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NEW ZEALAND DATA SHEET
Mencevax ACWY
Serogroups A, C, W-135 and Y polysaccharide meningococcal vaccine
Presentation(s)
Mencevax ACWY is a lyophilized preparation of purified polysaccharides from Neisseria
meningitidis (meningococcus) of serogroups A, C, W-135 and Y.
Mencevax ACWY is presented as a white pellet in a glass vial. The sterile diluent is clear and
colourless and presented in a glass vial, pre-filled syringe or ampoule.
Mencevax ACWY meets the World Health Organisation requirements for biological substances and
for meningococcal meningitis vaccines.
Each 0.5 ml dose of reconstituted vaccine contains 50 µg of each of the polysaccharide of
serogroups A, C, W-135 and Y.
Indications
Mencevax ACWY is indicated for active immunisation of adults and children over two years against
meningococcal meningitis caused by serogroup A, serogroup C, serogroup W-135 and serogroup
Y meningococci. The vaccine may also be used for:
• Subjects who are close contacts of patients with disease caused by meningococci of
serogroups A, C, W-135 and Y.
• Travellers to countries where the disease is epidemic or highly endemic.
• Controlling epidemics of infection caused by serogroups A, C, W-135, Y meningococci in
confined communities.
Mencevax ACWY is not recommended for use in infants and children under two years of age, as
antigenicity of the vaccine is low in this age group and antibodies persist for shorter duration.
Dosage and Administration
Mencevax ACWY should be reconstituted only with the sterile diluent supplied by adding the entire
contents of the diluent vial/ampoule/syringe to the vaccine vial. The reconstituted vaccine should
be inspected for any foreign particulate matter and/or colouration (other than a possible slight pink
cloudiness) prior to administration. In the event of either being observed, discard the vaccine. The
vaccine pellet should be completely dissolved in the diluent.
The reconstituted vaccine should be administered subcutaneously with a sterile syringe and
needle. For adults and children over 2 years, one dose of vaccine is contained in 0.5 ml.
Mencevax ACWY should under no circumstances be administered intravascularly.
Contraindications
Mencevax ACWY should not be administered to subjects with known hypersensitivity to any
component of the vaccine or to subjects having shown signs of hypersensitivity after previous
administration of Mencevax ACWY.
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Warnings and Precautions
As with other vaccines, the administration of Mencevax ACWY should be postponed in subjects
suffering from acute severe febrile illness. However, the presence of a minor infection, such as a
cold, should not result in the deferral of vaccination.
Mencevax ACWY will only confer protection against Neisseria meningitidis serogroups A, C, W135 and Y. As for any vaccine, complete protection cannot be guaranteed in every vaccinated
individual. An adequate immune response may not be elicited in patients receiving
immunosuppressive treatment or patients with immunodeficiency.
As with all injectable vaccines, appropriate medical treatment should always be readily available
for treatment in case of anaphylactic reactions following the administration of the vaccine.
Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response
to the needle injection. It is important that procedures are in place to avoid injury from faints.
Vaccination should be preceded by a review of the medical history (especially with regard to
previous vaccination and possible occurrence of undesirable events) and a clinical examination.
Re-vaccination with serogroup C polysaccharide containing vaccines may induce lower antibody
responses to meningococcal serogroup C polysaccharide compared to primary vaccination.
In subjects remaining at high risk of exposure to meningococcal disease caused by serogroups A,
C, W-135 and Y, re-vaccination should be considered according to official recommendations (see
section “Further Information”).
Mencevax ACWY should under no circumstances be administered intravascularly.
Interactions
Use with other vaccines
Mencevax ACWY can be administered at the same time as other vaccines.
The other injectable vaccines should always be administered at a different injection site.
Use with systemic immunosuppressive medications
See section “Warnings and Precautions”.
Pregnancy and lactation
Pregnancy
Adequate human data on use during pregnancy and adequate animal reproduction studies are not
available. Mencevax ACWY should be used during pregnancy only when clearly needed and
when the possible advantages outweigh the possible risks for the foetus.
