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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05089630 | A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults | PHASE1 | COMPLETED | 339 | — | — | Oct 14, 2021 | Apr 2, 2025 | Mar 2, 2026 | 18 | United States |
The solicited administration site events include pain, redness and swelling.
The solicited systemic events include fever, myalgia, fatigue, arthralgia and headache. The preferred location for measuring temperature is the oral cavity. Fever is defined as body temperature ≥38.0°C/100.4°F by any route.
An unsolicited AE is an AE that was not included in a list of solicited events using a Participant Diary. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or is an abnormal pregnancy outcome.
An unsolicited AE is an AE that was not included in a list of solicited events using a Participant Diary. Unsolicited events must have been spontaneously communicated by a participant who has signed the informed consent. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event.
A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or is an abnormal pregnancy outcome.
A MAE is an AE for which the participants received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.
The percentage of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
The percentage of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
The percentage of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
The percentage of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
The percentage of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
The percentage of participants having hematology and biochemistry results below or above the laboratory normal ranges are tabulated by time point.
| Arm | Type | Description |
|---|---|---|
| Pentamer(low)/gB(low)/Adjuvant Group | EXPERIMENTAL | Participants receive the candidate CMVsu vaccine consisting of a combination of low dose pentamer and low dose gB antigens, adjuvanted at 0, 2 and 6 months and are followed up until end of study (Day 546). |
| Pentamer (med)/gB(low)/Adjuvant Group | EXPERIMENTAL | Participants receive the candidate CMVsu vaccine consisting of a combination of medium dose pentamer and low dose gB antigens, adjuvanted at 0, 2 and 6 months and are followed up until end of study (Day 546). |
| Pentamer (med)/gB(med)/Adjuvant Group | EXPERIMENTAL | Participants receive the candidate CMVsu vaccine consisting of a combination of medium dose pentamer and medium dose gB antigens, adjuvanted at 0, 2 and 6 months and are followed up until end of study (Day 546). |
| Pentamer (high)/gB(med)/Adjuvant Group | EXPERIMENTAL | Participants receive the candidate CMVsu vaccine consisting of a combination of high dose pentamer and medium dose gB antigens, adjuvanted at 0, 2 and 6 months and are followed up until end of study (Day 546). |
| Placebo Group | PLACEBO_COMPARATOR | Participants receive placebo (saline) at 0,2 and 6 months and are followed up until end of study (Day 546). |
| Name | Type | Description |
|---|---|---|
| Pentamer (low)/gB(low)/Adjuvant vaccine | BIOLOGICAL | Three doses of the candidate CMVsu vaccine consisting of a combination of low dose pentamer and low dose gB antigens, adjuvanted are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule. |
| Pentamer (med)/gB(low)/Adjuvant vaccine | BIOLOGICAL | Three doses of the candidate CMVsu vaccine consisting of a combination of medium dose pentamer and low dose gB antigens, adjuvanted are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule. |
| Pentamer (med)/gB(med)/Adjuvant vaccine | BIOLOGICAL | Three doses of the candidate CMVsu vaccine consisting of a combination of medium dose pentamer and medium dose gB antigens, adjuvanted are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule. |
| Pentamer (high)/gB(med)/Adjuvant vaccine | BIOLOGICAL | Three doses of the candidate CMVsu vaccine consisting of a combination of high dose pentamer and medium dose gB antigens, adjuvanted are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule. |
| Placebo (saline) | COMBINATION_PRODUCT | Three doses of placebo (saline) are administered intramuscularly in the deltoid region of the non-dominant arm in a 0, 2, 6-month schedule. |
Inclusion Criteria: * Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written informed consent obtained from the participant prior to performance of any study specific procedure. * A healthy adult (woman or man), 18 to 50 years of a...