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CompletedNCT05886777Updated Dec 18, 2024Results posted

A Study to Learn About Two or More Vaccines That Are Put Together as One Shot Against Infectious Lung Illnesses, Including COVID-19 and Respiratory Syncytial Virus (RSV).

A Phase 2 interventional study of Combination [RSVpreF+BNTb162b2] and Bivalent BNT162b2 (original/Omi BA.4/BA.5) in Healthy Participants, sponsored by Pfizer. Completed at 37 sites in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-18.

Sponsored by Pfizer · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
1,142
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

The purpose of the study is to learn about the safety and effects of a combined vaccine for RSV and COVID-19 when given with a seasonal flu vaccine or when given alone. A combined vaccine will help to reduce the number of vaccinations given when trying to prevent respiratory infections.

This study is seeking participants who:

  • are 65 years of age or older.
  • are healthy or have well-controlled chronic conditions.
  • in the past have received at least 3 US-authorized mRNA COVID 19 vaccines, with the most recent vaccine being an updated booster vaccine given at least more than or equal to 150 days before Visit A101 (Day 1).
  • have not had a flu shot in the last 120 days.
  • agree to be present for all study visits, procedures, and blood draws.

Participants will be involved in this study for 6 months. During this time, participants will have 2 study visits at the study clinic and a 6-month telephone contact.

02

Conditions studied

  • Healthy Participants

Keywords

  • SARS-CoV-2
  • COVID-19
  • Flu
  • Influenza
  • Vaccine
  • RSV
  • Respiratory Syncytial Virus
  • Combination vaccine
  • mRNA vaccine
03

In context

COVID-19

7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 1,142 is above the median of 100 across 4,175 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.

Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Browse Pfizer studies →

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

04

Who can participate

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

Eligibility criteria

Substudy A Inclusion Criteria:

  1. Male or female participants ≥65 years of age at Visit 1 (Day 1).
  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 signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
  5. Participants who have received at least 3 prior US authorized mRNA COVID 19 vaccines, with the last dose being an updated (bivalent) vaccine given at least ≥150 days before Visit A101 (Day 1).

Substudy A Exclusion Criteria:

  1. A confirmed diagnosis of COVID 19, 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. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
  4. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
  5. Allergy to egg proteins (egg or egg products) or chicken proteins.
  6. Any 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 enrollment through conclusion of the study.
  8. Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, 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 ≤120 days before study enrollment.
  11. Participation in other studies involving a study intervention within 28 days before randomization. Anticipated participation in other studies within 28 days after receipt of study intervention in this study.
  12. 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 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
1,142 participants (actual)

Study arms

  • Experimental
    Group 1

    Combination \[RSVpreF+BNT162b2\] + Quadrivalent influenza vaccine (QIV)

    Biological: Combination [RSVpreF+BNTb162b2] · Biological: QIV

  • Experimental
    Group 2

    Combination \[RSVpreF+BNT162b2\] + placebo

    Biological: Combination [RSVpreF+BNTb162b2] · Biological: Normal Saline Placebo

  • Active comparator
    Group 3

    BNT162b2 + placebo

    Biological: Bivalent BNT162b2 (original/Omi BA.4/BA.5) · Biological: Normal Saline Placebo

  • Active comparator
    Group 4

    RSVpreF + placebo

    Biological: RSVpreF · Biological: Normal Saline Placebo

  • Active comparator
    Group 5

    QIV + placebo

    Biological: QIV · Biological: Normal Saline Placebo

  • Experimental
    Group 6

    Coadministration RSVpreF + bivalent BNT162b2 + placebo

    Biological: Bivalent BNT162b2 (original/Omi BA.4/BA.5) · Biological: RSVpreF · Biological: Normal Saline Placebo

  • Experimental
    Group 7

    Coadministration RSVpreF + bivalent BNT162b2 + QIV

    Biological: Bivalent BNT162b2 (original/Omi BA.4/BA.5) · Biological: RSVpreF · Biological: QIV

Interventions

  • BiologicalCombination [RSVpreF+BNTb162b2]

    Combination of RSVpreF and Bivalent BNT162b2 given as a single intramuscular injection

  • BiologicalBivalent BNT162b2 (original/Omi BA.4/BA.5)

    Bivalent BNT162b2 given as an intramuscular injection

  • BiologicalRSVpreF

    RSVpreF given as an intramuscular injection

  • BiologicalQIV

    Licensed QIV given as an intramuscular injection

  • BiologicalNormal Saline Placebo

    Normal saline (0.9% sodium chloride solution for injection)

06

What researchers measure

Primary outcomes

  1. 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 electronic diary (e-diary). Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity and severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 centimeter (cm) and 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: Day 1 to Day 7 after Vaccination on Day 1

  2. Percentage of Participants With Systemic Events Within 7 Days After Vaccination

    Systemic events included fever, fatigue, headache, vomiting, diarrhea, chills, new/worsened muscle pain and joint pain. These were recorded by participants in an e-diary. Fever was defined as oral temperature greater than or equal to (\>=) 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 and severe: \>38.9 to 40.0 deg C. Vomiting was categorized as mild: 1-2 times in 24 hours (h); moderate: \>2 times in 24h; severe: required intravenous (IV) hydration. Diarrhea was categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h and severe: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity and severe: prevented daily routine activity.

    Time frame: Day 1 to Day 7 after Vaccination on Day 1

  3. Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination

    An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention were included in evaluation of this outcome measure.

    Time frame: Within 1 Month after Vaccination

  4. Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination

    An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention. 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 were included in this outcome measure.

    Time frame: Within 6 Months after Vaccination

  5. Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Neutralizing Titers (NTs) for Respiratory Syncytial Virus Subgroup A (RSV A) at 1 Month After Vaccination: Group 1 Versus Group 4

    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV A were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV A, calculated as ratio of GMTs of Group 1 to Group 4, was reported in the statistical analysis section.

    Time frame: 1 Month after Vaccination

  6. GMT and GMR of NTs for Respiratory Syncytial Virus Subgroup B (RSV B) at 1 Month After Vaccination: Group 1 Versus Group 4

    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV B were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV B, calculated as ratio of GMTs of Group 1 to Group 4, was reported in the statistical analysis section.

    Time frame: 1 Month after Vaccination

  7. GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 1 Versus Group 3

    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 Omicron BA.4/BA.5 were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5, calculated as ratio of GMTs of Group 1 to Group 3, was reported in the statistical analysis section.

    Time frame: 1 Month after Vaccination

  8. GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 1 Versus Group 3

    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 reference strain were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 reference strain calculated as ratio of GMTs of Group 1 to Group 3, was reported in the statistical analysis section.

    Time frame: 1 Month after Vaccination

  9. GMT and GMR of the Strain-Specific Hemagglutination Inhibition (HAI) Titers (H1N1 A/Victoria) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5

    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (H1N1 A/Victoria) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (H1N1 A/Victoria), calculated as ratio of GMTs of Group 1 to Group 5, was reported in the statistical analysis section.

    Time frame: 1 Month after Vaccination

  10. GMT and GMR of the Strain-Specific HAI Titers (H3N2 A/Darwin) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5

    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (H3N2 A/Darwin) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (H3N2 A/Darwin), calculated as ratio of GMTs of Group 1 to Group 5, was reported in the statistical analysis section.

