Clinical trial NCT00756067: Evaluation of Pneumococcal Vaccine Formulations in Elderly
Official title: A Study to Evaluate GSK Biologicals' Candidate Formulations of Pneumococcal Vaccines (GSK2189241A) in Elderly Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infections, Streptococcal
Keywords: Streptococcus pneumoniae
pneumococcal vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-09-19
Enrollment: 168
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this observer-blind study is to evaluate the safety, reactogenicity and immunogenicity of pneumococcal vaccines in elderly. Subjects will be vaccinated twice with an interval of two months.


Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
* Male or female subjects between, and including, 65 and 85 years old at the time of the first vaccination, in relatively stable health.
* Written informed consent obtained from the subject.

Exclusion Criteria:

* Previous vaccination against Streptococcus pneumoniae (with a licensed vaccine or with an investigational candidate vaccine).
* Vaccination with diphtheria/tetanus toxoids within one month preceding the first dose of study vaccine.
* 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.
* Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine, with the exception of the influenza vaccine which can be administered at least 7 days preceding or at least 7 days following any vaccine dose.
* Administration of immunoglobulins and/or any blood products within the last 3 months.
* Bacterial pneumonia within 3 years prior to 1st vaccination.
* Invasive pneumococcal disease (I.P.D) within 3 years prior to 1st vaccination.
* History of thrombocytopenia or bleeding disorder.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* History of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
* History of administration of an experimental/licensed vaccine containing MPL or QS21.
* Current serious neurologic or mental disorders.
* Inflammatory processes such as known chronic active infections (e.g. Hepatitis B, C).
* All past or current malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
* Acute disease at the time of enrolment.
* Physical examination positive for acrocyanosis, jaundice, splenomegaly
* Acute or chronic, clinically significant anaemia, pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by history, physical examination or laboratory screening tests at the discretion of the investigator.
* Laboratory evidence of haematological abnormalities.
* Laboratory evidence of biochemical abnormalities.
* History of chronic alcohol consumption and/or drug abuse.
* Other conditions that the principal investigator judges may interfere with study findings.

Primary outcomes:
measure: Occurrence of any vaccine related and grade 3 solicited local and general adverse events
timeFrame: During a 7-day follow up period after each vaccine dose
measure: Occurrence of any vaccine related and grade 3 unsolicited adverse events
timeFrame: During a 31-day follow up period after each vaccine dose
measure: Occurrence of any vaccine related serious adverse events (SAE)
timeFrame: From dose 1 to study conclusion
measure: Occurrence of any grade 3 laboratory abnormalities
timeFrame: At 1 and 7 days after each vaccine dose
Secondary outcomes:
measure: Occurrence of any solicited local and general adverse events
timeFrame: During a 7-day follow up period after each vaccine dose
measure: Occurrence of any unsolicited adverse events
timeFrame: During a 31-day follow up period after each vaccine dose
measure: Occurrence of any laboratory abnormalities
timeFrame: At 1 and 7 days after each vaccine dose
measure: Occurrence of any medically significant conditions prompting emergency room visits or physician visits regardless of casual relationship to vaccination or intensity
timeFrame: From dose 1 to study conclusion
measure: Anti-pneumococcal and anti-NTHi candidate vaccine antigens
timeFrame: At Days 0, 30 and 90
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: GSK Investigational Site
city: Uppsala
country: Sweden
facility: GSK Investigational Site
city: Örebro
country: Sweden
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Pauksens K, Nilsson AC, Caubet M, Pascal TG, Van Belle P, Poolman JT, Vandepapeliere PG, Verlant V, Vink PE. Randomized controlled study of the safety and immunogenicity of pneumococcal vaccine formulations containing PhtD and detoxified pneumolysin with alum or adjuvant system AS02V in elderly adults. Clin Vaccine Immunol. 2014 May;21(5):651-60. doi: 10.1128/CVI.00807-13. Epub 2014 Mar 5.