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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hualan Biological Engineering, Inc.
ClinicalTrials.gov Identifier:
NCT01554826
First received: March 12, 2012
Last updated: September 4, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Influenza
Biological: Influenza Split Vaccine
Biological: Inactivated Influenza Vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:


Further study details as provided by Hualan Biological Engineering, Inc.:

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


Secondary Outcome Measures:
  • Observation of the immunogenicity [ Time Frame: 28 days after the immunization ] [ Designated as safety issue: Yes ]
    HI antibody seroconversion ratios, protection ratios, GMTs and GMT increase folds


Enrollment: 810
Study Start Date: March 2009
Study Completion Date: February 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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:

  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.
  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: NCT01554826

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

No publications provided

Responsible Party: Hualan Biological Engineering, Inc.
ClinicalTrials.gov Identifier: NCT01554826     History of Changes
Other Study ID Numbers: Hualanbio-influenza III-002
Study First Received: March 12, 2012
Last Updated: September 4, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Hualan Biological Engineering, Inc.:
Pediatric influenza vaccine

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 July 20, 2014