Two doses vaccination in adults subjects aged between 18 and 40 years old, in good general health and not previously immunized with the 23-valent pneumococcal polysaccharide vaccine.
Conditions
Interventions
Product Name: 11-valent Streptococcus pneumoniae conjugate vaccine reconstituted with AS02V adjuvant system
Product Code: 11Pn-PD-DiT/AS02V or 11PCV/AS02V
Pharmaceutical Form: Powder and solvent for s
PS-DT for 19F
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: PS:34
DT:9
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The cohort to be enrolled is 23-valent pneumococcal polysaccharide vaccine naïve adults aged between 18 and 40 years old, in good general health at the time of the first vaccine dose. All subjects must satisfy to the following criteria at study entry: • Subjects who the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits). • A male or female between 18 and 40 years of age at the time of the first vaccination. • Written informed consent obtained from the subject 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: The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study: • 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, at the discretion of the investigator. • Acute disease at the time of enrolment. (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 diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Oral temperature = 0.5 mg/kg/day. Inhaled and topical steroids are allowed.) • Planned administration/ administration of a vaccine not foreseen by the study protocol within 2 weeks of the first dose of vaccine. • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. • Administration of immunoglobulins and/or any blood products within three months preceding the first dose of study vaccine or planned administration during the study period. • History of administration of an experimental/licensed vaccine containing MPL or QS21. • History of chronic alcohol consumption and/or drug abuse. • Pregnant or lactating female. • Female planning to become pregnant or planning to discontinue contraceptive precautions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess in healthy adult subjects the safety and reactogenicity of the 11PCV adjuvanted with AS02V, given as a 2-dose vaccination 3 months apart. • To evaluate the B-cell memory response to 11 polysaccharides in all subjects, before vaccination 1, 1 month post vaccination 1, 2 weeks and 1 month post vaccination 2. ;Secondary Objective: ;Primary end point(s): Safety and Reactogenicity • Occurrence, intensity and relationship to vaccination of any solicited local and general signs and symptoms during a 7-day follow up period (i.e. day of vaccination and 6 subsequent days) after each vaccine dose. • Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms during a 31-day follow up period (i.e. day of vaccination and 30 subsequent days) after each vaccine dose. • Occurrence and relationship to vaccination of all serious adverse events (SAEs) occurring throughout the study period. Immunogenicity • Frequencies of IgG PS-specific plasma cells generated by in vitro cultivated memory B-cells (measured by B-cell ELISPOT) for 11 serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F) in all subjects, before vaccination 1, 1 month post vaccination 1, 2 weeks and 1 month post vaccination 2. | — |
Countries
Belgium
Outcome results
None listed