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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:
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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| SSA Group 2: Sequential | Experimental | Sequential administration of qIRV (Visit 1) followed by RSVpreF (Visit 2) |
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| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSVpreF+qIRV | Biological | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | SSB: From Day 1 to Day 7 after Vaccination |
| SSA: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | SSB: At 1 Month after Vaccination (Day 1) |
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Substudy A:
Inclusion Criteria:
Exclusion Criteria:
Substudy B
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich | Buenos Aires | 1426 | Argentina |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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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A total of 508 participants (SSA: 273 + SSB: 235) were enrolled in this study, 455 participants (SSA:251 + SSB: 204) were randomized to receive study intervention.
This study had sub-study A (SSA) and sub-study B (SSB).
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| ID | Title | Description |
|---|---|---|
| FG000 | SSA: Group 1: Combination (RSVpreF + qIRV)/ Placebo | Participants aged >= 60 years were randomized to receive 1.0 mL combination of RSVpreF and qIRV intramuscularly on Day 1 [Vaccination 1]. After 1 month, placebo (0.9% normal saline for injection) [Vaccination 2] was administered intramuscularly. Participants were followed up to maximum of 35 days after Vaccination 2. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| SSA (Approximately 2 Months) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 30, 2023 | Sep 25, 2024 |
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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.
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Substudy A: This is an observer-blinded study. Participants will be blinded to their assigned study intervention. The study staff receiving, storing, dispensing, preparing, and administering the study interventions will be unblinded. All other study and site personnel, including the investigator and investigator staff, will be blinded to assignment of study intervention.
With the exception of the staff conducting the immunogenicity assays, the sponsor will be unblinded.
Substudy B: This is an observer-blinded study. Participants will be blinded to their assigned study intervention. The study staff receiving, storing, dispensing, preparing, and administering the study interventions will be unblinded. All other study and site personnel, including the investigator and investigator staff, will be blinded to assignment of study intervention.
With the exception of the staff conducting the immunogenicity assays, the sponsor will be unblinded.
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| qIRV | Biological | Quadrivalent influenza modRNA vaccine (qIRV) encoding HA of 4 strains as recommended for the influenza season (2 A strains, 2 B strains) |
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| RSVpreF | Biological | RSVpreF containing 2 stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B |
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| Placebo | Drug | 0.9% saline for injection |
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| RSVpreF + qIRV 1.0 mL formulation | Biological | 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 |
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| RSVpreF + qIRV 0.5 mL formulation | Biological | 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) |
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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: 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | SSA- For Group 1: 1 Month after Vaccination 1 (Day 1); For Group 2: 1 Month after Vaccination 2 (1 Month after Vaccination 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. | SSB: At 1 Month after Vaccination (Day 1) |
| FG001 | SSA: Group 2: Sequential Administration qIRV/ RSVpreF | Participants aged >= 60 years were randomized to receive 1.0 mL of qIRV intramuscularly on Day 1 (Vaccination 1). After 1 month, RSVpreF (Vaccination 2) was administered intramuscularly. Participants were followed up to maximum of 35 days after Vaccination 2. |
| FG002 | SSB: Group 1: RSVpreF + qIRV 1.0 mL Formulation | Participants aged >=50 years were randomized to receive 1.0 mL of combination of RSVpreF and qIRV intramuscularly on Day 1. Participants were followed up to maximum of 35 days after Vaccination. |
| FG003 | SSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation | Participants aged >=50 years were randomized to receive 0.5 mL of combination of RSVpreF and qIRV intramuscularly on Day 1. Participants were followed up to maximum of 35 days after Vaccination. |
| Vaccination 1 |
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| Vaccination 2 |
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| NOT COMPLETED |
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| SSB (Approximately 1 Month) |
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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).
