Influenza, HumanPhase 4NCT02225327
MF59-adjuvanted Influenza Vaccine and 23-valent Pneumococcal Polysaccharide Vaccine
A Phase 4 study testing Fluad alone, Fluad and PPV23 on the different arms and Fluad and PPV23 on the same arm in people with Influenza, Human and Pneumococcal Infections, run by Korea University Guro Hospital.
Trial summary
Similar to children, adults frequently visit outpatient clinics to get two or more kinds of vaccines at the same time: pneumococcal vaccine, influenza vaccine, Td (diphtheria and tetanus) vaccine, HPV (human papilloma virus) vaccine, meningococcal vaccine, zoster vaccine, etc. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human, Pneumococcal Infections
- What is being tested?
- Fluad alone, Fluad and PPV23 on the different arms and Fluad and PPV23 on the same arm
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Jan 2014
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- At least 65 years of age who are eligible for the study vaccines;
- Who have given written informed consent at the time of enrollment);
- Those who are available for all the visits scheduled in the study;
- Subjects In good health as determined by medical history, physical examination and clinical judgment of the investigator
Who cannot join
- History of egg allergy
- History of influenza vaccination in previous 6 months
- History of any pneumococcal vaccination
- Documented S. pneumonia infection in the previous 5 years
- Chemotherapy for malignancy within the past 30 days
- High-dose systemic steroid (prednisone ≥0.5 mg/kg/day) in the past 30 days
Show all 10Show fewer
- Receipt of blood product within 6 months before enrollment
- Significant acute or chronic infection within the previous 7 days or fever within the previous day
- Any serious chronic or progressive disease
- Any condition that might interfere with the study results.
About this study
Official title: Immunogenicity and Safety of MF59-adjuvanted Trivalent Influenza Vaccine (Fluad) and 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) in the Elderly: Single Versus Concomitant Vaccination
Similar to children, adults frequently visit outpatient clinics to get two or more kinds of vaccines at the same time: pneumococcal vaccine, influenza vaccine, Td (diphtheria and tetanus) vaccine, HPV (human papilloma virus) vaccine, meningococcal vaccine, zoster vaccine, etc. This study is intended to evaluate the immunogenicity and safety of concomitant administration of 23-valent pneumococcal polysaccharide vaccine (PPV23, Prodiax) and MF59 adjuvanted trivalent influenza vaccine in the elderly subjects aged ≥65 years.
Read the detailed description
During influenza season, concomitant influenza and pneumococcal vaccination would be an effective strategy to enhance pneumococcal vaccine coverage rate in high-risk adults. However, the immunogenicity and safety of concomitant vaccination need to be further investigated. There is data on immunogenicity and safety after concomitant administration of pneumococcal polysaccharide vaccine (PPV) and unadjuvanted influenza vaccine; no interference was noted between two vaccines. However, there are no data for MF59 adjuvanted influenza vaccine with pneumococcal vaccine. MF59 only locally reacts for immune response, so immunogenicity should be assessed for both vaccines injected in same arm versus different arms.
This study is intended to evaluate the immunogenicity and safety of concomitant MF59-adjuvanted trivalent influenza vaccine (MF59-aTIV, Fluad) and 23-valent pneumococcal polysaccharide vaccine (PPV23, Prodiax) vaccination in the elderly subjects aged ≥65 years. Healthy elderly subjects (N = 424) are randomized in a 1:1:1:1 ratio to receive MF59-aTIV alone (group 1), MF59-aTIV +PPV23 at different arm (group 2), MF59-aTIV +PPV23 at same arm (group 3) or PPV23 alone (group 4).
Hemagglutination inhibition (HI) assay and multiplex opsono-phagocytic killing assay (MOPA) will be used to compare the immunogenicity of each vaccine after single or concomitant vaccination at pre-vaccination and 1 month post-vaccination. MOPA will be taken for four serotypes (5, 6B, 18C and 19A).
