Trial Outcomes & Findings for Comparison of GSK134612 in Subjects Previously Vaccinated Against Meningococcal Disease Versus Non-vaccinated Subjects (NCT NCT00661557)
NCT ID: NCT00661557
Last Updated: 2018-12-28
Results Overview
For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, titers were expressed as geometric mean titers (GMTs) and tabulated with 95% confidence intervals (CIs).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
271 participants
Primary outcome timeframe
One month post-vaccination (Month 1)
Results posted on
2018-12-28
Participant Flow
Participant milestones
| Measure |
Mencevax Primed Group
Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Mencevax Naive Group
Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|
|
Overall Study
STARTED
|
192
|
79
|
|
Overall Study
COMPLETED
|
183
|
79
|
|
Overall Study
NOT COMPLETED
|
9
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of GSK134612 in Subjects Previously Vaccinated Against Meningococcal Disease Versus Non-vaccinated Subjects
Baseline characteristics by cohort
| Measure |
Mencevax Primed Group
n=192 Participants
Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Mencevax Naive Group
n=79 Participants
Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Total
n=271 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.1 Years
STANDARD_DEVIATION 6.79 • n=5 Participants
|
14.2 Years
STANDARD_DEVIATION 7.23 • n=7 Participants
|
14.13 Years
STANDARD_DEVIATION 6.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
91 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African heritage
|
192 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
269 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian/European heritage
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One month post-vaccination (Month 1)Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available.
For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, titers were expressed as geometric mean titers (GMTs) and tabulated with 95% confidence intervals (CIs).
Outcome measures
| Measure |
Mencevax Primed Group
n=169 Participants
Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Mencevax Naive Group
n=75 Participants
Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|
|
Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers
rSBA-MenA
|
6868.8 Titers
Interval 6044.9 to 7805.0
|
13014.9 Titers
Interval 10722.2 to 15798.0
|
|
Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers
rSBA-MenC
|
1945.8 Titers
Interval 1583.3 to 2391.1
|
5494.6 Titers
Interval 4266.3 to 7076.5
|
|
Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers
rSBA-MenW-135
|
4635.7 Titers
Interval 3942.5 to 5450.7
|
9078.0 Titers
Interval 7087.7 to 11627.1
|
|
Meningococcal Serum Bactericidal Antibodies/Assay (rSBA) Titers
rSBA-MenY
|
7799.9 Titers
Interval 6682.8 to 9103.6
|
13895.5 Titers
Interval 11186.2 to 17260.9
|
SECONDARY outcome
Timeframe: Prior to vaccination (Day 0)Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available.
For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, titers were expressed as geometric mean titers (GMTs) and tabulated with 95% confidence intervals (CIs).
Outcome measures
| Measure |
Mencevax Primed Group
n=167 Participants
Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Mencevax Naive Group
n=74 Participants
Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|
|
Meningococcal rSBA Titers
rSBA-MenA
|
1770.1 Titers
Interval 1569.0 to 1996.9
|
1103.8 Titers
Interval 863.2 to 1411.5
|
|
Meningococcal rSBA Titers
rSBA-MenC
|
116.6 Titers
Interval 80.2 to 169.4
|
30.1 Titers
Interval 17.4 to 52.0
|
|
Meningococcal rSBA Titers
rSBA-MenW-135
|
154.0 Titers
Interval 114.0 to 208.1
|
36.9 Titers
Interval 22.7 to 59.9
|
|
Meningococcal rSBA Titers
rSBA-MenY
|
555.2 Titers
Interval 434.8 to 708.9
|
170.1 Titers
Interval 106.1 to 272.9
|
SECONDARY outcome
Timeframe: Prior to (Day 0) and one month post-vaccination (Month 1)Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available.
For each antibody assessed (serogroups A, C, W, and Y) at the corresponding time point, polysaccharide antibody concentrations were expressed as geometric mean concentrations (GMCs) in micrograms per milliliter (µg/mL) and tabulated with 95% confidence intervals (CIs).
