Serological Response to Porcine Circovirus Type 1 (PCV-1) and PCV-1 DNA in Stools of Infants Following Administration of Rotarix™

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Evidence of PCV-1 Replication and/or Immune Response to the PCV-1 in HRV Vaccinated Infants; Rotavirus Infection

Treatments: Procedure: Stool sample; Procedure: Serum sample

Study type: Observational

Funder types: Industry

Identifiers

NCT01511133

444563/033

444563/022

114444

104480

103477

Details and patient eligibility

About

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 response to the PCV-1 in vaccinated infants.

Full description

Serum and stool samples collected from 4 clinical trials previously conducted for HRV vaccine (Rotarix™) are used in this study.

Enrollment: 1 patient

Sex: All

Ages: 6 to 12 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

1 participants in 2 patient groups

HRV Group

Description:

Subjects received two or three doses of HRV in previous studies.

Treatment:

Procedure: Serum sample

Procedure: Stool sample

Placebo Group

Description:

Subjects received two or three doses of placebo in previous studies.

Treatment:

Procedure: Serum sample

Procedure: Stool sample