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PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)) Adverse Reactions

Adverse Reactions

Adverse Drug Reaction Overview

1. Infants and Children Aged 6 Weeks to 5 Years

The safety of the vaccine was assessed in 13 controlled clinical trials where approximately 15,000 doses were given to 4,729 healthy infants in ages ranging from 6 weeks to 16 months of age. In all trials, Prevnar 13 was co-administered with routine pediatric vaccines.

In a catch-up study, 354 children (7 months to 5 years of age) receiving at least 1 dose of Prevnar 13 were also assessed for safety.

In a clinical study (0887X-100811) with pneumococcal 7-valent conjugate vaccine in infants vaccinated at 2, 3 and 4 months of age, fever ≥38°C was reported at higher rates among infants who received pneumococcal 7-valent conjugate vaccine concomitantly with Infanrix hexa (28.3% to 42.3%) than in infants receiving Infanrix hexa alone (15.6% to 23.1%). After a booster dose at 12-15 months of age, the rate of fever ≥38°C was 50.0% in infants who received pneumococcal 7-valent conjugate vaccine and Infanrix hexa at the same time as compared to 33.6% in infants receiving Infanrix hexa alone. These reactions were mostly moderate (less than or equal to 39°C) and transient.

Analysis of postmarketing reporting rates suggests a potential increased risk of convulsions, with or without fever, and hypotonic-hyporesponsive episode when comparing groups which reported use of Prevnar 13 with Infanrix hexa to those which reported use of Prevnar 13 alone.

2. Children and Adolescents 5 to 17 Years of Age

Safety was evaluated in 592 healthy children and adolescents, including 17.4% of subjects with a history of asthma. Two hundred and ninety-four (294) children aged 5 to <10 years had previously been immunized with at least 1 dose of Prevnar (7-valent) vaccine and 298 children aged 10-17 years had not previously been vaccinated with a pneumococcal vaccine.

3. Adults 18 Years and Older

Safety was assessed in 7 clinical studies including 91,593 adults ranging in ages from 18 to 101 years. Prevnar 13 was administered to 48,806 adults; 2,616 adults were aged 50-64 years and 45,291 adults were 65 years and older. Of the Prevnar 13 recipients, 1,916 adults were previously vaccinated with PPSV23 at least 3 years prior, and 46,890 adults were PPSV23 unvaccinated. One of the 7 studies included a group of adults (n=899) ranging from 18-49 years who received Prevnar 13 and who were not previously vaccinated with PPSV23.

Immunogenicity Studies
Two of the 6 clinical studies supporting safety were randomized trials comparing the safety and immunogenicity of Prevnar 13 with PPSV23 as a single dose in PPSV23 unvaccinated adults aged 50-64 years (study 6115A1-004) and in adults ≥70 years PPSV23 previously vaccinated (≥5 years prior to enrollment) (study 6115A1-3005). Study 6115A1-004 also included a cohort of PPSV23 unvaccinated adults aged 18-49 years. One study was randomized comparing the safety and immunogenicity of a single dose of Prevnar 13 compared to a single dose of PPSV23 in PPSV23 unvaccinated adults aged 60-64 years (study 6115A1-3010). One clinical safety study (study 6115A1-3000) of Prevnar 13, conducted in PPSV23 previously vaccinated (≥ 3 years prior to enrollment) adults aged ≥ 68 years was a single arm study. Two studies, 1 in the US (study 6115A1-3001) in adults aged 50-59 years and the other in Europe (study 6115A1-3008) in adults aged ≥65 years, evaluated the concomitant administration of Prevnar 13 with trivalent inactivated influenza vaccine (TIV) in these 2 age groups in PPSV23 unvaccinated adults.

A trend to lower frequency of adverse reactions was associated with increasing age; adults >65 years of age (regardless of pneumococcal vaccination status) reported fewer adverse reactions than younger adults, with adverse reactions generally more common in adults 18-29 years of age.

Overall, the frequency categories were similar in adults 18-49 years of age compared to adults >50 years of age, with the exception of vomiting which was very common (≥ 1/10) in adults aged 18-49 years and common (≥ 1/100 to < 1/10) in adults >50 years of age.

Efficacy Study
Study 6115A1-3006, conducted in the Netherlands in adults aged 65 years and older, was a randomized, double-blind, placebo-controlled study. A single dose of Prevnar 13 was compared to placebo for efficacy in prevention of the first episodes of vaccine-type (VT) pneumococcal community-acquired pneumonia (CAP) and VT-IPD. 84,496 subjects received either Prevnar 13 (42,240) or placebo (42,256) in a 1:1 randomization.

For 1,006 Prevnar 13 vaccinated subjects, solicited adverse events were monitored by recording local and systemic events using electronic diaries for 7 days after vaccination; adverse events were collected for 28 days after vaccination, and serious adverse events were collected for 6 months after vaccination. For the remaining 41,234 Prevnar 13 vaccinated subjects, serious adverse events were collected for 28 days after vaccination.

Subjects with pre-existing medical conditions (heart disease, lung disease or asthma, diabetes mellitus with or without insulin use, liver disease and splenectomy) as well as subjects with a history of smoking were enrolled, except those with immunocompromising conditions.

Clinical Trial Adverse Drug Reactions

1. Infants and Children Aged 6 Weeks to 5 Years

These data are from clinical trials in which Prevnar 13 was administered simultaneously with other routine childhood vaccines. Expected frequency of adverse reactions is presented in CIOMS frequency categories:

Table 1: Adverse Reactions in Infants and Children Aged 6 Weeks to 5 Years

System Organ Class

Very Common

≥1/10

Common

≥1/100 to <1/10

Uncommon

≥1/1,000 to <1/100

Rare

≥1/10,000 to <1/1,000

Immune System Disorders

   

Hypersensitivity reaction including face edema, dyspnea, bronchospasm

Metabolism and Nutrition Disorders

Decreased appetite

   

Psychiatric Disorders

Irritability

 

Crying

 

Nervous System Disorders

Drowsiness/increased sleep; restless sleep/decreased sleep

 

Seizures (including febrile seizures)

Hypotonic-hyporesponsive episode

Gastrointestinal Disorders

 

Diarrhea; vomiting

  

Skin and Subcutaneous Tissue Disorders

 

Rash

Urticaria or  urticaria-like rash

 

General Disorders and Administration Site Conditions

Fever; any vaccination-site erythema, induration/swelling or pain/tenderness;

vaccination-site erythema or induration/swelling 2.5 cm – 7.0 cm (after toddler dose and in older children [age 2-5 years])

Fever greater than 39°C; vaccination-site erythema or induration/swelling 2.5 cm – 7.0 cm (after infant series); vaccination-site pain/tenderness interfering with movement

Vaccination-site induration/swelling or erythema greater  than 7.0 cm

 

Serious Adverse Events (SAEs)

During the 13 controlled clinical trials, SAEs that the investigator considered related to study vaccine were reported for 11 out of 7,489 total subjects (0.1%); 6 out of 4,729 subjects (0.1%) in the Prevnar 13 group and 5 out of 2,760 (0.2%) in the Prevnar (7-valent) group. Of these 11 cases, there were 3 cases of febrile convulsions and 4 cases of fever. Out of the 4 cases with fever, 1 subject had diffuse body rash, 1 subject had respiratory distress, and 1 subject had tense fontanelle. The remaining related SAE cases were crying (1), bronchitis (1), infantile spasms (1) and nephroblastoma (1).

