Protocol for Meningococcal Containing Vaccines
MenQuadfi®, Menveo®, Bexsero®, Trumenba®, and Penbraya™
Oregon Board of Pharmacy – For rulemaking purposes only v. 06/2024
1. What’s New
A. Meningococcal ABCWY vaccine, Penbraya™, was added as an alternative vaccine option for
individuals 10-25 years of age who are intending to receive both the MenACWY and MenB
vaccines at the same visit.
B. Menveo® dosage and administration updated for 1 and 2 vial presentations.
4
C. Menactra® has been removed from the market, all guidance related to Menactra® removed
from protocol.
2. Immunization Protocol
A. Administer a 0.5-mL dose, IM, of meningococcal vaccine according to age-appropriate
schedules and high-risk conditions.
B. Meningococcal ACWY vaccines are interchangeable when more than one brand is age-
appropriate.
1
C. Meningococcal B vaccines are not interchangeable. All doses of Meningococcal B must be of
the same brand of vaccine.
1
D. The MenACWY and MenB vaccines may be given simultaneously at different sites if
indicated.
1
Alternatively, patients intending to receive both MenACWY and MenB vaccines
at the same visit may instead receive the MenABCWY vaccine.
7
E. Meningococcal vaccines can be given with all other routinely recommended vaccines.
2
3. Vaccine Schedule
MenACWY Vaccines (MenQuadfi®, Menveo®) Schedule for Routine Use, Dose and Route –
0.5-mL, IM
Dose
Acceptable Age Range
Minimum Acceptable Spacing
1
11-18 years
Booster
16-18 years
8 weeks
MenACWY Vaccines (MenQuadfi®, Menveo®) Schedule for High-Risk Persons, Dose and
Route – 0.5-mL, IM
Dose
Acceptable Age Range
Minimum Acceptable Spacing
1
≥7 years
2
8 weeks if 2 doses indicated
Boosters
(if person
remains at
risk)
Aged <7 years at completion of primary series: Single dose at 3 years after
primary vaccination and every 5 years thereafter
Aged ≥7 years at completion of primary series: Single dose at 5 years after
primary vaccination and every 5 years thereafter
MenB Vaccines (Bexsero®, Trumenba®) Schedule for Healthy Persons*, Dose and Route –
0.5-mL, IM
Dose
Acceptable Age Range
Minimum Acceptable Spacing
1
16-23 years
2
28 days for Bexsero®, 6 months for
Trumenba®
*ACIP recommends a MenB series for persons aged 16–23 years (preferred age 16–18 years) on
the basis of shared clinical decision-making. See section 5 for guidance.
Protocol for Meningococcal Containing Vaccines
MenQuadfi®, Menveo®, Bexsero®, Trumenba®, and Penbraya™
Oregon Board of Pharmacy – For rulemaking purposes only v. 06/2024
MenB Vaccines (Bexsero®, Trumenba®) Schedule for High-Risk Persons, Dose and Route –
0.5-mL, IM
Dose
Acceptable Age Range
Minimum Acceptable Spacing
1
≥10 years
2
28 days
3*
4 months after dose 2
Boosters
(if person
remains at
risk)
Single dose at 1 year after completion of
primary vaccination and every 2–3 years
thereafter
*Dose 3 applies to Trumenba® only, not needed if dose 2 was administered at least 6 months
after dose 1. If dose 3 is administered earlier than 4 months after dose 2, a 4
th
dose should be
administered at least 4 months after dose 3.
MenABCWY Vaccines (Penbraya™) Schedule for Routine Use, Dose and Route – 0.5-mL, IM
Dose
Acceptable Age Range
Minimum Acceptable Spacing
1
10-25 years
2
6 months
*If a patient is receiving MenACWY and MenB vaccines at the same visit, MenABCWY may be given
instead. If a patient receives MenABCWY vaccine, which includes Trumenba
®
, then administer:
• Trumenba
®
for additional MenB dose(s) when MenACWY is not indicated
• Any MenACWY vaccine when MenB is not indicated
4. Licensed Vaccines
Product Name
Vaccine Components
Presentation
FDA
Approved
Age Range
Thimerosal
MenACWY-TT
3
(MenQuadfi®)
Neisseria meningitidis
serogroup A, C, W,
and Y capsular
polysaccharide
antigens that are
individually
conjugated to tetanus
toxoid protein
0.5-mL single-dose
vials
≥2 years
None
MenACWY-CRM
4
(Menveo®)
Neisseria meningitidis
serogroup A, C, Y, and
W-135
oligosaccharides
conjugated
individually to
Corynebacterium
diphtheriae CRM
protein
Single-dose 2 vial
presentation (gray
and orange caps)
that requires
reconstitution.
