Trial Outcomes & Findings for Safety of Purified Meningococcal Vaccine With Serogroups ACWY, in 3,000 Filipino Subjects Aged > 2 Years (NCT NCT00290329)
NCT ID: NCT00290329
Last Updated: 2018-06-08
Results Overview
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.
COMPLETED
PHASE4
249 participants
During the 31-day (Days 0-30) post-vaccination period
2018-06-08
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
102
|
86
|
61
|
|
Overall Study
COMPLETED
|
102
|
86
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety of Purified Meningococcal Vaccine With Serogroups ACWY, in 3,000 Filipino Subjects Aged > 2 Years
Baseline characteristics by cohort
| Measure |
Mencevax ACWY 2-5 YOA Group
n=102 Participants
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.
|
Mencevax ACWY 6-17 YOA Group
n=86 Participants
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.
|
Mencevax ACWY ≥ 18 YOA Group
n=61 Participants
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.
|
Total
n=249 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
3.0 Years
STANDARD_DEVIATION 1.11 • n=39 Participants
|
9.6 Years
STANDARD_DEVIATION 2.80 • n=41 Participants
|
32.5 Years
STANDARD_DEVIATION 10.98 • n=35 Participants
|
12.51 Years
STANDARD_DEVIATION 13.07 • n=31 Participants
|
|
Sex: Female, Male
Female
|
53 Participants
n=39 Participants
|
45 Participants
n=41 Participants
|
46 Participants
n=35 Participants
|
144 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=39 Participants
|
41 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
105 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
East/ South-east Asian
|
94 Participants
n=39 Participants
|
73 Participants
n=41 Participants
|
56 Participants
n=35 Participants
|
223 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
South Asian
|
8 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
26 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: During the 31-day (Days 0-30) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
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.
Outcome measures
| Measure |
Mencevax ACWY 2-5 YOA Group
n=102 Participants
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.
|
Mencevax ACWY 6-17 YOA Group
n=86 Participants
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.
|
Mencevax ACWY ≥ 18 YOA Group
n=61 Participants
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.
|
|---|---|---|---|
|
Number of Subjects With Severe (Grade 3) Unsolicited Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
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).
Outcome measures
| Measure |
Mencevax ACWY 2-5 YOA Group
n=102 Participants
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.
|
Mencevax ACWY 6-17 YOA Group
n=86 Participants
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.
|
Mencevax ACWY ≥ 18 YOA Group
n=61 Participants
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.
|
|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Adverse Events
Any Pain
|
18 Participants
|
10 Participants
|
9 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Adverse Events
Any Redness
|
8 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Adverse Events
Grade 3 Redness
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Adverse Events
Any Swelling
|
6 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Adverse Events
Grade 3 Swelling
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Adverse Events
Grade 3 Pain
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
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.
Outcome measures
| Measure |
Mencevax ACWY 2-5 YOA Group
n=102 Participants
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.
|
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.
|
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.
|
|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness
|
7 Participants
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever
|
3 Participants
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever
|
3 Participants
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness
|
7 Participants
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability
|
4 Participants
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability
|
4 Participants
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite
|
2 Participants
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite
|
2 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
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.
Outcome measures
| Measure |
Mencevax ACWY 2-5 YOA Group
n=86 Participants
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.
|
Mencevax ACWY 6-17 YOA Group
n=61 Participants
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.
|
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.
|
|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal symptoms
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache
|
1 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache
|
1 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal symptoms
|
1 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal symptoms
|
0 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: During the 31-day (Days 0-30) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects for whom data were available.
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.
Outcome measures
| Measure |
Mencevax ACWY 2-5 YOA Group
n=102 Participants
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.
|
Mencevax ACWY 6-17 YOA Group
n=86 Participants
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.
|
Mencevax ACWY ≥ 18 YOA Group
n=61 Participants
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.
|
|---|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
|
14 Participants
|
9 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 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.
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Mencevax ACWY 2-5 YOA Group
n=102 Participants
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.
|
Mencevax ACWY 6-17 YOA Group
n=86 Participants
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.
|
Mencevax ACWY ≥ 18 YOA Group
n=61 Participants
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.
|
|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Mencevax ACWY 2-5 YOA Group
Mencevax ACWY 6-17 YOA Group
Mencevax ACWY ≥ 18 YOA Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mencevax ACWY 2-5 YOA Group
n=102 participants at risk
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.
|
Mencevax ACWY 6-17 YOA Group
n=86 participants at risk
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.
|
Mencevax ACWY ≥ 18 YOA Group
n=61 participants at risk
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.
|
|---|---|---|---|
|
General disorders
Pain
|
17.6%
18/102 • 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).
|
11.6%
10/86 • 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).
|
14.8%
9/61 • 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).
|
|
General disorders
Redness
|
7.8%
8/102 • 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).
|
0.00%
0/86 • 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).
|
4.9%
3/61 • 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).
|
|
General disorders
Swelling
|
5.9%
6/102 • 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).
|
2.3%
2/86 • 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).
|
0.00%
0/61 • 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).
|
|
General disorders
Drowsiness
|
6.9%
7/102 • 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).
|
0.00%
0/86 • 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).
|
0.00%
0/61 • 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).
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER