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Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2010-2011, in Non-Elderly Adult and Elderly Subjects

NCT01356316 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-07-16

No results posted yet for this study

Summary

Each potential subject will be screened before the start of the study to determine their eligibility for participation. Just prior to vaccination, a 10 mL venous blood sample will be taken from each eligible subject, for baseline titration of circulating anti-HA antibodies. Immediately thereafter, each subject received one dose of vaccine (0.5 mL) by intramuscular injection into the upper arm. Subjects will be asked to stay at the site for 30 minutes post-vaccination to observe for immediate reaction. Subjects will be monitored for adverse events during the study. At three weeks (±3 days) after the vaccination, subjects will be asked to return to the site for final collection of blood samples.

Conditions

Interventions

BIOLOGICAL

AdimFlu-S Vaccine 2010-2011

Per ml contains following strains 30μg, A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008

Sponsors & Collaborators

  • Adimmune Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2010-08-31
Completion
2011-03-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01356316 on ClinicalTrials.gov