- Conditions
- Influenza, Human, Pneumococcal Infections
- Being tested
- Fluad alone, Fluad and PPV23 on the different arms, Fluad and PPV23 on the same arm, PPV23 alone
- Medical subject headings
- Influenza, Human, Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluad aloneBiological
Fluad
Fluad and PPV23 on the different armsBiological
Fluad and Prodiax
Fluad and PPV23 on the same armBiological
Fluad and Prodiax
PPV23 aloneBiological
Prodiax
| Study group | Role | What they receive |
|---|---|---|
| Fluad alone | Active comparator | 56 Fluad recipients: one vaccine injection administered on Day 0 Receives: Biological: Fluad alone |
| Fluad and PPV23 on the different arms | Active comparator | 56 concomitant Fluad-PPV23 recipients on the different arms: one dose of each vaccine administered on Day 0 Receives: Biological: Fluad and PPV23 on the different arms |
| Fluad and PPV23 on the same arm | Active comparator | 56 concomitant Fluad-PPV23 recipients on the same arm with 1 inch distance: one dose of each vaccine administered on Day 0 Receives: Biological: Fluad and PPV23 on the same arm |
| PPV23 alone | Active comparator | 56 PPV23 recipients: one vaccine injection administered on Day 0 Receives: Biological: PPV23 alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rates (A/H1N1, A/H3N2, and B)
a post-vaccination titer ≥1:40 in subjects with a pre-vaccination titer of <1:10 or a ≥4-fold titer increase in subjects with a pre-vaccination titer of ≥1:10
Measured: Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination)
Secondary outcomes (3)
Seroprotection rates (A/H1N1, A/H3N2, and B)
Percentage of subjects with a post-vaccination titer ≥1:40
Measured: Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination).
GMT folds (A/H1N1, A/H3N2, and B)
GMT-fold change: GMT ratio of the post-vaccination titer to pre-vaccination titer
Measured: Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination.
Opsonophagocytic assay (OPA) titers for four serotypes of PPV23 (serotypes 5, 6B, 18C and 19A)
OPA geometric mean titers for four PPV23 serotypes with corresponding 2-sided 95% confidence intervals will be compared between groups receiving PPV23: MF59-adjuvanted TIV + PPV23 at different arm, MF59-adjuvanted TIV + PPV23 at same arm and PPV23 alone.
Measured: Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startOct 2013
- Primary completionDec 2013
- Study completionJan 2014
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 Influenza, HumanStudies of the same condition, open and under way.
- 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
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Principal investigator, Hee Jin Cheong, Korea University Guro Hospital
- Investigators
- Hee Jin Cheong, MD, PhD, Principal investigator, Korea University Guro HospitalJoon Young Song, MD, PhD, Study director, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225327
- Sponsor's protocol ID
- FLUADPPV23
- Status last verified
- Aug 2014
- First submitted
- 22 Aug 2014
- Last updated
- 27 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Song JY, Cheong HJ, Tsai TF, Chang HA, Choi MJ, Jeon JH, Kang SH, Jeong EJ, Noh JY, Kim WJ. Immunogenicity and safety of concomitant MF59-adjuvanted influenza vaccine and 23-valent pneumococcal polysaccharide vaccine administration in older adults. Vaccine. 2015 Aug 26;33(36):4647-52. doi: 10.1016/j.vaccine.2015.05.003. Epub 2015 May 14.
PubMed 25980426
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of MF59-adjuvanted Trivalent Influenza Vaccine (Fluad) and 23-valent Pneumococcal Polysaccharide Vaccine (PPV23) in the Elderly: Single Versus Concomitant Vaccination
- ClinicalTrials.gov ID
- NCT02225327
- Acronym / sponsor ID
- FLUADPPV23
- Conditions
- Influenza, Human, Pneumococcal Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- Oct 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 26 Aug 2014 (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.
Similar to children, adults frequently visit outpatient clinics to get two or more kinds of vaccines at the same time: pneumococcal vaccine, influenza vaccine, Td (diphtheria and tetanus) vaccine, HPV (human papilloma virus) vaccine, meningococcal vaccine, zoster vaccine, etc. This study is intended to evaluate the immunogenicity and safety of concomitant administration of 23-valent pneumococcal polysaccharide vaccine (PPV23, Prodiax) and MF59 adjuvanted trivalent influenza vaccine in the elderly subjects aged ≥65 years.
Detailed description
During influenza season, concomitant influenza and pneumococcal vaccination would be an effective strategy to enhance pneumococcal vaccine coverage rate in high-risk adults. However, the immunogenicity and safety of concomitant vaccination need to be further investigated. There is data on immunogenicity and safety after concomitant administration of pneumococcal polysaccharide vaccine (PPV) and unadjuvanted influenza vaccine; no interference was noted between two vaccines. However, there are no data for MF59 adjuvanted influenza vaccine with pneumococcal vaccine. MF59 only locally reacts for immune response, so immunogenicity should be assessed for both vaccines injected in same arm versus different arms.
