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Meningococcal Vaccine (Menactra)
Meningococcal
(Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
FOR
INTRAMUSCULAR INJECTION
%20Effectiveness,%20Safety%20&%20Who%20Needs%20It.png "Meningococcal Vaccine (Menactra) Effectiveness, Safety & Who Needs It")
INDICATIONS AND USAGE
Menactra®,
a Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine, is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. Menactra is approved for use in individuals 9 months through 55 years of age. Menactra does not prevent N meningitidis serogroup B disease.
DOSAGE AND ADMINISTRATION
Preparation for Administration
Menactra is a clear to
slightly turbid solution, parenteral drug products should be inspected visually
for particulate matter and discoloration prior to administration, whenever
solution and container permit. If any of these conditions exist, the vaccine
should not be administered.
Withdraw the 0.5 ml
dose of vaccine from the single-dose vial using a sterile needle and syringe.
Dose and Schedule
Menactra is administered
as a single 0.5 ml dose by intramuscular injection preferably in the
anterolateral thigh or deltoid region depending on the recipient's age and
muscle mass.
Do not administer this
product intravenously or subcutaneously.
Primary Vaccination:
• In children 9 through
23 months of age, Menactra is given as a 2-dose series at least three months
apart.
• Individuals 2 through
55 years of age, Menactra is given as a single dose.
Booster Vaccination:
• A single booster dose
may be given to individuals 15 through 55 years of age at continued risk for
meningococcal disease, if at least 4 years have elapsed since the prior dose.
DOSAGE FORMS AND STRENGTHS
Menactra is a solution
supplied in 0.5 mL single-dose vials.
CONTRAINDICATIONS
Hypersensitivity
Severe allergic
reaction (e.g., anaphylaxis) after a previous dose of a meningococcal capsular
polysaccharide-, diphtheria toxoid-or CRM197-containing vaccine, or to any
component of Menactra [see DISCRIPTION]
Febrile or Acute Disease
Vaccination should be
postponed in case of febrile or acute disease that is moderate or severe.
However, a minor febrile or non-febrile illness, such as mild upper respiratory
infection, is not usually a wild reason to postpone immunization.
WARNINGS AND PRECAUTIONS
Guillain-Barre Syndrome
Persons previously
diagnosed with Guillain-Barre syndrome (GBS) may be at increased risk of GBS
following receipt of Menactra. The decision to give Menactra should take into
account the potential benefits and risks.
GBS has been reported
in temporal relationships following the of administration Menactra. The risk of GBS
following Menactra vaccination was evaluated in a post-marketing retrospective
cohort study [see Post-Marketing Experience, Post-Marketing Safety Study].
Preventing and Managing Allergic Vaccine
Reactions
Before administration, the healthcare provider should review the immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions to assess benefits and risks. Epinephrine and other
appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.
Thrombocytopenia or Bleeding Disorders
Menactra has not been
evaluated in persons with thrombocytopenia or bleeding disorders. As with any
other vaccine administered intramuscularly, the vaccine risk versus benefit for
persons at risk of hemorrhage following intramuscular injection must be
evaluated.
Altered Immunocompetence
·
Reduced Immune Response
Some individuals with
altered Immunocompetence, including some individual receiving immunosuppressant
therapy, may have reduced immune responses to Menactra.
· Complement Deficiency
Persons with certain
complement deficiencies and persons receiving treatment that inhibits terminal
complement activation (for example, eculizumab) are e at increased risk for
invasive disease caused by meningitidis, including invasive disease caused by
serogroups A, C, Y and W-135, even if they develop antibodies following
vaccination with Menactra [see CLINICAL PHARMACOLOGY)
Limitations of Vaccine Effectiveness
Menactra may not protect all recipients.
Syncope
Syncope (fainting) has
been reported following vaccination with Menactra. Procedures should be in
place to prevent falling injury and manage syncopal reactions.
Adverse REACTIONS
Clinical Trials Experience
Because clinical trials
are conducted under widely varying conditions, adverse reaction rates observed
in the clinical trials of a vaccine cannot be directly compared to rates in the
clinical trials of another vaccine and may not reflect the rates observed in
practice.
