Evaluation of Pneumococcal Vaccine Formulations in Elderly

NCT ID: NCT00756067

Last Updated: 2017-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-19
• Study Completion Date: 2009-05-28

Brief Summary

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.

Conditions

Infections, Streptococcal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Formulation 1

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK2189241A

Intervention Type: BIOLOGICAL

Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2.

Formulation 2

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK2189241A

Intervention Type: BIOLOGICAL

Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2.

Formulation 3

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK2189241A

Intervention Type: BIOLOGICAL

Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2.

Formulation 4

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK2189241A

Intervention Type: BIOLOGICAL

Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2.

Formulation 5

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK2189241A

Intervention Type: BIOLOGICAL

Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2.

Formulation 6

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK2189241A

Intervention Type: BIOLOGICAL

Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2.

23 valent pneumococcal vaccine

Group Type: ACTIVE_COMPARATOR

Pneumo 23™

Intervention Type: BIOLOGICAL

One dose of 0.5 ml will be administered intramuscularly at Month 0, and a placebo dose to keep the blinding at Month 2.

Interventions

Pneumococcal vaccine GSK2189241A

Two doses of 0.5 ml will be administered intramuscularly; one dose at Month 0 and another at Month 2.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Malmo, , Sweden

GSK Investigational Site

Örebro, , Sweden

GSK Investigational Site

Uppsala, , Sweden

Countries

Sweden

References

Pauksens K, Nilsson AC, Caubet M, Pascal TG, Van Belle P, Poolman JT, Vandepapeliere PG, Verlant V, Vink PE. Randomized controlled study of the safety and immunogenicity of pneumococcal vaccine formulations containing PhtD and detoxified pneumolysin with alum or adjuvant system AS02V in elderly adults. Clin Vaccine Immunol. 2014 May;21(5):651-60. doi: 10.1128/CVI.00807-13. Epub 2014 Mar 5.

Reference Type: DERIVED

PMID: 24599529 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

111652

Identifier Type: -

Identifier Source: org_study_id