Deaths

During the 13 controlled clinical trials, death occurred in 4 (out of 7,489) infants. All 4 cases were attributable to Sudden Infant Death Syndrome (SIDS). Three (out of 4,729 cases receiving 15,739 doses) cases were among Prevnar 13 recipients, and 1 (out of 2,760 cases receiving 9,030 doses) was in the Prevnar (7-valent) group. None of these cases were assessed by the investigator as causally related to vaccination.

2. Children and Adolescents 5 to 17 Years of Age

The incidence and severity of solicited adverse events that occurred within 7 days following 1 dose of Prevnar 13 administered to children and adolescents 5-17 years of age are shown in Tables 2 and 3.

Table 2: Percentage of Subjects 5-17 Years of Age Reporting Solicited Local Reactionsa Within 7 Days After Prevnar 13 Vaccination

Local Reaction

Study 6096A1-3011

Vaccine Group (as Administered)

Prevnar 13 (5 to <10 years)

Prevnar 13 (10-17 years)

Nb

nc

%

Nb

nc

%

Tenderness

      

      Any

265

230

86.8

283

252

89.0

      Significantd

221

43

19.5

242

106

43.8

Swelling

      

      Any

226

85

37.6

233

86

36.9

      Milde

220

48

21.8

221

50

22.6

      Moderatee

219

48

21.9

226

48

21.2

      Severee

211

7

3.3

214

4

1.9

Redness

      

      Any

233

100

42.9

232

70

30.2

      Milde

226

63

27.9

226

48

21.2

      Moderatee

218

48

22.0

221

31

14.0

      Severee

212

7

3.3

213

4

1.9

Any of the above

270

242

89.6

285

258

90.5

a All reported local reactions, regardless of causality.

N = Number of subjects reporting yes for at least 1 day or no for all days.
n = Number of subjects reporting the specific characteristic.
Significant = present and interfered with limb movement.
e Mild, 0.5 – 2.0 cm; moderate, 2.5 – 7.0 cm; severe, >7.0 cm.

Table 3: Percentage of Subjects 5 to 17 Years of Age Reporting Solicited Systemic Adverse Eventsa and Anti-Pyretic Medication Use Within 7 Days After Prevnar 13 Vaccination

Systemic Event

Study 6096A1-3011

Vaccine Group (as Administered)

Prevnar 13 (5 to <10 years)

Prevnar 13 (10-17 years)

Nb

nc

%

Nb

nc

%

Fever ≥38°C but ≤39°C

212

9

4.2

214

11

5.1

Fever >39°C but ≤40°C

212

5

2.4

212

1

0.5

Fever >40°C

210

1

0.5

212

1

0.5

Decreased appetite

227

52

22.9

223

51

22.9

Irritability

234

73

31.2

234

59

25.2

Increased sleep

226

48

21.2

229

61

26.6

Decreased sleep

212

12

5.7

224

42

18.8

Hives (urticaria)

213

4

1.9

214

3

1.4

Use of medication to treat symptoms

232

88

37.9

232

66

28.4

Use of medication to prevent symptoms

225

58

25.8

225

47

20.9

Use of medication to treat or to prevent symptoms

237

107

45.1

236

78

33.1

Use of medication to treat and to prevent symptoms

220

35

15.9

221

29

13.1

Any systemic eventd

250

118

47.2

253

130

51.4

a All reported systemic adverse events, regardless of causality.

b   N = Number of subjects reporting yes for at least 1 day or no for all days.
c   n = Number of subjects reporting the event.
d  Includes any fever ≥38°C, decreased appetite, irritability, increased sleep, decreased sleep, and hives (urticaria).

Other adverse reactions observed in other age groups may also be applicable in this age group but due to the small sample size in this study (6096A1-3011) were not seen.

