Back to resultsClinical Trial of the Inactivated Influenza Vaccine (0.25ml Formulation for Pediatric Use)
Primary Purpose
Influenza
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Influenza Split Vaccine
Inactivated Influenza Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Pediatric influenza vaccine
Eligibility Criteria
Inclusion Criteria:
- Infants aging 6-36 months, their guardians understand and sign the informed consent
- Healthy infant by inquiring illness history, physical examination and clinical judgment and who complies with vaccination of this product
- Be able to comply with the requirement of clinical trial protocol
- Have no history of vaccination within the past 6 months and vaccination with other product within the latest 1 week
- Axillary temperature ≤37.0℃.
Exclusion Criteria:
Exclusion criteria for primary vaccination:
- History of other vaccine or immunoglobulin inoculation within 2 weeks
- History of eclampsia, epilepsy, encephalopathy and mental disease or family disease
- History of vaccination allergy or allergy to drug and food (egg)
- Known or suspected immunological function defects, including immunosuppressant therapy (radiotherapy, chemotherapy, corticosteroid hormone, antimetabolites, cytotoxic drug), genetic defects (favism), HIV infection or other reasons
- Congenital malformation, maldevelopment or serious chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease)
- Acute and chronic contagion, active infection (history of fever within the past 3 days (axillary temperature ≥38.0℃) or acute disease needing application of antibiotics or anti-virus treatment in the whole body)
- Organic diseases such as liver, kidney, serious cardiovascular disease
- Malignancy (tumor), serious asthma
- Thrombopenia or other coagulopathy that may cause contraindication of intramuscular injection
- Any condition resulting in the absence or removal the spleen
- Hypertension (not including the higher blood pressure below 150mmHg and lower blood pressure below 100mmHg controlled by drug)
- Participating in another clinical trial or any condition that, in the judgment of investigator, may affect trial assessment.
Exclusion criteria for a boost vaccination:
- Any condition in the "Exclusion criteria" of the first injection after inclusion
- Adverse reactions level 3 or above within 72 hours after first vaccination;
- Serious adverse reactions having casual relationship with the first inoculation of test vaccine
- Subjects are not willing to be inoculated any more and quit
- Axillary temperature ≥37℃ before immunization
- Reasons that can not conduct inoculation, in the judgment of investigators.
Sites / Locations
- Jiangsu Provincial Center for Disease Prevention and Control
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Influenza Split Vaccine
Inactivated Influenza Vaccine
Arm Description
7.5μg HA/strain/0.25ml/syringe
7.5μg HA/strain/0.25ml/syringe
Outcomes
Primary Outcome Measures
Number of subjects with adverse reactions as a measure of safety study
Local reactions, systemic reactions, severity degree and AEFI correlation
Secondary Outcome Measures
Observation of the immunogenicity
HI antibody seroconversion ratios, protection ratios, GMTs and GMT increase folds
Full Information
NCT ID
NCT01554826
First Posted
March 12, 2012
Last Updated
September 4, 2012
Sponsor
Hualan Biological Engineering, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01554826
Brief Title
Clinical Trial of the Inactivated Influenza Vaccine (0.25ml Formulation for Pediatric Use)
Official Title
A Double - Blind, Randomized, - Controlled Clinical Trial With Inactivated Influenza Vaccine (Split Virion)(0.25ml Formulation for Pediatric Use)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hualan Biological Engineering, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The clinical trial was designed to evaluate the immunogenicity and safety against pediatric Inactivated influenza vaccine (Split Virion) (0.25ml formulation) of Hualan administered on infants age 6 months to 36 months.
Detailed Description
The clinical trial was designed randomized and double-blind. Participants included up to 810 persons (540 persons in test group and 270 persons in control group).
Healthy 6-36 months infants were selected, whose guardians were volunteers and had signed the informed consent. Subjects were selected according to the inclusion and exclusion criteria. Every subject accepted 30min's observation in the hospital after vaccination and received periodic follow-up till the fourth week after the boost vaccination.