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| ID | Title | Description |
|---|---|---|
| BG000 | SSA: Group 1: Combination (RSVpreF + qIRV)/ Placebo | Participants aged >= 60 years were randomized to receive 1.0 mL combination of RSVpreF and qIRV intramuscularly on Day 1 [Vaccination 1]. After 1 month, placebo (0.9% normal saline for injection) [Vaccination 2] was administered intramuscularly. Participants were followed up to maximum of 35 days after Vaccination 2. |
| BG001 | SSA: Group 2: Sequential Administration qIRV/ RSVpreF | Participants aged >= 60 years were randomized to receive 1.0 mL of qIRV intramuscularly on Day 1 (Vaccination 1). After 1 month, RSVpreF (Vaccination 2) was administered intramuscularly. Participants were followed up to maximum of 35 days after Vaccination 2. |
| BG002 | SSB: Group 1: RSVpreF + qIRV 1.0 mL Formulation | Participants aged >=50 years were randomized to receive 1.0 mL of combination of RSVpreF and qIRV intramuscularly on Day 1. Participants were followed up to maximum of 35 days after Vaccination. |
| BG003 | SSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation | Participants aged >=50 years were randomized to receive 0.5 mL of combination of RSVpreF and qIRV intramuscularly on Day 1. Participants were followed up to maximum of 35 days after Vaccination. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
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| Primary | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | SSA: From Day 1 to Day 7 after Vaccination 1 |
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| Primary | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | SSA: From Day 1 to Day 7 after Vaccination 2 (1 Month After Vaccination 1) |
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| Primary | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | SSB: From Day 1 to Day 7 after Vaccination |
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| Primary | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | SSA: From Day 1 to Day 7 after Vaccination 1 |
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| Primary | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | SSA: From Day 1 to Day 7 after Vaccination 2 (1 Month after Vaccination 1) |
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| Primary | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | SSB: From Day 1 to Day 7 After Vaccination |
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| Primary | 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. | SSA: Safety population consisted of all enrolled participants who received the study intervention either in combination RSVpreF + qIRV, or as placebo, qIRV, or RSVpreF alone. | Posted | Number | 95% Confidence Interval | Percentage of participants | SSA: Within 1 Month after Vaccination 1 |
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| Primary | 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. | SSA: Safety population consisted of all enrolled participants who received the study intervention either in combination RSVpreF + qIRV, or as placebo, qIRV, or RSVpreF alone. | Posted | Number | 95% Confidence Interval | Percentage of participants | SSA: Within 1 Month after Vaccination 2 |
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| Primary | 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. | SSB: Safety population consisted of all enrolled participants who received the study intervention (0.5 mL or 1.0 mL). | Posted | Number | 95% Confidence Interval | Percentage of participants | SSB: From Day 1 of Vaccination up to 35 days of follow-up post Vaccination |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | 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. | SSA: Safety population consisted of all enrolled participants who received the study intervention either in combination RSVpreF + qIRV, or as placebo, qIRV, or RSVpreF alone. | Posted | Number | 95% Confidence Interval | Percentage of participants | SSA: From Day 1 (Vaccination 1) up to 35 days of follow-up post Vaccination 2 (Maximum up to 70 days) |
| |||||||||||||||||||||||||||||||||||||
| Primary | 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. | SSB: Safety population consisted of all enrolled participants who received the study intervention (0.5 mL or 1.0 mL). | Posted | Number | 95% Confidence Interval | Percentage of participants | SSB: From Day 1 of Vaccination up to 35 days of follow-up post Vaccination (Maximum up to 36 days) |
| |||||||||||||||||||||||||||||||||||||
| Primary | 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. | Evaluable RSV immunogenicity population: all eligible participants who received the study intervention to which they were randomized, had the 1 month postvaccination blood collection within 27 to 42 days after vaccination, had at least 1 valid and determinate RSV NT result at the 1-month postvaccination blood collection, and had no major protocol violations from randomization through the 1 month postvaccination blood collection. | Posted | Geometric Mean | 95% Confidence Interval | Titer | SSA- For Group 1: 1 Month after Vaccination 1 (Day 1); For Group 2: 1 Month after Vaccination 2 (1 Month after Vaccination 1) |
| |||||||||||||||||||||||||||||||||||||
| Primary | 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. | Evaluable HAI immunogenicity population: all eligible participants who received the study intervention to which they were randomized, and had the 1month postvaccination blood collection for HAI assay within 27-42 days after vaccination, had at least 1 valid and determinate HAI result at 1 month postvaccination blood collection, had no major protocol violations from randomization through 1 month postvaccination blood collection. | Posted | Geometric Mean | 95% Confidence Interval | Titer | 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 | 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) | Evaluable RSV immunogenicity population: all eligible participants who received the study intervention to which they were randomized, had the 1-month postvaccination blood collection within 27 to 42 days after vaccination, had at least 1 valid and determinate RSV NT result at the 1 month postvaccination blood collection, and had no major protocol violations from randomization through the 1 month postvaccination blood collection. | Posted | Geometric Mean | 95% Confidence Interval | Titer | SSB: At 1 Month after Vaccination (Day 1) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Evaluable HAI immunogenicity population: all eligible participants who received the study intervention to which they were randomized, and had the 1month postvaccination blood collection for HAI assay within 27-42 days after vaccination,had atleast 1 valid and determinate HAI result at 1 month postvaccination blood collection,had no major protocol violations from randomization through 1 month postvaccination blood collection. 'Number Analyzed'=participants evaluable for specified rows. | Posted | Geometric Mean | 95% Confidence Interval | Titer | SSB: At 1 Month after Vaccination (Day 1) |
|
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)
Same event may appear as both SAE and non-SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. MedDRA versions used were v26.0 for SSA and v26.1 for SSB.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SSA: Group 1: RSVpreF + qIRV | Participants received 1 mL of combination of RSVpreF and qIRV intramuscularly on Day 1 [Vaccination 1]. | 0 | 125 | 0 | 125 | 117 | 125 |
| EG001 | SSA: Group 1: Placebo | Participants received placebo intramuscularly on 1 month after Vaccination 1 [Vaccination 2]. | 0 | 121 | 0 | 121 | 50 | 121 |
| EG002 | SSA: Group 2: qIRV | Participants received 1 mL of qIRV intramuscularly on Day 1 [Vaccination 1]. | 0 | 126 | 1 | 126 | 117 | 126 |
| EG003 | SSA: Group 2: RSVpreF | Participants received 1 mL of RSVpreF intramuscularly on 1 month after Vaccination 1 [Vaccination 2]. | 1 | 116 | 1 | 116 | 43 | 116 |
| EG004 | SSB: Group 1: RSVpreF + qIRV 1.0 mL Formulation | Participants aged >=50 years were randomized to receive 1.0 mL of combination of RSVpreF and qIRV intramuscularly on Day 1. | 0 | 101 | 2 | 101 | 91 | 101 |
