Assessment of the immunogenicity and safety of the Northern Hemisphere 2009/2010-season influenza vaccine in children aged 6 to 35 months in comparison to a commercially available influenza vaccine

Assessment of the immunogenicity and safety of the Northern Hemisphere 2009/2010-season influenza vaccine in children aged 6 to 35 months in comparison to a commercially available influenza vaccine: an observer-blind, randomised, controlled, safety/immunogenicity study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10483274

Enrollment

1239

Registered

2009-10-20

Start date

2009-09-28

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Influenza Respiratory Influenza, virus not identified

Interventions

Biological: two doses of trivalent virosomal adjuvanted influenza vaccine (Inflexal® V) or control vaccine. Total duration of follow-up: approximately 1.5 months.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy children (male or female) aged 6 to 35 months 2. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Previous influenza vaccination 2. Serious adverse reaction to any influenza vaccine 3. Medical treatment with immune suppressant or immune modulating drugs 4. Presentation of clinical symptoms of active infection and/or body temperature greater than or equal to 38°C

Design outcomes

Primary

Measure	Time frame
Immunogenicity, assessed by haemagglutination inhibition test; blood to be collected at baseline and approximately three weeks after second dose administration.	—

Secondary

Measure	Time frame
Safety, assessed at baseline and at three to four weeks after each vaccination, including a four-day adverse event questionnaire, soliciting a set of local and systemic adverse events (AEs).	—

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026