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

NCT01511133 | Completed

• 5 other identifiers: 114444444563/022444563/033103477104480
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

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 response to the PCV-1 in vaccinated infants.

Conditions

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

Keywords

Laboratory evaluations; infants; Porcine circovirus type 1 (PCV-1); serologic response; human rotavirus (HRV) vaccine

Outcome Measures

Primary Outcomes (2)

• Presence of PCV-1 DNA and pattern of detection in the stool samples collected

  At pre-defined time points after vaccination (3-7 time points up to day 45 after vaccination)

• Presence of serum anti-PCV-1 antibody

  At pre and post vaccination time points (At Day 0 and 2 Months after last dose vaccination)

Study Arms (2)

HRV Group

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

Procedure: Stool sample; Procedure: Serum sample

Placebo Group

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

Procedure: Stool sample; Procedure: Serum sample

Interventions

Stool sample PROCEDURE

Stool samples collected at pre-determined time points in previous studies will be analysed to detect the presence of PCV-1 DNA and pattern of detection.

HRV Group; Placebo Group

Serum sample PROCEDURE

Serum samples collected at pre and post vaccination time points in previous studies will be assessed for Anti-PCV-1 antibody.

HRV Group; Placebo Group

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Infants aged 6 to 12 weeks from 4 previously conducted clinical trials, who received 2 or 3 doses of either Rotarix™ or Placebo

You may qualify if:

• 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.

You may not qualify if:

• \- Not applicable

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• Han HH, Karkada N, Jayadeva G, Dubin G. Serologic response to porcine circovirus type 1 (PCV1) in infants vaccinated with the human rotavirus vaccine, Rotarix: A retrospective laboratory analysis. Hum Vaccin Immunother. 2017 Jan 2;13(1):237-244. doi: 10.1080/21645515.2016.1231262.

  PMID: 27657348 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum and stool samples

MeSH Terms

Conditions

Rotavirus Infections

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2011
• First Posted: January 18, 2012
• Study Start: April 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 16, 2017

Record last verified: 2017-05