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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02298179 | A Study to Evaluate the Safety and Ability of the Vaccine to Induce Antibodies Against the Respiratory Syncytial Virus in Healthy Adults | PHASE1 | COMPLETED | 288 | — | — | Dec 19, 2014 | Mar 27, 2017 | Aug 13, 2018 | 1 | Belgium |
Immunogenicity was measured in terms of the Geometric mean titers (GMTs) of the serum anti-RSV neutralizing antibody (NAb) titers at Day 57 (28 days after the second dose).
Immunogenicity was measured in terms of percentage of subjects with a ≥ 4-fold increase in serum anti-RSV NAb titers, from Day 1 (baseline) to Day 57 (28 days after the second dose).
Assessed solicited local symptoms were: induration, swelling, erythema and pain. Any induration/swelling/erythema = induration/swelling/erythema spreading beyond 25 millimeters (mm) of injection site. Any pain = occurrence of the symptom regardless of intensity grade.
Assessed solicited systemic symptoms were: nausea, fatigue, myalgia, arthralgia, headache, fever (body temperature ≥ 38.0°C), chills, coughing, diarrhea, rhinorrhea and wheezing. Other solicited data included: prevention of pain and/or fever and treatment of pain and/or fever. Any = occurrence of the symptom regardless of intensity grade.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity, congenital anomaly or birth defect. Any SAE = occurrence of the SAE regardless of intensity grade. Possibly or probably related SAE = SAE assessed by the investigator as possibly or probably related to the study vaccination. Other significant AE(s) assessed include unsolicited medically attended AEs, unsolicited AEs leading to study withdrawal, new onset of chronic diseases (NOCDs) and adverse events of special interest (AESIs). Medically attended AE = an adverse event that leads to an unscheduled visit to a healthcare practitioner. NOCD = an adverse event that represents a new diagnosis of a chronic medical condition that was not present or suspected in a subject prior to study enrollment.
| Arm | Type | Description |
|---|---|---|
| RSV F 45 No Adj Group | EXPERIMENTAL | Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine \[45 μg\], with no adjuvant. |
| RSV F 45 Alum Adj Group | EXPERIMENTAL | Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine \[45 μg\], with aluminum hydroxide adjuvant. |
| RSV F 45 MF59 Adj Group | EXPERIMENTAL | Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the low dose RSV F subunit vaccine \[45 μg\], with MF59 adjuvant. |
| Placebo 1 Group | PLACEBO_COMPARATOR | Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine \[45 μg\], Cohort 2: middle dosage of RSV F subunit vaccine \[90 μg\], and Cohort 3: high dosage of RSV F subunit vaccine \[135 μg\]). This placebo group belongs to Cohort 1. |
| RSV F 90 No Adj Group | EXPERIMENTAL | Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine \[90 μg\], with no adjuvant. |
| RSV F 90 Alum Adj Group | EXPERIMENTAL | Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine \[90 μg\], with aluminum hydroxide adjuvant. |
| RSV F 90 MF59 Adj Group | EXPERIMENTAL | Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the medium dose RSV F subunit vaccine \[90 μg\], with MF59 adjuvant. |
| Placebo 2 Group | PLACEBO_COMPARATOR | Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine \[45 μg\], Cohort 2: middle dosage of RSV F subunit vaccine \[90 μg\], and Cohort 3: high dosage of RSV F subunit vaccine \[135 μg\]). This placebo group belongs to Cohort 2. |
| RSV F 135 No Adj Group | EXPERIMENTAL | Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine \[135 μg\], with no adjuvant. |
| RSV F 135 Alum Adj Group | EXPERIMENTAL | Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine \[135 μg\], with aluminum hydroxide adjuvant. |
| RSV F 135 MF59 Adj Group | EXPERIMENTAL | Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of the high dose RSV F subunit vaccine \[135 μg\], with MF59 adjuvant. |
| Placebo 3 Group | PLACEBO_COMPARATOR | Healthy female and male subjects, 18 to 45 years of age, who received two doses of an intramuscular injection of saline solution. Subjects were enrolled in a stepwise dosage escalation manner into one of the three cohorts (Cohort 1: low dosage of RSV F subunit vaccine \[45 μg\], Cohort 2: middle dosage of RSV F subunit vaccine \[90 μg\], and Cohort 3: high dosage of RSV F subunit vaccine \[135 μg\]). This placebo group belongs to Cohort 3. |
| Name | Type | Description |
|---|---|---|
| RSV F subunit 45 μg No adjuvant | BIOLOGICAL | 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm. |
| RSV F subunit 45 μg Aluminum hydroxide adjuvant | BIOLOGICAL | 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm. |
| RSV F subunit 45 μg MF59 adjuvant | BIOLOGICAL | 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm. |
| RSV F subunit 90 μg No adjuvant | BIOLOGICAL | 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm. |
| RSV F subunit 90 μg Aluminum hydroxide adjuvant | BIOLOGICAL | 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm. |
| RSV F subunit 90 μg MF59 adjuvant | BIOLOGICAL | 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm. |
| RSV F subunit 135 μg No adjuvant | BIOLOGICAL | 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm. |
| RSV F subunit 135 μg Aluminum hydroxide adjuvant | BIOLOGICAL | 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm. |
| RSV F subunit 135 μg MF59 adjuvant | BIOLOGICAL | 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm. |
| Placebo | DRUG | 2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm. |
Inclusion Criteria: 1. Healthy males and non-pregnant females 18 to 45 years of age at time of enrollment. 2. Individuals who have given written consent after the nature of the study has been explained according to local regulatory requirements. 3. Individuals in good health as determined by the ou...