Completed

Study Description:

The purpose of this study is to evaluate the persistence of the vaccine induced immune responses at Month 48 (Year 4) and Month 60 (Year 5) in healthy subjects who received 3 doses of GSK Biologicals’ candidate CMV vaccine according to a 0-1-6 month schedule during the primary study 108890 (NCT00435396) (vaccine group). The immune response to CMV infection in naturally infected subjects who participated in the screening visit of the primary study 108890 (NCT00435396) and who were tested CMV-seropositive, will be used as a reference value (seropositive reference group). In addition, this study will continue to assess the occurrence of CMV infections as well as the continued development and validation of read-outs in the CMV project. The primary vaccination phase and Year 2 follow-up were posted as a separate protocol posting (NCT00435396).

GSK Study ID:

115429


Has Results Document Available
ClinicalTrials.gov Identifier:

NCT01357915


EudraCT Number:

2011-002702-78


Study Overview

Medical Conditions

Cytomegalovirus

Product

GSK1492903A

Collaborators

N/A


Date

June 2011 to September 2012

Type

Interventional

Phase

N/A


Gender

Male

Age

18 years - 45 years

Accepts Healthy Volunteers

Yes


Study Documents

This study has Protocol summary on ClinicalTrial.gov. Click here to learn more.

Locations

  • Central Contact :

    US GSK Clinical Trials Call Center

  • Central Contact Phone:

    877-379-3718

  • Central Contact Email:

    [email protected]

Belgium, La Louvière 7100Completed
Belgium, Wilrijk 2610Completed

Study Design

  • Primary Purpose: Prevention
  • Allocation: Non-randomized
  • Study Design: Parallel Assignment
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: No
  • Masked Caregiver: No
  • Masked Investigator: No
  • Masked Assessor: No
Primary Outcomes:

  • Concentrations of antibodies against anti-gB IgG
    Timeframe: At Month 48 and Month 60

  • Number of subjects with neutralizing response against anti-CMV antibodies
    Timeframe: At Month 48 and Month 60

Secondary Outcomes:

  • Avidity towards anti-gB IgG antibodies
    Timeframe: At Month 48 and Month 60

  • Frequency of gB-specific cluster of differentiation (CD4+/CD8+) T-cells expressing at least two immune markers
    Timeframe: At Month 48 and Month 60

  • Specific B cell memory immune response for gB
    Timeframe: At Month 48 and Month 60

  • Number of subjects with response for anti-CMV tegument IgG antibodies
    Timeframe: At Month 48 and Month 60

  • Assessment of CMV infection by CMV specific desoxyribonucleic acid (DNA) in blood
    Timeframe: At Month 48 and Month 60

Arms:
  • 2

Interventions:

  • Procedure/Surgery: Blood sampling
  • Biological/Vaccine: GSK149203A

Keyword:

  • Cytomegalovirus, Vaccine
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 47