Assessment of the Immunogenicity and Safety of an MF59™- Adjuvanted Trivalent Influenza Vaccine and a Non-adjuvanted Trivalent Influenza Vaccine Among Children in Senegal

NCT01819155 Phase 2 COMPLETED

This study will provide the Senegal Ministry of Health with data on the safety and immunogenicity of adjuvanted trivalent inactivated influenza vaccine (adjTIV) and full-dose seasonal non-adjuvanted trivalent inactivated influenza vaccine (TIV) in children. This data will inform future policy considerations for influenza vaccine. The study is not powered to detect significant differences between vaccines or groups, and no hypotheses are to be tested; therefore, immunogenicity and safety objectives are to be analyzed descriptively.

Details

Lead sponsor	PATH
Phase	Phase 2
Status	COMPLETED
Enrolment	296
Start date	2013-04
Completion	2013-09

Conditions

• Influenza

Interventions

• Adjuvanted seasonal trivalent inactivated influenza vaccine
• Seasonal trivalent inactivated influenza vaccine
• Saline (bacteriostatic 0.9% sodium chloride for injection)

Primary outcomes

• Immunogenicity of adjTIV — 28 days post-dose 2
  serum hemagglutination-inhibition antibodies
• Immunogenicity of TIV — 28 days post-dose 2
  serum hemagglutination-inhibition antibodies

Countries

Senegal