overall (≥2 Years) | Number of Subjects With Unsolicited Adverse Events | Any SAE | 0 participants |
| Overall (≥2 Years) | Number of Subjects With Unsolicited Adverse Events | Medically Attended AEs | 17 participants |
Secondary
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 1.
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup A at day 1.
Time frame: Day 1
Population: Analysis was done on the FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2 - 10 Years | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 1. | 0 Percentage of subjects |
| 11 - 18 Years | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 1. | 2 Percentage of subjects |
| 19 - 75 Years | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 1. | 2 Percentage of subjects |
| Overall (≥2 Years) | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 1. | 1 Percentage of subjects |
Secondary
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 29.
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup A at day 29.
Time frame: Day 29 (ie, 1 month post vaccination)
Population: Analysis was done on the FAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2 - 10 Years | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 29. | 75 Percentages of subjects |
| 11 - 18 Years | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 29. | 77 Percentages of subjects |
| 19 - 75 Years | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 29. | 66 Percentages of subjects |
| Overall (≥2 Years) | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup A at Day 29. | 72 Percentages of subjects |
Secondary
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 1.
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup C at day 1.
Time frame: Day 1
Population: Analysis was done on the FAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2 - 10 Years | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 1. | 14 Percentages of subjects |
| 11 - 18 Years | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 1. | 24 Percentages of subjects |
| 19 - 75 Years | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 1. | 25 Percentages of subjects |
| Overall (≥2 Years) | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 1. | 21 Percentages of subjects |
Secondary
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 29.
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup C at day 29.
Time frame: Day 29 (ie, 1 month post vaccination)
Population: Analysis was done on the FAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2 - 10 Years | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 29. | 92 Percentages of subjects |
| 11 - 18 Years | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 29. | 97 Percentages of subjects |
| 19 - 75 Years | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 29. | 97 Percentages of subjects |
| Overall (≥2 Years) | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup C at Day 29. | 95 Percentages of subjects |
Secondary
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 1.
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup W at day 1.
Time frame: Day 1
Population: Analysis was done on the FAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2 - 10 Years | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 1. | 52 Percentages of subjects |
| 11 - 18 Years | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 1. | 63 Percentages of subjects |
| 19 - 75 Years | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 1. | 59 Percentages of subjects |
| Overall (≥2 Years) | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 1. | 58 Percentages of subjects |
Secondary
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 29.
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup W.
Time frame: Day 29
Population: Analysis was done on the FAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2 - 10 Years | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 29. | 95 Percentage of subjects |
| 11 - 18 Years | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 29. | 95 Percentage of subjects |
| 19 - 75 Years | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 29. | 93 Percentage of subjects |
| Overall (≥2 Years) | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup W at Day 29. | 94 Percentage of subjects |
Secondary
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 1
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup Y at day 1.
Time frame: Day 1
Population: Analysis was done on the FAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2 - 10 Years | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 1 | 22 Percentages of subjects |
| 11 - 18 Years | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 1 | 53 Percentages of subjects |
| 19 - 75 Years | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 1 | 53 Percentages of subjects |
| Overall (≥2 Years) | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 1 | 42 Percentages of subjects |
Secondary
Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 29
To assess the immunogenicity of a single injection of MenACWY-CRM vaccine as measured by the percentage of subjects aged 2 through 75 with hSBA titer ≥ 1:8, directed against N. meningitidis serogroup Y at day 29.
Time frame: Day 29 (ie, 1 month post vaccination)
Population: Analysis was done on the FAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2 - 10 Years | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 29 | 83 Percentages of subjects |
| 11 - 18 Years | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 29 | 95 Percentages of subjects |
| 19 - 75 Years | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 29 | 93 Percentages of subjects |
| Overall (≥2 Years) | Percentages of Subjects With hSBA ≥1:8 Directed Against N.Meningitidis Serogroup Y at Day 29 | 90 Percentages of subjects |