Children 9 through 12 Months of Age
The safety of Menactra
was evaluated in four clinical studies that enrolled 3721 participants who
received Menactra at and 12 months of age 2 months of age, these children also
received one or more other vaccines [Measles, Mumps Rubella and Varicella Virus
Vaccine Live (MMRV) or Measles, Mumps, and Rubella Virus Vaccine (MMR) and
Varicella Virus Vaccine Live (V); Pneumococcal 7-valent Conjugate Vaccine
(Diphtheria CRM197 Protein) (PCV7); Hepatitis A Vaccine (HepA)]. A control
group of 997 children was enrolled at 12 months of age and received two or more
childhood vaccines [MMRV (or MMR + V), PCV7, HepA] at 12 months of age [see
Concomitant Vaccine Administration). Three percent of individuals received MMR
and V, instead of MMRV, at 12 months of age.
The primary safety
study was a controlled trial that enrolled 1256 children who received Menactra
at 9 and 12 months of age. At 12 months of age, these children received MMRV
(or MMR + V), PCV7, and HepA. A control group of 522 children received MMRV,
PCV7, and HepA. Of the 1778 children, 78% of participants (Menactra, N=1056;
control group, N=322) were enrolled at United States (US) sites and 22% at a
Chilean site (Menactra, N=200; control group, N=200).
Individuals 2 through 55 Years of Age
The safety of Menactra
was evaluated in eight clinical studies that enrolled 10,057 participants aged
2-55 years who received Menactra and 5266 participants who received Mernomune®
- A/CX/W-135, Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135
Combined. There were no substantive differences in demographic characteristics
between the vaccine groups. Among Menactra recipients, 2-55 years of age 240%,
16.2%, 40.4%, and 19.4% were in the 2-10, 11-14, 15-25 and 26-55-year age
groups, respectively. Among Menomune-A/C/Y/W-135 recipients 2-55 years of age
42.3%, 9.3%, 30.0%, and 18.5% were in the 2-10, 11-14, 15-25 and 26-55-year age
groups, respectively. The three primary safety studies were randomized,
active-controlled trials that enrolled participants 2-10 years of age, 11-18
years of age, and 18-55 years of age, respectively. Of the 3232 children 2-10
years of age, 68% of participants were enrolled at US sites and 32% of
participants at a Chilean site. The median ages in the Chilean and US
subpopulations were 5 and 6 years, respectively. All adolescents and adults
were enrolled at US sites. As the route of administration differed for the two
vaccines (Menactra given intramuscularly, Menomune - A/C/Y/W-135 given
subcutaneously), study personnel collecting the safety data differed from
personal administering the vaccine.
Booster Vaccination Study
In an open-label trial
conducted in the US, 834 individuals were enrolled to receive a single dose of
Menactra 4-6 years after a prior dose. The median age of participants was 17.1
years at the time of the booster dose.
Safety Evaluation
Participants were
monitored after each vaccination for 20 or 30 minutes for immediate reactions,
depending on the study.
Solicited injection
site and system reaction were recorded in a diary cart for 7 consecutive days
after each vaccination. Participants were monitored for 28 days (30 days for
infants and toddlers) for unsolicited adverse events and for 6 months post-vaccination
visits to an emergency room, unexpected visits to a physician, and serious
adverse events (SAEs) . Information regarding adverse events that occurred in
the 6-month post-vaccination time period was obtained via a scripted telephone
interview.
Serious Adverse Events in All Safety Studies
Serious adverse events
were reported during a 6-month time period follow vaccinations in individuals 9
months) through 55 years of age. In children 2-10 years of age, SAEs occurred
at a rate of 2.0% 2.5%. In participants who received one or more childhood
vaccine(s) (without out co-administration of Menactra) at 9 at 12 months of age,
SAEs occurred at a rate of 0.6%, depending on the number and type of vaccines
received. In adolescents 11 through 18 years of age and adults 18 through 55
years of age, SAES occurred at rates of 1.0% following Menactra and at a rate
of 1.3% following Menomune -A/C/Y/W-135.
Solicited Adverse Events in the Primary Safety
Studies
The most frequently
reported solicited injection site and systemic adverse reactions within 7 days
following vaccination in children 9 months and 12 months of age were injection
site tenderness and irritability.
The most frequently
reported solicited local and systemic adverse reactions in US children aged
2-10 years were injection site pain and irritability. Diarrhea, drowsiness, and
anorexia were also common. The most commonly reported solicited injection site
and systemic adverse reactions in adolescents, ages 11-18 years, and adults,
ages 18-55 years, after a single dose were injection site pain, headache, and
fatigue. Except for redness in adults, injection site reactions were more
frequently reported after Menactra vaccination than after Menomune -
A/C/Y/W-135 vaccination.
Solicited Adverse Events in a Booster Vaccination Study
For a description of
the study design and number of participants, [see Clinical Trials Experience,
Booster Vaccination Study]. The most common solicited injection site and
systemic reactions within 7 days of vaccination were pain (60.2%) and myalgia
(42.8%), respectively. Overall rates of solicited injection site reactions and
solicited systemic reactions were similar to those observed in adolescents and
adults after a single Menactra dose. The majority of solicited reactions were
grade 1 or 2 and resolved within 3 days.
Adverse Events in Concomitant Vaccine Studies
Solicited Injection Site and Systemic Reactions
When Given With Other Pediatric Vaccines
For a description of
the study design and number of participants (see Clinical Trials Experience,
Concomitant Vaccine Administration]. In the primary safety study, 1378 US
children were enrolled to receive Menactra alone at 9 months of age and
Menactra plus one or more other routinely administered vaccines (MMRV, PCV7,
and HepA) at 12 months of age (N=961). Another group of children received two
or more routinely administered vaccines (MMRV, PCV7, and HepA vaccines)
(control group, N=321) at 12 months of age. Participants who received Menactra
and the concomitant vaccines at 12 months of age described above reported
similar frequencies of tenderness, redness, and swelling at the Menactra
injection site and at the concomitant vaccine injection sites. Tenderness was
the most frequent injection site reaction (48%, 39%, 46%, and 43% at the
Menactra, MMRV, PCV7, and HepA sites, respectively). Irritability was the most
frequent systemic reaction, reported in 62% of recipients of Menactra plus
concomitant vaccines, and 65% of the control group, [See Concomitant Vaccine
Administration.]
In a randomized,
parallel group, US multi-center clinical trial conducted in children 4 through
6 years of age, Menactra was administered as follows: 30 days after concomitant
DAPTACEL®, Diphtheria and Tetanus Toxoids and Acellular Pertussis VaccineAdsorbed, (DTaP), manufactured by Sanofi Pasteur Limited + IPOL®, Poliovirus
Vaccine Inactivated (IPV), manufactured by Sanofi Pasteur SA [Group A);
concomitantly with DAPTACEL followed 30 days later by IPV [Group B);
concomitantly with IPV followed 30 days later by DAPTACÉL [Group C). Solicited
injection site and systemic reactions were recorded in a diary card for 7
consecutive days after each vaccination. For all study groups, the most
frequently reported solicited local reaction at the Menactra site was pain:
52.2%, 60.9% and 56.0% of participants in Groups A, B and C, respectively. For
all study groups, the most frequently reported systemic reaction following the
administration of Menactra alone or with the respective concomitant vaccines
was myalgia: 24.2%, 37.3% and 26.7% of participants in Groups A, B and C,
respectively. Fever >39.5°C occurred at <1.0% in all groups. [See
Concomitant Vaccine Administration.]
Solicited Injection Site and Systemic Reactions
When Given With Tetanus and Diphtheria Toxoid Adsorbed Vaccine (Td)
In a clinical study,
rates of local and systemic reactions after Menactra and Tetanus and Diphtheria
Toxoid Adsorbed (Td) vaccine manufactured by Sanofi Pasteur Inc. were compared
[see Drug Interactions and Concomitant Vaccine Administration for study
description). Injection site pain was reported more frequently after Td
vaccination than after Menactra vaccination (71% versus 53%). The overall rate
of systemic adverse events was higher when Menactra and Td vaccines were given
concomitantly than when Menactra was administered 28 days after Td vaccine (59%
versus 36%). In both groups, the most common reactions were headache (Menactra
+ Td vaccine, 36%; Td vaccine + Placebo, 34%; Menactra alone, 22%) and fatigue
(Menactra + Td vaccine, 32%; Td vaccine + Placebo, 29%; Menactra alone, 17%).
