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Completed

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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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aava Medical Centre, Helsinki, Finland

Loading trial locations.

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

Prevenar13

Biological

Hepatitis A Vaccine

Biological

Other names: Epaxal

Primary outcomes

  1. 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

  1. 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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