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NIMENRIX (Meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine) Adverse Reactions

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Adverse Reactions

Adverse Drug Reaction Overview

The safety profile is based on two data sets:

  • A pooled analysis on 9,621 subjects who have been vaccinated with one dose of NIMENRIX in clinical studies. The pooled analysis includes data for 3,079 toddlers 12 months to 23 months), 1,899 children (2 to 10 years), 2,317 adolescents (11 to 17 years) and 2,326 adults (18 – 55 years). In addition, a descriptive study provides safety data from 274 individuals aged 56 years and older and who have been vaccinated with one dose of NIMENRIX.
  • Data from approximately 1000 infants (6 weeks to 12 months of age) who have been primed and boosted with NIMENRIX.

Clinical Trial Adverse Drug Reactions

Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.

Solicited Adverse Reactions:

Infants 6 weeks to 12 months old
In Study MenACWY-TT-083, healthy infants received a primary series of 2 doses (at 2 and 4 months of age) of NIMENRIX or control vaccine (meningococcal group C CRM197-conjugate vaccine [MenC-CRM] or meningococcal group C tetanus toxoid conjugate vaccine [MenC-TT]), with the first dose administered between 6 and 12 weeks of age, followed by a booster dose at 12 months of age. Routinely used infant vaccines DTaP-HBV-IPV/Hib and a 10-valent pneumococcal vaccine (PCV10) were coadministered. Table 1 presents the rates of solicited symptoms reported during the 4-day post-vaccination period.

Table 1 Study MenACWY-TT-083: Percentage of subjects with solicited local and general symptoms reported during the 4-day (Days 0-3) post-vaccination period (Primary and Booster Total Vaccinated cohorts)
 

N= number of subjects with at least one documented dose. Doses 1 and 2 given at 2 and 4 months of age, respectively. Booster dose given at 12 months of age.

 

%= percentage of subjects reporting the symptom at least once

 

*Incidence of general symptoms reported for meningococcal vaccine (NIMENRIX, MenC-CRM or MenC-TT) coadministered with DTaP-HBV-IPV-Hib and PCV10

Type

NIMENRIX

MenC-CRM

MenC-TT

Dose 1

N=523

Dose 2

N=516

Booster

N=510

Dose 1

N=509

Dose 2

N=507

Booster

N=496

Dose 1

N=517

Dose 2

N=508

Booster

N=503

Local Symptoms, %

Pain

All

29.6

24.0

39.8

31.0

25.4

40.9

30.4

28.1

36.0

Grade 3

3.3

2.1

4.5

2.4

1.8

6.3

4.6

2.4

3.6

Redness

All

24.5

32.6

43.3

27.1

42.2

42.9

27.1

38.8

45.3

> 30 mm

0.2

0.0

1.2

0.4

0.0

1.0

0.2

0.2

0.8

Swelling

All

11.9

22.3

29.8

17.1

27.0

31.7

15.7

25.6

32.4

> 30 mm

0.0

0.2

0.4

0.6

0.0

0.4

0.0

0.8

1.0

General Symptoms, %*

Type

NIMENRIX

MenC-CRM

MenC-TT

Dose 1

N=523

Dose 2

N=516

Booster

N=510

Dose 1

N=508

Dose 2

N=505

Booster

N=496

Dose 1

N=517

Dose 2

N=507

Booster

N=504

Drowsiness

All

52.8

36.0

39.2

55.9

38.8

40.3

57.3

37.5

38.5

Grade 3

4.2

1.4

1.8

3.1

2.2

3.6

6.2

2.6

2.6

Irritability

All

62.9

52.3

56.7

68.3

52.9

56.9

68.5

50.7

57.5

Grade 3

7.6

5.4

6.3

7.7

6.3

7.1

9.7

7.5

7.7

Loss of appetite

All

38.4

33.1

36.3

37.4

29.7

38.1

41.4

29.6

37.3

Grade 3

1.9

1.9

3.5

1.6

1.8

3.6

1.4

1.8

4.4

Fever (Rectally)

