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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier:
NCT01047202
First received: January 11, 2010
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

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).


Condition Intervention Phase
Influenza
Biological: Pandemic influenza A/H1N1 vaccine
Biological: Seasonal trivalent vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: A Blinded, Randomized and Controlled Clinical Trial With Influenza A/H1N1 Split-virion Vaccine in 6 to 35 Months Infants

Resource links provided by NLM:


Further study details as provided by Sinovac Biotech Co., Ltd:

Primary Outcome Measures:
  • Evaluate immunogenicity of H1N1 vaccine with seasonal influenza vaccine in infants [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate safety of H1N1 vaccine with seasonal influenza vaccine in infants [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 310
Study Start Date: December 2009
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 0.5 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

  Eligibility

Ages Eligible for Study:   6 Months to 35 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01047202

Locations
China, Guangxi
GuangXi Center for Diseases Control and Prevention
Guilin, Guangxi, China
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
  More Information

No publications provided by Sinovac Biotech Co., Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT01047202     History of Changes
Other Study ID Numbers: PRO-PanFlu-4003
Study First Received: January 11, 2010
Last Updated: March 13, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014