Last updated: 07/17/2024 15:25:17

Evaluation of a booster dose of pneumococcal vaccine formulations in young adults

GSK study ID
112993
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 study to evaluate safety and immunogenicity of a booster dose of two formulations of GSK Biologicals’ pneumococcal candidate vaccine in healthy young adults
Trial description: The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of pneumococcal vaccines (GSK 2189242A) in young adults.
This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT 00707798)
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Number of subjects with Grade 3 solicited local symptoms

Timeframe: During the 7-day (Days 0-6) post-booster vaccination period

Number of subjects with Grade 3 and vaccine-related solicited general symptoms

Timeframe: During the 7-day (Days 0-6) post-booster vaccination period

Number of subjects with Grade 3 and vaccine-related unsolicited adverse events (AEs)

Timeframe: During the 31-day (Days 0-30) post-booster vaccination period

Number of subjects with any vaccine-related serious adverse events (SAEs)

Timeframe: During the entire study period (from Day 0 to Day 30)

Number of subjects with Grade 3 haematological or biochemical abnormalities

Timeframe: At Days 1 and 6 post-booster vaccination

Secondary outcomes:

Antibody concentrations against pneumococcal pneumolysin toxoid (dPly) and histidine triad protein D (PhtD) proteins

Timeframe: Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30)

Titers for antibodies against pneumolysin haemolysis (Hem-dPly) protein

Timeframe: Prior to the booster vaccination (Day 0) and one month post-booster vaccination (Day 30)

Number of subjects with any solicited local symptoms

Timeframe: During the 7-day (Days 0-6) post-booster vaccination period

Number of subjects with any solicited general symptoms

Timeframe: During the 7-day (Days 0-6) post-booster vaccination period

Number of subjects with any unsolicited AEs

Timeframe: During the 31-day (Days 0-30) post-booster vaccination period

Number of subjects with any SAEs

Timeframe: During the entire study period (from Day 0 to Day 30)

Number of subjects with Grade 1, Grade 2 and Grade 4 haematological or biochemical abnormalities

Timeframe: At 1 and 6 days post-booster vaccination

Interventions:
Biological/vaccine: Pneumococcal vaccine GSK2189242A (formulation 1)
Biological/vaccine: Pneumococcal vaccine GSK2189242A (formulation 2)
Enrollment:
43
Observational study model:
Not applicable
Primary completion date:
2009-05-08
Time perspective:
Not applicable
Clinical publications:
Leroux-Roels G et al. (2014) Safety, reactogenicity and immunogenicity of a novel pneumococcal protein-based vaccine in adults: a phase I/II randomized clinical study. Vaccine. 32(50):6838-6846.
Medical condition
Infections, Streptococcal
Product
GSK2189242A
Collaborators
Not applicable
Study date(s)
May 2009 to August 2009
Type
Interventional
Phase
2

Participation criteria

Sex
Female & Male
Age
18 - 41 years
Accepts healthy volunteers
Yes
  • Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female between, and including, 18 and 41 years old at the time of vaccination.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the vaccination, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Gent, Belgium, 9000
Status
Study Complete

Study documents

Scientific result summary
Available language(s): English
Clinical study report
Available language(s): English

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

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2009-05-08
Actual study completion date
2009-05-08

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
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