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TRUMENBA®Adverse Reactions (Meningococcal Group B Vaccine)

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%).

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 16,284 subjects 10 through 25 years of age in 12 clinical studies (9 randomized controlled and 3 supportive non-controlled studies) conducted in the U.S., Europe, Canada, Chile, and Australia. A total of 11,991 subjects 10 through 18 years of age, and 4,293 subjects 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 (Serogroups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (MenACWY) (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 (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 1 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. Among participants in clinical trials B1971009 (Study 1009), B1971016 (Study 1016), and B1971057 (Study 1057), 41.3% to 51.5% were male, 76.1% to 87.3% were White, 8.1% to 20.8% were Black or African-American, <2% were Asian, and 5.8% to 17.1% were Hispanic/Latino.

Solicited Local and Systemic Adverse Reactions

Study 1057 was a randomized, observer-blinded, multicenter trial in the U.S. and Europe. In this study, 1057 subjects 10 through 25 years of age received at least 1 dose of Trumenba on a 0- and 6-month schedule. Trumenba was co-administered with Meningococcal (Groups A, C, Y, W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MenACWY) (GSK Vaccines, SRL) for the first dose.

Study 1009 was a randomized, active-controlled, observer-blinded, multicenter trial in the U.S., Canada, and Europe in which 2,693 subjects 10 through 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.

Study 1016 was a randomized, placebo-controlled, observer-blinded, multicenter trial in the U.S., Canada, and Europe in which 2,471 subjects 18 through 25 years of age received at least 1 dose of Trumenba and 822 subjects received saline on a 0-, 2,- and 6- month schedule.

Local adverse reactions at the injection site were assessed in the three studies.

Tables 1, 2, and 3 present the percentage and severity of reported local adverse reactions within 7 days following each dose of Trumenba for Study 1057 and following each dose of Trumenba or control (HAV/saline or saline) for Study 1009 and Study 1016, respectively.

In Studies 1009 and 1016, local adverse reactions were reported more frequently following Trumenba compared to control (see Tables 2 and 3, respectively).

Table 1: Percentages of Subjects 10 through 25 Years of Age (Study 1057*) Reporting Local Adverse Reactions Within 7 Days After Each Vaccination
Local ReactionDose 1Dose 2
Trumenba+MenACWY-CRMTrumenba
N=1044N=903
*
Study 1057: National Clinical Trial (NCT) number NCT03135834.
Trumenba and MenACWY-CRM were administered at 0 month followed by Trumenba alone at 6 months. Local reactions were recorded at the Trumenba injection site only.
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§85.082.2
  Mild41.238.9
  Moderate39.137.9
  Severe4.75.4
Redness
  Any§ (≥ 2.5 cm)16.914.7
  Mild6.85.2
  Moderate8.08.4
  Severe2.01.1
Swelling
  Any§ (≥ 2.5 cm)17.014.3
  Mild9.86.4
  Moderate6.97.5
  Severe0.30.3
Table 2: Percentages of Subjects 10 through 18 Years of Age (Study 1009*) 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 1009: 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§ (≥ 2.5 cm)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§ (≥ 2.5 cm)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 3: Percentages of Subjects 18 through 25 Years of Age (Study 1016*) Reporting Local Adverse Reactions Within 7 Days After Each Vaccination
Dose 1Dose 2Dose 3
TrumenbaSalineTrumenbaSalineTrumenbaSaline
Local ReactionN=2425N=798N=2076N=706N=1823N=624
*
Study 1016: 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§ (≥ 2.5 cm)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§ (≥ 2.5 cm)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 1057, among Trumenba recipients, mean duration of pain was 2.7 days (range 1–17 days) after the first vaccination and 2.7 days (range 1–12 days) after the second vaccination; redness was 2.2 days (range 1–9 days) and 2.4 days (1–11 days), respectively; and swelling was 2.2 days (range 1–17 days) and 2.5 days (range 1–27 days), respectively.

In Study 1009, mean duration of pain was 2.4 to 2.6 days (range 1–17 days), redness was 2.0 to 2.2 days (range 1–12 days) and swelling was 2.0 to 2.1 days (range 1–21 days) for the three-dose series in the Trumenba groups. In Study 1016, mean duration of pain was 2.6 to 2.8 days (range 1–67 days), redness was 2.2 to 2.5 days (range 1–13 days) and swelling was 2.1 to 2.6 days (range 1–70 days) in the Trumenba group.

Tables 4, 5, and 6 present the percentage and severity of reported solicited systemic adverse reactions within 7 days of each dose of Trumenba for Study 1057 and within 7 days of each dose of Trumenba or control (HAV/saline or saline) for Study 1009 and Study 1016, respectively.

Table 4: Percentages of Subjects 10 through 25 Years of Age (Study 1057*) Reporting Systemic Adverse Reactions and Use of Antipyretic Medications Within 7 Days After Each Vaccination
Systemic ReactionDose 1Dose 2
Trumenba+MenACWY-CRMTrumenba
N=1044N=903
*
Study 1057: NCT03135834.
Trumenba and MenACWY-CRM were administered at 0 month followed by Trumenba alone at 6 months.
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).
#
Mild (does not interfere with activity); moderate (some interference with activity); severe (prevents daily routine activity).
Fever (≥38°C)
  ≥38.0°C6.73.2
  38.0°C to <38.5°C4.01.9
  38.5°C to <39.0°C2.10.7
  39.0°C to ≤40.0°C0.60.7
  >40.0°C0.00.0
Vomiting
  Any§3.72.8
  Mild2.92.0
  Moderate0.90.8
  Severe0.00.0
Diarrhea
  Any§14.110.6
  Mild10.77.6
  Moderate3.32.5
  Severe0.10.4
Headache#
  Any§46.541.6
  Mild25.123.1
  Moderate19.016.5
  Severe2.42.0
Fatigue#
  Any§51.945.2
  Mild25.423.0
  Moderate23.719.2
  Severe2.93.0
Chills#
  Any§18.518.5
  Mild11.511.6
  Moderate5.76.2
  Severe1.20.7
Muscle pain (other than muscle pain at the injection site)#
  Any§28.421.4
  Mild15.811.5
  Moderate11.67.8
  Severe1.12.1
Joint pain#
  Any§19.618.7
  Mild10.211.2
  Moderate8.66.5
  Severe0.81.0
Use of antipyretic medication18.614.4
Table 5: Percentages of Subjects 10 through 18 Years of Age (Study 1009*) 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 1009: 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 1009: 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 6: Percentages of Subjects 18 through 25 Years of Age (Study 1016*) 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 1016: NCT01352845.
Trumenba was administered at 0, 2, and 6 months. Saline was administered at 0, 2, and 6 months.
Study 1016: 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

In three early phase studies in which it was solicited, nausea was reported in up to 24% of adolescents.

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

Among the 8 controlled studies investigating the three-dose (0, 1–2, and 6 months) schedule (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

Among the 8 controlled studies investigating the three-dose (0, 1–2, and 6 months) schedule (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 at least one dose of Trumenba and 1,539 (28.0%) subjects in the control group 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 from a 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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