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CompletedNCT05071313Updated May 25, 2025Results posted

A Study of an Ad26.RSV.preF-based Vaccine and High-dose Seasonal Influenza Vaccine, With and Without Coadministration, in Adults Aged 65 Years and Older

A Phase 3 interventional study of Ad26.RSV.preF-based vaccine and Quadrivalent High-dose Influenza Vaccine in Influenza, Human Prevention and Respiratory Syncytial Viruses Prevention, sponsored by Janssen Vaccines & Prevention B.V.. Completed at 19 sites in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-05-25.

Sponsored by Janssen Vaccines & Prevention B.V. · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
777
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the immunogenicity and safety of Ad26.RSV.preF-based vaccine and quadrivalent high-dose seasonal influenza vaccine when administered either concomitantly or separately.

02

Conditions studied

  • Influenza, Human Prevention
  • Respiratory Syncytial Viruses Prevention

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03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 777 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Janssen Vaccines & Prevention B.V. is the lead sponsor of 48 studies on the registry; none are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 32 (89%) have results posted.

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
No

Inclusion criteria

  • Willing and able to adhere to the prohibitions and restrictions specified in this protocol
  • In the investigator's clinical judgment, the participant must be in stable health at the time of vaccination. Participants will be included on the basis of medical history and vital signs performed between informed consent from (ICF) signature and vaccination
  • Before randomization, a participant must be not intending to conceive by any methods, postmenopausal or surgically sterile
  • From the time of vaccination through 3 months after vaccination, agrees not to donate blood
  • Must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study
  • Participant must be able to work with smartphones/tablets/computers

Exclusion criteria

Exclusion Criteria:

  • History of malignancy within 5 years before screening not in the following categories: a) participants with squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix may be enrolled at the discretion of the investigator; b) participants with a history of malignancy within 5 years before screening, with minimal risk of recurrence per investigator's judgement, can be enrolled
  • Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
  • History of severe allergic reactions (example, anaphylaxis) to any component of the Quadrivalent high-dose influenza vaccine, including egg protein, or following a previous dose of any influenza vaccine
  • Has abnormal function of the immune system resulting from either clinical condition, chronic or recurrent use of systemic corticosteroids within 2 months prior to study vaccination, or immunomodulating agents within 6 months prior to study vaccination
  • Per medical history, participant has chronic active hepatitis B or hepatitis C infection
  • History of acute polyneuropathy (example, Guillain-Barre syndrome) or chronic idiopathic demyelinating polyneuropathy
  • Has a serious chronic disorder, example, chronic obstructive pulmonary disease or congestive heart failure, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, Alzheimer's disease, or has any condition, including conditions placing the participant at high risk for severe influenza, for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
  • Received vaccination with seasonal influenza vaccine for the current influenza season in the Northern Hemisphere
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
777 participants (actual)

Study arms

  • Experimental
    Group 1: Coadministration (CoAd) Group

    Participants will receive Ad26.RSV.preF-based vaccine and quadrivalent high dose influenza vaccine concomitantly on Day 1 and placebo on Day 29.

    Biological: Ad26.RSV.preF-based vaccine · Biological: Quadrivalent High-dose Influenza Vaccine · Biological: Placebo

  • Experimental
    Group 2: Control Group

    Participants will receive placebo and quadrivalent high-dose influenza vaccine on Day 1 and Ad26.RSV.preF-based vaccine on Day 29.

    Biological: Ad26.RSV.preF-based vaccine · Biological: Quadrivalent High-dose Influenza Vaccine · Biological: Placebo

Interventions

  • BiologicalAd26.RSV.preF-based vaccine

    Ad26.RSV.preF-based vaccine will be administered as single IM injection.

  • BiologicalQuadrivalent High-dose Influenza Vaccine

    Quadrivalent High-dose Influenza Vaccine will be administered as IM injection.

  • BiologicalPlacebo

    Placebo will be administered as IM injection to Ad26.RSV.preF-based vaccine.

06

What researchers measure

Primary outcomes

  1. Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Against Each of the Four Influenza Vaccine Strains as Measured by HI Assay

    Hemagglutination is a phenomenon by which the hemagglutinin protein of influenza viruses can bind to sialic acid receptors on the red blood cell membrane, thereby forming clumps and is the basis for the HI assay. GMTs of HI antibodies against each of the four influenza vaccine strains as measured by HI assay at 28 days after the administration of a quadrivalent high-dose seasonal influenza vaccine (fluzone) were reported. The analysis was performed on 2 influenza A strains \[A/Victoria and A/Tasmania\] and 2 influenza B strains \[B/Washington and B/Phuket\]).

    Time frame: 28 days after vaccination with Fluzone on Day 1 (Day 29)

  2. GMTs of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) on Day 29

    GMTs of preF antibodies at 28 days after the administration of Ad26.RSV.preF-based vaccine as assessed by ELISA on Day 29 were reported. This outcome measure was planned to be analyzed for specified arm only.

    Time frame: 28 days after vaccination with Ad26.RSV.preF-based vaccine on Day 1 (Day 29)

  3. GMTs of PreF Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) on Day 57

    GMTs of preF antibodies at 28 days after the administration of Ad26.RSV.preF-based vaccine as assessed by ELISA on Day 57 were reported. This outcome measure was planned to be analyzed for specified arm only.

    Time frame: 28 days after vaccination with Ad26.RSV.preF-based vaccine on Day 29 (Day 57)

Secondary outcomes

  1. Number of Participants With Solicited Local Adverse Events (AEs) After Study Vaccination 1

    Number of participants with solicited local AEs after study vaccination 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site). Solicited local AEs were reported separately for all vaccines because fluzone and RSV vaccine mixture (containing both Ad26. RSV. preF 1\*10\^11 vp and RSV preF protein 150 mcg) in group 1 were administered in opposite arms on Day 1. Similarly, fluzone and placebo in group 2 were administered in opposite arms on Day 1. Hence, the data for this outcome measure was analyzed separately for each vaccine.

    Time frame: Up to 7 days after study vaccination 1 on Day 1 (Day 8)

  2. Number of Participants With Solicited Local AEs After Study Vaccination 2

    Number of participants with solicited local AEs after study vaccination 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).

    Time frame: Up to 7 days after study vaccination 2 on Day 29 (Day 36)

  3. Number of Participants With Solicited Systemic AEs After Study Vaccination 1

    Number of participants with solicited systemic AEs after study vaccination 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).

    Time frame: Up to 7 days after study vaccination 1 on Day 1 (Day 8)

  4. Number of Participants With Solicited Systemic AEs After Study Vaccination 2

    Number of participants with solicited systemic AEs after study vaccination 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants will be specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).

    Time frame: Up to 7 days after study vaccination 2 on Day 29 (Day 36)

  5. Number of Participants With Unsolicited AEs After Study Vaccination 1

    Number of participants with unsolicited AEs after study vaccination 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary.

    Time frame: Up to 28 days after study vaccination 1 on Day 1 (Day 29)

  6. Number of Participants With Unsolicited AEs After Study Vaccination 2

    Number of participants with unsolicited AEs after study vaccination 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary.

    Time frame: Up to 28 days after study vaccination 2 on Day 29 (Day 57)

  7. Number of Participants With Serious Adverse Events (SAEs) Up to Study Vaccination 1

    Number of participants with SAEs up to study vaccination 1 were reported. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.

    Time frame: From Day 1 up to Day 29

  8. Number of Participants With Serious Adverse Events (SAEs) Up to Study Vaccination 2

    Number of participants with SAEs up to study vaccination 2 were reported. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.

    Time frame: From Day 29 up to 6 months after study vaccination 2 (up to 7 months)

  9. Number of Participants With Adverse Events of Special Interest (AESI) Up to Study Vaccination 1

    Number of participants with AESI up to study vaccination 1 were reported. Thrombosis with thrombocytopenia syndrome (TTS) was considered to be an AESI.

