Serologic Response to Porcine Circovirus Type 1 (PCV-1) in Infants Following Administration of Rotarix™

NCT02153333 | Completed

• 7 other identifiers: 114793444563/005 (Rota-005)444563/023 (Rota-023)444563/028 (Rota-028)444563/029 (Rota-029)102247 (Rota-036)106481 (Rota-054)
• Study Type: observational
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the serologic response to PCV-1 in the serum samples previously collected during initiation of vaccination series of Human Rotavirus (HRV) vaccine studies (1-2 months post Dose 2 of HRV vaccine or placebo). Additionally, pre-vaccination sera samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time point will also be evaluated.

Conditions

Infections, Rotavirus

Keywords

Human rotavirus (HRV) vaccine; Serologic response; Porcine circovirus type 1 (PCV-1); Laboratory evaluations

Outcome Measures

Primary Outcomes (2)

• Seropositivity rates for anti-PCV-1 antibodies.

  At 1-2 months post dose 2 of HRV vaccine or placebo.

• Seroconversion rates for anti-PCV-1 antibodies.

  At 1-2 months post dose 2 of HRV vaccine or placebo.

Study Arms (2)

HRV Group

Subjects who had received 2 doses of HRV vaccine in previous studies.

Procedure: Serum sample

Placebo Group

Subjects who had received 2 doses of placebo in previous studies.

Procedure: Serum sample

Interventions

Serum sample PROCEDURE

Serum samples collected at pre-vaccination and at 1-2 months post Dose 2 in the previously conducted clinical trials will be assessed for anti-PCV-1 antibodies in this study. Additionally, pre-vaccination sera samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time point will also be evaluated.

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 6 previously completed clinical trials, who received 2 doses of either Rotarix™ or Placebo.

You may qualify if:

• Not applicable as no subjects will be actively enrolled in this study, only the sera samples of the subjects who were a part of previously conducted trials will be used for testing. However, the archived serum samples of only those subjects who satisfy the following criteria will be included in this study:
• Subjects who received two doses of HRV vaccine or Placebo and were included in the ATP cohort for immunogenicity in the primary studies listed.
• Subjects for whom their parents or Legally Acceptable Representatives (LARs) had agreed that their child or wards blood samples could be used for further research while giving consent for any of the primary studies listed.
• Subjects who have sufficient residual volume of serum samples at both pre- and post-vaccination time points.

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 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
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2014
• First Posted: June 3, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 6, 2015

Record last verified: 2015-04