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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003953-43 | EudraCT Number | ||
| VAC31518COV3005 | Other Identifier | Janssen Vaccines & Prevention B.V. |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-dose (SD) Influenza Vaccine and Placebo | Experimental | Participants 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. |
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| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | Placebo Comparator | Participants 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. |
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| Group 3: Ad26.COV2.S + Q High-dose (HD) Influenza Vaccine and Placebo | Experimental | Participants 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. |
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| Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Placebo Comparator | Participants 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ad26.COV2.S | Biological | Ad26.COV2.S will be administered as an IM injection. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days after vaccination with seasonal quadrivalent standard-dose influenza vaccine (Day 29) |
| 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. | 28 days after vaccination with Ad26.COV2.S vaccine (Group 1: Day 29, Group 2: Day 57) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Vaccines & Prevention B.V. Clinical Trial | Janssen Vaccines & Prevention B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fiel Family and Sports Medicine Clinical Research Advantage | Tempe | Arizona | 85283 | United States | ||
| Wr McCr Llc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39866854 | Derived | 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. |
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | Participants aged greater than or equal to (>=) 18 years and older received a single intramuscular (IM) injection of Ad26.COV2.S at 5*10^10 viral particles (vp) dose level and a seasonal Q SD influenza vaccine with 60 micrograms (mcg) hemagglutinin (HA) on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 15, 2022 | Jun 16, 2023 |
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| Placebo | Other | Placebo will be administered as an IM injection. |
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| Influenza Vaccine | Biological | Influenza vaccine high and standard dose will be administered as IM injection. |
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| 7 days after first vaccination on Day 1 (up to Day 8); 7 days after second vaccination on Day 29 (up to Day 36) |
| 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. | 7 days after first vaccination on Day 1 (up to Day 8); 7 days after second vaccination on Day 29 (up to Day 36) |
| 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. | 28 days after first vaccination on Day 1 (up to Day 29); 28 days after second vaccination on Day 29 (up to Day 57) |
| 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. | From Day 1 (post-vaccination) to end of the study (up to 12.5 months) |
| 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. | From Day 1 (post-vaccination) to end of the study (up to 12.5 months) |
| 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. | From Day 1 (post-vaccination) to end of the study (up to 12.5 months) |
| Number of Participants With AEs Leading to Withdrawal From the Study | Number of participants with AE leading to withdrawal from the study was reported. | From Day 1 (post-vaccination) to end of the study (up to 12.5 months) |
| 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. | 28 days after vaccination with seasonal quadrivalent high-dose influenza vaccine (Day 29) |
| 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. | 28 days after vaccination with Ad26.COV2.S vaccine (Group 3: Day 29, Group 4: Day 57) |
| 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. | 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) |
| 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. | 28 days after the administration of a seasonal quadrivalent influenza vaccine (Day 29) |
| 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. | 28 days after the administration of a seasonal quadrivalent influenza vaccine (Day 29) |
| San Diego |
| California |
| 92120 |
| United States |
| Clinical Research of South Florida, an AMR Company | Coral Gables | Florida | 33134 | United States |
| AMR Fort Myers Clinical Physiology Associates, an AMR company | Fort Myers | Florida | 33912 | United States |
| Office of Emilio Mantero-Atienza, MD | Miami | Florida | 33135 | United States |
| University of Miami Health System | Miami | Florida | 33136 | United States |
| Premier Research Associate, Inc | Miami | Florida | 33165 | United States |
| Medisphere Medical Research Center, Llc | Evansville | Indiana | 47714 | United States |
| Meridian Clinical Research, LLC | Norfolk | Nebraska | 68701 | United States |
| Clinical Research Consortium, an AMR company | Las Vegas | Nevada | 89119 | United States |
| I.D. Care, Inc. | Hillsborough | New Jersey | 08844 | United States |
| Rochester Clinical Research, Inc | Rochester | New York | 14609 | United States |
| Carolina Institute for Clinical Research | Fayetteville | North Carolina | 28303 | United States |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | United States |
| Ventavia Research Group, LLC | Keller | Texas | 76248 | United States |
| Research Your Health | Plano | Texas | 75093 | United States |
| Clinical Research Partners, LLC | Richmond | Virginia | 23226 | United States |
| Anima | Alken | 3570 | Belgium |
| Institute of Tropical Medicine Antwerp | Antwerp | 2000 | Belgium |
| Clinical Pharmacology Unit | Merksem | 2170 | Belgium |
| Private Practice RESPISOM Namur | Namur | 5101 | Belgium |
| Synexus Polska Sp. z o.o. Oddzial w Czestochowie | Częstochowa | 42-202 | Poland |
| Synexus Polska Sp. z o.o. Oddzial w Gdansku | Gdansk | 80 382 | Poland |
| Gdanskie Centrum Zdrowia | Gdansk | 80-542 | Poland |
| Synexus Polska Sp. z o.o. Oddzial w Gdynia | Gdynia | 81 537 | Poland |
