InfluenzaPhase 4NCT02215863
Immunogenicity and Safety of PCV13 and Fluad in Adults Aged ≥60 Years
A Phase 4 study testing Fluad and Prevenar13, Fluad and Prevenar13 in people with Influenza and Streptococcus Pneumoniae, run by Korea University Guro Hospital at 3 sites in South Korea.
Trial summary
Recent reviews have highlighted the unpredictability and complexity of immune interference when multivalent conjugate vaccines are co-administered with other pediatric vaccines. It has become evident that the likelihood of immune interference (in response to conjugated- or co-administered antigens) increases in… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza, Streptococcus Pneumoniae
- What is being tested?
- Fluad and Prevenar13, Fluad and Prevenar13
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,195 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Sep 2014to Mar 2015
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged ≥60 years who signed the informed consent
Who cannot join
- Previous pneumococcal vaccine recipients
- Egg allergy
- History of serious adverse event after vaccination,
- any acute disease or infection
- History of neurological symptoms or signs
- Impairment of immune function or immunosuppressant use
- Bleeding diathesis
- Fever (defined as axillary temperature ³38.0°C) within 3 days (prior to Visit 1)
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Korea University Ansan Hospital
Ansan
Hallym University Gangnam Sacred Hospita
Seoul
Catholic University Medical College, St. Vincent's Hospital
Suwon
About this study
Official title: Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13) and MF59-adjuvanted Influenza Vaccine (Fluad) After Concomitant Vaccination in Adults Aged ≥60 Years
Recent reviews have highlighted the unpredictability and complexity of immune interference when multivalent conjugate vaccines are co-administered with other pediatric vaccines. It has become evident that the likelihood of immune interference (in response to conjugated- or co-administered antigens) increases in proportional to the number of glyco-conjugates (valencies) and dosages of carrier proteins. There are many kinds of carrier proteins: tetanus toxoid (TT), diphtheria toxoid (DT), CRM197 (non-toxic variant of DT), OMP (complex outer-membrane protein mixture from Neisseria meningitidis) and non-typeable Hemophilus influenza-derived protein D. Among them, TT is a more potent inducer of T-helper immunity, but carrier-induced-epitopic suppression (dose-dependent carrier antibody and carrier B cell dominance) may occur with TT. In comparison, DT and CRM197 are weaker B-cell immunogens, but apparently trigger more T-regulatory mechanism. Recent pediatric studies of PCV13 co-administered with DTaP vaccines showed 6B GMT (geometric mean titer) to be somewhat reduced compared to the results with PCV13 alone.
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. PCV13 has limited co-administration information for adjuvanted influenza vaccine.
This study is designed to evaluate the immunogenicity and safety of PCV13 and MF59-adjuvanted influenza vaccine (Fluad) after concomitant administration in adults aged 60 years or older.
Read the detailed description
This study is a multi-centered, randomized controlled clinical trial: Korea University Guro Hospital, Korea University Ansan Hospital, Hallym University Gangnam Sacred Hospital and Catholic University Medical College, St. Vincent's Hospital.
The primary objective is to evaluate the immunogenicity of Fluad after concomitant administration of Fluad and PCV13 in adults aged 60 years or more. This study is designed to demonstrate non-inferiority of sero-conversion rate after Fluad vaccination: Fluad-PCV13 co-administration group versus Fluad alone group
The secondary objective is to evaluate the immunogenicity of PCV13 after concomitant administration in adults aged 60 years or more. This study is designed to demonstrate non-inferiority of PCV13 when co-administered with Fluad compared with PCV13 alone.
This study is also designed to evaluate the safety of concomitant PCV13-Fluad administration in adults aged 60 years or more. All the participants will be followed for the duration of an expected average of 4 weeks after vaccination.
- Conditions
- Influenza, Streptococcus Pneumoniae
- Being tested
- Fluad and Prevenar13, Fluad, Prevenar13
- Keywords
- Immunogenicity, Safety, MF59, Influenza vaccine, Pneumococcal vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluad and Prevenar13Biological
FluadBiological
Prevenar13Biological
| Study group | Role | What they receive |
|---|---|---|
| PCV13 and Fluad | Active comparator | 437 concomitant Fluad-PCV13 recipients: one dose of each vaccine administered on Day 0 Receives: Biological: Fluad and Prevenar13 |
| Fluad alone | Active comparator | 437 Fluad recipients: one vaccine injection administered on Day 0 Receives: Biological: Fluad |
| PCV13 alone | Active comparator | 437 PCV13 recipients: one vaccine injection administered on Day 0 Receives: Biological: Prevenar13 |
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 (2)
Seroprotection rates and GMT folds (A/H1N1, A/H3N2, and B)
- Seroprotection rate: percentage of subjects with a post-vaccination titer ≥1:40
- 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 PCV13
OPA geometric mean titers for 13 PCV13 serotypes with corresponding 2-sided 95% confidence intervals between groups receiving PCV 13 and then compare the results
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 posted13 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2015
- Study completionMar 2015
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 InfluenzaStudies 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
- 1,195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Guro Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- 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, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02215863
- Sponsor's protocol ID
- FLUPCV13
- Status last verified
- Mar 2015
- First submitted
- 11 Aug 2014
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Song JY, Cheong HJ, Hyun HJ, Seo YB, Lee J, Wie SH, Choi MJ, Choi WS, Noh JY, Yun JW, Yun JG, Kim WJ. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine and an MF59-adjuvanted influenza vaccine after concomitant vaccination in ⩾60-year-old adults. Vaccine. 2017 Jan 5;35(2):313-320. doi: 10.1016/j.vaccine.2016.11.047. Epub 2016 Dec 3.
