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CompletedNCT05788237Updated Nov 22, 2024Results posted

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

A Phase 1 interventional study of RSVpreF+qIRV and qIRV in Healthy, sponsored by Pfizer. Completed at 1 site in Argentina. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-22.

Sponsored by Pfizer · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
508
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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. These vaccines are being developed to help prevent respiratory syncytial virus (RSV) and influenza (Flu) disease.

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.

02

Conditions studied

  • Healthy

Keywords

  • Flu
  • Influenza
  • Vaccine
  • RNA vaccine
  • RSV
  • Respiratory Syncytial Virus
  • Combination vaccine
  • Vaccine osmolality
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Substudy A:

Inclusion Criteria:

  1. Participants ≥60 years of age at study enrollment.
  2. Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
  3. 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.
  4. 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.
  5. Receipt of licensed influenza vaccination for the 2022-2023 northern hemisphere season or 2022 southern hemisphere season >120 days before study intervention administration.

Exclusion Criteria:

  1. A confirmed diagnosis of RSV infection or influenza ≤120 days before study intervention administration.
  2. History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
  3. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate IM injection.
  4. 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.
  5. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
  6. 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.
  7. 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.
  8. Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration, or planned receipt throughout the study.
  9. Receipt of any licensed RSV vaccine at any time prior to enrollment, or planned receipt throughout the study.
  10. Receipt of any licensed influenza vaccine ≤120 days before study enrollment, or planned receipt throughout the study.
  11. 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.
  12. Participation in any other interventional studies within 28 days before study enrollment through study completion.
  13. 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

Inclusion Criteria:

  1. Participants ≥50 years of age at study enrollment.
  2. Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
  3. 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.
  4. 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.
  5. Receipt of licensed influenza vaccination for the 2022-2023 northern hemisphere season or 2022 southern hemisphere season >180 days before study intervention administration.

Exclusion Criteria:

  1. A confirmed diagnosis of RSV infection or influenza ≤120 days before study intervention administration.
  2. History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
  3. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate IM injection.
  4. 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.
  5. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
  6. 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.
  7. 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.
  8. Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration, or planned receipt throughout the study.
  9. Receipt of any RSV vaccine at any time prior to enrollment, or planned receipt throughout the study.
  10. Receipt of any influenza vaccine ≤180 days before study enrollment, or planned receipt throughout the study.
  11. 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.
  12. Participation in any other interventional studies within 28 days before study enrollment through study completion. Participation in purely observational studies is acceptable.
  13. 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.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
508 participants (actual)

Study arms

  • Experimental
    SSA Group 1: Combination

    Combination (RSVpreF + qIRV) (Visit 1) followed by placebo (Visit 2). RSVpreF and qIRV are administered as concomitantly but as individual injections.

    Biological: RSVpreF+qIRV · Drug: Placebo

  • Experimental
    SSA Group 2: Sequential

    Sequential administration of qIRV (Visit 1) followed by RSVpreF (Visit 2)

    Biological: qIRV · Biological: RSVpreF

  • Experimental
    SSB Group 1: Combination (RSVpreF + qIRV) 1.0-mL formulation

    RSVpreF lyophilized cake reconstituted with water for injection and mixed with qIRV, yielding an injection volume of 1.0 mL

    Biological: RSVpreF + qIRV 1.0 mL formulation

  • Experimental
    SSB Group 2: Combination (RSVpreF +qIRV) 0.5-mL formulation

    RSVpreF lyophilized cake reconstituted with qIRV to yield an injection volume of 0.5 mL

    Biological: RSVpreF + qIRV 1.0 mL formulation · Biological: RSVpreF + qIRV 0.5 mL formulation

Interventions

  • BiologicalRSVpreF+qIRV

    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)

  • BiologicalqIRV

    Quadrivalent influenza modRNA vaccine (qIRV) encoding HA of 4 strains as recommended for the influenza season (2 A strains, 2 B strains)

    Also known as: PF-07252220

  • BiologicalRSVpreF

    RSVpreF containing 2 stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B

    Also known as: PF-06928316

  • DrugPlacebo

    0.9% saline for injection

  • BiologicalRSVpreF + qIRV 1.0 mL formulation

    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

    Also known as: PF-07941314

  • BiologicalRSVpreF + qIRV 0.5 mL formulation

    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)

    Also known as: PF-07941314

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: SSA: From Day 1 to Day 7 after Vaccination 1

  2. 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.

    Time frame: SSA: From Day 1 to Day 7 after Vaccination 2 (1 Month After Vaccination 1)

  3. 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.

    Time frame: SSB: From Day 1 to Day 7 after Vaccination

  4. 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.

    Time frame: SSA: From Day 1 to Day 7 after Vaccination 1

  5. 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.

    Time frame: SSA: From Day 1 to Day 7 after Vaccination 2 (1 Month after Vaccination 1)

  6. 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.

    Time frame: SSB: From Day 1 to Day 7 After Vaccination

  7. 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.

    Time frame: SSA: Within 1 Month after Vaccination 1

  8. 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.

    Time frame: SSA: Within 1 Month after Vaccination 2

  9. 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.

    Time frame: SSB: From Day 1 of Vaccination up to 35 days of follow-up post Vaccination

  10. 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.

    Time frame: SSA: From Day 1 (Vaccination 1) up to 35 days of follow-up post Vaccination 2 (Maximum up to 70 days)

  11. 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.

    Time frame: SSB: From Day 1 of Vaccination up to 35 days of follow-up post Vaccination (Maximum up to 36 days)

  12. 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.

    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)

  13. 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.

    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)

Secondary outcomes

  1. 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)

    Time frame: SSB: At 1 Month after Vaccination (Day 1)

  2. 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.

    Time frame: SSB: At 1 Month after Vaccination (Day 1)

07

Results

Posted Nov 22, 2024

Participant flow

This study had sub-study A (SSA) and sub-study B (SSB).

SSA (Approximately 2 Months)
Participant flow — SSA (Approximately 2 Months)
MilestoneSSA: Group 1: Combination (RSVpreF + qIRV)/ PlaceboSSA: Group 2: Sequential Administration qIRV/ RSVpreFSSB: Group 1: RSVpreF + qIRV 1.0 mL FormulationSSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation
Started12512600
Vaccination 112512600
Vaccination 212111600
Completed12011300
Not completed51300
Withdrew: No longer met eligibility criteria0100
Withdrew: Lost to follow-up0100
Withdrew: Withdrawal by subject4800
Withdrew: Adverse event1200
Withdrew: Death0100
SSB (Approximately 1 Month)
Participant flow — SSB (Approximately 1 Month)
MilestoneSSA: Group 1: Combination (RSVpreF + qIRV)/ PlaceboSSA: Group 2: Sequential Administration qIRV/ RSVpreFSSB: Group 1: RSVpreF + qIRV 1.0 mL FormulationSSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation
Started00102102
Vaccination00101102
Completed00101100
Not completed0012
Withdrew: Not vaccinated0010
Withdrew: Refused further study procedures0001
Withdrew: Other0001

Outcome measures

PrimarySSA: 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.

Time frame:
SSA: From Day 1 to Day 7 after Vaccination 1
Reported as:
Number · Percentage of participants
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Percentage of participantsSSA: Group 1: RSVpreF + qIRVSSA: Group 2: qIRV
Pain at the injection site: Mild49.6 (40.5 to 58.7)52.0 (42.9 to 61.0)
Pain at the injection site: Moderate20.8 (14.1 to 29.0)28.0 (20.3 to 36.7)
Pain at the injection site: Severe0 (0.0 to 2.9)2.4 (0.5 to 6.9)
Redness: Mild3.2 (0.9 to 8.0)3.2 (0.9 to 8.0)
Redness: Moderate4.0 (1.3 to 9.1)4.8 (1.8 to 10.2)
Redness: Severe0 (0.0 to 2.9)0.8 (0.0 to 4.4)
Swelling: Mild5.6 (2.3 to 11.2)6.4 (2.8 to 12.2)
Swelling: Moderate3.2 (0.9 to 8.0)8.0 (3.9 to 14.2)
Swelling: Severe0.8 (0.0 to 4.4)2.4 (0.5 to 6.9)
PrimarySSA: 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.

Time frame:
SSA: From Day 1 to Day 7 after Vaccination 2 (1 Month After Vaccination 1)
Reported as:
Number · Percentage of participants
SSA: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Percentage of participantsSSA: Group 1: PlaceboSSA: Group 2: RSVpreF
Pain at the injection site: Mild1.7 (0.2 to 5.8)7.8 (3.6 to 14.3)
Pain at the injection site: Moderate1.7 (0.2 to 5.8)0.9 (0.0 to 4.7)
Pain at the injection site: Severe0 (0.0 to 3.0)0 (0.0 to 3.2)
Redness: Mild0 (0.0 to 3.0)0 (0.0 to 3.2)
Redness: Moderate0 (0.0 to 3.0)0 (0.0 to 3.2)
Redness: Severe0 (0.0 to 3.0)0 (0.0 to 3.2)
Swelling: Mild0.8 (0.0 to 4.5)0.9 (0.0 to 4.7)
Swelling: Moderate0 (0.0 to 3.0)0 (0.0 to 3.2)
Swelling: Severe0 (0.0 to 3.0)0 (0.0 to 3.2)
PrimarySSB: 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.

Time frame:
SSB: From Day 1 to Day 7 after Vaccination
Reported as:
Number · Percentage of participants
SSB: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Percentage of participantsSSB: Group 1: RSVpreF + qIRV 1.0 mL FormulationSSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation
Pain at the injection site: Mild42.6 (32.8 to 52.8)43.1 (33.4 to 53.3)
Pain at the injection site: Moderate31.7 (22.8 to 41.7)32.4 (23.4 to 42.3)
Pain at the injection site: Severe1.0 (0.0 to 5.4)2.9 (0.6 to 8.4)
Redness: Mild2.0 (0.2 to 7.0)2.0 (0.2 to 6.9)
Redness: Moderate0 (0.0 to 3.6)3.9 (1.1 to 9.7)
Redness: Severe0 (0.0 to 3.6)0 (0.0 to 3.6)
Swelling: Mild4.0 (1.1 to 9.8)5.9 (2.2 to 12.4)
Swelling: Moderate5.9 (2.2 to 12.5)7.8 (3.4 to 14.9)
Swelling: Severe0 (0.0 to 3.6)0 (0.0 to 3.6)
PrimarySSA: 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.

Time frame:
SSA: From Day 1 to Day 7 after Vaccination 1
Reported as:
Number · Percentage of participants
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Percentage of participantsSSA: Group 1: RSVpreF + qIRVSSA: Group 2: qIRV
Fever: Mild4.0 (1.3 to 9.1)12.8 (7.5 to 20.0)
Fever: Moderate6.4 (2.8 to 12.2)4.0 (1.3 to 9.1)
Fever: Severe1.6 (0.2 to 5.7)5.6 (2.3 to 11.2)
Fatigue: Mild20.8 (14.1 to 29.0)20.8 (14.1 to 29.0)
Fatigue: Moderate30.4 (22.5 to 39.3)24.0 (16.8 to 32.5)
Fatigue: Severe0.8 (0.0 to 4.4)4.0 (1.3 to 9.1)
Headache: Mild24.0 (16.8 to 32.5)26.4 (18.9 to 35.0)
Headache: Moderate24.8 (17.5 to 33.3)11.2 (6.3 to 18.1)
Headache: Severe0 (0.0 to 2.9)0 (0.0 to 2.9)
Vomiting: Mild1.6 (0.2 to 5.7)1.6 (0.2 to 5.7)
Vomiting: Moderate0 (0.0 to 2.9)0 (0.0 to 2.9)
Vomiting: Severe0 (0.0 to 2.9)0 (0.0 to 2.9)
Nausea: Mild5.6 (2.3 to 11.2)5.6 (2.3 to 11.2)
Nausea: Moderate2.4 (0.5 to 6.9)3.2 (0.9 to 8.0)
Nausea: Severe0 (0.0 to 2.9)0 (0.0 to 2.9)
Diarrhea: Mild4.8 (1.8 to 10.2)4.0 (1.3 to 9.1)
Diarrhea: Moderate1.6 (0.2 to 5.7)1.6 (0.2 to 5.7)
Diarrhea: Severe0.8 (0.0 to 4.4)0 (0.0 to 2.9)
Chills: Mild15.2 (9.4 to 22.7)20.8 (14.1 to 29.0)
Chills: Moderate12.0 (6.9 to 19.0)11.2 (6.3 to 18.1)
Chills: Severe0 (0.0 to 2.9)0 (0.0 to 2.9)
New or worsened muscle pain: Mild17.6 (11.4 to 25.4)20.8 (14.1 to 29.0)
New or worsened muscle pain: Moderate22.4 (15.4 to 30.7)15.2 (9.4 to 22.7)
New or worsened muscle pain: Severe0 (0.0 to 2.9)1.6 (0.2 to 5.7)
New or worsened joint pain: Mild11.2 (6.3 to 18.1)11.2 (6.3 to 18.1)
New or worsened joint pain: Moderate14.4 (8.8 to 21.8)6.4 (2.8 to 12.2)
New or worsened joint pain: Severe0 (0.0 to 2.9)0.8 (0.0 to 4.4)
PrimarySSA: 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.

Time frame:
SSA: From Day 1 to Day 7 after Vaccination 2 (1 Month after Vaccination 1)
Reported as:
Number · Percentage of participants
SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Percentage of participantsSSA: Group 1: PlaceboSSA: Group 2: RSVpreF
Fever: Mild0 (0.0 to 3.0)0.9 (0.0 to 4.7)
Fever: Moderate0 (0.0 to 3.0)0.9 (0.0 to 4.7)
Fever: Severe0 (0.0 to 3.0)0.9 (0.0 to 4.7)
Fatigue: Mild7.4 (3.5 to 13.7)6.1 (2.5 to 12.1)
Fatigue: Moderate3.3 (0.9 to 8.2)7.0 (3.1 to 13.2)
Fatigue: Severe0 (0.0 to 3.0)1.7 (0.2 to 6.1)
Headache: Mild10.7 (5.8 to 17.7)10.4 (5.5 to 17.5)
Headache: Moderate5.8 (2.4 to 11.6)6.1 (2.5 to 12.1)
Headache: Severe0 (0.0 to 3.0)0.9 (0.0 to 4.7)
Vomiting: Mild0 (0.0 to 3.0)0 (0.0 to 3.2)
Vomiting: Moderate0 (0.0 to 3.0)0 (0.0 to 3.2)
Vomiting: Severe0 (0.0 to 3.0)0 (0.0 to 3.2)
Nausea: Mild3.3 (0.9 to 8.2)1.7 (0.2 to 6.1)
Nausea: Moderate0 (0.0 to 3.0)0 (0.0 to 3.2)
Nausea: Severe0 (0.0 to 3.0)0 (0.0 to 3.2)
Diarrhea: Mild5.0 (1.8 to 10.5)2.6 (0.5 to 7.4)
Diarrhea: Moderate1.7 (0.2 to 5.8)0.9 (0.0 to 4.7)
Diarrhea: Severe0 (0.0 to 3.0)0 (0.0 to 3.2)
Chills: Mild2.5 (0.5 to 7.1)3.5 (1.0 to 8.7)
Chills: Moderate1.7 (0.2 to 5.8)2.6 (0.5 to 7.4)
Chills: Severe0 (0.0 to 3.0)0 (0.0 to 3.2)
New or worsened muscle pain: Mild5.8 (2.4 to 11.6)4.3 (1.4 to 9.9)
New or worsened muscle pain: Moderate1.7 (0.2 to 5.8)7.0 (3.1 to 13.2)
New or worsened muscle pain: Severe0 (0.0 to 3.0)0 (0.0 to 3.2)
New or worsened joint pain: Mild4.1 (1.4 to 9.4)2.6 (0.5 to 7.4)
New or worsened joint pain: Moderate1.7 (0.2 to 5.8)6.1 (2.5 to 12.1)
New or worsened joint pain: Severe0 (0.0 to 3.0)0 (0.0 to 3.2)
PrimarySSB: 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.

Time frame:
SSB: From Day 1 to Day 7 After Vaccination
Reported as:
Number · Percentage of participants
SSB: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Percentage of participantsSSB: Group 1: RSVpreF + qIRV 1.0 mL FormulationSSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation
Fever: Mild15.8 (9.3 to 24.4)10.8 (5.5 to 18.5)
Fever: Moderate4.0 (1.1 to 9.8)2.0 (0.2 to 6.9)
Fever: Severe2.0 (0.2 to 7.0)0 (0.0 to 3.6)
Fatigue: Mild20.8 (13.4 to 30.0)28.4 (19.9 to 38.2)
Fatigue: Moderate36.6 (27.3 to 46.8)26.5 (18.2 to 36.1)
Fatigue: Severe0 (0.0 to 3.6)5.9 (2.2 to 12.4)
Headache: Mild18.8 (11.7 to 27.8)26.5 (18.2 to 36.1)
Headache: Moderate27.7 (19.3 to 37.5)15.7 (9.2 to 24.2)
Headache: Severe0 (0.0 to 3.6)2.0 (0.2 to 6.9)
Vomiting: Mild0 (0.0 to 3.6)2.0 (0.2 to 6.9)
Vomiting: Moderate0 (0.0 to 3.6)1.0 (0.0 to 5.3)
Vomiting: Severe0 (0.0 to 3.6)0 (0.0 to 3.6)
Nausea: Mild5.0 (1.6 to 11.2)11.8 (6.2 to 19.6)
Nausea: Moderate4.0 (1.1 to 9.8)2.9 (0.6 to 8.4)
Nausea: Severe0 (0.0 to 3.6)0 (0.0 to 3.6)
Diarrhea: Mild9.9 (4.9 to 17.5)10.8 (5.5 to 18.5)
Diarrhea: Moderate5.9 (2.2 to 12.5)2.9 (0.6 to 8.4)
Diarrhea: Severe0 (0.0 to 3.6)0 (0.0 to 3.6)
Chills: Mild15.8 (9.3 to 24.4)17.6 (10.8 to 26.4)
Chills: Moderate24.8 (16.7 to 34.3)13.7 (7.7 to 22.0)
Chills: Severe0 (0.0 to 3.6)1.0 (0.0 to 5.3)
New or worsened muscle pain: Mild18.8 (11.7 to 27.8)21.6 (14.0 to 30.8)
New or worsened muscle pain: Moderate27.7 (19.3 to 37.5)22.5 (14.9 to 31.9)
New or worsened muscle pain: Severe2.0 (0.2 to 7.0)1.0 (0.0 to 5.3)
New or worsened joint pain: Mild14.9 (8.6 to 23.3)11.8 (6.2 to 19.6)
New or worsened joint pain: Moderate20.8 (13.4 to 30.0)16.7 (10.0 to 25.3)
New or worsened joint pain: Severe0 (0.0 to 3.6)1.0 (0.0 to 5.3)
PrimarySSA: 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.

Time frame:
SSA: Within 1 Month after Vaccination 1
Reported as:
Number · Percentage of participants
SSA: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 1
Percentage of participantsSSA: Group 1: RSVpreF + qIRVSSA: Group 2: qIRV
SSA: Percentage of Participants Reporting Adverse Events (AEs) Within 1 Month After Vaccination 129.6 (21.8 to 38.4)33.3 (25.2 to 42.3)
PrimarySSA: 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.

Time frame:
SSA: Within 1 Month after Vaccination 2
Reported as:
Number · Percentage of participants
SSA: Percentage of Participants Reporting AEs Within 1 Month After Vaccination 2
Percentage of participantsSSA: Group 1: PlaceboSSA: Group 2: RSVpreF
SSA: Percentage of Participants Reporting AEs Within 1 Month After Vaccination 216.5 (10.4 to 24.4)13.8 (8.1 to 21.4)
PrimarySSB: 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.

