Trial Outcomes & Findings for Safety and Reactogenicity of GSK Biologicals' Inactivated Poliomyelitis Vaccine (IPV) (Poliorix) in Infants (NCT NCT00937404)
NCT ID: NCT00937404
Last Updated: 2018-12-17
Results Overview
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimetres (mm) of injection site.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
During the 4-day follow-up period after each dose of study vaccine.
Results posted on
2018-12-17
Participant Flow
Participant milestones
| Measure |
IPV Group
Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, received 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the thigh.
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|---|---|
|
Overall Study
STARTED
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25
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
IPV Group
Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, received 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the thigh.
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|---|---|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Safety and Reactogenicity of GSK Biologicals' Inactivated Poliomyelitis Vaccine (IPV) (Poliorix) in Infants
Baseline characteristics by cohort
| Measure |
IPV Group
n=25 Participants
Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, received 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the thigh.
|
|---|---|
|
Age, Continuous
|
9.6 Weeks
STANDARD_DEVIATION 1.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian-Chinese Heritage
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the 4-day follow-up period after each dose of study vaccine.Population: Analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of at least one dose of the study vaccine.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimetres (mm) of injection site.
Outcome measures
| Measure |
IPV Group
n=25 Participants
Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, received 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the thigh.
|
|---|---|
|
Number of Subjects Reporting Solicited Local Symptoms
Grade 3 Redness, Across doses
|
0 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Any Pain, Dose 1
|
1 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Grade 3 Pain, Dose 1
|
0 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Any Redness, Dose 1
|
2 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Grade 3 Redness, Dose 1
|
0 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Any Swelling, Dose 1
|
1 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Grade 3 Swelling, Dose 1
|
0 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Any Pain, Dose 2
|
2 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Grade 3 Pain, Dose 2
|
0 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Any Redness, Dose 2
|
1 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Grade 3 Redness, Dose 2
|
0 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Any Swelling, Dose 2
|
1 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Grade 3 Swelling, Dose 2
|
0 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Any Pain, Dose 3
|
1 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Grade 3 Pain, Dose 3
|
0 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Any Redness, Dose 3
|
0 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Grade 3 Redness, Dose 3
|
0 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Any Swelling, Dose 3
|
0 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Grade 3 Swelling, Dose 3
|
0 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Any Pain, Across doses
|
3 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Grade 3 Pain, Across doses
|
0 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Any Redness, Across doses
|
2 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Any Swelling, Across doses
|
2 Participants
|
|
Number of Subjects Reporting Solicited Local Symptoms
Grade 3 Swelling, Across doses
|
0 Participants
|
PRIMARY outcome
Timeframe: During the 4-day follow-up period after each dose of study vaccine.Population: Analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of at least one dose of the study vaccine.
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)\]. Any = occurrence of symptom regardless of intensity grade of 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 fever = fever above (\>) 39.0°C. Related = symptom assessed by the investigator as related to vaccination.
Outcome measures
| Measure |
IPV Group
n=25 Participants
Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, received 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the thigh.
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|---|---|
|
Number of Subjects Reporting Solicited General Symptoms
Any Fever, Dose 2
|
3 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Any Drowsiness, Dose 1
|
7 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Grade 3 Drowsiness, Dose 1
|
0 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Related Drowsiness, Dose 1
|
7 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Any Irritability, Dose 1
|
10 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Grade 3 Irritability, Dose 1
|
0 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Related Irritability, Dose 1
|
10 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Any Loss of appetite, Dose 1
|
7 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Grade 3 Loss of appetite, Dose 1
|
0 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Related Loss of appetite, Dose 1
|
7 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Any Fever, Dose 1
|
8 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Grade 3 Fever, Dose 1
|
0 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Related Fever, Dose 1
|
6 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Any Drowsiness, Dose 2
|
2 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Grade 3 Drowsiness, Dose 2
|
0 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Related Drowsiness, Dose 2
|
2 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Any Irritability, Dose 2
|
7 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Grade 3 Irritability, Dose 2
|
0 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Related Irritability, Dose 2
|
6 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Any Loss of appetite, Dose 2
|
4 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Grade 3 Loss of appetite, Dose 2
|
0 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Related Loss of appetite, Dose 2
|
3 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Grade 3 Fever, Dose 2
|
0 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Related Fever, Dose 2
|
3 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Any Drowsiness, Dose 3
|
3 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Grade 3 Drowsiness, Dose 3
|
0 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Related Drowsiness, Dose 3
|
1 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Any Irritability, Dose 3
|
7 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Grade 3 Irritability, Dose 3
|
2 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Related Irritability, Dose 3
|
3 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Any Loss of appetite, Dose 3
|
6 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Grade 3 Loss of appetite, Dose 3
|
0 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Related Loss of appetite, Dose 3
|
3 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Any Fever, Dose 3
|
4 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Grade 3 Fever, Dose 3
|
0 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Related Fever, Dose 3
|
2 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Any Drowsiness, Across doses
|
8 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Grade 3 Drowsiness, Across doses
|
0 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Related Drowsiness, Across doses
|
8 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Any Irritability, Across doses
|
14 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Grade 3 Irritability, Across doses
|
2 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Related Irritability, Across doses
|
12 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Any Loss of appetite, Across doses
|
9 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Grade 3 Loss of appetite, Across doses
|
0 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Related Loss of appetite, Across doses
|
8 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Any Fever, Across doses
|
12 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Grade 3 Fever, Across doses
|
0 Participants
|
|
Number of Subjects Reporting Solicited General Symptoms
Related Fever, Across doses
|
9 Participants
|
PRIMARY outcome
Timeframe: During the 31-days follow-up period after each dose of the study vaccine.Population: Analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of at least one dose of the study vaccine.
Unsolicited AE covers any AE 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 = occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
IPV Group
n=25 Participants
Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, received 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the thigh.
|
|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
|
15 Participants
|
PRIMARY outcome
Timeframe: During the entire study period (from Dose 1 up to one month following last vaccine dose).Population: Analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of at least one dose of the study vaccine.
SAEs assessed included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
IPV Group
n=25 Participants
Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, received 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the thigh.
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|---|---|
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Number of Subjects Reporting Serious Adverse Events (SAEs)
|
0 Participants
|
Adverse Events
IPV Group
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IPV Group
n=25 participants at risk
Healthy male or female subjects between, and including, 60 and 90 days of age at the time of the first vaccination, received 3 doses of Poliorix at 2 (Study Day 0, Visit 1), 3 (Study Month 1, Visit 2) and 4 (Study Month 2, Visit 3) months of age, administered intramuscularly into the upper right side of the thigh.
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|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
4.0%
1/25 • Number of events 1 • Solicited symptoms: during the 4-day post-vaccination period after each vaccine dose. Unsolicited AEs: during the 31-day post-vaccination period after each vaccine dose. SAEs: during the entire study period (from Dose 1 up to one month following last vaccine dose).
|
|
Infections and infestations
Bronchitis
|
4.0%
1/25 • Number of events 1 • Solicited symptoms: during the 4-day post-vaccination period after each vaccine dose. Unsolicited AEs: during the 31-day post-vaccination period after each vaccine dose. SAEs: during the entire study period (from Dose 1 up to one month following last vaccine dose).
|
|
Eye disorders
Conjunctivitis
|
4.0%
1/25 • Number of events 1 • Solicited symptoms: during the 4-day post-vaccination period after each vaccine dose. Unsolicited AEs: during the 31-day post-vaccination period after each vaccine dose. SAEs: during the entire study period (from Dose 1 up to one month following last vaccine dose).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
36.0%
9/25 • Number of events 17 • Solicited symptoms: during the 4-day post-vaccination period after each vaccine dose. Unsolicited AEs: during the 31-day post-vaccination period after each vaccine dose. SAEs: during the entire study period (from Dose 1 up to one month following last vaccine dose).