| Synexus Polska Sp z o o Oddzial w Katowicach | Katowice | 40 040 | Poland |
| Synexus Polska Sp Z O O Oddzial W Lodzi | Lodz | 90 127 | Poland |
| Synexus Polska Sp. z.o.o. Oddzial w Poznaniu | Poznan | 60-702 | Poland |
| Centrum Medyczne Pratia Poznan | Skorzewo | 60 185 | Poland |
| Synexus Polska Sp z o o Oddzial w Warszawie | Warsaw | 02 672 | Poland |
| Synexus Polska Sp z o o Oddzial we Wroclawiu | Wroclaw | 50 381 | Poland |
| FG001 | Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | Participants aged >=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level on Day 29. |
| FG002 | Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Participants aged >=65 years and older received a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29. |
| FG003 | Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Participants aged >=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level on Day 29. |
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| Treated | Vaccinated participants |
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| COMPLETED |
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| NOT COMPLETED |
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The Full Analysis Set (FAS) included all participants with a vaccine administration documented.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | Participants aged greater than or equal to (>=) 18 years and older received a single intramuscular (IM) injection of Ad26.COV2.S at 5*10^10 viral particles (vp) dose level and a seasonal Q SD influenza vaccine with 60 micrograms (mcg) hemagglutinin (HA) on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29. |
| BG001 | Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | Participants aged >=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level on Day 29. |
| BG002 | Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Participants aged >=65 years and older received a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29. |
| BG003 | Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Participants aged >=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level on Day 29. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | The PPII set included all randomized participants who received Ad26.COV2.S vaccine in combination with seasonal influenza vaccine for co-administration group and those who received seasonal influenza vaccine alone for control group, for whom immunogenicity data were available for at least one of influenza strains in vaccine. Participants with major protocol deviation were excluded from PPII analysis. 'N' (number of participants analyzed)=participants who were evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 28 days after vaccination with seasonal quadrivalent standard-dose influenza vaccine (Day 29) |
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| Primary | 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. | The per protocol SARS-CoV-2 immunogenicity set (PPSI) included all randomized participants who received Ad26.COV2.S vaccine in combination with seasonal influenza vaccine for co-administration group and Ad26.COV2.S vaccine alone for control group, and for whom immunogenicity data was available. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | ELISA Unit per milliliter (EU/mL) | 28 days after vaccination with Ad26.COV2.S vaccine (Group 1: Day 29, Group 2: Day 57) |
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| Secondary | 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. | The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration. Here, 'n' (number analyzed) signifies participants who were evaluated at each specified category. | Posted | Count of Participants | Participants | 7 days after first vaccination on Day 1 (up to Day 8); 7 days after second vaccination on Day 29 (up to Day 36) |
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| Secondary | 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. | The FAS included all randomized participants with at least 1 documented study vaccine administration. Here, 'n' (number analyzed) signifies participants who were evaluated at each specified category. | Posted | Count of Participants | Participants | 7 days after first vaccination on Day 1 (up to Day 8); 7 days after second vaccination on Day 29 (up to Day 36) |
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| Secondary | 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. | The FAS included all randomized participants with at least 1 documented study vaccine administration. Here, 'n' (number analyzed) signifies participants who were evaluated at each specified category. | Posted | Count of Participants | Participants | 28 days after first vaccination on Day 1 (up to Day 29); 28 days after second vaccination on Day 29 (up to Day 57) |
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| Secondary | 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. | The FAS included all randomized participants with at least 1 documented study vaccine administration. | Posted | Count of Participants | Participants | From Day 1 (post-vaccination) to end of the study (up to 12.5 months) |
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| Secondary | 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. | The FAS included all randomized participants with at least 1 documented study vaccine administration. | Posted | Count of Participants | Participants | From Day 1 (post-vaccination) to end of the study (up to 12.5 months) |
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| Secondary | 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. | The FAS included all randomized participants with at least 1 documented study vaccine administration. | Posted | Count of Participants | Participants | From Day 1 (post-vaccination) to end of the study (up to 12.5 months) |
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| Secondary | Number of Participants With AEs Leading to Withdrawal From the Study | Number of participants with AE leading to withdrawal from the study was reported. | The FAS included all randomized participants with at least 1 documented study vaccine administration. | Posted | Count of Participants | Participants | From Day 1 (post-vaccination) to end of the study (up to 12.5 months) |
