Trial Outcomes & Findings for Immunogenicity and Safety of Booster Dose of PoliorixTM Vaccine in Previously Vaccinated Toddlers (NCT NCT01323647)
NCT ID: NCT01323647
Last Updated: 2019-02-11
Results Overview
A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 Effective Dose 50 (ED50). This outcome measure concerns subjects in the Poliorix Group only.
COMPLETED
PHASE3
957 participants
One month after Poliorix™ booster vaccination.
2019-02-11
Participant Flow
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
Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
|
Control Group
Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
|
|---|---|---|
|
Overall Study
STARTED
|
470
|
487
|
|
Overall Study
COMPLETED
|
461
|
487
|
|
Overall Study
NOT COMPLETED
|
9
|
0
|
Reasons for withdrawal
| Measure |
Poliorix Group
Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
|
Control Group
Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
|
|---|---|---|
|
Overall Study
Migrated/moved from study area
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Immunogenicity and Safety of Booster Dose of PoliorixTM Vaccine in Previously Vaccinated Toddlers
Baseline characteristics by cohort
| Measure |
Poliorix Group
n=470 Participants
Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
|
Control Group
n=487 Participants
Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
|
Total
n=957 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
18.7 Months
STANDARD_DEVIATION 0.93 • n=93 Participants
|
18.8 Months
STANDARD_DEVIATION 1.01 • n=4 Participants
|
18.75 Months
STANDARD_DEVIATION 0.97 • n=27 Participants
|
|
Sex: Female, Male
Female
|
234 Participants
n=93 Participants
|
227 Participants
n=4 Participants
|
461 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
236 Participants
n=93 Participants
|
260 Participants
n=4 Participants
|
496 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian - Chinese heritage
|
470 Participants
n=93 Participants
|
487 Participants
n=4 Participants
|
957 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: One month after Poliorix™ booster vaccination.Population: The According-to-Protocol (ATP) cohort for immunogenicity included all evaluable subjects who did not receive a product or present a medical condition leading to exclusion from an ATP analysis as listed in protocol and for whom data concerning immunogenicity outcome variables were available.
A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 Effective Dose 50 (ED50). This outcome measure concerns subjects in the Poliorix Group only.
Outcome measures
| Measure |
Poliorix Group
n=456 Participants
Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
|
Control Group
Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
|
|---|---|---|
|
Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value
Anti-poliovirus 1
|
456 Participants
|
—
|
|
Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value
Anti-poliovirus 2
|
456 Participants
|
—
|
|
Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value
Anti-poliovirus 3
|
456 Participants
|
—
|
PRIMARY outcome
Timeframe: Before booster vaccination.Population: The ATP cohort for antibody persistence included all subjects who completed the full 3-dose primary vaccination course in the primary study and have not received an additional dose of Poliorix vaccine since the primary study.Those who had no history of poliovirus infection,and for whom serological results were available at the persistence timepoint
A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 ED50.
Outcome measures
| Measure |
Poliorix Group
n=470 Participants
Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
|
Control Group
n=484 Participants
Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
|
|---|---|---|
|
Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value
Anti-poliovirus 1
|
462 Participants
|
479 Participants
|
|
Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value
Anti-poliovirus 2
|
445 Participants
|
482 Participants
|
|
Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value
Anti-poliovirus 3
|
446 Participants
|
465 Participants
|
PRIMARY outcome
Timeframe: One month after Poliorix™ booster vaccination.Population: The ATP cohort for immunogenicity included all evaluable subjects who did not receive a product or present a medical condition leading to exclusion from an ATP analysis as listed in protocol and for whom data concerning immunogenicity outcome variables were available.
Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals (CIs). This outcome measure concerns subjects in the Poliorix Group only.
Outcome measures
| Measure |
Poliorix Group
n=456 Participants
Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
|
Control Group
Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
|
|---|---|---|
|
Antibody Titers Against Poliovirus Type 1, 2 and 3
Anti-poliovirus 1
|
3420.8 Titers
Interval 3153.8 to 3710.5
|
—
|
|
Antibody Titers Against Poliovirus Type 1, 2 and 3
Anti-poliovirus 2
|
1886.8 Titers
Interval 1732.7 to 2054.5
|
—
|
|
Antibody Titers Against Poliovirus Type 1, 2 and 3
Anti-poliovirus 3
|
5097 Titers
Interval 4706.8 to 5519.6
|
—
|
PRIMARY outcome
Timeframe: Before booster vaccination.Population: The ATP cohort for antibody persistence included all subjects who completed the full 3-dose primary vaccination course in the primary study and have not received an additional dose of Poliorix vaccine since the primary study.Those who had no history of poliovirus infection,and for whom serological results were available at the persistence timepoint
Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs.
Outcome measures
| Measure |
Poliorix Group
n=470 Participants
Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
|
Control Group
n=484 Participants
Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
|
|---|---|---|
|
Antibody Titers Against Poliovirus Type 1, 2 and 3.
Anti-poliovirus 3
|
109.7 Titers
Interval 94.2 to 127.8
|
85.0 Titers
Interval 76.1 to 95.0
|
|
Antibody Titers Against Poliovirus Type 1, 2 and 3.
Anti-poliovirus 1
|
97.6 Titers
Interval 87.3 to 109.2
|
533.0 Titers
Interval 468.0 to 607.0
|
|
Antibody Titers Against Poliovirus Type 1, 2 and 3.
Anti-poliovirus 2
|
87.8 Titers
Interval 75.4 to 102.2
|
205.5 Titers
Interval 185.6 to 227.5
|
SECONDARY outcome
Timeframe: Within 4-days (Days 0-3) post Poliorix™ booster vaccination.Population: The Total Vaccinated cohort included all subjects, with booster dose administration documented, for whom data were available and who had their symptom sheets filled in.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Cry 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 in the Poliorix Group only.
Outcome measures
| Measure |
Poliorix Group
n=467 Participants
Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
|
Control Group
Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
|
|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain
|
49 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain
|
3 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness
|
22 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling
|
11 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 4-days (Days 0-3) post Poliorix™ booster vaccination.Population: The Total Vaccinated cohort included all subjects, with booster dose administration documented, for whom data were available and who had their symptom sheets filled in.
Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature ≥ 37.1 degrees Celsius (°C)\]. Any = occurence of any general symptom regardless of their intensity grade or relationship to study vaccine. Grade 3 drowsiness = drowsiness that prevented normal activities. Grade 3 fever = fever (axillary temperature) \>39.0°C. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as causally related to the vaccination. This outcome measure concerns subjects in the Poliorix Group only.
Outcome measures
| Measure |
Poliorix Group
n=467 Participants
Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
|
Control Group
Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Drowsiness
|
59 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Drowsiness
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Drowsiness
|
59 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Irritability
|
86 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Irritability
|
2 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Irritability
|
84 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any Loss of appetite
|
84 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 Loss of appetite
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related Loss of appetite
|
83 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Any temperature
|
156 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Grade 3 temperature
|
8 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Related temperature
|
153 Participants
|
—
|
SECONDARY outcome
Timeframe: Within the 31-day (Days 0-30) follow-up period after the Poliorix™ booster vaccination.Population: The Total Vaccinated cohort included all subjects, with booster dose administration documented and for whom data were available.
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. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. This outcome measure concerns subjects in the Poliorix Group only.
Outcome measures
| Measure |
Poliorix Group
n=470 Participants
Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
|
Control Group
Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
|
|---|---|---|
|
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
|
22 Participants
|
—
|
SECONDARY outcome
Timeframe: During the entire study period (Day 0 to Month 1).Population: The Total Cohort included all subjects enrolled in the study.
Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Outcome measures
| Measure |
Poliorix Group
n=470 Participants
Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
|
Control Group
n=487 Participants
Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
0 Participants
|
1 Participants
|
Adverse Events
Poliorix Group
Control Group
Serious adverse events
| Measure |
Poliorix Group
n=470 participants at risk
Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
|
Control Group
n=487 participants at risk
Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
|
|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/470 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-Poliorix™ booster vaccination period; Unsolicited symptoms: during the 31-day (Days 0-30) post-Poliorix™ booster vaccination period. Serious Adverse Events (SAEs): during the entire study period (Day 0 to Month 1).
Other (non-serious) adverse events were collected only for those subjects who had received a booster dose of Poliorix, i.e. Poliorix Group. No other (non-serious) adverse events data was collected for the Control Group.
|
0.21%
1/487 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-Poliorix™ booster vaccination period; Unsolicited symptoms: during the 31-day (Days 0-30) post-Poliorix™ booster vaccination period. Serious Adverse Events (SAEs): during the entire study period (Day 0 to Month 1).
Other (non-serious) adverse events were collected only for those subjects who had received a booster dose of Poliorix, i.e. Poliorix Group. No other (non-serious) adverse events data was collected for the Control Group.
|
Other adverse events
| Measure |
Poliorix Group
n=470 participants at risk
Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
|
Control Group
n=487 participants at risk
Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
|
|---|---|---|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.9%
84/470 • Number of events 84 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-Poliorix™ booster vaccination period; Unsolicited symptoms: during the 31-day (Days 0-30) post-Poliorix™ booster vaccination period. Serious Adverse Events (SAEs): during the entire study period (Day 0 to Month 1).