    Time frame: 1 Month after Vaccination

  11. GMT and GMR of the Strain-Specific HAI Titers (B/Austria) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5

    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (B/Austria) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (B/Austria), calculated as ratio of GMTs of Group 1 to Group 5, was reported in the statistical analysis section.

    Time frame: 1 Month after Vaccination

  12. GMT and GMR of the Strain-Specific HAI Titers (B/Phuket) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5

    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (B/Phuket) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (B/Phuket), calculated as ratio of GMTs of Group 1 to Group 5, was reported in the statistical analysis section.

    Time frame: 1 Month after Vaccination

  13. GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 2 Versus Group 4

    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV A were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV A, calculated as ratio of GMTs of Group 2 to Group 4, was reported in the statistical analysis section.

    Time frame: 1 Month after Vaccination

  14. GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 2 Versus Group 4

    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV B were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV B, calculated as ratio of GMTs of Group 2 to Group 4, was reported in the statistical analysis section.

    Time frame: 1 Month after Vaccination

  15. GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 2 Versus Group 3

    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 Omicron BA.4/BA.5 were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5, calculated as ratio of GMTs of Group 2 to Group 3, was reported in the statistical analysis section.

    Time frame: 1 Month after Vaccination

  16. GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 2 Versus Group 3

    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 reference strain were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 reference strain calculated as ratio of GMTs of Group 2 to Group 3, was reported in the statistical analysis section.

    Time frame: 1 Month after Vaccination

Secondary outcomes

  1. GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 7 Versus Group 4

    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV A were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV A, calculated as ratio of GMTs of Group 7 to Group 4, was reported in the statistical analysis section.

    Time frame: 1 Month after Vaccination

  2. GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 7 Versus Group 4

    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV B were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV B, calculated as ratio of GMTs of Group 7 to Group 4, was reported in the statistical analysis section.

    Time frame: 1 Month after Vaccination

  3. GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 7 Versus Group 3

    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 Omicron BA.4/BA.5 were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5, calculated as ratio of GMTs of Group 7 to Group 3, was reported in the statistical analysis section.

    Time frame: 1 Month after Vaccination

  4. GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 7 Versus Group 3

    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 reference strain were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 reference strain calculated as ratio of GMTs of Group 7 to Group 3, was reported in the statistical analysis section.

    Time frame: 1 Month after Vaccination

  5. GMT and GMR of the Strain-Specific HAI Titers (H1N1 A/Victoria) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5

    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (H1N1 A/Victoria) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (H1N1 A/Victoria), calculated as ratio of GMTs of Group 7 to Group 5, was reported in the statistical analysis section.

    Time frame: 1 Month after Vaccination

  6. GMT and GMR of the Strain-Specific HAI Titers (H3N2 A/Darwin) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5

    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (H3N2 A/Darwin) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (H3N2 A/Darwin), calculated as ratio of GMTs of Group 7 to Group 5, was reported in the statistical analysis section.

    Time frame: 1 Month after Vaccination

  7. GMT and GMR of the Strain-Specific HAI Titers (B/Austria) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5

    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (B/Austria) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (B/Austria), calculated as ratio of GMTs of Group 7 to Group 5, was reported in the statistical analysis section.

    Time frame: 1 Month after Vaccination

  8. GMT and GMR of the Strain-Specific HAI Titers (B/Phuket) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5

    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (B/Phuket) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (B/Phuket), calculated as ratio of GMTs of Group 7 to Group 5, was reported in the statistical analysis section.

    Time frame: 1 Month after Vaccination

  9. GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 6 Versus Group 4

    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV A were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV A, calculated as ratio of GMTs of Group 6 to Group 4, was reported in the statistical analysis section.

    Time frame: 1 Month after Vaccination

  10. GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 6 Versus Group 4

    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV B were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV B, calculated as ratio of GMTs of Group 6 to Group 4, was reported in the statistical analysis section.

    Time frame: 1 Month after Vaccination

  11. GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 6 Versus Group 3

    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 Omicron BA.4/BA.5 were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5, calculated as ratio of GMTs of Group 6 to Group 3, was reported in the statistical analysis section.

    Time frame: 1 Month after Vaccination

  12. GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 6 Versus Group 3

    GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 reference strain were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 reference strain calculated as ratio of GMTs of Group 6 to Group 3, was reported in the statistical analysis section.

    Time frame: 1 Month after Vaccination

07

Results

Posted Dec 18, 2024

Participant flow

A total of 1142 participants were enrolled in this study, 1083 participants were randomized to receive study vaccination, out of which, 1073 participants were vaccinated.

Participant flow — Overall Study
MilestoneGroup 1: [RSVpreF + BNT162b2] + QIVGroup 2: [RSVpreF+BNT162b2] + PlaceboGroup 3: BNT162b2 + PlaceboGroup 4: RSVpreF + PlaceboGroup 5: QIV + PlaceboGroup 6: RSVpreF + BNT162b2 + PlaceboGroup 7: RSVpreF + BNT162b2 + QIV
Started155154152155151158158
Completed153151147150148155157
Not completed2355331
Withdrew: Lost to follow-up1021020
Withdrew: Other0210000
Withdrew: Withdrawal by subject1014311
Withdrew: Protocol violation0010000
Withdrew: No longer met eligibility criteria0100000

Outcome measures

PrimaryPercentage 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 electronic diary (e-diary). Pain at injection site was graded as mild: did not interfere with activity; moderate: interfered with activity and severe: prevented daily activity. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit=0.5 centimeter (cm) and 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:
Day 1 to Day 7 after Vaccination on Day 1
Reported as:
Number · Percentage of participants
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Percentage of participantsGroup 1: [RSVpreF + BNT162b2] + QIVGroup 2: [RSVpreF+BNT162b2] + PlaceboGroup 3: BNT162b2 + PlaceboGroup 4: RSVpreF + PlaceboGroup 5: QIV + PlaceboGroup 6: RSVpreF + BNT162b2 + PlaceboGroup 7: RSVpreF + BNT162b2 + QIV
Pain at the injection site: Mild49.4 (41.2 to 57.5)45.8 (37.7 to 54.0)54.7 (46.3 to 62.8)10.5 (6.1 to 16.5)48.3 (40.1 to 56.6)45.2 (37.3 to 53.4)44.9 (37.0 to 53.0)
Pain at the injection site: Moderate7.8 (4.1 to 13.2)5.9 (2.7 to 10.9)7.3 (3.7 to 12.7)0 (0.0 to 2.4)3.4 (1.1 to 7.7)11.5 (6.9 to 17.5)7.6 (4.0 to 12.9)
Pain at the injection site: Severe0 (0.0 to 2.4)0.7 (0.0 to 3.6)0.7 (0.0 to 3.7)0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.3)1.3 (0.2 to 4.5)
Redness: Mild3.2 (1.1 to 7.4)5.9 (2.7 to 10.9)5.3 (2.3 to 10.2)1.3 (0.2 to 4.7)2.0 (0.4 to 5.8)6.4 (3.1 to 11.4)5.1 (2.2 to 9.7)
Redness: Moderate4.5 (1.8 to 9.1)3.3 (1.1 to 7.5)2.0 (0.4 to 5.7)1.3 (0.2 to 4.7)2.0 (0.4 to 5.8)5.1 (2.2 to 9.8)3.2 (1.0 to 7.2)
Redness: Severe0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)1.3 (0.2 to 4.5)0.6 (0.0 to 3.5)
Swelling: Mild3.2 (1.1 to 7.4)6.5 (3.2 to 11.7)5.3 (2.3 to 10.2)2.0 (0.4 to 5.7)4.0 (1.5 to 8.6)7.6 (4.0 to 13.0)2.5 (0.7 to 6.4)
Swelling: Moderate1.9 (0.4 to 5.6)4.6 (1.9 to 9.2)4.0 (1.5 to 8.5)1.3 (0.2 to 4.7)2.0 (0.4 to 5.8)4.5 (1.8 to 9.0)4.4 (1.8 to 8.9)
Swelling: Severe0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)0.6 (0.0 to 3.5)0 (0.0 to 2.3)
PrimaryPercentage of Participants With Systemic Events Within 7 Days After Vaccination

