Infections, Meningococcal
Conditions
Keywords
Safety, Meningococcal disease, Meningitidis serogroups A, C,W & Y diseases, Meningococcal vaccine
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALMencevax ACWY
1 subcutaneous injection.
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that they and/or their parent/guardian can and will comply with the requirements of the protocol. * A Filipino male or female \> 2 years of age at the time of the first vaccination. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Written informed consent obtained from the subject and/or from the parent/ guardian of the subject.
Exclusion criteria
* Subjects suffering from acute severe febrile illness. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures. * Pregnant or lactating female. * Female planning to become pregnant. * History of chronic alcohol consumption and/or intravenous drug abuse. * Any contraindications as stated on the Prescribing Information.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Severe (Grade 3) Unsolicited Adverse Events | During the 31-day (Days 0-30) post-vaccination period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited Local Adverse Events | During the 4-day (Days 0-3) post-vaccination period | 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). |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 4-day (Days 0-3) post-vaccination period | 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. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During the 31-day (Days 0-30) post-vaccination period | 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. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (from Day 0 to Month 1) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
Countries
Philippines
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 102 |
| 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. | 86 |
| 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. | 61 |
| Total | 249 |
Baseline characteristics
| Characteristic | Mencevax ACWY 2-5 YOA Group | Mencevax ACWY 6-17 YOA Group | Mencevax ACWY ≥ 18 YOA Group | Total |
|---|---|---|---|---|
| Age, Continuous | 3.0 Years STANDARD_DEVIATION 1.11 | 9.6 Years STANDARD_DEVIATION 2.8 | 32.5 Years STANDARD_DEVIATION 10.98 | 12.51 Years STANDARD_DEVIATION 13.07 |
| Race/Ethnicity, Customized East/ South-east Asian | 94 Participants | 73 Participants | 56 Participants | 223 Participants |
| Race/Ethnicity, Customized South Asian | 8 Participants | 13 Participants | 5 Participants | 26 Participants |
| Sex: Female, Male Female | 53 Participants | 45 Participants | 46 Participants | 144 Participants |
| Sex: Female, Male Male | 49 Participants | 41 Participants | 15 Participants | 105 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 102 | 0 / 86 | 0 / 61 |
| other Total, other adverse events | 24 / 102 | 10 / 86 | 11 / 61 |
| serious Total, serious adverse events | 0 / 102 | 0 / 86 | 0 / 61 |
Outcome results
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.
Time frame: During the 31-day (Days 0-30) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Severe (Grade 3) Unsolicited Adverse Events | 0 Participants |
| Mencevax ACWY 6-17 YOA Group | Number of Subjects With Severe (Grade 3) Unsolicited Adverse Events | 0 Participants |
| Mencevax ACWY ≥ 18 YOA Group | Number of Subjects With Severe (Grade 3) Unsolicited Adverse Events | 0 Participants |
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).
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events | Grade 3 Swelling | 0 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events | Any Redness | 8 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events | Any Swelling | 6 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events | Any Pain | 18 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events | Grade 3 Redness | 0 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events | Grade 3 Pain | 0 Participants |
| Mencevax ACWY 6-17 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events | Grade 3 Redness | 0 Participants |
| Mencevax ACWY 6-17 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events | Any Swelling | 2 Participants |
| Mencevax ACWY 6-17 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events | Grade 3 Pain | 0 Participants |
| Mencevax ACWY 6-17 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events | Grade 3 Swelling | 0 Participants |
| Mencevax ACWY 6-17 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events | Any Pain | 10 Participants |
| Mencevax ACWY 6-17 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events | Any Redness | 0 Participants |
| Mencevax ACWY ≥ 18 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events | Any Redness | 3 Participants |
| Mencevax ACWY ≥ 18 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events | Any Pain | 9 Participants |
| Mencevax ACWY ≥ 18 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events | Grade 3 Pain | 0 Participants |
| Mencevax ACWY ≥ 18 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events | Grade 3 Swelling | 0 Participants |
| Mencevax ACWY ≥ 18 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events | Grade 3 Redness | 0 Participants |
| Mencevax ACWY ≥ 18 YOA Group | Number of Subjects With Any and Grade 3 Solicited Local Adverse Events | Any Swelling | 0 Participants |
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.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 7 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 0 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 7 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 3 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 3 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability | 4 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability | 0 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability | 4 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite | 2 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite | 0 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite | 2 Participants |
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.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 1 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 1 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 1 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 1 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 1 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms | 1 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms | 0 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms | 1 Participants |
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 1 Participants |
| Mencevax ACWY 6-17 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Gastrointestinal symptoms | 0 Participants |
| Mencevax ACWY 6-17 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Headache | 0 Participants |
| Mencevax ACWY 6-17 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Mencevax ACWY 6-17 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Headache | 3 Participants |
| Mencevax ACWY 6-17 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Gastrointestinal symptoms | 0 Participants |
| Mencevax ACWY 6-17 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fatigue | 0 Participants |
| Mencevax ACWY 6-17 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 0 Participants |
| Mencevax ACWY 6-17 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fatigue | 0 Participants |
| Mencevax ACWY 6-17 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Headache | 3 Participants |
| Mencevax ACWY 6-17 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fatigue | 0 Participants |
| Mencevax ACWY 6-17 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Gastrointestinal symptoms | 1 Participants |
| Mencevax ACWY 6-17 YOA Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 0 Participants |
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.
Time frame: During the entire study period (from Day 0 to Month 1)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Mencevax ACWY 6-17 YOA Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Mencevax ACWY ≥ 18 YOA Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
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.
Time frame: During the 31-day (Days 0-30) post-vaccination period
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mencevax ACWY 2-5 YOA Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 14 Participants |
| Mencevax ACWY 6-17 YOA Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 9 Participants |
| Mencevax ACWY ≥ 18 YOA Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 1 Participants |