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An exploratory study to assess the RSV titer in healthy volunteers as guidance for the main study

An exploratory study to assess the RSV titer in healthy volunteers as guidance for the main study - RSV titer assessment in healthy adult volunteers

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44515
Enrollment
100
Registered
2017-06-09
Start date
2017-06-15
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

common cold RSV infection

Interventions

reference

Sponsors

Intravacc
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1.Healthy male or female subjects, 18-45 years of age, inclusive; 2.Signed informed consent prior to any study-mandated procedure 3. Has the ability to communicate well with the Investigator in the Dutch language

Exclusion criteria

Exclusion criteria: 1. Immune-compromised individuals (known or expected immune deficiency, disease or use of medication that may affect the immune system); 2. Chronic airway diseases; 3. Airway infection / common cold within 14 days prior to blood sample collection; 4. Hay fever or other allergies that involve the airways; 5. Blood donation would result in loss of blood outside the limits of the national blood bank (>500 mL within 90 days.

Design outcomes

Primary

MeasureTime frame
Virus neutralization titer levels against RSV

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)