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Evaluation of Pneumococcal Vaccine Formulations in Elderly

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00756067
First Posted: September 19, 2008
Last Update Posted: May 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
The purpose of this observer-blind study is to evaluate the safety, reactogenicity and immunogenicity of pneumococcal vaccines in elderly. Subjects will be vaccinated twice with an interval of two months.

Condition Intervention Phase
Infections, Streptococcal Biological: Pneumococcal vaccine GSK2189241A Biological: Pneumo 23™ Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189241A) in Elderly Subjects.

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 a 7-day follow up period after each vaccine dose ]
  • Occurrence of any vaccine related and grade 3 unsolicited adverse events [ Time Frame: During a 31-day follow up period after each vaccine dose ]
  • Occurrence of any vaccine related serious adverse events (SAE) [ Time Frame: From dose 1 to study conclusion ]
  • Occurrence of any grade 3 laboratory abnormalities [ Time Frame: At 1 and 7 days after each vaccine dose ]

Secondary Outcome Measures:
  • Occurrence of any solicited local and general adverse events [ Time Frame: During a 7-day follow up period after each vaccine dose ]
  • Occurrence of any unsolicited adverse events [ Time Frame: During a 31-day follow up period after each vaccine dose ]
  • Occurrence of any laboratory abnormalities [ Time Frame: At 1 and 7 days after each vaccine dose ]
  • Occurrence of any medically significant conditions prompting emergency room visits or physician visits regardless of casual relationship to vaccination or intensity [ Time Frame: From dose 1 to study conclusion ]
  • Anti-pneumococcal and anti-NTHi candidate vaccine antigens [ Time Frame: At Days 0, 30 and 90 ]

Enrollment: 168
Actual Study Start Date: September 19, 2008
Study Completion Date: May 28, 2009
Primary Completion Date: May 28, 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Formulation 1 Biological: Pneumococcal vaccine GSK2189241A
Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2.
Experimental: Formulation 2 Biological: Pneumococcal vaccine GSK2189241A
Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2.
Experimental: Formulation 3 Biological: Pneumococcal vaccine GSK2189241A
Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2.
Experimental: Formulation 4 Biological: Pneumococcal vaccine GSK2189241A
Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2.
Experimental: Formulation 5 Biological: Pneumococcal vaccine GSK2189241A
Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2.
Experimental: Formulation 6 Biological: Pneumococcal vaccine GSK2189241A
Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2.
Active Comparator: 23 valent pneumococcal vaccine Biological: Pneumo 23™
One dose of 0.5 ml will be administered intramuscularly at Month 0, and a placebo dose to keep the blinding at Month 2.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.
  • Male or female subjects between, and including, 65 and 85 years old at the time of the first vaccination, in relatively stable health.
  • Written informed consent obtained from the subject.

Exclusion Criteria:

  • Previous vaccination against Streptococcus pneumoniae (with a licensed vaccine or with an investigational candidate vaccine).
  • Vaccination with diphtheria/tetanus toxoids within one month preceding the first dose of study vaccine.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine, with the exception of the influenza vaccine which can be administered at least 7 days preceding or at least 7 days following any vaccine dose.
  • Administration of immunoglobulins and/or any blood products within the last 3 months.
  • Bacterial pneumonia within 3 years prior to 1st vaccination.
  • Invasive pneumococcal disease (I.P.D) within 3 years prior to 1st vaccination.
  • History of thrombocytopenia or bleeding disorder.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • History of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
  • History of administration of an experimental/licensed vaccine containing MPL or QS21.
  • 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 diagnosed or treated actively during the past 5 years.
  • Acute disease at the time of enrolment.
  • Physical examination positive for acrocyanosis, jaundice, splenomegaly
  • Acute or chronic, clinically significant anaemia, pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by history, physical examination or laboratory screening tests at the discretion of the investigator.
  • Laboratory evidence of haematological abnormalities.
  • Laboratory evidence of biochemical abnormalities.
  • History of chronic alcohol consumption and/or drug abuse.
  • Other conditions that the principal investigator judges may interfere with study findings.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00756067


Locations
Sweden
GSK Investigational Site
Malmö, Sweden, SE-205 02
GSK Investigational Site
Uppsala, Sweden, SE-751 85
GSK Investigational Site
Örebro, Sweden, SE-701 85
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 111652
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 111652
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 111652
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 111652
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 111652
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00756067     History of Changes
Other Study ID Numbers: 111652
First Submitted: September 18, 2008
First Posted: September 19, 2008
Last Update Posted: May 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Streptococcus pneumoniae
pneumococcal vaccine

Additional relevant MeSH terms:
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs