Safety and Immunogenicity of an Inactivated Pandemic Influenza Vaccine

NCT00535665 | Completed Phase 2 DMC

• 1 other identifier: PRO-PanFlu-2001
• Study Type: interventional
• Target: 402
• Locations: 0 countries
• Sites: N/A

Brief Summary

A single center, randomized and double-blind phase II clinical trial is to be conducted in adults to evaluate the safety and immunogenicity of an inactivated pandemic influenza vaccine (whole-virion, aluminium-adjuvanted).

Conditions

Pandemic Influenza; Prevention

Outcome Measures

Primary Outcomes (1)

• HI antibody and Neutralization antibody

  0,28,42,56

Secondary Outcomes (1)

• adverse reactions

  0,28,42,56

Study Arms (4)

1: 10 ug, 14 days

EXPERIMENTAL

Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)

2: 5 ug, 28 days

EXPERIMENTAL

Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)

3: 10 ug, 28 days

EXPERIMENTAL

Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)

4: 15 ug, 28days

EXPERIMENTAL

Biological: pandemic influenza vaccine (H5N1 strain NIBRG-14)

Interventions

pandemic influenza vaccine (H5N1 strain NIBRG-14) BIOLOGICAL

two-dose regimen with 14 days apart: 5 microgram per dose

1: 10 ug, 14 days

Eligibility Criteria

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

You may qualify if:

• Healthy adults aged 18-60 years old
• Be able to show legal identity card for the sake of recruitment
• Be able to understand and sign the informed consent.

You may not qualify if:

• Woman： Who breast-feeding or planning to become pregnant during the 56 days of study participation
• Any history of allergic reactions was allergic to any component of the vaccine, such as eggs or ovalbumin;
• Any history of severe adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
• Autoimmune disease or immunodeficiency
• 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
• Diabetes mellitus (type I or II), with the exception of gestational diabetes
• 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
• Hypertension that was not well controlled by medication or is more than 145/95 mmHg at enrollment
• 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
• Active malignancy or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of study
• Seizure disorder other than:
• Febrile seizures under the age of two years old,
• Seizures secondary to alcohol withdrawal more than 3 years ago, or
• A singular seizure not requiring treatment within the last 3 years

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead
• Centers for Disease Control and Prevention, China: collaborator

Related Publications (1)

• Wu J, Fang HH, Chen JT, Zhou JC, Feng ZJ, Li CG, Qiu YZ, Liu Y, Lu M, Liu LY, Dong SS, Gao Q, Zhang XM, Wang N, Yin WD, Dong XP. Immunogenicity, safety, and cross-reactivity of an inactivated, adjuvanted, prototype pandemic influenza (H5N1) vaccine: a phase II, double-blind, randomized trial. Clin Infect Dis. 2009 Apr 15;48(8):1087-95. doi: 10.1086/597401.

  PMID: 19281330 DERIVED

Study Officials

• Jiang Wu

  Beijing Centers for Diseases Control and Prevention

  PRINCIPAL INVESTIGATOR

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

Study Record Dates

• First Submitted: September 24, 2007
• First Posted: September 26, 2007
• Study Start: September 1, 2007
• Study Completion: November 1, 2007
• Last Updated: November 9, 2007

Record last verified: 2007-11