Clinical Trial of the Inactivated Influenza Vaccine (0.25ml Formulation for Pediatric Use)
NCT ID: NCT01554826
Last Updated: 2012-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
810 participants
INTERVENTIONAL
2009-03-31
2010-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Influenza Split Vaccine
7.5μg HA/strain/0.25ml/syringe
Influenza Split Vaccine
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
Inactivated Influenza Vaccine
7.5μg HA/strain/0.25ml/syringe
Inactivated Influenza Vaccine
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
Interventions
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Influenza Split Vaccine
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
Inactivated Influenza Vaccine
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
* 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.
6 Months
36 Months
ALL
Yes
Sponsors
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Hualan Biological Engineering, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Feng-cai Zhu, M.D.
Role: STUDY_DIRECTOR
Jiangsu Provincial Center for Disease Prevention and Control
Locations
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Jiangsu Provincial Center for Disease Prevention and Control
Huaian, Jiangsu, China
Countries
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Other Identifiers
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Hualanbio-influenza III-002
Identifier Type: -
Identifier Source: org_study_id