HealthyPhase 1NCT05788237

A Study to Examine Respiratory Combination Vaccines Against Respiratory Syncytial Virus (RSV) and Flu in Older Adults

A Phase 1 study testing RSVpreF+qIRV, qIRV and RSVpreF in people with Healthy, run by Pfizer at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Substudy A: The study aims to learn about the safety and effects of two new vaccines for RSV (RSVpreF) and influenza (modRNA qIRV) when given as a single shot compared to when given separately. RSV and influenza lead to infections, mainly in the fall and winter. Read more about this study

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: RSVpreF+qIRV, qIRV and RSVpreF
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 508 participants
Where: 1 siteArgentina
Study dates: 9 Mar 2023to 27 Sep 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Participants ≥60 years of age at study enrollment.
Participants who are willing and able to comply with all scheduled visits, investigational 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 and having signed the informed consent as described in the protocol, which includes complying with the requirements and restrictions listed in the ICD and in this protocol.
Receipt of licensed influenza vaccination for the 2022-2023 northern hemisphere season or 2022 southern hemisphere season >120 days before study intervention administration.
Participants ≥50 years of age at study enrollment.

Show all 10Show fewer

Participants who are willing and able to comply with all scheduled visits, investigational 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 and having signed the informed consent as described in the protocol, which includes complying with the requirements and restrictions listed in the ICD and in this protocol.
Receipt of licensed influenza vaccination for the 2022-2023 northern hemisphere season or 2022 southern hemisphere season >180 days before study intervention administration.

Who cannot join

A confirmed diagnosis of RSV infection or influenza ≤120 days before study intervention administration.
History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate IM injection.
Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

Show all 27Show fewer

Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study intervention administration, or planned receipt throughout the study.
Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration, or planned receipt throughout the study.
Receipt of any licensed RSV vaccine at any time prior to enrollment, or planned receipt throughout the study.
Receipt of any licensed influenza vaccine ≤120 days before study enrollment, or planned receipt throughout the study.
Participation in other studies involving an investigational RSV or mRNA influenza vaccine at any time prior to enrollment, and thereafter until study completion, regardless of vaccine assignment.
Participation in any other interventional studies within 28 days before study enrollment through study completion.
Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
Substudy B
A confirmed diagnosis of RSV infection or influenza ≤120 days before study intervention administration.
History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate IM injection.
Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study intervention administration, or planned receipt throughout the study.
Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration, or planned receipt throughout the study.
Receipt of any RSV vaccine at any time prior to enrollment, or planned receipt throughout the study.
Receipt of any influenza vaccine ≤180 days before study enrollment, or planned receipt throughout the study.
Participation in other studies involving an investigational RSV vaccine or mRNA influenza vaccine at any time prior to enrollment, and thereafter until study completion, regardless of vaccine assignment.
Participation in any other interventional studies within 28 days before study enrollment through study completion. Participation in purely observational studies is acceptable.
Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Trial locations and contacts

1 site in 1 country.

Argentina1 site

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Buenos Aires, 1426

Other trials in Argentina

About this study

Official title: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Respiratory Combination Vaccine Candidates in Older Adults

This study is seeking participants who:

are 60 years or older
are healthy or have well-controlled chronic conditions
have not had a flu shot in the last 120 days
and agree to be present for all study visits, procedures, and blood draws.

The participants will be divided into 2 groups. Group 1 will receive RSVpreF plus qIRV combo shot, after which participants will receive the placebo (a shot which has no medicine). Group 2 will receive shots for qIRV first and then RSVpreF 1 month apart.

The investigators will examine the experiences of the participants receiving the study vaccines. This will help the investigators determine if the study vaccines are safe and produce a similar immune response.

Participants will be involved in this study for 2 months. During this time, participants will have 3 visits at the study clinic.

Substudy B will investigate 2 formulations of RSVpreF + qIRV of different volumes and osmolaities (concentrations). These formulations will be examined for safety, tolerability, and immunogenicity, with the goal of selecting a formulation for further study.

This study is seeking participants who:

are 50 years or older
are healthy or have well-controlled chronic conditions
have not had a flu shot in the last 180 days
and agree to be present for all study visits, procedures, and blood draws.

The participants will be divided into 2 groups. Group 1 will receive RSVpreF plus qIRV in a 1.0-mL formulation while Group 2 will receive RSVpreF plus qIRV in a 0.5-mL formulation.

The investigators will examine the experiences of the participants receiving the study vaccines. This will help the investigators determine if the study vaccines are safe, well tolerated and produce a similar immune response.

Participants will be involved in this study for 1 month. During this time, participants will have 2 visits at the study clinic.

Read the detailed description

Substudy A: This study is designed to evaluate the safety, tolerability, and immunogenicity of respiratory combination vaccine candidates. This initial study will be conducted as a Phase 1b, parallel-group, randomized, placebo-controlled, observer-blinded substudy of RSVpreF and a nucleoside-modified RNA vaccine (qIRV) against RSV and influenza when administered as a combined vaccine and when administered alone.

Healthy adults ≥60 years of age will be randomized 1:1 to either Group 1: combination (RSVpreF + qIRV) followed by placebo; or Group 2: sequential administration of qIRV followed by RSVpreF administered 1 month apart.

Substudy B will be conducted as a Phase 1b, parallel-group, randomized, observer-blinded substudy of RSVpreF and a nucleoside-modified RNA vaccine (qIRV) against RSV and influenza administered as a combined vaccine in a 1.0-mL formulation and when administered in a 0.5-mL formulation.

Healthy adults ≥50 years of age will be randomized 1:1 to either Group 1: combination (RSVpreF + qIRV) 1.0-mL formulation; or Group 2: combination (RSVpreF + qIRV) 0.5 mL formulation. Approximately 100 participants will be randomized within the 50- through 64-year-old group, and 100 participants ≥65 years of age will be randomized.

Conditions: Healthy
Being tested: RSVpreF+qIRV, qIRV, RSVpreF, Placebo, RSVpreF + qIRV 1.0 mL formulation
Keywords: Flu, Influenza, Vaccine, RNA vaccine, RSV, Respiratory Syncytial Virus, Combination vaccine, Vaccine osmolality
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RSVpreF+qIRVBiological
RSVpreF containing 2 stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B combined with Quadrivalent influenza modRNA vaccine (qIRV) encoding HA of 4 strains as recommended for the influenza season (2 A strains, 2 B strains)
qIRVBiological
Also called PF-07252220
Quadrivalent influenza modRNA vaccine (qIRV) encoding HA of 4 strains as recommended for the influenza season (2 A strains, 2 B strains)
RSVpreFBiological
Also called PF-06928316
RSVpreF containing 2 stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B
PlaceboDrug
0.9% saline for injection
RSVpreF + qIRV 1.0 mL formulationBiological
Also called PF-07941314
RSVpreF containing 2 Stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B plus qIRV Encoding HA of 4 strains as recommended for the influenza season (2 A strains and 2 B strains) plus sterile water as diluent for injection
RSVpreF + qIRV 0.5 mL formulationBiological
Also called PF-07941314
RSVpreF containing 2 Stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B plus qIRV Encoding HA of 4 strains as recommended for the influenza season (2 A strains and 2 B strains)

Study groups in NCT05788237
Study group	Role	What they receive
SSA Group 1: Combination	Experimental	Combination (RSVpreF + qIRV) (Visit 1) followed by placebo (Visit 2). RSVpreF and qIRV are administered as concomitantly but as individual injections. Receives: Biological: RSVpreF+qIRV; Drug: Placebo
SSA Group 2: Sequential	Experimental	Sequential administration of qIRV (Visit 1) followed by RSVpreF (Visit 2) Receives: Biological: qIRV; Biological: RSVpreF
SSB Group 1: Combination (RSVpreF + qIRV) 1.0-mL formulation	Experimental	RSVpreF lyophilized cake reconstituted with water for injection and mixed with qIRV, yielding an injection volume of 1.0 mL Receives: Biological: RSVpreF + qIRV 1.0 mL formulation
SSB Group 2: Combination (RSVpreF +qIRV) 0.5-mL formulation	Experimental	RSVpreF lyophilized cake reconstituted with qIRV to yield an injection volume of 0.5 mL Receives: Biological: RSVpreF + qIRV 1.0 mL formulation; Biological: RSVpreF + qIRV 0.5 mL formulation

What is being measured

The primary outcome is the main question the study is designed to answer.

SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Local reactions included pain, redness and swelling at the injection site, recorded by participants in an electronic diary (e-diary). Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as mild: 2.5 cm to 5.0 cm; moderate: greater than (>) 5.0 cm to 10.0 cm; severe: > 10 cm.
Measured: SSA: From Day 1 to Day 7 after Vaccination 1
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Local reactions included pain, redness and swelling at the injection site, recorded by participants in an e-diary. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild: 2.5 cm to 5.0 cm; moderate: > 5.0 cm to 10.0 cm; severe: > 10 cm.
Measured: SSA: From Day 1 to Day 7 after Vaccination 2 (1 Month After Vaccination 1)
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Local reactions included pain, redness and swelling at the injection site, recorded by participants in an e-diary. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild: 2.5 cm to 5.0 cm; moderate: > 5.0 cm to 10.0 cm; severe: > 10 cm.
Measured: SSB: From Day 1 to Day 7 after Vaccination
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, chills, new/worsened muscle pain and new/worsened joint pain. These were recorded by participants in an e-diary. Fever defined as oral temperature >=38.0 degrees Celsius (deg C) and categorized as mild: >=38.0 to 38.4 deg C, moderate: >38.4 to 38.9 deg C, severe: >38.9 to 40.0 deg C. Vomiting categorized as mild: 1-2 times in 24 hours (h); moderate: >2 times in 24h; severe: required intravenous (IV) hydration. Diarrhea categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h; severe: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity; severe: prevented daily routine activity.
Measured: SSA: From Day 1 to Day 7 after Vaccination 1
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, chills, new/worsened muscle pain and new/worsened joint pain. These were recorded by participants in an e-diary. Fever defined as oral temperature >=38.0 deg C and categorized as mild: >=38.0 to 38.4 deg C, moderate: >38.4 to 38.9 deg C, severe: >38.9 to 40.0 deg C. Vomiting categorized as mild: 1-2 times in 24h; moderate: >2 times in 24h; severe: required IV hydration. Diarrhea categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h; severe: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity; severe: prevented daily routine activity.
Measured: SSA: From Day 1 to Day 7 after Vaccination 2 (1 Month after Vaccination 1)
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, chills, new/worsened muscle pain and new/worsened joint pain. These were recorded by participants in an e-diary. Fever defined as oral temperature >=38.0 deg C and categorized as mild: >=38.0 to 38.4 deg C, moderate: >38.4 to 38.9 deg C, severe: >38.9 to 40.0 deg C. Vomiting categorized as mild: 1-2 times in 24h; moderate: >2 times in 24h; severe: required IV hydration. Diarrhea categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h; severe: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity; severe: prevented daily routine activity.
Measured: SSB: From Day 1 to Day 7 After Vaccination
SSA: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 1
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included.
Measured: SSA: Within 1 Month after Vaccination 1
SSA: Percentage of Participants Reporting AEs Within 1 Month After Vaccination 2
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included.
Measured: SSA: Within 1 Month after Vaccination 2
SSB: Percentage of Participants Reporting AEs Throughout the Sub Study
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included.
Measured: SSB: From Day 1 of Vaccination up to 35 days of follow-up post Vaccination
SSA: Percentage of Participants Reporting Serious Adverse Events (SAEs) Throughout the Sub Study
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event.
Measured: SSA: From Day 1 (Vaccination 1) up to 35 days of follow-up post Vaccination 2 (Maximum up to 70 days)
SSB: Percentage of Participants Reporting SAEs Throughout the Sub Study
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event.
Measured: SSB: From Day 1 of Vaccination up to 35 days of follow-up post Vaccination (Maximum up to 36 days)
SSA: Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Neutralizing Titers (NT) for Each RSV Subgroup (A or B) 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and RSVpreF Alone (Group 2)
GMTs and associated 2-sided 95% CIs are reported as descriptive data. GMRs and associated 2-sided 95% CIs are reported in statistical analysis section of this outcome measure. GMR was the ratio of RSV subgroup A (RSV A) or RSV subgroup B (RSV B) neutralizing GMTs in the combination RSVpreF + qIRV group to that in the sequential-administration RSVpreF group.
Measured: SSA- For Group 1: 1 Month after Vaccination 1 (Day 1); For Group 2: 1 Month after Vaccination 2 (1 Month after Vaccination 1)
SSA: GMT and GMR of Strain-Specific Hemagglutination Inhibition (HAI) Titers For 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and qIRV Alone (Group 2)
GMTs and associated 2-sided 95% CIs are reported as descriptive data. GMRs and associated 2-sided 95% CIs are reported in statistical analysis section of this outcome measure. GMR was the ratio of each strain neutralizing GMTs in the combination RSVpreF + qIRV group to that in the sequential-administration RSVpreF group. The analysis was performed on the influenza strains: H1N1 A/Sydney, H3N2 A/Darwin, B/Austria, and B/Phuket.
Measured: SSA- For Group 1: 1 Month after Vaccination 1 (Day 1); For Group 2: 1 Month after Vaccination 2 (1 Month after Vaccination 1)

Secondary outcomes (2)

SSB: GMT and GMR of NT for Each RSV A or RSV B 1 Month After Vaccination
GMTs and associated 2-sided 95% CIs are reported as descriptive data. GMRs and associated 2-sided 95% CIs are reported in statistical analysis section of this outcome measure. GMR was the ratio of RSV A or RSV B neutralizing GMTs in the combination of 1 mL RSVpreF + qIRV (group 1) and 0.5 ml of RSVpreF + qIRV (group 2)
Measured: SSB: At 1 Month after Vaccination (Day 1)
SSB: GMTs of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After Vaccination
GMTs and associated 2-sided 95% CIs are reported as descriptive data. GMRs and associated 2-sided 95% CIs are reported in statistical analysis section of this outcome measure. GMR was the ratio of each strain neutralizing GMTs to the combination of 1 mL RSVpreF + qIRV (Group 1) and 0.5 ml of RSVpreF + qIRV (Group 2). The analysis was performed on the influenza strains: H1N1 A/Sydney, H3N2 A/Darwin, B/Austria, and B/Phuket.
Measured: SSB: At 1 Month after Vaccination (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Mar 202327 Sep 2023

First posted28 Mar 2023
Study start9 Mar 2023
Primary completion27 Sep 2023
Study completion27 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by PfizerThe 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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Substudy A: Approximately 250 healthy adults ≥60 years of age will be randomized 1:1 to either Group 1: combination (RSVpreF + qIRV) (Visit 1) followed by placebo (Visit 2); or Group 2: sequential administration of qIRV (Visit 1) followed by RSVpreF (Visit 2) administered 1 month apart. Randomization will be stratified by 3 age groups (60-64, 65-79, and ≥80 years) within each study site. Substudy B: Approximately 200 healthy adults ≥50 years of age will be randomized 1:1 to either Group 1: combination (RSVpreF + qIRV) 1.0-mL formulation; or Group 2: combination (RSVpreF + qIRV) 0.5 mL formulation. Randomization will be stratified by 6 age/sex groups (female 50-64, female 65-79, and female ≥80 years; male 50-64, male 65-79, and male ≥80 years) within the study site.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 508 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05788237
Sponsor's protocol ID: C5401001
Status last verified: Sep 2024
First submitted: 3 Mar 2023
Last updated: 22 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Respiratory Combination Vaccine Candidates in Older Adults
ClinicalTrials.gov ID: NCT05788237
Acronym / sponsor ID: C5401001
Conditions: Healthy
Keywords: Flu, Influenza, Vaccine, RNA vaccine, RSV, Respiratory Syncytial Virus, Combination vaccine, Vaccine osmolality
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 508 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 9 Mar 2023 (actual)
Primary completion: 27 Sep 2023 (actual)
Study completion: 27 Sep 2023 (actual)
First posted: 28 Mar 2023 (actual)
Results: Posted 22 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is seeking participants who:

are 60 years or older
are healthy or have well-controlled chronic conditions
have not had a flu shot in the last 120 days
and agree to be present for all study visits, procedures, and blood draws.

Participants will be involved in this study for 2 months. During this time, participants will have 3 visits at the study clinic.

This study is seeking participants who:

are 50 years or older
are healthy or have well-controlled chronic conditions
have not had a flu shot in the last 180 days
and agree to be present for all study visits, procedures, and blood draws.

The participants will be divided into 2 groups. Group 1 will receive RSVpreF plus qIRV in a 1.0-mL formulation while Group 2 will receive RSVpreF plus qIRV in a 0.5-mL formulation.

Participants will be involved in this study for 1 month. During this time, participants will have 2 visits at the study clinic.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Substudy A: Approximately 250 healthy adults ≥60 years of age will be randomized 1:1 to either Group 1: combination (RSVpreF + qIRV) (Visit 1) followed by placebo (Visit 2); or Group 2: sequential administration of qIRV (Visit 1) followed by RSVpreF (Visit 2) administered 1 month apart. Randomization will be stratified by 3 age groups (60-64, 65-79, and ≥80 years) within each study site. Substudy B: Approximately 200 healthy adults ≥50 years of age will be randomized 1:1 to either Group 1: combination (RSVpreF + qIRV) 1.0-mL formulation; or Group 2: combination (RSVpreF + qIRV) 0.5 mL formulation. Randomization will be stratified by 6 age/sex groups (female 50-64, female 65-79, and female ≥80 years; male 50-64, male 65-79, and male ≥80 years) within the study site.

Arm	Type	Receives
SSA Group 1: Combination	Experimental	Biological: RSVpreF+qIRV, Drug: PlaceboCombination (RSVpreF + qIRV) (Visit 1) followed by placebo (Visit 2). RSVpreF and qIRV are administered as concomitantly but as individual injections.
SSA Group 2: Sequential	Experimental	Biological: qIRV, Biological: RSVpreFSequential administration of qIRV (Visit 1) followed by RSVpreF (Visit 2)
SSB Group 1: Combination (RSVpreF + qIRV) 1.0-mL formulation	Experimental	Biological: RSVpreF + qIRV 1.0 mL formulationRSVpreF lyophilized cake reconstituted with water for injection and mixed with qIRV, yielding an injection volume of 1.0 mL
SSB Group 2: Combination (RSVpreF +qIRV) 0.5-mL formulation	Experimental	Biological: RSVpreF + qIRV 1.0 mL formulation, Biological: RSVpreF + qIRV 0.5 mL formulationRSVpreF lyophilized cake reconstituted with qIRV to yield an injection volume of 0.5 mL

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Participants ≥60 years of age at study enrollment.
Participants who are willing and able to comply with all scheduled visits, investigational 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 and having signed the informed consent as described in the protocol, which includes complying with the requirements and restrictions listed in the ICD and in this protocol.
Receipt of licensed influenza vaccination for the 2022-2023 northern hemisphere season or 2022 southern hemisphere season >120 days before study intervention administration.

Key exclusion criteria (27 listed)

A confirmed diagnosis of RSV infection or influenza ≤120 days before study intervention administration.
History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate IM injection.
Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.

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
RSVpreF+qIRVRSVpreF containing 2 stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B combined with Quadrivalent influenza modRNA vaccine (qIRV) encoding HA of 4 strains as recommended for the influenza season (2 A strains, 2 B strains)	Biological	SSA Group 1: Combination
qIRVAlso: PF-07252220Quadrivalent influenza modRNA vaccine (qIRV) encoding HA of 4 strains as recommended for the influenza season (2 A strains, 2 B strains)	Biological	SSA Group 2: Sequential
RSVpreFAlso: PF-06928316RSVpreF containing 2 stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B	Biological	SSA Group 2: Sequential
Placebo0.9% saline for injection	Drug	SSA Group 1: Combination
RSVpreF + qIRV 1.0 mL formulationAlso: PF-07941314RSVpreF containing 2 Stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B plus qIRV Encoding HA of 4 strains as recommended for the influenza season (2 A strains and 2 B strains) plus sterile water as diluent for injection	Biological	SSB Group 1: Combination (RSVpreF + qIRV) 1.0-mL formulation, SSB Group 2: Combination (RSVpreF +qIRV) 0.5-mL formulation
RSVpreF + qIRV 0.5 mL formulationAlso: PF-07941314RSVpreF containing 2 Stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B plus qIRV Encoding HA of 4 strains as recommended for the influenza season (2 A strains and 2 B strains)	Biological	SSB Group 2: Combination (RSVpreF +qIRV) 0.5-mL formulation

Primary outcome

SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Time frame: SSA: From Day 1 to Day 7 after Vaccination 1
Local reactions included pain, redness and swelling at the injection site, recorded by participants in an electronic diary (e-diary). Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 centimeter (cm). Redness and swelling were graded as mild: 2.5 cm to 5.0 cm; moderate: greater than (>) 5.0 cm to 10.0 cm; severe: > 10 cm.
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Time frame: SSA: From Day 1 to Day 7 after Vaccination 2 (1 Month After Vaccination 1)
Local reactions included pain, redness and swelling at the injection site, recorded by participants in an e-diary. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild: 2.5 cm to 5.0 cm; moderate: > 5.0 cm to 10.0 cm; severe: > 10 cm.
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Time frame: SSB: From Day 1 to Day 7 after Vaccination
Local reactions included pain, redness and swelling at the injection site, recorded by participants in an e-diary. Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity; severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 cm. Redness and swelling were graded as mild: 2.5 cm to 5.0 cm; moderate: > 5.0 cm to 10.0 cm; severe: > 10 cm.
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Time frame: SSA: From Day 1 to Day 7 after Vaccination 1
Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, chills, new/worsened muscle pain and new/worsened joint pain. These were recorded by participants in an e-diary. Fever defined as oral temperature >=38.0 degrees Celsius (deg C) and categorized as mild: >=38.0 to 38.4 deg C, moderate: >38.4 to 38.9 deg C, severe: >38.9 to 40.0 deg C. Vomiting categorized as mild: 1-2 times in 24 hours (h); moderate: >2 times in 24h; severe: required intravenous (IV) hydration. Diarrhea categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h; severe: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity; severe: prevented daily routine activity.
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Time frame: SSA: From Day 1 to Day 7 after Vaccination 2 (1 Month after Vaccination 1)
Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, chills, new/worsened muscle pain and new/worsened joint pain. These were recorded by participants in an e-diary. Fever defined as oral temperature >=38.0 deg C and categorized as mild: >=38.0 to 38.4 deg C, moderate: >38.4 to 38.9 deg C, severe: >38.9 to 40.0 deg C. Vomiting categorized as mild: 1-2 times in 24h; moderate: >2 times in 24h; severe: required IV hydration. Diarrhea categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h; severe: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity; severe: prevented daily routine activity.
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Time frame: SSB: From Day 1 to Day 7 After Vaccination
Systemic events included fever, fatigue, headache, vomiting, nausea, diarrhea, chills, new/worsened muscle pain and new/worsened joint pain. These were recorded by participants in an e-diary. Fever defined as oral temperature >=38.0 deg C and categorized as mild: >=38.0 to 38.4 deg C, moderate: >38.4 to 38.9 deg C, severe: >38.9 to 40.0 deg C. Vomiting categorized as mild: 1-2 times in 24h; moderate: >2 times in 24h; severe: required IV hydration. Diarrhea categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h; severe: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and new/worsened joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity; severe: prevented daily routine activity.
SSA: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 1
Time frame: SSA: Within 1 Month after Vaccination 1
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included.
SSA: Percentage of Participants Reporting AEs Within 1 Month After Vaccination 2
Time frame: SSA: Within 1 Month after Vaccination 2
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included.
SSB: Percentage of Participants Reporting AEs Throughout the Sub Study
Time frame: SSB: From Day 1 of Vaccination up to 35 days of follow-up post Vaccination
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI was based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were included.
SSA: Percentage of Participants Reporting Serious Adverse Events (SAEs) Throughout the Sub Study
Time frame: SSA: From Day 1 (Vaccination 1) up to 35 days of follow-up post Vaccination 2 (Maximum up to 70 days)
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event.
SSB: Percentage of Participants Reporting SAEs Throughout the Sub Study
Time frame: SSB: From Day 1 of Vaccination up to 35 days of follow-up post Vaccination (Maximum up to 36 days)
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect and was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic and other important medical event.
SSA: Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Neutralizing Titers (NT) for Each RSV Subgroup (A or B) 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and RSVpreF Alone (Group 2)
Time frame: SSA- For Group 1: 1 Month after Vaccination 1 (Day 1); For Group 2: 1 Month after Vaccination 2 (1 Month after Vaccination 1)
GMTs and associated 2-sided 95% CIs are reported as descriptive data. GMRs and associated 2-sided 95% CIs are reported in statistical analysis section of this outcome measure. GMR was the ratio of RSV subgroup A (RSV A) or RSV subgroup B (RSV B) neutralizing GMTs in the combination RSVpreF + qIRV group to that in the sequential-administration RSVpreF group.
SSA: GMT and GMR of Strain-Specific Hemagglutination Inhibition (HAI) Titers For 1 Month After Vaccination With Combination RSVpreF + qIRV (Group 1) and qIRV Alone (Group 2)
Time frame: SSA- For Group 1: 1 Month after Vaccination 1 (Day 1); For Group 2: 1 Month after Vaccination 2 (1 Month after Vaccination 1)
GMTs and associated 2-sided 95% CIs are reported as descriptive data. GMRs and associated 2-sided 95% CIs are reported in statistical analysis section of this outcome measure. GMR was the ratio of each strain neutralizing GMTs in the combination RSVpreF + qIRV group to that in the sequential-administration RSVpreF group. The analysis was performed on the influenza strains: H1N1 A/Sydney, H3N2 A/Darwin, B/Austria, and B/Phuket.