All (>38oC)

30.6

22.7

32.4

32.9

19.8

35.5

34.6

20.9

31.0

>40oC

0

0.2

0.4

0

0.2

0.4

0

0.2

1.0

Toddlers 12 to 23 months old
In Study MenACWY-TT-039, healthy children 12 through 23 months of age were administered one dose of NIMENRIX either alone or co-administered with a first dose of PRIORIX-TETRA®, 1 dose of PRIORIX-TETRA or 1 dose of a licensed MenC-CRM197 (MenC-CRM) vaccine.

Table 2 presents the rates of solicited symptoms reported during the 4-day post-vaccination period in the Co-administered (Co-ad), NIMENRIX, PRIORIX-TETRA and MenC-CRM groups.

Table 2 Study MenACWY-TT-039: Percentage of subjects with solicited local and general symptoms reported during the 4-day (Days 0-3) post-vaccination period (Total vaccinated cohort)
 

N= number of subjects with the dose documented

 

%= percentage of subjects reporting the symptom at least once

Type

NIMENRIX + PRIORIX-TETRA N=375

NIMENRIX

N=367

PRIORIX-TETRA

N=124

MenC-CRM

N=123

Local Symptoms, %

Pain

All

24.3

29.2

17.7

25.2

Grade 3

0.3

0.8

0.0

0.0

Redness

All

35.5

37.1

38.7

31.7

> 30 mm

1.9

4.4

0.0

0.0

Swelling

All

13.9

18.8

5.6

8.1

> 30 mm

2.4

4.1

0.0

0.0

General Symptoms, %

Type

NIMENRIX + PRIORIX-TETRA N=375

NIMENRIX

N=367

PRIORIX-TETRA

N=124

MenC-CRM

N=124

Drowsiness

All

32.5

28.1

23.4

32.3

Grade 3

0.3

0.0

0.8

0.0

Fever (Rectally)

All (>38oC)

14.9

9.3

11.3

12.9

>40oC

0.0

0.0

0.8

0.0

Irritability

All

50.7

40.9

38.7

43.5

Grade 3

0.8

0.5

1.6

0.0

Loss of appetite

All

28.5

22.9

23.4

26.6

Grade 3

0.3

0.0

0

0.0

Redness was the most frequently reported solicited local symptom in each group after each vaccination (38.7% in the PRIORIX-TETRA group, 35.5% in the Co-ad group and 37.1% in the NIMENRIX group and 31.7% in the MenC-CRM group).

Irritability was the most frequently reported solicited general symptom in the 4 groups (50.7% in the Co-ad group, 40.9% in the NIMENRIX group, 38.7% in the PRIORIX-TETRA group and 43.5% in the MenC-CRM group).

In Study Men ACWY-TT-104, toddlers 12-14 months of age were vaccinated with either a single dose of NIMENRIX or 2 NIMENRIX doses administered 2 months apart. In the group who received 2 doses, the first and second doses were associated with similar local and systemic reactogenicity.

Children (2-10 years old), Adolescents (10-25 years old), and Adults (18-55 years old)

Children (2-5 years old)
In Study MenACWY-TT-081, healthy children aged 2 through 10 years of age were administered 1 dose of NIMENRIX or 1 dose of a licensed MenC-CRM vaccine.

Table 3 presents the percentage of subjects (aged 2 through 5 years of age) with solicited adverse reactions during the 4-day post vaccination period in the NIMENRIX and MenC-CRM groups.

