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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg; Biological: split-virion, non-adjuvanted H1N1 vaccine of 30 μg; Biological: split-virion, non-adjuvanted H1N1 vaccine of 45 μg; Biological: Placebo control

• Study Type: Interventional
• Enrollment (Actual): 480
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410005
      • Hunan Provincial Center of Disease Prevention and Control

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo control	Biological: Placebo control; 120 adults were assigned to receive 1 dose of placebo.
Experimental: split-virion, non-adjuvanted vaccine of 15 μg; split-virion, non-adjuvanted H1N1 vaccine of 15 μg.	Biological: 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 vaccine of 30 μg; split-virion, non-adjuvanted H1N1 vaccine of 30 μg.	Biological: 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 vaccine of 45 μg; split-virion, non-adjuvanted H1N1 vaccine of 45 μg.	Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hemagglutination inhibition antibody titer	Day 180

Secondary Outcome Measures

Outcome Measure	Time Frame
occurrence of solicited local and systemic adverse events after vaccination	Days 0-42

Collaborators and Investigators

• Sponsor: Shanghai Institute Of Biological Products

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: April 7, 2011
• First Submitted That Met QC Criteria: April 14, 2011
• First Posted (Estimate): April 15, 2011

Study Record Updates

• Last Update Posted (Actual): September 11, 2018
• Last Update Submitted That Met QC Criteria: September 8, 2018
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Safety; Vaccine; Immunogenicity; H1N1
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: SIBP-2009