Evaluation of Pneumococcal Vaccine Formulations in Elderly

A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189241A) in Elderly Subjects.

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.

Study Overview

• Status: Completed
• Conditions: Infections, Streptococcal
• Intervention / Treatment: Biological: Pneumococcal vaccine GSK2189241A; Biological: Pneumo 23™

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Malmö, Sweden, SE-205 02
    • GSK Investigational Site
  • Uppsala, Sweden, SE-751 85
    • GSK Investigational Site
  • Örebro, Sweden, SE-701 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 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 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 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of any solicited local and general adverse events	During a 7-day follow up period after each vaccine dose
Occurrence of any unsolicited adverse events	During a 31-day follow up period after each vaccine dose
Occurrence of any laboratory abnormalities	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	From dose 1 to study conclusion
Anti-pneumococcal and anti-NTHi candidate vaccine antigens	At Days 0, 30 and 90

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.

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): September 19, 2008
• Primary Completion (Actual): May 28, 2009
• Study Completion (Actual): May 28, 2009

Study Registration Dates

• First Submitted: September 18, 2008
• First Submitted That Met QC Criteria: September 18, 2008
• First Posted (Estimate): September 19, 2008

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: May 9, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Streptococcus pneumoniae; pneumococcal vaccine
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Streptococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 111652

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. Individual Participant Data Set
   Information identifier: 111652
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Informed Consent Form
   Information identifier: 111652
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Dataset Specification
   Information identifier: 111652
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Clinical Study Report
   Information identifier: 111652
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Study Protocol
   Information identifier: 111652
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register