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COVID-19 PreventionPhase 3NCT05091307

A Study of Ad26.COV2.S and Influenza Vaccines in Healthy Adults

A Phase 3 study testing Ad26.COV2.S and Influenza Vaccine in people with COVID-19 Prevention, run by Janssen Vaccines & Prevention B.V. at 31 sites in 3 countries.

Completed

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

Official record
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Trial summary

The purpose of this study is to demonstrate the non-inferiority (NI) of the humoral immune response of the 4 influenza vaccine strains after concomitant administration of the Ad26.COV2.S vaccine and a seasonal quadrivalent standard-dose influenza vaccine versus the administration of a seasonal quadrivalent… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19 Prevention
What is being tested?
Ad26.COV2.S and Influenza Vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
861 participants
Where
31 sitesin 3 countries
Study dates
2 Nov 2021to 15 Nov 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participant must be healthy, in the investigator's clinical judgment, as confirmed by medical history, physical examination, and vital signs performed at screening. Participants may have underlying illnesses, as long as the symptoms and signs are medically controlled
  • Participant either received complete primary vaccination with an authorized/licensed coronavirus disease-2019 (COVID-19) vaccine (completed greater than or equal to [>=] 6 months prior to the last vaccination received against COVID-19) or is COVID-19 vaccine-naive
  • All participants who were born female and are of childbearing potential must: a. Have a negative highly sensitive urine pregnancy test at screening, b. Have a negative highly sensitive urine pregnancy test on the day of vaccination prior to each study vaccine administration
  • Participant agrees to not donate or receive bone marrow, blood, and blood products from the administration of the study vaccine until 3 months after receiving the study vaccines
  • Participant must be willing to provide verifiable identification to be contacted and to contact the investigator during the study

Who cannot join

  • Participant has a history of malignancy within 1 year before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancies considered cured with minimal risk of recurrence per investigator's clinical judgment)
  • Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature >= 38.0 degrees celsius (ºC) (100.4 degrees fahrenheit [°F]) within 24 hours prior to the planned dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator
  • Participant has history of thrombosis with thrombocytopenia syndrome (TTS) or heparin-induced thrombocytopenia and thrombosis (HITT)
  • Participant has history of capillary leak syndrome
  • Participant received a licensed/registered severe acute respiratory syndrome coronavirus(-2) (SARS-CoV-2) vaccine less than 6 months prior to first study vaccination (other than study vaccination)
  • Participant has a history of any neurological disorders or seizures including Guillain-Barre syndrome, with the exception of febrile seizures during childhood

Trial locations and contacts

31 sites in 3 countries.

31 sites in 3 countries

United States17 sites

  • Clinical Research of South Florida, an AMR Company

    Coral Gables, Florida, 33134

  • Medisphere Medical Research Center, Llc

    Evansville, Indiana, 47714

  • Carolina Institute for Clinical Research

    Fayetteville, North Carolina, 28303

  • AMR Fort Myers Clinical Physiology Associates, an AMR company

    Fort Myers, Florida, 33912

  • I.D. Care, Inc.

