CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 84 enrolled
Drug / intervention
MF59C.1-adjuvanted subunit influenza vaccine +1 morebiological
Likely dose
MF59C.1-adjuvanted subunit influenza vaccine 0.25 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01342796
NCT01342796Phase 2Completed
CompareCT.gov

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

Novartis Vaccines·interventional·Posted Apr 27, 2011·Updated Apr 19, 2021

In Brief

A Phase 2 clinical trial evaluating MF59C.1-adjuvanted subunit influenza vaccine and Sub unit, Inactivated, Influenza vaccine for Seasonal Influenza and 3 related conditions. Completed, enrolled 84 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeasonal Influenza, Influenza, Influenza Due to Unspecified Influenza Virus, Human Influenza
CountriesBelgium
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 27, 2011
Enrollment StartMay 1, 2011
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.2 years ago

Interventions

MF59C.1-adjuvanted subunit influenza vaccinebiological

2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm

Sub unit, Inactivated, Influenza vaccinebiological

2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm