Trial Outcomes & Findings for Evaluation of the Safety and Immune Responses of the Towne Strain of CMV in Seronegative Women (NCT NCT00201448)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

82 participants

Primary outcome timeframe

One year

Results posted on

2016-05-30

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo (Hepatitis A)	Towne CMV Vaccine
Overall Study STARTED	42	40
Overall Study COMPLETED	42	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Safety and Immune Responses of the Towne Strain of CMV in Seronegative Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo (Hepatitis A) n=42 Participants	Towne CMV Vaccine n=40 Participants	Total n=82 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants	40 Participants n=7 Participants	82 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	33 years STANDARD_DEVIATION 4.5 • n=5 Participants	34 years STANDARD_DEVIATION 5.6 • n=7 Participants	33.5 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	40 Participants n=7 Participants	82 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants	40 participants n=7 Participants	82 participants n=5 Participants

PRIMARY outcome

Timeframe: One year

Population: per protocol and randomized

Outcome measures

Outcome measures
Measure	(Placebo) Hepatitis a n=42 Participants This is the comparator group.	Towne CMV Vaccine n=40 Participants
Participants With Adverse Events	0 participants	0 participants

PRIMARY outcome

Timeframe: Urine, saliva, will be collected every 2 months for 12 months and serum will be collected 1,2,4,6, 9, 12, 18, 24, 30 and 36 months after vaccination.

Population: Study was terminated (suspended due to lack of funding). PI is no longer with the institution; data and results cannot be accessed, analyzed, and reported.

The primary objective of the study is to evaluate safety and immune responses induced by the Towne vaccine in in seronegative women with children in daycare

Outcome measures

Outcome data not reported

Adverse Events

Placebo (Hepatitis A)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Towne CMV Vaccine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Stuart Adler

Virginia Commonwealth University

Phone: 8048281807

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place