Infections, Rotavirus Clinical Trial
Official title:
A Phase II, Randomized, Double-blind, Placebo-controlled Study of Safety, Reactogenicity and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine at 10E6.5 CCID50 Viral Concentration in Healthy Infants (Approximately 5-10 Weeks Old) in the Republic of South Africa
Verified date | September 2016 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Africa: Medicines Control Council |
Study type | Interventional |
The purpose of this study is to determine the appropriate regimen of GSK HRV vaccine for concomitant administration with EPI vaccines to infants in South Africa.
Status | Completed |
Enrollment | 472 |
Est. completion date | September 2004 |
Est. primary completion date | September 2004 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 5 Weeks to 10 Weeks |
Eligibility |
Inclusion Criteria: - Healthy infants born after a normal gestation period (>=36 weeks), between 5 and 10 weeks of age at Dose 1 with confirmed negative HIV status of the subject's mother. - Written informed consent was obtained from the parent/guardian of the subject before study entry. Exclusion Criteria: - History of allergic disease/polio disease, - Confirmed or suspected immunosuppressive or immunodeficient condition, - Clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator, - Received treatment prohibited by the protocol. - Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
South Africa | GSK Investigational Site | Brits | |
South Africa | GSK Investigational Site | Ga-Rankuwa | |
South Africa | GSK Investigational Site | Pretoria | |
South Africa | GSK Investigational Site | Pretoria North | |
South Africa | GSK Investigational Site | Rooihuiskraal | |
South Africa | GSK Investigational Site | Sunnyside, Pretoria |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
South Africa,
Steele AD et al. Comparison of 2 different regimens (two doses versus three doses) in terms of reactogenicity and immunogenicity of the live attenuated human rotavirus vaccine Rotarix™ (RIX4414) in South African infants. Abstract presented at ASCOOD. Bangkok, Thailand, 8-10 March 2006.
Steele AD et al. Comparison of 2 different regimens (two doses versus three doses) in terms of reactogenicity and immunogenicity of the live attenuated human rotavirus vaccine Rotarix™ (RIX4414) in South African infants. Abstract presented at the 9th dsRNA Virus Meeting. Cape Town, South Africa, 21-26 Oct 2006.
Steele AD et al. Difference in immune responses between 2 different regimens of RIX4414 ( 106.5 CCID50 viral concentration) in South Africa. Abstract presented at the 4th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Warsaw, Poland, 01-04 Sept 2005.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Seroconversion after HRV vaccination | No | ||
Secondary | shedding, serum anti-rota IgA antibody concentrations, anti-polio 1, 2 and 3 seroprotection rates, reactogenicity, safety | No |
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