Lactation
Adequate data on the administration of Mencevax ACWY to women who are breast-feeding are not
available. However, as with other polysaccharide vaccines, one does not expect vaccination with
Mencevax ACWY to harm the mother or the infant. Mencevax ACWY should be administered to
women who are breast-feeding when needed and the possible advantages outweigh the possible
risks.
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Effects on ability to drive and use machines
There have been no studies to investigate the effect of Mencevax ACWY on driving performance
or the ability to operate machinery. Further, a detrimental effect on such activities cannot be
predicted from the pharmacology of the active substance. Nevertheless, the clinical status of the
patient and the adverse event profile of Mencevax ACWY should be borne in mind when
considering the patient's ability to perform tasks that require judgement, motor or cognitive skills.
Adverse Effects
The safety profile presented below is based on data from clinical studies. Adverse reactions
occurring during these studies were mostly reported within 48 hours following vaccination.
Frequencies are reported as:
Very common: ≥ 1/10
Common: ≥ 1/100 to < 1/10
Uncommon: ≥ 1/1000 to < 1/100
Rare: ≥ 1/10000 to < 1/1000
Very rare: < 1/10000
Metabolism and nutrition disorders:
Common: decreased appetite
Psychiatric disorders:
Very common: irritability
Nervous system disorders:
Very common: somnolence, headache
Uncommon: dizziness, hypoaesthesia
Gastrointestinal disorders:
Common: gastrointestinal symptoms e.g. nausea, vomiting and diarrhoea
Musculoskeletal and connective tissue disorders:
Common: myalgia
General disorders and administration site conditions:
Very common: pain and redness at the injection site, fatigue
Common: swelling at the injection site, fever
Uncommon: injection site anaesthesia and injection site haematoma
In addition, the following adverse reactions have been reported during post-marketing surveillance:
Immune system disorders
Allergic reactions, including anaphylactic and anaphylactoid reactions
Skin and subcutaneous tissue disorders
Urticaria, rash, angioneurotic oedema
Musculoskeletal and connective tissue disorders
Arthralgia, musculoskeletal stiffness
General disorders and administration site conditions
Influenza-like symptoms, chills
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Overdose
Cases of overdose (up to 10 times the recommended dose) have been reported during postmarketing surveillance. Adverse events reported following overdosage were similar to those
reported with normal vaccine administration.
Further Information
Pharmacodynamic properties
Immunogenicity data
Mencevax ACWY induces the production of bactericidal antibodies against meningococci of the
serogroups A, C, W-135 and Y.
Immunogenicity was measured with a serum bactericidal assay using rabbit complement (rSBA).
The percentage of subjects with bactericidal antibody titres ≥ 1:8 is considered as an immunologic
correlate for protective efficacy against meningococcal serogroups A, C, W-135 and Y.
The immunogenicity of one dose of Mencevax ACWY has been evaluated in studies involving
more than 2200 subjects aged 2 years and above.
The vaccine response was defined in subjects as:
•
rSBA titres ≥ 32 for initially seronegative subjects (i.e. pre-vaccination rSBA titre < 8)
•
at least a 4-fold increase in rSBA titres from pre- to post-vaccination for initially seropositive
subjects (i.e. pre-vaccination rSBA titre ≥ 8)
Immunogenicity in children aged 2-10 years
In clinical study MenACWY-TT-038, the immune response to vaccination with one dose of
Mencevax ACWY was evaluated one month after vaccination. The results obtained in this clinical
study for all seroroups are summarised in the table below:
Table 1: Bactericidal antibody responses (rSBA*) to Mencevax ACWY in children aged 2-10 years
1 month after vaccination
Serogroup
N
Mencevax ACWY
VR
GMT
(95%CI)
(95%CI)
A
192
64.6%
(57.4; 71.3)
2283
(2023; 2577)
C
234
89.7%
(85.1; 93.3)
1317
(1043; 1663)
W-135
236
82.6%
(77.2; 87.2)
2158
(1815; 2565)
4
Y
240
68.8%
(62.5; 74.6)
2613
(2237; 3052)
The analysis of immunogenicity was conducted on the according-to-protocol (ATP) cohort for
immunogenicity.