    Time frame: From Day 1 up to Day 29

  10. Number of Participants With Adverse Events of Special Interest (AESI) Up to Study Vaccination 2

    Number of participants with AESI up to study vaccination 2 were reported. Thrombosis with thrombocytopenia syndrome (TTS) was considered to be an AESI.

    Time frame: From Day 29 up to 6 months after study vaccination 2 (up to 7 months)

  11. Number of Seroconverted Participants After 28 Days of Administration of Influenza Vaccine

    Number of seroconverted participants after 28 days of administration of influenza vaccine (fluzone) were reported. Seroconversion is defined for each of the 4 influenza vaccine strains at 28 days after the administration of a quadrivalent high-dose seasonal influenza vaccine: HI titer greater than or equal to (\>=) 1:40 in participants with a pre-vaccination HI titer of less than (\<) 1:10, or a \>=4-fold HI titer increase in participants with a pre-vaccination HI titer of \>=1:10.

    Time frame: 28 days after vaccination with fluzone on Day 1 (up to Day 29)

  12. Number of Seroprotected Participants After 28 Days of Administration of Influenza Vaccine

    Number of seroprotected participants after 28 days of administration of influenza vaccine (fluzone) were reported. Seroprotection is defined for each of the 4 influenza vaccine strains as HI titer \>=1:40 at 28 days after the administration of a quadrivalent high-dose seasonal influenza vaccine.

    Time frame: 28 days after vaccination with fluzone on Day 1 (up to Day 29)

07

Results

Posted Sep 13, 2023

Participant flow

Participant flow — Overall Study
MilestoneGroup 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV + Placebo (CoAd Group)Group 2: Placebo With Fluzone HD QIV + Ad26/Protein preF RSV Vaccine (Control Group)
Started389388
Received ad26/protein pref rsv vaccine with fluzone in coad group at day 13850
Received placebo with fluzone in control group at day 10386
Received placebo in coad group at day 293570
Received ad26/protein pref rsv vaccine in control group at day 290363
Completed355355
Not completed3433
Withdrew: Lost to follow-up1710
Withdrew: Physician decision16
Withdrew: Death10
Withdrew: Withdrawal by subject1015
Withdrew: Other10
Withdrew: Randomized but not vaccinated42

Outcome measures

PrimaryGeometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Against Each of the Four Influenza Vaccine Strains as Measured by HI Assay

Hemagglutination is a phenomenon by which the hemagglutinin protein of influenza viruses can bind to sialic acid receptors on the red blood cell membrane, thereby forming clumps and is the basis for the HI assay. GMTs of HI antibodies against each of the four influenza vaccine strains as measured by HI assay at 28 days after the administration of a quadrivalent high-dose seasonal influenza vaccine (fluzone) were reported. The analysis was performed on 2 influenza A strains \[A/Victoria and A/Tasmania\] and 2 influenza B strains \[B/Washington and B/Phuket\]).

Time frame:
28 days after vaccination with Fluzone on Day 1 (Day 29)
Reported as:
Geometric mean · Titers
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Against Each of the Four Influenza Vaccine Strains as Measured by HI Assay
TitersGroup 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV + Placebo (CoAd Group)Group 2: Placebo With Fluzone HD QIV + Ad26/Protein preF RSV Vaccine (Control Group)
A/Victoria178 (145 to 217)179 (146 to 219)
A/Tasmania111 (89 to 139)123 (98 to 155)
B/Washington93 (74 to 117)84 (67 to 106)
B/Phuket38 (31 to 47)37 (30 to 46)
Statistical analysis
  • Group 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV + Placebo (CoAd Group) vs Group 2: Placebo With Fluzone HD QIV + Ad26/Protein preF RSV Vaccine (Control Group) · Geometric mean ratio: 1.01 · 95% CI 0.89 to 1.14
  • Group 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV + Placebo (CoAd Group) vs Group 2: Placebo With Fluzone HD QIV + Ad26/Protein preF RSV Vaccine (Control Group) · Geometric mean ratio: 1.11 · 95% CI 0.97 to 1.28
  • Group 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV + Placebo (CoAd Group) vs Group 2: Placebo With Fluzone HD QIV + Ad26/Protein preF RSV Vaccine (Control Group) · Geometric mean ratio: 0.91 · 95% CI 0.79 to 1.05
  • Group 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV + Placebo (CoAd Group) vs Group 2: Placebo With Fluzone HD QIV + Ad26/Protein preF RSV Vaccine (Control Group) · Geometric mean ratio: 0.97 · 95% CI 0.85 to 1.10
PrimaryGMTs of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) on Day 29

GMTs of preF antibodies at 28 days after the administration of Ad26.RSV.preF-based vaccine as assessed by ELISA on Day 29 were reported. This outcome measure was planned to be analyzed for specified arm only.

