Study Summary
This trial will have two substudies - Substudy A and Substudy B. Substudy A will look at the safety and immunogenicity of different influenza vaccines in people aged 65-85, while Substudy B will look at different vaccination schedules in people aged 65-85.
Treatment Effectiveness
Phase-Based Effectiveness
Phase 1 & 2
Study Objectives
28 Primary · 35 Secondary · Reporting Duration: Prior to Vaccination 2 (if applicable), and at 1-, 4-, and 8-weeks after the last vaccination
Week 1
Percentage of participants with abnormal hematology and chemistry laboratory values
Percentage of participants with new ECG abnormalities
SSA: Percentage of participants with abnormal hematology and chemistry laboratory values
SSA: Percentage of participants with new ECG abnormalities
Day 2
Percentage of participants with new electrocardiogram (ECG) abnormalities
SSA: Percentage of participants with new electrocardiogram (ECG) abnormalities
Day 2
SSB: Percentage of participants with abnormal troponin I laboratory values
SSB: Percentage of participants with abnormal troponin I laboratory values (18 to 64 and 65 to 85 years of age)
SSB: Percentage of participants with new ECG abnormalities
SSB: Percentage of participants with new ECG abnormalities (18 to 64 and 65 to 85 years of age)
At 1-, 4-, and 8-weeks after Vaccination 1
Geometric mean fold rise (GMFR) in HAI titers from before vaccination to each subsequent timepoint
In participants who receive either qIRV or QIV at Vaccination 1, the proportion of participants achieving HAI seroconversion for all strains
Proportion of participants achieving HAI seroconversion for each strain
SSA: Geometric mean fold rise (GMFR) in HAI titers from before vaccination to each subsequent timepoint
SSA: In participants who receive either qIRV or QIV at Vaccination 1, the proportion of participants achieving HAI seroconversion for all strains
SSA: Proportion of participants achieving HAI seroconversion for each strain
At 1-, 4-, and 8-weeks after vaccination
In qIRV and QIV recipients, the proportion of participants achieving HAI seroconversion for all strains
Week 4
SSA: The difference in percentage of participants achieving HAI seroconversion for each strain in qIRV recipients compared to licensed QIV recipients
The difference in percentage of participants achieving HAI seroconversion for each strain in qIRV recipients compared to licensed QIV recipients
Week 4
SSA: The geometric mean ratio (GMR) of the geometric mean of HAI titers from participants receiving qIRV to the geometric mean of HAI titers from participants receiving QIV
The geometric mean ratio (GMR) of the geometric mean of HAI titers from participants receiving qIRV to the geometric mean of HAI titers from participants receiving QIV
At Baseline, and 1-, 4- and 8-weeks after Vaccination 1
Hemagglutination Inhibition Tests
SSA: Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers
At Baseline, and 1-, 4-, and 8-weeks after Vaccination 1
In participants who receive either qIRV or QIV at Vaccination 1, the proportion of participants with HAI titer >=1:40 for all strains
Proportion of participants with HAI titer >=1:40 for each strain
SSA: In participants who receive either qIRV or QIV at Vaccination 1, the proportion of participants with HAI titer >=1:40 for all strains
SSA: Proportion of participants with HAI titer >=1:40 for each strain
At Baseline, and 1-, 4-, and 8-weeks after vaccination
In qIRV and QIV recipients, the proportion of participants with HAI titer >=1:40 for all strains
At Baseline, prior to Vaccination 2 (if applicable), and 1-, 4- and 8-weeks after the last vaccination
SSB: GMTs of HAI titers
Hemagglutination Inhibition Tests
At Baseline, prior to Vaccination 2 (if applicable), and 1-, 4-, and 8-weeks after the last vaccination
SSB: In participants who receive either qIRV or QIV at Vaccination 1, the proportion of participants with HAI titer >=1:40 for all strains (65-85 years of age)
SSB: Proportion of participants with HAI titer >=1:40 for each strain
SSB: Proportion of participants with HAI titer >=1:40 for each strain (65-85 years of age)
At Baseline, prior to Vaccination and 1-, 4- and 8-weeks after vaccination
SSB: GMTs of HAI titers (18-64 years of age)
At Baseline, prior to Vaccination, and 1-, 4-, and 8-weeks after vaccination
SSB: In participants who receive either qIRV or QIV at Vaccination 1, the proportion of participants with HAI titer >=1:40 for all strains (18-64 years of age)
SSB: Proportion of participants with HAI titer >=1:40 for each strain (18-64 years of age)
Week 1
Percentage of participants with grading shifts in hematology and chemistry laboratory assessments
SSA: Percentage of participants with grading shifts in hematology and chemistry laboratory assessments
Day 7
Percentage of participants reporting local reactions
Percentage of participants reporting systemic events
SSA: Percentage of participants reporting local reactions
SSA: Percentage of participants reporting systemic events
Day 7
SSB: Percentage of participants reporting local reactions
SSB: Percentage of participants reporting local reactions (18 to 64 and 65 to 85 years of age)
SSB: Percentage of participants reporting systemic events
SSB: Percentage of participants reporting systemic events (18 to 64 and 65 to 85 years of age)
Week 4
SSB: Percentage of participants reporting adverse events
SSB: Percentage of participants reporting adverse events (18 to 64 and 65 to 85 years of age)
Month 6
SSB: Percentage of participants reporting serious adverse events
SSB: Percentage of participants reporting serious adverse events (18 to 64 and 65 to 85 years of age)
Week 4
Percentage of participants reporting adverse events
SSA: Percentage of participants reporting adverse events
Month 6
Percentage of participants reporting serious adverse events
SSA: Percentage of participants reporting serious adverse events
Prior to Vaccination 2 (if applicable), and at 1-, 4-, and 8-weeks after the last vaccination
Hemagglutination Inhibition Tests
SSB: GMFR in HAI titers from before vaccination to each subsequent timepoint (65-85 years of age)
SSB: In participants who receive either qIRV or QIV, the proportion of participants achieving HAI seroconversion for all strains
SSB: In participants who receive either qIRV or QIV, the proportion of participants achieving HAI seroconversion for all strains (65-85 years of age)
SSB: Proportion of participants achieving HAI seroconversion for each strain
Hemagglutination Inhibition Tests
Prior to Vaccination, and at 1-, 4-, and 8-weeks after vaccination
SSB: GMFR in HAI titers from before vaccination to each subsequent timepoint (18-64years of age)
SSB: In participants who receive either qIRV or QIV, the proportion of participants achieving HAI seroconversion for all strains (18-64 years of age)
SSB: Proportion of participants achieving HAI seroconversion for each strain (18-64 years of age)
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
57 Treatment Groups
QIV
1 of 57
SSB: QIV + bIRV AA (dose level combination 2), 1-visit schedule
1 of 57
mIRV B strain (15ug dose) + QIV
1 of 57
mIRV B strain (30ug dose) + QIV
1 of 57
SSB: qIRV (dose level 1), 1-visit schedule
1 of 57
SSB: QIV + bIRV AA (dose level combination 2), 2-visit schedule
1 of 57
SSA: mIRV A (dose level 2) + QIV
1 of 57
SSA: mIRV B (dose level 3) + QIV
1 of 57
SSA: bIRV AB (dose level combination 2) + QIV
1 of 57
SSA: bIRV AB (dose level combination 3) + QIV
1 of 57
SSB: 2 doses of qIRV (dose level 1), 2-visit schedule
1 of 57
SSB: 2 doses of QIV, 2-visit schedule
1 of 57
SSB: qIRV (dose level 2), 1-visit schedule
1 of 57
SSA: QIV + mIRV A strain (dose level 4)
1 of 57
SSA: mIRV B (dose level 1) + QIV
1 of 57
mIRV A strain, 3.75 micrograms (ug) dose
1 of 57
mIRV A strain, 7.5ug dose
1 of 57
mIRV B strain, 7.5ug dose
1 of 57
mIRV B strain, 30ug dose
1 of 57
qIRV
1 of 57
mIRV A strain, 15ug dose
1 of 57
mIRV B strain, 15ug dose
1 of 57
mIRV B strain, 3.75ug dose
1 of 57
bIRV 15ug + 15ug dose
1 of 57
bIRV 7.5ug + 15ug dose
1 of 57
bIRV 3.75ug + 15ug dose
1 of 57
mIRV A strain, 30ug dose
1 of 57
SSA: mIRV A (dose level 1) + QIV
1 of 57
SSA: mIRV A (dose level 3) + QIV
1 of 57
SSA: qIRV (dose level 1) + QIV
1 of 57
SSA: QIV + mIRV B strain (dose level 4)
1 of 57
SSA: mIRV B (dose level 4) + QIV
1 of 57
SSA: mIRV B (dose level 2) + QIV
1 of 57
SSA: mIRV A (dose level 4) + QIV
1 of 57
SSA: bIRV AB (dose level combination 1) + QIV
1 of 57
SSA: bIRV AB (dose level combination 4) + QIV
1 of 57
SSB: QIV + bIRV AA (dose level combination 1), 2-visit schedule
1 of 57
SSB: qIRV (dose level 3), 1-visit schedule
1 of 57
SSB: QIV + bIRV AA (dose level combination 1), 1-visit schedule
1 of 57
SSB: qIRV (dose level 2, dose combination 1), 1-visit schedule
1 of 57
SSB: qIRV (dose level 2, dose combination 2), 1-visit schedule
1 of 57
SSB: bIRV AA + bIRV BB (both dose level combination 1), 1-visit schedule
1 of 57
SSB: 1 dose of QIV, 1-visit schedule
1 of 57
bIRV 7.5ug + 7.5ug dose
1 of 57
mIRV A strain (3.75 micrograms (ug) dose) + QIV
1 of 57
mIRV B strain (7.5ug dose) + QIV
1 of 57
mIRV A strain (30ug dose) + QIV
1 of 57
mIRV A strain (15ug dose) + QIV
1 of 57
bIRV (3.75ug + 15ug dose) + QIV
1 of 57
QIV + mIRV A Strain (30ug dose)
1 of 57
mIRV A strain (7.5ug dose) + QIV
1 of 57
bIRV (15ug + 15ug dose) + QIV
1 of 57
qIRV + QIV
1 of 57
bIRV (7.5ug + 7.5ug dose) + QIV
1 of 57
mIRV B strain (3.75ug dose) + QIV
1 of 57
bIRV (7.5ug + 15ug dose) + QIV
1 of 57
QIV + mIRV B Strain (30ug dose)
1 of 57
Active Control
Experimental Treatment
1168 Total Participants · 57 Treatment Groups
Primary Treatment: qIRV · No Placebo Group · Phase 1 & 2
SSB: QIV + bIRV AA (dose level combination 2), 1-visit scheduleExperimental Group · 2 Interventions: bIRV AA, QIV · Intervention Types: Biological, Biological
mIRV B strain (15ug dose) + QIVExperimental Group · 2 Interventions: mIRV, QIV · Intervention Types: Biological, Biological
mIRV B strain (30ug dose) + QIVExperimental Group · 2 Interventions: mIRV, QIV · Intervention Types: Biological, Biological
SSB: qIRV (dose level 1), 1-visit schedule
Biological
Experimental Group · 1 Intervention: qIRV · Intervention Types: BiologicalSSB: QIV + bIRV AA (dose level combination 2), 2-visit scheduleExperimental Group · 2 Interventions: bIRV AA, QIV · Intervention Types: Biological, Biological
SSA: mIRV A (dose level 2) + QIVExperimental Group · 2 Interventions: mIRV, QIV · Intervention Types: Biological, Biological
SSA: mIRV B (dose level 3) + QIVExperimental Group · 2 Interventions: mIRV, QIV · Intervention Types: Biological, Biological
SSA: bIRV AB (dose level combination 2) + QIVExperimental Group · 2 Interventions: bIRV AB, QIV · Intervention Types: Biological, Biological
SSA: bIRV AB (dose level combination 3) + QIVExperimental Group · 2 Interventions: bIRV AB, QIV · Intervention Types: Biological, Biological
SSB: 2 doses of qIRV (dose level 1), 2-visit schedule
Biological
Experimental Group · 1 Intervention: qIRV · Intervention Types: BiologicalSSB: 2 doses of QIV, 2-visit schedule
Biological
Experimental Group · 1 Intervention: QIV · Intervention Types: BiologicalSSB: qIRV (dose level 2), 1-visit schedule
Biological
Experimental Group · 1 Intervention: qIRV · Intervention Types: BiologicalSSA: QIV + mIRV A strain (dose level 4)Experimental Group · 2 Interventions: mIRV, QIV · Intervention Types: Biological, Biological
SSA: mIRV B (dose level 1) + QIVExperimental Group · 2 Interventions: mIRV, QIV · Intervention Types: Biological, Biological
mIRV A strain, 3.75 micrograms (ug) dose
Biological
Experimental Group · 1 Intervention: mIRV · Intervention Types: BiologicalmIRV A strain, 7.5ug dose
Biological
Experimental Group · 1 Intervention: mIRV · Intervention Types: BiologicalmIRV B strain, 7.5ug dose
Biological
Experimental Group · 1 Intervention: mIRV · Intervention Types: BiologicalmIRV B strain, 30ug dose
Biological
Experimental Group · 1 Intervention: mIRV · Intervention Types: BiologicalqIRV
Biological
Experimental Group · 1 Intervention: qIRV · Intervention Types: BiologicalmIRV A strain, 15ug dose
Biological
Experimental Group · 1 Intervention: mIRV · Intervention Types: BiologicalmIRV B strain, 15ug dose
Biological
Experimental Group · 1 Intervention: mIRV · Intervention Types: BiologicalmIRV B strain, 3.75ug dose
Biological
