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OpenTrials
Completed

NCT Number: NCT01336166

The Long-term Immunogenicity of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hunan Provincial Center of Disease Prevention and Control

Changsha, Hunan, 410005, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

split-virion, non-adjuvanted H1N1 vaccine of 15 μg

Biological

120 adults were assigned to receive 1 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine.

split-virion, non-adjuvanted H1N1 vaccine of 30 μg

Biological

120 adults were assigned to receive 1 dose of 30μg split-virion, non-adjuvanted H1N1 vaccine.

split-virion, non-adjuvanted H1N1 vaccine of 45 μg

Biological

120 adults were assigned to receive 1 dose of 45μg split-virion, non-adjuvanted H1N1 vaccine.

Placebo control

Biological

120 adults were assigned to receive 1 dose of placebo.

Primary outcomes

  1. Hemagglutination inhibition antibody titer

    Time frame: Day 180

Secondary outcomes

  1. occurrence of solicited local and systemic adverse events after vaccination

    Time frame: Days 0-42

Sponsors and collaborators

Lead sponsor

Shanghai Institute Of Biological Products

Industry

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 15, 2011
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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