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Quadrivalent Subunit Influenza Vaccine（0.5ml）
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Instruction Manual for Quadrivalent Subunit Influenza Vaccine
Please read the instruction manual carefully and use only under medical supervision
[Drug Name]
Generic Name: Quadrivalent Subunit Influenza Vaccine
Trade name: HRK-X
English name: Quadrivalent Subunit Influenza Vaccine
Pinyin: Sijia Liugan Bingdu Yadanwei Yimiao
[Ingredients]
The production method of this product is to inoculate chicken embryos with influenza A and influenza B (referred to as influenza) virus strains recommended by the World Health Organization (WHO), followed by culture, virus liquid harvesting, ultrafiltration concentration, virus lysis and centrifugation, purification, virus inactivation, and final purification to harvest hemagglutinin and neuraminidase. The product is free from preservatives and antibiotics.
This product contains egg ingredients protein.
Active ingredients: hemagglutinin of various influenza virus strains used in the current year. Each 0.5 mL of this product contains:
A/Victoria/4897/2022(H1N1)pdm09-like virus 15 µg hemagglutinin
A/Thailand/8/2022(H3N2)-like virus 15 µg hemagglutinin
B/Phuket/3073/2013(B/Yamagata lineage)-like virus 15 µg hemagglutinin
B/Austria/1359417/2021(B/Victoria lineage)-like virus 15 µg hemagglutinin
Excipients: sodium dihydrogen phosphate, anhydrous disodium hydrogen phosphate, sodium chloride.
[Properties]
This product is an injection, a slightly milky white liquid.
[Targeted Population]
This product is used for people aged 3 and older; it is especially recommended for susceptible people and people who are prone to related complications, such as children, the elderly, the infirm, and people in influenza-endemic areas.
[Function and Use]
After vaccination with this product, it can stimulate the body to produce immunity against influenza virus. For the prevention of influenza caused by vaccine-associated types of influenza virus.
[Strength]
Each pre-filled syringe is 0.5 mL. One human dose is 0.5 mL which should contain 15 μg haemagglutinin for each strain of influenza virus.
[Immunization Program and Dosage]
(1) Inject into the deltoid muscle of the upper arm.
(2) Vaccinate before or during the influenza epidemic season. People aged 3 and older are vaccinated with 1 dose, and each dose is 0.5 mL.
[Adverse Reactions]
According to the classification of the incidence of adverse reactions recommended by the Committee for International Organizations of Medical Sciences (CIOMS): very common (≥10%), common (1%-10%, including 1%), occasional (0.1%-1%, including 0.1%), rare (0.01%-0.1%, including 0.01%), very rare (<0.01%). The safety information is summarized and described as follows:
(1) Clinical trials of this product
Two clinical studies of this product have been carried out in China, in which a total of 3,240 subjects aged 3 and older were enrolled, of which 1,619 subjects were vaccinated with at least one dose of this product. The safety observation period of this product system was from the beginning of vaccination to 30 days after the full-course vaccination, and the long-term safety observation period was from 31 days to 180 days after the full-course vaccination.
Systemic adverse reactions
Common: fever, cough;
Occasional: headache, runny nose, chest pain, fatigue, nausea, vomiting, abdominal pain, diarrhea, arthralgia, myalgia, maculopapular rash;
Rare: loss of appetite, pain in extremity.
Local adverse reactions
Common: pain, swelling;
Occasional: erythema, pruritus, induration;
Rare: bruising.
(2) Clinical trials of domestic and international similar products
In addition to the above adverse reactions, the following adverse reactions were also observed in clinical trials of domestic and international similar products:
Systemic adverse reactions
Very common: malaise, gastrointestinal symptoms, lethargy, irritability;
Common: chills;
Occasional: dyspnea, dysphagia, nasopharyngitis, tonsillitis, allergy, dizziness, lymphadenopathy;
Rare: palpitations, macule, constipation, hypersensitivity reactions, pruritus, nasal congestion, increased sputum production, throat irritation, hyperhidrosis, allergic purpura.
Local adverse reactions
Very common: redness;
Occasional: ecchymosis;
Rare: rash, pallor, discoloration.
(3) Post-marketing surveillance of international similar products
In addition to the safety information in clinical trials, the safety data obtained from post-approval monitoring of similar overseas products (Spontaneous reports from a population of unknown size which cannot accurately estimate the incidence of symptoms or effectively assess the correlation between symptom occurrence and vaccine use) are summarized as follows:
Digestive system: abdominal pain/discomfort, swelling of the mouth/throat/tongue;
Blood and lymphatic system: transient thrombocytopenia;
Infections and infestations: injection site cellulitis;
Nervous system: convulsions, encephalomyelitis, facial paralysis, Guillain-Barré syndrome, myelitis, neuritis, paresthesias, syncope;
Respiratory system: asthma, bronchospasm;
Cardiovascular system: tachycardia, vasculitis;
Skin system: angioedema, Stevens-Johnson syndrome, sweating, urticaria;
Eyes: conjunctivitis, eye pain/redness/swelling, eyelid swelling;
Immune system: anaphylactic shock, serum sickness.
[Contraindications]
(1) Those who are known to be allergic to any ingredients contained in this product, including eggs, excipients, formaldehyde, and Triton N-101.
(2) Those who suffer from acute exacerbation of acute disease, severe chronic disease and chronic disease, cold and fever.
(3) Those with uncontrolled epilepsy and other progressive neurological diseases, and those with a history of Guillain-Barré syndrome.
[Precautions]
(1) Use with caution in the following situations: family and personal history of convulsions, chronic diseases, history of epilepsy, allergies.
(2) Pre-filled syringes with cracks, products with unclear labels or expired, turbid vaccines, products with lumpy flocs that cannot be shaken apart, and products with other abnormal appearances should not be used.
(3) This product is strictly forbidden to be frozen, and it is strictly forbidden to use in divided doses. The pre-filled syringe should be used immediately after opening.
(4) This product should not be mixed with other medical products and injected together in a syringe.
(5) For patients with thrombocytopenia or bleeding disorders, intramuscular injection of this product may cause bleeding.
(6) Intravenous injection is strictly prohibited.
(7) Adrenaline and other drugs should be prepared for emergency use in case of occasional severe allergic reactions. Recipients should be observed on site for at least 30 minutes after injection.
(8) Those who receive immunoglobulin injection should be vaccinated with this product at least one month apart to avoid affecting the immune effect.
(9) Those who have any nervous system reaction after injection are prohibited from using this product again.
(10) This product must be used within the validity period.
(11) Those who are immunocompromised or have any questions before use should consult and listen to the doctor's advice.
[Use in Pregnant and Lactating Women]
There are no clinical trial data on the use of this product in pregnant and lactating women. If this group of people needs to use this product, it is recommended to make a decision after joint benefit/risk assessment with the doctor.
[Drug Interactions]
At present, there is no clinical study on the combined use of this product with other vaccines or drugs. There are no data to evaluate the effect of this product when used concurrently with other vaccines or drugs.
The use of immunosuppressants may reduce the body's immune response to this product.
If you are currently or have recently used any other vaccines or drugs, in order to avoid possible drug interactions, it is recommended to consult a professional physician before vaccinating with this product.
[Clinical Trials]
In a randomized, blinded, positive-controlled Phase III pivotal registration clinical trial completed in China, a total of 3,000 subjects aged 3 and above were enrolled, including 800 subjects aged ≥65 years, and 700 subjects aged 18-64 years, 700 subjects aged 9-17 years, and 800 subjects aged 3-8 years. The subjects in each age group were randomly assigned to receive 1 dose of this product or the quadrivalent influenza virus split vaccine at a ratio of 1:1. Blood samples were collected before immunization and at 28 days after immunization, and the HI antibody titer against influenza virus in the serum of subjects was detected by the micro-hemagglutination inhibition test method.
The HI antibody GMTs against influenza virus in the whole study population in the trial group after immunization were: 400.39 for H1N1, 436.71 for H3N2, 267.60 for BY, and 77.80 for BV (see Table 1 for details); the antibody seroconversion rates after immunization were: 82.71% for H1N1, 91.22% for H3N2, 88.36% for BY, 84.96% for BV (see Table 2 for details); and the antibody protection rates (≥1:40) after immunization were: 96.60% for H1N1, 97.96% for H3N2, 95.92% for BY, 89.45% for BV (see Table 2 for details). FAS and PPS results were consistent.
Table 1. Antibody GMT and GMI Analysis of the Whole Study Population after Immunization (PPS Set)
|
Antibody type |
Group |
Number of detections |
Antibody GMT |
GMT ratio |
Antibody GMI |
|
H1N1 |
Trial group |
1469 |
400.39 (377.13-425.09) |
1.201 (1.107-1.303) |
11.84 (11.06-12.67) |
|
Control group |
1480 |
333.46 (315.49-352.46) |
|
9.90 (9.24-10.61) |
|
|
H3N2 |
Trial group |
1469 |
436.71 (410.88-464.16) |
1.137 (1.043-1.240) |
16.66 (15.70-17.68) |
|
Control group |
1480 |
384.13 (361.25-408.45) |
|
14.05 (13.21-14.95) |
|
|
B (Y) |
Trial group |
1469 |
267.60 (251.98-284.19) |
1.481 (1.362-1.611) |
12.58 (11.85-13.35) |
|
Control group |
1480 |
180.63 (170.32-191.57) |
|
8.45 (7.99-8.93) |
|
|
B (V) |
Trial group |
1469 |
77.80 (73.50-82.36) |
1.146 (1.058-1.241) |
9.76 (9.28-10.27) |
|
Control group |
1480 |
67.90 (64.21-71.81) |
|
8.34 (7.92-8.77) |
Note: The strain types contained in the vaccines of the trial group and the control group were: A/Brisbane/02/2018(H1N1)pdm09-like virus strain in H1N1, A/Kansas/14/2017(H3N2)-like virus strain in H3N2, B/Phuket/3073/2013-like virus (B/Yamagata/16/88 lineage) strain in B (Y), and B/Colorado/06/2017-like virus (B/Victoria /2/87 lineage) strain in B (V).
The non-inferiority test was valid if the lower limit of the 95% CI of the antibody GMT ratio (trial group/control group) was not less than 0.67.
Table 2. Antibody Seroconversion Rate and Protection Rate Analysis of the Whole Study Population after Immunization (PPS Set)
|
Antibody type |
Group |
Number of detections |
Antibody seroconversion rate % (95% CI) |
Seroconversion rate difference % (95% CI) |
Antibody protection rate (≥1:40) % (95% CI) |
|
H1N1 |
Trial group |
1469 |
82.71 (80.68-84.61) |
4.06 (1.21-6.91) |
96.60 (95.54-97.46) |
|
Control group |
1480 |
78.65 (76.47-80.71) |
|
96.01 (94.89-96.95) |
|
|
H3N2 |
Trial group |
1469 |
91.22 (89.65-92.62) |
1.89 (-0.24-4.03) |
97.96 (97.10-98.62) |
|
Control group |
1480 |
89.32 (87.64-90.85) |
|
97.36 (96.42-98.12) |
|
|
B (Y) |
Trial group |
1469 |
88.36 (86.61-89.96) |
6.40 (3.85-8.95) |
95.92 (94.77-96.87) |
|
Control group |
1480 |
81.96 (79.90-83.89) |
|
94.26 (92.95-95.39) |
|
|
B (V) |
Trial group |
1469 |
84.96 (83.02-86.75) |
3.87 (1.17-6.58) |
89.45 (87.76-90.97) |
|
Control group |
1480 |
81.08 (78.99-83.05) |
|
87.50 (85.71-89.14) |
Note: The strain types contained in the vaccines of the trial group and the control group were: A/Brisbane/02/2018(H1N1)pdm09-like virus strain in H1N1, A/Kansas/14/2017(H3N2)-like virus strain in H3N2, B/Phuket/3073/2013-like virus (B/Yamagata/16/88 lineage) strain in B (Y), and B/Colorado/06/2017-like virus (B/Victoria /2/87 lineage) strain in B (V).
Seroconversion: With 1:10 serum as the lowest dilution, those with HI antibody <1:10 before immunization and HI antibody titer ≥1:40 after immunization were considered to achieve seroconversion, or those with HI antibody ≥1:10 before immunization and 4-fold increase in HI antibody titer after immunization were considered to achieve seroconversion.
Seroconversion rate: the ratio of subjects who achieved HI antibody seroconversion after immunization; protection rate: the ratio of subjects who had HI antibody titer ≥ 1:40 after immunization.
The non-inferiority test was valid if the lower limit of the 95% CI of the antibody seroconversion rate difference (trial group - control group) was >-10%.
Please refer to [Adverse Reactions] for the safety data obtained in the above clinical trials.
[Storage] Store and transport at 2-8 °C, protected from light.
[Packing] Pre-filled syringe, 1 syringe/box.
[Shelf life] 12 months.
[Executive Standard] YBS00362023
[Approval Number] GYZZS20230029
[Marketing Authorization Holder]
Name: Ab&B Bio-Tech Co., Ltd. JS
Registered address: No. 32, Xinglin Road, Medical Hi-Tech Zone, Taizhou, Jiangsu, China
Zip code: 225300
Phone: 4006080059
Fax: 0523-82205726
Website: http://www.abbbio.com
[Manufacturer]
Name: Ab&B Bio-Tech Co., Ltd. JS
Production address: No. 32, Xinglin Road, Medical Hi-Tech Zone, Taizhou, Jiangsu, China
Zip code: 225300
Phone: 4006080059
Fax: 0523-82205726
Website: http://www.abbbio.com
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E-mail:haixin.zhang@yitherbiotech.com
Add:No. 32, Xinglin Road, Medical High-tech Zone, Taizhou City
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