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OpenTrials
Completed

NCT Number: NCT00327522

Safety and Immune Response Study of an Investigational Pneumococcal Vaccine.

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 .

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Key information

Conditions

Prophylactic Pneumococcal Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site

Ghent, 9000, Belgium

About this study

The study is open and subjects will receive two vaccine doses of GSK Biologicals' 11 PCV vaccine. Five blood samples will be taken: prior to and one month after each vaccine dose, and 2 weeks after dose 2.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Pneumococcal vaccine

Biological

Primary outcomes

  1. 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;

  2. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Open, Phase I/II Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' 11PCV Vaccine Given as a 2-Dose Vaccination in Adults Aged 18-40 Years Old.

Important dates

Study start
2006
First posted
May 18, 2006
Registry last updated
Oct 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.