0.5-mL dose once
reconstituted
2 months-
55 years
None
0.5-mL single-dose
1 vial presentation
(pink cap) that
does not require
reconstitution
10-55 years
None
Protocol for Meningococcal Containing Vaccines
MenQuadfi®, Menveo®, Bexsero®, Trumenba®, and Penbraya™
Oregon Board of Pharmacy – For rulemaking purposes only v. 06/2024
Product Name
Vaccine Components
Presentation
FDA
Approved
Age Range
Thimerosal
MenB-4C
(Bexsero®)
5
Recombinant proteins
Neisserial adhesin A
(NadA), Neisserial
Heparin Binding
Antigen (NHBA), and
factor H binding
protein (fHbp)
0.5-mL prefilled
syringes
10-25 years
None
MenB-fHbp
(Trumenba®)
6
Two recombinant
lipidated factor H
binding protein (fHbp)
variants from N.
meningitidis
serogroup B, one
from fHbp subfamily
A and one from
subfamily B (A05 and
B01, respectively)
0.5-mL prefilled
syringes
10-25 years
None
Product Name
Vaccine Components
Presentation
FDA
Approved
Age Range
Thimerosal
MenABCWY
(Penbraya™)
7
Neisseria meningitidis
serogroup A, C, W,
and Y polysaccharides
conjugated to
tetatnus toxoid and
two recombinant
lipidated factor H
binding protein (fHbp)
variants from N.
meningitidis
serogroup B, one
from fHbp subfamily
A and one from
subfamily B (A05 and
B01, respectively)
0.5-mL single-dose
diluent in
prefilled syringe
and vial with
lyophilized
antigen
10-25 years
None
5. Recommendations for Use
A. Routine use of Meningococcal ACWY vaccine
1
a. All adolescents 11–18 years of age without contraindications. Preferred age for dose
one is 11-12 years with a booster dose at age 16 years. Catch-up vaccination age for
dose one is 13–15 years with a booster dose at age 16–18 years. If series started at age
16 or older, no booster dose is indicated.
Protocol for Meningococcal Containing Vaccines
MenQuadfi®, Menveo®, Bexsero®, Trumenba®, and Penbraya™
Oregon Board of Pharmacy – For rulemaking purposes only v. 06/2024
i. Children who received MenACWY at age 10 years do not need an additional dose at
age 11–12 years but should receive the booster dose at age 16 years. Children who
received MenACWY before age 10 years and with no ongoing risk for meningococcal
disease for which boosters are recommended should still receive MenACWY
according to the recommended adolescent schedule.
b. Unvaccinated or under vaccinated first-year college students living in residence halls.
One dose may be administered to persons 19-21 years who have not received a dose
after their 16
th
birthday. Boosters are not routinely recommended unless there is
another indication.
c. Military recruits 19-21 years of age who have not received a dose after their 16
th
birthday. Administer one dose with booster every 5 years based on assignment. Vaccine
recommendations for military personnel are made by the U.S. Department of Defense.
d. Booster doses for previously vaccinated persons who become or remain at increased
risk. At 3 or 5 years after primary vaccination depending on age at last dose and every 5
years thereafter.
B. Use of Meningococcal ACWY vaccine in high-risk persons
1
a. Persons with complement component deficiency or who are taking complement
inhibitor medications, with anatomical or functional asplenia, or with HIV should receive
2 doses 8 weeks apart.
b. Microbiologists routinely exposed to isolates of Neisseria meningitidis, persons at
increased risk during an outbreak (e.g., in community or organizational settings, and
among men who have sex with men [MSM]), and persons who travel to or live in
countries in which meningococcal disease is hyperendemic or epidemic, particularly the
meningitis belt in sub-Saharan Africa, should receive 1 dose.
i. Vaccination is required for entry for persons traveling to Saudi Arabia for the Hajj
and Umrah pilgrimages.
