Status:
COMPLETED
Serological Response to Porcine Circovirus Type 1 (PCV-1) and PCV-1 DNA in Stools of Infants Following Administration of Rotarix™
Lead Sponsor:
GlaxoSmithKline
Conditions:
Rotavirus Infection
Evidence of PCV-1 Replication and/or Immune Response to the PCV-1 in HRV Vaccinated Infants
Eligibility:
All Genders
6-12 years
Brief Summary
This study aims to test the clinical samples (stool and serum) previously collected during clinical development of HRV vaccine, to identify if there is any evidence of PCV-1 replication and/or immune ...
Detailed Description
Serum and stool samples collected from 4 clinical trials previously conducted for HRV vaccine (Rotarix™) are used in this study.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Subjects enrolled previously in randomized, double-blind and placebo-controlled studies 444563/022 (NCT00263666), 444563/033 (NCT00757770), 103477 (NCT00169455), and 104480 (NCT00137930);
- Infants aged 6 to 12 weeks at Dose 1 vaccinated with either HRV vaccine or placebo;
- Infants for whom sufficient residual volume of the stool samples at predetermined time points is available;
- Infants for whom sufficient residual volume of the pre and post vaccination blood samples is available.
- Exclusion criteria:
- \- Not applicable
Exclusion
Key Trial Info
Start Date :
April 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01511133
Start Date
April 1 2010
End Date
June 1 2010
Last Update
May 16 2017
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