Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Poliorix™ Vaccine
|ClinicalTrials.gov Identifier: NCT01021293|
Recruitment Status : Completed
First Posted : November 26, 2009
Results First Posted : April 25, 2017
Last Update Posted : April 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Poliomyelitis||Biological: Poliorix™ Biological: Oral Poliovirus vaccine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunogenicity and Safety of GSK Biologicals' IPV (Poliorix™) in Infants|
|Study Start Date :||November 1, 2009|
|Primary Completion Date :||July 5, 2010|
|Study Completion Date :||July 5, 2010|
Experimental: Poliorix Group
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
3 doses, intramuscular administration
Active Comparator: Control Group
Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
Biological: Oral Poliovirus vaccine
3 doses, oral administration
- Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 [ Time Frame: At Month 3, one month after the third vaccine dose ]A seroprotected subject was defined as a vaccinated subject with anti-polio types 1, 2 and 3 titers greater than or equal to (≥) 8 effective dose 50 (ED50).
- Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 [ Time Frame: At Day 0, prior to the first vaccine dose ]A seroprotected subject was defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 titers ≥ 8 ED50.
- Anti-poliovirus Types 1, 2 and 3 Antibody Titers [ Time Frame: Prior to the first vaccine dose (Day 0) and one month after the third vaccine dose (Month 3) ]Antibody titers were presented as geometric mean titers (GMTs).
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across doses ]Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless 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. This outcome measure concerns subjects from the Poliorix Group only.
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across doses ]Assessed solicited general symptoms were drowsiness, gastrointestinal symptoms, irritability/fussiness, loss of appetite and fever [defined as axillary temperature higher than (>) 37.0°C degrees Celsius]. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of any general symptom regardless of intensity grade or 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 gastrointestinal symptoms = gastrointestinal symptoms that prevented normal activity. Grade 3 fever= temperature > 39°C. Related = symptom assessed by the investigator as causally related to the vaccination.
- Number of Subjects With Any Unsolicited Adverse Events (AEs) [ Time Frame: Within 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.
- Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Day 0 to Month 3) ]Serious adverse events (SAEs) assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01021293
|GSK Investigational Site|
|Wuzhou, Guangxi, China|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|