COVID-19 Prevention
Conditions
Brief 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 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.
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.
Interventions
BIOLOGICALAd26.COV2.S
Ad26.COV2.S will be administered as an IM injection.
OTHERPlacebo
Placebo will be administered as an IM injection.
BIOLOGICALInfluenza Vaccine
Influenza vaccine high and standard dose will be administered as IM injection.
Sponsors
Janssen Vaccines & Prevention B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 28 days after vaccination with seasonal quadrivalent standard-dose influenza vaccine (Day 29) | 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. |
| 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 | 28 days after vaccination with Ad26.COV2.S vaccine (Group 1: Day 29, Group 2: Day 57) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Unsolicited AEs up to 28 Days After Each Vaccination | 28 days after first vaccination on Day 1 (up to Day 29); 28 days after second vaccination on Day 29 (up to Day 57) | 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. |
| Number of Participants With Serious Adverse Events (SAEs) | From Day 1 (post-vaccination) to end of the study (up to 12.5 months) | 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. |
| Number of Participants With Medically-attended Adverse Events (MAAEs) | From Day 1 (post-vaccination) to end of the study (up to 12.5 months) | 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. |
| Number of Participants With Adverse Events of Special Interest (AESIs) | From Day 1 (post-vaccination) to end of the study (up to 12.5 months) | 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. |
| Number of Participants With AEs Leading to Withdrawal From the Study | From Day 1 (post-vaccination) to end of the study (up to 12.5 months) | Number of participants with AE leading to withdrawal from the study was reported. |
| Number of Participants With Solicited Local Adverse Events (AEs) up to 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) | 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. |
| Group 3 and 4: GMCs of Antibodies Measured by S-ELISA 28 Days After Administration of Ad26.COV2.S Vaccine | 28 days after vaccination with Ad26.COV2.S vaccine (Group 3: Day 29, Group 4: Day 57) | 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. |
| GMCs of Antibodies Measured by S-ELISA 28 Days After Administration of Ad26.COV2.S Vaccine in COVID-19 Vaccine Naive Participants | 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) | 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. |
| 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 | 28 days after the administration of a seasonal quadrivalent influenza vaccine (Day 29) | 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. |
| 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 | 28 days after the administration of a seasonal quadrivalent influenza vaccine (Day 29) | 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. |
| 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 | 28 days after vaccination with seasonal quadrivalent high-dose influenza vaccine (Day 29) | 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. |
| Number of Participants With Solicited Systemic AEs up to 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) | 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. |
Countries
Belgium, Poland, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 382 |
| 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. | 384 |
| 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. | 47 |
| 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. | 46 |
| Total | 859 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Covid-19 Vaccine/Treatment | 14 | 15 | 1 | 1 |
| Overall Study | Death | 0 | 0 | 1 | 0 |
| Overall Study | Initiated Prohibited Medication | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 33 | 33 | 2 | 0 |
| Overall Study | Other | 4 | 4 | 0 | 0 |
| Overall Study | Physician Decision | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 |
| Overall Study | Randomized but not vaccinated | 0 | 2 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 16 | 16 | 0 | 1 |
Baseline characteristics
| Characteristic | Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 46 Participants | 47 Participants | 47 Participants | 46 Participants | 186 Participants |
| Age, Categorical Between 18 and 65 years | 336 Participants | 337 Participants | 0 Participants | 0 Participants | 673 Participants |
| Age, Continuous | 46.2 years STANDARD_DEVIATION 14.92 | 45.5 years STANDARD_DEVIATION 15.25 | 71.1 years STANDARD_DEVIATION 4.58 | 71.3 years STANDARD_DEVIATION 5.29 | 48.6 years STANDARD_DEVIATION 16.35 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 117 Participants | 109 Participants | 4 Participants | 4 Participants | 234 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 262 Participants | 274 Participants | 43 Participants | 42 Participants | 621 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 3 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 10 Participants | 1 Participants | 1 Participants | 19 Participants |
| Race (NIH/OMB) Black or African American | 48 Participants | 52 Participants | 0 Participants | 0 Participants | 100 Participants |
| Race (NIH/OMB) More than one race | 9 Participants | 3 Participants | 0 Participants | 0 Participants | 12 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 5 Participants | 0 Participants | 0 Participants | 11 Participants |
| Race (NIH/OMB) White | 311 Participants | 310 Participants | 46 Participants | 45 Participants | 712 Participants |
| Region of Enrollment Belgium | 24 Participants | 26 Participants | 25 Participants | 24 Participants | 99 Participants |
| Region of Enrollment Poland | 52 Participants | 51 Participants | 8 Participants | 3 Participants | 114 Participants |
| Region of Enrollment United States | 306 Participants | 307 Participants | 14 Participants | 19 Participants | 646 Participants |
| Sex: Female, Male Female | 191 Participants | 177 Participants | 22 Participants | 33 Participants | 423 Participants |
| Sex: Female, Male Male | 191 Participants | 207 Participants | 25 Participants | 13 Participants | 436 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 382 | 0 / 384 | 1 / 47 | 0 / 46 |
| other Total, other adverse events | 45 / 382 | 45 / 384 | 11 / 47 | 6 / 46 |
| serious Total, serious adverse events | 9 / 382 | 7 / 384 | 1 / 47 | 2 / 46 |
Outcome results
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.
