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Clinical Trial of the Inactivated Influenza Vaccine (0.25ml Formulation for Pediatric Use)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01554826
Recruitment Status : Completed
First Posted : March 15, 2012
Last Update Posted : September 6, 2012
Information provided by (Responsible Party):
Hualan Biological Engineering, Inc.

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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Influenza Split Vaccine Biological: Inactivated Influenza Vaccine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 810 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Double - Blind, Randomized, - Controlled Clinical Trial With Inactivated Influenza Vaccine (Split Virion)(0.25ml Formulation for Pediatric Use)
Study Start Date : March 2009
Actual Primary Completion Date : May 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Influenza Split Vaccine
7.5μg HA/strain/0.25ml/syringe
Biological: 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
Other Name: Hualan Biologicals

Active Comparator: Inactivated Influenza Vaccine
7.5μg HA/strain/0.25ml/syringe
Biological: 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 Name: Vaxigrip, Shenzhen Aventis Pasteur Biological

Primary Outcome Measures :
  1. Number of subjects with adverse reactions as a measure of safety study [ Time Frame: 28 days after the vaccination ]
    Local reactions, systemic reactions, severity degree and AEFI correlation

Secondary Outcome Measures :
  1. Observation of the immunogenicity [ Time Frame: 28 days after the immunization ]
    HI antibody seroconversion ratios, protection ratios, GMTs and GMT increase folds

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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:

  1. 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.
  2. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01554826

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China, Jiangsu
Jiangsu Provincial Center for Disease Prevention and Control
Huaian, Jiangsu, China, 223000
Sponsors and Collaborators
Hualan Biological Engineering, Inc.
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Study Director: Feng-cai Zhu, M.D. Jiangsu Provincial Center for Disease Prevention and Control

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Responsible Party: Hualan Biological Engineering, Inc. Identifier: NCT01554826     History of Changes
Other Study ID Numbers: Hualanbio-influenza III-002
First Posted: March 15, 2012    Key Record Dates
Last Update Posted: September 6, 2012
Last Verified: April 2012
Keywords provided by Hualan Biological Engineering, Inc.:
Pediatric influenza vaccine
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs