Study to Assess the Safety of GSK Biologicals' Liquid Human Rotavirus Vaccine in Healthy Infants
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|ClinicalTrials.gov Identifier: NCT01107587|
Recruitment Status : Completed
First Posted : April 21, 2010
Last Update Posted : May 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Infections, Rotavirus||Biological: GSK Biologicals' human rotavirus vaccine 444563 Biological: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Reactogenicity and Safety of Two Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Liquid Human Rotavirus (HRV) Vaccine 444563, in Healthy Infants|
|Actual Study Start Date :||April 13, 2010|
|Primary Completion Date :||June 28, 2010|
|Study Completion Date :||June 28, 2010|
Experimental: HRV group
Subjects will receive GSK Biologicals' human rotavirus vaccine 444563.
Biological: GSK Biologicals' human rotavirus vaccine 444563
Oral, two doses.
Placebo Comparator: Placebo Group
Subjects will receive placebo.
Oral, two doses.
- Occurrence of grade 3 solicited adverse events. [ Time Frame: Within the 8-day (Day 0 - 7) follow-up period after each vaccine dose. ]
- Occurrence of each solicited adverse event. [ Time Frame: Within the 8-day (Day 0 - 7) follow-up period after each vaccine dose. ]
- Occurrence of unsolicited adverse events. [ Time Frame: Within the 31-day (Day 0 - 30) follow-up period after any vaccine dose. ]
- Occurrence of serious adverse events. [ Time Frame: Throughout the study period (Day 0 to Month 2). ]
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): NCT01107587
|GSK Investigational Site|
|Liucheng County, Guangxi, China, 545200|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|