VR: Vaccine Response
GMT: Geometric Mean Titre
* tested at GSK laboratories
Immunogenicity in adolescents aged 11-17 years and adults aged 18-55 years
In two clinical studies, conducted in adolescents 11-17 years of age (study MenACWY-TT-036)
and in adults 18-55 years of age (study MenACWY-TT-035), the immune response to vaccination
with one dose of Mencevax ACWY was evaluated one month after vaccination. The results
obtained in those clinical studies for all serogroups are summarised in the table below:
Table 2: Bactericidal antibody responses (rSBA*) to Mencevax ACWY in adolescents aged 11-17
years and adults aged 18-55 years 1 month after vaccination
Mencevax ACWY
Study
Serogrou
VR
GMT
(Age range)
p
N
(95%CI)
(95%CI)
77.5%
2947
A
191
(70.9; 83.2)
(2612; 3326)
96.7%
8222
C
211
(93.3; 98.7)
(6807; 9930)
Study MenACWY-TT-036
(11-17 years)
87.5%
2633
W-135
216
(82.3; 91.6)
(2299; 3014)
78.5%
5066
Y
219
(72.5; 83.8)
(4463; 5751)
69.8%
2127
A
252
(63.8; 75.4)
(1909; 2370)
92.0%
7371
C
288
(88.3; 94.9)
(6297; 8628)
Study MenACWY-TT-035
(18-55 years)
85.5%
2461
W-135
283
(80.9; 89.4)
(2081; 2911)
78.8%
4314
Y
288
(73.6; 83.4)
(3782; 4921)
The analysis of immunogenicity was conducted on ATP cohorts for immunogenicity.
VR: Vaccine Response
GMT: Geometric Mean Titre
* tested in GSK laboratories
Immunogenicity in adults aged ≥ 56 years
In clinical study MenACWY-TT-085, the immune response to vaccination with one dose of
Mencevax ACWY was evaluated one month after vaccination. The results obtained for all
serogroups are summarised in the table below:
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Table 3: Bactericidal antibody responses (rSBA*) to Mencevax ACWY in adults aged ≥ 56 years 1
month after vaccination
Serogrou
p
N
A
60
C
66
W-135
62
Y
64
Mencevax ACWY
VR
(95%CI)
73.3
(60.3;83.9)
74.2
(62.0;84.2)
77.4
(65.0;87.1)
76.6
(64.3;86.2)
GMT
(95%CI)
2840
(2062; 3911)
4815
(2827; 8201)
1838
(1135; 2979)
3932
(2726; 5670)
The analysis of immunogenicity was conducted on ATP cohort for immunogenicity.
VR: Vaccine Response
GMT: Geometric Mean Titre
* tested at GSK laboratories
Immunogenicity in high risk population
According to data reported in the literature, studies conducted among late complement component
deficient subjects (LCCD) (N=31) and subjects after Bone Marrow Transplant (BMT) (N=44)
demonstrated that vaccination with Mencevax ACWY elicited a satisfactory immune response. In
LCCD patients, geometric mean concentrations (GMCs) of 26.8µg/ml for MenA, 19.2 µg/ml for
MenC, 16.4 µg/ml for MenW-135 and 30.7 µg/ml for MenY were observed at 13 weeks after
vaccination. In BMT patients, 62% to 84% of subjects had anti-polysaccharide A concentrations ≥
2.0 µg/ml and 76% to 84% of subjects had anti-polysaccharide C concentrations ≥ 2.0 µg/ml one
month after vaccination.
Efficacy data
In response to a meningococcal disease epidemic in Burkina Faso, a mass vaccination campaign
with Mencevax ACWY was performed in more than 1.68 million children and adults aged from 2 to
29 years. Following this mass vaccination campaign 32 cases of meningitis due to Neisseria
meningitidis serogroup A and 3 cases of meningitis due to Neisseria meningitidis serogroup W-135
were reported.
Persistence of immune response
The persistence of the immune response elicited by Mencevax ACWY was evaluated up to 5 years
after vaccination in adolescents and adults aged 11-55 years primed in study MenACWY-TT-015.
The results obtained up to 5 years for all serogroups are summarised in the table below:
Table 4: 1 month post-vaccination and 5 year persistence data (rSBA*) in adolescents and adults
as vaccination
Serogroup
Time-point**
Mencevax ACWY
N
rSBA* ≥1:8
6
GMT
(95%CI)
(95%CI)
Month 1
19
100%
(82.4-100)
1463
(886-2415)
Year 1
19
84.2%
(60.4-96.6)
218
(71.0-670)
Year 2
98
91.8%
(84.5-96.4)
386
(259-574)
Year 4
107
Year 5
105
73.8%
(64.4-81.9)
74.3%
(64.8-82.3)
105
(67.6-164)
104
(67.8-158)
Month 1
18
100%
(81.5-100)
8071
(4897-13302)
Year 1
17
94.1%
(71.3-99.9)
1957
(732-5233)
Year 2
99
86.9%
(78.6-92.8)
286
(182-451)
Year 4
107
Year 5
104
84.1%
(75.8-90.5)
71.2%
(61.4-79.6)
315
(197-504)
142
(85.3-238)
Month 1
17
76.5%
(50.1-93.2)
882
(151-5154)
Year 1
18
66.7%
(41.0-86.7)
120
(23.6-614)
Year 2
100
24.0%
(16.0-33.6)
6.5
(4.2-10.0)
Year 4
107
Year 5
105
25.2%
(17.3-34.6)
24.8%
(16.9-34.1)
11.3
(7.8-16.3)
11.7
(7.9-17.1)
Month 1
12
100%
(73.5-100)
2663
(1822-3892)
Year 1
12
50.0%
(21.1-78.9)
22.3
(3.4-146)
Year 2
100
44.0%
(34.1-54.3)
19.4
(11.4-33.0)
Year 4
107
Year 5
105
43.9%
(34.3-53.9)
44.8%
26.0
(16.6-40.7)
29.6
A
C
W-135
Y
7
(35.0-54.8)
(18.7-46.7)
GMT: Geometric Mean Titre
*rSBA testing performed at Public Health England (PHE) laboratories in UK
**Month 1, Year 1 and Year 2: the analysis of immunogenicity was performed post-hoc following testing of
available samples with PHE rSBA
Year 4: the analysis of immunogenicity was conducted on the ATP cohort for persistence
Year 5: the analysis of immunogenicity was conducted on the Total Cohort for persistence
In contrast to the observed rSBA-MenA persistence, limited data showed a waning of serum
bactericidal antibody titres against serogroup A one year post-vaccination when using human
complement in the assay (hSBA). The clinical relevance of the waning of hSBA-MenA antibody
titres is unknown.
Pharmacokinetic properties
Evaluation of pharmacokinetic data is not required for vaccines.
Preclinical safety data
Not applicable.
Pharmaceutical Precautions
Excipients
Powder: sucrose, trometamol
Diluent: sodium chloride, water for injections
Special precautions for storage
o
o
The lyophilised vaccine should be stored in a refrigerator between 2 C and 8 C. The diluent can
be stored at ambient temperatures.
After reconstitution, the vaccine should be injected promptly or kept in a refrigerator. If not used
within 8 hours, it should be discarded because of the risk of contamination. It is recommended to
protect the reconstituted vaccine from direct sunlight.
When supplies of Mencevax ACWY are distributed from a central cold-store, it is good practice to
arrange transport under refrigerated conditions, particularly in hot climates.
Additional information on stability
Experimental data show that the powder is stable at 37°C for 1 week. However, these data are not
recommendations for storage.
Shelf life
The expiry date of the vaccine is indicated on the label and packaging. When stored under
o
o
prescribed conditions of temperatures between 2 C and 8 C the shelf-life is 3 years.
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other
medicinal products.
Medicine Schedule
Prescription Medicine.
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Package Quantities
Monodose vials. A container of sterile diluent is supplied for reconstitution of the lyophilized
vaccine.
Sponsor Details
Pfizer New Zealand Limited
P O Box 3998
Auckland, New Zealand, 1140.
Toll Free Number: 0800 736 363
Date of Preparation
20 January 2016
Version 8.0
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