2 secondary outcomes

SSB: GMT and GMR of NT for Each RSV A or RSV B 1 Month After Vaccination
Time frame: SSB: At 1 Month after Vaccination (Day 1)
SSB: GMTs of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After Vaccination
Time frame: SSB: At 1 Month after Vaccination (Day 1)

Results and safety

Results posted to the registry on 22 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SSA: Group 1: Combination (RSVpreF + qIRV)/ Placebo	125	120
SSA: Group 2: Sequential Administration qIRV/ RSVpreF	126	113
SSB: Group 1: RSVpreF + qIRV 1.0 mL Formulation	0	0
SSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation	0	0

Primary outcome: SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1

Time frame: SSA: From Day 1 to Day 7 after Vaccination 1. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	SSA: Group 1: RSVpreF + qIRV n = 125	SSA: Group 2: qIRV n = 125
Pain at the injection site: Mild	49.6 (40.5 to 58.7)	52.0 (42.9 to 61.0)
Pain at the injection site: Moderate	20.8 (14.1 to 29.0)	28.0 (20.3 to 36.7)
Pain at the injection site: Severe	0 (0.0 to 2.9)	2.4 (0.5 to 6.9)
Redness: Mild	3.2 (0.9 to 8.0)	3.2 (0.9 to 8.0)
Redness: Moderate	4.0 (1.3 to 9.1)	4.8 (1.8 to 10.2)
Redness: Severe	0 (0.0 to 2.9)	0.8 (0.0 to 4.4)
Swelling: Mild	5.6 (2.3 to 11.2)	6.4 (2.8 to 12.2)
Swelling: Moderate	3.2 (0.9 to 8.0)	8.0 (3.9 to 14.2)

Population analysed: SSA: E-diary safety population consisted of all enrolled participants who received the study intervention either in combination RSVpreF + qIRV, or as placebo, qIRV, or RSVpreF alone, and had at least 1 day of e-diary data transferred.