Fever ≥40.0°C occurred at ≤0.5% in all groups.
Solicited Injection Site and Systemic Reactions
When Given With Typhoid VI Polysaccharide Vaccine
In a clinical study,
rates of local and systemic reactions after Menactra and Typhim Vi® [Typhoid Vi
Polysaccharide Vaccine) (Typhoid), produced by Sanofi Pasteur SA were compared
[see Drug Interactions and Concomitant Vaccine Administration] for a
description of the concomitantly administered vaccine, study design and number
of participants. More participants experienced pain after Typhoid vaccination
than after Menactra vaccination (Typhoid + Placebo, 76% versus Menactra +
Typhoid, 47%). The majority (70%-77%) of injection site solicited reactions for
both groups at either injection site were reported as Grade 1 and resolved
within 3 days post-vaccination. In both groups, the most common systemic
reaction was headache (Menactra + Typhoid, 41%; Typhoid Placebo, 42%; Menactra
alone, 33%) and fatigue (Menactra + Typhoid, 38%; Typhoid + Placebo, 35%;
Menactra alone, 27%). Fever ≥40.0°C and seizures were not reported in either
group.
Post-Marketing Experience
In addition to reports
in clinical trials, worldwide voluntary adverse events reports received since
market introduction of Menactra are listed below. This list indudes serious
events and/or events which were included based on severity frequency of
reporting or a plausible causal connection to Menactra. Because these events
were reported voluntarily from a population of uncertain size, it is not
possible to reliably estimate their frequency or establish a causal relationship
to vaccination.
Blood and Lymphatic System Disorders
Lymphadenopathy
Immune System Disorders
Hypersensitivity
reactions such as anaphylaxis/anaphylactic reaction, wheezing, difficulty
breathing, upper airway swelling, urticaria, erythema, pruritus, hypotension
Nervous System Disorders
Guillain-Barre
syndrome, paresthesia, dizziness convulsion, facial palsy, acute disseminated
encephalitis, transverse myelitis.
Musculoskeletal and Connective Tissue Disorders
Myalgia
General Disorders and Administrative Site
Conditions
Large injection site
reactions, extensive swelling of the injected limb (may be associated with
erythema, warmth, tenderness or pain at the injection site).
Post-Marketing Safety Study
The risk of GBS
following receipt of Menactra was evaluated in a US retrospective cohort study
using healthcare claims data from 9,578,688 individuals 11 through 18 years of
age, of whom 1,431,906 (15%) received Menactra. Of 72 medical chart-confirmed
GBS cases, none had received Menactra within 42 days prior to symptom onset. An
additional 129 potential cases of GBS could not be confirmed or excluded due to
absent or insufficient medical chart information. In an analysis that took into
account the missing data, estimates of the attributable risk of GBS ranged from
0 to 5 additional cases of GBS per 1,000,000 vaccines within the 6 week period
following vaccination.
DRUG INTERACTIONS
Concomitant Administration with Other Vaccines
Menactra was
concomitantly administered with Typhim Vi® [Typhoid Vi Polysaccharide Vaccine]
(Typhoid) and Tetanus and Diphtheria Toxoids Adsorbed, For Adult Use (Td)
vaccine, in individuals 18 through 55 and 11 through 17 years of age,
respectively. In children 4 through 6 years of age, Menactra was
co-administered with DAPTACEL, and in children younger than 2 years of age,
Menactra vaccine was co-administered with one or more of the following
vaccines: PCV7, MMR, V, MMRV, HepA, or Hib vaccine [see CLINICAL STUDIES and
ADVERSE REACTIONS].
When Menactra and
DAPTACEL are to be administered to children 4 through 6 years of age,
preference should be given to simultaneous administration of the 2 vaccines or
administration of Menactra prior to DAPTACEL; Administration of Menactra one
month after DAPTACEL has been shown to reduce meningococcal antibody responses
to Menactra. Data are not available to evaluate the immune response to Menactra
administered to younger children following DAPTACEL or to Menactra administered
to persons <11 years of age following other diphtheria toxoid-containing
vaccines [see CLINICAL STUDIES].
