Overview

This trial is active, not recruiting.

Condition influenza
Treatments split-virion, non-adjuvanted h1n1 vaccine of 15 μg, split-virion, non-adjuvanted h1n1 vaccine of 30 μg, split-virion, non-adjuvanted h1n1 vaccine of 45 μg, placebo control
Phase phase 2
Sponsor Shanghai Institute Of Biological Products
Start date July 2009
End date July 2011
Trial size 480 participants
Trial identifier NCT01336166, SIBP-2009

Summary

The aim of this study is to investigate the long-term immunogenicity and safety of the inactivated split-virion vaccine after one immunization.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
split-virion, non-adjuvanted H1N1 vaccine of 15 μg.
split-virion, non-adjuvanted h1n1 vaccine of 15 μg
120 adults were assigned to receive 1 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine.
(Experimental)
split-virion, non-adjuvanted H1N1 vaccine of 30 μg.
split-virion, non-adjuvanted h1n1 vaccine of 30 μg
120 adults were assigned to receive 1 dose of 30μg split-virion, non-adjuvanted H1N1 vaccine.
(Experimental)
split-virion, non-adjuvanted H1N1 vaccine of 45 μg.
split-virion, non-adjuvanted h1n1 vaccine of 45 μg
120 adults were assigned to receive 1 dose of 45μg split-virion, non-adjuvanted H1N1 vaccine.
(Placebo Comparator)
Placebo control
placebo control
120 adults were assigned to receive 1 dose of placebo.

Primary Outcomes

Measure
Hemagglutination inhibition antibody titer
time frame: Day 180

Secondary Outcomes

Measure
occurrence of solicited local and systemic adverse events after vaccination
time frame: Days 0-42

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: 1. Different age groups from 18 to 60 years, with normal intelligence and health. Volunteers (or their guardians) are well informed of the situation and sign the consent 2. Vaccination recipients qualified for this product have been inquired about medical history and clinically proven to be healthy 3. Requests of clinical research program can be obeyed 4. No other protective product is inoculated in last week 5. Axillary temperature below 37 degrees Celsius Exclusion Criteria: 1. Volunteers in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination 2. Volunteers allergic to ingredient of vaccine composition (can be checked from vaccination history), especially to egg 3. History of progressive or severe neurologic disorder 4. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain 5. Known or suspected impairment/alteration of immune function, for example receiving immunosuppressive therapy or receiving blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation 6. 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 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. History of thyroidectomy or thyroid disease that required medication within the past 12 months 9. Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years 10. Guillain-Barre Syndrome 11. Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C 12. Any other vaccines or immunoglobulin preparation within 1 weeks prior to enrollment 13. Axillary temperature ≥ 38.0 degrees Celsius within 3 days of intended study vaccination 14. Any conditions may influence the evaluation

Trial information was received from ClinicalTrials.gov and was last updated in April 2011.
Information provided to ClinicalTrials.gov by Shanghai Institute Of Biological Products.