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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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25 November 2019 |
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Main ID: |
EUCTR2005-002789-12-GB |
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Date of registration:
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24/08/2005 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A double blind comparative and randomised study in healthy adults of the safety, tolerability, and immunogenicity of PNEUMOVAX®II formulated with either all new process polysaccharides or all current process polysaccharides
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Scientific title:
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A double blind comparative and randomised study in healthy adults of the safety, tolerability, and immunogenicity of PNEUMOVAX®II formulated with either all new process polysaccharides or all current process polysaccharides |
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Date of first enrolment:
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28/09/2005 |
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Target sample size:
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220 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-002789-12 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: PNEUMOVAX® II formulated with all current process polysaccharides
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Age =50 years
2. In good health. Any underlying chronic illness has to be documented to be in stable condition.
3. Signed and dated informed consent
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) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Hypersensitivity to any of the components of the study vaccines, including phenol.
2. Prior vaccination with any pneumococcal vaccine (14-valent or 23-valent). When available, written medical records should be reviewed to verify the subject’s denial of receiving a prior pneumococcal vaccination.
3. Known or suspected immune dysfunction, including persons with congenital immunodeficiency, HIV infection, leukemia, lymphoma, Hodgkin’s disease, multiple myeloma, generalised malignancy, chronic renal failure (most recent serum creatinine values in medical record ?3 mg/dL), nephrotic syndrome, or other conditions associated with immunosuppression such as organ or bone marrow transplantation, or those receiving immunosuppressive chemotherapy, including long-term systemic corticosteroids. (Subjects with prostate or skin cancer who are not on chemotherapeutic drugs [other than hormone blocking drugs], subjects with breast cancer who are taking tamoxifen, and subjects with other malignancies who have been disease-free for at least 5 years will be eligible for enrollment).
4. Functional or anatomic asplenia.
5. History of autoimmune disease.
6. Significant underlying illness pre-venting completion of this study.
7. Receipt of other licensed vaccines during the study period as follows:
a. licensed live virus vaccines received during the 42 days prior to injection with the study vaccine through the final post-vaccination visit.
b. other licensed vaccines received during the 14 days prior to injection with the study vaccine through the final post-vaccination visit.
c. Exception: Flu vaccine can be administered during the study, but it must be given at least 7 days prior to receipt of the study vaccine or at least 15 days after receipt of the study vaccine.
8. Receipt of investigational drugs or other investigational vaccines within 2 months prior to injection with the study vaccine, or anticipated receipt of these products prior to the final post-vaccination visit.
9. Receipt of any blood product or immunoglobulin preparation within 3 months prior to injection with the study vaccine, or anticipated receipt of these products prior to the final post-vaccination visit.
10. Pregnant women, nursing mothers, or premenopausal women expecting to conceive during the study period.
11. Premenopausal women who are not using birth control during the study period.
12. History of invasive pneumococcal disease (positive culture from blood, cerebrospinal fluid, or other sterile site).
13. Known history of other culture-positive pneumococcal disease.
14. Significant febrile illness (= 100oF/ = 37.8oC) occurring within 3 days (72 hours) before receipt of the study vaccine.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Prevention of invasive pneumococcal disease (IPD)
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Intervention(s)
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Trade Name: Pneumovax® II – Polysaccharide polyvalent pneumococcal vaccine
Product Name: Pneumovax® II
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: purified capsular polysaccharides of Streptococcus pneumoniae: 1,2,3,4,5,6B,7F,8,9N,9V,10A,11A,12F,14,15B,17F,18C,19F,19A,20,22F,23F and 33F
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 25 / serotype-
Trade Name: Pneumovax® II – Polysaccharide polyvalent pneumococcal vaccine
[All new process polysaccharide]
Product Name: Pneumovax® II
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: purified capsular polysaccharides of Streptococcus pneumoniae: 1,2,3,4,5,6B,7F,8,9N,9V,10A,11A,12F,14,15B,17F,18C,19F,19A,20,22F,23F and 33F
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 25 / Serotype-
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Primary Outcome(s)
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Primary end point(s): The primary criteria defined for immunogenicity will be one month post vaccination GMTs of antibody to pneumococcal serotypes 3 and 8 measured by ELISA.
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Main Objective: To compare the post-vaccination geometric mean titres (GMTs) of antibody to pneumococcal serotypes 3 and 8 in recipients of PNEUMOVAX®II formulated with all new process polysaccharides to the same antibody responses in recipients of PNEUMOVAX® II formulated with all current process polysaccharides.
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Secondary Objective: To assess the safety and tolerability of PNEUMOVAX®II formulated with all new process polysaccharides
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Secondary ID(s)
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U05-PnPS-403
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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