Time frame:
28 days after vaccination with Ad26.RSV.preF-based vaccine on Day 1 (Day 29)
Reported as:
Geometric mean · ELISA units per liter (EU/L)
GMTs of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) on Day 29
ELISA units per liter (EU/L)Group 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV + Placebo (CoAd Group)
GMTs of Prefusion F-protein (preF) Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) on Day 292665 (2209 to 3216)
PrimaryGMTs of PreF Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) on Day 57

GMTs of preF antibodies at 28 days after the administration of Ad26.RSV.preF-based vaccine as assessed by ELISA on Day 57 were reported. This outcome measure was planned to be analyzed for specified arm only.

Time frame:
28 days after vaccination with Ad26.RSV.preF-based vaccine on Day 29 (Day 57)
Reported as:
Geometric mean · EU/L
GMTs of PreF Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) on Day 57
EU/LGroup 2: Placebo With Fluzone HD QIV + Ad26/Protein preF RSV Vaccine (Control Group)
GMTs of PreF Antibodies as Assessed by Enzyme-linked Immunosorbent Assay (ELISA) on Day 573206 (2648 to 3881)
SecondaryNumber of Participants With Solicited Local Adverse Events (AEs) After Study Vaccination 1

Number of participants with solicited local AEs after study vaccination 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site). Solicited local AEs were reported separately for all vaccines because fluzone and RSV vaccine mixture (containing both Ad26. RSV. preF 1\*10\^11 vp and RSV preF protein 150 mcg) in group 1 were administered in opposite arms on Day 1. Similarly, fluzone and placebo in group 2 were administered in opposite arms on Day 1. Hence, the data for this outcome measure was analyzed separately for each vaccine.

Time frame:
Up to 7 days after study vaccination 1 on Day 1 (Day 8)
Reported as:
Count of participants · Participants
Number of Participants With Solicited Local Adverse Events (AEs) After Study Vaccination 1
ParticipantsGroup 1: Fluzone HD QIV (CoAd Group)Group 1: Ad26/Protein preF RSV Vaccine (CoAd Group)Group 2: Fluzone HD QIV (Control Group)Group 2: Placebo (Control Group)
Number of Participants With Solicited Local Adverse Events (AEs) After Study Vaccination 123726321998
SecondaryNumber of Participants With Solicited Local AEs After Study Vaccination 2

Number of participants with solicited local AEs after study vaccination 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs that included injection site pain/tenderness, erythema and swelling at the study vaccine injection site, were used to assess the reactogenicity of the study vaccine and were pre-defined local (injection site).

Time frame:
Up to 7 days after study vaccination 2 on Day 29 (Day 36)
Reported as:
Count of participants · Participants
Number of Participants With Solicited Local AEs After Study Vaccination 2
ParticipantsGroup 1: Placebo (CoAdGroup)Group 2: Ad26/Protein preF RSV Vaccine (Control Group)
Number of Participants With Solicited Local AEs After Study Vaccination 253241
SecondaryNumber of Participants With Solicited Systemic AEs After Study Vaccination 1

Number of participants with solicited systemic AEs after study vaccination 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants were specifically questioned and which were noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).

