Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novartis Vaccines | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MenACWY - 2 - 10 Years old | Experimental | Subjects between 2 and 10 years of age who received one injection of Meningococcal ACWY conjugate vaccine -CRM vaccine on day 1. |
|
| MenACWY - 11 - 18 Years old | Experimental | Subjects between 11 and 18 years of age who received one injection of Meningococcal ACWY conjugate vaccine-CRM vaccine on day 1. |
|
| MenACWY - 19 - 75 Years old | Experimental | Subjects between 11 and 18 years of age who received one injection of Meningococcal ACWY conjugate vaccine-CRM vaccine on day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal ACWY conjugate vaccine | Biological | All subjects received a single dose of Meningococcal ACWY conjugate vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Day 29 (1 month post vaccination) |
| 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. | Day 29 (1 month post vaccination) |
| 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. | Day 29 (1 month post vaccination) |
| 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. | Day 29 (1 month post vaccination) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
Not provided
Inclusion Criteria:
Individuals eligible for enrollment in this study are those:
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:
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).
who are in good health as determined by medical history, physical exam, clinical judgment of the investigator
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:
who are unwilling or unable to give written informed assent or consent to participate in the study.
who are perceived to be unreliable or unavailable for the duration of the study period.
who had a previous or suspected disease caused by N. meningitidis.
who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment.
who have previously been immunized with a meningococcal vaccine.
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.
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)
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.
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).
who have epilepsy or any progressive neurological disease.
who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components.
who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
who have any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr. Sanjay Lalwani | Bharati Hospital and Research Center | Principal Investigator |
| Dr. Nitya Gogtay | Seth GS Medical College and KEM Hospital | Principal Investigator |
| Dr. A Amaresh | Niloufer Hospital, Hyderabad | Principal Investigator |
| Dr. Sharad Agarkhedkar | Padmasree Dr. D.Y.patil Medical College, Hospital & Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osmania Medical College Ethics Commitee, Niloufer Hospital | Hyderabad | Andrapradesh | 500004 | India | ||
All the enrolled subjects were included in the trial.
Subjects were enrolled from 3 study sites.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 2 - 10 Years | Subjects between 2 and 10 years of age received one injection of MenACWY -CRM vaccine on day 1. |
| FG001 | 11 - 18 Years | Subjects between 11 and 18 years of age received one injection of MenACWY -CRM vaccine on day 1. |
| FG002 | 19 - 75 Years | Subjects between 19 and 75 years of age received one injection of MenACWY -CRM vaccine on day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 2 - 10 Years | Subjects between 2 and 10 years of age received one injection of MenACWY -CRM vaccine on day 1 |
| BG001 | 11 - 18 Years | Subjects between 11 and 18 years of age received one injection of MenACWY -CRM vaccine on day 1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
| 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. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 29 (1 month post vaccination) |
|
Day 1 to Day 29 post vaccination.
Any solicited and unsolicited adverse events were collected from 30 minutes post vaccination up to 7 days. Serious Adverse Events (SAE), medically attended AEs, AEs leading to withdrawal from the study were collected from day 1 through day 29.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2 - 10 Years | Subjects between 2 and 10 years of age who received one injection of MenACWY -CRM vaccine on day 1. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PYREXIA | General disorders | 14.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CHILLS | General disorders | 14.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics SRL | RegistryContactVaccinesUS@novartis.com |
Not provided
| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| ID | Term |
|---|---|
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
| Day 29 (ie, 1 month post vaccination) |
| 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. | Day 1 |
| 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. | Day 29 (ie, 1 month post vaccination) |
| 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. | Day 1 |
| 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. | Day 29 |
| 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. | Day 1 |
| 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. | Day 29 (ie, 1 month post vaccination) |
| 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. | Day 1 |
| 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. | Day 29 ( ie, 1 month post vaccination) |
| 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. | Day 1 |
| 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. | Day 29 (ie, 1 month post vaccination) |
| 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. | Day 1 |
| 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. | Day 29 (ie, 1 month post vaccination) |
| 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. | Day 1 |
| 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. | Day 29 (ie, 1 month post vaccination) |
| 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. | From day 1 to Day 7 post vaccination |