Time frame: 28 days after vaccination with Ad26.COV2.S vaccine (Group 1: Day 29, Group 2: Day 57)
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | 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 | 22531 ELISA Unit per milliliter (EU/mL) |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | 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 | 25035 ELISA Unit per milliliter (EU/mL) |
Comparison: 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).95% CI: [0.97, 1.26]ANOVA
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.
Time frame: 28 days after vaccination with seasonal quadrivalent standard-dose influenza vaccine (Day 29)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | 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 | B/Phuket (B/Yamagata) | 32 Titers |
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | 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 | A/Victoria (H1N1) | 306 Titers |
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | 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 | A/Cambodia (H3N2) | 134 Titers |
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | 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 | B/Victoria (B/Victoria) | 38 Titers |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | 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 | B/Victoria (B/Victoria) | 38 Titers |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | 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 | B/Phuket (B/Yamagata) | 33 Titers |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | 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 | A/Cambodia (H3N2) | 165 Titers |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | 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 | A/Victoria (H1N1) | 393 Titers |
Comparison: A/Victoria (H1N1): 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).95% CI: [1.09, 1.53]ANOVA
Comparison: 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).95% CI: [1.05, 1.45]ANOVA
Comparison: 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).95% CI: [0.84, 1.19]ANOVA
Comparison: 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).95% CI: [0.88, 1.21]ANOVA
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | GMCs of Antibodies Measured by S-ELISA 28 Days After Administration of Ad26.COV2.S Vaccine in COVID-19 Vaccine Naive Participants | 10340 EU/mL |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | GMCs of Antibodies Measured by S-ELISA 28 Days After Administration of Ad26.COV2.S Vaccine in COVID-19 Vaccine Naive Participants | 14704 EU/mL |
| Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | GMCs of Antibodies Measured by S-ELISA 28 Days After Administration of Ad26.COV2.S Vaccine in COVID-19 Vaccine Naive Participants | 38905 EU/mL |
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.
Time frame: 28 days after vaccination with Ad26.COV2.S vaccine (Group 3: Day 29, Group 4: Day 57)
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | Group 3 and 4: GMCs of Antibodies Measured by S-ELISA 28 Days After Administration of Ad26.COV2.S Vaccine | 17569 EU/mL |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | Group 3 and 4: GMCs of Antibodies Measured by S-ELISA 28 Days After Administration of Ad26.COV2.S Vaccine | 20743 EU/mL |
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.
Time frame: 28 days after vaccination with seasonal quadrivalent high-dose influenza vaccine (Day 29)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | 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 | A/Victoria (H1N1) | 286 Titers |
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | 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 | A/Tasmania (H3N2) | 284 Titers |
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | 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 | B/Washington (B/Victoria) | 61 Titers |
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | 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 | B/Phuket (B/Yamagata) | 38 Titers |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | 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 | B/Phuket (B/Yamagata) | 39 Titers |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | 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 | A/Victoria (H1N1) | 484 Titers |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | 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 | B/Washington (B/Victoria) | 75 Titers |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | 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 | A/Tasmania (H3N2) | 509 Titers |
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.