Time frame:
Up to 7 days after study vaccination 1 on Day 1 (Day 8)
Reported as:
Count of participants · Participants
Number of Participants With Solicited Systemic AEs After Study Vaccination 1
ParticipantsGroup 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV (CoAd Group)Group 2: Fluzone HD QIV With Placebo (Control Group)
Number of Participants With Solicited Systemic AEs After Study Vaccination 1285181
SecondaryNumber of Participants With Solicited Systemic AEs After Study Vaccination 2

Number of participants with solicited systemic AEs after study vaccination 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Systemic events included events such as fatigue, headache, nausea, and myalgia, for which participants will be specifically questioned and which will be noted by participants in their participant diary for 7 days post vaccination (day of vaccination and the subsequent 7 days).

Time frame:
Up to 7 days after study vaccination 2 on Day 29 (Day 36)
Reported as:
Count of participants · Participants
Number of Participants With Solicited Systemic AEs After Study Vaccination 2
ParticipantsGroup 1: Placebo (CoAdGroup)Group 2: Ad26/Protein preF RSV Vaccine (Control Group)
Number of Participants With Solicited Systemic AEs After Study Vaccination 280218
SecondaryNumber of Participants With Unsolicited AEs After Study Vaccination 1

Number of participants with unsolicited AEs after study vaccination 1 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary.

Time frame:
Up to 28 days after study vaccination 1 on Day 1 (Day 29)
Reported as:
Count of participants · Participants
Number of Participants With Unsolicited AEs After Study Vaccination 1
ParticipantsGroup 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV (CoAd Group)Group 2: Fluzone HD QIV With Placebo (Control Group)
Number of Participants With Unsolicited AEs After Study Vaccination 15761
SecondaryNumber of Participants With Unsolicited AEs After Study Vaccination 2

Number of participants with unsolicited AEs after study vaccination 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were all AEs for which the participant was not specifically questioned in the participant diary.

Time frame:
Up to 28 days after study vaccination 2 on Day 29 (Day 57)
Reported as:
Count of participants · Participants
Number of Participants With Unsolicited AEs After Study Vaccination 2
ParticipantsGroup 1: Placebo (CoAdGroup)Group 2: Ad26/Protein preF RSV Vaccine (Control Group)
Number of Participants With Unsolicited AEs After Study Vaccination 23435
SecondaryNumber of Participants With Serious Adverse Events (SAEs) Up to Study Vaccination 1

Number of participants with SAEs up to study vaccination 1 were reported. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.

Time frame:
From Day 1 up to Day 29
Reported as:
Count of participants · Participants
Number of Participants With Serious Adverse Events (SAEs) Up to Study Vaccination 1
ParticipantsGroup 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV (CoAd Group)Group 2: Fluzone HD QIV With Placebo (Control Group)
Number of Participants With Serious Adverse Events (SAEs) Up to Study Vaccination 122
SecondaryNumber of Participants With Serious Adverse Events (SAEs) Up to Study Vaccination 2

Number of participants with SAEs up to study vaccination 2 were reported. SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.

Time frame:
From Day 29 up to 6 months after study vaccination 2 (up to 7 months)
Reported as:
Count of participants · Participants
Number of Participants With Serious Adverse Events (SAEs) Up to Study Vaccination 2
ParticipantsGroup 1: Placebo (CoAd Group)Group 2: Ad26/Protein preF RSV Vaccine (Control Group)
Number of Participants With Serious Adverse Events (SAEs) Up to Study Vaccination 21111
SecondaryNumber of Participants With Adverse Events of Special Interest (AESI) Up to Study Vaccination 1

Number of participants with AESI up to study vaccination 1 were reported. Thrombosis with thrombocytopenia syndrome (TTS) was considered to be an AESI.

Time frame:
From Day 1 up to Day 29
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events of Special Interest (AESI) Up to Study Vaccination 1
ParticipantsGroup 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV (CoAd Group)Group 2: Fluzone HD QIV With Placebo (Control Group)
Number of Participants With Adverse Events of Special Interest (AESI) Up to Study Vaccination 100
SecondaryNumber of Participants With Adverse Events of Special Interest (AESI) Up to Study Vaccination 2

Number of participants with AESI up to study vaccination 2 were reported. Thrombosis with thrombocytopenia syndrome (TTS) was considered to be an AESI.

