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

Phase 1

• Conditions: Prevention of invasive pneumococcal disease (IPD)

• Registration Number: EUCTR2005-002789-12-GB
• Lead Sponsor: Sanofi Pasteur MSD S.N.C

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-08-24
• Study Completion: 2006-01-13
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: To assess the safety and tolerability of PNEUMOVAX®II formulated with all new process polysaccharides;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.;<br> 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.<br>