Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03500679 | A Study to Evaluate Safety and Immunogenicity of the ExPEC4V Clinical Trial Material After a Single Intramuscular Dose and a Second Dose 6 Months Later in Healthy Participants Aged 18 Years and Older | PHASE2 | COMPLETED | 100 | — | — | May 9, 2018 | Jun 11, 2019 | Nov 26, 2019 | 2 | United States |
| NCT02546960 | A Study in Healthy Adults to Evaluate the Safety and Immunogenicity of Different Doses of JNJ-63871860 | PHASE2 | COMPLETED | 848 | — | — | Nov 12, 2015 | Jun 21, 2019 | Apr 22, 2020 | 17 | United States |
| NCT02748967 | A Study to Evaluate the Safety and Immunogenicity of Different Doses of ExPEC4V (JNJ-63871860) in Healthy Japanese Adult Participants | PHASE1 | COMPLETED | 48 | — | — | Apr 1, 2016 | Aug 1, 2016 | Oct 4, 2016 | 1 | Japan |
An AE is 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 study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited local AEs were precisely defined local events that participants were specifically asked about and which were noted by participants in the diary. Solicited local AEs included injection-site pain/tenderness, injection-site erythema and injection-site swelling/induration.
An AE is 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 study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Solicited systemic AEs were precisely defined systemic events that participants were specifically asked about and which were noted by participants in the diary. Solicited systemic AEs included fatigue, headache, nausea, myalgia and fever.
An AE is 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 study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Unsolicited AEs were precisely defined events that participants were not asked about and which were not noted by participants in the diary.
An AE is 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 study vaccine. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. An SAE is any AE that results in: death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect and is a suspected transmission of any infectious agent via a medicinal product.
Immunoglobulin G (IgG) antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Day 1 were reported.
IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMTs for serotypes O1A, O2, O6A and O25B at Day 15 were reported.
IgG antibody levels elicited by the vaccine against each of the 4 vaccine serotypes (serotype O1A, O2, O6A and O25B) were measured by ELISA. GMR for serotypes O1A, O2, O6A and O25B (Day 15/Day 1) was reported.
Percentage of participants with a 2-fold and 4-fold increase from baseline in serum antibody titers as measured by ELISA at Day 15 were reported.
Solicited AEs are precisely defined events that participants are specifically asked about and which are noted by participants through the electronic Subject Diary. Solicited Local AEs: Participants will be instructed on how to note occurrences of pain/tenderness, erythema, and induration/swelling at the injection site daily for 8 days postvaccination (day of vaccination and the subsequent 7 days) in the electronic Subject Diary. Participants will be instructed on how to measure (using the ruler supplied) and record erythema and induration.
Solicited AEs are precisely defined events that participants are specifically asked about and which are noted by participants through the electronic Subject Diary. Solicited Systemic AEs: Participants will be instructed on how to note daily symptoms in the electronic Subject Diary for 8 days post vaccination (day of vaccination and the subsequent 7 days) of the following systemic events: fever, headache, fatigue, malaise, nausea, and myalgia.
An SAE is any adverse event 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 and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.
Dose-dependent immunogenicity will be measured by enzyme-linked immunosorbent assay (ELISA) on day 15 in participants with \>=18 years of age. Immunoglobulin G (IgG) antibody levels elicited by the vaccine will be measured by ELISA.
Evaluation of the immunogenicity of a single vaccination with the ExPEC4V dose selected for further clinical development based on the primary analysis, as measured by ELISA.