Time frame: From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
Population: The FAS included all randomized participants with at least 1 documented study vaccine administration.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | Number of Participants With Adverse Events of Special Interest (AESIs) | 9 Participants |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | Number of Participants With Adverse Events of Special Interest (AESIs) | 12 Participants |
| Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
| Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Number of Participants With Adverse Events of Special Interest (AESIs) | 0 Participants |
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.
Time frame: From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
Population: The FAS included all randomized participants with at least 1 documented study vaccine administration.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | Number of Participants With AEs Leading to Withdrawal From the Study | 0 Participants |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | Number of Participants With AEs Leading to Withdrawal From the Study | 0 Participants |
| Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Number of Participants With AEs Leading to Withdrawal From the Study | 0 Participants |
| Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Number of Participants With AEs Leading to Withdrawal From the Study | 0 Participants |
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.
Time frame: From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
Population: The FAS included all randomized participants with at least 1 documented study vaccine administration.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | Number of Participants With Medically-attended Adverse Events (MAAEs) | 51 Participants |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | Number of Participants With Medically-attended Adverse Events (MAAEs) | 51 Participants |
| Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Number of Participants With Medically-attended Adverse Events (MAAEs) | 11 Participants |
| Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Number of Participants With Medically-attended Adverse Events (MAAEs) | 16 Participants |
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.
Time frame: From Day 1 (post-vaccination) to end of the study (up to 12.5 months)
Population: The FAS included all randomized participants with at least 1 documented study vaccine administration.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | Number of Participants With Serious Adverse Events (SAEs) | 9 Participants |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | Number of Participants With Serious Adverse Events (SAEs) | 7 Participants |
| Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Number of Participants With Serious Adverse Events (SAEs) | 1 Participants |
| Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Number of Participants With Serious Adverse Events (SAEs) | 2 Participants |
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.
Time frame: 7 days after first vaccination on Day 1 (up to Day 8); 7 days after second vaccination on Day 29 (up to Day 36)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Each Vaccination | After first vaccination | 261 Participants |
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Each Vaccination | After second vaccination | 34 Participants |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Each Vaccination | After second vaccination | 210 Participants |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Each Vaccination | After first vaccination | 204 Participants |
| Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Each Vaccination | After first vaccination | 23 Participants |
| Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Each Vaccination | After second vaccination | 3 Participants |
| Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Each Vaccination | After first vaccination | 21 Participants |
| Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Number of Participants With Solicited Local Adverse Events (AEs) up to 7 Days After Each Vaccination | After second vaccination | 24 Participants |
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.
Time frame: 7 days after first vaccination on Day 1 (up to Day 8); 7 days after second vaccination on Day 29 (up to Day 36)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | Number of Participants With Solicited Systemic AEs up to 7 Days After Each Vaccination | After second vaccination | 84 Participants |
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | Number of Participants With Solicited Systemic AEs up to 7 Days After Each Vaccination | After first vaccination | 256 Participants |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | Number of Participants With Solicited Systemic AEs up to 7 Days After Each Vaccination | After second vaccination | 208 Participants |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | Number of Participants With Solicited Systemic AEs up to 7 Days After Each Vaccination | After first vaccination | 205 Participants |
| Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Number of Participants With Solicited Systemic AEs up to 7 Days After Each Vaccination | After first vaccination | 30 Participants |
| Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Number of Participants With Solicited Systemic AEs up to 7 Days After Each Vaccination | After second vaccination | 8 Participants |
| Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Number of Participants With Solicited Systemic AEs up to 7 Days After Each Vaccination | After second vaccination | 22 Participants |
| Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Number of Participants With Solicited Systemic AEs up to 7 Days After Each Vaccination | After first vaccination | 26 Participants |
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.
