Evaluation of a Booster Dose of Pneumococcal Vaccine Formulations in Young Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00896064
First received: May 7, 2009
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of pneumococcal vaccines (GSK 2189242A) in young adults.

This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT 00707798)


Condition Intervention Phase
Diseases Caused by Streptococcus Pneumoniae
Biological: Pneumococcal vaccine GSK2189242A (formulation 1)
Biological: Pneumococcal vaccine GSK2189242A (formulation 2)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Study to Evaluate Safety & Immunogenicity of a Booster Dose of Two Formulations of GSK Biologicals' Pneumococcal Candidate Vaccine in Healthy Young Adults

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of any vaccine related and grade 3 solicited local and general adverse events. [ Time Frame: During the 7-day follow up period after vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of any vaccine related and grade 3 unsolicited adverse events [ Time Frame: During the 31-day follow up period after vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of any vaccine related serious adverse events (SAEs) [ Time Frame: From Visit 1 to study conclusion ] [ Designated as safety issue: No ]
  • Occurrence of any grade 3 haematological or biochemical abnormalities [ Time Frame: At 1 and 7 days after vaccination. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of any solicited local and general adverse events [ Time Frame: During the 7-day follow up period after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of any unsolicited adverse events [ Time Frame: During the 31-day follow up period after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of any SAEs [ Time Frame: From Visit 1 to study conclusion ] [ Designated as safety issue: No ]
  • Occurrence of any haematological or biochemical abnormalities [ Time Frame: At 1 and 7 days after vaccination ] [ Designated as safety issue: No ]
  • Evaluation of the immune responses to components of the investigational vaccine [ Time Frame: At Days 0 and 30 after vaccination ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: May 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formulation 1 Biological: Pneumococcal vaccine GSK2189242A (formulation 1)
One dose will be administered intramuscularly at Study Day 0.
Experimental: Formulation 2 Biological: Pneumococcal vaccine GSK2189242A (formulation 2)
One dose will be administered intramuscularly at Study Day 0.

  Eligibility

Ages Eligible for Study:   18 Years to 41 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female between, and including, 18 and 41 years old at the time of vaccination.
  • Subjects who previously participated in the study NCT00707798 and received one of the two investigational GSK2189242A vaccine formulations during the primary study.
  • Written informed consent obtained from the subject.
  • Free of obvious health problems as established by medical history, clinical examination and clinical laboratory assessment before entering into the study.
  • Female subjects of non-childbearing potential (defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause) may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

    • has practiced adequate contraception for 30 days prior to vaccination, and
    • has a negative pregnancy test on the day of vaccination, and
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after vaccination.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the vaccination, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to the vaccination and ending one month (minimum 30 days) after vaccination.
  • Administration of any pneumococcal vaccine other than the study vaccine during the period between end of study NCT00707798 and study vaccination.
  • Bacterial pneumonia within the period between end of study NCT00707798 and study vaccination.
  • Invasive pneumococcal disease (IPD) within the period between end of study NCT00707798 and study vaccination.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection (no laboratory testing required).
  • History of thrombocytopenia or bleeding disorder.
  • Anaphylactic reaction following the previous administration of the vaccine or history of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
  • Current serious neurologic or mental disorders.
  • Inflammatory processes such as known chronic active infections (e.g. Hepatitis B, C).
  • All past or current malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders.
  • Acute disease at the time of enrolment/vaccination.
  • Fever at the time of vaccination. Fever is defined as temperature >= 37.5°C on oral setting.
  • Physical examination positive for acrocyanosis, jaundice, splenomegaly.
  • Acute or chronic, clinically significant anaemia, pulmonary, cardiovascular, hematologic, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, at the discretion of the investigator
  • Administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration during the study period.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • History of chronic alcohol consumption and/or drug abuse.
  • Other conditions that the principal investigator judges may interfere with study findings.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896064

Locations
Belgium
GSK Investigational Site
Gent, Belgium, 9000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00896064     History of Changes
Other Study ID Numbers: 112993
Study First Received: May 7, 2009
Last Updated: June 14, 2012
Health Authority: Belgium: Agence Fédérale des Médicaments et des Produits de la Santé

Keywords provided by GlaxoSmithKline:
Pneumococcal vaccine
Streptococcus pneumoniae
Young adults

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 17, 2014