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

Sanofi Pasteur MSD S.N.C0 sites0 target enrollmentAugust 24, 2005

ConditionsPrevention of invasive pneumococcal disease (IPD)

DrugsPneumovax® II – Polysaccharide polyvalent pneumococcal vaccine

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Prevention of invasive pneumococcal disease (IPD)
Sponsor: Sanofi Pasteur MSD S.N.C
Status: Active, Not Recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 24, 2005

End Date

January 13, 2006

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Sanofi Pasteur MSD S.N.C

Eligibility Criteria

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.