Sinovac, Pandemic Influenza A/H1N1 Vaccine in 6 to 35 Months Infants
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).
Study Design
Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention
Conditions
Influenza
Intervention
Pandemic influenza A/H1N1 vaccine, Pandemic influenza A/H1N1 vaccine, Seasonal trivalent vaccine
Location
GuangXi Center for Diseases Control and Prevention
Guilin
GuangXi
China
Status
Enrolling by invitation
Source
Sinovac Biotech Co., Ltd
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01047202
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Influenza A Virus, H1n1 Subtype
A subtype of INFLUENZA A VIRUS comprised of the surface proteins hemagglutinin 1 and neuraminidase 1. The H1N1 subtype was responsible for the Spanish flu pandemic of 1918.
Influenza A Virus, H3n2 Subtype
A subtype of INFLUENZA A VIRUS comprised of the surface proteins hemagglutinin 3 and neuraminidase 2. The H3N2 subtype was responsible for the Hong Kong flu pandemic of 1968.
Influenza A Virus, H2n2 Subtype
A subtype of INFLUENZA A VIRUS comprised of the surface proteins hemagglutinin 2 and neuraminidase 2. The H2N2 subtype was responsible for the Asian flu pandemic of 1957.
Influenza Vaccines
Vaccines used to prevent infection by viruses in the family ORTHOMYXOVIRIDAE. It includes both killed or attenuated vaccines. The composition of the vaccines is changed each year in response to antigenic shifts and changes in prevalence of influenza virus strains. The vaccine is usually bivalent or trivalent, containing one or two INFLUENZAVIRUS A strains and one INFLUENZAVIRUS B strain.
Diphtheria-tetanus Vaccine
A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.
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