Primary outcome: SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2

Time frame: SSA: From Day 1 to Day 7 after Vaccination 2 (1 Month After Vaccination 1). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	SSA: Group 1: Placebo n = 121	SSA: Group 2: RSVpreF n = 115
Pain at the injection site: Mild	1.7 (0.2 to 5.8)	7.8 (3.6 to 14.3)
Pain at the injection site: Moderate	1.7 (0.2 to 5.8)	0.9 (0.0 to 4.7)
Pain at the injection site: Severe	0 (0.0 to 3.0)	0 (0.0 to 3.2)
Redness: Mild	0 (0.0 to 3.0)	0 (0.0 to 3.2)
Redness: Moderate	0 (0.0 to 3.0)	0 (0.0 to 3.2)
Redness: Severe	0 (0.0 to 3.0)	0 (0.0 to 3.2)
Swelling: Mild	0.8 (0.0 to 4.5)	0.9 (0.0 to 4.7)
Swelling: Moderate	0 (0.0 to 3.0)	0 (0.0 to 3.2)

Primary outcome: SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination

Time frame: SSB: From Day 1 to Day 7 after Vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	SSB: Group 1: RSVpreF + qIRV 1.0 mL Formulation n = 101	SSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation n = 102
Pain at the injection site: Mild	42.6 (32.8 to 52.8)	43.1 (33.4 to 53.3)
Pain at the injection site: Moderate	31.7 (22.8 to 41.7)	32.4 (23.4 to 42.3)
Pain at the injection site: Severe	1.0 (0.0 to 5.4)	2.9 (0.6 to 8.4)
Redness: Mild	2.0 (0.2 to 7.0)	2.0 (0.2 to 6.9)
Redness: Moderate	0 (0.0 to 3.6)	3.9 (1.1 to 9.7)
Redness: Severe	0 (0.0 to 3.6)	0 (0.0 to 3.6)
Swelling: Mild	4.0 (1.1 to 9.8)	5.9 (2.2 to 12.4)
Swelling: Moderate	5.9 (2.2 to 12.5)	7.8 (3.4 to 14.9)

Population analysed: SSB: E-diary safety population consisted of all enrolled participants who received the study intervention (0.5 mL or 1.0 mL) and with at least 1 day of e-diary data transferred.

Primary outcome: SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1

Time frame: SSA: From Day 1 to Day 7 after Vaccination 1. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	SSA: Group 1: RSVpreF + qIRV n = 125	SSA: Group 2: qIRV n = 125
Fever: Mild	4.0 (1.3 to 9.1)	12.8 (7.5 to 20.0)
Fever: Moderate	6.4 (2.8 to 12.2)	4.0 (1.3 to 9.1)
Fever: Severe	1.6 (0.2 to 5.7)	5.6 (2.3 to 11.2)
Fatigue: Mild	20.8 (14.1 to 29.0)	20.8 (14.1 to 29.0)
Fatigue: Moderate	30.4 (22.5 to 39.3)	24.0 (16.8 to 32.5)
Fatigue: Severe	0.8 (0.0 to 4.4)	4.0 (1.3 to 9.1)
Headache: Mild	24.0 (16.8 to 32.5)	26.4 (18.9 to 35.0)
Headache: Moderate	24.8 (17.5 to 33.3)	11.2 (6.3 to 18.1)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Local reactions/systemic events (systematic assessment): Day 1 up to Day 7 after each Vaccination; AEs (non-systematic assessment): SSA- Day 1 up to 35 days after Vaccination 2 (Maximum up to approximately 70 days) and SSB- Day 1 up to 35 days after Vaccination (Maximum up to approximately 36 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SSA: Group 1: RSVpreF + qIRV	0 of 125 (0%)	117 of 125 (93.6%)	0 of 125
SSA: Group 1: Placebo	0 of 121 (0%)	50 of 121 (41.3%)	0 of 121
SSA: Group 2: qIRV	1 of 126 (0.8%)	117 of 126 (92.9%)	0 of 126
SSA: Group 2: RSVpreF	1 of 116 (0.9%)	43 of 116 (37.1%)	1 of 116
SSB: Group 1: RSVpreF + qIRV 1.0 mL Formulation	2 of 101 (2%)	91 of 101 (90.1%)	0 of 101
SSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation	0 of 102 (0%)	96 of 102 (94.1%)	0 of 102

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RSVpreF+qIRV, qIRV and RSVpreF in people with Healthy, run by Pfizer at 1 site in Argentina.

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 10 inclusion and 27 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 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 (time frame: SSA: From Day 1 to Day 7 after Vaccination 1). The study lists 13 primary outcomes in all. 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 NCT05788237.

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 22 Nov 2024.