MenQuadfi

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 8/11/2021
MenQuadfi Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What is MenQuadfi?

MenQuadfi, Meningococcal (Groups A, C, Y, W) is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. MenQuadfi vaccine is approved for use in individuals 2 years of age and older. MenQuadfi does not prevent N. meningitidis serogroup B disease.

What are the possible side effects of MenQuadfi?

MenQuadfi may cause serious side effects, including:

  • injection site reactions (pain, redness, and swelling),
  • feeling unwell (malaise),
  • muscle aches/pains,
  • headache, and
  • fever

Dosage for MenQuadfi

MenQuadfi is a 0.5 mL dose for intramuscular injection. For primary vaccination of individuals 2 years of age and older: a single dose. As a booster vaccination: a single dose of MenQuadfi may be administered to individuals 15 years of age and older who are at continued risk for meningococcal disease if at least 4 years have elapsed since a prior dose of meningococcal (Groups A, C, W, Y) conjugate vaccine.

MenQuadfi In Children

The safety and effectiveness of MenQuadfi have not been established in individuals younger than 2 years of age in the U.S.

What Drugs, Substances, or Supplements Interact with MenQuadfi?

MenQuadfi may interact with other medicines such as:

Tell your doctor all medications and supplements you use and all vaccines you recently received.

MenQuadfi During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using MenQuadfi. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to MenQuadfi during pregnancy. To enroll in or obtain information about the registry, call Sanofi Pasteur at 1-800-822-2463. It is unknown if MenQuadfi is excreted into breast milk. Data are not available to assess the effects of MenQuadfi on the breastfed infant or on milk production. Consult your doctor before breastfeeding.

Additional Information

Our MenQuadfi, Meningococcal (Groups A, C, Y, W) Conjugate Vaccine Solution for Intramuscular Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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MenQuadfi Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; dizziness, weakness; fast heartbeats; difficult breathing; swelling of your face, lips, tongue, or throat.

Keep track of all side effects you have. If you need a booster dose, you will need to tell the vaccination provider if the previous shot caused any side effects.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Becoming infected with meningococcal disease and developing meningitis is much more dangerous to your health than receiving this vaccine. Any vaccine may cause side effects but the risk of serious side effects is low.

You may feel faint after receiving this vaccine. Some people have had seizure like reactions after receiving this vaccine. Your doctor may want you to remain under observation during the first 15 minutes after the injection.

Call your doctor at once if you have:

  • severe weakness or unusual feeling in your arms and legs (may occur 2 to 4 weeks after you receive the vaccine);
  • high fever; or
  • unusual behavior.

Common side effects may include:

  • nausea, vomiting, diarrhea;
  • changes in appetite;
  • redness, pain, swelling, or a hard lump where the shot was given;
  • joint or muscle pain;
  • headache, drowsiness, tiredness
  • low fever, not feeling well; or
  • (in babies) fussiness, irritability.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1 800 822 7967.

Read the entire detailed patient monograph for MenQuadfi (Meningococcal (Groups A, C, Y, W) Vaccine for Injection)

MenQuadfi Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trial(s) of a vaccine cannot be directly compared to rates in the clinical trial(s) of another vaccine and may not reflect the rates observed in practice.

The safety of a single dose of MenQuadfi in individuals 2 years of age and older was evaluated in five randomized, active-controlled, multi-center clinical studies conducted in the US and Puerto Rico. In these studies, a total of 4,919 participants received either a primary dose (N = 4517) or a booster dose (N = 402) of MenQuadfi and were included in the safety analyses.

Safety Monitoring

Participants were monitored for immediate reactions for 30 minutes following vaccination while at the study site. Solicited injection site and systemic reactions were recorded by participants or by parents/guardians in a diary card at home daily for 7 days following vaccination. All unsolicited adverse events that occurred within 30 days following vaccination were recorded by participants or by parents/guardians and collected by the study site at the next visit. Unsolicited adverse events that were medically attended (i.e., visits to an emergency room, or an unexpected visit to a health care provider), and all serious adverse events (SAEs) were collected for at least 6 months after vaccination.