Other (non-serious) adverse events were collected only for those subjects who had received a booster dose of Poliorix, i.e. Poliorix Group. No other (non-serious) adverse events data was collected for the Control Group.
|
—
0/0 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-Poliorix™ booster vaccination period; Unsolicited symptoms: during the 31-day (Days 0-30) post-Poliorix™ booster vaccination period. Serious Adverse Events (SAEs): during the entire study period (Day 0 to Month 1).
Other (non-serious) adverse events were collected only for those subjects who had received a booster dose of Poliorix, i.e. Poliorix Group. No other (non-serious) adverse events data was collected for the Control Group.
|
|
Psychiatric disorders
Irritability
|
18.3%
86/470 • Number of events 86 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-Poliorix™ booster vaccination period; Unsolicited symptoms: during the 31-day (Days 0-30) post-Poliorix™ booster vaccination period. Serious Adverse Events (SAEs): during the entire study period (Day 0 to Month 1).
Other (non-serious) adverse events were collected only for those subjects who had received a booster dose of Poliorix, i.e. Poliorix Group. No other (non-serious) adverse events data was collected for the Control Group.
|
—
0/0 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-Poliorix™ booster vaccination period; Unsolicited symptoms: during the 31-day (Days 0-30) post-Poliorix™ booster vaccination period. Serious Adverse Events (SAEs): during the entire study period (Day 0 to Month 1).
Other (non-serious) adverse events were collected only for those subjects who had received a booster dose of Poliorix, i.e. Poliorix Group. No other (non-serious) adverse events data was collected for the Control Group.
|
|
General disorders
Pain
|
10.4%
49/470 • Number of events 49 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-Poliorix™ booster vaccination period; Unsolicited symptoms: during the 31-day (Days 0-30) post-Poliorix™ booster vaccination period. Serious Adverse Events (SAEs): during the entire study period (Day 0 to Month 1).
Other (non-serious) adverse events were collected only for those subjects who had received a booster dose of Poliorix, i.e. Poliorix Group. No other (non-serious) adverse events data was collected for the Control Group.
|
—
0/0 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-Poliorix™ booster vaccination period; Unsolicited symptoms: during the 31-day (Days 0-30) post-Poliorix™ booster vaccination period. Serious Adverse Events (SAEs): during the entire study period (Day 0 to Month 1).
Other (non-serious) adverse events were collected only for those subjects who had received a booster dose of Poliorix, i.e. Poliorix Group. No other (non-serious) adverse events data was collected for the Control Group.
|
|
General disorders
Pyrexia
|
33.4%
157/470 • Number of events 158 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-Poliorix™ booster vaccination period; Unsolicited symptoms: during the 31-day (Days 0-30) post-Poliorix™ booster vaccination period. Serious Adverse Events (SAEs): during the entire study period (Day 0 to Month 1).
Other (non-serious) adverse events were collected only for those subjects who had received a booster dose of Poliorix, i.e. Poliorix Group. No other (non-serious) adverse events data was collected for the Control Group.
|
—
0/0 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-Poliorix™ booster vaccination period; Unsolicited symptoms: during the 31-day (Days 0-30) post-Poliorix™ booster vaccination period. Serious Adverse Events (SAEs): during the entire study period (Day 0 to Month 1).
Other (non-serious) adverse events were collected only for those subjects who had received a booster dose of Poliorix, i.e. Poliorix Group. No other (non-serious) adverse events data was collected for the Control Group.
|
|
Nervous system disorders
Somnolence
|
12.6%
59/470 • Number of events 59 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-Poliorix™ booster vaccination period; Unsolicited symptoms: during the 31-day (Days 0-30) post-Poliorix™ booster vaccination period. Serious Adverse Events (SAEs): during the entire study period (Day 0 to Month 1).
Other (non-serious) adverse events were collected only for those subjects who had received a booster dose of Poliorix, i.e. Poliorix Group. No other (non-serious) adverse events data was collected for the Control Group.
|
—
0/0 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-Poliorix™ booster vaccination period; Unsolicited symptoms: during the 31-day (Days 0-30) post-Poliorix™ booster vaccination period. Serious Adverse Events (SAEs): during the entire study period (Day 0 to Month 1).
Other (non-serious) adverse events were collected only for those subjects who had received a booster dose of Poliorix, i.e. Poliorix Group. No other (non-serious) adverse events data was collected for the Control Group.
|
Additional Information
GSK Response Center
GlaxoSmithKline
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