Outcome measures
| Measure |
Mencevax Primed Group
n=86 Participants
Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Mencevax Naive Group
n=38 Participants
Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|
|
Anti-meningococcal Polysaccharide (PS) Antibody Concentrations
Anti-PSW-135, Month 1
|
25.10 µg/mL
Interval 19.49 to 32.33
|
14.67 µg/mL
Interval 9.25 to 23.28
|
|
Anti-meningococcal Polysaccharide (PS) Antibody Concentrations
Anti-PSY, Day 0
|
4.05 µg/mL
Interval 2.83 to 5.81
|
0.21 µg/mL
Interval 0.15 to 0.29
|
|
Anti-meningococcal Polysaccharide (PS) Antibody Concentrations
Anti-PSY, Month 1
|
29.98 µg/mL
Interval 23.48 to 38.28
|
17.58 µg/mL
Interval 11.89 to 25.99
|
|
Anti-meningococcal Polysaccharide (PS) Antibody Concentrations
Anti-PSA, Day 0
|
9.38 µg/mL
Interval 6.37 to 13.81
|
0.41 µg/mL
Interval 0.24 to 0.7
|
|
Anti-meningococcal Polysaccharide (PS) Antibody Concentrations
Anti-PSA, Month 1
|
79.15 µg/mL
Interval 57.61 to 108.73
|
47.45 µg/mL
Interval 30.48 to 73.85
|
|
Anti-meningococcal Polysaccharide (PS) Antibody Concentrations
Anti-PSC, Day 0
|
6.46 µg/mL
Interval 4.49 to 9.3
|
0.31 µg/mL
Interval 0.2 to 0.47
|
|
Anti-meningococcal Polysaccharide (PS) Antibody Concentrations
Anti-PSC, Month 1
|
31.19 µg/mL
Interval 25.34 to 38.39
|
18.81 µg/mL
Interval 12.92 to 27.38
|
|
Anti-meningococcal Polysaccharide (PS) Antibody Concentrations
Anti-PSW-135, Day 0
|
3.40 µg/mL
Interval 2.2 to 5.26
|
0.20 µg/mL
Interval 0.14 to 0.29
|
SECONDARY outcome
Timeframe: Prior to (Day 0) and one month post-vaccination (Month 1)Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available.
Antibody concentrations were tabulated as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL), with 95% confidence intervals (CIs).
Outcome measures
| Measure |
Mencevax Primed Group
n=169 Participants
Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Mencevax Naive Group
n=75 Participants
Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|
|
Anti-tetanus Toxoid Antibody Concentrations
Pre-vaccination
|
0.718 IU/mL
Interval 0.561 to 0.919
|
1.515 IU/mL
Interval 1.032 to 2.223
|
|
Anti-tetanus Toxoid Antibody Concentrations
Post-vaccination
|
17.678 IU/mL
Interval 14.494 to 21.562
|
41.600 IU/mL
Interval 31.587 to 54.787
|
SECONDARY outcome
Timeframe: One month post-vaccination (Month 1)Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variable measures at the defined timepoint were available.
Vaccine response defined as: For initially seronegative subjects: post-vaccination antibody titer ≥1:32 For initially seropositive subjects: post-vaccination antibody titer ≥4-fold the pre-vaccination antibody titer
Outcome measures
| Measure |
Mencevax Primed Group
n=167 Participants
Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Mencevax Naive Group
n=74 Participants
Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With a Vaccine Response to Meningococcal Antigens A, C, W and Y
rSBA-MenA
|
58 Participants
|
50 Participants
|
|
Number of Subjects With a Vaccine Response to Meningococcal Antigens A, C, W and Y
rSBA-MenC
|
110 Participants
|
68 Participants
|
|
Number of Subjects With a Vaccine Response to Meningococcal Antigens A, C, W and Y
rSBA-MenW-135
|
137 Participants
|
72 Participants
|
|
Number of Subjects With a Vaccine Response to Meningococcal Antigens A, C, W and Y
rSBA-MenY
|
125 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0 to Day 3) period after vaccinationPopulation: This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects. Only subjects who completed their symptom sheets are included.
