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

NCT01554826 | Completed Phase 3 DMC

• 1 other identifier: Hualanbio-influenza III-002
• Study Type: interventional
• Target: 810
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

Pediatric influenza vaccine

Outcome Measures

Primary Outcomes (1)

• Number of subjects with adverse reactions as a measure of safety study

  Local reactions, systemic reactions, severity degree and AEFI correlation

  28 days after the vaccination

Secondary Outcomes (1)

• Observation of the immunogenicity

  28 days after the immunization

Study Arms (2)

Influenza Split Vaccine

EXPERIMENTAL

7.5μg HA/strain/0.25ml/syringe

Biological: Influenza Split Vaccine

Inactivated Influenza Vaccine

ACTIVE COMPARATOR

7.5μg HA/strain/0.25ml/syringe

Biological: Inactivated Influenza Vaccine

Interventions

Influenza Split Vaccine BIOLOGICAL

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

Also known as: Hualan Biologicals

Influenza Split Vaccine

Inactivated Influenza Vaccine BIOLOGICAL

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

Also known as: Vaxigrip, Shenzhen Aventis Pasteur Biological

Inactivated Influenza Vaccine

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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℃.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Hualan Biological Engineering, Inc.: lead

Study Sites (1)

Jiangsu Provincial Center for Disease Prevention and Control

Huaian, Jiangsu, 223000, China

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

vaxigrip

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Feng-cai Zhu, M.D.

  Jiangsu Provincial Center for Disease Prevention and Control

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2012
• First Posted: March 15, 2012
• Study Start: March 1, 2009
• Primary Completion: May 1, 2009
• Study Completion: February 1, 2010
• Last Updated: September 6, 2012

Record last verified: 2012-04

Locations

CN (1)