Measurement of Immune Response to Prevenar13Phase 4PCV13+HepANCT01926860
PCV13 + Hepatitis A Vaccine for Adults
A Phase 4 study testing Prevenar13 and Hepatitis A vaccine in people with Measurement of Immune Response to Prevenar13 and Measurement of Immune Response to Hepatitis A, run by Helsinki University Central Hospital at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Measurement of Immune Response to Prevenar13, Measurement of Immune Response to Hepatitis A
- What is being tested?
- Prevenar13 and Hepatitis A vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 24 Aug 2013to 28 Apr 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Immune Response to Pneumococcal Conjugate Vaccine in Adults Receiving Hepatitis A Vaccine at the Same Time
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.
- Conditions
- Measurement of Immune Response to Prevenar13, Measurement of Immune Response to Hepatitis A
- Being tested
- Prevenar13, Hepatitis A vaccine
- Keywords
- Prevenar13, pneumococcal conjugate vaccine, Epaxal, hepatitis A vaccine
- Medical subject headings
- Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevenar13Biological
Hepatitis A vaccineBiological
Also called Epaxal
| Study group | Role | What they receive |
|---|---|---|
| Study group - Prevenar®13 and Hepatitis A vaccines | Experimental | Study group (group 1) - Prevenar®13 and Hepatitis A: one dose of each vaccine administered on Day 0 Receives: Biological: Prevenar13; Biological: Hepatitis A vaccine |
| Pneumococcal conjugate vaccine -Control group - Prevenar®13 | Active comparator | PCV -Control group (group 2) - Prevenar®13: one vaccine injection administered on Day 0 Receives: Biological: Prevenar13 |
| HepA -Control group - Hepatitis A vaccine | Active comparator | HepA -Control group (group 3) - Hepatitis A vaccine: one vaccine injection administered on Day 0 Receives: Biological: Hepatitis A vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response to PCV13
- 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.
Measured: 2 years
Secondary outcomes (1)
Immune response to Hep A vaccine
- 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2013 (estimated)
- Study start24 Aug 2013
- Primary completion28 Oct 2019
- Study completion28 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Measurement of Immune Response to Prevenar13Studies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anu Kantele, Helsinki University Central Hospital
- Investigators
- Anu Kantele, Assoc. prof., Principal investigator, Helsinki University Central HospitalLars Rombo, Professor, Principal investigator, Sörmland County Council, Centre for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01926860
- Sponsor's protocol ID
- PCV13 adults + Hep A
- Acronym
- PCV13+HepA
- Status last verified
- Dec 2024
- First submitted
- 19 Aug 2013
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37572831
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Response to Pneumococcal Conjugate Vaccine in Adults Receiving Hepatitis A Vaccine at the Same Time
- ClinicalTrials.gov ID
- NCT01926860
- Acronym / sponsor ID
- PCV13+HepA / PCV13 adults + Hep A
- Conditions
- Measurement of Immune Response to Prevenar13, Measurement of Immune Response to Hepatitis A
- Keywords
- Prevenar13, pneumococcal conjugate vaccine, Epaxal, hepatitis A vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 24 Aug 2013 (actual)
- Primary completion
- 28 Oct 2019 (actual)
- Study completion
- 28 Apr 2020 (actual)
- First posted
- 21 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group - Prevenar®13 and Hepatitis A vaccines | Experimental | Biological: Prevenar13, Biological: Hepatitis A vaccineStudy group (group 1) - Prevenar®13 and Hepatitis A: one dose of each vaccine administered on Day 0 |
| Pneumococcal conjugate vaccine -Control group - Prevenar®13 | Active comparator | Biological: Prevenar13PCV -Control group (group 2) - Prevenar®13: one vaccine injection administered on Day 0 |
| HepA -Control group - Hepatitis A vaccine | Active comparator | Biological: Hepatitis A vaccineHepA -Control group (group 3) - Hepatitis A vaccine: one vaccine injection administered on Day 0 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevenar13 | Biological | Pneumococcal conjugate vaccine -Control group - Prevenar®13, Study group - Prevenar®13 and Hepatitis A vaccines |
| Hepatitis A vaccineAlso: Epaxal | Biological | HepA -Control group - Hepatitis A vaccine, Study group - Prevenar®13 and Hepatitis A vaccines |
Primary outcome
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.
1 secondary outcome
Immune response to Hep A vaccine
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Results publication: PubMed 37572831Riekkinen 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anu Kantele, Assoc. prof. principal investigator
Helsinki University Central Hospital
Lars Rombo, Professor principal investigator
Sörmland County Council, Centre for Clinical Research
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prevenar13 and Hepatitis A vaccine in people with Measurement of Immune Response to Prevenar13 and Measurement of Immune Response to Hepatitis A, run by Helsinki University Central Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune response to PCV13 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01926860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.