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

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ClinicalTrials.gov Identifier: NCT02153333
Recruitment Status : Completed
First Posted : June 3, 2014
Last Update Posted : April 6, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment
Infections, Rotavirus Procedure: Serum sample

Detailed Description:
Serum samples collected from 6 clinical trials previously conducted for HRV vaccine (Rotarix™) are used in this study.

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Study Type : Observational
Actual Enrollment : 1 participants
Time Perspective: Retrospective
Official Title: Blinded Retrospective Laboratory Evaluations to Assess the Serologic Response to Porcine Circovirus Type 1 (PCV-1) in Infants Following the Administration of GlaxoSmithKline (GSK) Biologicals' Human Rotavirus Vaccine (444563)
Study Start Date : February 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Group/Cohort Intervention/treatment
HRV Group
Subjects who had received 2 doses of HRV vaccine in previous studies.
Procedure: Serum sample
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.

Placebo Group
Subjects who had received 2 doses of placebo in previous studies.
Procedure: Serum sample
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.




Primary Outcome Measures :
  1. Seropositivity rates for anti-PCV-1 antibodies. [ Time Frame: At 1-2 months post dose 2 of HRV vaccine or placebo. ]
  2. Seroconversion rates for anti-PCV-1 antibodies. [ Time Frame: At 1-2 months post dose 2 of HRV vaccine or placebo. ]

Biospecimen Retention:   Samples With DNA
Serum samples


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  • Not Applicable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153333


Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02153333     History of Changes
Other Study ID Numbers: 114793
444563/005 (Rota-005)
444563/023 (Rota-023)
444563/028 (Rota-028)
444563/029 (Rota-029)
102247 (Rota-036)
106481 (Rota-054)
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: April 6, 2015
Last Verified: April 2015
Keywords provided by GlaxoSmithKline:
Human rotavirus (HRV) vaccine
Serologic response
Porcine circovirus type 1 (PCV-1)
Laboratory evaluations
Additional relevant MeSH terms:
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Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs