NCT01342796

Humoral and Cell Mediated Immunity and Safety of MF59C.1-adjuvanted Subunit Influenza Vaccine or a Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects

A Phase II, Randomized, Controlled, Observer-Blind, Clinical Study to Evaluate the Humoral and Cell Mediated Immunity and Safety of Two Intramuscular Doses of MF59C.1-adjuvanted Subunit Influenza Vaccine or Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects Aged 6 to <36 Months

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 6 Months – 36 Months
• Healthy volunteers: Accepted

Summary

This study aims to evaluate the immunogenicity, by means of cell mediated immunity (CMI) and hemagglutination inhibition (HI) assay, and also the safety of a MF59C.1-adjuvanted subunit influenza vaccine compared with a conventional subunit vaccine in previously unvaccinated children aged 6 to \<36 months.

Conditions

• Seasonal Influenza
• Influenza
• Influenza Due to Unspecified Influenza Virus
• Human Influenza

Interventions

Type	Name	Description
BIOLOGICAL	MF59C.1-adjuvanted subunit influenza vaccine	2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm
BIOLOGICAL	Sub unit, Inactivated, Influenza vaccine	2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2011-04-27
• Last updated: 2021-04-19
• Results posted: 2021-04-19

Locations

2 sites across 1 country: Belgium