Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants
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|ClinicalTrials.gov Identifier: NCT00779779|
Recruitment Status : Completed
First Posted : October 24, 2008
Results First Posted : July 30, 2010
Last Update Posted : December 15, 2010
|Condition or disease||Intervention/treatment||Phase|
|Rotavirus Gastroenteritis Rotavirus Vaccines||Biological: Rotarix™||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||522 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Reactogenicity and Safety of Two Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine, Rotarix™ When Administered in Sri Lankan Infants Aged at Least 6 Weeks at the Time of First Vaccination.|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
Experimental: Rotarix Group
Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.
Two oral doses, with at least 4 weeks interval in-between
- Number of Subjects With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea [ Time Frame: During the 8-day solicited follow-up period ]
Grade 2 fever was defined as axillary temperature > 38.0 to <= 39.0 degrees Celsius and grade 3 fever as axillary temperature > 39.0 degrees Celsius.
Grade 2 vomiting was defined as 2 episodes of vomiting per day and grade 3 as 3 or more episodes of vomiting per day.
Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day and grade 3 as 6 or more looser than normal stools a day.
- Number of Subjects Reporting Each Type of Solicited General Symptoms [ Time Frame: During the 8-day follow-up period ]Solicited symptoms included cough, diarrhoea, irritability, loss of appetite, fever (degrees Celsius) and vomiting.
- Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day follow-up period ]Unsolicited AEs cover any AE 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.
- Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: Throughout the study period (Day 0 to Month 3 or 4) ]SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject
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): NCT00779779
|GSK Investigational Site|
|Colombo, Sri Lanka, 03|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|