CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,648 enrolled
Drug / intervention
FluBlok® +1 morebiological
Likely dose
FluBlok® 0.5 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/NCT00539981
NCT00539981Phase 3Completed
CompareCT.gov

Evaluation of the Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlok® Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine in Healthy Adults Aged 18 to 49 Years

Sanofi·interventional·Posted Oct 5, 2007·Updated Apr 6, 2022

In Brief

A Phase 3 clinical trial evaluating FluBlok® and Placebo for Influenza. Completed, enrolled 4,648 participants across 24 sites.

Detailed Summary

The purpose of this study was to evaluate a single dose of FluBlok in terms of safety, efficacy and effectiveness in prevention of influenza and influenza-like illness and assess clinical lot-to-lot consistency in manufacturing by evaluating and comparing the immunogenicity of three different lots of FluBlok in a subset of participants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesUnited States
CollaboratorsProtein Sciences Corporation

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 5, 2007
Enrollment StartSep 15, 2007
Primary CompletionMay 28, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.7 years ago

Interventions

FluBlok®biological

Dose: 0.5 mL, single dose; Route of administration: intramuscular. Recombinant Trivalent Hemagglutinin Influenza Vaccine containing 45 microgram (mcg) of each hemagglutinin derived from A/Solomon Islands/3/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004

Placebobiological

Dose: 0.5 mL normal saline for injection, single dose; Route of administration: intramuscular