| Arm | Type | Description |
|---|---|---|
| Group 1: ExPEC4V (JNJ-63871860) | EXPERIMENTAL | Participants will receive vaccination of ExPEC4V dose as an intramuscular (IM) injection into deltoid muscle on Days 1 and 181. The ExPEC4V doses contain polysaccharide antigen (4:4:4:8 microgram \[mcg\]) from the ExPEC4V serotypes O1A, O2, O6A, and O25B. |
| Group 2: Placebo | PLACEBO_COMPARATOR | Participants will receive placebo matching to ExPEC4V as an IM injection on Days 1 and 181. |
| ExPEC4V (4 : 4 : 4 : 4) | EXPERIMENTAL | Participants will be stratified according to their age in 2 groups \>=18 to \<50 years and \>=50 years. Part 1: In age group \>= 18 to \<50 years, participants will receive single vaccination of ExPEC4V dose (4 : 4 : 4 : 4) as an intramuscular (i.m) injection into deltoid muscle. The ExPEC4V doses contain polysaccharide antigen (in microgram \[mcg\]) from the ExPEC serotypes O1A, O2, O6A, and O25B. Participants in \>=50 years group will be enrolled in stepwise,dose-escalating procedure. In step 1, lowest dose of ExPEC4V (4:4:4:4) or Placebo will be given, in step 2 either of 2 medium doses of ExPEC4V or placebo and in step 3, either of 2 highest doses of ExPEC4V or placebo. Participants will be enrolled into subsequent steps only if vaccination in previous steps is deemed safe based on review of safety data by the IDMC. Participants will be enrolled into Part 2 only if vaccination in Part 1 is deemed safe based on the review of safety data through Day 8 by the IDMC. |
| ExPEC4V (4 : 4 : 4 : 8) | EXPERIMENTAL | Participants will be stratified according to their age in 2 groups \>=18 to \<50 years and \>=50 years. Part 1: In age group \>= 18 to \<50 years, participants will receive single vaccination of ExPEC4V dose (4 : 4 : 4 : 8) as an i.m injection into deltoid muscle. The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B. Participants in \>=50 years group will be enrolled in stepwise,dose-escalating procedure. In step 1, lowest dose of ExPEC4V or Placebo will be given, in step 2 either of 2 medium doses (4 : 4 : 4 : 8/8 : 8 : 8 : 8) of ExPEC4V or placebo and in step 3, either of 2 highest doses of ExPEC4V or placebo. Participants will be enrolled into subsequent steps only if vaccination in previous steps is deemed safe based on review of safety data by the IDMC. Participants will be enrolled into Part 2 only if vaccination in Part 1 is deemed safe based on the review of safety data through Day 8 by the IDMC. |
| ExPEC4V (8 : 8 : 8 : 8) | EXPERIMENTAL | Participants will be stratified according to their age in 2 groups \>=18 to \<50 years and \>=50 years. Part 1: In age group \>= 18 to \<50 years, participants will receive single vaccination of ExPEC4V dose (8 : 8 : 8 : 8) as an i.m injection into deltoid muscle. The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B. Participants in \>=50 years group will be enrolled in stepwise,dose-escalating procedure. In step 1, lowest dose of ExPEC4V or Placebo will be given, in step 2 either of 2 medium doses (4 : 4 : 4 : 8/8 : 8 : 8 : 8) of ExPEC4V or placebo and in step 3, either of 2 highest doses of ExPEC4V or placebo. Participants will be enrolled into subsequent steps only if vaccination in previous steps is deemed safe based on review of safety data by the IDMC. Participants will be enrolled into Part 2 only if vaccination in Part 1 is deemed safe based on the review of safety data through Day 8 by the IDMC. |
| ExPEC4V (8 : 8 : 8 : 16) | EXPERIMENTAL | Participants will be stratified according to their age in 2 groups \>=18 to \<50 years and \>=50 years. Part 1: In age group \>= 18 to \<50 years, participants will receive single vaccination of ExPEC4V dose (8 : 8 : 8 : 16) as an i.m injection into deltoid muscle. The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B. Participants in \>=50 years group will be enrolled in stepwise,dose-escalating procedure. In step 1, lowest dose of ExPEC4V or Placebo will be given, in step 2 either of 2 medium doses of ExPEC4V or placebo and in step 3, either of 2 highest doses (8 : 8 : 8 : 16/16 : 16 : 16 : 16) of ExPEC4V or placebo. Participants will be enrolled into subsequent steps only if vaccination in previous steps is deemed safe based on review of safety data by the IDMC. Participants will be enrolled into Part 2 only if vaccination in Part 1 is deemed safe based on the review of safety data through Day 8 by the IDMC. |
| ExPEC4V (16 : 16 : 16 : 16) | EXPERIMENTAL | Participants will be stratified according to their age in 2 groups \>=18 to \<50 years and \>=50 years. Part 1: In age group \>= 18 to \<50 years, participants will receive single vaccination of ExPEC4V dose (16 : 16 : 16 : 16) as an i.m injection into deltoid muscle. The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B. Participants in \>=50 years group will be enrolled in stepwise,dose-escalating procedure. In step 1, lowest dose of ExPEC4V or Placebo will be given, in step 2 either of 2 medium doses of ExPEC4V or placebo and in step 3, either of 2 highest doses (8 : 8 : 8 : 16/16 : 16 : 16 : 16) of ExPEC4V or placebo. Participants will be enrolled into subsequent steps only if vaccination in previous steps is deemed safe based on review of safety data by the IDMC. Participants will be enrolled into Part 2 only if vaccination in Part 1 is deemed safe based on the review of safety data through Day 8 by the IDMC. |
| Placebo | PLACEBO_COMPARATOR | Participants will be stratified according to their age in 2 groups \>= 18 to \<50 years and \>=50 years. Part 1: Participants will receive matching placebo to ExPEC4V as an intramuscular injection into the deltoid muscle. Participants will be enrolled into Part 2 only if vaccination in Part 1 is deemed safe and well tolerated based on the review of safety data through Day 8 by the IDMC. |
| Group 1 | EXPERIMENTAL | Participants with age (greater than or equal to \[\>=\] 20 to less than \[\<\] 50 years) will receive single dose of 0.5 milliliter (mL) of ExPEC4V (4:4:4:4) or placebo on Day 1. |
| Group 2 | EXPERIMENTAL | Participants with age \>= 20 to \< 50 will receive single dose of 0.5 mL of ExPEC4V (8:8:8:8) or placebo on Day 1. |
| Group 3 | EXPERIMENTAL | Participants with age \>= 20 to \< 50 will receive single dose of 0.5 mL of ExPEC4V (16:16:16:16) or placebo on Day 1. |
| Group 4 | EXPERIMENTAL | Participants with age greater than or equal to \[\>=\] 50 will receive single dose of 0.5 mL of ExPEC4V (4:4:4:4) or placebo on Day 1. |
| Group 5 | EXPERIMENTAL | Participants with age \>= 50 will receive single dose of 0.5 mL of ExPEC4V (8:8:8:8) or placebo on Day 1. |
| Group 6 | EXPERIMENTAL | Participants with age \>= 50 will receive single dose of 0.5 mL of ExPEC4V (16:16:16:16) or placebo on Day 1. |
| Name | Type | Description |
|---|---|---|
| ExPEC4V | BIOLOGICAL | Participants will receive ExPEC4V vaccine as an IM injection on Days 1 and 181. |
| Placebo | BIOLOGICAL | Participants will receive placebo as an IM injection on Days 1 and 181. |
| ExPEC4V (4 : 4 : 4 : 4) | BIOLOGICAL | Participants will receive single vaccination of ExPEC4V dose (4 : 4 : 4 : 4) as an intramuscular (i.m) injection into deltoid muscle in part 1 (age groups \>=18 to \<50 years and \>=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in microgram \[mcg\]) from the ExPEC serotypes O1A, O2, O6A, and O25B. |
| ExPEC4V (4 : 4 : 4 : 8) | BIOLOGICAL | Participants will receive single vaccination of ExPEC4V dose (4 : 4 : 4 : 8) as an i.m injection into deltoid muscle in part 1 (age groups \>=18 to \<50 years and \>=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B. |
| ExPEC4V (8 : 8 : 8 : 8) | BIOLOGICAL | Participants will receive single vaccination of ExPEC4V dose (8 : 8 : 8 : 8) as an i.m injection into deltoid muscle in part 1 (age groups \>=18 to \<50 years and \>=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B. |
| ExPEC4V (8 : 8 : 8 : 16) | BIOLOGICAL | Participants will receive single vaccination of ExPEC4V dose (8 : 8 : 8 : 16) as an i.m injection into deltoid muscle in part 1 (age groups \>=18 to \<50 years and \>=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B. |
| ExPEC4V (16 : 16 : 16 : 16) | BIOLOGICAL | Participants will receive single vaccination of ExPEC4V dose (16 : 16 : 16 : 16) as an i.m injection into deltoid muscle in part 1 (age groups \>=18 to \<50 years and \>=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B. |
Inclusion Criteria: * Participants who provides written informed consent and signs the informed consent form (ICF) indicating that he or she understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study * Participant is medically stabl...