Influenza, HumanPhase 4NCT02582047
Influenza Vaccine and Pneumococcal Vaccine
A Phase 4 study testing Influenza vaccination with PPV23 and Influenza vaccination with PCV13 in people with Influenza, Human and Pneumococcal Infections, run by Korea University Guro Hospital at 2 sites in South Korea.
Trial summary
Previous studies have demonstrated the immunogenicity and safety of the co-administration of the trivalent inactivated influenza vaccine (IIV3) with the polysaccharide pneumococcal vaccine (PPV) or pneumococcal conjugate vaccine (PCV). 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?
- Influenza vaccination with PPV23 and Influenza vaccination with PCV13
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Oct 2012to Jan 2013
- 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
- Adults aged ≥65 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
Show all 9Show fewer
- Bleeding diathesis
- Fever (defined as axillary temperature ³38.0°C) within 3 days
- History of Streptococcal pneumoniae infection within the previous 5 years
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Korea University Ansan Hospital
Ansan, Kyoungido, 15355
Hallym University Gangnam Sacred Hospital
Seoul, Seoul, 07441
About this study
Official title: Immunogenicity and Safety of an Influenza Vaccine Administered Concomitantly With a 13-Valent Pneumococcal Conjugate Vaccine or 23-Valent Polysaccharide Pneumococcal Vaccine in Elderly Patients
Previous studies have demonstrated the immunogenicity and safety of the co-administration of the trivalent inactivated influenza vaccine (IIV3) with the polysaccharide pneumococcal vaccine (PPV) or pneumococcal conjugate vaccine (PCV). However, there is no direct comparison study that evaluates the immunogenicity and safety of IIV3 given concomitantly with PCV13 or PPV23 in the elderly. This study is intended to compare the immunogenicity and safety of concomitant administration in the elderly subjects.
Read the detailed description
During the influenza vaccination period, 224 healthy elderly volunteers randomly received IIV3 given concomitantly with either PCV13 (PCV13+IIV3) or PPV23 (PPV23+IIV3) in a 1:1 ratio. Serum hemagglutination-inhibiting (HI) antibodies for IIV3 were measured at the time of vaccination and 1 month after vaccination. Adverse events were recorded prospectively in a clinical diary during a 7-day period.
- Conditions
- Influenza, Human, Pneumococcal Infections
- Being tested
- Influenza vaccination with PPV23, Influenza vaccination with PCV13
- Keywords
- influenza vaccine, pneumococcal vaccine, simultaneous vaccination
- 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.
Influenza vaccination with PPV23Biological
GCflu and Pneumovax-23
Influenza vaccination with PCV13Biological
GCflu and Prevenar-13
| Study group | Role | What they receive |
|---|---|---|
| Influenza vaccination with PPV23 | Active comparator | concomitant vaccination with trivalent inactivated influenza vaccine and 23-valent polysaccharide pneumococcal vaccine Receives: Biological: Influenza vaccination with PPV23 |
| Influenza vaccination with PCV13 | Active comparator | concomitant vaccination with trivalent inactivated influenza vaccine and 13-valent pneumococcal conjugate vaccine Receives: Biological: Influenza vaccination with PCV13 |
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)
Seroconversion: 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: Change from baseline titer at 4 weeks
Secondary outcomes (2)
Seroprotection rates (A/H1N1, A/H3N2, and B)
Seroprotection rate: percentage of subjects with a post-vaccination titer ≥1:40
Measured: Change from baseline titer at 4 weeks
GMT folds (A/H1N1, A/H3N2, and B)
GMT-fold change: GMT ratio of the post-vaccination titer to pre-vaccination titer
Measured: Change from baseline titer at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startOct 2012
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Responsible party
- Principal investigator, Hee Jin Cheong, Korea University Guro Hospital
- Investigators
- Hee Jin Cheong, MD, PhD, Principal investigator, Korea University Guro Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582047
- Sponsor's protocol ID
- INFLUENZAPNEUMO
- Status last verified
- Oct 2015
- First submitted
- 5 Oct 2015
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of an Influenza Vaccine Administered Concomitantly With a 13-Valent Pneumococcal Conjugate Vaccine or 23-Valent Polysaccharide Pneumococcal Vaccine in Elderly Patients
- ClinicalTrials.gov ID
- NCT02582047
- Acronym / sponsor ID
- INFLUENZAPNEUMO
- Conditions
- Influenza, Human, Pneumococcal Infections
- Keywords
- influenza vaccine, pneumococcal vaccine, simultaneous vaccination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Korea University Guro HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 21 Oct 2015 (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.
Previous studies have demonstrated the immunogenicity and safety of the co-administration of the trivalent inactivated influenza vaccine (IIV3) with the polysaccharide pneumococcal vaccine (PPV) or pneumococcal conjugate vaccine (PCV). However, there is no direct comparison study that evaluates the immunogenicity and safety of IIV3 given concomitantly with PCV13 or PPV23 in the elderly. This study is intended to compare the immunogenicity and safety of concomitant administration in the elderly subjects.
Detailed description
During the influenza vaccination period, 224 healthy elderly volunteers randomly received IIV3 given concomitantly with either PCV13 (PCV13+IIV3) or PPV23 (PPV23+IIV3) in a 1:1 ratio. Serum hemagglutination-inhibiting (HI) antibodies for IIV3 were measured at the time of vaccination and 1 month after vaccination. Adverse events were recorded prospectively in a clinical diary during a 7-day period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza vaccination with PPV23 | Active comparator | Biological: Influenza vaccination with PPV23concomitant vaccination with trivalent inactivated influenza vaccine and 23-valent polysaccharide pneumococcal vaccine |
| Influenza vaccination with PCV13 | Active comparator | Biological: Influenza vaccination with PCV13concomitant vaccination with trivalent inactivated influenza vaccine and 13-valent pneumococcal conjugate vaccine |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Adults aged ≥65 years who signed the informed consent
Key exclusion criteria (9 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 |
|---|---|---|
| Influenza vaccination with PPV23GCflu and Pneumovax-23 | Biological | Influenza vaccination with PPV23 |
| Influenza vaccination with PCV13GCflu and Prevenar-13 | Biological | Influenza vaccination with PCV13 |
Primary outcome
Seroconversion rates (A/H1N1, A/H3N2, and B)
Time frame: Change from baseline titer at 4 weeks
Seroconversion: 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 (A/H1N1, A/H3N2, and B)
Time frame: Change from baseline titer at 4 weeks
GMT folds (A/H1N1, A/H3N2, and B)
Time frame: Change from baseline titer at 4 weeks
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 21 Oct 2015.
Related trials for Influenza, Human
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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
2 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 Influenza vaccination with PPV23 and Influenza vaccination with PCV13 in people with Influenza, Human and Pneumococcal Infections, run by Korea University Guro Hospital at 2 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 9 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 21 Oct 2015. 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 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: Change from baseline titer at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2015.