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HibACon

HibACon

Date approved: 2014-4-2
Instruction of Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine
Please read the instruction carefully and use under guidance of physician
Drug Names
Generic name: Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine
English name: Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine
Chinese Pinyin: A C Qun Naomoyanqiujun (Jiehe) b Xing Liuganshixueganjun (Jiehe) Lianhe Yimiao
Ingredients and Description
This product is made using purified polysaccharide of Neisseria meningitidis group A and C, polysaccharide of Haemophilus influenza type b, after covalent binding and purification with tetanus toxoid respectively, adding aluminium hydroxide adjuvant for absorption. It is manufactured as milky-white suspension, which should not contain insoluble massive substance after shaking.
Active substances: conjugate of Neisseria meningitidis group A polysaccharide and tetanus toxoid, conjugate of Neisseria meningitidis group C polysaccharide and tetanus toxoid, conjugate of Haemophilus influenza type b polysaccharide and tetanus toxoid
Excipients: aluminium hydroxide, sodium chloride
Object of Inoculation
This product is indicated for children 2 months through 71 months of age (prior to the 6th birthday)
Function and Use
The inoculation of the product can provoke humoral immune response thus can be used to the prevention of invasive disease caused by meningococcal groups A,C and Haemophilus influenza type b such as cerebrospinal meningitis, pneumonia, septicemia, epiglottitis etc. Yet this product cannot be used as preventions to infections caused by other pathogenic bacteria and diseases like meningitis and pneumonia caused by other reasons.
Specification
0.5 ml each dose/bottle per person. Contents of Meningococcal groups A, C polysaccharide, Haemophilus influenza type b polysaccharide should be not less than 10 mg respectively.
Vaccination Schedule and Dosage
1Upper arm deltoid muscle Intramuscular injection, 0.5 mL dose each person.
2Vaccination Schedule
1. Infants 2-5 months of age are recommended to receive three doses with intervals of one month each;
2. Infants 6-11 of age are recommended to receive two doses with intervals of one month each;
3. Toddlers 12-71 month of age are recommended to receive one dose.
Immune persistence study data this vaccine is not yet available, and thus it is so far not clear whether extra immunization is needed.
Adverse Reaction
Based on the clinical trials results(see detailsclinical trails) of over 900 test subjects that inoculated the vaccine, the possible adverse reactions are as following:
For the adverse reactions listed below, most common means incidence rate ≥10%;【commonmeans incidence rate between 1-10%(1% included); occasionalmeans incidence rate between 0.1-1%(0.1% included).
Local adverse reactions: injection site redness, swelling, induration and pain are common; blister and itching are occasional.
Systemic adverse reactions: fever is most commonIrritabilitydiarrhea, loss of appetite, vomiting, lacking in strength and rash are common.
Adverse reactions listed above are mainly mild and moderate, and digestive tract symptoms, apart from fever, are quite common, which usually happen within 24hours after inoculation and can disappear without treatment. Use symptomatic treatment when necessary and when symptoms that are not listed above happen, please contact the doctor in time.
Contraindications
(1) People who are allergic to any component of this vaccine, especially to tetanus toxoid.
(2) People who suffer from encephalopathy, uncontrolled seizures, convulsions and other progressive neurological diseases.
(3) People who have serious heart diseases, hypertension, hepatic diseases, renal diseases, active tuberculosis or is HIV-positive.
(4) People who have acute diseases, serious or in acute phase of chronic diseases, or having a fever.
Precautions
(1)      This product should be used with caution for people whose family or themself have a history of seizure, people who have chronic diseases or a history of epilepsy.
(2)      Shake well before use. Do not use the product in the case that there is insoluble massive substance after shaking or any crack in the container, or in the case that the product has a unclear label or is out of expiry date.
(3)      The immune effect may be hampered by the exercising of immunosuppressive therapy or injecting people who have immunodeficiency.
(4)      Adrenalin and other first aid medicine should be prepared at the vaccination place in case of serious allergic reaction. After vaccination, the people should not leave until having been observed for 30 minutes.
(5)      No clinical data about the vaccine inoculated with other vaccines is available, thus vaccination at the same time should be avoid. If necessary, inject at different sites.
(6)      In any case, the tetanus toxoid contained in the vaccine can not be used to replace regular tetanus toxoid in immunization.
(7)      Do not freeze.
Clinical Trials
Safety and immunogenicity trial on 1800 test subjects in the country has completed. The trial divides all subjects into three age groups: 2 - 5 months of age, 6 - 11 months of age and 12 - 71 months of age with number of subjects being 299, 300 and 299 respectively. Three age groups were injected 3, 2 and 1 dose of the vaccine respectively; the number of each age group in the control group is 300 and three age groups were injected 3, 2 and 1 dose of control vaccine respectively. After each injection, observe and collect adverse reactions within 30 minutes (right after injection) and within 30 days.
Venous blood samples of all subjects were taken before and 30-35 days after the whole vaccination to determine the bactericidal antibody titer against meningococcal groups A and C and the antibody concentration of haemophilus influenza type b. Bactericidal antibody titre was measured by rabbit complement taking the rise of antibody after immunization ≥1:8 or 4-fold as the standard of positive seroconversion and the antibody concentration of haemophilus influenza type b should be no less than 0.15 µg/ml and1µg/ml. In the meantime, add stratification analysis of two more group ≥1:128 and compare the bactericidal antibody titer against meningococcal groups A and C and the antibody GMT against haemophilus influenza type b of the two groups.
 Table 1 below is the antibody GMT or concentration and the antibody positive seroconversion rate of each age group after the whole immunization. The result is that after immunization with meningococcal groups A and C and haemophilus type b conjugate vaccine the positive seroconversion rates of both meningococcal groups A and C and haemophilus influenza type b are no less than 90%. All the comparisons made in the study conform to the non-inferiority hypothesis.
Table 1 Antibody responses to meningococcal groups A and C and haemophilus b after immunization. 
 