    Hillsborough, New Jersey, 08844

  • Ventavia Research Group, LLC

    Keller, Texas, 76248

  • Clinical Research Consortium, an AMR company

    Las Vegas, Nevada, 89119

  • Office of Emilio Mantero-Atienza, MD

    Miami, Florida, 33135

  • University of Miami Health System

    Miami, Florida, 33136

  • Premier Research Associate, Inc

    Miami, Florida, 33165

  • Meridian Clinical Research, LLC

    Norfolk, Nebraska, 68701

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

  • Research Your Health

    Plano, Texas, 75093

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23226

  • Rochester Clinical Research, Inc

    Rochester, New York, 14609

  • Wr McCr Llc

    San Diego, California, 92120

  • Fiel Family and Sports Medicine Clinical Research Advantage

    Tempe, Arizona, 85283

Other trials in United States

Poland10 sites

  • Synexus Polska Sp. z o.o. Oddzial w Czestochowie

    Częstochowa, 42-202

  • Synexus Polska Sp. z o.o. Oddzial w Gdansku

    Gdansk, 80 382

  • Gdanskie Centrum Zdrowia

    Gdansk, 80-542

  • Synexus Polska Sp. z o.o. Oddzial w Gdynia

    Gdynia, 81 537

  • Synexus Polska Sp z o o Oddzial w Katowicach

    Katowice, 40 040

  • Synexus Polska Sp Z O O Oddzial W Lodzi

    Lodz, 90 127

  • Synexus Polska Sp. z.o.o. Oddzial w Poznaniu

    Poznan, 60-702

  • Centrum Medyczne Pratia Poznan

    Skorzewo, 60 185

  • Synexus Polska Sp z o o Oddzial w Warszawie

    Warsaw, 02 672

  • Synexus Polska Sp z o o Oddzial we Wroclawiu

    Wroclaw, 50 381

Other trials in Poland

Belgium4 sites

  • Anima

    Alken, 3570

  • Institute of Tropical Medicine Antwerp

    Antwerp, 2000

  • Clinical Pharmacology Unit

    Merksem, 2170

  • Private Practice RESPISOM Namur

    Namur, 5101

Other trials in Belgium

About this study

Official title: A Randomized, Double-blind, Phase 3 Study to Evaluate Safety, Reactogenicity, and Immunogenicity of Co-administration of Ad26.COV2.S and Influenza Vaccines in Healthy Adults 18 Years of Age and Older

The purpose of this study is to demonstrate the non-inferiority (NI) of the humoral immune response of the 4 influenza vaccine strains after concomitant administration of the Ad26.COV2.S vaccine and a seasonal quadrivalent standard-dose influenza vaccine versus the administration of a seasonal quadrivalent standard-dose influenza vaccine administered alone; and to demonstrate the NI of the binding antibody response after concomitant administration of Ad26.COV2.S vaccine and a seasonal quadrivalent standard-dose influenza vaccine versus the administration of Ad26.COV2.S vaccine administered alone.

Read the detailed description

Severe acute respiratory syndrome coronavirus(-2) (SARS CoV-2) is a highly transmissible and pathogenic coronavirus that has spread rapidly and globally and Influenza is a worldwide public health problem, responsible for significant morbidity and mortality. Ad26.COV2.S (also known as VAC31518, JNJ-78436735) is a monovalent vaccine composed of a recombinant, replication-incompetent human adenovirus type 26 (Ad26) vector, constructed to encode SARS-CoV-2 spike (S) protein, stabilized in its prefusion conformation. The seasonal influenza vaccines to be used in this study are quadrivalent (standard dose) and quadrivalent (high-dose) or equivalent formulated. The aim is to demonstrate the concomitant administration of the Ad26.COV2.S vaccine and a seasonal quadrivalent influenza vaccine (standard-dose) is non-inferior than the administration of either seasonal quadrivalent influenza vaccine (standard-dose) alone as measured by HI titers against each of the 4 influenza vaccine strains at 28 days after the administration of a quadrivalent seasonal influenza vaccine or Ad26.COV2.S vaccine alone as measured by Spiked-Enzyme-linked Immunosorbent Assay (S-ELISA) antibody titers at 28 days after the administration of the Ad26.COV2.S vaccine. This study consists of 3 phases: screening phase (Day -28 to 1), treatment phase (vaccination visits on Days 1 and 29), and a follow-up phase (28 days after each vaccination). Some of safety assessments will include physical examination, vital signs, clinical safety laboratory assessments, pregnancy testing, monitoring of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESI). The total duration of the study is up to 7-8 months.

Note: The Informed Consent Form dated 25-Mar-2022 is final version of the study MASTER ICF, used by local countries to prepare the local language version of the ICF, which have been approved by the Ethics Committees. And the highlighted text in the ICF document are the guidance for country specific adaptation.

Being tested
Ad26.COV2.S, Placebo, Influenza Vaccine

What participants receive

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

  • Ad26.COV2.SBiological

    Also called VAC31518, JNJ-78436735

    Ad26.COV2.S will be administered as an IM injection.

  • PlaceboOther

    Placebo will be administered as an IM injection.

  • Influenza VaccineBiological

    Influenza vaccine high and standard dose will be administered as IM injection.

Study groups in NCT05091307
Study groupRoleWhat they receive
Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-dose (SD) Influenza Vaccine and PlaceboExperimentalParticipants aged greater than or equal to (>=) 18 years will receive a single intramuscular (IM) injection of Ad26.COV2.S and a seasonal Q SD influenza vaccine on Day 1 and placebo on Day 29.
Receives: Biological: Ad26.COV2.S; Other: Placebo; Biological: Influenza Vaccine
Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.SPlacebo comparatorParticipants aged >=18 years will receive a single IM injection of placebo and a seasonal Q SD influenza vaccine on Day 1 followed by Ad26.COV2.S on Day 29.
Receives: Biological: Ad26.COV2.S; Other: Placebo; Biological: Influenza Vaccine
Group 3: Ad26.COV2.S + Q High-dose (HD) Influenza Vaccine and PlaceboExperimentalParticipants aged >=65 years will receive a single IM injection of Ad26.COV2.S and a seasonal Q HD influenza vaccine on Day 1 followed by placebo on Day 29.
Receives: Biological: Ad26.COV2.S; Other: Placebo; Biological: Influenza Vaccine
Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.SPlacebo comparatorParticipants aged >=65 years will receive a single IM injection of placebo and a seasonal Q HD influenza vaccine on Day 1 followed by Ad26.COV2.S on Day 29.
Receives: Biological: Ad26.COV2.S; Other: Placebo; Biological: Influenza Vaccine

