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GlaxoSmithKline Philippines has submitted a registration file for its Purified Meningococcal Polysaccharide of Serogroup ACWY Vaccine (Mencevax ACWY). This study is being conducted to collect clinical data in the local target population in order to assess the occurrence of rare adverse events after vaccination as per the requirement of Philippines Bureau of Food and Drugs Directive.
All subjects will receive a single dose of GSK Biologicals' Mencevax ACWY vaccine according to the prescribing information. Subjects will be stratified into the following age groups:
2 to 5 years 6 to 17 years > 18 years The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mencevax ACWY | Biological | 1 subcutaneous injection. |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Severe (Grade 3) Unsolicited Adverse Events | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 AE = an AE which prevented normal, everyday activities. | During the 31-day (Days 0-30) post-vaccination period |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited Local Adverse Events | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site (Mencevax ACWY 2-5 YOA Group) and beyond 50 millimeters (mm) of injection site (Mencevax ACWY 6-17 YOA Group and Mencevax ACWY ≥ 18 YOA Group). |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Alabang, Muntinlupa City | 1780 | Philippines | |||
| GSK Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mencevax ACWY 2-5 YOA Group | Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm. |
| FG001 | Mencevax ACWY 6-17 YOA Group | Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm. |
| FG002 | Mencevax ACWY ≥ 18 YOA Group | Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mencevax ACWY 2-5 YOA Group | Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm. |
| BG001 | Mencevax ACWY 6-17 YOA Group |
| 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 | Number of Subjects With Severe (Grade 3) Unsolicited Adverse Events | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 AE = an AE which prevented normal, everyday activities. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 31-day (Days 0-30) post-vaccination period |
|
Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: during the entire study period (from Day 0 to Month 1).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mencevax ACWY 2-5 YOA Group | Filipino male or female subjects, between and including 2 to 5 years of age, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C000610192 | PsACWY vaccine |
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| During the 4-day (Days 0-3) post-vaccination period |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination. | During the 4-day (Days 0-3) post-vaccination period |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms and headache. Any = occurrence of the symptom reported irrespective of intensity grade and causal relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | During the 4-day (Days 0-3) post-vaccination period |
| Number of Subjects With Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | During the 31-day (Days 0-30) post-vaccination period |
| Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | During the entire study period (from Day 0 to Month 1) |
| Binangonan, Rizal |
| Philippines |
| GSK Investigational Site | Cainta, Rizal | Philippines |
| GSK Investigational Site | City of Muntinlupa | 1781 | Philippines |
| GSK Investigational Site | Las Piñas | Philippines |
| GSK Investigational Site | Los Banos, Laguna | 4027 | Philippines |
| GSK Investigational Site | Manila | 1000 | Philippines |
| GSK Investigational Site | Pasay | Philippines |
Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm. |
| BG002 | Mencevax ACWY ≥ 18 YOA Group | Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | Mencevax ACWY 6-17 YOA Group | Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm. |
| OG002 | Mencevax ACWY ≥ 18 YOA Group | Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm. |
|
|
| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site (Mencevax ACWY 2-5 YOA Group) and beyond 50 millimeters (mm) of injection site (Mencevax ACWY 6-17 YOA Group and Mencevax ACWY ≥ 18 YOA Group). | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) post-vaccination period |
|
|
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) post-vaccination period |
|
|
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms and headache. Any = occurrence of the symptom reported irrespective of intensity grade and causal relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 4-day (Days 0-3) post-vaccination period |
|
|
|
| Secondary | Number of Subjects With Unsolicited Adverse Events (AEs) | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the 31-day (Days 0-30) post-vaccination period |
|
|
|
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | During the entire study period (from Day 0 to Month 1) |
|
|
|
| 0 |
| 102 |
| 0 |
| 102 |
| 24 |
| 102 |
| EG001 | Mencevax ACWY 6-17 YOA Group | Filipino male or female subjects, between and including 6 to 17 years of age, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm. | 0 | 86 | 0 | 86 | 10 | 86 |
| EG002 | Mencevax ACWY ≥ 18 YOA Group | Filipino male or female subjects, aged 18 or older, received a single dose of the Mencevax ACWY vaccine, administered by subcutaneous injection in the deltoid region of the arm. | 0 | 61 | 0 | 61 | 11 | 61 |
| Redness | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| Drowsiness | General disorders | MedDRA 11.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D007239 | Infections |
| Title | Measurements |
|---|---|
|
| Any Redness |
|
| Grade 3 Redness |
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| Any Swelling |
|
| Grade 3 Swelling |
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| Title | Measurements |
|---|---|
|
| Any Fever |
|
| Grade 3 Fever |
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| Related Fever |
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| Any Irritability |
|
| Grade 3 Irritability |
|
| Related Irritability |
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| Any Loss of appetite |
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| Grade 3 Loss of appetite |
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| Related Loss of appetite |
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| Related Fatigue |
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| Any Fever |
|
| Grade 3 Fever |
|
| Related Fever |
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| Any Gastrointestinal symptoms |
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| Grade 3 Gastrointestinal symptoms |
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| Related Gastrointestinal symptoms |
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| Any Headache |
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| Grade 3 Headache |
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| Related Headache |
|