Trial Outcomes & Findings for Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Poliorix™ Vaccine (NCT NCT01021293)
NCT ID: NCT01021293
Last Updated: 2020-01-21
Results Overview
A seroprotected subject was defined as a vaccinated subject with anti-polio types 1, 2 and 3 titers greater than or equal to (≥) 8 effective dose 50 (ED50).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1101 participants
Primary outcome timeframe
At Month 3, one month after the third vaccine dose
Results posted on
2020-01-21
Participant Flow
Of the 1101 enrolled subjects, one subject was not randomised and administered any vaccine as the parents of the subject refused to vaccinate their child after blood collection at Visit 1 and withdrew their consent.
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participant milestones
| Measure |
Poliorix Group
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
|
Control Group
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
|
|---|---|---|
|
Overall Study
STARTED
|
550
|
550
|
|
Overall Study
COMPLETED
|
538
|
526
|
|
Overall Study
NOT COMPLETED
|
12
|
24
|
Reasons for withdrawal
| Measure |
Poliorix Group
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
|
Control Group
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
|
|---|---|---|
|
Overall Study
Serious Adverse Event
|
2
|
1
|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Migrated/moved from study area
|
6
|
18
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Poliorix™ Vaccine
Baseline characteristics by cohort
| Measure |
Poliorix Group
n=550 Participants
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
|
Control Group
n=550 Participants
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
|
Total
n=1100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10 Weeks
STANDARD_DEVIATION 1.16 • n=5 Participants
|
10.1 Weeks
STANDARD_DEVIATION 1.18 • n=7 Participants
|
10.05 Weeks
STANDARD_DEVIATION 1.17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
268 Participants
n=5 Participants
|
259 Participants
n=7 Participants
|
527 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
282 Participants
n=5 Participants
|
291 Participants
n=7 Participants
|
573 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-Chinese heritage
|
550 Participants
n=5 Participants
|
550 Participants
n=7 Participants
|
1100 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Month 3, one month after the third vaccine dosePopulation: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
A seroprotected subject was defined as a vaccinated subject with anti-polio types 1, 2 and 3 titers greater than or equal to (≥) 8 effective dose 50 (ED50).
Outcome measures
| Measure |
Poliorix Group
n=306 Participants
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
|
Control Group
n=296 Participants
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
|
|---|---|---|
|
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Anti-poliovirus 1
|
306 Participants
|
296 Participants
|
|
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Anti-poliovirus 2
|
306 Participants
|
296 Participants
|
|
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Anti-poliovirus 3
|
306 Participants
|
291 Participants
|
SECONDARY outcome
Timeframe: At Day 0, prior to the first vaccine dosePopulation: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
A seroprotected subject was defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 titers ≥ 8 ED50.
Outcome measures
| Measure |
Poliorix Group
n=306 Participants
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
|
Control Group
n=296 Participants
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
|
|---|---|---|
|
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Anti-poliovirus 1
|
131 Participants
|
113 Participants
|
|
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Anti-poliovirus 2
|
93 Participants
|
99 Participants
|
|
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Anti-poliovirus 3
|
48 Participants
|
52 Participants
|
SECONDARY outcome
Timeframe: Prior to the first vaccine dose (Day 0) and one month after the third vaccine dose (Month 3)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome variables and assay results for antibodies against at least one study vaccine antigen component after vaccination were available.
Antibody titers were presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
Poliorix Group
n=306 Participants
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
|
Control Group
n=296 Participants
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
|
|---|---|---|
|
Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Anti-poliovirus 2, D0
|
6.5 Titers
Interval 5.9 to 7.1
|
7.2 Titers
Interval 6.5 to 8.1
|
|
Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Anti-poliovirus 1, D0
|
8.7 Titers
Interval 7.6 to 9.8
|
7.8 Titers
Interval 6.9 to 8.9
|
|
Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Anti-poliovirus 1, M3
|
485.1 Titers
Interval 436.7 to 538.9
|
2817 Titers
Interval 2479.5 to 3200.4
|
|
Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Anti-poliovirus 2, M3
|
234.3 Titers
Interval 209.0 to 262.6
|
468.5 Titers
Interval 416.6 to 526.9
|
|
Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Anti-poliovirus 3, D0
|
5.2 Titers
Interval 4.8 to 5.7
|
5.2 Titers
Interval 4.8 to 5.7
|
|
Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Anti-poliovirus 3, M3
|
824.3 Titers
Interval 725.3 to 936.9
|
423.4 Titers
Interval 363.3 to 493.3
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across dosesPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had filled in their symptom sheets.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure concerns subjects from the Poliorix Group only.
Outcome measures
| Measure |
Poliorix Group
n=550 Participants
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
|
Control Group
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
|
|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Across doses
|
3 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 1
|
80 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
1 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 1
|
20 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 1
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 1
|
9 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 1
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 2
|
58 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
2 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 2
|
23 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 2
|
1 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 2
|
8 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 2
|
1 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Dose 3
|
41 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Dose 3
|
15 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Dose 3
|
6 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain, Across doses
|
113 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness, Across doses
|
46 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness, Across doses
|
1 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling, Across doses
|
18 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling, Across doses
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across dosesPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had filled in their symptom sheets.