| EG005 | SSB: Group 2: RSVpreF + qIRV 0.5 mL Formulation | Participants aged >=50 years were randomized to receive 0.5 mL of combination of RSVpreF and qIRV intramuscularly on Day 1. | 0 | 102 | 0 | 102 | 96 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Cardiac failure | Cardiac disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Haemorrhage intracranial | Nervous system disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Syncope | Nervous system disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Bundle branch block left | Cardiac disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Cardiac septal hypertrophy | Cardiac disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Dilated cardiomyopathy | Cardiac disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Left atrial dilatation | Cardiac disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Mitral valve incompetence | Cardiac disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Ventricular extrasystoles | Cardiac disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Vertigo | Ear and labyrinth disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Conjunctival haemorrhage | Eye disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Axillary pain | General disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Chest pain | General disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Influenza like illness | General disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Injection site bruising | General disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Injection site erythema | General disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Injection site lymphadenopathy | General disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Injection site pruritus | General disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Pyrexia | General disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Vaccination site papule | General disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Abdominal distension | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Chronic gastritis | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Coeliac disease | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Constipation | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Flatulence | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Gastritis | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Mouth ulceration | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Odynophagia | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Toothache | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Acute sinusitis | Infections and infestations | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Atypical pneumonia | Infections and infestations | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Bronchitis | Infections and infestations | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Conjunctivitis viral | Infections and infestations | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Diverticulitis | Infections and infestations | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Gastroenteritis | Infections and infestations | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Gastroenteritis viral | Infections and infestations | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Laryngitis | Infections and infestations | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Localised infection | Infections and infestations | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Oral candidiasis | Infections and infestations | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Pharyngitis | Infections and infestations | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Pharyngotonsillitis | Infections and infestations | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Pneumonia | Infections and infestations | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Sinusitis | Infections and infestations | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Tooth infection | Infections and infestations | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Urinary tract infection | Infections and infestations | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Buttock injury | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Joint injury | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Ligament sprain | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Tooth fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Troponin T increased | Investigations | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Muscle contracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Dizziness | Nervous system disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Headache | Nervous system disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Presyncope | Nervous system disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Sciatica | Nervous system disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Syncope | Nervous system disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Tension headache | Nervous system disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Trigeminal neuralgia | Nervous system disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Adjustment disorder with depressed mood | Psychiatric disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Dysuria | Renal and urinary disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Renal disorder | Renal and urinary disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Stress urinary incontinence | Renal and urinary disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Catarrh | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Rash papular | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Urticaria | Skin and subcutaneous tissue disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Haematoma | Vascular disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Hypertension | Vascular disorders | Non-systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Chills (CHILLS) | General disorders | Systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Fatigue (FATIGUE) | General disorders | Systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Injection site erythema (REDNESS) | General disorders | Systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Injection site pain (PAIN AT THE INJECTION SITE) | General disorders | Systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Injection site swelling (SWELLING) | General disorders | Systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Pyrexia (FEVER) | General disorders | Systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Diarrhoea (DIARRHEA) | Gastrointestinal disorders | Systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Nausea (NAUSEA) | Gastrointestinal disorders | Systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Vomiting (VOMITING) | Gastrointestinal disorders | Systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Arthralgia (NEW OR WORSENED JOINT PAIN) | Musculoskeletal and connective tissue disorders | Systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Myalgia (NEW OR WORSENED MUSCLE PAIN) | Musculoskeletal and connective tissue disorders | Systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
| |
| Headache (HEADACHE) | Nervous system disorders | Systematic Assessment | MedDRA v26.0 for SSA, MedDRA v26.1 for SSB |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 14, 2023 | Sep 25, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Refused further study procedures |
|
| Other |
|
| 65-79 years |
|
| >=80 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Pain at the injection site: Severe |
|
| Redness: Mild |
|
| Redness: Moderate |
|
| Redness: Severe |
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| Swelling: Mild |
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| Swelling: Moderate |
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| Swelling: Severe |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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Participants received 1 mL of qIRV intramuscularly on Day 1 [Vaccination 1].
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Participants aged >=50 years received 0.5 mL of combination of RSVpreF and qIRV intramuscularly on Day 1. Participants were followed up to maximum of 35 days after Vaccination.
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| Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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