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| Secondary | 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. | The PPII set included all randomized participants who received Ad26.COV2.S vaccine in combination with a seasonal influenza vaccine for the coadministration group and those who received a seasonal influenza vaccine alone for the control group, for whom immunogenicity data were available for at least one of the influenza strains in the vaccine. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 28 days after vaccination with seasonal quadrivalent high-dose influenza vaccine (Day 29) |
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| Secondary | 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. | The PPSI included all randomized participants who received Ad26.COV2.S vaccine in combination with seasonal influenza vaccine for the co-administration group and Ad26.COV2.S vaccine alone for the control group, and for whom immunogenicity data was available. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | 28 days after vaccination with Ad26.COV2.S vaccine (Group 3: Day 29, Group 4: Day 57) |
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| Secondary | 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. | PPSI included all randomized participants who received Ad26.COV2.S vaccine in combination with seasonal influenza vaccine for co-administration group and Ad26.COV2.S vaccine alone for control group and for whom immunogenicity data was available. Participants with positive molecular test for SARSCoV-2 were also excluded. Here, 'N'(number of participants analyzed)=who were evaluable for this outcome measure, 'n'(number analyzed)=participant who were evaluated at specified timepoint. | Posted | Geometric Mean | 95% Confidence Interval | EU/mL | 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) |
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| Secondary | 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. | The PPII set included all randomized participants who received Ad26.COV2.S vaccine in combination with seasonal influenza vaccine for co-administration group and those who received seasonal influenza vaccine alone for control group, for whom immunogenicity data were available for at least one of influenza strains in vaccine. Participants with major protocol deviation were excluded from PPII analysis. 'N' (number of participants analyzed)=participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | 28 days after the administration of a seasonal quadrivalent influenza vaccine (Day 29) |
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| Secondary | 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. | The PPII set included all randomized participants who received Ad26.COV2.S vaccine in combination with seasonal influenza vaccine for coadministration group and those who received seasonal influenza vaccine alone for control group, for whom immunogenicity data were available for at least one of influenza strains in vaccine. Participants with major protocol deviation were excluded from PPII analysis. 'N' (number of participants analyzed)=participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | 28 days after the administration of a seasonal quadrivalent influenza vaccine (Day 29) |
|
From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
The full analysis set (FAS) included all randomized participants with at least 1 documented study vaccine administration.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | Participants aged greater than or equal to (>=) 18 years and older received a single intramuscular (IM) injection of Ad26.COV2.S at 5*10^10 viral particles (vp) dose level and a seasonal Q SD influenza vaccine with 60 micrograms (mcg) hemagglutinin (HA) on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29. | 0 | 382 | 9 | 382 | 45 | 382 |
| EG001 | Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | Participants aged >=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level on Day 29. | 0 | 384 | 7 | 384 | 45 | 384 |
| EG002 | Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Participants aged >=65 years and older received a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29. | 1 | 47 | 1 | 47 | 11 | 47 |
| EG003 | Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Participants aged >=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level on Day 29. | 0 | 46 | 2 | 46 | 6 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Chronic Left Ventricular Failure | Cardiac disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Biliary Obstruction | Hepatobiliary disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Covid-19 | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Staphylococcal Infection | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Fibula Fracture | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Joint Injury | Injury, poisoning and procedural complications | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Gastrointestinal Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Polycythaemia Vera | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Optic Neuritis | Nervous system disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Bipolar Disorder | Psychiatric disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Calculus Urinary | Renal and urinary disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Abnormal Uterine Bleeding | Reproductive system and breast disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Skin Ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA Version 25.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 25.1 | Non-systematic Assessment |
|
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will with hold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Leader | Janssen Vaccines & Prevention B.V. | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 17, 2022 | Jun 16, 2023 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 25, 2022 | Jan 16, 2024 | ICF_005.pdf |
Not provided
| ID | Term |
|---|---|