Systemic events included fever, fatigue, headache, vomiting, diarrhea, chills, new/worsened muscle pain and joint pain. These were recorded by participants in an e-diary. Fever was defined as oral temperature greater than or equal to (\>=) 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 and severe: \>38.9 to 40.0 deg C. Vomiting was categorized as mild: 1-2 times in 24 hours (h); moderate: \>2 times in 24h; severe: required intravenous (IV) hydration. Diarrhea was categorized as mild: 2-3 loose stools in 24h; moderate: 4-5 loose stools in 24h and severe: 6 or more loose stools in 24h. Headache, fatigue, chills, new/worsened muscle pain and joint pain were categorized as mild: didn't interfere with activity; moderate: some interference with activity and severe: prevented daily routine activity.

Time frame:
Day 1 to Day 7 after Vaccination on Day 1
Reported as:
Number · Percentage of participants
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Percentage of participantsGroup 1: [RSVpreF + BNT162b2] + QIVGroup 2: [RSVpreF+BNT162b2] + PlaceboGroup 3: BNT162b2 + PlaceboGroup 4: RSVpreF + PlaceboGroup 5: QIV + PlaceboGroup 6: RSVpreF + BNT162b2 + PlaceboGroup 7: RSVpreF + BNT162b2 + QIV
Fever: Mild3.2 (1.1 to 7.4)2.0 (0.4 to 5.6)1.3 (0.2 to 4.7)0 (0.0 to 2.4)0 (0.0 to 2.4)1.3 (0.2 to 4.5)2.5 (0.7 to 6.4)
Fever: Moderate0.6 (0.0 to 3.6)1.3 (0.2 to 4.6)0 (0.0 to 2.4)1.3 (0.2 to 4.7)0 (0.0 to 2.4)0.6 (0.0 to 3.5)1.9 (0.4 to 5.4)
Fever: Severe0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.3)0 (0.0 to 2.3)
Fatigue: Mild21.4 (15.2 to 28.8)17.0 (11.4 to 23.9)18.0 (12.2 to 25.1)15.8 (10.4 to 22.6)17.4 (11.7 to 24.5)17.2 (11.6 to 24.0)20.9 (14.8 to 28.1)
Fatigue: Moderate19.5 (13.5 to 26.6)19.0 (13.1 to 26.1)16.7 (11.1 to 23.6)7.9 (4.1 to 13.4)10.7 (6.3 to 16.9)20.4 (14.4 to 27.5)24.1 (17.6 to 31.5)
Fatigue: Severe1.3 (0.2 to 4.6)1.3 (0.2 to 4.6)0.7 (0.0 to 3.7)0.7 (0.0 to 3.6)0.7 (0.0 to 3.7)1.3 (0.2 to 4.5)1.9 (0.4 to 5.4)
Headache: Mild16.2 (10.8 to 23.0)19.0 (13.1 to 26.1)14.0 (8.9 to 20.6)15.8 (10.4 to 22.6)10.1 (5.7 to 16.1)15.3 (10.0 to 21.9)11.4 (6.9 to 17.4)
Headache: Moderate5.2 (2.3 to 10.0)5.9 (2.7 to 10.9)8.7 (4.7 to 14.4)3.3 (1.1 to 7.5)2.7 (0.7 to 6.7)8.3 (4.5 to 13.7)7.0 (3.5 to 12.1)
Headache: Severe0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)0.6 (0.0 to 3.5)0.6 (0.0 to 3.5)
Vomiting: Mild1.3 (0.2 to 4.6)0 (0.0 to 2.4)1.3 (0.2 to 4.7)2.6 (0.7 to 6.6)0.7 (0.0 to 3.7)0.6 (0.0 to 3.5)1.3 (0.2 to 4.5)
Vomiting: Moderate0.6 (0.0 to 3.6)0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.3)0 (0.0 to 2.3)
Vomiting: Severe0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.3)0 (0.0 to 2.3)
Diarrhea: Mild5.8 (2.7 to 10.8)3.3 (1.1 to 7.5)4.0 (1.5 to 8.5)7.2 (3.7 to 12.6)7.4 (3.7 to 12.8)4.5 (1.8 to 9.0)10.1 (5.9 to 15.9)
Diarrhea: Moderate5.2 (2.3 to 10.0)0 (0.0 to 2.4)1.3 (0.2 to 4.7)2.6 (0.7 to 6.6)2.0 (0.4 to 5.8)0 (0.0 to 2.3)1.9 (0.4 to 5.4)
Diarrhea: Severe0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)0.7 (0.0 to 3.6)0 (0.0 to 2.4)0 (0.0 to 2.3)0.6 (0.0 to 3.5)
Chills: Mild7.1 (3.6 to 12.4)5.9 (2.7 to 10.9)6.7 (3.2 to 11.9)2.0 (0.4 to 5.7)2.0 (0.4 to 5.8)4.5 (1.8 to 9.0)5.7 (2.6 to 10.5)
Chills: Moderate3.2 (1.1 to 7.4)2.0 (0.4 to 5.6)2.7 (0.7 to 6.7)2.0 (0.4 to 5.7)0 (0.0 to 2.4)5.1 (2.2 to 9.8)5.1 (2.2 to 9.7)
Chills: Severe0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)0.6 (0.0 to 3.5)0 (0.0 to 2.3)
New or worsened muscle pain: Mild7.8 (4.1 to 13.2)5.9 (2.7 to 10.9)6.0 (2.8 to 11.1)3.9 (1.5 to 8.4)6.0 (2.8 to 11.2)8.3 (4.5 to 13.7)7.0 (3.5 to 12.1)
New or worsened muscle pain: Moderate5.2 (2.3 to 10.0)4.6 (1.9 to 9.2)4.7 (1.9 to 9.4)5.9 (2.7 to 10.9)4.7 (1.9 to 9.4)5.1 (2.2 to 9.8)7.6 (4.0 to 12.9)
New or worsened muscle pain: Severe0 (0.0 to 2.4)0.7 (0.0 to 3.6)0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)0.6 (0.0 to 3.5)0 (0.0 to 2.3)
New or worsened joint pain: Mild4.5 (1.8 to 9.1)4.6 (1.9 to 9.2)1.3 (0.2 to 4.7)2.0 (0.4 to 5.7)0.7 (0.0 to 3.7)4.5 (1.8 to 9.0)5.1 (2.2 to 9.7)
New or worsened joint pain: Moderate3.9 (1.4 to 8.3)2.6 (0.7 to 6.6)7.3 (3.7 to 12.7)3.9 (1.5 to 8.4)3.4 (1.1 to 7.7)5.7 (2.7 to 10.6)3.8 (1.4 to 8.1)
New or worsened joint pain: Severe0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.4)0 (0.0 to 2.3)0.6 (0.0 to 3.5)
PrimaryPercentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination

An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention were included in evaluation of this outcome measure.

Time frame:
Within 1 Month after Vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
Percentage of participantsGroup 1: [RSVpreF + BNT162b2] + QIVGroup 2: [RSVpreF+BNT162b2] + PlaceboGroup 3: BNT162b2 + PlaceboGroup 4: RSVpreF + PlaceboGroup 5: QIV + PlaceboGroup 6: RSVpreF + BNT162b2 + PlaceboGroup 7: RSVpreF + BNT162b2 + QIV
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination9.1 (5.1 to 14.8)8.5 (4.6 to 14.1)8.0 (4.2 to 13.6)7.2 (3.7 to 12.6)8.1 (4.2 to 13.6)8.9 (5.0 to 14.5)8.9 (4.9 to 14.4)
PrimaryPercentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention. 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 were included in this outcome measure.

Time frame:
Within 6 Months after Vaccination
Reported as:
Number · Percentage of participants
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
Percentage of participantsGroup 1: [RSVpreF + BNT162b2] + QIVGroup 2: [RSVpreF+BNT162b2] + PlaceboGroup 3: BNT162b2 + PlaceboGroup 4: RSVpreF + PlaceboGroup 5: QIV + PlaceboGroup 6: RSVpreF + BNT162b2 + PlaceboGroup 7: RSVpreF + BNT162b2 + QIV
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination0.6 (0.0 to 3.6)1.3 (0.2 to 4.6)2.7 (0.7 to 6.7)1.3 (0.2 to 4.7)1.3 (0.2 to 4.8)0.6 (0.0 to 3.5)1.9 (0.4 to 5.4)
PrimaryGeometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Neutralizing Titers (NTs) for Respiratory Syncytial Virus Subgroup A (RSV A) at 1 Month After Vaccination: Group 1 Versus Group 4

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV A were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV A, calculated as ratio of GMTs of Group 1 to Group 4, was reported in the statistical analysis section.

Time frame:
1 Month after Vaccination
Reported as:
Geometric mean · Titer
Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Neutralizing Titers (NTs) for Respiratory Syncytial Virus Subgroup A (RSV A) at 1 Month After Vaccination: Group 1 Versus Group 4
TiterGroup 1: [RSVpreF + BNT162b2] + QIVGroup 4: RSVpreF + Placebo
Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) of Neutralizing Titers (NTs) for Respiratory Syncytial Virus Subgroup A (RSV A) at 1 Month After Vaccination: Group 1 Versus Group 418284 (15576.6 to 21462.6)18498 (15570.0 to 21975.9)
Statistical analysis
  • Group 1: [RSVpreF + BNT162b2] + QIV vs Group 4: RSVpreF + Placebo · Geometric mean ratio: 0.99 · 97.5% CI 0.782 to 1.249GMRs and 2-sided confidence intervals (CIs) were calculated by exponentiating mean differences of logarithms of titers (Intervention Group \[Group 1\] minus Reference Group \[Group 4\]) and corresponding CIs (based on the Student t distribution).
PrimaryGMT and GMR of NTs for Respiratory Syncytial Virus Subgroup B (RSV B) at 1 Month After Vaccination: Group 1 Versus Group 4

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV B were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV B, calculated as ratio of GMTs of Group 1 to Group 4, was reported in the statistical analysis section.

Time frame:
1 Month after Vaccination
Reported as:
Geometric mean · Titer
GMT and GMR of NTs for Respiratory Syncytial Virus Subgroup B (RSV B) at 1 Month After Vaccination: Group 1 Versus Group 4
TiterGroup 1: [RSVpreF + BNT162b2] + QIVGroup 4: RSVpreF + Placebo
GMT and GMR of NTs for Respiratory Syncytial Virus Subgroup B (RSV B) at 1 Month After Vaccination: Group 1 Versus Group 415014 (12543.8 to 17971.8)16677 (13884.0 to 20031.4)
Statistical analysis
  • Group 1: [RSVpreF + BNT162b2] + QIV vs Group 4: RSVpreF + Placebo · Geometric mean ratio: 0.90 · 97.5% CI 0.697 to 1.162GMRs and 2-sided CIs were calculated by exponentiating mean differences of the logarithms of titers (Intervention Group \[Group 1\] minus Reference Group \[Group 4\]) and corresponding CIs (based on the Student t distribution).
PrimaryGMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 1 Versus Group 3

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 Omicron BA.4/BA.5 were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5, calculated as ratio of GMTs of Group 1 to Group 3, was reported in the statistical analysis section.

Time frame:
1 Month after Vaccination
Reported as:
Geometric mean · Titer
GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 1 Versus Group 3
TiterGroup 1: [RSVpreF + BNT162b2] + QIVGroup 3: BNT162b2 + Placebo
GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 1 Versus Group 33083 (2476.7 to 3838.1)3667 (2861.9 to 4697.5)
Statistical analysis
  • Group 1: [RSVpreF + BNT162b2] + QIV vs Group 3: BNT162b2 + Placebo · Geometric mean ratio: 0.84 · 97.5% CI 0.605 to 1.168GMRs and 2-sided CIs were calculated by exponentiating mean differences of the logarithms of titers (Intervention Group \[Group 1\] minus Reference Group \[Group 3\]) and corresponding CIs (based on the Student t distribution).
PrimaryGMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 1 Versus Group 3

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 reference strain were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 reference strain calculated as ratio of GMTs of Group 1 to Group 3, was reported in the statistical analysis section.

Time frame:
1 Month after Vaccination
Reported as:
Geometric mean · Titer
GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 1 Versus Group 3
TiterGroup 1: [RSVpreF + BNT162b2] + QIVGroup 3: BNT162b2 + Placebo
GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 1 Versus Group 39849 (8497.6 to 11416.5)12439 (10185.9 to 15190.1)
Statistical analysis
  • Group 1: [RSVpreF + BNT162b2] + QIV vs Group 3: BNT162b2 + Placebo · Geometric mean ratio: 0.79 · 97.5% CI 0.618 to 1.014GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).
PrimaryGMT and GMR of the Strain-Specific Hemagglutination Inhibition (HAI) Titers (H1N1 A/Victoria) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (H1N1 A/Victoria) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (H1N1 A/Victoria), calculated as ratio of GMTs of Group 1 to Group 5, was reported in the statistical analysis section.