What is being measured

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

  1. Groups 1 and 2: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Against Each of the Four Influenza Vaccine Strains 28 Days After the Administration of a Seasonal Quadrivalent Standard-dose Influenza Vaccine

    GMTs of HI antibodies were measured using hemagglutination inhibition (HAI) assay against each of four influenza vaccine strains (A/Victoria [H1N1], A/Cambodia [H3N2], B/Victoria [B/Victoria] and B/Phuket [B/Yamagata]). This outcome measure was planned to be analyzed for specified arms only. PPII=Per-protocol influenza immunogenicity.

    Measured: 28 days after vaccination with seasonal quadrivalent standard-dose influenza vaccine (Day 29)

  2. Groups 1 and 2: Geometric Mean Concentrations (GMCs) of Antibodies Measured by Spiked-Enzyme-linked Immunosorbent Assay (S-ELISA) 28 Days After Administration of Ad26.COV2.S Vaccine

    GMCs of antibody titers measured by S-ELISA at 28 days after administration of Ad26.COV2.S vaccine was reported. This outcome measure was planned to be analyzed for specified arms only. Seronegative participants (at Day 1) who became serology positive during the study, participants with positive molecular test for severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) and major protocol deviation were excluded from PPSI analysis.

    Measured: 28 days after vaccination with Ad26.COV2.S vaccine (Group 1: Day 29, Group 2: Day 57)

Secondary outcomes (12)

  1. Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Each Vaccination

    An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited local AEs were defined events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included erythema, swelling/induration, and pain/tenderness.

    Measured: 7 days after first vaccination on Day 1 (up to Day 8); 7 days after second vaccination on Day 29 (up to Day 36)

  2. Number of Participants With Solicited Systemic AEs up to 7 Days After Each Vaccination

    An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Solicited systemic AEs included fever (defined as body temperature of 38.0-degree celsius or higher), headache, fatigue, myalgia, nausea, vomiting were collected within 7 days after each vaccination.

    Measured: 7 days after first vaccination on Day 1 (up to Day 8); 7 days after second vaccination on Day 29 (up to Day 36)

  3. Number of Participants With Unsolicited AEs up to 28 Days After Each Vaccination

    An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.

    Measured: 28 days after first vaccination on Day 1 (up to Day 29); 28 days after second vaccination on Day 29 (up to Day 57)

  4. Number of Participants With Serious Adverse Events (SAEs)

    An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. SAE was any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

    Measured: From Day 1 (post-vaccination) to end of the study (up to 12.5 months)

  5. Number of Participants With Medically-attended Adverse Events (MAAEs)

    Number of participants with MAAEs was reported. MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. New onset of chronic diseases was collected as part of the MAAEs.

    Measured: From Day 1 (post-vaccination) to end of the study (up to 12.5 months)

  6. Number of Participants With Adverse Events of Special Interest (AESIs)

    Number of participants with AESIs was reported. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, was considered to be an AESI in this study. A suspected TTS case was defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/microliter.

    Measured: From Day 1 (post-vaccination) to end of the study (up to 12.5 months)

  7. Number of Participants With AEs Leading to Withdrawal From the Study

    Number of participants with AE leading to withdrawal from the study was reported.

    Measured: From Day 1 (post-vaccination) to end of the study (up to 12.5 months)

  8. Groups 3 and 4: GMTs of HI Antibodies Against Each of the Four Influenza Vaccine Strains 28 Days After the Administration of a Seasonal Quadrivalent High-dose Influenza Vaccine

    GMTs of HI antibodies were measured using hemagglutination inhibition (HAI) assay against each of four influenza vaccine strains (A/Victoria [H1N1], A/Tasmania[H3N2], B/Washington [B/Victoria] and B/Phuket [B/Yamagata]). This outcome measure was planned to be analyzed for specified arms only.

