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

NCT01336166 | Completed Phase 2 DMC

• 1 other identifier: SIBP-2009
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Influenza

Keywords

H1N1; Vaccine; Immunogenicity; Safety

Outcome Measures

Primary Outcomes (1)

• Hemagglutination inhibition antibody titer

  Day 180

Secondary Outcomes (1)

• occurrence of solicited local and systemic adverse events after vaccination

  Days 0-42

Study Arms (4)

split-virion, non-adjuvanted vaccine of 15 μg

EXPERIMENTAL

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

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

split-virion, non-adjuvanted vaccine of 30 μg

EXPERIMENTAL

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

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

split-virion, non-adjuvanted vaccine of 45 μg

EXPERIMENTAL

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

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

Placebo control

PLACEBO COMPARATOR

Placebo control

Biological: Placebo control

Interventions

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 vaccine of 15 μg

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 vaccine of 30 μg

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.

split-virion, non-adjuvanted vaccine of 45 μg

Placebo control BIOLOGICAL

120 adults were assigned to receive 1 dose of placebo.

Placebo control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Institute Of Biological Products: lead

Study Sites (1)

Hunan Provincial Center of Disease Prevention and Control

Changsha, Hunan, 410005, China

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2011
• First Posted: April 15, 2011
• Study Start: July 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 11, 2018

Record last verified: 2015-10

Locations

CN (1)