Primary Vaccination Studies

Children 2 Through 9 Years of Age

The safety of MenQuadfi in children 2 years through 9 years of age was evaluated in Study 1 (NCT03077438). The safety analysis set included 498 participants who received MenQuadfi and 494 participants who received Menveo (Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine). Of the participants 2 through 9 years of age who received MenQuadfi (N = 498), 50.2% were 2 through 5 years of age, 49.8% were 6 through 9 years of age, 49.0% were female, 80.5% were White, 13.3% were Black or African American, 0.4% were Asian, 5.2% were of other racial groups, and 22.9% were of Hispanic or Latino ethnicity. There were no substantive differences in demographic characteristics between the vaccine groups.

The rates and severity of the solicited adverse reactions that occurred within 7 days following MenQuadfi compared with Menveo (Study 1) are presented in Table 1.

SAEs occurred at a rate of 1.4% following MenQuadfi and at a rate of 0.6% following Menveo during the entire study period. Most SAEs occurred more than 30 days following vaccination and were commonly occurring events in the general population in this age group. No SAEs were determined to be vaccine related.

Table 1: Percentages of Solicited Injection-Site Reactions and Systemic Adverse Reactions within 7 Days after Vaccination with MenQuadfi or Menveo in Children 2 through 9 Years of Age (Study 1)*

MenQuadfi
(N=484-487)
%
Menveo
(N=479-486)
%
Adverse ReactionsAnyGrade 3AnyGrade 3
Local Reactions
Injection Site Pain38.60.642.41.0
Injection Site Erythema§22.63.131.59.9
Injection Site Swelling§13.81.421.55.6
Systemic Reactions
Myalgia20.10.423.00.8
Malaise21.11.820.41.0
Headache12.50.011.50.4
Fever#1.90.02.70.4
* Clinical trial identifier NCT03077438
N is the number of vaccinated participants with available data for the events listed
Grade 3: Unable to perform usual activities
§ Any: > 0 mm; Grade 3: ≥ 50 mm
Grade 3: Prevents daily activity
# Any: ≥ 100.4°F (38.0°C); Grade 3: ≥ 102.1°F (39.0°C)

Adolescents 10 Through 17 Years of Age

The safety of MenQuadfi in adolescents 10 through 17 years of age was evaluated in two clinical trial studies Study 2 (NCT02199691) and Study 3 (NCT02842853). The safety analysis set in these two studies included 3,196 participants who received MenQuadfi alone (1,684 participants), MenQuadfi concomitantly with Adacel® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) (Tdap) and Gardasil® (Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant) (HPV) (392 participants), the concomitant vaccines without MenQuadfi (296 participants), or a U.S.-licensed comparator meningococcal vaccine (824 participants). The comparator meningococcal vaccine was either Menveo (501 participants) or Menactra (Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine) (323 participants).

Of the participants 10 through 17 years of age who received MenQuadfi (N = 1,684), 49.6% were female. Among those with reported race and ethnicity, 79.3% were White, 14.2% were Black or African American, 1.1% were Asian, 5.4% were of other racial groups, and 21.5% were of Hispanic or Latino ethnicity. Mean age was 11.9 years at time of administration. There were no substantive differences in demographic characteristics between the vaccine groups.

The rates and severity of the solicited adverse reactions that occurred within 7 days following MenQuadfi compared with Menveo and Menactra are presented in Table 2. The most common injection site and systemic reactions occurring after MenQuadfi administration (in Study 2 and Study 3) were injection site pain (34.8% and 45.2%) and myalgia (27.4% and 35.3%), respectively.

In Study 2, SAEs occurred at a rate of 0.8% following MenQuadfi and 0.8% following Menveo. In Study 3, SAEs occurred at a rate of 0.3% following MenQuadfi and 0.9% following Menactra. No SAEs were determined to be vaccine related.

Table 2: Percentages of Solicited Injection-Site Reactions and Systemic Adverse Reactions within 7 Days after Vaccination with MenQuadfi or Menveo in Individuals 10 through 17 Years of Age Study 2* and MenQuadfi or Menactra in Individuals 10 through 17 Years of Age Study 3

Study 2Study 3
MenQuadfi
(N=494-496)
%
Menveo
(N=488-491)
%
MenQuadfi
(N=1129-1159)
%
Menactra
(N=310-314)
%
Adverse ReactionsAnyGrade 3AnyGrade 3AnyGrade 3AnyGrade 3
Local Reactions
Injection Site Pain§45.21.442.51.034.81.841.42.2
Injection Site Erythema5.00.47.51.24.50.34.50.3
Injection Site Swelling5.40.26.50.44.1<0.14.80.0
Systemic Reactions
Myalgia§35.31.635.21.827.41.931.21.9
Headache§30.21.830.91.826.52.328.01.9
Malaise§26.02.226.42.819.41.223.91.3
Fever#1.40.41.20.60.70.20.60.0
* Clinical trial identifier NCT02199691
Clinical trial identifier NCT02842853
N is the number of vaccinated participants with available data for the events listed
§ Grade 3: Prevents daily activity
Any: > 25 mm; Grade 3: > 100 mm
#Any: ≥ 100.4°F (38.0°C); Grade 3: ≥ 102.1°F (39.0°C)

Among 296 participants who received Tdap and HPV concomitantly (without MenQuadfi) and 392 participants who received MenQuadfi concomitantly with Tdap and HPV, there were no notable differences in the rates of systemic solicited adverse reactions within 7 days following vaccination.

Dizziness within 30 minutes following vaccination was experienced by 1 (0.2%) participant who received MenQuadfi in Study 2 (NCT02199691) and 2 (0.2%) participants who received MenQuadfi in Study 3 (NCT02842853). Three participants in Study 2 experienced syncope within 30 minutes following vaccination: 1 (0.2%) participant who received Menveo, 1 (0.3%) participant who received MenQuadfi concomitantly with Tdap and HPV, and 1 (0.3%) participant who received Tdap and HPV concomitantly (without MenQuadfi). These events were non-serious and spontaneously resolved on the same day.

Adults 18 Through 55 Years of Age

The safety of MenQuadfi in adults 18 through 55 years of age was evaluated in Study 3 (NCT02842853). The safety analysis set included 1,495 participants who received MenQuadfi and 312 participants who received Menactra. Of the participants 18 years through 55 years of age who received MenQuadfi (N = 1,495), 65.2% were female. Among those with reported race and ethnicity, 73.3% were White, 21.0% were Black or African American, 2.2% were Asian, 3.5% were of other racial groups, and 20.0% were of Hispanic or Latino ethnicity. Mean age was 39.4 years at time of administration.

The rates and severity of the solicited adverse reactions that occurred within 7 days following MenQuadfi compared with Menactra are presented in Table 3.

Dizziness within 30 minutes following vaccination was experienced by 5 (0.3%) participants who received MenQuadfi and 1 (0.3%) participant who received Menactra. These events were non-serious and spontaneously resolved on the same day.

SAEs occurred at a rate of 1.6% following MenQuadfi and at a rate of 0.6% following Menactra during the entire study period. No SAEs were determined to be vaccine related.

Table 3: Percentages of Solicited Injection-Site Reactions and Systemic Adverse Reactions within 7 Days after Vaccination with MenQuadfi or Menactra in Individuals 18 through 55 Years of Age (Study 3)*

MenQuadfi
(N=1,441-1,460)
%
Menactra
(N=297-301)
%
Adverse ReactionsAnyGrade 3AnyGrade 3
Local Reactions
Injection Site Pain41.91.935.01.3
Injection Site Erythema§5.10.33.70.3
Injection Site Swelling§4.30.23.40.3
Systemic Reactions
Myalgia35.63.631.22.3
Headache29.02.927.62.7
Malaise22.92.918.93.3
Fever1.40.11.70.7
* Clinical trial identifier NCT02842853
N is the number of vaccinated participants with available data for the events listed
Grade 3: Prevents daily activity
§ Any: > 25 mm; Grade 3: > 100 mm
Any: ≥ 100.4°F (38.0°C); Grade 3: ≥ 102.1°F (39.0°C)

