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

  • 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
  • Vaccination recipients qualified for this product have been inquired about medical history and clinically proven to be healthy
  • Requests of clinical research program can be obeyed
  • No other protective product is inoculated in last week
  • Axillary temperature below 37 degrees Celsius

Exclusion Criteria

  • Volunteers in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
  • Volunteers allergic to ingredient of vaccine composition (can be checked from vaccination history), especially to egg
  • History of progressive or severe neurologic disorder
  • Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
  • 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
  • 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
  • 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
  • History of thyroidectomy or thyroid disease that required medication within the past 12 months
  • Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
  • Guillain-Barre Syndrome
  • Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
  • Any other vaccines or immunoglobulin preparation within 1 weeks prior to enrollment
  • Axillary temperature ≥ 38.0 degrees Celsius within 3 days of intended study vaccination
  • 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.