Time frame:
1 Month after Vaccination
Reported as:
Geometric mean · Titer
GMT and GMR of the Strain-Specific Hemagglutination Inhibition (HAI) Titers (H1N1 A/Victoria) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5
TiterGroup 1: [RSVpreF + BNT162b2] + QIVGroup 5: QIV + Placebo
GMT and GMR of the Strain-Specific Hemagglutination Inhibition (HAI) Titers (H1N1 A/Victoria) of QIV at 1 Month After Vaccination: Group 1 Versus Group 570 (56.8 to 87.3)67 (54.1 to 82.0)
Statistical analysis
  • Group 1: [RSVpreF + BNT162b2] + QIV vs Group 5: QIV + Placebo · Geometric mean ratio: 1.06 · 97.5% CI 0.785 to 1.423GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).
PrimaryGMT and GMR of the Strain-Specific HAI Titers (H3N2 A/Darwin) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (H3N2 A/Darwin) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (H3N2 A/Darwin), calculated as ratio of GMTs of Group 1 to Group 5, was reported in the statistical analysis section.

Time frame:
1 Month after Vaccination
Reported as:
Geometric mean · Titer
GMT and GMR of the Strain-Specific HAI Titers (H3N2 A/Darwin) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5
TiterGroup 1: [RSVpreF + BNT162b2] + QIVGroup 5: QIV + Placebo
GMT and GMR of the Strain-Specific HAI Titers (H3N2 A/Darwin) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5138 (117.3 to 162.3)122 (105.7 to 141.4)
Statistical analysis
  • Group 1: [RSVpreF + BNT162b2] + QIV vs Group 5: QIV + Placebo · Geometric mean ratio: 1.13 · 97.5% CI 0.909 to 1.402GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).
PrimaryGMT and GMR of the Strain-Specific HAI Titers (B/Austria) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (B/Austria) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (B/Austria), calculated as ratio of GMTs of Group 1 to Group 5, was reported in the statistical analysis section.

Time frame:
1 Month after Vaccination
Reported as:
Geometric mean · Titer
GMT and GMR of the Strain-Specific HAI Titers (B/Austria) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5
TiterGroup 1: [RSVpreF + BNT162b2] + QIVGroup 5: QIV + Placebo
GMT and GMR of the Strain-Specific HAI Titers (B/Austria) of QIV at 1 Month After Vaccination: Group 1 Versus Group 571 (57.5 to 88.8)68 (54.3 to 84.8)
Statistical analysis
  • Group 1: [RSVpreF + BNT162b2] + QIV vs Group 5: QIV + Placebo · Geometric mean ratio: 1.05 · 97.5% CI 0.773 to 1.434GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).
PrimaryGMT and GMR of the Strain-Specific HAI Titers (B/Phuket) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (B/Phuket) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (B/Phuket), calculated as ratio of GMTs of Group 1 to Group 5, was reported in the statistical analysis section.

Time frame:
1 Month after Vaccination
Reported as:
Geometric mean · Titer
GMT and GMR of the Strain-Specific HAI Titers (B/Phuket) of QIV at 1 Month After Vaccination: Group 1 Versus Group 5
TiterGroup 1: [RSVpreF + BNT162b2] + QIVGroup 5: QIV + Placebo
GMT and GMR of the Strain-Specific HAI Titers (B/Phuket) of QIV at 1 Month After Vaccination: Group 1 Versus Group 530 (23.6 to 37.2)27 (21.5 to 33.3)
Statistical analysis
  • Group 1: [RSVpreF + BNT162b2] + QIV vs Group 5: QIV + Placebo · Geometric mean ratio: 1.11 · 97.5% CI 0.807 to 1.515GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 1\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).
PrimaryGMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 2 Versus Group 4

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV A were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV A, calculated as ratio of GMTs of Group 2 to Group 4, was reported in the statistical analysis section.

Time frame:
1 Month after Vaccination
Reported as:
Geometric mean · Titer
GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 2 Versus Group 4
TiterGroup 2: [RSVpreF+BNT162b2] + PlaceboGroup 4: RSVpreF + Placebo
GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 2 Versus Group 418414 (15172.8 to 22346.9)18498 (15570.0 to 21975.9)
Statistical analysis
  • Group 2: [RSVpreF+BNT162b2] + Placebo vs Group 4: RSVpreF + Placebo · Geometric mean ratio: 1.00 · 97.5% CI 0.769 to 1.288GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 2\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).
PrimaryGMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 2 Versus Group 4

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV B were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV B, calculated as ratio of GMTs of Group 2 to Group 4, was reported in the statistical analysis section.

Time frame:
1 Month after Vaccination
Reported as:
Geometric mean · Titer
GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 2 Versus Group 4
TiterGroup 2: [RSVpreF+BNT162b2] + PlaceboGroup 4: RSVpreF + Placebo
GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 2 Versus Group 418227 (14961.9 to 22204.2)16677 (13884.0 to 20031.4)
Statistical analysis
  • Group 2: [RSVpreF+BNT162b2] + Placebo vs Group 4: RSVpreF + Placebo · Geometric mean ratio: 1.09 · 97.5% CI 0.836 to 1.429GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 2\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).
PrimaryGMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 2 Versus Group 3

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 Omicron BA.4/BA.5 were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5, calculated as ratio of GMTs of Group 2 to Group 3, was reported in the statistical analysis section.

Time frame:
1 Month after Vaccination
Reported as:
Geometric mean · Titer
GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 2 Versus Group 3
TiterGroup 2: [RSVpreF+BNT162b2] + PlaceboGroup 3: BNT162b2 + Placebo
GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 2 Versus Group 33083 (2412.5 to 3940.4)3667 (2861.9 to 4697.5)
Statistical analysis
  • Group 2: [RSVpreF+BNT162b2] + Placebo vs Group 3: BNT162b2 + Placebo · Geometric mean ratio: 0.84 · 97.5% CI 0.594 to 1.190GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 2\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).
PrimaryGMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 2 Versus Group 3

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 reference strain were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 reference strain calculated as ratio of GMTs of Group 2 to Group 3, was reported in the statistical analysis section.

Time frame:
1 Month after Vaccination
Reported as:
Geometric mean · Titer
GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 2 Versus Group 3
TiterGroup 2: [RSVpreF+BNT162b2] + PlaceboGroup 3: BNT162b2 + Placebo
GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 2 Versus Group 310489 (8500.2 to 12943.5)12439 (10185.9 to 15190.1)
Statistical analysis
  • Group 2: [RSVpreF+BNT162b2] + Placebo vs Group 3: BNT162b2 + Placebo · Geometric mean ratio: 0.84 · 97.5% CI 0.632 to 1.125GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 2\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).
SecondaryGMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 7 Versus Group 4

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV A were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV A, calculated as ratio of GMTs of Group 7 to Group 4, was reported in the statistical analysis section.

Time frame:
1 Month after Vaccination
Reported as:
Geometric mean · Titer
GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 7 Versus Group 4
TiterGroup 7: RSVpreF + BNT162b2 + QIVGroup 4: RSVpreF + Placebo
GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 7 Versus Group 426303 (22338.8 to 30970.5)18498 (15570.0 to 21975.9)
Statistical analysis
  • Group 7: RSVpreF + BNT162b2 + QIV vs Group 4: RSVpreF + Placebo · Geometric mean ratio: 1.42 · 97.5% CI 1.123 to 1.801GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).
SecondaryGMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 7 Versus Group 4

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV B were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV B, calculated as ratio of GMTs of Group 7 to Group 4, was reported in the statistical analysis section.

