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

NCT01047202 | Completed Phase 4

• 1 other identifier: PRO-PanFlu-4003
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Evaluate immunogenicity of H1N1 vaccine with seasonal influenza vaccine in infants

  3 months

Secondary Outcomes (1)

• Evaluate safety of H1N1 vaccine with seasonal influenza vaccine in infants

  3 months

Study Arms (3)

Group 1: 7.5 μg pandemic influenza A/H1N1 vaccine

EXPERIMENTAL

120 subjects to receive two doses of 7.5 μg pandemic influenza A/H1N1 vaccine 21 days apart

Biological: Pandemic influenza A/H1N1 vaccine

Group 2 : 15 μg pandemic influenza A/H1N1 vaccine

EXPERIMENTAL

120 subjects to receive two doses of 15 μg pandemic influenza A/H1N1 vaccine 21 days apart

Biological: Pandemic influenza A/H1N1 vaccine

Group 3 : 7.5 μg seasonal trivalent vaccine

SHAM COMPARATOR

60 subjects to receive two doses of 7.5 μg seasonal trivalent vaccine 21 days apart

Biological: Seasonal trivalent vaccine

Interventions

Pandemic influenza A/H1N1 vaccine BIOLOGICAL

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

Group 1: 7.5 μg pandemic influenza A/H1N1 vaccine

Seasonal trivalent vaccine BIOLOGICAL

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

Group 3 : 7.5 μg seasonal trivalent vaccine

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Cases, cured cases and close contact of influenza A (H1N1) virus
• 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
• Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
• Symptoms of acute infection within a week
• Autoimmune disease or immunodeficiency
• Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders)
• 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
• 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
• History or family history of convulsions, epilepsy, brain disease and psychiatric
• Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen
• Guillain-Barre Syndrome
• Administration of 2009-2010 seasonal vaccine
• History of any blood products within 3 months
• Administration of any other investigational research agents within 30 days
• Administration of any live attenuated vaccine within 30 days

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (1)

GuangXi Center for Diseases Control and Prevention

Guilin, Guangxi, China

Location

Related Publications (1)

• Li YP, Li W, Liang XF, Liu Y, Huang XC, Li CG, Li RC, Wang JZ, Wang HQ, Yin WD. Immunogenicity and safety of a 2009 pandemic influenza A (H1N1) monovalent vaccine in Chinese infants aged 6-35 months: a randomized, double-blind, controlled phase I clinical trial. Influenza Other Respir Viruses. 2013 Nov;7(6):1297-307. doi: 10.1111/irv.12028. Epub 2012 Nov 8.

  PMID: 23134570 DERIVED

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 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2010
• First Posted: January 12, 2010
• Study Start: December 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2010
• Last Updated: March 15, 2013

Record last verified: 2013-03

Locations

CN (1)