A Clinical Trial of an Inactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8 Years
Study Details
Study Description
Brief Summary
Routine annual influenza vaccination is recommended for all persons aged≥6 months who do not have contraindications. For those aged 6 monthsthrough 8 years who have previously received ≥2 total doses of trivalent orquadrivalent influenza vaccine ≥4 weeks apart, they require only 1 dose ofinfluenza vaccine. For those who have not previously received ≥2 doses oftrivalent or quadrivalent influenza vaccine, they require 2 dose of influenzavaccine. but the evidence on how to select vaccine doses for quadrivalentinfluenza vaccine is limited in China. The study is a prospective, open-labelcomparison of the immunogenicity and reactogenicity of 1 versus 2 doses ofan inactivated quadrivalent influenza vaccine in subjects of 3-8 years old withdifferent history of influenza vaccination.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Subjects receive 2 dosed of quadrivalent influenza vaccine 4 weeks apart.Blood samples were obtained from children at 3 time points-before receiptof dose 1, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeksafter dose 2. Hemagglutination inhibition (HAI) antibody titers to the A/H3N2,A/H1N1, and B antigens included in the vaccine were measured at each timepoint
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Quadrivalent influenza vaccine Subjects received 2 doses of 0.5 mL of quadrivalentinfluenza vaccine, 4 weeks apart. Each 0.5-ml dosecontained 15 μg of hemagglutinin per strain. |
Biological: Quadrivalent influenza vaccine
Subjects receive two doses of quadrivalent influenzavaccine administered 4 weeks apart by intramuscularinjection. Each 0.5-ml dosecontained 15 μg of hemagglutinin per strain.
|
Outcome Measures
Primary Outcome Measures
- the 95% confidence interval (CI) lower limit for Seroconversion Rate (SCR) of Hemagglutination inhibition (HAI)antibodies against each virus strain after 2nd vaccination ≥40% [day 28 after dose 2]
The lowest dilution used in the assay is 1/10. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.
- Number of participants with Adverse Reactions (ARs) [28 days after each vaccination]
Frequency and severity of ARs for 28 days after each vaccination
Secondary Outcome Measures
- the 95% CI lower limit for seroprotection rates of HAI antibodies against each virus strain after 2nd vaccination≥70% [day 28 after dose 2]
A seroprotected subject is defined as a vaccinated subject with serum HAI titer≥ 1:40.
- Geometric Mean Fold Increase (GMFI) of HAI titer against each virus strain after 2nd vaccination>2.5 [day 28 after dose 2]
Hemagglutination inhibition (HAI) titers were used to calculate post-vaccination geometric mean fold increase (GMFI)against each virus strain
- Number of participants with Adverse Events (AEs) [28 days after each vaccination]
Frequency and severity of AEs for 28 days after each vaccination
- Number of participants with Serious Adverse Events (SAE) [6 months after the last vaccination]
Frequency of SAEs for 6 months after the last vaccination
Other Outcome Measures
- Comparision between Seroconversion Rate (SCR) of HAI antibodies against each virus strain post dose 1 and dose 2 [day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2]
The lowest dilution used in the assay is 1/10. Seroconversion was defined as either a pre-vaccination HAI titer < 1:10and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and ≥ four-fold increase in post-vaccination titer.
- Comparision between Geometric Mean Titre (GMT) of HAI antibodies against each virus strain post dose 1 and dose 2 [day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2]
- Comparision between seroprotection rates of HAI antibodies against each virus strain post dose 1 and dose 2 [day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2]
A seroprotected subject is defined as a vaccinated subject with serum HAI titer≥ 1:40.
- Comparision between Geometric Mean Fold Increase (GMFI) of HAI antibodies against each virus strain post dose 1and dose 2 [day 28 after receipt of dose 1 and before dose 2, and day 28 after dose 2]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged 3-8 years old
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Healthy subjects judged from medical history and clinical examination
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Subjects themselves or their guardians able to understand and sign theinformed consent
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Subjects themselves or their guardians can and will comply with therequirements of the protocol
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Subjects have received ≥2 doses of trivalent or quadrivalent infuenzavaccine before enrollment (Doses need not have been received duringsame or consecutive seasons); Subjects have not received infuenzavaccine before enrollment
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Subjects with temperature <=37.0°C on axillary setting
Exclusion Criteria:
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Any prior administration of other research medicine/vaccine in last 30 days
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Any prior administration of influenza vaccine in last 6 month
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Any prior administration of immunodepressant or corticosteroids in last 3 months
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Any prior administration of blood products in last 3 months
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Any prior administration of any attenuated live vaccine in last 14 days
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Any prior administration of subunit or inactivated vaccines in last 7 days
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Subject who developed guillain-Barre syndrome post influenza vaccination
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Subject who is allergic to any ingredient of the vaccine
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Subject with acute febrile illness or infectious disease
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Thrombocytopenia, blood coagulation disorder or bleeding difficulties withintramuscular injection
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Subject with damaged or low immune function which has already beenknown
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Subject with congenital heart disease or other birth defects unsuitable for vaccination.
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Subject with respiratory diseases (including pneumonia, tuberculosis, severe asthma, etc.), heart, liver and kidney diseases, mental disorders, or chronic infections.
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Any medical, psychological, social or other condition judged byinvestigator, that may interfere subject's compliance with the protocol
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Donghai County Center for Disease Control and Prevention | Lianyungang | Jiangsu | China | 222300 |
Sponsors and Collaborators
- Jiangsu Province Centers for Disease Control and Prevention
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SJLGYM-2021-Ⅳ-01