Clinical trial NCT00896064: Evaluation of a Booster Dose of Pneumococcal Vaccine Formulations in Young Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infections, Streptococcal
Keywords: Pneumococcal vaccine
Streptococcus pneumoniae
Young adults
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-05-11
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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)


Eligibility criteria: Inclusion Criteria:

* 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.
* Subjects who previously participated in the study NCT00707798 and received one of the two investigational GSK2189242A vaccine formulations during the primary study.
* Written informed consent obtained from the subject.
* Free of obvious health problems as established by medical history, clinical examination and clinical laboratory assessment before entering into the study.
* Female subjects of non-childbearing potential (defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause) may be enrolled in the study.
* Female subjects of childbearing potential may be enrolled in the study, if the subject:

  * has practiced adequate contraception for 30 days prior to vaccination, and
  * has a negative pregnancy test on the day of vaccination, and
  * has agreed to continue adequate contraception during the entire treatment period and for 2 months after vaccination.

Exclusion Criteria:

* 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.
* Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to the vaccination and ending one month (minimum 30 days) after vaccination.
* Administration of any pneumococcal vaccine other than the study vaccine during the period between end of study NCT00707798 and study vaccination.
* Bacterial pneumonia within the period between end of study NCT00707798 and study vaccination.
* Invasive pneumococcal disease (IPD) within the period between end of study NCT00707798 and study vaccination.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection (no laboratory testing required).
* History of thrombocytopenia or bleeding disorder.
* Anaphylactic reaction following the previous administration of the vaccine or history of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
* 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.
* Acute disease at the time of enrolment/vaccination.
* Fever at the time of vaccination. Fever is defined as temperature \>= 37.5°C on oral setting.
* Physical examination positive for acrocyanosis, jaundice, splenomegaly.
* Acute or chronic, clinically significant anaemia, pulmonary, cardiovascular, hematologic, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, at the discretion of the investigator
* Administration of immunoglobulins and/or any blood products within the three months preceding vaccination or planned administration during the study period.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* History of chronic alcohol consumption and/or drug abuse.
* Other conditions that the principal investigator judges may interfere with study findings.

Primary outcomes:
measure: Number of Subjects With Grade 3 Solicited Local Symptoms
timeFrame: During the 7-day (Days 0-6) post-booster vaccination period
measure: Number of Subjects With Grade 3 and Vaccine-related Solicited General Symptoms
timeFrame: During the 7-day (Days 0-6) post-booster vaccination period
measure: 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
measure: Number of Subjects With Any Vaccine-related Serious Adverse Events (SAEs)
timeFrame: During the entire study period (from Day 0 to Day 30)
measure: Number of Subjects With Grade 3 Haematological or Biochemical Abnormalities
timeFrame: At Days 1 and 6 post-booster vaccination
Secondary outcomes:
measure: 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)
measure: 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)
measure: Number of Subjects With Any Solicited Local Symptoms
timeFrame: During the 7-day (Days 0-6) post-booster vaccination period
measure: Number of Subjects With Any Solicited General Symptoms
timeFrame: During the 7-day (Days 0-6) post-booster vaccination period
measure: Number of Subjects With Any Unsolicited AEs
timeFrame: During the 31-day (Days 0-30) post-booster vaccination period
measure: Number of Subjects With Any SAEs
timeFrame: During the entire study period (from Day 0 to Day 30)
measure: Number of Subjects With Grade 1, Grade 2 and Grade 4 Haematological or Biochemical Abnormalities
timeFrame: At 1 and 6 days post-booster vaccination
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: