Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
305 participants
INTERVENTIONAL
2013-08-24
2020-04-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Study group - Prevenar®13 and Hepatitis A vaccines
Study group (group 1) - Prevenar®13 and Hepatitis A: one dose of each vaccine administered on Day 0
Prevenar13
Hepatitis A vaccine
Pneumococcal conjugate vaccine -Control group - Prevenar®13
PCV -Control group (group 2) - Prevenar®13: one vaccine injection administered on Day 0
Prevenar13
HepA -Control group - Hepatitis A vaccine
HepA -Control group (group 3) - Hepatitis A vaccine: one vaccine injection administered on Day 0
Hepatitis A vaccine
Interventions
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Prevenar13
Hepatitis A vaccine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 vaccine
8. No other vaccines administered 30 days prior to or during the study
Exclusion Criteria
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 vaccine; 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
5. Pregnancy or lactation
6. 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).
7. Alcohol or drug abuse
8. Suspected non-compliance
9. Use of any investigational drug within 30 days preceding the study vaccine, or planned use during the study period
10. Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator
11. Employee at the investigational site, relative or spouse of the investigator
12. 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
50 Years
ALL
Yes
Sponsors
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Helsinki University Central Hospital
OTHER
Responsible Party
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Anu Kantele
Associate Professor
Principal Investigators
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Anu Kantele, Assoc. prof.
Role: PRINCIPAL_INVESTIGATOR
Helsinki University Central Hospital
Lars Rombo, Professor
Role: PRINCIPAL_INVESTIGATOR
Sörmland County Council, Centre for Clinical Research
Locations
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Aava Medical Centre
Helsinki, , Finland
Department of Infectious Diseases
Eskilstuna, , Sweden
Countries
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References
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Riekkinen M, Pakkanen SH, Hutse V, Roukaerts I, Ollgren J, Kayhty H, Herzog C, Rombo L, Kantele A. Coadministered pneumococcal conjugate vaccine decreases immune response to hepatitis A vaccine: a randomized controlled trial. Clin Microbiol Infect. 2023 Dec;29(12):1553-1560. doi: 10.1016/j.cmi.2023.08.006. Epub 2023 Aug 10.
Other Identifiers
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PCV13 adults + Hep A
Identifier Type: -
Identifier Source: org_study_id