Experimental Group · 1 Intervention: mIRV · Intervention Types: BiologicalbIRV 15ug + 15ug dose
Biological
Experimental Group · 1 Intervention: bIRV · Intervention Types: BiologicalbIRV 7.5ug + 15ug dose
Biological
Experimental Group · 1 Intervention: bIRV · Intervention Types: BiologicalbIRV 3.75ug + 15ug dose
Biological
Experimental Group · 1 Intervention: bIRV · Intervention Types: BiologicalmIRV A strain, 30ug dose
Biological
Experimental Group · 1 Intervention: mIRV · Intervention Types: BiologicalSSA: mIRV A (dose level 1) + QIVExperimental Group · 2 Interventions: mIRV, QIV · Intervention Types: Biological, Biological
SSA: mIRV A (dose level 3) + QIVExperimental Group · 2 Interventions: mIRV, QIV · Intervention Types: Biological, Biological
SSA: qIRV (dose level 1) + QIVExperimental Group · 2 Interventions: qIRV, QIV · Intervention Types: Biological, Biological
SSA: QIV + mIRV B strain (dose level 4)Experimental Group · 2 Interventions: mIRV, QIV · Intervention Types: Biological, Biological
SSA: mIRV B (dose level 4) + QIVExperimental Group · 2 Interventions: mIRV, QIV · Intervention Types: Biological, Biological
SSA: mIRV B (dose level 2) + QIVExperimental Group · 2 Interventions: mIRV, QIV · Intervention Types: Biological, Biological
SSA: mIRV A (dose level 4) + QIVExperimental Group · 2 Interventions: mIRV, QIV · Intervention Types: Biological, Biological
SSA: bIRV AB (dose level combination 1) + QIVExperimental Group · 2 Interventions: bIRV AB, QIV · Intervention Types: Biological, Biological
SSA: bIRV AB (dose level combination 4) + QIVExperimental Group · 2 Interventions: bIRV AB, QIV · Intervention Types: Biological, Biological
SSB: QIV + bIRV AA (dose level combination 1), 2-visit scheduleExperimental Group · 2 Interventions: bIRV AA, QIV · Intervention Types: Biological, Biological
SSB: qIRV (dose level 3), 1-visit schedule
Biological
Experimental Group · 1 Intervention: qIRV · Intervention Types: BiologicalSSB: QIV + bIRV AA (dose level combination 1), 1-visit scheduleExperimental Group · 2 Interventions: bIRV AA, QIV · Intervention Types: Biological, Biological
SSB: qIRV (dose level 2, dose combination 1), 1-visit schedule
Biological
Experimental Group · 1 Intervention: qIRV · Intervention Types: BiologicalSSB: qIRV (dose level 2, dose combination 2), 1-visit schedule
Biological
Experimental Group · 1 Intervention: qIRV · Intervention Types: BiologicalSSB: bIRV AA + bIRV BB (both dose level combination 1), 1-visit scheduleExperimental Group · 2 Interventions: bIRV AA, bIRV BB · Intervention Types: Biological, Biological
SSB: 1 dose of QIV, 1-visit schedule
Biological
Experimental Group · 1 Intervention: QIV · Intervention Types: BiologicalbIRV 7.5ug + 7.5ug dose
Biological
Experimental Group · 1 Intervention: bIRV · Intervention Types: BiologicalmIRV A strain (3.75 micrograms (ug) dose) + QIVExperimental Group · 2 Interventions: mIRV, QIV · Intervention Types: Biological, Biological
mIRV B strain (7.5ug dose) + QIVExperimental Group · 2 Interventions: mIRV, QIV · Intervention Types: Biological, Biological
mIRV A strain (30ug dose) + QIVExperimental Group · 2 Interventions: mIRV, QIV · Intervention Types: Biological, Biological
mIRV A strain (15ug dose) + QIVExperimental Group · 2 Interventions: mIRV, QIV · Intervention Types: Biological, Biological
bIRV (3.75ug + 15ug dose) + QIVExperimental Group · 2 Interventions: bIRV, QIV · Intervention Types: Biological, Biological
QIV + mIRV A Strain (30ug dose)Experimental Group · 2 Interventions: mIRV, QIV · Intervention Types: Biological, Biological
mIRV A strain (7.5ug dose) + QIVExperimental Group · 2 Interventions: mIRV, QIV · Intervention Types: Biological, Biological
bIRV (15ug + 15ug dose) + QIVExperimental Group · 2 Interventions: bIRV, QIV · Intervention Types: Biological, Biological
qIRV + QIVExperimental Group · 2 Interventions: qIRV, QIV · Intervention Types: Biological, Biological
bIRV (7.5ug + 7.5ug dose) + QIVExperimental Group · 2 Interventions: bIRV, QIV · Intervention Types: Biological, Biological
