EUCTR2012-003484-22-SE
Active, not recruiting
Not Applicable
Immune response to pneumococcal conjugate vaccine in adults receiving hepatitis A vaccine concomitantly
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Helsinki University Central Hospital
- Enrollment
- 300
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female subjects aged \=50
- •2\. General good health as established by medical history and physical examination
- •3\. Written informed consent
- •4\. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable.
- •5\. Available for all visits scheduled in this study.
- •6\. No previous Pnc vaccination
- •7\. No other vaccines administered 30 days prior to or during the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •1\. Previous pneumococcal vaccination
- •2\. Immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study start or planned vaccination during the study
- •3\. Chronic administration of immunosuppressants or other immune\-modifying drugs within 6 months before the first dose of IMP; patients using oral corticosteroids in dosages of \=0\.5 mg/kg/d prednisolone or equivalent are excluded; inhaled or topical steroids are allowed
- •4\. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- •6\. Pregnancy or lactation
- •7\. Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever (fever is defined as body temperature of \=38 °C).
- •8\. Alcohol or drug abuse
- •9\. Suspected non\-compliance
- •10\. Use of any investigational drug within 30 days preceding the study vaccine, or planned use during the study period
- •11\. Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator
Outcomes
Primary Outcomes
Not specified
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