Last updated: 11/03/2018 08:42:11

Study to evaluate the safety and immunogenicity of an investigational pneumococcal vaccine in the elderly population

GSK study ID
106068
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Occurrence, intensity and relationship to vaccination of any solicited local and general signs and symptoms.

Timeframe: 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

Timeframe: during a 31-day follow up period after each vaccine dose.

Occurrence and relationship to vaccination of all serious adverse events (SAEs).

Timeframe: 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

Timeframe: 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.

Timeframe: One month after the first vaccine dose.

Secondary outcomes:

Haematological and biochemical levels within or outside the normal ranges in all groups.

Timeframe: At Months 0, 1, 3, 4 and 12.

IgG antibody concentrations to vaccine pneumococcal serotypes in all groups.

Timeframe: At Months 0, 1, 3, 4 and 12.

Opsonophagocytic activity titres (OPA) against pneumococcal serotypes in all groups.

Timeframe: 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.

Timeframe: 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.

Timeframe: At Months 0, 1, 3, 4 and 12.

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.

Timeframe: At Months 0, 1, 4 and 12.

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.

Timeframe: At Months 0, 1, 4 and 12.

Interventions:
  • Biological/vaccine: 11-valent pneumococcal vaccine GSK513026
  • Biological/vaccine: Pneumo 23™
  • Biological/vaccine: Placebo
  • Biological/vaccine: 10-valent pneumococcal vaccine GSK513026
  • Enrollment:
    335
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Streptococcal
    Product
    SB513026
    Collaborators
    Not applicable
    Study date(s)
    May 2006 to January 2007
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    65 - 85 years
    Accepts healthy volunteers
    Yes
    • 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.
    • 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Pirkkala, Finland, 33960
    Status
    Study Complete
    Location
    GSK Investigational Site
    Gent, Belgium, 9000
    Status
    Study Complete
    Location
    GSK Investigational Site
    UPPSALA, Sweden, SE-751 85
    Status
    Study Complete

    Study documents

    Clinical study report
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-08-01

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Results for study 106068 can be found on the GSK Clinical Study Register
    Click here
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Click here
    Access to clinical trial data by researchers
    Visit website