NCT00336453

Immunogenicity and Safety of FluBlok Trivalent Recombinant Hemagglutinin Influenza Vaccine in Healthy Pediatrics

Evaluation of the Safety, Reactogenicity and Immunogenicity of FluBlok Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine Administered Intramuscularly to Healthy Children Aged 6 To 59 Months

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Protein Sciences Corporation · Industry
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study was to evaluate dose-related safety, reactogenicity and immunogenicity of FluBlok trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine, administered to healthy children aged 6 to 59 months.

Detailed description

Influenza has been identified as a major health problem in young children. Influenza related hospitalizations are very high in children less than 24 months of age and children age 24-59 months have a high rate of medical care utilization due to influenza. Recently, it has been noted that there are deaths attributable to influenza even in previously healthy children. Recent CDC recommendations reflect this growing awareness of the impact of influenza in children and state that virtually all children less than 18 years of age should receive annual influenza vaccination. Currently available licensed trivalent influenza vaccines (TIVs) are prepared from viruses that are grown in embryonated hens' eggs. Alternative substrates for vaccine production are desirable in order to reduce the vulnerability of and to expand influenza vaccine supply. Recombinant DNA techniques allow for expression of the influenza hemagglutinin (rHA) by baculovirus vectors in insect cell cultures. Advantages of this technique include speed of production, absence of egg protein, and a highly purified product.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Influenza Vaccination	0.5mL dose for intramuscular injection
BIOLOGICAL	Influenza Vaccination	0.25mL dose for intramuscular injection

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2006-06-13
• Last updated: 2009-12-17

Locations

3 sites across 1 country: United States