PubMed 27919632
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13) and MF59-adjuvanted Influenza Vaccine (Fluad) After Concomitant Vaccination in Adults Aged ≥60 Years
- ClinicalTrials.gov ID
- NCT02215863
- Acronym / sponsor ID
- FLUPCV13
- Conditions
- Influenza, Streptococcus Pneumoniae
- Keywords
- Immunogenicity, Safety, MF59, Influenza vaccine, Pneumococcal vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,195 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Sep 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 13 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.
Recent reviews have highlighted the unpredictability and complexity of immune interference when multivalent conjugate vaccines are co-administered with other pediatric vaccines. It has become evident that the likelihood of immune interference (in response to conjugated- or co-administered antigens) increases in proportional to the number of glyco-conjugates (valencies) and dosages of carrier proteins. There are many kinds of carrier proteins: tetanus toxoid (TT), diphtheria toxoid (DT), CRM197 (non-toxic variant of DT), OMP (complex outer-membrane protein mixture from Neisseria meningitidis) and non-typeable Hemophilus influenza-derived protein D. Among them, TT is a more potent inducer of T-helper immunity, but carrier-induced-epitopic suppression (dose-dependent carrier antibody and carrier B cell dominance) may occur with TT. In comparison, DT and CRM197 are weaker B-cell immunogens, but apparently trigger more T-regulatory mechanism. Recent pediatric studies of PCV13 co-administered with DTaP vaccines showed 6B GMT (geometric mean titer) to be somewhat reduced compared to the results with PCV13 alone.
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. PCV13 has limited co-administration information for adjuvanted influenza vaccine.
This study is designed to evaluate the immunogenicity and safety of PCV13 and MF59-adjuvanted influenza vaccine (Fluad) after concomitant administration in adults aged 60 years or older.
Detailed description
This study is a multi-centered, randomized controlled clinical trial: Korea University Guro Hospital, Korea University Ansan Hospital, Hallym University Gangnam Sacred Hospital and Catholic University Medical College, St. Vincent's Hospital.
The primary objective is to evaluate the immunogenicity of Fluad after concomitant administration of Fluad and PCV13 in adults aged 60 years or more. This study is designed to demonstrate non-inferiority of sero-conversion rate after Fluad vaccination: Fluad-PCV13 co-administration group versus Fluad alone group
The secondary objective is to evaluate the immunogenicity of PCV13 after concomitant administration in adults aged 60 years or more. This study is designed to demonstrate non-inferiority of PCV13 when co-administered with Fluad compared with PCV13 alone.
This study is also designed to evaluate the safety of concomitant PCV13-Fluad administration in adults aged 60 years or more. All the participants will be followed for the duration of an expected average of 4 weeks after vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCV13 and Fluad | Active comparator | Biological: Fluad and Prevenar13437 concomitant Fluad-PCV13 recipients: one dose of each vaccine administered on Day 0 |
| Fluad alone | Active comparator | Biological: Fluad437 Fluad recipients: one vaccine injection administered on Day 0 |
| PCV13 alone | Active comparator | Biological: Prevenar13437 PCV13 recipients: one vaccine injection administered on Day 0 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged ≥60 years who signed the informed consent
Key exclusion criteria (8 listed)
- Previous pneumococcal vaccine recipients
- Egg allergy
- History of serious adverse event after vaccination,
- any acute disease or infection
- History of neurological symptoms or signs
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 and Prevenar13 | Biological | PCV13 and Fluad |
| Fluad | Biological | Fluad alone |
| Prevenar13 | Biological | PCV13 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
2 secondary outcomes
Seroprotection rates and 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 PCV13
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 1 Apr 2015.
- Derived from this study: PubMed 27919632Song JY, Cheong HJ, Hyun HJ, Seo YB, Lee J, Wie SH, Choi MJ, Choi WS, Noh JY, Yun JW, Yun JG, Kim WJ. Immunogenicity and safety of a 13-valent pneumococcal conjugate vaccine and an MF59-adjuvanted influenza vaccine after concomitant vaccination in ⩾60-year-old adults. Vaccine. 2017 Jan 5;35(2):313-320. doi: 10.1016/j.vaccine.2016.11.047. Epub 2016 Dec 3.
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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 principal investigator
Korea University Guro Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluad and Prevenar13, Fluad and Prevenar13 in people with Influenza and Streptococcus Pneumoniae, run by Korea University Guro Hospital at 3 sites in South Korea.
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 1 inclusion and 8 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 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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?
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 NCT02215863, 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 1 Apr 2015.