Trial Outcomes & Findings for Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' IPV Vaccine (PoliorixTM) in Toddlers (NCT NCT00920439)

NCT ID: NCT00920439

Last Updated: 2018-01-19

Results Overview

Assessed solicited local symptoms were pain, redness and swelling. Any = all reports of the specified symptom irrespective 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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

26 participants

Primary outcome timeframe

During the 4-day (Days 0-3) post-vaccination period

Results posted on

2018-01-19

Participant Flow

Out of 26 subjects enrolled in the study, one did not receive any vaccination.

Participant milestones

Participant milestones
Measure	Poliorix Group Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorix vaccine that was administrated into the upper right thigh by intramuscular injection (IM).
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' IPV Vaccine (PoliorixTM) in Toddlers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Poliorix Group n=25 Participants Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorix vaccine that was administrated into the upper right thigh by intramuscular injection (IM).
Age, Continuous	20.3 Months STANDARD_DEVIATION 1.49 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of the study vaccine.

Outcome measures

Outcome measures
Measure	Poliorix Group n=25 Participants Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorix vaccine that was administrated into the upper right thigh by intramuscular injection (IM).
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Pain	4 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Pain	0 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Redness	5 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Redness	0 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Any Swelling	3 Subjects
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Grade 3 Swelling	0 Subjects

PRIMARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of the study vaccine.

Assessed solicited general symptoms were temperature \[defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)\], drowsiness, irritability and loss of appetite. Any = all reports of the specified symptom irrespective of intensity grade and 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 the vaccination.

Outcome measures

Outcome measures
Measure	Poliorix Group n=25 Participants Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorix vaccine that was administrated into the upper right thigh by intramuscular injection (IM).
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Drowsiness	3 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Drowsiness	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Drowsiness	3 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Irritability	5 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Irritability	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Irritability	3 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Loss of appetite	3 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Loss of appetite	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Loss of appetite	2 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Any Temperature	6 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Grade 3 Temperature	0 Subjects
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms Related Temperature	5 Subjects

PRIMARY outcome

Timeframe: During the 31-day (Days 0-30) post-vaccination period

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of the study vaccine.

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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

Outcome measures

Outcome measures
Measure	Poliorix Group n=25 Participants Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorix vaccine that was administrated into the upper right thigh by intramuscular injection (IM).
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Any AE(s)	10 Subjects
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Grade 3 AE(s)	0 Subjects
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Related AE(s)	0 Subjects

PRIMARY outcome

Timeframe: During the entire study period (from Day 0 to Month 1)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with documented administration of the study vaccine.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Poliorix Group n=25 Participants Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorix vaccine that was administrated into the upper right thigh by intramuscular injection (IM).
Number of Subjects With Serious Adverse Events (SAEs)	0 Subjects

Adverse Events

Poliorix Group

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Poliorix Group n=25 participants at risk Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorix vaccine that was administrated into the upper right thigh by intramuscular injection (IM).
Metabolism and nutrition disorders Decreased appetite	12.0% 3/25 • Number of events 3 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 1).
Skin and subcutaneous tissue disorders Erythema	20.0% 5/25 • Number of events 5 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 1).
Psychiatric disorders Irritability	20.0% 5/25 • Number of events 5 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 1).
Infections and infestations Nasopharyngitis	12.0% 3/25 • Number of events 4 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 1).
General disorders Pain	16.0% 4/25 • Number of events 4 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 1).
General disorders Pyrexia	28.0% 7/25 • Number of events 10 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 1).
Nervous system disorders Somnolence	12.0% 3/25 • Number of events 3 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 1).
General disorders Swelling	12.0% 3/25 • Number of events 3 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 1).
Infections and infestations Upper respiratory tract infection	12.0% 3/25 • Number of events 4 • Solicited symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 1).

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