Safety and Efficacy Study of Investigational Pneumococcal Vaccine in Elderly Population

NCT00307528 | Completed Phase 2

• 3 other identifiers: 100409100463100464
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

As the licensed Pneumovax 23™ vaccine is not always satisfactory in elderly subjects, the safety and the immune response of the new investigational pneumococcal protein vaccine is evaluated in healthy elderly population.

Conditions

Prophylaxis Invasive Pneumococcal Diseases and Pneumonia

Outcome Measures

Primary Outcomes (5)

• Occurrence, intensity and relationship 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 30-day follow up period after each vaccine dose.

• Occurrence of all serious adverse events (SAE).

  During the entire study period.

• Anti- PhtD antibody concentration

  One month after the first injection

• Anti-PhtD antibody concentration.

  One month after 2 injections

Secondary Outcomes (11)

• Number and percentage of subjects with normal or abnormal values for biochemical assessments and for haematological analysis.

  At each scheduled time point (month 0, 1, 3, 12, 24 and 36).

• Anti- PhtD antibody concentration.

  At 12, 24 and 36 months after the first vaccination.

• Anti-PhtD antibody avidity.

  At month 0, 1 and 3.

• Evaluation of protection afforded by passive transfer of anti PhtD antibodies sera pooled from all individuals.

  At month 0, 1 and 3.

• Frequency of PhtD specific plasma cells generated by in vitro cultivated memory B-cells, in a subset of subjects.

  At month 0, 1, 3, 12.

Study Arms (6)

Group A

ACTIVE COMPARATOR

Biological: Pneumovax 23™

Group B

EXPERIMENTAL

Biological: Pneumococcal vaccine GSK513026

Group C

EXPERIMENTAL

Biological: Pneumococcal vaccine GSK513026

Group D

EXPERIMENTAL

Biological: Pneumococcal vaccine GSK513026

Group E

EXPERIMENTAL

Biological: Pneumococcal vaccine GSK513026

Group F

EXPERIMENTAL

Biological: Pneumococcal vaccine GSK513026

Interventions

Pneumococcal vaccine GSK513026 BIOLOGICAL

Two-dose intramuscular injection. Five different formulations, each administered to one Group

Group B; Group C; Group D; Group E; Group F

Pneumovax 23™ BIOLOGICAL

Single dose intramuscular injection.

Group A

Eligibility Criteria

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

You may qualify if:

• Subjects who the investigator believes will comply with the requirements of the protocol
• A male or female ≥ 65 years at the time of the first vaccination.
• Written informed consent obtained from the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.

You may not qualify if:

• 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.
• Use of any anticoagulants.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within 2 weeks of the first dose of vaccines.
• Previous vaccination against Streptococcus pneumoniae.
• Bacterial pneumonia within 3 years prior to 1st vaccination.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Current serious neurologic or mental disorders.
• Currently smoking \> 25 cigarettes per day.
• Inflammatory processes such as known chronic active infections
• All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
• History of administration of an experimental vaccine containing MPL or QS21.
• Acute disease at the time of enrolment.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, at the discretion of the investigator.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Ghent, 9000, Belgium

Location

Related Publications (1)

• Leroux-Roels I, Devaster JM, Leroux-Roels G, Verlant V, Henckaerts I, Moris P, Hermand P, Van Belle P, Poolman JT, Vandepapeliere P, Horsmans Y. Adjuvant system AS02V enhances humoral and cellular immune responses to pneumococcal protein PhtD vaccine in healthy young and older adults: randomised, controlled trials. Vaccine. 2015 Jan 15;33(4):577-84. doi: 10.1016/j.vaccine.2013.10.052. Epub 2013 Oct 29.

  PMID: 24176494 DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

23-valent pneumococcal capsular polysaccharide vaccine

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2006
• First Posted: March 28, 2006
• Study Start: January 20, 2004
• Primary Completion: March 30, 2005
• Study Completion: March 30, 2005
• Last Updated: October 30, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

BE (1)