Assessed solicited general symptoms were drowsiness, gastrointestinal symptoms, irritability/fussiness, loss of appetite and fever \[defined as axillary temperature higher than (\>) 37.0°C degrees Celsius\]. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = subject did not eat at all. Grade 3 gastrointestinal symptoms = gastrointestinal symptoms that prevented normal activity. Grade 3 fever= temperature \> 39°C. Related = symptom assessed by the investigator as causally related to the vaccination.
Outcome measures
| Measure |
Poliorix Group
n=550 Participants
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
|
Control Group
n=550 Participants
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 3
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 1
|
99 Participants
|
75 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 1
|
71 Participants
|
51 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal Symptoms, Dose 1
|
102 Participants
|
89 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 1
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Dose 1
|
44 Participants
|
43 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability/Fussiness, Dose 1
|
160 Participants
|
151 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability/Fussiness, Dose 1
|
1 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability/Fussiness, Dose 1
|
130 Participants
|
105 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 1
|
82 Participants
|
83 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 1
|
54 Participants
|
47 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any temperature, Dose 1
|
39 Participants
|
20 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 temperature, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related temperature, Dose 1
|
28 Participants
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 2
|
68 Participants
|
50 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 2
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 2
|
51 Participants
|
25 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Dose 2
|
66 Participants
|
67 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Dose 2
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Dose 2
|
32 Participants
|
35 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability/Fussiness, Dose 2
|
121 Participants
|
86 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability/Fussiness, Dose 2
|
7 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability/Fussiness, Dose 2
|
105 Participants
|
50 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 2
|
70 Participants
|
78 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 2
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 2
|
48 Participants
|
47 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any temperature, Dose 2
|
39 Participants
|
26 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 temperature, Dose 2
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related temperature, Dose 2
|
29 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Dose 3
|
47 Participants
|
45 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Dose 3
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Dose 3
|
36 Participants
|
25 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Dose 3
|
46 Participants
|
67 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Dose 3
|
16 Participants
|
25 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability/Fussiness, Dose 3
|
87 Participants
|
72 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability/Fussiness, Dose 3
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability/Fussiness, Dose 3
|
77 Participants
|
44 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Dose 3
|
52 Participants
|
64 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Dose 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Dose 3
|
34 Participants
|
36 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any temperature, Dose 3
|
33 Participants
|
32 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 temperature, Dose 3
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related temperature, Dose 3
|
18 Participants
|
17 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness, Across doses
|
140 Participants
|
125 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness, Across doses
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness, Across doses
|
115 Participants
|
80 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Gastrointestinal, Across doses
|
154 Participants
|
156 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Gastrointestinal, Across doses
|
5 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Gastrointestinal, Across doses
|
76 Participants
|
87 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irritability, Across doses
|
244 Participants
|
216 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability, Across doses
|
10 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irritability, Across doses
|
214 Participants
|
159 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite, Across doses
|
147 Participants
|
168 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite, Across doses
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite, Across doses
|
109 Participants
|
109 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever, Across doses
|
99 Participants
|
71 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever, Across doses
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever, Across doses
|
68 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Within the 31-day (Days 0-30) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
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 |
Poliorix Group
n=550 Participants
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
|
Control Group
n=550 Participants
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
|
|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
|
155 Participants
|
162 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (from Day 0 to Month 3)Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
Serious adverse events (SAEs) assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity.
Outcome measures
| Measure |
Poliorix Group
n=550 Participants
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
|
Control Group
n=550 Participants
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
3 Participants
|
6 Participants
|
Adverse Events
Poliorix Group
Serious events: 3 serious events
Other events: 391 other events
Deaths: 0 deaths
Control Group
Serious events: 6 serious events
Other events: 366 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Poliorix Group
n=550 participants at risk
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
|
Control Group
n=550 participants at risk
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
|
|---|---|---|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
0.18%
1/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
0.18%
1/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
0.18%
1/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
|
Nervous system disorders
Hydrocephalus
|
0.18%
1/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
0.00%
0/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
0.18%
1/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.18%
1/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
0.00%
0/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
0.18%
1/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
0.36%
2/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
0.18%
1/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
|
Infections and infestations
Herpes zoster
|
0.18%
1/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
0.00%
0/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
0.18%
1/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
Other adverse events
| Measure |
Poliorix Group
n=550 participants at risk
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
|
Control Group
n=550 participants at risk
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
18.0%
99/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
17.6%
97/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
|
Infections and infestations
Nasopharyngitis
|
5.8%
32/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
6.9%
38/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
|
General disorders
Pain
|
20.5%
113/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
0.00%
0/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
|
General disorders
Redness
|
8.4%
46/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
0.00%
0/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
|
General disorders
Drowsiness
|
25.5%
140/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
22.7%
125/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
|
General disorders
Gastrointestinal symptoms
|
28.0%
154/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
28.4%
156/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
|
General disorders
Irritability/Fussiness
|
44.4%
244/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
39.3%
216/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
|
General disorders
Loss of appetite
|
26.7%
147/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
30.5%
168/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
|
General disorders
Fever (Axillary)
|
18.0%
99/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
12.9%
71/550 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).
|
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