Trial Outcomes & Findings for Study to Evaluate the Safety of Co-administration of GSK Biologicals' Poliorix and Infanrix in Healthy Children in Russia (NCT NCT01094171)
NCT ID: NCT01094171
Last Updated: 2019-03-11
Results Overview
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal everyday activities. Grade 3 redness and swelling were defined as redness and swelling greater than (\>) 20 millimeters (mm)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
400 participants
Primary outcome timeframe
During the 4-day (Days 0 - 3) post vaccination period
Results posted on
2019-03-11
Participant Flow
Participant milestones
| Measure |
Poliorix Group
Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
|
|---|---|
|
Overall Study
STARTED
|
400
|
|
Overall Study
COMPLETED
|
390
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Poliorix Group
Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
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|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Informed consent withdrawal
|
4
|
|
Overall Study
Migration from the study area
|
3
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
Study to Evaluate the Safety of Co-administration of GSK Biologicals' Poliorix and Infanrix in Healthy Children in Russia
Baseline characteristics by cohort
| Measure |
Poliorix Group
n=400 Participants
Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
|
|---|---|
|
Age, Continuous
|
3.40 Months
STANDARD_DEVIATION 0.50 • n=99 Participants
|
|
Sex: Female, Male
Female
|
178 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
222 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: During the 4-day (Days 0 - 3) post vaccination periodSolicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal everyday activities. Grade 3 redness and swelling were defined as redness and swelling greater than (\>) 20 millimeters (mm)
Outcome measures
| Measure |
Poliorix Group
n=400 Participants
Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
|
|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
[Any Pain]
|
114 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
[Grade 3 Pain]
|
7 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
[Any Redness]
|
258 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
[Grade 3 Redness]
|
12 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
[Any Swelling]
|
152 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
[Grade 3 Swelling]
|
8 Subjects
|
PRIMARY outcome
Timeframe: During the 4-day (Days 0 - 3) post vaccination periodSolicited general symptoms assessed were Drowsiness, Irritability, Loss of appetite and Fever \[Axillary temperature greater than or equal to (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 degrees Celsius (°C). Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature \> 39.0°C.
Outcome measures
| Measure |
Poliorix Group
n=400 Participants
Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
|
|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms
[Any Drowsiness]
|
227 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms
[Grade 3 Drowsiness]
|
15 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms
[Any Irritability]
|
240 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms
[Grade 3 Irritability]
|
20 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms
[Any Loss of appetite]
|
133 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms
[Grade 3 Loss of appetite]
|
10 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms
[Any Fever]
|
69 Subjects
|
|
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms
[Grade 3 Fever]
|
1 Subjects
|
PRIMARY outcome
Timeframe: During the 31-day (Days 0 - 30) post vaccination periodUnsolicited 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Poliorix Group
n=400 Participants
Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
|
|---|---|
|
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
|
91 Subjects
|
PRIMARY outcome
Timeframe: During the entire study period (Day 0 - Month 4)SAEs assessed included medical occurrences that resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Outcome measures
| Measure |
Poliorix Group
n=400 Participants
Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
|
|---|---|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
[Any SAEs]
|
4 Subjects
|
|
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
[Related SAEs]
|
0 Subjects
|
Adverse Events
Poliorix Group
Serious events: 4 serious events
Other events: 258 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Poliorix Group
n=400 participants at risk
Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
|
|---|---|
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General disorders
Body temperature increased
|
0.25%
1/400 • Serious Adverse Events: From Day 0 to Month 4; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.25%
1/400 • Serious Adverse Events: From Day 0 to Month 4; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Gastrointestinal disorders
Periproctitis
|
0.25%
1/400 • Serious Adverse Events: From Day 0 to Month 4; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.25%
1/400 • Serious Adverse Events: From Day 0 to Month 4; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
Other adverse events
| Measure |
Poliorix Group
n=400 participants at risk
Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
|
|---|---|
|
General disorders
Pain
|
28.5%
114/400 • Serious Adverse Events: From Day 0 to Month 4; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Redness
|
64.5%
258/400 • Serious Adverse Events: From Day 0 to Month 4; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Swelling
|
38.0%
152/400 • Serious Adverse Events: From Day 0 to Month 4; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Drowsiness
|
56.8%
227/400 • Serious Adverse Events: From Day 0 to Month 4; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Irritability
|
60.0%
240/400 • Serious Adverse Events: From Day 0 to Month 4; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Loss of appetite
|
33.2%
133/400 • Serious Adverse Events: From Day 0 to Month 4; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Fever
|
17.2%
69/400 • Serious Adverse Events: From Day 0 to Month 4; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.8%
27/400 • Serious Adverse Events: From Day 0 to Month 4; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.8%
23/400 • Serious Adverse Events: From Day 0 to Month 4; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Body temperature increased
|
5.0%
20/400 • Serious Adverse Events: From Day 0 to Month 4; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
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