Tolerability and Immunogenicity Study of FLUVAL P H1N1 Flu Vaccine of Omninvest in Children and Adolescents

NACompletedINTERVENTIONAL
Enrollment

58

Participants

Timeline

Start Date

August 31, 2009

Primary Completion Date

March 31, 2010

Study Completion Date

March 31, 2010

Conditions
Novel 2009 Influenza H1N1Influenza, Human
Interventions
BIOLOGICAL

Vaccination with Fluval P monovalent influenza vaccine

"* Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant.~* Dose: 0.25 ml /total 3 μg HA/ in age group 3-12 years, and 0.5 ml /total 6 μg HA/ in age group 12-18 years, single dose."

BIOLOGICAL

Vaccination with Fluval AB

"* Vaccination with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant.~* Dose: 0.25 ml /total 3x7.5 μg HA/ in age group 3-12 years, 0.5 ml /total 3x15 μg HA/ in age group 12-18 years, single dose."

BIOLOGICAL

Vaccination with Fluval AB Novo

"* Vaccination with Fluval AB Novo trivalent influenza vaccine with 6 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant.~* Dose: 0.25 ml /total 3x3 μg HA/ in age group 3-12 years, 0.5 ml /total 3x6 μg HA/ in age group 12-18 years, single dose."

Trial Locations (1)

8200

"Csolnoky Ferenc Veszprém County Hospital", Veszprém

All Listed Sponsors
lead

Fluart Innovative Vaccine Ltd, Hungary

INDUSTRY