Sinovac, Pandemic Influenza A/H1N1 Vaccine in 6 to 35 Months Infants

March 13, 2013 updated by: Sinovac Biotech Co., Ltd

A Blinded, Randomized and Controlled Clinical Trial With Influenza A/H1N1 Split-virion Vaccine in 6 to 35 Months Infants

A single center, observer-masked, randomized clinical trial is to be conducted in 6-35 months infants to evaluate the safety and immunogenicity of Sinovac's influenza A/H1N1 Vaccine (PANFLU.1).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

310

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangxi
      • Guilin, Guangxi, China
        • GuangXi Center for Diseases Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 2 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy male or female aged between 6 and 35 months
  2. Full-term birth, birth weight 2,500 grams or more
  3. provided birth certification or vaccination card Parent(s) or legal guardian(s) are able to understand and sign the informed consent

Exclusion Criteria:

  1. Cases, cured cases and close contact of influenza A (H1N1) virus
  2. Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc
  3. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
  4. Symptoms of acute infection within a week
  5. Autoimmune disease or immunodeficiency
  6. Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders)
  7. 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
  8. 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
  9. History or family history of convulsions, epilepsy, brain disease and psychiatric
  10. Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen
  11. Guillain-Barre Syndrome
  12. Administration of 2009-2010 seasonal vaccine
  13. History of any blood products within 3 months
  14. Administration of any other investigational research agents within 30 days
  15. Administration of any live attenuated vaccine within 30 days
  16. Administration of subunit or inactivated vaccines within 14 days
  17. Be receiving anti-TB prophylaxis or therapy currently
  18. Axillary temperature > 37.0 centigrade at the time of dosing
  19. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: 7.5 μg pandemic influenza A/H1N1 vaccine
120 subjects to receive two doses of 7.5 μg pandemic influenza A/H1N1 vaccine 21 days apart
Biological: Pandemic influenza A/H1N1 vaccine
Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose
Biological: Pandemic influenza A/H1N1 vaccine
Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose
Experimental: Group 2 : 15 μg pandemic influenza A/H1N1 vaccine
120 subjects to receive two doses of 15 μg pandemic influenza A/H1N1 vaccine 21 days apart
Biological: Pandemic influenza A/H1N1 vaccine
Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose
Biological: Pandemic influenza A/H1N1 vaccine
Pandemic influenza A/H1N1 vaccine (PANFLU.1), 15 micrograms per dose per 0.5 millilitre. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose
Sham Comparator: Group 3 : 7.5 μg seasonal trivalent vaccine
60 subjects to receive two doses of 7.5 μg seasonal trivalent vaccine 21 days apart
Biological: Seasonal trivalent vaccine
Trivalent Inactivated Influenza Vaccine (ANFLU), 7.5 micrograms of each strain per dose per 0.25 millilitre. Vaccines will be administered as a single 0.25 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm) at the first dose and the other arm for the second dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate immunogenicity of H1N1 vaccine with seasonal influenza vaccine in infants
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate safety of H1N1 vaccine with seasonal influenza vaccine in infants
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinovac Biotech Co., Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

January 11, 2010

First Submitted That Met QC Criteria

January 11, 2010

First Posted (Estimate)

January 12, 2010

Study Record Updates

Last Update Posted (Estimate)

March 15, 2013

Last Update Submitted That Met QC Criteria

March 13, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-PanFlu-4003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Influenza

Clinical Trials on Pandemic influenza A/H1N1 vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe