Safety and Immunogenicity of a Split-Virion Pandemic Influenza A (H5N1) Vaccine in Children

NCT00900991 | Completed Phase 2 DMC

• 1 other identifier: PRO-sPanFlu-2002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A single center, stratified, randomized and double-blind phase II clinical trial was conducted in children to evaluate the safety and immunogenicity of an split-virion pandemic influenza A vaccine (H5N1).

Conditions

Influenza

Keywords

Pandemic Influenza A Vaccine; Immunogenictiy; Safety

Outcome Measures

Primary Outcomes (1)

• HI antibody and Neutralization antibody

Secondary Outcomes (1)

• Adverse reactions

Study Arms (2)

10 ug

EXPERIMENTAL

10 microgram per dose

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

15 ug

EXPERIMENTAL

15 microgram per dose

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

Interventions

split-virion pandemic influenza vaccine (H5N1 strain NIBRG-14) BIOLOGICAL

10 ug; 15 ug

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children aged 3-11 years old
• Be able to show legal identity card for the sake of recruitment
• Volunteers or their parents are able to understand and sign the informed consent
• Do not participate in other clinical trial

You may not qualify if:

• Any history of allergic reactions
• 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 the blood pressure 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
• Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
• Guillain-Barre Syndrome

Sponsors & Collaborators

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

Study Sites (1)

Beijing Centers for Diseases Control and Prevention

Beijing, 100013, 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

Study Record Dates

• First Submitted: May 12, 2009
• First Posted: May 13, 2009
• Last Updated: May 14, 2009

Record last verified: 2009-05

Locations

CN (1)