Assessment of Needle-free Disposable-syringe Jet Injector (DSJI) ID Dose-sparing of Pandemic A H1N1 Influenza Vaccine

Launched by UNIVERSITY OF SAO PAULO GENERAL HOSPITAL · Apr 19, 2012

Keywords

ClinConnect Summary

This study will evaluate the immunological response and the safety profiles of seasonal, inactivated vaccine which contains in its composition the A/California/7/2009 H1N1 "pandemic" influenza virus, delivered via ID in reduced dose (0,1 mL) and (0,2 mL), and via IM in full dose (0,5 mL) delivered with needle-free, disposable-syringe jet injector, and control group with via IM in full dose (0,5 mL) delivered syringes and needles in subjects from 42 to 60 years old.

Reduced doses into the skin will be delivered by an investigational intradermal model of a licensed, needle-free, disposable-s...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Between 42 and up to 60 years of age.
• • Available for follow up visits, at least at day 21.
• • Written informed consent signed by the volunteer after reading and explanation.
• Exclusion Criteria:
• • Suspect or verified diagnosis of congenital or acquired immunodeficiency including AIDS.
• • Suspect or verified diagnosis of malignant neoplasia, other than basocellular carcinoma.
• • Volunteer ongoing treatment with high doses of systemic corticosteroids (equivalent to prednisone (2 mg/kg/d for more than two weeks) or on immunosuppressant therapy.
• • Received or planning to receive a vaccine with live attenuated strain of virus within 30 days of the intended day(s) of study vaccination(s).
• • Verified diagnosis of Influenza A/California/H1N1 or has already been immunized against (Influenza A/California/H1N1).
• • Suspect or confirmed pregnancy (no need of pregnancy test, information on possible pregnancy is enough. These cases must be referred to routine vaccination).
• • Suspect or verified diagnosis of hypersensitivity to any ingredient of the vaccine, to egg proteins or any component of the vaccine or life-threatening reactions after previous administration of any influenza vaccine.
• • Any other circumstances that may potentially damage the minor or prevent procedures from being carried out according to evaluation of the research team.
• • Volunteer shows signs or symptoms of an active intercurrent disease (e.g. fever, rash, etc.) that may interfere with the evaluation of adverse events following immunization at the research team's discretion.