C. Use of Meningococcal B vaccine in healthy persons
1
a. Vaccination of adolescents and young adults aged 16–23 years with a 2-dose MenB
series on the basis of shared clinical decision-making. MenB vaccination is not routinely
recommended for all adolescents. Instead, ACIP recommends a MenB series for persons
aged 16–23 years (preferred age 16–18 years) on the basis of shared clinical decision-
making. Shared clinical decision-making refers to an individually based vaccine
recommendation informed by a decision-making process between the health care
provider and the patient or parent/guardian. Pharmacists can engage in shared clinical
decision making to discuss MenB vaccination with persons aged 16-23 years who are
most likely to benefit.
i. Pharmacists are authorized to administer MenB vaccine if the following risk factor is
present: College students, especially those who are freshmen, attend a 4-year
university, live in on-campus housing, or participate in sororities and fraternities
D. Use of Meningococcal B vaccine in high-risk persons
1
a. Persons with persistent complement component deficiencies or who are taking
complement inhibitor medications, with anatomic or functional asplenia, and
Microbiologists routinely exposed to isolates of Neisseria meningitidis should receive
the 2-dose series of Bexsero® or the 3-dose series of Trumenba®.
i. A single booster dose for previously vaccinated persons who remain at increased
risk should be given at 1 year after completion of primary vaccination and every 2-3
years thereafter.
Protocol for Meningococcal Containing Vaccines
MenQuadfi®, Menveo®, Bexsero®, Trumenba®, and Penbraya™
Oregon Board of Pharmacy – For rulemaking purposes only v. 06/2024
b. Persons at increased risk during an outbreak (e.g., in community or organizational
settings, and among MSM should receive the 2-dose series of Bexsero® or the 3-dose
series of Trumenba®.
i. A single booster dose for previously vaccinated persons and identified at increased
risk during an outbreak should be given if ≥1 year after completion of primary series
(a ≥ 6-month interval might also be considered by public health).
E. Use of Meningococcal ABCWY vaccine
a. If a patient is receiving MenACWY and MenB vaccines at the same visit, MenABCWY
may be given instead.
i. If a patient receives MenABCWY vaccine, which includes Trumenba®, then
administer:
1. Trumenba® for additional MenB dose(s) when MenACWY is not
indicated
2. Any MenACWY vaccine when MenB is not indicated
ii. The minimum interval between MenABCWY doses is 6 months.
b. People with prolonged increased risk for serogroup A, C, W, or Y and B
meningococcal disease need regular boosters. However, the recommended interval
between doses varies by age and vaccine type. MenABCWY vaccine can be used
only when both MenACWY and MenB vaccines are indicated at the same visit.
Otherwise, MenACWY and MenB vaccines should be given separately as
appropriate.
6. Contraindications
A. Severe allergic reaction (e.g., anaphylaxis) to a previous dose or to any vaccine component.
3-
7
Vaccine
Contains
MenACWY-TT – MenQuadfi®
sodium chloride, sodium acetate, formaldehyde, tetanus
toxoid
MenACWY-CRM - Menveo®
formaldehyde, CRM197 protein
MenB-4C - Bexsero®
aluminum hydroxide, sodium chloride, histidine, sucrose,
kanamycin
MenB-FHbp - Trumenba®
polysorbate 80, aluminum phosphate, histidine buffered
saline
MenABCWY- Penbrayra™
L-histidine, trometamol, sucrose, aluminum phosphate,
sodium chloride, and polysorbate 80
7. Warnings and Precautions
3-6
A. N/A
8. Other Considerations
A. Immunocompromised: individuals with altered immunocompetence may have reduced
immune responses.
3-6
B. Pregnant and lactating women should receive MenACWY vaccine if indicated. However, due
to a lack of data, vaccination with MenB should be deferred unless the woman is at
increased risk and, after consultation with her health care provider, the benefits of
vaccination are considered to outweigh the potential risks.
1
Protocol for Meningococcal Containing Vaccines
MenQuadfi®, Menveo®, Bexsero®, Trumenba®, and Penbraya™
Oregon Board of Pharmacy – For rulemaking purposes only v. 06/2024
C. Lactation: It is not known whether meningococcal vaccines are excreted in human milk. Use
with caution in nursing mothers.
1
D. MenACWY meningococcal vaccines will stimulate protection only against infections caused
by organisms from serogroups A, C, Y and W meningococci. They are not protective against
serogroup B meningococci.
5,6
E. Meningococcal vaccine is recommended 2 weeks before or ≥2 weeks after splenectomy
surgery for persons ≥7years of age.
1
F. Immunization with MenQuadfi® or Penbraya™ does not substitute for routine tetanus
immunization.
3,7
9. Side Effects and Adverse Reactions
3-7
MenACWY Vaccines
Adverse Event
Frequency
Low-grade fever, headache, redness at injection site, dizziness
Up to 40%
Grade 3 - fever, headache, redness at injection site, dizziness
Up to 3%
MenB Vaccines
Adverse Event
Frequency
Headache, fatigue, redness at injection site
Up to 51%
Pain at injection site
Up to 26%
Chills, joint pain
Up to 20%
Fever
Up to 2.5%
MenABCWY Vaccine
Adverse Event
Frequency
Pain at injection site
Up to 89%
Fatigue
Up to 52%
Headache
Up to 47%
Muscle pain
Up to 26%
Injection site redness
Up to 26%
Injection site swelling
Up to 25%
Joint pain
Up to 20%
Chills
Up to 20%
10. Storage and Handling
A. Store medications according to OAR 855-041-1036.
B. All clinics and pharmacies enrolled with the Vaccines for Children (VFC) Program must
immediately report any storage and handling deviations to the Oregon Immunization
Program at 971-673-4VFC (4823).
Vaccine
Temp
Storage Issues
Notes
MenQuadfi®
3
Store at 2°to 8°C
(36° to 46°F)
Protect from light. Do
not use if vaccine has
been frozen.
Menveo®
4
and diluent
After reconstitution,
administer Menveo®
immediately or store
between 2°C and 25°C
(36°F and 77°F) for up
Protocol for Meningococcal Containing Vaccines
MenQuadfi®, Menveo®, Bexsero®, Trumenba®, and Penbraya™
Oregon Board of Pharmacy – For rulemaking purposes only v. 06/2024
to 8 hours. Shake well
before using. Discard
reconstituted vaccine if
it has been frozen or
not used within 8
hours.
Bexsero®
5
and
Trumenba®
6
Penbraya™
7
During storage, a white
deposit and clear
supernatant may be
observed in the
prefilled syringe
containing the MenB
Component. Store the
carton horizontally to
minimize the time
necessary to resuspend
the MenB Component.
Do not freeze. Discard
if the carton has been
frozen
After reconstitution,
administer PENBRAYA
immediately or store
between 2°C and 30°C
(36°F and 86°F) and use
within 4 hours. Do not
freeze.
10. References
1. Mbaeyi S, Bozio C, Duffy J, et al. Meningococcal vaccination: Recommendations of the
Advisory Committee on Immunization Practices, United States, 2020. Available at:
https://www.cdc.gov/mmwr/volumes/69/rr/rr6909a1.htm
. Accessed 20 January 2024.
2. Ezeanolue E, Harriman K, Hunter P, Kroger A, Pellegrini C. General Best Practice Guidelines
for Immunization. Available at:
https://www.cdc.gov/vaccines/hcp/acip-recs/general-
recs/index.html. Accessed 20 January 2024.
3. MenQuadfi®. [Package insert]. June 2023. Available at:
https://www.vaccineshoppe.com/assets/pdf/vsh/2023/Prescribing-
Information_menquadfi.pdf. Accessed 20 January 2024.
4. Menveo®. [Package insert]. December 2023. Available at:
https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Menve
o/pdf/MENVEO.PDF. Accessed 20 January 2024.
5. Bexsero®. [Package insert]. April 2023. Available at
https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Bexser
o/pdf/BEXSERO.PDF. Accessed 20 January 2024.
6. Trumenba®. [Package insert]. November 2021. Available at:
https://labeling.pfizer.com/ShowLabeling.aspx?id=1796. Accessed 20 January 2024.
7. Penbraya™. [Package insert]. October 2023. Available at:
https://labeling.pfizer.com/ShowLabeling.aspx?id=19937. Accessed 20 January 2024.
8. Centers for Disease Control and Prevention. Vaccine Excipient Summary. November 2021.
Available at:
https://www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/b/excipient-table-
2.pdf. Accessed 20 January 2024.
Protocol for Meningococcal Containing Vaccines
MenQuadfi®, Menveo®, Bexsero®, Trumenba®, and Penbraya™
Oregon Board of Pharmacy – For rulemaking purposes only v. 06/2024
11. Appendix
A. Centers for Disease Control and Prevention (CDC). Shared Clinical Decision-Making for
Meningococcal B Vaccination in Adolescents and Adults: Job Aid for Healthcare Professionals.
Atlanta, GA: US Department of Health and Human Services, CDC; 2022.
https://www.cdc.gov/vaccines/hcp/admin/downloads/ISD-job-aid-SCDM-mening-b-shared-
clinical-decision-making.pdf