Phase I clinical trial to assess safety and immunogenicity of an MVA-based influenza H5 vaccine in healthy adults

Phase I clinical trial to assess safety and immunogenicity of an MVA-based influenza H5 vaccine in healthy adults - Phase 1 study with an MVA-based influenza H5 vaccine

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38408

Enrollment

Registered

2012-11-13

Start date

2012-12-17

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

flu Influenza

Interventions

The study subjects will receive one or two intramuscular immunizations (four week interval) with the vaccine or the control vaccine in the upper arm.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • 18-35 years of age • Female volunteers must acquire an acceptable form of contraception during the study period and to have a negative pregnancy test on the days of immunization. • Refrain from blood donation during the study period • Written informed consent • Able and willing to comply with all study requirements

Exclusion criteria

Exclusion criteria: • Pregnancy or lactation • Acute or chronic illness • Known allergy to eggs, egg products or chicken protein • Previous immunization with a recombinant MVA • Previous immunization with an influenza A/H5N1 vaccine

Design outcomes

Primary

Measure	Time frame
Safety of the vaccine (registration of local and systemic reactions and clinical chemistry analysis)	—

Secondary

Measure	Time frame
Immune responses to influenza virus hemagglutinin and the vector (MVA) (both cellular and humoral immune responses)	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)