Time frame:
1 Month after Vaccination
Reported as:
Geometric mean · Titer
GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 7 Versus Group 4
TiterGroup 7: RSVpreF + BNT162b2 + QIVGroup 4: RSVpreF + Placebo
GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 7 Versus Group 421182 (17525.4 to 25600.8)16677 (13884.0 to 20031.4)
Statistical analysis
  • Group 7: RSVpreF + BNT162b2 + QIV vs Group 4: RSVpreF + Placebo · Geometric mean ratio: 1.27 · 97.5% CI 0.977 to 1.651GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).
SecondaryGMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 7 Versus Group 3

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 Omicron BA.4/BA.5 were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5, calculated as ratio of GMTs of Group 7 to Group 3, was reported in the statistical analysis section.

Time frame:
1 Month after Vaccination
Reported as:
Geometric mean · Titer
GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 7 Versus Group 3
TiterGroup 7: RSVpreF + BNT162b2 + QIVGroup 3: BNT162b2 + Placebo
GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 7 Versus Group 33148 (2482.6 to 3992.0)3667 (2861.9 to 4697.5)
Statistical analysis
  • Group 7: RSVpreF + BNT162b2 + QIV vs Group 3: BNT162b2 + Placebo · Geometric mean ratio: 0.86 · 97.5% CI 0.610 to 1.208GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).
SecondaryGMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 7 Versus Group 3

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 reference strain were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 reference strain calculated as ratio of GMTs of Group 7 to Group 3, was reported in the statistical analysis section.

Time frame:
1 Month after Vaccination
Reported as:
Geometric mean · Titer
GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 7 Versus Group 3
TiterGroup 7: RSVpreF + BNT162b2 + QIVGroup 3: BNT162b2 + Placebo
GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 7 Versus Group 312588 (10312.2 to 15365.4)12439 (10185.9 to 15190.1)
Statistical analysis
  • Group 7: RSVpreF + BNT162b2 + QIV vs Group 3: BNT162b2 + Placebo · Geometric mean ratio: 1.01 · 97.5% CI 0.764 to 1.340GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).
SecondaryGMT and GMR of the Strain-Specific HAI Titers (H1N1 A/Victoria) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (H1N1 A/Victoria) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (H1N1 A/Victoria), calculated as ratio of GMTs of Group 7 to Group 5, was reported in the statistical analysis section.

Time frame:
1 Month after Vaccination
Reported as:
Geometric mean · Titer
GMT and GMR of the Strain-Specific HAI Titers (H1N1 A/Victoria) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5
TiterGroup 7: RSVpreF + BNT162b2 + QIVGroup 5: QIV + Placebo
GMT and GMR of the Strain-Specific HAI Titers (H1N1 A/Victoria) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5166 (141.0 to 194.7)67 (54.1 to 82.0)
Statistical analysis
  • Group 7: RSVpreF + BNT162b2 + QIV vs Group 5: QIV + Placebo · Geometric mean ratio: 2.49 · 97.5% CI 1.914 to 3.232GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).
SecondaryGMT and GMR of the Strain-Specific HAI Titers (H3N2 A/Darwin) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (H3N2 A/Darwin) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (H3N2 A/Darwin), calculated as ratio of GMTs of Group 7 to Group 5, was reported in the statistical analysis section.

Time frame:
1 Month after Vaccination
Reported as:
Geometric mean · Titer
GMT and GMR of the Strain-Specific HAI Titers (H3N2 A/Darwin) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5
TiterGroup 7: RSVpreF + BNT162b2 + QIVGroup 5: QIV + Placebo
GMT and GMR of the Strain-Specific HAI Titers (H3N2 A/Darwin) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5159 (135.6 to 186.5)122 (105.7 to 141.4)
Statistical analysis
  • Group 7: RSVpreF + BNT162b2 + QIV vs Group 5: QIV + Placebo · Geometric mean ratio: 1.30 · 97.5% CI 1.049 to 1.612GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).
SecondaryGMT and GMR of the Strain-Specific HAI Titers (B/Austria) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (B/Austria) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (B/Austria), calculated as ratio of GMTs of Group 7 to Group 5, was reported in the statistical analysis section.

Time frame:
1 Month after Vaccination
Reported as:
Geometric mean · Titer
GMT and GMR of the Strain-Specific HAI Titers (B/Austria) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5
TiterGroup 7: RSVpreF + BNT162b2 + QIVGroup 5: QIV + Placebo
GMT and GMR of the Strain-Specific HAI Titers (B/Austria) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5107 (85.8 to 134.4)68 (54.3 to 84.8)
Statistical analysis
  • Group 7: RSVpreF + BNT162b2 + QIV vs Group 5: QIV + Placebo · Geometric mean ratio: 1.58 · 97.5% CI 1.155 to 2.165GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).
SecondaryGMT and GMR of the Strain-Specific HAI Titers (B/Phuket) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for hemagglutination inhibition titers (B/Phuket) were reported in the descriptive data section of this outcome measure. GMR of NTs for hemagglutination inhibition titers (B/Phuket), calculated as ratio of GMTs of Group 7 to Group 5, was reported in the statistical analysis section.

Time frame:
1 Month after Vaccination
Reported as:
Geometric mean · Titer
GMT and GMR of the Strain-Specific HAI Titers (B/Phuket) of QIV at 1 Month After Vaccination: Group 7 Versus Group 5
TiterGroup 7: RSVpreF + BNT162b2 + QIVGroup 5: QIV + Placebo
GMT and GMR of the Strain-Specific HAI Titers (B/Phuket) of QIV at 1 Month After Vaccination: Group 7 Versus Group 593 (78.5 to 111.0)27 (21.5 to 33.3)
Statistical analysis
  • Group 7: RSVpreF + BNT162b2 + QIV vs Group 5: QIV + Placebo · Geometric mean ratio: 3.49 · 97.5% CI 2.640 to 4.604GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 7\] minus Reference Group \[Group 5\]) and the corresponding CIs (based on the Student t distribution).
SecondaryGMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 6 Versus Group 4

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV A were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV A, calculated as ratio of GMTs of Group 6 to Group 4, was reported in the statistical analysis section.

Time frame:
1 Month after Vaccination
Reported as:
Geometric mean · Titer
GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 6 Versus Group 4
TiterGroup 6: RSVpreF + BNT162b2 + PlaceboGroup 4: RSVpreF + Placebo
GMT and GMR of NTs for RSV A at 1 Month After Vaccination: Group 6 Versus Group 426452 (22515.2 to 31076.8)18498 (15570.0 to 21975.9)
Statistical analysis
  • Group 6: RSVpreF + BNT162b2 + Placebo vs Group 4: RSVpreF + Placebo · Geometric mean ratio: 1.43 · 97.5% CI 1.131 to 1.808GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 6\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).
SecondaryGMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 6 Versus Group 4

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for RSV B were reported in the descriptive data section of this outcome measure. GMR of NTs for RSV B, calculated as ratio of GMTs of Group 6 to Group 4, was reported in the statistical analysis section.

