Booster vaccination with a pneumococcal protein candidate vaccine in healthy young adults aged between 18 and 41 years old, previously primed with 2 doses of pneumococcal protein vaccine in study SPNG-001.
Conditions
Interventions
Product Name: Pneumococcal protein vaccine (10 µg) adsorbed on Aluminium
Product Code: dPly/PhtD-10-AlPO4
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Detoxified pneumolysin (dPl
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Subjects who the investigator believes will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) 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 SPNG-001 (111651) and received either dPly/PhtD-10 or dPly/PhtD-30 vaccine formulation 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 may be enrolled in the study. - Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause. •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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. (For corticosteroids, this will mean prednisone = 10 mg/day, or equivalent. Inhaled and topical steroids are allowed.) •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 SPNG-001 and study vaccination. •Bacterial pneumonia within the period between end of study SPNG-001 and study vaccination. •Invasive pneumococcal disease (IPD) within the period between end of study SPNG-001 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. Acute disease is defined as the presence of a moderate or severe illness with or without fever). All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection without fever. Fever is defined as temperature = 37.5°C on oral setting. •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, such as: - Type 2 diabetes - Uncontrolled hypertension - Current or history of coronary artery disease or cardiac insufficiency - Current or history of rheumatoid arthritis or temporal arthritis •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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): •Occurrence of any vaccine related and grade 3 solicited local and general adverse events during the 7-day follow up period (i.e. day of vaccination and 6 subsequent days) after vaccination. •Occurrence of any vaccine related and grade 3 unsolicited adverse events during the 31-day follow up period (i.e. day of vaccination and 30 subsequent days) after vaccination. •Occurrence of any vaccine related serious adverse events (SAEs) occurring during the entire study period (from Visit 1 to Visit 4). •Occurrence of any grade 3 haematological or biochemical abnormalities, utilizing the standard FDA Toxicity Grading Scale (Section IIIB of Appendix B of protocol) and the grades for study required blood tests not included within the FDA Toxicity Grading Scales (Appendix C of protocol) at 1 and 7 days after vaccination. ;Main Objective: •To assess the safety and reactogenicity of a booster dose of two formulations of GSK Biologicals’ candidate pneumococcal proteins vaccine when administered intramuscularly in healthy adults, in terms of vaccine-related and grade 3 solicited, unsolicited AEs and haematological or biochemical abnormalities and vaccine-related SAEs. ;Secondary Objective: •To assess the safety and reactogenicity of a booster dose of two formulations of GSK Biologicals’ candidate pneumococcal proteins vaccine when administered intramuscularly in healthy adults, in terms of any AEs including SAEs and haematological or biochemical abnormalities. •To evaluate the immunogenicity of booster dose of two formulations of GSK Biologicals’ candidate pneumococcal protein vaccine when administered intramuscularly in healthy adults. •To evaluate the persistence of antibodies induced by two formulations of GSK Biologicals’ candidate pneumococcal protein vaccine, 5-9 months after completion of a 2-dose primary immunization course in study SPNG-001. | — |
Countries
Belgium
Outcome results
None listed