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 100 millimeters (mm) of injection site.
Outcome measures
| Measure |
Mencevax Primed Group
n=165 Participants
Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Mencevax Naive Group
n=77 Participants
Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain
|
84 Participants
|
27 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain
|
8 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness
|
35 Participants
|
17 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling
|
40 Participants
|
20 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling
|
9 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Day 0 to Day 3) period after vaccinationPopulation: This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects. Only subjects who completed their symptom sheets are included.
Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], headache, myalgia, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade. 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 Primed Group
n=165 Participants
Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Mencevax Naive Group
n=77 Participants
Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fatigue
|
59 Participants
|
15 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fatigue
|
9 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fatigue
|
54 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever (oral temperature)
|
33 Participants
|
15 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever (oral temperature)
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever (oral temperature)
|
31 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal Symptoms
|
26 Participants
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal Symptoms
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal Symptoms
|
24 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Headache
|
52 Participants
|
17 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Headache
|
5 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Headache
|
45 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to one month post-vaccination (Month 1)Population: This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.
An unsolicited symptom 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 symptom regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Mencevax Primed Group
n=192 Participants
Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Mencevax Naive Group
n=79 Participants
Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Unsolicited Symptoms
|
19 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Day 0 to study month 6Population: This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.
Serious adverse events (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 Primed Group
n=192 Participants
Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Mencevax Naive Group
n=79 Participants
Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects Reporting Any Serious Adverse Events
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0 to study month 6Population: This analysis was based on the Total Vaccinated cohort, which included all vaccinated subjects.
Specific adverse events comprised rash, new onset of chronic illnesses (NOCIs), conditions prompting emergency room (ER) visits and/or any event related to lack of vaccine efficacy (i.e. documented meningococcal disease). Events related to lack of vaccine efficacy (i.e. meningococcal disease) were recorded, but because such events were life threatening and were thus reported as SAEs, these events were not analyzed or reported here separately.
Outcome measures
| Measure |
Mencevax Primed Group
n=192 Participants
Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Mencevax Naive Group
n=79 Participants
Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|
|
Number of Subjects With Any Specific Adverse Events
Subjects with any rash
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Specific Adverse Events
Subjects with any NOCI(s)
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any Specific Adverse Events
Subjects with any ER visit(s)
|
0 Participants
|
1 Participants
|
Adverse Events
Mencevax Primed Group
Serious events: 1 serious events
Other events: 111 other events
Deaths: 0 deaths
Mencevax Naive Group
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mencevax Primed Group
n=192 participants at risk
Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Mencevax Naive Group
n=79 participants at risk
Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.52%
1/192 • Solicited symptoms: Day 0 to Day 3 post-vaccination; Unsolicited symptoms: Day 0-Day 30 post-vaccination. Serious adverse events: Day 0 up to study end at Month 6.
|
0.00%
0/79 • Solicited symptoms: Day 0 to Day 3 post-vaccination; Unsolicited symptoms: Day 0-Day 30 post-vaccination. Serious adverse events: Day 0 up to study end at Month 6.
|
Other adverse events
| Measure |
Mencevax Primed Group
n=192 participants at risk
Subjects who were previously vaccinated with meningococcal vaccine Mencevax ACWY in study NCT00227422 received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
Mencevax Naive Group
n=79 participants at risk
Subjects who did not receive (or had not received in the preceding 10 years) any meningococcal vaccination received in the current study a single dose of meningococcal conjugate vaccine Nimenrix, administered intramuscularly in the deltoid muscle of the non-dominant arm.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
18.2%
35/192 • Number of events 35 • Solicited symptoms: Day 0 to Day 3 post-vaccination; Unsolicited symptoms: Day 0-Day 30 post-vaccination. Serious adverse events: Day 0 up to study end at Month 6.
|
21.5%
17/79 • Number of events 17 • Solicited symptoms: Day 0 to Day 3 post-vaccination; Unsolicited symptoms: Day 0-Day 30 post-vaccination. Serious adverse events: Day 0 up to study end at Month 6.
|
|
General disorders
Fatigue
|
30.7%
59/192 • Number of events 59 • Solicited symptoms: Day 0 to Day 3 post-vaccination; Unsolicited symptoms: Day 0-Day 30 post-vaccination. Serious adverse events: Day 0 up to study end at Month 6.
|
19.0%
15/79 • Number of events 15 • Solicited symptoms: Day 0 to Day 3 post-vaccination; Unsolicited symptoms: Day 0-Day 30 post-vaccination. Serious adverse events: Day 0 up to study end at Month 6.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
13.5%
26/192 • Number of events 26 • Solicited symptoms: Day 0 to Day 3 post-vaccination; Unsolicited symptoms: Day 0-Day 30 post-vaccination. Serious adverse events: Day 0 up to study end at Month 6.
|
12.7%
10/79 • Number of events 10 • Solicited symptoms: Day 0 to Day 3 post-vaccination; Unsolicited symptoms: Day 0-Day 30 post-vaccination. Serious adverse events: Day 0 up to study end at Month 6.
|
|
Nervous system disorders
Headache
|
27.6%
53/192 • Number of events 53 • Solicited symptoms: Day 0 to Day 3 post-vaccination; Unsolicited symptoms: Day 0-Day 30 post-vaccination. Serious adverse events: Day 0 up to study end at Month 6.
|
21.5%
17/79 • Number of events 17 • Solicited symptoms: Day 0 to Day 3 post-vaccination; Unsolicited symptoms: Day 0-Day 30 post-vaccination. Serious adverse events: Day 0 up to study end at Month 6.
|
|
General disorders
Pain
|
43.8%
84/192 • Number of events 85 • Solicited symptoms: Day 0 to Day 3 post-vaccination; Unsolicited symptoms: Day 0-Day 30 post-vaccination. Serious adverse events: Day 0 up to study end at Month 6.
|
34.2%
27/79 • Number of events 27 • Solicited symptoms: Day 0 to Day 3 post-vaccination; Unsolicited symptoms: Day 0-Day 30 post-vaccination. Serious adverse events: Day 0 up to study end at Month 6.
|
|
General disorders
Pyrexia
|
17.7%
34/192 • Number of events 34 • Solicited symptoms: Day 0 to Day 3 post-vaccination; Unsolicited symptoms: Day 0-Day 30 post-vaccination. Serious adverse events: Day 0 up to study end at Month 6.
|
19.0%
15/79 • Number of events 15 • Solicited symptoms: Day 0 to Day 3 post-vaccination; Unsolicited symptoms: Day 0-Day 30 post-vaccination. Serious adverse events: Day 0 up to study end at Month 6.
|
|
General disorders
Swelling
|
20.8%
40/192 • Number of events 40 • Solicited symptoms: Day 0 to Day 3 post-vaccination; Unsolicited symptoms: Day 0-Day 30 post-vaccination. Serious adverse events: Day 0 up to study end at Month 6.
|
25.3%
20/79 • Number of events 20 • Solicited symptoms: Day 0 to Day 3 post-vaccination; Unsolicited symptoms: Day 0-Day 30 post-vaccination. Serious adverse events: Day 0 up to study end at Month 6.
|
|
Infections and infestations
Tonsillitis
|
2.1%
4/192 • Number of events 4 • Solicited symptoms: Day 0 to Day 3 post-vaccination; Unsolicited symptoms: Day 0-Day 30 post-vaccination. Serious adverse events: Day 0 up to study end at Month 6.
|
5.1%
4/79 • Number of events 4 • Solicited symptoms: Day 0 to Day 3 post-vaccination; Unsolicited symptoms: Day 0-Day 30 post-vaccination. Serious adverse events: Day 0 up to study end at Month 6.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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