Study to Evaluate the Safety and Immunogenicity of an Investigational Pneumococcal Vaccine in the Elderly Population

A Phase I/II, Randomized, Observer Blinded Study to Evaluate and Compare the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline Biologicals' Investigational Pneumococcal Vaccine Formulations Versus a Licensed Non-GlaxoSmithKline Biologicals' Vaccine and GlaxoSmithKline Biologicals' Aluminum-based 10-valent Pneumococcal Conjugate Vaccine, in Healthy Elderly Subjects

As the licensed pneumococcal vaccine is not always satisfactory in elderly, new investigational pneumococcal vaccines are evaluated in the healthy elderly population. Note: The study consists of the primary phase (106068): vaccination and follow-up and the extension (106072) of the primary phase: 1 year follow-up.

This protocol posting details the procedures of both the primary & extension phase.

Study Overview

• Status: Completed
• Conditions: Infections, Streptococcal
• Intervention / Treatment: Biological: 11-valent pneumococcal vaccine GSK513026; Biological: Pneumo 23™; Biological: Placebo; Biological: 10-valent pneumococcal vaccine GSK513026

Detailed Description

No new subjects will be enrolled in the Extension Phase of the study. All outcome measures at Month 12 will only be evaluated in the subjects in the Belgian site.

Upon request, volunteers will receive flu vaccination free of charge. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

• Study Type: Interventional
• Enrollment (Actual): 335
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • GSK Investigational Site
• Finland
  • Pirkkala, Finland, 33960
    • GSK Investigational Site
• Sweden
  • Uppsala, Sweden, SE-751 85
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
• A male or female between 65 and 85 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject.

Exclusion Criteria:

• Previous vaccination against Streptococcus pneumoniae.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
• Acute disease at the time of enrolment.
• History of documented radiologically confirmed pneumonia within 3 years prior to first vaccination.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
• Current or history of Parkinson disease, Alzheimer disease, stroke, dementia or any serious neurologic or mental disorders.
• 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.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within 2 weeks of the first dose of vaccine(s) with the exception of a Flu vaccine which can be administered at least 1 week preceding the first dose of vaccine(s) or 1 month after the first dose of the vaccine(s).
• 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.
• Administration of immunoglobulins and/or any blood products within three months preceding the first dose of study vaccine or planned administration during the study period.
• History of administration of an experimental/licensed vaccine containing MPL or QS21.
• History of chronic alcohol consumption and/or drug abuse.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A	Biological: 11-valent pneumococcal vaccine GSK513026; Two-dose intramuscular injection. Each group receiving one of the 3 formulations
Experimental: Group B	Biological: 11-valent pneumococcal vaccine GSK513026; Two-dose intramuscular injection. Each group receiving one of the 3 formulations
Experimental: Group C	Biological: 11-valent pneumococcal vaccine GSK513026; Two-dose intramuscular injection. Each group receiving one of the 3 formulations
Active Comparator: Group D	Biological: Pneumo 23™; Single-dose intramuscular injection.; Biological: Placebo; 1 intramuscular injection.
Active Comparator: Group E	Biological: 10-valent pneumococcal vaccine GSK513026; Two-dose intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence, intensity and relationship to vaccination of any solicited local and general signs and symptoms.	during a 7-day follow up period after each vaccine dose.
Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms	during a 31-day follow up period after each vaccine dose.
Occurrence and relationship to vaccination of all serious adverse events (SAEs).	Throughout the study period.
Post vaccination concentration IgG ≥5 µg/mL and fold increase Post/Pre ≥2 for at least 6 serotypes out of 11	1 month after Dose 2 in Groups A, B, C and 1 month after Dose 1 for Group D
Post vaccination concentration and fold increase Post/Pre ≥2 for at least 6 serotypes out of 11, in Groups A through D.	One month after the first vaccine dose.

Secondary Outcome Measures

Outcome Measure	Time Frame
Haematological and biochemical levels within or outside the normal ranges in all groups.	At Months 0, 1, 3, 4 and 12.
IgG antibody concentrations to vaccine pneumococcal serotypes in all groups.	At Months 0, 1, 3, 4 and 12.
Opsonophagocytic activity titres (OPA) against pneumococcal serotypes in all groups.	At Months 0, 1, 3, 4 and 12
Frequencies of IgG PS-specific plasma cells generated by in vitro cultivated memory B-cells for 4 serotypes in all groups, and for 11 serotypes in 10 subjects per group.	At Months 0, 1, 4 and 12.
Anti-protein D, anti-tetanus and anti-diphtheria toxoids IgG antibody concentrations in Groups A, B, C and E.	At Months 0, 1, 3, 4 and 12.
Frequencies of IgG carrier protein-specific plasma cells generated by in vitro cultivated memory B-cells in a subset of subjects (all subjects minus PS B-cell memory subset) of the Groups A, B, C and E.	At Months 0, 1, 4 and 12.
Freq. of CD4+&CD8+ T cells with antigen-specific IL-2 &/or INFy &/or TNFa &/or CD40L secretion/expression to carrier protein as determined by ICS, in a subset of subjects (all subjects minus PS B-cell memory subset) of the Groups A, B, C and E.	At Months 0, 1, 4 and 12.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2006
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): January 8, 2007

Study Registration Dates

• First Submitted: May 17, 2006
• First Submitted That Met QC Criteria: May 17, 2006
• First Posted (Estimate): May 18, 2006

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 5, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: pneumonia; Prophylaxis; pneumococcal vaccine; elderly subjects; invasive pneumococcal diseases
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Streptococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 106068; 106072 (Other Identifier: GSK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Study Data/Documents

1. Dataset Specification
   Information identifier: 106068
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Study Protocol
   Information identifier: 106068
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Clinical Study Report
   Information identifier: 106068
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Informed Consent Form
   Information identifier: 106068
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Individual Participant Data Set
   Information identifier: 106068
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Statistical Analysis Plan
   Information identifier: 106068
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register