Safety Study of GSK Biologicals' DTPa-IPV/Hib (Infanrix™-IPV/Hib)
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|ClinicalTrials.gov Identifier: NCT00964028|
Recruitment Status : Completed
First Posted : August 24, 2009
Results First Posted : April 10, 2017
Last Update Posted : June 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Haemophilus Influenzae Type b Acellular Pertussis Diphtheria Tetanus Poliomyelitis||Biological: Infanrix™-IPV/Hib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Reactogenicity of GSK Biologicals' DTPa-IPV/Hib (Infanrix™-IPV/Hib) in Infants|
|Study Start Date :||December 1, 2009|
|Actual Primary Completion Date :||April 12, 2010|
|Actual Study Completion Date :||April 12, 2010|
Experimental: INFANRIX-IPV/HIB M2-M3-M4 GROUP
Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
Intramuscular, three doses
Experimental: INFANRIX-IPV/HIB M3-M4-M5 GROUP
Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
Intramuscular, three doses
- Number of Subjects With Any Solicited Local Symptoms [ Time Frame: During the 4-day (Days 0-3) follow-up period after each dose and across doses ]Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
- Number of Subjects With Any Solicited General Symptoms [ Time Frame: During the 4-day (Days 0-3) follow-up period after each dose and across doses ]Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.0 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination.
- Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Days 0-30) follow-up period after each vaccination ]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 whole study period (from Day 0 until Month 3 or Month 4) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00964028
|GSK Investigational Site|
|Wuzhou, Guangxi, China, 543100|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|