Time frame: 28 days after first vaccination on Day 1 (up to Day 29); 28 days after second vaccination on Day 29 (up to Day 57)
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | Number of Participants With Unsolicited AEs up to 28 Days After Each Vaccination | After second vaccination | 36 Participants |
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | Number of Participants With Unsolicited AEs up to 28 Days After Each Vaccination | After first vaccination | 71 Participants |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | Number of Participants With Unsolicited AEs up to 28 Days After Each Vaccination | After second vaccination | 50 Participants |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | Number of Participants With Unsolicited AEs up to 28 Days After Each Vaccination | After first vaccination | 71 Participants |
| Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Number of Participants With Unsolicited AEs up to 28 Days After Each Vaccination | After first vaccination | 10 Participants |
| Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | Number of Participants With Unsolicited AEs up to 28 Days After Each Vaccination | After second vaccination | 11 Participants |
| Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Number of Participants With Unsolicited AEs up to 28 Days After Each Vaccination | After first vaccination | 9 Participants |
| Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | Number of Participants With Unsolicited AEs up to 28 Days After Each Vaccination | After second vaccination | 8 Participants |
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.
Time frame: 28 days after the administration of a seasonal quadrivalent influenza vaccine (Day 29)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | 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 | A/Cambodia (H3N2) | 39.1 Percentage of participants |
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | 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 | A/Victoria (H1N1) | 64.1 Percentage of participants |
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | 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 | B/Phuket (B/Yamagata) | 35.3 Percentage of participants |
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | 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 | B/Victoria (B/Victoria) | 42.8 Percentage of participants |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | 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 | A/Victoria (H1N1) | 70.0 Percentage of participants |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | 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 | A/Cambodia (H3N2) | 46.8 Percentage of participants |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | 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 | B/Victoria (B/Victoria) | 43.5 Percentage of participants |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | 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 | B/Phuket (B/Yamagata) | 36.9 Percentage of participants |
| Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | 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 | B/Phuket (B/Yamagata) | 37.2 Percentage of participants |
| Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | 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 | A/Victoria (H1N1) | 65.1 Percentage of participants |
| Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | 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 | A/Tasmania (H3N2) | 72.1 Percentage of participants |
| Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | 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 | B/Washington (B/Victoria) | 41.9 Percentage of participants |
| Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | 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 | A/Victoria (H1N1) | 70.7 Percentage of participants |
| Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | 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 | B/Washington (B/Victoria) | 53.7 Percentage of participants |
| Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | 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 | A/Tasmania (H3N2) | 70.7 Percentage of participants |
| Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | 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 | B/Phuket (B/Yamagata) | 34.1 Percentage of participants |
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.
Time frame: 28 days after the administration of a seasonal quadrivalent influenza vaccine (Day 29)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | 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 | B/Victoria (B/Victoria) | 56.9 Percentage of participants |
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | 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 | A/Cambodia (H3N2) | 92.8 Percentage of participants |
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | 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 | B/Phuket (B/Yamagata) | 52.2 Percentage of participants |
| Group 1: Ad26.COV2.S + Quadrivalent (Q) Standard-Dose (SD) Influenza Vaccine and Placebo | 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 | A/Victoria (H1N1) | 97.8 Percentage of participants |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | 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 | B/Victoria (B/Victoria) | 57.4 Percentage of participants |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | 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 | A/Victoria (H1N1) | 97.3 Percentage of participants |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | 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 | A/Cambodia (H3N2) | 93.4 Percentage of participants |
| Group 2: Placebo + Q SD Influenza Vaccine and Ad26.COV2.S | 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 | B/Phuket (B/Yamagata) | 55.0 Percentage of participants |
| Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | 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 | A/Victoria (H1N1) | 100.0 Percentage of participants |
| Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | 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 | A/Tasmania (H3N2) | 97.7 Percentage of participants |
| Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | 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 | B/Washington (B/Victoria) | 79.1 Percentage of participants |
| Group 3: Ad26.COV2.S + Q High Dose (HD) Influenza Vaccine and Placebo | 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 | B/Phuket (B/Yamagata) | 62.8 Percentage of participants |
| Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | 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 | A/Victoria (H1N1) | 100.0 Percentage of participants |
| Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | 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 | B/Phuket (B/Yamagata) | 63.4 Percentage of participants |
| Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | 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 | A/Tasmania (H3N2) | 100.0 Percentage of participants |
| Group 4: Placebo + Q HD Influenza Vaccine and Ad26.COV2.S | 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 | B/Washington (B/Victoria) | 82.9 Percentage of participants |