Blood of subjects was collected at the third week after the boost vaccination for the analysis of the immunogenicity. During the test, the adverse reactions and detailed information were reported to the SFDA under the status of blinding every month. Unblinding was conducted after the completion of the follow-up of subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Pediatric influenza vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
810 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Influenza Split Vaccine
Arm Type
Experimental
Arm Description
7.5μg HA/strain/0.25ml/syringe
Arm Title
Inactivated Influenza Vaccine
Arm Type
Active Comparator
Arm Description
7.5μg HA/strain/0.25ml/syringe
Intervention Type
Biological
Intervention Name(s)
Influenza Split Vaccine
Other Intervention Name(s)
Hualan Biologicals
Intervention Description
0.25ml, two doses (540 subjects were randomly assigned to receive the first dose, among them, 515 subjects received a boost dose); two doses were assigned to be vaccinated 4 weeks apart
Intervention Type
Biological
Intervention Name(s)
Inactivated Influenza Vaccine
Other Intervention Name(s)
Vaxigrip, Shenzhen Aventis Pasteur Biological
Intervention Description
0.25ml, two doses (270 subjects were randomly assigned to receive the first dose; among them, 263 subjects received a boost dose); two doses was administrated at 4 weeks apart
Primary Outcome Measure Information:
Title
Number of subjects with adverse reactions as a measure of safety study
Description
Local reactions, systemic reactions, severity degree and AEFI correlation
Time Frame
28 days after the vaccination
Secondary Outcome Measure Information:
Title
Observation of the immunogenicity
Description
HI antibody seroconversion ratios, protection ratios, GMTs and GMT increase folds
Time Frame
28 days after the immunization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Infants aging 6-36 months, their guardians understand and sign the informed consent
Healthy infant by inquiring illness history, physical examination and clinical judgment and who complies with vaccination of this product
Be able to comply with the requirement of clinical trial protocol
Have no history of vaccination within the past 6 months and vaccination with other product within the latest 1 week
Axillary temperature ≤37.0℃.
Exclusion Criteria:
Exclusion criteria for primary vaccination:
History of other vaccine or immunoglobulin inoculation within 2 weeks
History of eclampsia, epilepsy, encephalopathy and mental disease or family disease
History of vaccination allergy or allergy to drug and food (egg)
Known or suspected immunological function defects, including immunosuppressant therapy (radiotherapy, chemotherapy, corticosteroid hormone, antimetabolites, cytotoxic drug), genetic defects (favism), HIV infection or other reasons
Congenital malformation, maldevelopment or serious chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease)
Acute and chronic contagion, active infection (history of fever within the past 3 days (axillary temperature ≥38.0℃) or acute disease needing application of antibiotics or anti-virus treatment in the whole body)
Organic diseases such as liver, kidney, serious cardiovascular disease
Malignancy (tumor), serious asthma
Thrombopenia or other coagulopathy that may cause contraindication of intramuscular injection
Any condition resulting in the absence or removal the spleen
Hypertension (not including the higher blood pressure below 150mmHg and lower blood pressure below 100mmHg controlled by drug)
Participating in another clinical trial or any condition that, in the judgment of investigator, may affect trial assessment.
Exclusion criteria for a boost vaccination:
Any condition in the "Exclusion criteria" of the first injection after inclusion
Adverse reactions level 3 or above within 72 hours after first vaccination;
Serious adverse reactions having casual relationship with the first inoculation of test vaccine
Subjects are not willing to be inoculated any more and quit
Axillary temperature ≥37℃ before immunization
Reasons that can not conduct inoculation, in the judgment of investigators.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng-cai Zhu, M.D.
Organizational Affiliation
Jiangsu Provincial Center for Disease Prevention and Control
Official's Role
Study Director
Facility Information:
Facility Name
Jiangsu Provincial Center for Disease Prevention and Control
City
Huaian
State/Province
Jiangsu
ZIP/Postal Code
223000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial of the Inactivated Influenza Vaccine (0.25ml Formulation for Pediatric Use)
We'll reach out to this number within 24 hrs