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TRUMENBA® (Meningococcal Group B Vaccine) Adverse Reactions

6 ADVERSE REACTIONS

In clinical studies, the most common solicited adverse reactions in adolescents and young adults were pain at the injection site (≥85%), fatigue (≥60%), headache (≥55%), and muscle pain (≥35%). Nausea was reported in up to 24% of adolescents in early phase studies.

6.1 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 clinical practice.

The safety of Trumenba was evaluated in 15,227 subjects 10 through 25 years of age in 11 clinical studies (8 randomized controlled and 3 supportive non-controlled studies) conducted in the U.S., Europe, Canada, Chile, and Australia. A total of 11,333 adolescents (10 through 18 years of age) and 3,894 adults (19 through 25 years of age) received at least one dose of Trumenba. A total of 5,501 subjects 10 through 25 years of age in the control groups received saline placebo and/or one of the following vaccine(s): Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant (HPV4) (Merck & Co., Inc.); Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) (Sanofi Pasteur Ltd.); Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine (MCV4) (Sanofi Pasteur Inc.); a non-U.S. licensed reduced diphtheria toxoid, tetanus toxoid, acellular pertussis and inactivated polio virus vaccine (dTaP-IPV) (Sanofi Pasteur, Inc.); Hepatitis A Vaccine, Inactivated (HAV) (GlaxoSmithKline Biologicals).

The safety evaluation in the clinical studies included an assessment of: (1) solicited local and systemic reactions, and use of antipyretic medication after each vaccination in an electronic diary maintained by the subject or the subject's parent/legal guardian and (2) spontaneous reports of adverse events (AEs), including serious adverse events (SAEs), throughout the study (day of vaccination through one month or 6 months after the last vaccination, depending on the study and safety parameter).

In controlled studies, demographic characteristics were generally similar with regard to gender, race, and ethnicity among subjects who received Trumenba and those who received control. Overall, across the 11 studies, among the subjects who received Trumenba, 50.5% were male and 49.5% were female, and the majority were White (86.3%) and non-Hispanic/non-Latino (87.3%).

Solicited Local and Systemic Adverse Reactions

Study 1 was a Phase 3, randomized, active-controlled, observer-blinded, multicenter trial in the U.S., Canada, and Europe in which 2,693 subjects 10 to 18 years of age received at least 1 dose of Trumenba on a 0-, 2-, and 6- month schedule. A control group (n=897) received HAV at 0 and 6 months and saline at 2 months. 87.3% of subjects were White, 8.1% were Black or African-American, 0.4% were Asian, and 5.8% were Hispanic or Latino. Overall, 51.5% of subjects were male, 55.6% of participants were 10 to 14 years age, and 44.4% were 15 to 18 years of age.

Study 2 was a Phase 3, randomized, placebo-controlled, observer-blinded, multicenter trial in the U.S., Canada, and Europe in which 2,471 subjects 18 to 25 years of age received at least 1 dose of Trumenba and 822 subjects received saline on a 0-, 2,- and 6- month schedule. 76.1% of subjects were White, 20.8% were Black or African-American, 1.6% were Asian, and 17.1% were Hispanic or Latino. Overall, 41.3% of subjects were male.

Local adverse reactions at the Trumenba injection site and control (HAV/saline or saline) injection site were assessed in both studies.

Tables 1 and 2 present the percentage and severity of reported local adverse reactions within 7 days following each dose of Trumenba or control (HAV/saline or saline) for Study 1 and Study 2, respectively.

Local adverse reactions were reported more frequently following Trumenba compared to control (see Tables 1 and 2).

Table 1: Percentages of Subjects 10 to 18 Years of Age (Study 1*) Reporting Local Adverse Reactions Within 7 Days After Each Vaccination
Dose 1Dose 2Dose 3
TrumenbaHAV/SalineTrumenbaHAV/SalineTrumenbaHAV/Saline
Local ReactionN=2681N=890N=2545N=843N=2421N=821
*
Study 1: National Clinical Trial (NCT) number NCT01830855.
Trumenba was administered at 0, 2, and 6 months. HAV was administered at 0 and 6 months and saline was administered at 2 months.
Mild (does not interfere with activity); moderate (interferes with activity); severe (prevents daily activity).
§
"Any" is defined as the cumulative frequency of subjects who reported a reaction as "mild", "moderate", or "severe" within 7 days of vaccination.
Mild (2.5–5.0 cm); moderate (>5.0–10.0 cm); severe (>10.0 cm).
Pain
  Any§86.747.077.715.276.034.0
  Mild41.136.539.412.334.123.8
  Moderate40.79.933.22.736.59.9
  Severe5.00.65.10.15.40.4
Redness
  Any§16.21.312.50.613.91.1
  Mild5.61.25.20.64.91.0
  Moderate8.80.16.10.06.80.1
  Severe1.90.01.10.02.20.0
Swelling
  Any§18.02.213.90.615.40.9
  Mild8.51.86.30.57.90.7
  Moderate8.80.47.30.16.80.1
  Severe0.70.00.20.00.70.0
Table 2: Percentages of Subjects 18 to 25 Years of Age (Study 2*) Reporting Local Adverse Reactions Within 7 Days After Each Vaccination
Dose 1Dose 2Dose 3
TrumenbaSalineTrumenbaSalineTrumenbaSaline
Local ReactionN=2425N=798N=2076N=706N=1823N=624
*
Study 2: National Clinical Trial (NCT) number NCT01352845.
Trumenba was administered at 0, 2, and 6 months. Saline was administered at 0, 2, and 6 months.
Mild (does not interfere with activity); moderate (interferes with activity); severe (prevents daily activity).
§
"Any" is defined as the cumulative frequency of subjects who reported a reaction as "mild", "moderate", or "severe" within 7 days of vaccination.
Mild (2.5–5.0 cm); moderate (>5.0–10.0 cm); severe (>10.0 cm).
Pain
  Any§84.211.879.37.880.46.7
  Mild42.310.742.26.836.16.4
  Moderate37.11.132.71.038.90.3
  Severe4.80.04.40.05.30.0
Redness
  Any§13.80.611.80.317.10.2
  Mild5.80.54.60.16.20.2
  Moderate7.10.06.30.08.60.0
  Severe0.90.10.90.12.30.0
Swelling
  Any§15.50.614.00.416.60.3
  Mild8.50.37.70.38.80.0
  Moderate6.80.36.00.17.20.3
  Severe0.20.10.30.00.50.0

In Study 1, mean duration of pain was 2.4 to 2.6 days (range 1–17 days), for redness 2.0 to 2.2 days (range 1–12 days) and for swelling 2.0 to 2.1 days (range 1–21 days) in the combined Trumenba group. In Study 2, mean duration of pain was 2.6 to 2.8 days (range 1–67 days), for redness 2.2 to 2.5 days (range 1–13 days) and for swelling 2.1 to 2.6 days (range 1–70 days) in the Trumenba group.

Tables 3 and 4 present the percentage and severity of reported solicited systemic adverse reactions within 7 days of each dose of Trumenba or control (HAV/saline or saline) for Study 1 and Study 2, respectively.

Table 3: Percentages of Subjects 10 to 18 Years of Age (Study 1*) Reporting Systemic Adverse Reactions and Use of Antipyretic Medications Within 7 Days After Each Vaccination
Dose 1Dose 2Dose 3
TrumenbaHAV/SalineTrumenbaHAV/SalineTrumenbaHAV/Saline
Systemic ReactionN=2681N=890N=2545N=843N=2421N=821
*
Study 1: National Clinical Trial (NCT) number NCT01830855.
Trumenba was administered at 0, 2, and 6 months. HAV was administered at 0 and 6 months and saline was administered at 2 months.
Study 1: Fever (≥38°C): N=2679, 2540, and 2414 for Trumenba at Dose 1, Dose 2, and Dose 3, respectively; N=890, 840, and 819 for HAV/saline at Dose 1, Dose 2, and Dose 3, respectively.
§
Mild (1–2 times in 24 hours); moderate (>2 times in 24 hours); severe (requires intravenous hydration).
"Any" is defined as the cumulative frequency of subjects who reported a reaction as "mild", "moderate", or "severe" within 7 days of vaccination.
#
Mild (2–3 loose stools in 24 hours); moderate (4–5 loose stools in 24 hours); severe (6 or more loose stools in 24 hours).
Þ
Mild (does not interfere with activity); moderate (interferes with activity); severe (prevents daily activity).
Fever (≥38°C)
  ≥38.0°C6.41.92.01.52.72.3
  38.0°C to <38.5°C4.01.31.20.71.81.3
  38.5°C to <39.0°C1.90.30.70.70.60.4
  39.0°C to ≤40.0°C0.50.20.10.10.30.5
  >40.0°C0.00.00.00.00.00.1
Vomiting§
  Any3.71.92.21.41.72.2
  Mild2.81.71.71.11.41.7
  Moderate0.90.20.40.40.30.5
  Severe0.00.00.00.00.00.0
Diarrhea#
  Any10.612.17.69.17.77.6
  Mild9.110.96.27.66.46.2
  Moderate1.31.11.31.21.01.1
  Severe0.30.10.10.40.30.2
HeadacheÞ
  Any51.837.237.828.135.424.8
  Mild28.724.020.215.718.913.5
  Moderate21.012.516.010.915.210.4
  Severe2.20.71.71.51.31.0
FatigueÞ
  Any54.040.338.326.335.924.4
  Mild27.823.520.613.218.413.5
  Moderate23.215.215.811.715.210.0
  Severe3.01.71.91.42.30.9
ChillsÞ
  Any25.317.216.010.313.18.3
  Mild16.213.310.68.18.76.5
  Moderate8.03.54.81.83.81.7
  Severe1.20.40.60.50.50.1
Muscle pain (other than muscle pain at the injection site)Þ
  Any24.419.217.810.317.611.1
  Mild13.213.58.75.29.56.6
  Moderate10.15.47.94.57.24.3
  Severe1.20.31.20.60.80.2
Joint painÞ
  Any21.913.616.79.116.08.9
  Mild11.88.38.45.08.95.5
  Moderate8.74.67.53.45.93.0
  Severe1.40.70.80.71.20.4
Use of antipyretic medication20.710.413.68.912.76.8
Table 4: Percentages of Subjects 18 to 25 Years of Age (Study 2*) Reporting Systemic Adverse Reactions and Use of Antipyretic Medications Within 7 Days After Each Vaccination
Dose 1Dose 2Dose 3
TrumenbaSalineTrumenbaSalineTrumenbaSaline
Systemic ReactionN=2425N=798N=2076N=706N=1823N=624
*
Study 2: National Clinical Trial (NCT) number NCT01352845.
Trumenba was administered at 0, 2, and 6 months. Saline was administered at 0, 2, and 6 months.
Study 2: Fever (≥38°C): N=2415, 2067, and 1814 for Trumenba at Dose 1, Dose 2, and Dose 3, respectively; N=796, 705, and 621 for saline at Dose 1, Dose 2, and Dose 3, respectively.
§
Mild (1–2 times in 24 hours); moderate (>2 times in 24 hours); severe (requires intravenous hydration).
"Any" is defined as the cumulative frequency of subjects who reported a reaction as "mild", "moderate", or "severe" within 7 days of vaccination.
#
Mild (2–3 loose stools in 24 hours); moderate (4–5 loose stools in 24 hours); severe (6 or more loose stools in 24 hours).
Þ
Mild (does not interfere with activity); moderate (interferes with activity); severe (prevents daily activity).
Fever (≥38°C)
  ≥38.0°C2.40.61.21.02.00.6
  38.0°C to <38.5°C1.60.40.70.61.40.5
  38.5°C to <39.0°C0.70.00.40.30.40.2
  39.0°C to ≤40.0°C0.00.30.10.10.10.0
  >40.0°C0.00.00.00.00.10.0
Vomiting§
  Any2.62.12.11.62.01.4
  Mild2.22.11.61.31.81.1
  Moderate0.40.00.50.30.20.3
  Severe0.00.00.00.00.00.0
Diarrhea#
  Any12.711.88.68.17.56.9
  Mild10.29.86.44.76.15.3
  Moderate2.41.91.72.81.21.3
  Severe0.20.10.50.60.20.3
HeadacheÞ
  Any43.936.233.124.932.521.6
  Mild24.322.118.413.617.612.5
  Moderate17.913.513.310.113.38.3
  Severe1.60.61.41.31.60.8
FatigueÞ
  Any50.939.839.227.339.324.5
  Mild25.423.220.613.918.913.1
  Moderate22.115.816.411.518.89.6
  Severe3.40.92.22.01.61.8
ChillsÞ
  Any18.19.812.48.512.66.4
  Mild12.08.18.16.97.74.3
  Moderate4.91.63.51.64.22.1
  Severe1.10.00.80.00.80.0
Muscle pain (other than muscle pain at the injection site)Þ
  Any25.914.515.68.516.97.5
  Mild13.09.67.65.88.94.5
  Moderate11.34.47.12.36.82.9
  Severe1.60.50.80.41.20.2
Joint painÞ
  Any19.610.915.16.512.65.3
  Mild10.36.98.13.76.62.9
  Moderate7.93.56.22.55.42.4
  Severe1.40.50.90.30.60.0
Use of antipyretic medication13.48.912.37.612.86.6

The frequencies of adverse reactions were highest after the first dose regardless of the schedule. After subsequent doses, the frequencies of adverse reactions were similar regardless of dose number and schedule.

Serious Adverse Events

Overall in clinical studies in which 15,227 subjects 10 through 25 years of age received at least one dose of Trumenba, serious adverse events (SAEs) were reported by 269 (1.8%) subjects.

Among the 8 controlled studies (Trumenba N=13,275, control N=5,501), SAEs were reported by 213 (1.6%) subjects and by 106 (1.9%) subjects who received at least one dose of Trumenba or control, respectively.

Non-serious Adverse Events

Overall in clinical studies in which 15,227 subjects 10 through 25 years of age received Trumenba, non-serious AEs within 30 days after any dose were reported in 4,463 (29.3%) subjects. Among the 8 controlled studies (Trumenba N=13,275, control N=5,501), AEs that occurred within 30 days of vaccination were reported in 4,056 (30.6%) subjects who received Trumenba and 1,539 (28.0%) subjects in the control group, for individuals who received at least one dose. AEs that occurred at a frequency of at least 2% and were more frequently observed in subjects who received Trumenba than subjects in the control group were injection site pain, fever, and headache.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Trumenba. Because these reactions are reported voluntarily froma population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure.

Immune System Disorders: Hypersensitivity reactions, including anaphylactic reactions.

Nervous system disorder: Syncope (fainting).

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