Adults 56 Years of Age and Older

The safety of MenQuadfi in adults 56 years of age and older was evaluated in Study 4 (NCT02842866). The safety analysis set included 448 participants who received MenQuadfi intramuscularly and 453 participants who received a non-conjugate comparator meningococcal vaccine (Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined – Menomune, Sanofi Pasteur) subcutaneously. Of the participants 56 years of age and older who received MenQuadfi (N = 448), 44.4% were 56 through 64 years of age, 55.6% were 65 years of age and older, 57.6% were female, 86.6% were White, 11.6% were Black or African American, 1.1% were Asian, 0.4% were of other racial groups and 7.8% were of Hispanic or Latino ethnicity. Mean age was 67.0 years at time of administration.

The rates and severity of the solicited adverse reactions that occurred within 7 days following MenQuadfi compared with Menomune in Study 4 (NCT02842866) are presented in Table 4.

SAEs occurred at a rate of 3.3% following MenQuadfi and at a rate of 3.3% following Menomune during the entire study period. No SAEs were determined to be vaccine related.

Table 4: Percentages of Solicited Injection-Site Reactions and Systemic Adverse Reactions within 7 Days after Vaccination with MenQuadfi or Menomune in Individuals 56 Years of Age and Older Study 4*

MenQuadfi
(N=436-443)
%
Menomune
(N=449-451)
%
Adverse ReactionsAnyGrade 3AnyGrade 3
Local Reactions
Injection Site Pain§25.50.79.60.7
Injection Site Erythema5.20.20.00.0
Injection Site Swelling4.50.00.00.0
Systemic Reactions
Myalgia§21.91.615.31.3
Headache§19.00.714.60.7
Malaise§14.51.411.31.8
Fever#2.10.20.40.0
* Clinical trial identifier NCT02842866
N is the number of vaccinated participants with available data for the events listed
Menomune was given subcutaneously
§ Grade 3: Prevents daily activity
Any: > 25 mm; Grade 3: > 100 mm
# Any: ≥ 100.4°F (38.0°C); Grade 3: ≥ 102.1°F (39.0°C)

Booster Vaccination Study

The safety of MenQuadfi in previously vaccinated adolescents and adults 15 years of age and older was evaluated in Study 5 (NCT02752906). All randomized participants had received a primary dose of either (Menveo or Menactra) 4 to 10 years previously. The safety analysis set included 402 participants who received a single booster dose of MenQuadfi (median age: 17.8 years) and 407 participants who received a single booster dose of Menactra (median age: 17.9 years). Of the participants who received MenQuadfi, 51.5% were female, 85.1% were White, 9.7% were Black, 2.7 % were Asian and 2.2 % were of other racial groups, and 15.7% were of Hispanic or Latino ethnicity.

The most commonly reported solicited adverse reactions (≥10%) within 7 days of MenQuadfi booster vaccination were injection site pain (44.7%) and headache (37.9%), myalgia (36.7%), and malaise (27.6%). The majority of solicited adverse reactions were Grade 1 or 2 and resolved within 3 days. Compared with recipients of a Menactra booster dose, recipients of a MenQuadfi booster dose had higher rates of injection site erythema (MenQuadfi 5.0%, Menactra 1.5%) and swelling (MenQuadfi 4.0%, Menactra 0.7%). Overall rates of solicited adverse reactions were comparable to those observed in unvaccinated adolescents and adults after a single MenQuadfi dose.

SAEs occurred at a rate of 1.2% following MenQuadfi and at a rate of 1.0% following Menactra during the entire study period. No SAEs were determined to be vaccine related.

Read the entire FDA prescribing information for MenQuadfi (Meningococcal (Groups A, C, Y, W) Vaccine for Injection)

© MenQuadfi Patient Information is supplied by Cerner Multum, Inc. and MenQuadfi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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