NCT02642822

Brief Summary

In this study, 100 female students aged 18 to 30 years old in Xiamen University will be enrolled. On the first visit, blood, saliva and urine samples of all participants will be collected. Then saliva and urine samples will be collected at two-week interval until 6 months. Serum samples will be tested the PP150-IgG titer. Saliva and urine samples will be used to test CMV DNA by PCR. The primary purpose of this study is to identify the relationship between baseline PP150-IgG titer and CMV infection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 24, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

July 14, 2016

Status Verified

December 1, 2015

Enrollment Period

1.5 years

First QC Date

December 24, 2015

Last Update Submit

July 13, 2016

Conditions

Keywords

Cytomegalovirus

Outcome Measures

Primary Outcomes (1)

  • rate of active CMV infection in different PP150-IgG titer

    1 year

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

100 female students aged 18 to 30 years old will be recruited from Xiamen University.

You may qualify if:

  • years old
  • female students of Xiamen University

You may not qualify if:

  • students who have the serious diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of public health of Xiamen University

Xiamen, Fujian, 361000, China

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
vice dean of School of Public Health

Study Record Dates

First Submitted

December 24, 2015

First Posted

December 30, 2015

Study Start

October 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

July 14, 2016

Record last verified: 2015-12

Locations