Time frame:
1 Month after Vaccination
Reported as:
Geometric mean · Titer
GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 6 Versus Group 4
TiterGroup 6: RSVpreF + BNT162b2 + PlaceboGroup 4: RSVpreF + Placebo
GMT and GMR of NTs for RSV B at 1 Month After Vaccination: Group 6 Versus Group 422859 (19040.4 to 27442.5)16677 (13884.0 to 20031.4)
Statistical analysis
  • Group 6: RSVpreF + BNT162b2 + Placebo vs Group 4: RSVpreF + Placebo · Geometric mean ratio: 1.37 · 97.5% CI 1.060 to 1.773GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 6\] minus Reference Group \[Group 4\]) and the corresponding CIs (based on the Student t distribution).
SecondaryGMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 6 Versus Group 3

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 Omicron BA.4/BA.5 were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5, calculated as ratio of GMTs of Group 6 to Group 3, was reported in the statistical analysis section.

Time frame:
1 Month after Vaccination
Reported as:
Geometric mean · Titer
GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 6 Versus Group 3
TiterGroup 6: RSVpreF + BNT162b2 + PlaceboGroup 3: BNT162b2 + Placebo
GMT and GMR of NTs for SARS-CoV-2 Omicron BA.4/BA.5 at 1 Month After Vaccination: Group 6 Versus Group 33430 (2756.9 to 4267.7)3667 (2861.9 to 4697.5)
Statistical analysis
  • Group 6: RSVpreF + BNT162b2 + Placebo vs Group 3: BNT162b2 + Placebo · Geometric mean ratio: 0.94 · 97.5% CI 0.673 to 1.300GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 6\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).
SecondaryGMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 6 Versus Group 3

GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). GMTs of NTs for SARS-CoV-2 reference strain were reported in the descriptive data section of this outcome measure. GMR of NTs for SARS-CoV-2 reference strain calculated as ratio of GMTs of Group 6 to Group 3, was reported in the statistical analysis section.

Time frame:
1 Month after Vaccination
Reported as:
Geometric mean · Titer
GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 6 Versus Group 3
TiterGroup 6: RSVpreF + BNT162b2 + PlaceboGroup 3: BNT162b2 + Placebo
GMT and GMR of NTs for SARS-CoV-2 Reference Strain at 1 Month After Vaccination: Group 6 Versus Group 312111 (10010.3 to 14652.1)12439 (10185.9 to 15190.1)
Statistical analysis
  • Group 6: RSVpreF + BNT162b2 + Placebo vs Group 3: BNT162b2 + Placebo · Geometric mean ratio: 0.97 · 97.5% CI 0.740 to 1.281GMRs and 2-sided CIs were calculated by exponentiating the mean differences of the logarithms of the titers (Intervention Group \[Group 6\] minus Reference Group \[Group 3\]) and the corresponding CIs (based on the Student t distribution).

Adverse events

Collected over Local reactions and systemic events: From Day 1 to Day 7 after Vaccination 1; Non serious AEs: up to 1 month after Vaccination 1, SAEs: up to 6 months after Vaccination 1. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1: [RSVpreF + BNT162b2] + QIV0/154 (0%)1/154 (0.6%)114/154 (74%)
Group 2: [RSVpreF+BNT162b2] + Placebo0/153 (0%)2/153 (1.3%)107/153 (69.9%)
Group 3: BNT162b2 + Placebo0/150 (0%)4/150 (2.7%)110/150 (73.3%)
Group 4: RSVpreF + Placebo0/152 (0%)2/152 (1.3%)73/152 (48%)
Group 5: QIV + Placebo0/149 (0%)2/149 (1.3%)96/149 (64.4%)
Group 6: RSVpreF + BNT162b2 + Placebo0/157 (0%)1/157 (0.6%)114/157 (72.6%)
Group 7: RSVpreF + BNT162b2 + QIV0/158 (0%)3/158 (1.9%)122/158 (77.2%)
Most frequent serious events
Showing 10 of 18
Most frequent serious events
EventGroup 1: [RSVpreF + BNT162b2] + QIVGroup 2: [RSVpreF+BNT162b2] + PlaceboGroup 3: BNT162b2 + PlaceboGroup 4: RSVpreF + PlaceboGroup 5: QIV + PlaceboGroup 6: RSVpreF + BNT162b2 + PlaceboGroup 7: RSVpreF + BNT162b2 + QIV
Chest painGeneral disorders0/1540/1530/1501/1521/1490/1570/158
Cerebellar ataxiaNervous system disorders0/1540/1530/1500/1521/1490/1570/158
TremorNervous system disorders0/1540/1530/1500/1521/1490/1570/158
Lumbar vertebral fractureInjury, poisoning and procedural complications0/1540/1531/1500/1520/1490/1570/158
Ischaemic strokeNervous system disorders0/1540/1531/1500/1520/1490/1570/158
Thalamic strokeNervous system disorders0/1540/1531/1500/1520/1490/1570/158
CystoceleReproductive system and breast disorders0/1540/1531/1500/1520/1490/1570/158
RectoceleReproductive system and breast disorders0/1540/1531/1500/1520/1490/1570/158
Vaginal prolapseReproductive system and breast disorders0/1540/1531/1500/1520/1490/1570/158
Middle cerebral artery strokeNervous system disorders0/1540/1530/1501/1520/1490/1570/158
Most frequent other events
Showing 10 of 14
Most frequent other events
EventGroup 1: [RSVpreF + BNT162b2] + QIVGroup 2: [RSVpreF+BNT162b2] + PlaceboGroup 3: BNT162b2 + PlaceboGroup 4: RSVpreF + PlaceboGroup 5: QIV + PlaceboGroup 6: RSVpreF + BNT162b2 + PlaceboGroup 7: RSVpreF + BNT162b2 + QIV
Injection site pain (PAIN AT THE INJECTION SITE)General disorders88/15480/15394/15016/15277/14989/15785/158
Fatigue (FATIGUE)General disorders65/15457/15353/15037/15243/14961/15774/158
Headache (HEADACHE)Nervous system disorders33/15438/15334/15029/15219/14938/15730/158
Myalgia (NEW OR WORSENED MUSCLE PAIN)Musculoskeletal and connective tissue disorders20/15417/15316/15015/15216/14922/15723/158
Injection site erythema (REDNESS)General disorders12/15414/15311/1504/1526/14920/15714/158
Injection site swelling (SWELLING)General disorders8/15417/15314/1505/1529/14920/15711/158
Diarrhoea (DIARRHEA)Gastrointestinal disorders17/1545/1538/15016/15214/1497/15720/158
Chills (CHILLS)General disorders16/15412/15314/1506/1523/14916/15717/158
Arthralgia (NEW OR WORSENED JOINT PAIN)Musculoskeletal and connective tissue disorders13/15411/15313/1509/1526/14916/15715/158
Pyrexia (FEVER)General disorders6/1545/1532/1502/1520/1493/1577/158

Baseline characteristics

Safety population included all participants who received the study intervention.

