NCT00327522

Brief Summary

The purpose of this study is to evaluate the safety and immunogenicity of two doses of GSK Biologicals' 11 PCV vaccine when given to healthy subjects aged 18 to 40 years .

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2006

Completed
14 days until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
Last Updated

October 13, 2008

Status Verified

October 1, 2008

First QC Date

May 17, 2006

Last Update Submit

October 9, 2008

Conditions

Prophylactic Pneumococcal Diseases

Outcome Measures

Primary Outcomes (2)

  • Occurrence of solicited local & general symptoms (Day 0-7) and unsolicited symptoms (Day 0-30) after vaccination. Occurrence of serious adverse events during the entire study;

  • Frequencies of IgG PS-specific plasma cells (by B-cell ELISPOT) for 11 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F) prior to & 1 month post dose 1, 2 weeks & 1 month post dose 2

Interventions

pneumococcal vaccineBIOLOGICAL

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male or female between 18 and 40 years of age
  • valent pneumococcal polysaccharide vaccine naive adults.

You may not qualify if:

  • Previous vaccination against Streptococcus pneumoniae.
  • History of pneumonia within 3 years prior to the first vaccination
  • Any confirmed or suspected immunosuppressive or immunodeficient condition
  • All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
  • Subjects with documented anaemia or iron-deficiency (Hemoglobin level more than 10% below lower limit of normal)
  • History of administration of an experimental/licensed vaccine containing similar adjuvants.
  • History of chronic alcohol consumption and/or drug abuse.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Ghent, 9000, Belgium

Location

MeSH Terms

Interventions

Pneumococcal Vaccines

Intervention Hierarchy (Ancestors)

Streptococcal VaccinesBacterial VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 17, 2006

First Posted

May 18, 2006

Study Start

June 1, 2006

Last Updated

October 13, 2008

Record last verified: 2008-10

Locations

BE(1)