Russian Registration Study of PPV23

Conditions: Vaccination against pneumococcal disease caused by the 23 serotypes included in the vaccine
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2015-001656-29-Outside-EU/EEA

Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 102

Inclusion Criteria

All subjects must be from the Russian population.
a. Subjects 50 years of age or older. Any underlying chronic illness must be documented to be in stable condition.
b. Subjects 2 to 49 years of age with an increased risk for pneumococcal disease as a result of one of the following conditions:
• Chronic cardiovascular disease (including congestive heart failure and cardiomyopathies)
• Chronic pulmonary disease (including chronic obstructive pulmonary disease & emphysema)
• Diabetes mellitus
• Alcoholism
• Chronic liver disease (including cirrhosis)
•Cerebrospinal fluid leaks
• Functional or anatomic asplenia
• Sickle cell anemia
• Persons living in special environments or social settings (Individuals living in crowded, closed communities such as shelters, military camps, or long-term care facilities).
c. Subject or parent (for minor subjects) has signed and dated informed consent/assent prior to receipt of the study vaccine. For this study, parent is defined as biological or adoptive. The subject or parent may also provide consent/assent for Future Biomedical Research (FBR) for future assay/vaccine development and/or FBR. However, the subject may participate in the main trial without participating in either future assay/vaccine development or FBR.
d. Subject is highly unlikely to become pregnant at any time from signing the informed consent through 6 weeks after receiving the study vaccine, as indicated by at least one yes” answer to the following questions:
• Subject is male.
• Subject is a female of reproductive potential who agrees to remain abstinent or use (or have her partner use) 2 acceptable methods of contraception during the time period at any time from signing the informed consent through 6 weeks after receiving the study vaccine. Acceptable methods of birth control are: hormonal contraceptives, diaphragm with spermicide, intrauterine device (IUD), contraceptive sponge, condom, or vasectomy. Note that simultaneous use of 2 reliable forms of contraception is recommended.
• Subject is a female who is not of reproductive potential. A female subject who is not of reproductive potential is defined as: one who has either (1) Not reached Puberty (2) reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone [FSH] levels in the postmenopausal range as determined by a laboratory, or 12 months of spontaneous amenorrhea), (3) post-surgical bilateral oophorectomy and/or hysterectomy, or (4) bilateral tubal ligation.

Are the trial subjects under 18? yes
Number of subjects for this age range: 26
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 62
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

a. Hypersensitivity to any of the components of the study vaccine, including phenol. See Attachments for PNEUMOVAX™ 23 Package Labeling.
b. Prior vaccination with any pneumococcal polysaccharide or conjugate vaccine. When available, written medical records should be reviewed to verify the subject’s denial of receiving a prior pneumococcal vaccination.
c. Known or suspected immune dysfunction, including persons with congenital immunodeficiency, HIV infection, leukemia, lymphoma, Hodgkin’s disease, multiple myeloma, generalized malignancy, chronic renal failure (most recent serum creatinine values in medical record =3mg/dL), 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, breast, or skin cancer who are not on chemotherapeutic drugs [other than hormone blocking drugs] and subjects with other malignancies who have been disease-free for at least 5 years will be eligible for enrollment).
d. History of autoimmune disease
e. Receipt of other licensed vaccines during the study period as follows:
• Licensed live virus vaccines received during the 3 months prior to injection with the study vaccine or scheduled within 3 months after receipt of the study vaccine.
• Inactivated licensed vaccines received during the 28 days prior to injection with the study vaccine or scheduled prior to the Day 28 postvaccination visit.
f. 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 (Day 28) postvaccination visit (3 months if a live virus vaccine).
g. Receipt of any blood product or immunoglobulin preparation within the 6 months prior to injection with the study vaccine, or anticipated receipt of these products prior to the final (Day 28) postvaccination visit.
h. Recent hospitalization for acute illness within the 3 months before receipt of the study vaccine.
i. Pregnant women, nursing mothers.
j. History of IPD (positive culture from blood, cerebrospinal fluid, or other sterile site).
k. Known history of other culture-positive pneumococcal disease.
l. History of febrile illness (=37.6°C axillary; =38.0°C oral or equivalent) occurring within 3 days (72 hours) before receipt of the study vaccine.
m. Subject has received antibiotic therapy for any acute illness within 7 days before receipt of study vaccine.