| D000090984 | Ad26COVS1 |
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Poland |
|
| United States |
|
| B/Victoria (B/Victoria) |
|
| B/Phuket (B/Yamagata) |
|
| A/Cambodia (H3N2): Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 [control group] minus Group 1 [CoAd group]) was calculated and back-transformed (by exponentiation: 2^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd). | ANOVA | Geometric Mean Ratio | 1.23 | 2-Sided | 95 | 1.05 | 1.45 | Non-Inferiority | The criterion for NI was the upper bound of the 2-sided 95% CI for the GMR was below 1.5. |
| B/Victoria (B/Victoria): Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 [control group] minus Group 1 [CoAd group]) was calculated and back-transformed (by exponentiation: 2^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd). | ANOVA | Geometric Mean Ratio | 0.99 | 2-Sided | 95 | 0.84 | 1.19 | Non-Inferiority | The criterion for NI was the upper bound of the 2-sided 95% CI for the GMR was below 1.5. |
| B/Phuket (B/Yamagata): Based on analysis of variance (ANOVA) models, CIs around the difference (Group 2 [control group] minus Group 1 [CoAd group]) was calculated and back-transformed (by exponentiation: 2^CI) to CIs around a geometric mean ratio (GMR: GMTControl/GMTCoAd). | ANOVA | Geometric Mean Ratio | 1.03 | 2-Sided | 95 | 0.88 | 1.21 | Non-Inferiority | The criterion for NI was the upper bound of the 2-sided 95% CI for the GMR was below 1.5. |
| OG001 | Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | Participants aged >=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level on Day 29. |
|
|
|
Participants aged >=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level on Day 29.
| OG002 | Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Participants aged >=65 years and older received a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29. |
| OG003 | Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Participants aged >=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level on Day 29. |
|
|
| OG002 | Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Participants aged >=65 years and older received a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29. |
| OG003 | Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Participants aged >=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level on Day 29. |
|
|
| OG002 | Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Participants aged >=65 years and older received a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29. |
| OG003 | Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Participants aged >=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level on Day 29. |
|
|
| OG002 | Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Participants aged >=65 years and older received a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29. |
| OG003 | Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Participants aged >=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level on Day 29. |
|
|
| OG002 |
| Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo |
Participants aged >=65 years and older received a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29. |
| OG003 | Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Participants aged >=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level on Day 29. |
|
|
| OG002 | Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Participants aged >=65 years and older received a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29. |
| OG003 | Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Participants aged >=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level on Day 29. |
|
|
Participants aged >=65 years and older received a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
| OG003 | Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Participants aged >=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level on Day 29. |
|
|
Participants aged >=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level on Day 29.
|
|
|
|
Participants aged >=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level on Day 29. |
| OG002 | Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Participants aged >=65 years and older received a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29. |
| OG003 | Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Participants aged >=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level on Day 29. |
|
|
Participants aged greater than or equal to (>=) 18 years and older received a single intramuscular (IM) injection of Ad26.COV2.S at 5*10^10 viral particles (vp) dose level and a seasonal Q SD influenza vaccine with 60 micrograms (mcg) hemagglutinin (HA) on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29.
| OG001 | Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | Participants aged >=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level on Day 29. |
| OG002 | Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Participants aged >=65 years and older received a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29. |
| OG003 | Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Participants aged >=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level on Day 29. |
|
|
| OG001 | Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | Participants aged >=18 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q SD influenza vaccine with 60 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level on Day 29. |
| OG002 | Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Participants aged >=65 years and older received a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level and a seasonal Q HD influenza vaccine with 240 mcg HA on Day 1 followed by a single IM injection of placebo (matched to Ad26.COV2.S) on Day 29. |
| OG003 | Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Participants aged >=65 years and older received a single IM injection of placebo (matched to Ad26.COV2.S) and a seasonal Q HD influenza vaccine with 240 mcg of HA on Day 1 followed by a single IM injection of Ad26.COV2.S at 5*10^10 vp dose level on Day 29. |
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