|
|
Gastrointestinal disorders
Diarrhoea
|
20.0%
5/25 • Number of events 7 • Solicited symptoms: during the 4-day post-vaccination period after each vaccine dose. Unsolicited AEs: during the 31-day post-vaccination period after each vaccine dose. SAEs: during the entire study period (from Dose 1 up to one month following last vaccine dose).
|
|
Gastrointestinal disorders
Dyspepsia
|
12.0%
3/25 • Number of events 4 • Solicited symptoms: during the 4-day post-vaccination period after each vaccine dose. Unsolicited AEs: during the 31-day post-vaccination period after each vaccine dose. SAEs: during the entire study period (from Dose 1 up to one month following last vaccine dose).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.0%
2/25 • Number of events 3 • Solicited symptoms: during the 4-day post-vaccination period after each vaccine dose. Unsolicited AEs: during the 31-day post-vaccination period after each vaccine dose. SAEs: during the entire study period (from Dose 1 up to one month following last vaccine dose).
|
|
Psychiatric disorders
Irritability
|
56.0%
14/25 • Number of events 24 • Solicited symptoms: during the 4-day post-vaccination period after each vaccine dose. Unsolicited AEs: during the 31-day post-vaccination period after each vaccine dose. SAEs: during the entire study period (from Dose 1 up to one month following last vaccine dose).
|
|
Infections and infestations
Nasopharyngitis
|
16.0%
4/25 • Number of events 9 • Solicited symptoms: during the 4-day post-vaccination period after each vaccine dose. Unsolicited AEs: during the 31-day post-vaccination period after each vaccine dose. SAEs: during the entire study period (from Dose 1 up to one month following last vaccine dose).
|
|
General disorders
Pain
|
12.0%
3/25 • Number of events 4 • Solicited symptoms: during the 4-day post-vaccination period after each vaccine dose. Unsolicited AEs: during the 31-day post-vaccination period after each vaccine dose. SAEs: during the entire study period (from Dose 1 up to one month following last vaccine dose).
|
|
General disorders
Pyrexia
|
64.0%
16/25 • Number of events 21 • Solicited symptoms: during the 4-day post-vaccination period after each vaccine dose. Unsolicited AEs: during the 31-day post-vaccination period after each vaccine dose. SAEs: during the entire study period (from Dose 1 up to one month following last vaccine dose).
|
|
Infections and infestations
Skin infection
|
4.0%
1/25 • Number of events 1 • Solicited symptoms: during the 4-day post-vaccination period after each vaccine dose. Unsolicited AEs: during the 31-day post-vaccination period after each vaccine dose. SAEs: during the entire study period (from Dose 1 up to one month following last vaccine dose).
|
|
Nervous system disorders
Somnolence
|
32.0%
8/25 • Number of events 12 • Solicited symptoms: during the 4-day post-vaccination period after each vaccine dose. Unsolicited AEs: during the 31-day post-vaccination period after each vaccine dose. SAEs: during the entire study period (from Dose 1 up to one month following last vaccine dose).
|
|
General disorders
Swelling
|
8.0%
2/25 • Number of events 2 • Solicited symptoms: during the 4-day post-vaccination period after each vaccine dose. Unsolicited AEs: during the 31-day post-vaccination period after each vaccine dose. SAEs: during the entire study period (from Dose 1 up to one month following last vaccine dose).
|
|
Infections and infestations
Upper respiratory tract infection
|
28.0%
7/25 • Number of events 8 • Solicited symptoms: during the 4-day post-vaccination period after each vaccine dose. Unsolicited AEs: during the 31-day post-vaccination period after each vaccine dose. SAEs: during the entire study period (from Dose 1 up to one month following last vaccine dose).
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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