When Menactra was
administered concomitantly with PCV, antibody responses to 3 of the 7 serotypes
in PCV and to serogroup W-135 of Menactra did not meet the non-inferiority
criteria. Given the high antibody response rates to all PCV serotypes when
assessed by either ELISA or OPA, and considering that >81% of subjects
achieved SBA-HC antibody titers 21:8 for all 4 serogroups of Menactra, it is
unlikely that there will be any impact on the clinical efficacy of either of
these vaccines when administered concomitantly [see CLINICAL STUDIES -
Concomitant Vaccine Administration].
Do not mix Menactra
with other vaccines in the same syringe. When Menactra is administered
concomitantly with other injectable vaccines, the vaccines should be
administered with different syringes and given at separate injection sites.
Immunosuppressive therapies,
including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and
corticosteroids (used in greater than physiologic doses) may reduce the immune
response to vaccines.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Exposure Registry
There is a pregnancy
exposure registry that monitors pregnancy outcomes in women exposed to Menactra
during preg To enroll in nor obtain information about the registry, please send
an email to Sanofi Pasteur Pharmaco@sanofi.com or call Sanofi Pasteur at
1-800-822-2463.
Risk Summary
All pregnancies have a
risk of birth defect, or other adverse outcomes. In the US general population,
the estimated background risk of major birth defects and, miscarriage in
clinically recognized pregnancies is 2% to 4% and 15th the s respectively.
There are no adequate and well-controlle -controlled studies of Menactra
administration in pregnant women in US. Available data suggest that rates of
major birth defects and miscarriage in women who received Menactra 30 days prior
to pregnancy or during pregnancy are consistent with estimated background
rates.
A developmental
toxicity study was performed in female mice given 0.1 mL (in divided doses) of
Menactra prior to mating and during gestational (a single human dose is 0.5ml).
The study revealed no evidence of harm to the fetus due Menactra [see Animal
Data].
CLINICAL STUDIES
Efficacy
The serum bactericidal
assay (SBA) used to test sera contained an exogenous complement source that was
either human (SBA-1H) or baby rabbit (SBA-BR).
The response to
Menactra vaccination administered to children 9 months through 10 years of age
was evaluated by the proportion of participants having an SBA-H antibody titer
of 1:8 or greater, for each serogroup. In individuals 11 through 55 years of
age, the response to Menactra vaccination was evaluated by the proportion of
participants with a 4-fold or greater increase in baseline bactericidal
antibody titers to each serogroup as measured by SBA-BR. For individuals 2
through 55 years of age, vaccine efficacy after a single dose was inferred from
the demonstration of Immunologic equivalence to a US-licensed meningococcal
polysaccharide vaccine, Menomune-A/C/Y/M vaccine as assessed by SEA
Immunogenicity
Immunogenicity in Children 9 through 23 Months
of Age
In a randomized, US,
multi-center trial, children received Menactra at 9 months and 12 months of
age. The first Menactra dose was administered alone, followed by a second
Menactra dose given alone (N=404), or with MMRV (N=302), or With PCV7 (N=422).
For all participants, sera were obtained approximately 30 days after last
vaccination. There were no substantive differences in demographic
characteristics between the vaccine groups. The median age for administration
of the first dose of Menactra was approximately 9 months. In the primary
immunogenicity study, children received Menactra at 9 and 12 months of age, the
majority of the participants in groups that received the second dose of
Menactra alone or with concomitant pediatric vaccine(s), achieved SBA-HC titers
21:8 for all serogroups. Groups that received the second dose of Menactra alone
had 291% of subjects achieving an SBA-HC titer 21:8 for serogroups A, C, and Y
and ≥86% for serogroup W-135. When the second dose of Menactra was given
concomitantly with MMRV (or MMRV+Hib) or with PCV, the percentages of subjects
with SBA-HC titers ≥1:8 were high (>90% for serogroups A, C, and Y and
>81% for serogroup W-135). SBA-HC geometric mean titers (GMTs) were high for
all serogroups.