Table 3 MenACWY-TT-081: Percentage of subjects with solicited local and general symptoms reported during the 4-day (Days 0-3) post-vaccination period (Total vaccinated cohort), subjects 2 through 5 years of age
 

N = number of subjects with the dose documented

 

% = percentage of subjects reporting the symptom at least once

Type

NIMENRIX

N=162

MenC-CRM

N=53

Local Symptoms, %

Pain

All

27.8

28.3

Grade 3

0.0

1.9

Redness

All

35.2

39.6

>30 mm

6.8

15.1

Swelling

All

26.5

24.5

>30 mm

4.3

5.7

General Symptoms, %

Drowsiness

All

14.2

11.3

Grade 3

0.0

1.9

Fever/(Orally)

All (>37.5oC)

5.6

5.7

>39.5oC

0.0

0.0

Irritability

All

15.4

11.3

Grade 3

0.6

1.9

Loss of Appetite

All

10.5

9.4

Grade 3

0.0

0.0

Redness was the most frequently reported solicited local symptom in each group (35.2% and 39.6% of the subjects in the NIMENRIX group and MenC-CRM group, respectively).

Irritability was the most frequently reported solicited general symptom in each group (15.4% and 11.3% of the subjects in the NIMENRIX group and MenC-CRM group, respectively). Drowsiness was also reported by 11.3% of the subjects in the MenC-CRM group, as compared to 14.2% of the subjects in the NIMENRIX group. Fever ≥ 37.5°C was reported by 5.6% of the subjects in the NIMENRIX group and 5.7% of the subjects in the MenC-CRM. The majority of fevers were measured by the rectal route (66.7% in the NIMENRIX group and 100% in the MenC-CRM group).

Children aged 6-10 years
Table 4 includes the percentage of subjects (aged 6 through 10 years of age) with solicited adverse reactions during the 4-day post vaccination period in the NIMENRIX and MenC-CRM groups.

Pain was the most frequently reported solicited local symptom in each group (43.9% and 54.0% of the subjects in the NIMENRIX group and MenC-CRM group, respectively).

Fatigue was the most frequently reported solicited general symptom in each group (22.3% and 22.0% of the subjects in the NIMENRIX group and MenC-CRM group, respectively). Fever ≥ 37.5°C was reported in 6.8% of the subjects in the NIMENRIX group and 2.0% of the subjects in the MenC-CRM group.

Adolescents aged 10-25 years
In Study MenACWY-TT-071, healthy subjects aged 10 through 25 years of age were administered 1 dose of NIMENRIX or 1 dose of MENACTRA® (ACWY-DT vaccine).

Table 4 includes the percentage of subjects (aged 10 through 25 years of age) with solicited adverse reactions during the 4-day post vaccination period in the NIMENRIX and MENACTRA groups.

The most common solicited local symptom during the 4-day post-vaccination period was pain at the injection site, reported by 51.4% and 55.4% of subjects in the NIMENRIX and MENACTRA groups, respectively. A much smaller percentage of these subjects reported pain with grade 3 intensity, ranging between 0.6% and 2.4% across all vaccine groups.

The incidence of redness at the injection site was 25.8% and 20.3% of subjects in the NIMENRIX and MENACTRA groups, respectively. The incidence of swelling was 19.1% and 13.5% of subjects, respectively. The majority of these events were grade 1 in intensity. Grade 3 events of redness (i.e. > 50 mm in diameter) were reported by 3 and 6 subjects in the NIMENRIX and MENACTRA groups, respectively. Grade 3 events of swelling (i.e. > 50 mm in diameter) were reported by 3 subjects each of the two vaccine groups.

The most common solicited general symptom was fatigue with an incidence of 27.3% to 29.2% across the two vaccine groups. Headache was reported by 25.5% to 26.4% and gastrointestinal symptoms by 13.1% to 13.5% of subjects across the two vaccine groups.

Adults aged 18-55 years
In Study MenACWY-TT-035, healthy adults aged 18 through 55 years of age were administered either 1 dose of NIMENRIX, 1 dose of a licensed ACWY-PS (polysaccharide) vaccine, or 1 dose of NIMENRIX co-administered with a licensed influenza vaccine, FLUARIX®.

Table 4 includes the percentage of subjects (aged 18 through 55 years of age) with solicited adverse reactions during the 4-day post vaccination period in the NIMENRIX, ACWY-PS and Co-administered groups.

