Ad26.RSV.PreF-based Vaccine

GMTs of pre-F antibodies as assessed by ELISA at 14 days post administration of Ad26/protein preF RSV vaccine were reported.

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

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

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

Number of participants with solicited local AEs at 7 days post-vaccination in Cohorts 1 and 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs were predefined local events (at the injection site: erythema, pain/tenderness and swelling) that were by definition considered as related to the study vaccine and collected within 7 days after vaccination.

Number of participants with solicited systemic AEs at 7 days post-vaccination in Cohorts 1 and 2 were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited systemic AEs including pyrexia, headache, fatigue, myalgia and nausea were collected within 7 days after vaccination.

Number of participants with unsolicited AEs post-vaccination in Cohorts 1 and 2 were reported. An AE was defined as any untoward medical occurrence in a participant participating in a clinical study that did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs were defined as all AEs for which the participant was not specifically questioned in the participant diary.

Number of participants with SAEs post-vaccination were reported. An AE was defined as any untoward medical event that occurred in a participant administered an investigational product, and it did not necessarily indicated only events with clear causal relationship with the relevant investigational product. SAE was defined as any AE that resulted in: death, persistent or significant disability/incapacity, required inpatient hospitalization or prolongation of existing hospitalization, was life-threatening experience, was a congenital anomaly/birth defect and would jeopardize participant and/or required medical or surgical intervention to prevent one of the outcomes listed above.

Number of participants with AESI post-vaccination were 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) was considered as an AESI.

RSV A2 strain neutralizing antibody titers of the vaccine-induced immune response was assessed through virus neutralization assay and were expressed as 50% inhibitory concentration (IC50) units.

Percentage of participants with seroresponse as assessed by VNA-A2 strain were reported. Seroresponse was defined as a 4-fold increase from baseline in Day 15 VNA A2 antibody titers.