Primary Vaccination Study With GSK Biologicals' Pneumococcal Vaccine in Healthy Infants in Vietnam
|ClinicalTrials.gov Identifier: NCT01153841|
Recruitment Status : Completed
First Posted : June 30, 2010
Results First Posted : February 27, 2017
Last Update Posted : March 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Infections, Streptococcal||Biological: Synflorix™( GSK1024850A) Biological: Infanrix hexa™||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Primary Vaccination Course With the Pneumococcal Vaccine GSK 1024850A, in Healthy Infants in Vietnam When Co-administered With GSK Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine|
|Study Start Date :||February 2011|
|Primary Completion Date :||July 2011|
|Study Completion Date :||July 2011|
Experimental: Synflorix Group
Subjects receiving Synflorix™(GSK 1024850A) co-administered along with Infanrix hexa™.
Biological: Synflorix™( GSK1024850A)
Intramuscular, 3 dosesBiological: Infanrix hexa™
Intramuscular, 3 doses
Active Comparator: Control Group
Subjects receiving Infanrix hexa™ vaccine alone.
Biological: Infanrix hexa™
Intramuscular, 3 doses
- Number of Subjects With Grade 3 Symptoms (Solicited and Unsolicited) [ Time Frame: Within the 31-day (Days 0-30) after each dose and across doses ]The incidence and nature of Grade 3 symptoms (solicited and unsolicited) reported during the 31-day post-vaccination period following each dose and across doses are presented.
- Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following each dose ]Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.
- Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period following each dose ]Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.
- Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Days 0-30) follow-up period after each dose ]An unsolicited AE is 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" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
- Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: After the first vaccination up to study end (From Month 0 to Month 3) ]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): NCT01153841
|GSK Investigational Site|
|Ho Chi Minh City, Vietnam|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|