Influenza
Conditions
Keywords
Safety, Immunogenicity, Quadrivalent influenza vaccine
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.
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
Interventions
BIOLOGICALQuadrivalent 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.
Sponsors
Jiangsu Province Centers for Disease Control and Prevention
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Subjects received 2 doses of an inactivated quadrivalent influenza vaccine,4 weeks apart. Blood samples were obtained from children at 3 time points-before receipt of dose 1, 4 weeks after receipt of dose 1 and before dose 2, and4 weeks after dose 2.
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 3-8 years old * Healthy subjects judged from medical history and clinical examination * Subjects themselves or their guardians able to understand and sign theinformed consent * Subjects themselves or their guardians can and will comply with therequirements of the protocol * 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 * Subjects with temperature \<=37.0°C on axillary setting
Exclusion criteria
* Any prior administration of other research medicine/vaccine in last 30 days * Any prior administration of influenza vaccine in last 6 month * Any prior administration of immunodepressant or corticosteroids in last 3 months * Any prior administration of blood products in last 3 months * Any prior administration of any attenuated live vaccine in last 14 days * Any prior administration of subunit or inactivated vaccines in last 7 days * Subject who developed guillain-Barre syndrome post influenza vaccination * Subject who is allergic to any ingredient of the vaccine * Subject with acute febrile illness or infectious disease * Thrombocytopenia, blood coagulation disorder or bleeding difficulties withintramuscular injection * Subject with damaged or low immune function which has already beenknown * Subject with congenital heart disease or other birth defects unsuitable for vaccination. * Subject with respiratory diseases (including pneumonia, tuberculosis, severe asthma, etc.), heart, liver and kidney diseases, mental disorders, or chronic infections. * Any medical, psychological, social or other condition judged byinvestigator, that may interfere subject's compliance with the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 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. |
Countries
China
Outcome results
None listed