An additional study
evaluating responses to a 2-dose series of Menactra administered at either 9
and 15 months or at 12 and 15 months of age was conducted. Following the second
dose of Menactra in the 9-15 months group, the percentages of participants with
hSBA titer ≥1:8 were high for all of the serogroups (>96% for C, Y and W-135
and >85.2% for strogroup A). Similar responses were observed in the 12-15
months group. The percentages of participants with an HSBA titer ≥1:8 were:
85.2% for A; 100.0% for Cand >96% for both Y and W-135 serogroups.
Immunogenicity in Individuals 2 through 55 Years
of Age
Immunogenicity was
evaluated in three comparative, randomized, US, multi-center, active controlled
clinical trials that enrolled children (2 through 10 years of age), adolescents
(11 through 18 years of age), and adults (18 through 55 years of age).
Participants received a single dose of Menactra (N=2526) or
Menomune-A/C/Y/W-135 (N=2317). For all age groups studied, sera were obtained
before and approximately 28 days after vaccination. [Blinding procedures for
safety assessments are described in ADVERSE REACTIONS section.]
In each of the trials,
there were no substantive differences in demographic characteristics between
the vaccine groups, between immunogenicity subsets or the overall study
population. In the study of children 2 through 10 years of age, the median age
of participants was 3 years: 95% completed the study. In the adolescent trial,
the median age for both groups was 14 years; 99% completed the study. In the
adult trial, the median age for both groups was 24 years, 94% completed the
study.
Immunogenicity in Children 2 through 10 Years of
Age
Of 1408 enrolled
children 2 through 10 years of age, immune responses evaluated by hSBA in a
subset of Menactra participants (2 through 3 years of age, N=52; 4 through 10
years of age, N=84) and Menomune-A/C/Y/W-135 partitipants (2 through 3 years of
age, N=53; 4 through 10 years of age, N=84), the percentages of subjects with a
titer 21:8 were constantly higher in the Menactra group for all four
serogroups.
In the evaluated subset
of participants 2 through 3 years of age, the percentage of participants with
an SBA-H titer 21:8 at Day 28 were 73%, Serogroup A: 63%, Serogroup C; 88%,
Serogroup Y; 63%, Serogroup W-135 in the Menactra group and 64%, Serogroup A;
38%, Serogroup C; 73%, Serogroup Y; and 33%, Serogroup W-135 in the
Menomune-A/C/Y/W-135 group.
In the evaluated subset
of participants 4 through 10 years of age, the percentage of participants with
an SBA-H titer 21:8 at Day 28 were 81%, Serogroup A: 79%, Serogroup C; 99%,
Serogroup Y; 85%, Serogroup W-135 in the Menactra group and 55%, Serogroup A;
48%, Serogroup C, 92%, Serogroup Y, and 79%, Serogroup W-135 in the
Menomune-A/C/Y/W-135 group.
Immunogenicity in Adolescents 11 through 18
Years of Age
Results from the
comparative clinical trial conducted in 881 adolescents (aged 11 through 18
years) showed that the immune responses to Menactra and Menomune-A/C/Y/W-135
were similar for all four serogroups.
The percentage of
participants with an SBA-BR titer with a 24-fold rise from the baseline were
93%, Serogroup A: 92%, Serogroup C: 82%, Serogroup Y; 97%, Serogroup W-135 in
the Menactra group and 92%, Serogroup A; 89%, Serogroup C 80%, Serogroup Y; and
95%, Serogroup W-135 in the Menomune -A/C/Y/W-135 group.
In participants with
undetectable pre-vaccination titers (ie, SBA-BR titers <1:8 at Day 0),
seroconversion rates (defined as the proportions of participants achieving a
24-fold rise in SBA-BR titers by Day 28) were similar between the Menactra and
Menomune-A/C/Y/W-135 recipients. Menactra participants achieved seroconversion
rates of: 100%, Serogroup A 99%, Serogroup C: 98%, Serogroup Y; 98%, Serogroup
W-135. The seroconversion rates for Menomune - A/C/Y/W-135 recipients were:
100%, Serogroup A: 99%, Serogroup C, 100%, Serogroup Y, 99%, Serogroup W-135.
Immunogenicity in Adults 18 through 55 Years of
Age
55 years showed that
the immune responses to Menactra and Menomune-A/C/Y/W-135 were similar for all
four serogroups.
