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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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
Completed
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

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Additional information
Results for study 106068 can be found on the GSK Clinical Study Register
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