2 ~ 5 months
6 ~ 11 months
12 ~ 71 months
Test group
Control group
Test group
Control group
Test group
Control group
Antibody of meningococcal group A
N*=259
N=257
N=273
N=278
N=290
N=292
Positive seroconversion rates (%)
95%CI
100
100
99.63
99.64
97.93
97.26
/
/
97.98, 99.99
98.01,99.99
95.55,99.24
94.67,98.81
GMT 95%CI
185.18
178.12
158.43
172.21
139.54
139.09
163.68, 209.51
156.77, 202.39
136.98,183.24
149.44,198.46
122.92,158.42
124.28,155.66
Antibody of meningococcal group C
N=259
N=258
N=273
N=278
N=290
N=292
Positive seroconversion rate (%)
95%CI
92.66
95.35
99.27
98.56
97.93
97.95
88.78,95.53
92.02,97.57
97.38,99.91
96.36, 99.61
95.55,99.24
95.58, 99.24
GMT
95%CI
169.84
158.63
228.94
204.89
247.52
246.39
145.99, 197.57
138.13. 182.17
200.78,261.06
180.01,233.21
219.60,280.26
217.03,279.73
Antibody of haemophilus type b
N=259
N=258
N=273
N=278
N=290
N=292
≥0.15 g/ml(%)
95%CI
96.53
98.45
96.34
97.84
92.76
94.52
93.51, 98.40
96.08, 99.58
93.37,98.23
95.36,99.20
89.14,95.46
91.25,96.84
≥1.0 g/ml (%)
95%CI
95.75
98.45
95.97
97.84
92.76
94.52
92.53, 97.86
96.08, 99.58
92.90,97.97
95.36,99.20
89.14,95.46
91.25,96.84
GMC
95%CI
12.95
26.92
12.09
44.07
24.52
49.18
11.50,14.59
24.53,29.54
11.03,13.25
39.97,48.59
21.58,27.85
42.98,56.28
*N: number of test subjects.
Table 2 indicates adverse reactions happened within 30 minutes after injection; table 3 indicates all adverse reactions collected within 30 days after injection.
Table 2   Adverse reactions happened right after injection
 
