Immune response to pneumococcal conjugate vaccine in adults receiving hepatitis A vaccine concomitantly

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 600

Inclusion Criteria

1. Male or female subjects aged =18
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 previous hepatitis A vaccination or incomplete series (one dose) of hepatitis A vaccination
8. 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
F.1.2.1 Number of subjects for this age range 550
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. Previous pneumococcal vaccination
2. Two or more previous doses of hepatitis A vaccine
3. Immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study start or planned vaccination during the study
4. 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
5. 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
12. Employee at the investigational site, relative or spouse of the investigator
13. Any other criteria which, in the investigator’s opinion, would compromise the ability of the subject to participate in the study, the subject’s well-being, or the outcome of the study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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