Serogroup C: 79%,
Serogroup Y; and 94%, Serogroup W-135 in the Menomune-A/C/Y/W-135 group. The
percentage of participants with an SBA-BR titer with a 24-fold rise from the
baseline were 81%, Serogroup 89%, Serogroup C; 74%, Serogroup Y; and 89%,
Serogroup W-135 in the Menactra baup and 85%, Serogroup A; 90%,
In participants with
undetectable pre-vaccination titers (ie, SBA-BR titers <1:8 at Day 0),
seroconversion rates (defined as the proportions of participants achieving a
24-fold rise Menomune-A/C/Y/W-135 recipients. Menactra participants achieved
seroconversion rates Serogroup C; 91%, Serogroup Y; in SBA-BR titers by y Day
28) were similar between the Menactra and 97%, Serogroup W-135. The
seroconversion on rate or Menomune - A/C/Y/W-135 Percipients were: 99%,
Serogroup A; 98%, Serogroup C, 97%, Serogroup Y; and 99%, Serogroup W-135. of:
100%, Serogroup A; 99%, serogroup C.
Immunogenicity in Adolescents and adults
Following Booster Vaccination
For a description of
the study design and number of participants, (see Clinical Trials Experience,
Booster Vaccination Study]. Prior to revaccination, the percentage of participants
(n=781) with an SBA-H titer 21:8 were
64.5%, 44.2%, 38.7%, and 68.5% for Serogroups A, C, Y, and WJ5, respectively.
Among the subset of trial participants (n=112) for whom SBA-H responses at Day
6 were assessed, 86.6991.1%, 9. 94.6%, and 92.0% achieved a 24-fold rise in
SBA-H titer for Serogroups A, C, Y, and W-135, respectively. The proportions of
participants (n=781) who achieved a 24-fold rise in SBA-H titer by Day 28 were
95.0%, 95.3%, 97.1%, and 96% Serogroups A, C, Y, and W-135, respectively. The
proportions of participants who achieved an SBA-H titer ≥1:8 by Day 8 were
>99% for each serogroup.
Concomitant Vaccine Administration
MMRV (or MMR+V) or PCV7
In a US, active-controlled
trial, 1179 children received Menactra at 9 months and 12 months of age. At 12
months of age, these children received Menactra concomitantly with MMRV
(N=616), or MMR+V (N=48), or PCV7 (N=250), Another group of 12-month old
children received MMRV+P67 (N=485). Sera were obtained approximately 30 days
after the last vaccinations. Measles, mumps, rubella and d varicella antibody responses
among children who received Menactra and MMRV were comparable to corresponding
antibody responses among children who
received MMRV and PCV7. (or MMR and V)
When Menactra was given
concomitant with PCV7, the non-inferiority criteria for comparisons of
pneumococcal IgG geometric mean concentrations (GMCs) (upper limit of the
two-sided 95% CI of the GMC ratio ≤2) were not met for 3 of 7 serotypes (4, 6B,
18C). In a subset of participants with available sera, pneumococcal
opsonophagocytic assay GMT data were consistent with IgG GMC data.
Td Vaccine
In a double-blind,
randomized, controlled trial, 1021 participants aged 11 through 17 years
received Td vaccine and Menactra concomitantly (N=509), or Tb Vaccine followed
one month later by Menactra (N=512). Sera were obtained approximately 28 days
after each respective vaccination. The proportions of participants with a
4-fold or greater increase in SBA-BR titer to meningococcal Serogroups C, Y and
W-135 were higher when Menactra was given concomitantly with Td vaccine
(86%-96%) than when Menactra was given one month following Td vaccine
(65%-91%). Anti-tetanus and anti-diphtheria antibody responses were similar in
both study groups.
Typhim Vi
In a double-blind,
randomized, controlled trial, 945 participants aged 18 through 55 years
received Typhim Vi and Menactra concomitantly (N=469), or Typhim Vi followed
one month later by Menactra (N=476). Sera were obtained approximately 28 days
after each respective vaccination. The antibody responses to Menactra and to
Typhim Vi components were similar in both study groups.
