Study of a Pandemic Influenza Vaccine in Children

Seqirus

Status and phase: Completed; Phase 2

Conditions: Influenza

Treatments: Biological: H5N1 pandemic influenza vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00370864

CSLCT-PAN-05-17

Details and patient eligibility

About

The World Health Organisation has warned that an influenza pandemic is inevitable. The avian influenza strain H5N1 is one of the leading candidates to cause the next influenza pandemic. Children are likely to be a special target group for vaccination; therefore, this study will test the safety and immunogenicity of an H5N1 pandemic influenza vaccine in healthy children.

Enrollment: 220 estimated patients

Sex: All

Ages: 6 months to 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy children aged greater or equal to 6 months to less than 9 years
• Normal gestation period

Exclusion criteria

• History of clinically significant medical conditions
• History of Guillain Barre syndrome or active neurological disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind