NCT Number: NCT01926860
PCV13 + Hepatitis A Vaccine for Adults
The present study explores whether a simultaneously given hepatitis A vaccine (Epaxal) will have an impact on the immune response to PCV13 (pneumococcal conjugate vaccine; Prevenar13) vaccine in adults. The immune response to PCV13 is measured as levels of serotype specific serum antibodies and their opsonophagocytic activity. The results of volunteers receiving PCV13 and Epaxal will be compared to that in a control groups of adults receiving either hepatitis A or PCV13 vaccines only.
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Conditions
Age range
50 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Aava Medical Centre, Helsinki, Finland
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Male or female subjects aged ≥50
- General good health as established by medical history and physical examination
- Written informed consent
- Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable.
- Available for all visits scheduled in this study.
- No previous Pnc vaccination
- No previous hepatitis A vaccine
- No other vaccines administered 30 days prior to or during the study
Exclusion criteria
- Previous pneumococcal or hepatitis A vaccination
- Immunization with any other vaccine (oral or parenteral) within 4 weeks prior to study start or planned vaccination during the study
- 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
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
- Pregnancy or lactation
- 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).
- Alcohol or drug abuse
- Suspected non-compliance
- Use of any investigational drug within 30 days preceding the study vaccine, or planned use during the study period
- Any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction based on the judgement of the investigator
- Employee at the investigational site, relative or spouse of the investigator
- 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
Treatment and study plan
Hepatitis A Vaccine
BiologicalOther names: Epaxal
Primary outcomes
-
Immune response to PCV13
Time frame: 2 years
- To study whether a simultaneously given hepatitis A vaccine (Epaxal) will have an impact on the immune response to PCV13 (Prevenar13) vaccine in adults. The immune response to PCV13 is measured as levels of serotype specific serum antibodies and their opsonophagocytic activity. The results of volunteers receiving PCV13 and Epaxal will be compared to that in a control group of adults receiving PCV13 vaccine only.
Secondary outcomes
-
Immune response to Hep A vaccine
Time frame: 2 years
- To study whether a simultaneously given PCV13 vaccine will have an impact on the immune response to hepatitis A vaccine in adults. The immune response to hepatitis A vaccine is measured as levels of serum antibodies (ELISA). The results of volunteers receiving PCV13 and hepatitis A will be compared to that in a control group of adults receiving hepatitis A vaccine only.
Sponsors and collaborators
Lead sponsor
Helsinki University Central Hospital
Other
Registry information
Official study title
Immune Response to Pneumococcal Conjugate Vaccine in Adults Receiving Hepatitis A Vaccine at the Same Time
Acronym: PCV13+HepA
Important dates
- Study start
- 2013
- Primary completion
- 2019
- Study completion
- 2020
- First posted
- Aug 21, 2013
- Registry last updated
- Dec 5, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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