The Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated) （Children Forms of Drug）
- Conditions
- Influenza
- Interventions
- Biological: Influenza Virus Vaccine(contains Preservative)Biological: Influenza Virus Vaccine(no Preservative )
- Registration Number
- NCT01551823
- Brief Summary
The purpose of this study is to evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated)(children forms of drug) that do not contains Preservative.
- Detailed Description
Influenza Virus Vaccine (Split Virion, Inactivated) that do not contain Preservative. HA contents 7.5μg/0.5ml per dose include H1N1、H3N2 and B.
Inactivated Split Influenza Vaccine was manufactured by Sanofi Pasteur HA contents 7.5μg/0.5ml per dose include H1N1、H3N2 and B.
This is a randomized, blind phase 3 clinical trial. Total 1200 adults (ages from 6 months to 36 months ) were selected, randomized to two groups \[Influenza Virus Vaccine (Split Virion, Inactivated) and Inactivated Split Influenza Vaccine , each group n=600\], adults in each group will be vaccinated with two doses of either Influenza Virus Vaccine (Split Virion, Inactivated) or Sanof IVV respectively,21 days apart.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1200
- Males and females, age from 6 months to 35 months ;
- Adults, parent(s) or guardians are able to understand and sign informed consent for participation;
- Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
- Infants no vaccinated with influenza or other preventive biologicals in recent 7 days;
- Axillary temperature ≤37℃.
- Have medical record of participants or their family on allergy and egg, convulsion, falling sickness, encephalopathy and psychopathy;
- Low platelet or bleeding disorder do not allow vaccination into the muscle;
- Have damaged or lower immunological function;
- Received blood, plasma or immunoglobulin treatment since birth; Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome );
- Have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, HIV.
Exclusion Criteria for doses 2
- Have serious anaphylaxis or high fever, convulsion during first dose;
- Have any circus of Exclusion Criteria after Eligible for study;
- Have serious adverse event which related to previous vaccination;
- Withdrawal and Discontinuance Criteria;
- Received necessary or interference study drugs such as: immune-inhibition or immune-stimulating agents;
- Vaccinated with any other vaccine（except DTP）;
- Stop observation determined by investigator owing to occurring serious adverse event.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Team 2 Influenza Virus Vaccine(contains Preservative) Influenza Virus Vaccine(contains Preservative)2×0.25ml intramuscular injections Team 1 Influenza Virus Vaccine(no Preservative ) Influenza Virus Vaccine(no Preservative) 2×0.25ml intramuscular injections
- Primary Outcome Measures
Name Time Method To evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated) （Children Forms of Drug） six months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Dingxing Center for Disease Prevention and Control
🇨🇳Shijiazhuang, Hebei, China