Additional Information in Special Populations

In a single-arm study (6096A1-3014) conducted in 158 children and adolescents 6-17 years of age with sickle cell disease (see Part II, CLINICAL TRIALS), the frequencies of solicited local reactions after the first or second doses of Prevnar 13 were comparable to those reported after a single Prevnar 13 dose in healthy children and adolescents 5-17 years of age from study 6096A1-3011 (see Table 2). All solicited systemic events were reported by ≥10% of subjects in study 6096A1-3014. Frequencies after the first and second doses of Prevnar 13, respectively, were muscle pain (74.8% and 75.5%), fatigue (66.1% and 62.5%), headache (53.6% and 59.3%), joint pain (39.8% and 44.9%), vomiting (15.4% and 13.4%) fever ≥38°C but ≤38.4°C (13.6% and 9.5%) and diarrhea (13.3% and 25.0%).

In a single-arm study (6115A1-3002) which included 150 HIV-infected children and adolescents 6-17 years of age not previously vaccinated with a pneumococcal vaccine (see Part II, CLINICAL TRIALS), the frequencies of solicited local reactions reported within 14 days after the first, second or third dose of Prevnar 13(range across the 3 doses) were: redness (8.3-20.7%), swelling (18.0-29.9%), and pain at the injection site (52.9-68.4%). Frequencies of solicited systemic events reported within 14 days of each dose (range across the 3 doses) were: fever ≥38ºC (10.6-19.1%), fatigue (25.0-47.7%), headache (18.2-39.3%), vomiting (8.2-18.0%), diarrhea (4.9-25.5%), muscle pain (37.4-48.1%), and joint pain (24.2-34.0%).

In children and adolescents 2-17 years of age with a hematopoietic stem cell transplant (N=59) vaccinated with up to 4 doses of Prevnar 13 in single-arm study 6115A1-3003 (see Part II, CLINICAL TRIALS), the frequencies of solicited local reactions reported within 14 days after each study vaccination (range across the 4 doses) were: redness (21.1-71.4%), swelling (25.0-66.7%), and pain (70.3-86.7%). Frequencies of solicited systemic events (range across the 4 doses) were: fever ≥38ºC (12.8-27.8%), fatigue (48.6-67.9%), headache (32.3-52.4%), vomiting (6.3-21.4%), diarrhea (15.4-31.8%), muscle pain (44.4-58.3%), and joint pain (25.0-32.3%).

3. Adults 18 Years and Older

Solicited Adverse Events in Adult Clinical Studies

The incidence and severity of solicited adverse events that occurred within 14 days following each dose of Prevnar 13 or PPSV23 administered to adults in 4 immunogenicity studies (safety data presented from 2 studies in PPSV23 unvaccinated adults and 2 studies in PPSV23 pre-vaccinated adults), and within 7 days following the dose of Prevnar 13 or placebo administered to PPSV23 unvaccinated adults in the efficacy study, are shown in Tables 4 and 5.

Table 4: Percentage of Subjects With Solicited Local Reactionsa Within 7† or 14 Days After Vaccination

 

Study 6115A1-004

(PPSV23Unvaccinated Adults)

Study 6115A1-3010

(PPSV23 Unvaccinated Adults)

Study 6115A1-3006

(PPSV23 Unvaccinated Adults)

Study 6115A1-3005

(PPSV23

Pre-Vaccinated Adults)

Study 6115A1-3000b (PPSV23

Pre-Vaccinated Adults)

Age in Years

18-49

50-59

60-64

60-64

≥ 65

≥70

≥ 68

Local Reaction

Prevnar 13b

Nc=
266-787

%

Prevnar 13b

Nc=
152-322

%

Prevnar 13
Nc=

193-331

%

PPSV23
Nc=

190-301

%

Prevnar 13
Nc=

270-370

%

PPSV23
Nc=

134-175

%

Prevnar 13

Nc=

886-914

%

Placebo

Nc=

859-865

%

Prevnar 13
Nc=

306-362

%

PPSV23
Nc=

324-383

%

Prevnar 13
Nc=

664-777

%

Rednessd

           

        Any

30.5

15.8

20.2

14.2

12.2

11.2

4.9*

1.2

10.8

22.2*

14.3

        Mild

26.4

15.2

15.9

11.2

8.3

9.7

3.7*

0.8

9.5

13.5

12.6

        Moderate

11.9

5.0

8.6

4.9

6.4

3.9

1.7*

0.3

4.7

11.5*

6.5

        Severe

2.8

0.7

1.7

0.0

1.2

0.8

0.5

0.1

1.7

4.8*

1.1

Swellingd

           

        Any

39.4

21.7

19.3

13.1

10.0

10.4

6.8*

1.2

10.4

23.1*

12.8

        Mild

37.2

20.6

15.6

10.1

8.2

6.1

5.5*

0.7

8.9

14.0*

10.9

        Moderate

15.1

4.3

8.2

4.4

3.8

7.6

2.6*

0.6

4.0

13.6*

5.5

        Severe

1.4

0.0

0.6

1.1

0.0

0.0

0.1

0.1

0.0

4.8*

0.6

Paine

           

        Any

96.7

88.8

80.1

73.4

69.2*

58.3

36.1*

6.1

51.7

58.5

51.0

        Mild

93.2

85.9

78.6*

68.6

66.1*

52.9

32.9*

5.6

50.1

54.1

49.4

        Moderate

77.1

39.5

23.3

30.0

20.1

21.7

7.7*

0.6

7.5

23.6*

9.0

        Severe

16.0

3.6

1.7

8.6*

2.3

0.8

0.3

0.1

1.3

2.3

0.2

Limitation of arm movementf

           

        Any

75.2

40.7

28.5

30.8

23.5

28.2

14.1*

3.2

10.5

27.6*

16.2

        Mild

71.5

38.6

26.9

29.3

22.7

26.1

12.4*

2.5

10.3

25.2*

14.8

        Moderate

18.5

2.9

2.2

3.8

1.2

3.1

1.7*

0.5

0.3

2.6*

1.6

        Severe

15.6

2.9

1.7

4.3

1.1

2.3

1.2

0.7

0.7

3.0*

1.6

†  All studies in this table reported local reactions within 14 days after vaccination, except Study 6115A1-3006, which reported local reactions within 7 days.

* Statistically significant difference p < 0.05.

 a All reported local reactions, regardless of causality assessment.

 b Open label administration of Prevnar 13.

  c Number of subjects with known values for any local reaction.

 d Mild = 2.5 to 5.0 cm, moderate = 5.1 to 10.0 cm, and severe is >10.0 cm.
 e Mild = awareness of symptom but easily tolerated, moderate = discomfort enough to cause interference with usual activity, severe = incapacitating with inability to do usual activity.
 f Mild = some limitation of arm movement, moderate = unable to move arm above head but able to move arm above shoulder, severe = unable to move arm above shoulder.

Table 5: Percentage of Subjects With Solicited Systemic Eventsa Within 7 or 14 Days After Vaccination

 

Study 6115A1-004

(PPSV23

Unvaccinated Adults)

Study 6115A1-3010

(PPSV23

Unvaccinated Adults)

Study 6115A1-3006

(PPSV23 Unvaccinated Adults)

Study 6115A1-3005

(PPSV23

Pre-Vaccinated Adults)

Study 6115A1-3000b (PPSV23 Pre-Vaccinated Adults)

Age in Years

18-49

50-59

60-64

60-64

≥ 65

≥70

≥68

Systemic Event

Prevnar 13b

Nc=

221-561

%

Prevnar 13b

Nc=

137-248

%

Prevnar 13

Nc=

180-277

%

PPSV23

Nc=

185-273

%

Prevnar 13

Nc=

263-324

%

PPSV23

Nc=

127-173

%

Prevnar 13

Nc=

881-896

%

Placebo

Nc=

859-878

%

Prevnar 13

Nc=

299-350

%

PPSV23

Nc=

304-367

%

Prevnar 13

Nc=

638-733

%

Fever

           