This study is intended to evaluate the immunogenicity and safety of concomitant MF59-adjuvanted trivalent influenza vaccine (MF59-aTIV, Fluad) and 23-valent pneumococcal polysaccharide vaccine (PPV23, Prodiax) vaccination in the elderly subjects aged ≥65 years. Healthy elderly subjects (N = 424) are randomized in a 1:1:1:1 ratio to receive MF59-aTIV alone (group 1), MF59-aTIV +PPV23 at different arm (group 2), MF59-aTIV +PPV23 at same arm (group 3) or PPV23 alone (group 4).
Hemagglutination inhibition (HI) assay and multiplex opsono-phagocytic killing assay (MOPA) will be used to compare the immunogenicity of each vaccine after single or concomitant vaccination at pre-vaccination and 1 month post-vaccination. MOPA will be taken for four serotypes (5, 6B, 18C and 19A).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fluad alone | Active comparator | Biological: Fluad alone56 Fluad recipients: one vaccine injection administered on Day 0 |
| Fluad and PPV23 on the different arms | Active comparator | Biological: Fluad and PPV23 on the different arms56 concomitant Fluad-PPV23 recipients on the different arms: one dose of each vaccine administered on Day 0 |
| Fluad and PPV23 on the same arm | Active comparator | Biological: Fluad and PPV23 on the same arm56 concomitant Fluad-PPV23 recipients on the same arm with 1 inch distance: one dose of each vaccine administered on Day 0 |
| PPV23 alone | Active comparator | Biological: PPV23 alone56 PPV23 recipients: one vaccine injection administered on Day 0 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- At least 65 years of age who are eligible for the study vaccines;
- Who have given written informed consent at the time of enrollment);
- Those who are available for all the visits scheduled in the study;
- Subjects In good health as determined by medical history, physical examination and clinical judgment of the investigator
Key exclusion criteria (10 listed)
- History of egg allergy
- History of influenza vaccination in previous 6 months
- History of any pneumococcal vaccination
- Documented S. pneumonia infection in the previous 5 years
- Chemotherapy for malignancy within the past 30 days
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 |
|---|---|---|
| Fluad aloneFluad | Biological | Fluad alone |
| Fluad and PPV23 on the different armsFluad and Prodiax | Biological | Fluad and PPV23 on the different arms |
| Fluad and PPV23 on the same armFluad and Prodiax | Biological | Fluad and PPV23 on the same arm |
| PPV23 aloneProdiax | Biological | PPV23 alone |
Primary outcome
Seroconversion rates (A/H1N1, A/H3N2, and B)
Time frame: Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination)
a post-vaccination titer ≥1:40 in subjects with a pre-vaccination titer of <1:10 or a ≥4-fold titer increase in subjects with a pre-vaccination titer of ≥1:10
3 secondary outcomes
Seroprotection rates (A/H1N1, A/H3N2, and B)
Time frame: Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination).
GMT folds (A/H1N1, A/H3N2, and B)
Time frame: Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination.
Opsonophagocytic assay (OPA) titers for four serotypes of PPV23 (serotypes 5, 6B, 18C and 19A)
Time frame: Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination).
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 27 Aug 2014.
- Derived from this study: PubMed 25980426Song JY, Cheong HJ, Tsai TF, Chang HA, Choi MJ, Jeon JH, Kang SH, Jeong EJ, Noh JY, Kim WJ. Immunogenicity and safety of concomitant MF59-adjuvanted influenza vaccine and 23-valent pneumococcal polysaccharide vaccine administration in older adults. Vaccine. 2015 Aug 26;33(36):4647-52. doi: 10.1016/j.vaccine.2015.05.003. Epub 2015 May 14.
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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.
Hee Jin Cheong, MD, PhD principal investigator
Korea University Guro Hospital
Joon Young Song, MD, PhD study director
Korea University Guro Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluad alone, Fluad and PPV23 on the different arms and Fluad and PPV23 on the same arm in people with Influenza, Human and Pneumococcal Infections, run by Korea University Guro Hospital.
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 4 inclusion and 10 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 27 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Seroconversion rates (A/H1N1, A/H3N2, and B) (time frame: Outcome measure will be assessed at two points (baseline and 4 weeks after vaccination)). 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 NCT02225327, 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 27 Aug 2014.