Time frame:
SSB: From Day 1 of Vaccination up to 35 days of follow-up post Vaccination
Reported as:
Number · Percentage of participants
SSB: Percentage of Participants Reporting AEs Throughout the Sub Study
Percentage of participantsSSB: Group 1: RSVpreF + qIRV 1.0 mL FormulationSSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation
SSB: Percentage of Participants Reporting AEs Throughout the Sub Study22.8 (15.0 to 32.2)33.3 (24.3 to 43.4)
PrimarySSA: 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.

Time frame:
SSA: From Day 1 (Vaccination 1) up to 35 days of follow-up post Vaccination 2 (Maximum up to 70 days)
Reported as:
Number · Percentage of participants
SSA: Percentage of Participants Reporting Serious Adverse Events (SAEs) Throughout the Sub Study
Percentage of participantsSSA: Group 1: Combination (RSVpreF + qIRV)/ PlaceboSSA: Group 2: Sequential Administration qIRV/ RSVpreF
SSA: Percentage of Participants Reporting Serious Adverse Events (SAEs) Throughout the Sub Study0 (0.0 to 2.9)2.4 (0.5 to 6.8)
PrimarySSB: 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.

Time frame:
SSB: From Day 1 of Vaccination up to 35 days of follow-up post Vaccination (Maximum up to 36 days)
Reported as:
Number · Percentage of participants
SSB: Percentage of Participants Reporting SAEs Throughout the Sub Study
Percentage of participantsSSB: Group 1: RSVpreF + qIRV 1.0 mL FormulationSSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation
SSB: Percentage of Participants Reporting SAEs Throughout the Sub Study2.0 (0.2 to 7.0)0 (0.0 to 3.6)
PrimarySSA: 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.

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)
Reported as:
Geometric mean · Titer
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)
TiterSSA: Group 1: Combination RSVpreF + qIRVSSA: Group 2: Sequential Administration RSVpreF Alone
NT: RSV A16553 (14120.9 to 19403.1)19740 (16555.5 to 23536.4)
NT: RSV B11795 (9961.1 to 13966.7)14959 (12408.8 to 18032.4)
Statistical analysis
  • SSA: Group 1: Combination RSVpreF + qIRV vs SSA: Group 2: Sequential Administration RSVpreF Alone · Gmr: 0.84 · 95% CI 0.662 to 1.062
  • SSA: Group 1: Combination RSVpreF + qIRV vs SSA: Group 2: Sequential Administration RSVpreF Alone · Gmr: 0.79 · 95% CI 0.614 to 1.013
PrimarySSA: 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.

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)
Reported as:
Geometric mean · Titer
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)
TiterSSA: Group 1: Combination RSVpreF + qIRVSSA: Group 2: Sequential Administration RSVpreF Alone
HAI: H1N1 A/Wisconsin194 (164.3 to 227.9)238 (196.5 to 288.7)
HAI: H3N2 A/Darwin161 (136.9 to 189.9)219 (178.1 to 269.0)
HAI: B/Austria53 (44.6 to 62.1)56 (47.7 to 66.3)
HAI: B/Phuket22 (18.5 to 26.4)24 (20.2 to 29.1)
Statistical analysis
  • SSA: Group 1: Combination RSVpreF + qIRV vs SSA: Group 2: Sequential Administration RSVpreF Alone · Gmr: 0.81 · 95% CI 0.632 to 1.044
  • SSA: Group 1: Combination RSVpreF + qIRV vs SSA: Group 2: Sequential Administration RSVpreF Alone · Geometric mean ratio: 0.74 · 95% CI 0.567 to 0.957
  • SSA: Group 1: Combination RSVpreF + qIRV vs SSA: Group 2: Sequential Administration RSVpreF Alone · Gmr: 0.94 · 95% CI 0.741 to 1.181
  • SSA: Group 1: Combination RSVpreF + qIRV vs SSA: Group 2: Sequential Administration RSVpreF Alone · Gmr: 0.91 · 95% CI 0.707 to 1.174
SecondarySSB: 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)