    Measured: 28 days after vaccination with seasonal quadrivalent high-dose influenza vaccine (Day 29)

  9. Group 3 and 4: GMCs of Antibodies Measured by S-ELISA 28 Days After Administration of Ad26.COV2.S Vaccine

    GMCs of antibody titers measured by S-ELISA at 28 days after administration of Ad26.COV2.S vaccine was reported. This outcome measure was planned to be analyzed for specified arms only. Seronegative participants (at Day 1) who became serology positive during the study, participants with positive molecular test for SARSCoV-2 and major protocol deviation were excluded from PPSI analysis.

    Measured: 28 days after vaccination with Ad26.COV2.S vaccine (Group 3: Day 29, Group 4: Day 57)

  10. GMCs of Antibodies Measured by S-ELISA 28 Days After Administration of Ad26.COV2.S Vaccine in COVID-19 Vaccine Naive Participants

    GMCs of antibodies measured by S-ELISA 28 days after administration of Ad26.COV.S vaccine in Covid-19 vaccine naive participants was reported. In the below data table, '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint.

    Measured: 28 days after the administration of Ad26.COV2.S vaccine (that is, for Groups 1 and 3: Day 29; for Groups 2 and 4: Day 57)

  11. Percentage of Participants With Seroconversion for Each of the 4 Influenza Vaccine Strains at 28 Days After the Administration of a Seasonal Quadrivalent (High-dose and Standard-dose) Influenza Vaccine

    Seroconversion was defined for each of the 4 influenza vaccine strains (For group 1 and 2: A/Victoria [H1N1], A/Cambodia [H3N2], B/Victoria [B/Victoria], B/Phuket [B/Yamagata]; For group 3 and 4: A/Victoria [H1N1], B/Phuket (B/Yamagata), A/Tasmania [H3N2], B/Washington [B/Victoria]) at 28 days after the administration of a seasonal quadrivalent (high-dose and standard-dose) 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. In the below data table, '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint.

    Measured: 28 days after the administration of a seasonal quadrivalent influenza vaccine (Day 29)

  12. Percentage of Participants With Seroprotection for Each of the 4 Influenza Vaccine Strains as HI Titer >= 1:40 at 28 Days After the Administration of a Seasonal Quadrivalent (High-dose and Standard-dose) Influenza Vaccine

    Seroprotection was defined for each of the 4 influenza vaccine strains (For group 1 and 2: A/Victoria [H1N1], A/Cambodia [H3N2], B/Victoria [B/Victoria], B/Phuket [B/Yamagata]; For group 3 and 4: A/Victoria [H1N1], B/Phuket (B/Yamagata), A/Tasmania [H3N2], B/Washington [B/Victoria]) as HI titer >=1:40 at 28 days after the administration of a seasonal quadrivalent (high-dose and standard-dose) influenza vaccine. In the below data table, '0' in the number analyzed field signifies that none of the participants were evaluable at the specified timepoint.

    Measured: 28 days after the administration of a seasonal quadrivalent influenza vaccine (Day 29)

Timeline

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

  1. First posted25 Oct 2021
  2. Study start2 Nov 2021
  3. Primary completion17 Jun 2022
  4. Study completion15 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
861 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05091307
Sponsor's protocol ID
CR109083
Other IDs
2021-003953-43, VAC31518COV3005
Status last verified
May 2025
First submitted
1 Oct 2021
Last updated
25 May 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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
Expanded access
Available

Publications

  • Tapia-Calle G, Aguilar G, Vaissiere N, Truyers C, Ylisastigui P, Buntinx E, Le Gars M, Struyf F, Scheper G, Douoguih M, Ruiz-Guinazu J; COV3005 Study group. Safety, reactogenicity, and immunogenicity of Ad26.COV2.S co-administered with a quadrivalent standard-dose or high-dose seasonal influenza vaccine: a non-inferiority randomised controlled trial. EClinicalMedicine. 2025 Jan 7;79:103016. doi: 10.1016/j.eclinm.2024.103016. eCollection 2025 Jan.

    PubMed 39866854

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ad26.COV2.S and Influenza Vaccine in people with COVID-19 Prevention, run by Janssen Vaccines & Prevention B.V. at 31 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States, Poland, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Groups 1 and 2: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibodies Against Each of the Four Influenza Vaccine Strains 28 Days After the Administration of a Seasonal Quadrivalent Standard-dose Influenza Vaccine (time frame: 28 days after vaccination with seasonal quadrivalent standard-dose influenza vaccine (Day 29)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05091307, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.

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