DAPTACEL and IPV
In a randomized,
parallel group, US multi-center clinical trial conducted in children 4 through
6 years of age, Menactra was administered as follows: 30 days after concomitant
DTaP (DAPTACEL®, Sanofi Pasteur Limited) + IPV (IPOL®, Sanofi Pasteur SA)
[Group A); concomitantly with DAPTACEL followed 30 days later by IPV [Group B);
concomitantly with IPV followed 30 days later by DAPTACEL [Group C). Sera were
obtained approximately 30 days after each respective vaccination. [See Clinical
Trials Experience.]
When Menactra was
administered 30 days after DAPTACEL (and IPV) [Group A], significantly lower
SBA-H GMTs to all 4 meningococcal serogroups were observed compared to Menactra
(and IPV) administered 30 days before DAPTACEL [Group C). When Menactra was
administered concomitantly with DAPTACEL [Group B], SBA-H GMTs to meningococcal
serogroups A, C, and W-135 were non-interior to those observed after Menactra
(and IPV) [Group C). The non-inferiority criterion was marginally missed for
meringococcal serogroup Y. Non-inferiority of SBA-H GMTs following concomitant
administration of Menactra and DAPTACEL compared to those after concomitant
Menactra and IPV was concluded if the upper limit of the 2-sided 95% CI of (GMT
Group C divided by GMTGroup B) computed separately for each of the serogroups
was <2.
When Menactra was
administered concomitantly with DAPTACEL, antibody responses to three of the
pertussis antigens (pertussis toxin, filamentous hemagglutinin, and pertactin)
(GMCs), tetanus toxin (% participants with antibody concentrations 21.0 IU/mL),
and diphtheria toxin (% participants with antibody concentrations ≥1.0 IU/mL)
were non-inferior to those observed after DARTACEL and IPV. The pertussis
anti-fimbriae GMCs were marginally lower when Menactra and DAPTACEL were
administered concomitantly.
HOW SUPPLIED
Single-dose vial, 0.5
mL. Supplied as a package of 5 vials.
Single-dose vial, 0.5
mL. Supplied as a package of 1 vial.
STORAGE AND HANDLING
Store at 2° to 8°C (35°
to 46°F). DO NOT FREEZE. Product that has been exposed to freezing should not
be used. Do not uses after expiration date.
PATIENT COUNSELING INFORMATION
Prior to administration
of Menactra, the healthcare professional should inform the patient, parent,
guardian, or other responsible adult of the potential benefits and risks to the
patient (see ADVERSE REACTIONS and WARNINGS AND PRECAUTIONS], Patients, parents
or guardians should be instructed to report any suspected adverse reactions to
their healthcare professional who should report these events to Sanofi Pasteur
Inc.
MENACTRA® is a
registered trademark of Sanofi, its affiliates and subsidiaries. Product
Information as of June 2018.
Manufactured by:
Sanofi Pasteur Inc.
Swift Water PA 18370
USA
References
2. Rivero-Calle I, Raguindin PF, Gómez-Rial J, Rodriguez-Tenreiro C, Martinón-Torres F. Meningococcal Group B Vaccine For The Prevention Of Invasive Meningococcal Disease Caused By Neisseria meningitidis Serogroup B. Infect Drug Resist. 2019 Oct 9;12:3169-3188. doi: 10.2147/IDR.S159952. PMID: 31632103; PMCID: PMC6793463.
3. Rivero Calle I, Rodriguez-Tenreiro Sánchez C, Martinón-Torres F. Vacunas antimeningocócicas. Situación epidemiológica mundial y estrategias de prevención mediante la vacunación [Meningococcal vaccines. Global epidemiological situation and strategies for prevention by vaccination]. Enferm Infecc Microbiol Clin. 2015 Apr;33(4):257-67. Spanish. doi: 10.1016/j.eimc.2015.03.001. Epub 2015 Mar 18. PMID: 25795150.
4. Bechini A, Levi M, Boccalini S, Tiscione E, Balocchini E, Canessa C, Azzari C, Bonanni P. Impact on disease incidence of a routine universal and catch-up vaccination strategy against Neisseria meningitidis C in Tuscany, Italy. Vaccine. 2012 Oct 5;30(45):6396-401. doi: 10.1016/j.vaccine.2012.08.019. Epub 2012 Aug 23. PMID: 22921931.
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Very Informative
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