Time frame:
From Day 29 up to 6 months after study vaccination 2 (up to 7 months)
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events of Special Interest (AESI) Up to Study Vaccination 2
ParticipantsGroup 1: Placebo (CoAd Group)Group 2: Ad26/Protein preF RSV Vaccine (Control Group)
Number of Participants With Adverse Events of Special Interest (AESI) Up to Study Vaccination 200
SecondaryNumber of Seroconverted Participants After 28 Days of Administration of Influenza Vaccine

Number of seroconverted participants after 28 days of administration of influenza vaccine (fluzone) were reported. Seroconversion is defined for each of the 4 influenza vaccine strains at 28 days after the administration of a quadrivalent high-dose seasonal influenza vaccine: HI titer greater than or equal to (\>=) 1:40 in participants with a pre-vaccination HI titer of less than (\<) 1:10, or a \>=4-fold HI titer increase in participants with a pre-vaccination HI titer of \>=1:10.

Time frame:
28 days after vaccination with fluzone on Day 1 (up to Day 29)
Reported as:
Count of participants · Participants
Number of Seroconverted Participants After 28 Days of Administration of Influenza Vaccine
ParticipantsGroup 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV + Placebo (CoAd Group)Group 2: Placebo With Fluzone HD QIV + Ad26/Protein preF RSV Vaccine (Control Group)
A/Victoria203190
A/Tasmania150165
B/Washington134117
B/Phuket7984
SecondaryNumber of Seroprotected Participants After 28 Days of Administration of Influenza Vaccine

Number of seroprotected participants after 28 days of administration of influenza vaccine (fluzone) were reported. Seroprotection is defined for each of the 4 influenza vaccine strains as HI titer \>=1:40 at 28 days after the administration of a quadrivalent high-dose seasonal influenza vaccine.

Time frame:
28 days after vaccination with fluzone on Day 1 (up to Day 29)
Reported as:
Count of participants · Participants
Number of Seroprotected Participants After 28 Days of Administration of Influenza Vaccine
ParticipantsGroup 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV + Placebo (CoAd Group)Group 2: Placebo With Fluzone HD QIV + Ad26/Protein preF RSV Vaccine (Control Group)
A/Victoria323313
A/Tasmania282285
B/Washington247245
B/Phuket117122

Adverse events

Collected over From Day 1 up to 7 months. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV (CoAd Group)0/385 (0%)2/385 (0.5%)18/385 (4.7%)
Group 2: Fluzone HD QIV With Placebo (Control Group)0/386 (0%)2/386 (0.5%)12/386 (3.1%)
Group 1: Placebo (CoAd Group)1/357 (0.3%)11/357 (3.1%)1/357 (0.3%)
Group 2: Ad26/Protein preF RSV Vaccine (Control Group)0/363 (0%)11/363 (3%)10/363 (2.8%)
Most frequent serious events
Showing 10 of 30
Most frequent serious events
EventGroup 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV (CoAd Group)Group 2: Fluzone HD QIV With Placebo (Control Group)Group 1: Placebo (CoAd Group)Group 2: Ad26/Protein preF RSV Vaccine (Control Group)
SepsisInfections and infestations0/3850/3860/3574/363
OsteoarthritisMusculoskeletal and connective tissue disorders0/3850/3862/3571/363
Covid-19Infections and infestations0/3850/3861/3572/363
Acute Respiratory FailureRespiratory, thoracic and mediastinal disorders0/3850/3861/3572/363
Cardiac ArrestCardiac disorders0/3850/3861/3570/363
ProctitisGastrointestinal disorders0/3850/3861/3570/363
Jaundice CholestaticHepatobiliary disorders0/3850/3861/3570/363
Femoral Neck FractureInjury, poisoning and procedural complications0/3850/3861/3570/363
Femur FractureInjury, poisoning and procedural complications0/3850/3861/3570/363
Lower Limb FractureInjury, poisoning and procedural complications0/3850/3861/3570/363
Most frequent other events
Most frequent other events
EventGroup 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV (CoAd Group)Group 2: Fluzone HD QIV With Placebo (Control Group)Group 1: Placebo (CoAd Group)Group 2: Ad26/Protein preF RSV Vaccine (Control Group)
ChillsGeneral disorders11/3854/3861/3578/363
HypertensionVascular disorders7/3858/3860/3572/363

Baseline characteristics

The full analysis set (FAS) included all participants who received at least 1 study vaccination, regardless of the occurrence of protocol deviations and vaccine type (seasonal influenza, Ad26/protein preF RSV vaccine, or placebo).

