Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' IPV Vaccine (PoliorixTM) in Toddlers
|ClinicalTrials.gov Identifier: NCT00920439|
Recruitment Status : Completed
First Posted : June 15, 2009
Results First Posted : October 19, 2017
Last Update Posted : January 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Poliomyelitis||Biological: PoliorixTM||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Study to Assess the Safety and Reactogenicity of GlaxoSmithKline Biologicals' Inactivated Poliomyelitis Vaccine Poliorix Administered as a Booster Dose at 18-24 Months of Age in Healthy Toddlers in China.|
|Actual Study Start Date :||June 1, 2009|
|Actual Primary Completion Date :||August 3, 2009|
|Actual Study Completion Date :||August 3, 2009|
Experimental: 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).
Single dose, intramuscular administration.
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ]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.
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ]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.
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Days 0-30) post-vaccination period ]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.
- Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Day 0 to Month 1) ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00920439
|GSK Investigational Site|
|Wuzhou, Guangxi, China, 543002|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|