Pain was the most frequently reported solicited local symptom in each group (19.4% in the NIMENRIX group, 21.9% in the Co-administered group and 13.5% in the ACWY-PS group). Headache was the most frequently reported solicited general symptom in each group (16.3% in the NIMENRIX group, 14.2% in the ACWY-PS group, and 13.3% in the Co-administered group).

Table 4 Percentage of subjects with solicited local and general symptoms reported during the 4-day (Days 0-3) post-vaccination period (Total vaccinated cohort), subjects 6 through 55 years of age
 

N = number of subjects with the dose documented

 

% = percentage of subjects reporting the symptom at least once

 

Study 081 and Study 071: Fever (>37.5oC) (Orally)

 

Study 035: Fever (>37.5oC) (Axillary)

MenACWY-TT-081

MenACWY-TT-071

MenACWY-TT- 035

Age

6-10 Years old

10-25 Years old

18-55 Years old

Type

NIMENRIX

N=148

MenC

N=50

NIMENRIX

N=329

MENACTRA N=325

NIMENRIX N=927

NIMENRIX + FLUARIX N=105

ACWY-PS

N=310

Local Symptoms, %

Pain

All

43.9

54.0

51.4

55.4

19.4

21.9

13.5

Grade 3

2.0

6.0

2.4

0.6

0.4

1.0

0.3

Redness

All

39.2

38.0

25.8

20.3

8.8

5.7

4.5

>50 mm

6.1

10.0

0.9

1.8

1.3

0.0

0.0

Swelling

All

29.7

30.0

19.1

13.5

7.9

1.0

1.9

>50 mm

2.7

6.0

0.9

0.9

1.1

0.0

0.0

General Symptoms, %

Type

NIMENRIX N=148

MenC

N=50

NIMENRIX

N=329

MENACTRAN=326

NIMENRIX N=927

NIMENRIX + FLUARIX N=105

ACWY-PS

N=310

Fatigue

All

22.3

22.0

29.2

27.3

12.3

9.5

9.7

Grade 3

2.7

0.0

2.7

1.5

0.9

0.0

0.0

Fever

All (>37.5oC)

6.8

2.0

5.2

4.9

4.0

2.9

4.5

>39.5oC

0.0

0.0

0.3

0.0

0.2

0.0

0.6

Gastro-intestinal

All

14.9

8.0

13.1

13.5

4.6

1.9

3.2

Grade 3

0.7

0.0

1.2

1.2

0.2

0.0

0.3

Headache

All

20.3

8.0

26.1

25.5

16.3

13.3

14.2

Grade 3

1.4

0.0

1.5

1.8

1.5

0.0

1.6

Adults aged > 55 years
In a descriptive study a single dose of NIMENRIX was administered to 274 individuals aged 56 years and older. The adverse reactions reported in this study were already observed in younger age groups.

Common and Uncommon Clinical Trial Adverse Drug Reactions:

Additional adverse reactions reported during clinical studies included in the safety pooled analysis:
Common (≥ 1% to < 10%)*: Injection site hematoma, gastrointestinal symptoms (including diarrhea, vomiting and nausea)

Uncommon (≥ 0.1% to < 1%)**: insomnia, crying, hypoesthesia, dizziness, pruritus, rash, myalgia, pain in extremity, malaise, and injection site reaction (including induration, pruritus, warmth, anesthesia).


*
Nausea and injection site hematoma occurred at a frequency of Uncommon in infants.
**
Rash occurred at a frequency of Common in infants. The adverse reactions hypoesthesia, dizziness, pruritus, myalgia and pain in extremity were not reported in the infant clinical study.

Post-Market Adverse Drug Reactions

General disorders and administration site conditions

Unknown: extensive limb swelling at the injection site, frequently associated with erythema, sometimes involving the adjacent joint or swelling of the entire injected limb.

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