Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-24 @ 3:41 PM
NCT ID:
NCT02798692
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Male or female, aged 18-45 years, in good health.
* Negative for HCMV
* Body mass index between 19 and 32 kg/m²
* Willing to forego receipt of other routine vaccinations (with the exception of seasonal influenza vaccination) for five months after study entry.
* For female volunteers: use of effective birth control for at least 2 months prior to study entry and willing to use effective birth control measures up to the Month 12 visit
* Comply with the requirements of this protocol (e.g. return for follow-up visits), as judged by the Investigator.
Exclusion Criteria:
* Works as a childcare provider.
* Pregnant or breastfeeding woman.
* Any screening safety laboratory value that is 2 times above the upper limit of normal value.
* Any confirmed or suspected immunodeficiency or autoimmune disorder.
* Treatment with any chronic immunosuppressive medication or other immuno-modifying drugs within 6 months prior to study entry. However, inhaled and topical steroids are allowed.
* Any vaccination other than for seasonal influenza within 3 months prior to study entry.
* Previous vaccination with an investigational HCMV vaccine.
* Receipt of blood, blood products and/or immunoglobulins within 3 months prior to study entry.
* History of severe allergic reactions and /or anaphylaxis
* Allergy to any component of the vaccine preparation.
* Expected to be unavailable to complete study follow up.
* Tested positive for HIV, HBsAg and/or anti-HCV.
* Participating in another clinical trial.
* Subject with a rash, dermatological condition or tattoos in the area of the injection site, as these may interfere with administration site reaction rating.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02798692
Study Brief:
Protocol Section:
NCT02798692