Age, Continuous
Age, Continuous(years)Group 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV + Placebo (CoAd Group)Group 2: Placebo With Fluzone HD QIV + Ad26/Protein preF RSV Vaccine (Control Group)Total
Mean70.4 ± 4.9470.7 ± 4.7270.5 ± 4.83
Sex: Female, Male
Sex: Female, Male(Participants)Group 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV + Placebo (CoAd Group)Group 2: Placebo With Fluzone HD QIV + Ad26/Protein preF RSV Vaccine (Control Group)Total
Female223208431
Male162178340
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Group 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV + Placebo (CoAd Group)Group 2: Placebo With Fluzone HD QIV + Ad26/Protein preF RSV Vaccine (Control Group)Total
Hispanic or Latino393372
Not Hispanic or Latino339344683
Unknown or Not Reported7916
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Group 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV + Placebo (CoAd Group)Group 2: Placebo With Fluzone HD QIV + Ad26/Protein preF RSV Vaccine (Control Group)Total
American Indian or Alaska Native336
Asian213
Native Hawaiian or Other Pacific Islander112
Black or African American383977
White336333669
More than one race235
Unknown or Not Reported369
Region of Enrollment
Region of Enrollment(Participants)Group 1: Ad26/Protein preF RSV Vaccine With Fluzone HD QIV + Placebo (CoAd Group)Group 2: Placebo With Fluzone HD QIV + Ad26/Protein preF RSV Vaccine (Control Group)Total
UNITED STATES385386771
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Study locations

19 sites
  • Ark Clinical Research
    Long Beach, California 90806, United States
  • Research Centers of America, LLC
    Hollywood, Florida 33024, United States
  • Progressive Medical Research
    Port Orange, Florida 32127, United States
  • Synexus Clinical Research US Inc
    The Villages, Florida 32162, United States
  • Synexus Clinical Research US Inc
    Chicago, Illinois 60602, United States
  • Meridian Clinical Research, LLC
    Rockville, Maryland 20854, United States
  • Sundance Clinical Research
    Saint Louis, Missouri 63141, United States
  • Synexus Clinical Research US Inc
    Saint Louis, Missouri 63141, United States
  • Meridian Clinical Research, LLC
    Grand Island, Nebraska 68803, United States
  • Meridian Clinical Research, LLC
    Lincoln, Nebraska 68510, United States
  • Meridian Clinical Research, LLC
    Norfolk, Nebraska 68701, United States
  • Meridian Clinical Research, LLC
    Omaha, Nebraska 68134, United States
  • Tekton Research Inc.
    Yukon, Oklahoma 73099, United States
  • Coastal Carolina Research Center
    North Charleston, South Carolina 29405, United States
  • VitaLink Research Spartanburg
    Spartanburg, South Carolina 29303, United States
  • AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
    Knoxville, Tennessee 37920, United States
  • Optimal Research
    Austin, Texas 78705, United States
  • Tekton Research Inc.
    Austin, Texas 78745, United States
  • DM Clinical Research
    Tomball, Texas 77375, United States
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References and documents

Study documents

  • Study protocol · Feb 7, 2022
  • Statistical analysis plan · Jul 5, 2022

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

Individual participant data

Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05071313
Lead sponsor
Janssen Vaccines & Prevention B.V.
Responsible party
Sponsor
First posted
Oct 8, 2021
Start date
Oct 4, 2021
Primary completion
Apr 20, 2022
Completion
Oct 11, 2022
Results posted
Sep 13, 2023
Last update
May 25, 2025

Study contacts

Janssen Vaccines & Prevention B.V. Clinical Trial
study director · Janssen Vaccines & Prevention B.V.

Oversight

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

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