The Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated) (Children Forms of Drug)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Chinese Academy of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Hebei province Center for Disease Prevention and Control
National Institute for the Control of Pharmaceutical and Biological Products, China
Information provided by (Responsible Party):
Guoyang Liao, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01551823
First received: March 9, 2012
Last updated: March 13, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: Influenza Virus Vaccine(no Preservative )
Biological: Influenza Virus Vaccine(contains Preservative)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Phase Ⅲ Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated)(Children Forms of Drug)

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • To evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated) (Children Forms of Drug) [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1200
Study Start Date: March 2012
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Team 1
Influenza Virus Vaccine(no Preservative) 2×0.25ml intramuscular injections
Biological: Influenza Virus Vaccine(no Preservative )
Influenza Virus Vaccine(no Preservative) 2×0.25ml intramuscular injections
Experimental: Team 2
Influenza Virus Vaccine(contains Preservative)2×0.25ml intramuscular injections
Biological: Influenza Virus Vaccine(contains Preservative)
Influenza Virus Vaccine(contains Preservative)2×0.25ml intramuscular injections
Other Name: Vaxigrip

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.

  Eligibility

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

Inclusion Criteria:

  • 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℃.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551823

Contacts
Contact: Guoyang Liao, Ph. D 86-0871-8334330 liaogy@imbcams.com.cn
Contact: Yuliang Zhao, MD 86-0311-86573212 yuliangzhao@yahoo.com.cn

Locations
China, Hopei
Dingxing Center for Disease Prevention and Control Recruiting
Shijiazhuang, Hopei, China
Contact: Jingchen Ma    86-0311-86573212    jinchenma@yahoo.com.cn   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Hebei province Center for Disease Prevention and Control
National Institute for the Control of Pharmaceutical and Biological Products, China
Investigators
Principal Investigator: Guoyang Liao, Ph. D Institute of Medical Biology, Chinese Academy of Medical Sciences
Principal Investigator: Yuliang Zhao, MD Hebei province Center for Disease Prevention and Control
  More Information

Additional Information:
No publications provided

Responsible Party: Guoyang Liao, Head of Biologicals No.15, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01551823     History of Changes
Other Study ID Numbers: IMBCAMS-05, 2011L01487
Study First Received: March 9, 2012
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Chinese Academy of Medical Sciences:
Influenza Virus Vaccine (Split Virion, Inactivated)
Influenza

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 August 01, 2014