A randomized, double blind, comparative, phase II/III study to evaluate the immunogenicity and safety of three formulations (15mcg without adjuvant and 7.5mcg with adjuvant and 3.75mcg with adjuvant) of monovalent H1N1 influenza A (2009) virus vaccine in healthy adults. - H1N1 Adult

Panacea Biotec Limited0 sites360 target enrollmentTBD

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional

Sponsor

•1\.Healthy male or female volunteers aged 18 years and above.
•2\.Subjects with normal health as determined by personal medical history, clinical examination and past laboratory examinations (within the clinically acceptable normal range) done during screening.
•3\.Subject willing to give written informed consent and fulfill all study requirements.
•4\.If female subjects and;
•?Of child bearing potential but practicing acceptable method of contraception or surgically sterile.
•?Acceptable methods of contraception are:
•ï??Intra\-uterine contraceptive device without hormone release system (placed at least 4weeks prior to study drug administration.
•ï??Effective method of barrier contraception like condom or diaphragm with spermicidal gel/foam/film/cream/suppository

•1\.Cases, cured cases and contact of influenza A (H1N1\) virus
•2\.Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, thiomersal, squalene.
•3\.Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
•4\.Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
•5\. Uncontrolled Diabetes mellitus (type I or II),
•6\.History of thyroidectomy or thyroid disease that required medication within the past 12 months
•7\.Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
•8\.Active malignancy or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of study
•9\.Subjects with progressive neurological disorder, uncontrolled epilepsy or progressive encephalopathy .Seizure disorder other than:
•a.Seizures secondary to alcohol withdrawal more than 3 years ago, or

Not specified