Time frame:
SSB: At 1 Month after Vaccination (Day 1)
Reported as:
Geometric mean · Titer
SSB: GMT and GMR of NT for Each RSV A or RSV B 1 Month After Vaccination
TiterSSB: Group 1: RSVpreF + qIRV 1.0 mL FormulationSSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation
NT: RSV A32044 (26676.5 to 38492.2)30575 (25922.1 to 36062.4)
NT: RSV B30364 (25533.4 to 36108.2)28614 (24113.5 to 33954.8)
Statistical analysis
  • SSB: Group 1: RSVpreF + qIRV 1.0 mL Formulation vs SSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation · Geometric mean ratio: 1.05 · 95% CI 0.820 to 1.339
  • SSB: Group 1: RSVpreF + qIRV 1.0 mL Formulation vs SSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation · Geometric mean ratio: 1.06 · 95% CI 0.833 to 1.352
SecondarySSB: 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.

Time frame:
SSB: At 1 Month after Vaccination (Day 1)
Reported as:
Geometric mean · Titer
SSB: GMTs of Strain-Specific Hemagglutination Inhibition (HAI) at 1 Month After Vaccination
TiterSSB: Group 1: RSVpreF + qIRV 1.0 mL FormulationSSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation
HAI: H1N1 A/Sydney257 (212.6 to 311.8)217 (170.2 to 275.8)
HAI: H3N2 A/Darwin259 (216.4 to 310.8)229 (188.7 to 279.0)
HAI: B/Austria58 (49.0 to 69.0)54 (45.0 to 64.1)
HAI: B/Phuket32 (27.0 to 38.6)29 (25.1 to 34.4)
Statistical analysis
  • SSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation · Gmr: 1.19 · 95% CI 0.875 to 1.614
  • SSB: Group 1: RSVpreF + qIRV 1.0 mL Formulation vs SSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation · Geometric mean ratio: 1.13 · 95% CI 0.867 to 1.473
  • SSB: Group 1: RSVpreF + qIRV 1.0 mL Formulation vs SSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation · Geometric mean ratio: 1.08 · 95% CI 0.849 to 1.383
  • SSB: Group 1: RSVpreF + qIRV 1.0 mL Formulation vs SSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation · Geometric mean ratio: 1.10 · 95% CI 0.866 to 1.392

Adverse events

Collected over 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). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SSA: Group 1: RSVpreF + qIRV0/125 (0%)0/125 (0%)117/125 (93.6%)
SSA: Group 1: Placebo0/121 (0%)0/121 (0%)50/121 (41.3%)
SSA: Group 2: qIRV0/126 (0%)1/126 (0.8%)117/126 (92.9%)
SSA: Group 2: RSVpreF1/116 (0.9%)1/116 (0.9%)43/116 (37.1%)
SSB: Group 1: RSVpreF + qIRV 1.0 mL Formulation0/101 (0%)2/101 (2%)91/101 (90.1%)
SSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation0/102 (0%)0/102 (0%)96/102 (94.1%)
Most frequent serious events
Most frequent serious events
EventSSA: Group 1: RSVpreF + qIRVSSA: Group 1: PlaceboSSA: Group 2: qIRVSSA: Group 2: RSVpreFSSB: Group 1: RSVpreF + qIRV 1.0 mL FormulationSSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation
Acute myocardial infarctionCardiac disorders0/1250/1210/1260/1161/1010/102
Haemorrhage intracranialNervous system disorders0/1250/1210/1260/1161/1010/102
Cardiac arrestCardiac disorders0/1250/1210/1261/1160/1010/102
Cardiac failureCardiac disorders0/1250/1210/1261/1160/1010/102
Respiratory failureRespiratory, thoracic and mediastinal disorders0/1250/1210/1261/1160/1010/102
Craniocerebral injuryInjury, poisoning and procedural complications0/1250/1211/1260/1160/1010/102
SyncopeNervous system disorders0/1250/1211/1260/1160/1010/102
Most frequent other events
Showing 10 of 106
Most frequent other events
EventSSA: Group 1: RSVpreF + qIRVSSA: Group 1: PlaceboSSA: Group 2: qIRVSSA: Group 2: RSVpreFSSB: Group 1: RSVpreF + qIRV 1.0 mL FormulationSSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation
Injection site pain (PAIN AT THE INJECTION SITE)General disorders88/1254/121103/12510/11576/10180/102
Fatigue (FATIGUE)General disorders65/12513/12161/12517/11558/10162/102
Headache (HEADACHE)Nervous system disorders61/12520/12147/12520/11547/10145/102
Myalgia (NEW OR WORSENED MUSCLE PAIN)Musculoskeletal and connective tissue disorders50/1259/12147/12513/11549/10146/102
Chills (CHILLS)General disorders34/1255/12140/1257/11541/10133/102
Arthralgia (NEW OR WORSENED JOINT PAIN)Musculoskeletal and connective tissue disorders32/1257/12123/12510/11536/10130/102
Pyrexia (FEVER)General disorders15/1250/12128/1253/11522/10113/102
Injection site swelling (SWELLING)General disorders12/1251/12121/1251/11510/10114/102
Diarrhoea (DIARRHEA)Gastrointestinal disorders9/1258/1217/1254/11516/10114/102
Nausea (NAUSEA)Gastrointestinal disorders10/1254/12111/1252/1159/10115/102

Baseline characteristics

Safety population was evaluated. SSA= All enrolled participants who received the study intervention either in combination RSVpreF + qIRV, or as placebo, qIRV, or RSVpreF alone. SSB= All enrolled participants who received the study intervention (0.5 mL or 1.0 mL).

Age, Customized
Age, Customized(Participants)SSA: Group 1: Combination (RSVpreF + qIRV)/ PlaceboSSA: Group 2: Sequential Administration qIRV/ RSVpreFSSB: Group 1: RSVpreF + qIRV 1.0 mL FormulationSSB: Group 2: RSVpreF + qIRV 0.5 mL FormulationTotal
50-64 years22235052147
65-79 years94934847282
>=80 years9103325
Sex: Female, Male
Sex: Female, Male(Participants)SSA: Group 1: Combination (RSVpreF + qIRV)/ PlaceboSSA: Group 2: Sequential Administration qIRV/ RSVpreFSSB: Group 1: RSVpreF + qIRV 1.0 mL FormulationSSB: Group 2: RSVpreF + qIRV 0.5 mL FormulationTotal
Female62734748230
Male63535454224
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SSA: Group 1: Combination (RSVpreF + qIRV)/ PlaceboSSA: Group 2: Sequential Administration qIRV/ RSVpreFSSB: Group 1: RSVpreF + qIRV 1.0 mL FormulationSSB: Group 2: RSVpreF + qIRV 0.5 mL FormulationTotal
Hispanic or Latino125126101101453
Not Hispanic or Latino00011
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SSA: Group 1: Combination (RSVpreF + qIRV)/ PlaceboSSA: Group 2: Sequential Administration qIRV/ RSVpreFSSB: Group 1: RSVpreF + qIRV 1.0 mL FormulationSSB: Group 2: RSVpreF + qIRV 0.5 mL FormulationTotal
American Indian or Alaska Native00000
Asian00000
Native Hawaiian or Other Pacific Islander00000
Black or African American00000
White125126101102454
More than one race00000
Unknown or Not Reported00000
08

Study locations

1 site
  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
    Buenos Aires, 1426, Argentina
09

References and documents

Study documents

  • Study protocol · May 30, 2023
  • Statistical analysis plan · Jul 14, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: 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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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05788237
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Mar 28, 2023
Start date
Mar 9, 2023
Primary completion
Sep 27, 2023
Completion
Sep 27, 2023
Results posted
Nov 22, 2024
Last update
Nov 22, 2024

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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