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

NCT00327665 | Completed Phase 1

• 2 other identifiers: 106068106072
• Study Type: interventional
• Target: 335
• Locations: 3 countries
• Sites: 3

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.

Conditions

Infections, Streptococcal

Keywords

pneumonia; pneumococcal vaccine; elderly subjects; invasive pneumococcal diseases; Prophylaxis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• 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.

Study Arms (5)

Group A

EXPERIMENTAL

Biological: 11-valent pneumococcal vaccine GSK513026

Group B

EXPERIMENTAL

Biological: 11-valent pneumococcal vaccine GSK513026

Group C

EXPERIMENTAL

Biological: 11-valent pneumococcal vaccine GSK513026

Group D

ACTIVE COMPARATOR

Biological: Pneumo 23™; Biological: Placebo

Group E

ACTIVE COMPARATOR

Biological: 10-valent pneumococcal vaccine GSK513026

Interventions

11-valent pneumococcal vaccine GSK513026 BIOLOGICAL

Two-dose intramuscular injection. Each group receiving one of the 3 formulations

Group A; Group B; Group C

Pneumo 23™ BIOLOGICAL

Single-dose intramuscular injection.

Group D

Placebo BIOLOGICAL

1 intramuscular injection.

Group D

10-valent pneumococcal vaccine GSK513026 BIOLOGICAL

Two-dose intramuscular injection

Group E

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Pirkkala, 33960, Finland

Location

GSK Investigational Site

Uppsala, SE-751 85, Sweden

Location

Related Links

• Results for study 106068 can be found on the GSK Clinical Study Register
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Streptococcal Infections; Pneumonia

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2006
• First Posted: May 18, 2006
• Study Start: May 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: January 8, 2007
• Last Updated: May 8, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

BE (1); FI (1); SE (1)