Age, Continuous
Age, Continuous(Years)Group 1: [RSVpreF + BNT162b2] + QIVGroup 2: [RSVpreF+BNT162b2] + PlaceboGroup 3: BNT162b2 + PlaceboGroup 4: RSVpreF + PlaceboGroup 5: QIV + PlaceboGroup 6: RSVpreF + BNT162b2 + PlaceboGroup 7: RSVpreF + BNT162b2 + QIVTotal
Mean71.7 ± 5.3671.7 ± 5.0171.1 ± 4.7072.1 ± 4.6972.3 ± 5.1271.3 ± 4.8771.6 ± 4.7971.7 ± 4.94
Sex: Female, Male
Sex: Female, Male(Participants)Group 1: [RSVpreF + BNT162b2] + QIVGroup 2: [RSVpreF+BNT162b2] + PlaceboGroup 3: BNT162b2 + PlaceboGroup 4: RSVpreF + PlaceboGroup 5: QIV + PlaceboGroup 6: RSVpreF + BNT162b2 + PlaceboGroup 7: RSVpreF + BNT162b2 + QIVTotal
Female88948181819583603
Male67607174706375480
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Group 1: [RSVpreF + BNT162b2] + QIVGroup 2: [RSVpreF+BNT162b2] + PlaceboGroup 3: BNT162b2 + PlaceboGroup 4: RSVpreF + PlaceboGroup 5: QIV + PlaceboGroup 6: RSVpreF + BNT162b2 + PlaceboGroup 7: RSVpreF + BNT162b2 + QIVTotal
Hispanic or Latino21151118121815110
Not Hispanic or Latino134138140137139139142969
Unknown or Not Reported01100114
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Group 1: [RSVpreF + BNT162b2] + QIVGroup 2: [RSVpreF+BNT162b2] + PlaceboGroup 3: BNT162b2 + PlaceboGroup 4: RSVpreF + PlaceboGroup 5: QIV + PlaceboGroup 6: RSVpreF + BNT162b2 + PlaceboGroup 7: RSVpreF + BNT162b2 + QIVTotal
American Indian or Alaska Native10101014
Asian842133526
Native Hawaiian or Other Pacific Islander00001001
Black or African American101213109141381
White135138133143136140138963
More than one race10100103
Unknown or Not Reported00211015
08

Study locations

37 sites
  • West Coast Research
    Dublin, California 94568, United States
  • Marvel Clinical Research
    Huntington Beach, California 92647, United States
  • Orange County Research Center
    Lake Forest, California 92630, United States
  • Artemis Institute for Clinical Research
    San Diego, California 92103, United States
  • California Research Foundation
    San Diego, California 92123, United States
  • Orange County Research Center
    Tustin, California 92780, United States
  • Diablo Clinical Research, Inc.
    Walnut Creek, California 94598, United States
  • Clinical Research Consulting
    Milford, Connecticut 06460, United States
  • Indago Research & Health Center, Inc
    Hialeah, Florida 33012, United States
  • Wr-Msra.Llc
    Lake City, Florida 32055, United States
  • Optimal Research
    Melbourne, Florida 32934, United States
  • Suncoast Research Group
    Miami, Florida 33135, United States
  • Clinical Site Partners, LLC dba CSP Orlando
    Winter Park, Florida 32789, United States
  • Clinical Site Partners, LLC dba Flourish Research
    Winter Park, Florida 32789, United States
  • Great Lakes Clinical Trials - Gurnee
    Gurnee, Illinois 60031, United States
  • Optimal Research
    Peoria, Illinois 61614, United States
  • Bio-Kinetic Clinical Applications LLC DBA QPS_MO (Patient Screening Only)
    Springfield, Missouri 65802, United States
  • Bio-Kinetic Clinical Applications, LLC dba QPS-MO
    Springfield, Missouri 65802, United States
  • Bio-Kinetic Clinical Applications, LLD dba QPS-MO
    Springfield, Missouri 65802, United States
  • Las Vegas Clinical Trials
    Las Vegas, Nevada 89030, United States
  • Las Vegas Clinical Trials
    North Las Vegas, Nevada 89030, United States
  • Drug Trials America
    Hartsdale, New York 10530, United States
  • Accellacare - Wilmington - 1917 Tradd Court
    Wilmington, North Carolina 28401, United States
  • Accellacare - Wilmington
    Wilmington, North Carolina 28401, United States
  • Centricity Research Columbus Ohio Multispecialty
    Columbus, Ohio 43213, United States
  • Coastal Carolina Research Center
    North Charleston, South Carolina 29405, United States
  • Clinical Research Associates Inc
    Nashville, Tennessee 37203, United States
  • Headlands Horizons LLC
    Brownsville, Texas 78526, United States
  • DM Clinical Research - Cy Fair
    Houston, Texas 77065, United States
  • DM Clinical Research- Cyfair
    Houston, Texas 77065, United States
  • DM Clinical Research - Bellaire
    Houston, Texas 77081, United States
  • SMS Clinical Research
    Mesquite, Texas 75149, United States
  • Clinical Trials of Texas, LLC
    San Antonio, Texas 78229, United States
  • DM Clinical Research, Martin Diagnostic Clinic
    Tomball, Texas 77375, United States
  • J. Lewis Research, Inc. / Foothill Family Clinic
    Salt Lake City, Utah 84109, United States
  • J. Lewis Research, Inc. / Foothill Family Clinic South
    Salt Lake City, Utah 84121, United States
  • Virginia Research Center
    Midlothian, Virginia 23114, United States
09

References and documents

Publications

  • Neutel JM, Erdem R, Jiang Q, Cannon K, Stacey H, Newton R, Gomme E, Li W, Mensa FJ, Tureci O, Sahin U, Swanson KA, Munjal I, Cooper D, Koury K, Anderson AS, Gurtman A, Kitchin N; C5481001 Study Group. Safety and Immunogenicity of Concomitant Administration and Combined Administration of Bivalent BNT162b2 COVID-19 Vaccine and Bivalent RSVpreF Respiratory Syncytial Virus Vaccine with or Without Quadrivalent Influenza Vaccine in Adults >/= 65 Years of Age. Vaccines (Basel). 2025 Feb 5;13(2):158. doi: 10.3390/vaccines13020158. PubMed 40006705 ↗

Study documents

  • Study protocol · Jan 18, 2024
  • Statistical analysis plan · Aug 1, 2023

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

Individual participant data

Plan to share: Yes — 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.

Data sharing details ↗ · www.pfizer.com

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2023 to primary completion in Jan 2024, 6 months.

Results were first posted in Dec 2024, 11 months after primary completion.

Of 220 industry-sponsored phase 2 interventional studies under COVID-19, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 14. This study's 6 months is below that.

Counting every sponsor, half of 569 studies reached it within 9 months; a quarter within 5 and three quarters within 16.

How these figures are worked out, and which studies are left out of them.

Registered
May 31, 2023
First posted
Jun 2, 2023
StartActual
Jun 5, 2023
Primary completionActual
Jan 1, 2024
CompletionActual
Jan 1, 2024
Results first posted
Dec 18, 2024
Last update
Dec 18, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05886777
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Jun 2, 2023
Start date
Jun 5, 2023
Primary completion
Jan 1, 2024
Completion
Jan 1, 2024
Results posted
Dec 18, 2024
Last update
Dec 18, 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 Nov 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Abrysvo

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