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

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.

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.

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.

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.

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.

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 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 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 AE leading to withdrawal from the study was reported.

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.

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.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.

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.

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.