Any (≥38°C)

7.2

1.5

4.0

1.1

4.2

1.6

2.9*

1.3

1.0

2.3

1.1

≥38°C but <38.5°C

4.2

1.5

4.0

1.1

3.8

0.8

1.1

0.6

1.0

2.0

0.8

 ≥38.5°C but <39°C

1.9

0.0

0.6

0.0

0.8

0.0

0.6

0.2

0.0

0.0

0.0

 ≥39°C but ≤40°C

1.4

0.0

0.0

0.0

0.4

0.8

0.7

0.2

0.0

0.3

0.3

 >40°C

0.5

0.0

0.0

0.0

0.0

0.0

0.8

0.3

0.0

0.0

0.0

Fatigue

80.5

63.3

63.2

61.5

50.5

49.1

18.8*

14.8

34.0

43.3*

34.4

Headache

81.4

65.9

54.0

54.4

49.7

46.1

15.9

14.8

23.7

26.0

26.1

Chills

38.1

19.6

23.5

24.1

19.9

26.9

9.4

8.4

7.9

11.2

7.5

Rash

21.3

14.2

16.5

13.0

8.6

13.4

3.3*

0.8

7.3

16.4*

8.4

Vomiting

15.0

6.9

3.9

5.4

3.1

3.1

0.3

0.9

1.7

1.3

0.9

Diarrhea

NA

NA

NA

NA

NA

NA

5.7

8.7

NA

NA

14.5

Decreased appetite

55.6

25.3

21.3

21.7

14.7

23.0*

5.3

3.7

10.4

11.5

11.2

Generalized new muscle pain

82.0

61.8

56.2

57.8

46.9

51.5

18.4*

8.4

36.8

44.7*

25.3

Generalized aggravated muscle pain

55.9

39.9

32.6

37.3

22.0

32.5*

9.1*

4.4

20.6

27.5*

12.3

Generalized new joint pain

41.7

31.5

24.4

30.1

15.5

23.8*

7.4

5.4

12.6

14.9

12.8

Generalized aggravated joint pain

28.6

25.6

24.9

21.4

14.0

21.1

5.2

4.2

11.6

16.5

9.7

 †  All studies in this table reported systemic events within 14 days after vaccination, except Study 6115A1-3006, which reported systemic events within 7 days.

* Statistically significant difference p < 0.05.

 a All reported systemic events, regardless of causality assessment.

 b Open label administration of Prevnar 13.

 c Number of subjects with known values for any systemic event.

NA = not applicable

Solicited Adverse Events in Adult Studies with Prevnar 13 and TIV

The safety of concomitant administration of Prevnar 13 with seasonal trivalent influenza vaccine (TIV) was assessed in 2 studies in PPSV23 unvaccinated adults. The incidence of solicited local and systemic adverse events that occurred within 14 days following Prevnar 13 administered concomitantly with TIV compared to Prevnar 13 or TIV administered alone are shown in Tables 6 and 7, respectively.

Table 6: Percentage of Subjects* With Local Reactionsa Within 14 Days After Vaccination With Prevnar 13 Administered Concomitantly With TIV Compared to Prevnar 13 Alone

Local Reaction 

Adults Aged 50-59 Years

(Study 6115A1-3001)

Adults Aged ≥65 Years

(Study 6115A1-3008)

Prevnar 13 +TIV

Nc=262-469

%

Prevnar 13b

Nc=241-453

%

Prevnar 13 +TIV

Nc=428-480

%

Prevnar 13b

Nc=420-470

%

Rednessd

    

Any

16.3

12.1

16.6

12.3

Mild

15.7

10.2

14.4*

9.7

Moderate

4.2

5.6

6.0

6.1

Severe

0.4

1.2

0.7

1.0

Swellingd

    

Any

18.4

14.7

13.8

10.2

Mild

17.0

12.3

11.8

8.1

Moderate

5.7

6.4

4.2

5.0

Severe

0.4

0.4

0.2

0.0

Paine

    

