A Multi-center, Phase III, Randomized, Observer Blind Study to Evaluate the Safety, Tolerability and Immunogenicity of a Trivalent Subunit Inactivated Flu Vaccine in Healthy Children and Adolescents 3 to 17 Years of Age

NCT01209780 Phase 3 COMPLETED Results posted

This study will evaluate the safety and immunogenicity in healthy children and adolescents after one or two IM dose(s) of trivalent subunit inactivated flu vaccine.

Details

Lead sponsor	Novartis Vaccines
Phase	Phase 3
Status	COMPLETED
Enrolment	3116
Start date	2010-09
Completion	2011-09

Conditions

• Seasonal Influenza

Interventions

• TIV
• TIVf
• Comparator TIV

Primary outcomes

• Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of the Percentage of Subjects Achieving Seroconversion — Day 22 for non-naive/Day 50 for naive subjects
  The non-inferiority of the antibody responses of investigational TIV compared to control TIV assessed in terms of the percentage of subjects achieving seroconversion, against the three homologous vaccine strains,in children 3 to 8 years of age, at 21 days after last vaccination. Seroconversion was defined as a pre-vaccination haemagglutinin inhibition (HI) titer \<1:10 and post-vaccination HI titer ≥1:40 or as a pre-vaccination HI titer ≥1:10 and at minimum four-fold rise in post-vaccination antibody titer
• Comparison of Antibody Responses of Investigational TIV to Control Vaccine in Terms of Post Vaccination Geometric Mean Titers (GMTs) — Day 22 for non-naive/Day 50 for naive subjects
  The non-inferiority of the antibody responses of investigational TIV compared to control vaccine assessed in terms of post vaccination GMTs, at 21 days after last vaccination against the three homologous vaccine strains in 3 to 8 year old children.

Countries

Colombia, Mexico, Panama, Philippines