Test group
Control group
Dose
Dose 1
Dose 2
Dose 3
Dose 1
Dose 2
Dose 3
Number of subjectsN
898
566
273
900
569
271
Fever
8.677
11.062
9.927
7.769
10.560
13.336
Injection site pain
0
0
0
0.11
0.21
0
Injection site redness
1.715
1.48
2.98
327
7.241
11.832
Injection site swelling
0
0
0.41
0.98
1.69
1.85
* 1. Test group was injected with the vaccine, the control group was injected at the same time meningococcal groups A and C polysaccharide conjugate vaccine and haemophilus influenza type b vaccine at different site.
2. In the brackets are number of cases of adverse reactions.
Table 3   Adverse reactions happened within 30 days after injection
 
Test group
Control group
Dose
Dose 1
Dose 2
Dose 3
Dose 1
Dose 2
Dose 3
Number of subjectsN
898
566
273
900
569
271
Number of location reactions
10.493
6.034
6.618
10.796
10.459
13.737
Rednessall
4.640
2.514
3.710
6.155
8.850
12.935
Third degree
0.11
0
0
0.65
1.16
4.412
Pain all
3.027
0
0.41
2.825
0.74
0
Third degree
0
0
0
0
0
0
Indurationall
2.220
1.911
1.54
1.816
1.27
1.13
Third degree
0
0
0
0
0
0
Swellingall
3.733
2.112
2.67
3.128
2.615
4.111
Third degree
0.11
0
0
0
0.42
0
Itchingall
0.44
0
0
0.22
0
0
Third degree
0
0
0
0
0
0
Number of systemic reactions
44.8402
45.1255
44.3121
42.8385
43.2246
45.0122
Rednessall
33.3299
36.9209
36.6100
31.3282
34.6197
36.9100
Third degree
1.09
0.42
1.13
0.98
1.16
0.41
Lacking in Strengthall
4.238
3.017
0.72
4.137
1.9211
0.72
Third degree
0
0
0
0
0
0
Irritationall
10.796
6.738
6.618
11.9107
6.537
5.214
Third degree
0
0
0
0
0
0
Diarrheaall
6.357
6.537
9.225
5.953
6.034
8.122
Third degree
0.22
0
0
0
0
0
Vomitingall
5.348
3.520
4.011
4.339
3.218
4.111
Third degree
0
0
0
0
0
0
Rashall
2.018
1.27
0.72
2.119
1.27
0.72
Third degree
0
0
0
0.11
0
0
Loss of appetiteall
6.962
5.129
4.813
5.953
5.632
5.214
Third degree
0
0
0
0.11
0
0
* 1.  In the brackets are number of cases of adverse reactions.
2. The classification of adverse reaction conforms to Guideline on the Classification Standard of Adverse Reactions of Prophylactic Vaccine in Clinical Trials issued by SFDA.
Systemic and local reactions of tests subjects are mainly mild and moderate with Third degree adverse reactions occur occasionally. No cases of 4th adverse reactions or serious adverse events have been observed in all test subjects.
Storage Store and transport between 2°C to 8°C, protected from light. Do Not Freeze.
Packagevial;  0.5 ml/ vial;  1 vial/ box.
Shelf life24 months
Quality criterionMeningococcal Groups A and C and Haemophilus b Conjugate Vaccine Manufacturing and Testing Procedures
Approval numberGYZZ No: 2014S00240
Manufacturer
Beijing Zhifei Luzhu Biopharmaceutical Co., Ltd.,
 
No.22 Tongji Beilu, Beijing Economic-Technological Development Area, China.
 
Post code: 100176
 
Tel: 01067870189
 
Fax: 01067870318