Any

86.8

84.5

40.0

43.4

Mild

82.8

82.1

34.3

37.9

Moderate

39.2

41.1

14.8

19.7

Severe

4.1

4.8

1.4

2.6

Limitation of Arm Movementf

    

Any

35.6

42.5

13.9

14.8

Mild

32.6*

41.1

13.1

13.4

Moderate

5.2

5.2

1.4

1.0

Severe

 3.4

2.9

1.9

1.4

* Statistically significant difference p < 0.05 – Prevnar 13 + TIV versus Prevnar 13.

 a All reported local reactions, regardless of causality assessment.

 b TIV and placebo were administered 1 month prior to Prevnar 13.

 c Number of subjects with known values for any local reaction.

 d Mild is 2.5-5.0 cm. moderate is 5.1-10.0 cm and severe is > 10.0 cm.

 e Mild = awareness of symptom but easily tolerated, moderate = discomfort enough to cause interference with usual activity, and severe = incapacitating with inability to do usual activity.

 f Mild = some limitation of arm movement, moderate = unable to move arm above head but able to move arm above shoulder, and severe = unable to move arm above shoulder.

Table 7: Percentage of Subjects* With Systemic Eventsa Within 14 Days After Vaccination With Prevnar 13 Administered Concomitantly With TIV Compared to Prevnar 13 and TIV Alone

Systemic Event

Adults Aged 50-59 Years

(Study 6115A1-3001)

Adults Aged ≥65 Years

(Study 6115A1-3008)

Prevnar 13 +TIV

Nd=261-399

%

Prevnar 13c

Nd=240-350

%

TIVb

Nd=257‑382

%

Prevnar 13 +TIV

Nd=428-476

%

Prevnar 13c

Nd=420-456

%

TIVb

Nd=431‑483

%

Fever

      

Any (≥38°C)

3.4

2.5

1.2

4.2

3.6

3.2

≥38°C but <38.5°C

1.5

1.2

1.2

3.0

3.1

1.9

≥38.5°C but <39°C

1.5

0.8

0.0

1.4

1.0

1.2

≥39°C but <40°C

0.4

0.4

0.0

0.0

0.0

0.2

>40°C

0.0

0.0

0.0

0.0

0.0

0.0

Fatigue

58.1

51.8

52.4

37.4*

28.5

31.9

Headache

65.9*,†

50.9

56.5

32.6*

24.7

29.7

Chills

31.4

24.6

21.0

13.8*,†

9.1

9.1

Rash

12.6

9.5

4.9

6.9

6.8

3.4

Vomiting

5.3

6.1

3.4

3.0

1.7

3.4

Decreased appetite

30.2

25.8

22.6

16.9*

11.3

14.6

Generalized new muscle pain

65.5

59.1

37.7

26.9

23.4

16.7

Generalized aggravated muscle pain

34.7

36.7

24.1

18.7

15.0

14.0

Generalized new joint pain

33.0

27.4

24.7

16.2*

11.5

13.1

Generalized aggravated joint pain

21.2

23.8

18.0

15.7*

8.6

13.0

* Statistically significant difference p < 0.05 – Prevnar 13 + TIV versus Prevnar 13.

Statistically significant difference p < 0.05 – Prevnar 13 + TIV versus TIV

a All reported systemic events, regardless of causality assessment.

b TIV was administered with placebo.

c TIV and placebo were administered 1 month prior to Prevnar 13.

d  Number of subjects with known values for any systemic event.

Additional Information in Special Populations

In a single-arm study (6115A1-3017) conducted in 329 HIV-infected adults ≥ 18 years of age previously vaccinated with PPSV23, and in a single-arm study (6115A1-3002) conducted in 151 HIV-infected adults ≥18 years of age not previously vaccinated with PPSV23 (see Part II, CLINICAL TRIALS), the frequencies of solicited local reactions and systemic adverse events after the first, second or third doses of Prevnar 13 were comparable to those reported after a single Prevnar 13 dose in healthy adults ≥18 years of age from study 6115A1-004 (see Tables 4 and 5), except that fever was very common (11.0-17.9% across the 3 doses) in study 6115A1-3002.

In adults ≥18 years of age with a hematopoietic stem cell transplant (N=188) vaccinated with up to 4 doses of Prevnar 13 in single-arm study 6115A1-3003 (see Part II, CLINICAL TRIALS), the frequencies of solicited local reactions and systemic events after the first, second, third, or fourth doses of Prevnar 13 were comparable to those reported after a single Prevnar 13 dose in healthy adults ≥18 years of age from study 6115A1-004 (see Tables 4 and 5), except that fever was very common (4.3-15.4% across the 4 doses) in study 6115A1-3003.

Serious Adverse Events (SAEs)

Immunogenicity Studies: Adults 50 Years and Older
Across the 6 studies, serious adverse events within 1 month of vaccination were reported in 0.2% to 1.7% of 5,667 persons vaccinated at any time during the study with Prevnar 13 and in 0.4% to 1.7% of 1,391 persons vaccinated at any time during the study with PPSV23. From 1 month to 6 months postvaccination, serious adverse events were reported in 1.2% to 5.8% of persons vaccinated at any time during the study with Prevnar 13 and in 2.4% to 5.5% of persons vaccinated at any time during the study with PPSV23.

Twelve of 5,667 (0.21%) Prevnar 13 recipients and 4 of 1,391 (0.29%) PPSV23 recipients died; none of the deaths were considered related to vaccination. Deaths occurred between day 3 and day 309 after study vaccination with Prevnar 13 or PPSV23. Two of 12 deaths occurred within 30 days of vaccination and both deaths were in subjects >65 years of age. One death due to cardiac failure occurred 3 days after receiving placebo. This subject had received Prevnar 13 and TIV 1 month earlier. The other death was due to peritonitis 20 days after receiving Prevnar 13. The reported causes of the 10 remaining deaths occurring greater than 30 days after receiving Prevnar 13 were cardiac disorders (4), neoplasms (4), Mycobacterium avium complex pulmonary infection (1) and septic shock (1).

Immunogenicity Study: Adults 18-49 Years of Age
Serious adverse events occurring within 1 month of vaccination and considered possibly related to vaccination were reported in 0.1% of 899 subjects vaccinated. There were no deaths or adverse events that led to withdrawal from the study.

Efficacy Study: Adults 65 Years and Older
Serious adverse events within 1 month of vaccination were reported in 0.8% of 42,237 Prevnar 13 recipients and in 0.7% of 42,225 placebo recipients in the safety population. In the subset of subjects where serious adverse events were monitored for 6 months, 7% of 1,006 Prevnar 13 vaccinated subjects and 6% of 1,005 placebo vaccinated subjects reported serious adverse events.

Adverse Reactions from Prevnar 13 Postmarketing Experience

Although the following adverse drug reactions were not observed in the clinical trials, they are considered adverse drug reactions for Prevnar 13 as they were reported in the postmarketing experience. Because these reactions were derived from spontaneous reports, the frequencies could not be determined and are thus considered as not known.

Table 8: Adverse Reactions from Prevnar 13 Postmarketing Experience

System Organ Class

Frequency Not Known

(cannot be estimated from available data)*

Blood and lymphatic system disorders

Lymphadenopathy localized to the region of the vaccination-site

Immune system disorders

Anaphylactic/anaphylactoid reaction including shock

Skin and subcutaneous tissue disorders

Angioedema; erythema multiforme

General disorders and administration site conditions

Vaccination-site dermatitis; vaccination-site urticaria; vaccination-site pruritus

*Adverse drug reaction identified post-marketing

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