A Phase 4 interventional study of Mencevax ACWY in Infections, Meningococcal, sponsored by GlaxoSmithKline. Completed at 8 sites in Philippines. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-08.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Prevention
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.
219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.
This study's enrollment of 249 is below the median of 450 across 190 interventional studies indexed under Meningococcal Infections.
Browse Meningococcal Infections studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Biological: Mencevax ACWY
1 subcutaneous injection.
Also known as: Neisseria meningitidis serogroups A, C, W and Y vaccine
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
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
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
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
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
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)
| Milestone | Mencevax ACWY 2-5 YOA Group | Mencevax ACWY 6-17 YOA Group | Mencevax ACWY ≥ 18 YOA Group |
|---|---|---|---|
| Started | 102 | 86 | 61 |
| Completed | 102 | 86 | 61 |
| Not completed | 0 | 0 | 0 |
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.
| Participants | Mencevax ACWY 2-5 YOA Group | Mencevax ACWY 6-17 YOA Group | Mencevax ACWY ≥ 18 YOA Group |
|---|---|---|---|
| Number of Subjects With Severe (Grade 3) Unsolicited Adverse Events | 0 | 0 | 0 |
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).
| Participants | Mencevax ACWY 2-5 YOA Group | Mencevax ACWY 6-17 YOA Group | Mencevax ACWY ≥ 18 YOA Group |
|---|---|---|---|
| Any Pain | 18 | 10 | 9 |
| Grade 3 Pain | 0 | 0 | 0 |
| Any Redness | 8 | 0 | 3 |
| Grade 3 Redness | 0 | 0 | 0 |
| Any Swelling | 6 | 2 | 0 |
| Grade 3 Swelling | 0 | 0 | 0 |
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.
| Participants | Mencevax ACWY 2-5 YOA Group |
|---|---|
| Any Drowsiness | 7 |
| Grade 3 Drowsiness | 0 |
| Related Drowsiness | 7 |
| Any Fever | 3 |
| Grade 3 Fever | 0 |
| Related Fever | 3 |
| Any Irritability | 4 |
| Grade 3 Irritability | 0 |
| Related Irritability | 4 |
| Any Loss of appetite | 2 |
| Grade 3 Loss of appetite | 0 |
| Related Loss of appetite | 2 |
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.
| Participants | Mencevax ACWY 6-17 YOA Group | Mencevax ACWY ≥ 18 YOA Group |
|---|---|---|
| Any Fatigue | 1 | 0 |
| Grade 3 Fatigue | 0 | 0 |
| Related Fatigue | 1 | 0 |
| Any Fever | 1 | 0 |
| Grade 3 Fever | 0 | 0 |
| Related Fever | 1 | 0 |
| Any Gastrointestinal symptoms | 1 | 1 |
| Grade 3 Gastrointestinal symptoms | 0 | 0 |
| Related Gastrointestinal symptoms | 1 | 0 |
| Any Headache | 1 | 3 |
| Grade 3 Headache | 0 | 0 |
| Related Headache | 1 | 3 |
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.
| Participants | Mencevax ACWY 2-5 YOA Group | Mencevax ACWY 6-17 YOA Group | Mencevax ACWY ≥ 18 YOA Group |
|---|---|---|---|
| Number of Subjects With Unsolicited Adverse Events (AEs) | 14 | 9 | 1 |
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
| Participants | Mencevax ACWY 2-5 YOA Group | Mencevax ACWY 6-17 YOA Group | Mencevax ACWY ≥ 18 YOA Group |
|---|---|---|---|
| Number of Subjects With Serious Adverse Events (SAEs) | 0 | 0 | 0 |
Collected over 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).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mencevax ACWY 2-5 YOA Group | 0/102 (0%) | 0/102 (0%) | 24/102 (23.5%) |
| Mencevax ACWY 6-17 YOA Group | 0/86 (0%) | 0/86 (0%) | 10/86 (11.6%) |
| Mencevax ACWY ≥ 18 YOA Group | 0/61 (0%) | 0/61 (0%) | 11/61 (18%) |
| Event | Mencevax ACWY 2-5 YOA Group | Mencevax ACWY 6-17 YOA Group | Mencevax ACWY ≥ 18 YOA Group |
|---|---|---|---|
| PainGeneral disorders | 18/102 | 10/86 | 9/61 |
| RednessGeneral disorders | 8/102 | 0/86 | 3/61 |
| DrowsinessGeneral disorders | 7/102 | 0/86 | 0/61 |
| SwellingGeneral disorders | 6/102 | 2/86 | 0/61 |
| Age, Continuous(Years) | Mencevax ACWY 2-5 YOA Group | Mencevax ACWY 6-17 YOA Group | Mencevax ACWY ≥ 18 YOA Group | Total |
|---|---|---|---|---|
| Mean | 3.0 ± 1.11 | 9.6 ± 2.80 | 32.5 ± 10.98 | 12.51 ± 13.07 |
| Sex: Female, Male(Participants) | Mencevax ACWY 2-5 YOA Group | Mencevax ACWY 6-17 YOA Group | Mencevax ACWY ≥ 18 YOA Group | Total |
|---|---|---|---|---|
| Female | 53 | 45 | 46 | 144 |
| Male | 49 | 41 | 15 | 105 |
| Race/Ethnicity, Customized(Participants) | Mencevax ACWY 2-5 YOA Group | Mencevax ACWY 6-17 YOA Group | Mencevax ACWY ≥ 18 YOA Group | Total |
|---|---|---|---|---|
| East/ South-east Asian | 94 | 73 | 56 | 223 |
| South Asian | 8 | 13 | 5 | 26 |
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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