Influenza
Conditions
Keywords
Pediatric influenza vaccine
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.
Interventions
BIOLOGICALInfluenza 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
BIOLOGICALInactivated 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
Sponsors
Hualan Biological Engineering, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 36 Months
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with adverse reactions as a measure of safety study | 28 days after the vaccination | Local reactions, systemic reactions, severity degree and AEFI correlation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Observation of the immunogenicity | 28 days after the immunization | HI antibody seroconversion ratios, protection ratios, GMTs and GMT increase folds |
Countries
China
Outcome results
None listed