Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy Infants in South Africa

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00383903
• Other study ID #: 444563/013
• Status: Completed
• Phase: Phase 2
• First received: October 3, 2006
• Last updated: September 14, 2016
• Start date: September 2003
• Est. completion date: September 2004

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infections, Rotavirus
• Rotavirus Infections

Intervention

Biological:
• HRV vaccine
Two or three oral doses

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

South Africa, 

References & Publications (3)

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.

Outcome

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

External Links

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