| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04453202 | A Study to Evaluate a Range of Dose Levels of an Adenovirus Serotype 26 (Ad26.RSV.preF)-Based Vaccine in Older Adults | PHASE2 | COMPLETED | 459 | — | — | Jul 16, 2020 | Apr 9, 2021 | May 25, 2025 | 9 | United States |
| NCT04354480 | A Study to Evaluate the Single Vaccination of an Adenovirus Serotype 26 Pre-Fusion F (Ad26.preF) Based Respiratory Syncytial Virus (RSV) Vaccine in Japanese Adults Aged 60 Years and Older | PHASE1 | COMPLETED | 36 | — | — | May 15, 2020 | Jan 20, 2021 | Feb 3, 2025 | 1 | Japan |
Geometric mean antibody titers (ELISA units per liter \[EU/L\]) to RSV preF protein using preF ELISA at 14 days after vaccination were reported.
Number of participants with solicited local AEs until 7 days after vaccination on Day 1 were reported. An AE was 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 pre-defined local (at the injection site) AEs for which participants were specifically questioned and which were noted by participants in their e-diary until 7 days after vaccination on Day 1 (day of vaccination and the subsequent 7 days). Solicited local AEs included: injection site pain/tenderness, erythema and swelling at the vaccination site.
Number of participants with solicited systemic AEs until 7 days after vaccination on Day 1 were reported. An AE was 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. Participants were instructed on how to note signs and symptoms in their diary on a daily basis until 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic AEs included fatigue, headache, myalgia, nausea and fever (body temperature greater than or equal to \[\>=\] 38 degree celsius).
Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary. An AE was 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. Unsolicited AEs included chills, injection site erythema, injection site pruritus Et cetera (etc).
Number of participants with solicited local AE's will be evaluated. Solicited local AEs (including erythema, swelling, and pain/tenderness at the study vaccine injection site) will be noted in the participant diary after 7 days of vaccination.
Number of participants with solicited systemic AEs will be evaluated. Solicited systemic AEs (fatigue, headache, myalgia, nausea and fever) will be noted in the participant diary after 7 days of vaccination.
Number of participants with unsolicited AEs will be evaluated. An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Unsolicited AEs will include all AEs for which the participant is not specifically questioned in the participant diary.
Number of participants with SAEs will be evaluated. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 Group 1: RSV Vaccine | EXPERIMENTAL | Participants will receive a single intramuscular (IM) injection of an Ad26-based RSV vaccine on Day 1. |
| Cohort 1 Group 2: RSV Vaccine | EXPERIMENTAL | Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 1) on Day 1. |
| Cohort 1 Group 3: RSV Vaccine | EXPERIMENTAL | Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 2) on Day 1. |
| Cohort 1 Group 4: RSV Vaccine | EXPERIMENTAL | Participants will receive a single IM injection of an Ad26-based RSV vaccine (low dose 3) on Day 1. |
| Cohort 1 Group 5: Placebo | PLACEBO_COMPARATOR | Participants will receive IM injection of placebo on Day 1. |
| Cohort 2 Group 6: RSV Vaccine | EXPERIMENTAL | Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1. |
| Cohort 2 Group 7: RSV Vaccine | EXPERIMENTAL | Participants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 1) on Day 1. |
| Cohort 2 Group 8: Placebo | PLACEBO_COMPARATOR | Participants will receive IM injection of placebo on Day 1. |
| Cohort 3 Group 9: RSV Vaccine | EXPERIMENTAL | Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1. |
| Cohort 3 Group 10: RSV Vaccine | EXPERIMENTAL | Participants will receive a single IM injection of an Ad26-based RSV vaccine (high dose 2) on Day 1. |
| Cohort 3 Group 11: Placebo | EXPERIMENTAL | Participants will receive IM injection of placebo on Day 1. |
| RSV Vaccine | EXPERIMENTAL | Participants will receive a single intramuscular (IM) injection of an adenovirus serotype 26 (Ad26)-based respiratory syncytial virus (RSV) vaccine at a single dose level on Day 1. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive single IM injection in the deltoid muscle of matching placebo on Day 1. |
| Name | Type | Description |
|---|---|---|
| RSV Vaccine | BIOLOGICAL | Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1. |
| Placebo | OTHER | Participants will receive a single IM injection of placebo on Day 1. |
Inclusion Criteria: * In the investigator's clinical judgment, participants must be either in good or stable health. Participants may have underlying illnesses such as hypertension, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism, as long as their signs and symptoms are stable and...