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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047202
• Other study ID #: PRO-PanFlu-4003
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2010
• Last updated: March 13, 2013
• Start date: December 2009
• Est. completion date: May 2010

Study information

• Verified date: March 2013
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: May 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 35 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
China	GuangXi Center for Diseases Control and Prevention	Guilin	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate immunogenicity of H1N1 vaccine with seasonal influenza vaccine in infants		3 months	No
Secondary	Evaluate safety of H1N1 vaccine with seasonal influenza vaccine in infants		3 months	Yes