Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Two Different Influenza Vaccines in Healthy Children Aged 6 to <60 Months

PHASE2CompletedINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

January 31, 2008

Primary Completion Date

April 30, 2008

Study Completion Date

October 31, 2008

Conditions
Influenza
Interventions
BIOLOGICAL

Influenza Trivalent Inactivated vaccines Novartis

Children 6 to \<36 months of age will receive two 0.25 mL doses, and children 36 to \<60 months of age will receive two 0.5 mL doses of investigational influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm.

BIOLOGICAL

Influenza Trivalent Inactivated vaccines

Children 6 to \<36 months of age will receive two 0.25 mL doses, and children 36 to \<60 months of age will receive two 0.5 mL doses of active control influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm.

Trial Locations (5)

Unknown

Centro Clínico La Quinta, Guatemala City

Clínicas Dr. Rafael Montiel, Guatemala City

Dr. Carlos Fernando Grazioso Aragón, Guatemala City

Fundación Pediátrica Guatemalteca, Guatemala City

Hospital Infantil de Infectologia y rehabilitacion, Guatemala City

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Novartis Vaccines

INDUSTRY

lead

Novartis

INDUSTRY

NCT00649883 - Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Two Different Influenza Vaccines in Healthy Children Aged 6 to <60 Months | Biotech Hunter | Biotech Hunter