Safety and immunogenicity of whole virion influenza vaccines.

Safety and immunogenicity of seasonal and pandemic inactivated whole virion influenza vaccine in healthy adults.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22232

Enrollment

150

Registered

2011-01-13

Start date

2011-04-01

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

influenza (griep)

Interventions

Four treatment arms will be included: 1. Seasonal influenza vaccine (one dose) and a placebo dose

2. Pandemic influenza vaccine (two doses)

3. Placebo (two doses)

4. Commercial seasonal influenza vaccine (one dose) and a placebo dose. Blood samples are drawn on screening, day 0 (prior to vaccine/placebo administration), day 21 (prior to vaccine/placebo adminis

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 to 49 years; 2. If female: Willing to use contraceptive measures during the study; 3. Good health according to the investigator; 4. Willing and able to adhere to the study regimen; 5. Having a signed informed consent form.

Exclusion criteria

Exclusion criteria: 1. Having had an infectious disease with fever (including influenza) within the last 14 days; 2. Present evidence of serious disease(s) demanding medical treatment that might interfere with the results of the study such as diseases which interfere with the immune system; 3. Known or suspected allergy to any of the vaccine components: egg components, chicken protein, ovalbumin (by medical history); 4. Known or suspected immune deficiency; 5. History of any neurologic disorder, including epilepsy; 6. Females: Positive pregnancy test; 7. Positive HBV or HCV serology; 8. Previous vaccination with an influenza vaccine in the previous winter season (2010-2011); 9. Previous vaccination with any vaccine within 3 months before screening; 10. Previous administration of plasma products (including immunoglobulins) within 3 months before vaccination; 11. Systemic treatment with corticosteroids within one month before screening; 12. Blood donation within one month before screening; 13. Participation in another clinical trial within three months before screening; 14. Abnormal pre-treatment laboratory parameters which are clinically relevant according to the investigator.

Design outcomes

Primary

Measure	Time frame
The incidence of systemic and local adverse events.	—

Secondary

Measure	Time frame
Anti-hemagglutinin antibody against the influenza vaccine strain by HI test.	—

Contacts

Public ContactR.A.J. Boxtel, van

Antonie van Leeuwenhoeklaan 9-11

renee.van.boxtel@rivm.nl+31 (0)30 2742755

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)