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

Primary Purpose

Infections, Streptococcal

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
11-valent pneumococcal vaccine GSK513026
Pneumo 23™
Placebo
10-valent pneumococcal vaccine GSK513026
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections, Streptococcal focused on measuring pneumonia, pneumococcal vaccine, elderly subjects, invasive pneumococcal diseases, Prophylaxis

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Group C

Group D

Group E

Arm Description

Outcomes

Primary Outcome Measures

Occurrence, intensity and relationship to vaccination of any solicited local and general signs and symptoms.
Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms
Occurrence and relationship to vaccination of all serious adverse events (SAEs).
Post vaccination concentration IgG ≥5 µg/mL and fold increase Post/Pre ≥2 for at least 6 serotypes out of 11
Post vaccination concentration and fold increase Post/Pre ≥2 for at least 6 serotypes out of 11, in Groups A through D.

Secondary Outcome Measures

Haematological and biochemical levels within or outside the normal ranges in all groups.
IgG antibody concentrations to vaccine pneumococcal serotypes in all groups.
Opsonophagocytic activity titres (OPA) against pneumococcal serotypes in all groups.
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.
Anti-protein D, anti-tetanus and anti-diphtheria toxoids IgG antibody concentrations in Groups A, B, C and E.
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.
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.

Full Information

First Posted
May 17, 2006
Last Updated
May 5, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00327665
Brief Title
Study to Evaluate the Safety and Immunogenicity of an Investigational Pneumococcal Vaccine in the Elderly Population
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2006 (Actual)
Primary Completion Date
January 1, 2007 (Actual)
Study Completion Date
January 8, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Streptococcal
Keywords
pneumonia, pneumococcal vaccine, elderly subjects, invasive pneumococcal diseases, Prophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
335 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Experimental
Arm Title
Group C
Arm Type
Experimental
Arm Title
Group D
Arm Type
Active Comparator
Arm Title
Group E
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
11-valent pneumococcal vaccine GSK513026
Intervention Description
Two-dose intramuscular injection. Each group receiving one of the 3 formulations
Intervention Type
Biological
Intervention Name(s)
Pneumo 23™
Intervention Description
Single-dose intramuscular injection.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
1 intramuscular injection.
Intervention Type
Biological
Intervention Name(s)
10-valent pneumococcal vaccine GSK513026
Intervention Description
Two-dose intramuscular injection
Primary Outcome Measure Information:
Title
Occurrence, intensity and relationship to vaccination of any solicited local and general signs and symptoms.
Time Frame
during a 7-day follow up period after each vaccine dose.
Title
Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms
Time Frame
during a 31-day follow up period after each vaccine dose.
Title
Occurrence and relationship to vaccination of all serious adverse events (SAEs).
Time Frame
Throughout the study period.
Title
Post vaccination concentration IgG ≥5 µg/mL and fold increase Post/Pre ≥2 for at least 6 serotypes out of 11
Time Frame
1 month after Dose 2 in Groups A, B, C and 1 month after Dose 1 for Group D
Title
Post vaccination concentration and fold increase Post/Pre ≥2 for at least 6 serotypes out of 11, in Groups A through D.
Time Frame
One month after the first vaccine dose.
Secondary Outcome Measure Information:
Title
Haematological and biochemical levels within or outside the normal ranges in all groups.
Time Frame
At Months 0, 1, 3, 4 and 12.
Title
IgG antibody concentrations to vaccine pneumococcal serotypes in all groups.
Time Frame
At Months 0, 1, 3, 4 and 12.
Title
Opsonophagocytic activity titres (OPA) against pneumococcal serotypes in all groups.
Time Frame
At Months 0, 1, 3, 4 and 12
Title
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.
Time Frame
At Months 0, 1, 4 and 12.
Title
Anti-protein D, anti-tetanus and anti-diphtheria toxoids IgG antibody concentrations in Groups A, B, C and E.
Time Frame
At Months 0, 1, 3, 4 and 12.
Title
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.
Time Frame
At Months 0, 1, 4 and 12.
Title
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.
Time Frame
At Months 0, 1, 4 and 12.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
GSK Investigational Site
City
Pirkkala
ZIP/Postal Code
33960
Country
Finland
Facility Name
GSK Investigational Site
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
106068
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
106068
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
106068
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
106068
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
106068
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
106068
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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