CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,902 enrolled
Drug / intervention
Adjuvanted trivalent inactivated subunit influenza vaccine +2 morebiological
Likely dose
Not stated in 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/NCT00644059
NCT00644059Phase 3Completed
CompareCT.gov

A Phase III, Randomized, Observer-blind, Controlled, Multi-center Clinical Trial to Evaluate the Efficacy, Safety and Immunogenicity of One and Two Intramuscular Doses of Influenza Vaccine Versus Control Vaccines in Healthy Subject Aged 6 to <72 Months

Novartis·interventional·Posted Mar 26, 2008·Updated Sep 18, 2015

In Brief

A Phase 3 clinical trial evaluating Adjuvanted trivalent inactivated subunit influenza vaccine, Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine, and 1 other intervention for Influenza, Human. Completed, enrolled 4,902 participants across 101 sites in 3 countries.

Detailed Summary

This study will evaluate the efficacy, safety and immunogenicity of one or two 0.25 mL or 0.5 mL intramuscular injections of an adjuvanted influenza vaccine compared with non-influenza and non-adjuvanted influenza control vaccines in subjects 6 to \<72 months of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Human
CountriesFinland, Germany, Italy
CollaboratorsNovartis Vaccines

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 26, 2008
Enrollment StartNov 1, 2007
Primary CompletionApr 1, 2010
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 18.3 years ago

Interventions

Adjuvanted trivalent inactivated subunit influenza vaccinebiological

Either two intramuscular (IM) injections of half dose or one IM injection of full dose, depending on age of subject, were administered in the deltoid muscle preferably of the non-dominant arm.

Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccinebiological

For both vaccines, either two intramuscular (IM) injections of half dose or one IM injection of full dose, depending on age of subject, were administered in the deltoid muscle preferably of the non-dominant arm.

Meningococcal C conjugate vaccine or tick-borne encephalitis vaccinebiological

1. Meningococcal vaccine: two IM injections 2. Tick-borne encephalitis vaccine: two IM injections