Safety and Immune Response Study of an Investigational Pneumococcal Vaccine.

Prophylactic Pneumococcal Diseases Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00327522
• Other study ID #: 106962
• Status: Completed
• Phase: Phase 2
• First received: May 17, 2006
• Last updated: October 9, 2008
• Start date: June 2006

Study information

• Verified date: October 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical Trial 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 .

Description:

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.

Other known NCT identifiers

• NCT00309153

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prophylactic Pneumococcal Diseases

Intervention

Biological:
• pneumococcal vaccine

Locations

Country	Name	City	State
Belgium	GSK Investigational Site	Gent

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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;
Primary	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