| 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. | From day 1 to Day 7 post vaccination |
| 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. | Day 1 through day 29 |
| Bharati Vidyapeeth University Institutional Ethics Commitee |
| Katraj |
| Dhankawadi |
| 411043 |
| India |
| Seth GS Medical College and KEM Hospital | Mumbai | Maharashtra | 400012 | India |
| Padmasree Dr. D.Y Patil medical College | Pune | Maharashtra | 411018 | India |
| BG002 | 19 - 75 Years | Subjects between 19 and 75 years of age received one injection of MenACWY -CRM vaccine on day 1. |
| BG003 | Total | Total of all reporting groups |
| YEARS |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 11 - 18 Years | Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1. |
| OG002 | 19 - 75 Years | Subjects between 19 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1. |
| OG003 | Overall (≥2 Years) | Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1. |
|
|
| 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. | Analysis was done on the FAS. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 29 (1 month post vaccination) |
|
|
|
| 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. | Analysis was done on the FAS. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 29 (1 month post vaccination) |
|
|
|
| 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. | Analysis was done on the FAS. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 29 (1 month post vaccination) |
|
|
|
| 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. | Analysis was done on the FAS | Posted | Number | 95% Confidence Interval | Percentage of subjects | Day 1 |
|
|
|
| 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. | Analysis was done on the FAS. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 29 (ie, 1 month post vaccination) |
|
|
|
| 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. | Analysis was done on the FAS. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 1 |
|
|
|
| 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. | Analysis was done on the FAS. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 29 (ie, 1 month post vaccination) |
|
|
|
| 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. | Analysis was done on the FAS. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 1 |
|
|
|
| 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. | Analysis was done on the FAS. | Posted | Number | 95% Confidence Interval | Percentage of subjects | Day 29 |
|
|
|
| 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. | Analysis was done on the FAS. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 1 |
|
|
|
| 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. | Analysis was done on the FAS. | Posted | Number | 95% Confidence Interval | Percentages of subjects | Day 29 (ie, 1 month post vaccination) |
|
|
|
| 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. | Analysis was done on the FAS. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 1 |
|
|
|
| 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. | Analysis was done on the FAS. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 29 ( ie, 1 month post vaccination) |
|
|
|
| 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. | Analysis was done on the FAS. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 1 |
|
|
|
| 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. | Analysis was done on the FAS. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 29 (ie, 1 month post vaccination) |
|
|
|
| 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. | Analysis was done on the FAS. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 1 |
|
|
|
| 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. | Analysis was done on the FAS. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 29 (ie, 1 month post vaccination) |
|
|
|
| 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. | Analysis was done on the FAS. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 1 |
|
|
|
| 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. | Analysis was done on the FAS. | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 29 (ie, 1 month post vaccination) |
|
|
|
| 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. | The analysis was performed on the safety analysis set, ie, all subjects in the exposed population who provided any post-baseline safety data. | Posted | Number | Participants | From day 1 to Day 7 post vaccination |
|
|
|
| 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. | The analysis was performed on the safety analysis set. | Posted | Number | Participants | From day 1 to Day 7 post vaccination |
|
|
|
| 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. | The analysis was performed on the safety analysis dataset. | Posted | Number | participants | Day 1 through day 29 |
|
|
|
| 0 |
| 60 |
| 10 |
| 60 |
| EG001 | 11 - 18 Years | Subjects between 11 and 18 years of age who received one injection of MenACWY -CRM vaccine on day 1. | 0 | 60 | 21 | 60 |
| EG002 | 19 - 75 Years | Subjects between 19 and 75 years of age received one injection of MenACWY -CRM vaccine on day 1 | 1 | 60 | 10 | 60 |
| EG003 | Overall (≥2 Years) | Subjects between 2 and 75 years of age who received one injection of MenACWY -CRM vaccine on day 1. | 1 | 180 | 41 | 180 |
| INJECTION SITE PAIN | General disorders | 14.1 | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | 14.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | 14.1 | Systematic Assessment |
|
Not provided
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |
| SYSTEMIC REACTIONS |
|
| Body Temperature >=40C |
|
| ERYTHEMA (mm) |
|
| INDURATION (mm) |
|
| PAIN |
|
| TENDERNESS |
|
| ARTHRALGIA |
|
| BODY TEMPERATURE >=38C |
|
| CHANGE IN EATING HABITS |
|
| CHILLS |
|
| DIARRHEA |
|
| HEADACHE |
|
| IRRITABILITY |
|
| MALAISE |
|
| MYALGIA |
|
| NAUSEA |
|
| RASH |
|
| SLEEPINESS |
|
| VOMITING |
|
| Any SAE |
|
| Medically Attended AEs |
|
| AEs Leading to premature withdrawal |
|