mIRV B strain (3.75ug dose) + QIVExperimental Group · 2 Interventions: mIRV, QIV · Intervention Types: Biological, Biological
bIRV (7.5ug + 15ug dose) + QIVExperimental Group · 2 Interventions: bIRV, QIV · Intervention Types: Biological, Biological
QIV + mIRV B Strain (30ug dose)Experimental Group · 2 Interventions: mIRV, QIV · Intervention Types: Biological, Biological
QIV
Biological
ActiveComparator Group · 1 Intervention: QIV · Intervention Types: BiologicalTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
bIRV AB
2021
Completed Phase 2
~1170
qIRV
2021
Completed Phase 2
~1170
mIRV
2021
Completed Phase 2
~1170
bIRV
2021
Completed Phase 2
~1170
bIRV AA
2021
Completed Phase 2
~1170
bIRV BB
2021
Completed Phase 2
~1170
QIV
2018
Completed Phase 3
~2370
Trial Logistics
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: prior to vaccination 2 (if applicable), and at 1-, 4-, and 8-weeks after the last vaccination
Who is running the clinical trial?
PfizerLead Sponsor
4,402 Previous Clinical Trials
25,774,256 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,343 Previous Clinical Trials
23,426,499 Total Patients Enrolled
Eligibility Criteria
Age 18 - 85 · All Participants · 0 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Texas | 50.0% |
| Arizona | 33.3% |
| District of Columbia | 16.7% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| DM Clinical Research | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 40.0% |
| Did not meet criteria | 60.0% |
Frequently Asked Questions
Is it possible to sign up for this trial currently?
"Yes, this is an active trial according to the information available on clinicaltrials.gov. The listing says that the study was first posted on 9/13/2021 and last updated on 10/18/2022. They are looking for a total of 1980 patients at 100 different sites." - Anonymous Online Contributor
Unverified Answer
How can I sign up to be a test subject for this research?
"This trial is looking for 1980 participants aged 18 to 85 who have influenza. Additionally, patients must meet the following criteria: Substudy A – Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures., Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study., Capable of giving signed informed consent., Male or female participants 65 to 85 years of age., Male participant who is able to father children and willing to use an acceptable method of contraception; or female participant not" - Anonymous Online Contributor
Unverified Answer
What difference do researchers expect this study will make?
"The purpose of this clinical trial is to assess the percentage of participants reporting systemic events (between the ages of 18 and 64, as well as 65 and 85) over a one-week period after receiving vaccination. Additionally, secondary outcomes being monitored include geometric mean titers (GMTs) of hemagglutination inhibition (HAI) – which will be measured at central laboratories – for participants aged 65 to 85, as well as the proportion of participants in this age group who achieve HAI seroconversion for each strain." - Anonymous Online Contributor
Unverified Answer
Does this study allow elderly patients to participate?
"According to the inclusion criteria found on this clinical trial's website, patients must be aged 18 to 85. There are currently 39 trials ongoing for individuals who are under 18 and 76 studies for people over the age of 65." - Anonymous Online Contributor
Unverified Answer
How many test subjects are in this clinical trial?
"To successfully complete this clinical trial, 1980 eligible individuals are required to participate. Patients can choose to partake in this study at different sites such as Invesclinic US LLC located in Davie, Florida and Meridian Clinical Research LLC based in Omaha, Nebraska." - Anonymous Online Contributor
Unverified Answer
Are there any other research facilities besides those in North America conducting this experiment?
"100 different research facilities are conducting this study, like Invesclinic US LLC in Davie, Meridian Clinical Research LLC in Omaha, Progressive Medical Research in Port Orange, and many others." - Anonymous Online Contributor
Unverified Answer