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Prevnar 13

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Prevnar 13

Prevnar 13 Side Effects Center

Reviewed by Melissa Conrad Stöppler, MD

Prevnar 13 (Pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) suspension for intramuscular injection is indicated for active immunization for the prevention of disease caused by Streptococcus pneumoniae. In adults 50 years and older, Prevnar 13 is used to immunize against pneumococcal pneumonia and invasive disease. In adults, antibody responses to Prevnar 13 were diminished when given with inactivated Influenza Virus Vaccine. In children 6 weeks through 5 years of age, Prevnar 13 is used to immunize against invasive pneumococcal disease and otitis media. In infants and toddlers, the most commonly reported side effects were irritability, injection site tenderness, decreased appetite, increased/ decreased sleep, fever, injection site redness, and injection site swelling. In adults aged 50 years and older the commonly reported solicited adverse reactions were pain at the injection site, fatigue, headache, muscle pain, joint pain, decreased appetite, injection site redness, injection site swelling, limitation of arm movement, chills and/or rash.

Children 6 weeks through 5 years should receive a four-dose immunization series. Adults 50 years and older should receive a single dose. The safety and effectiveness of Prevnar 13 in pregnant women have not been established. It is not known whether this vaccine is excreted in human milk.

Our Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) 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.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Prevnar 13 FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 practice. As with any vaccine, there is the possibility that broad use of Prevnar 13 could reveal adverse reactions not observed in clinical trials.

Clinical Trials Experience With Prevnar 13 in Infants and Toddlers

The safety of Prevnar 13 was evaluated in 13 clinical trials in which 4,729 infants and toddlers received at least one dose of Prevnar 13 and 2,760 infants and toddlers received at least one dose of Prevnar active control. Safety data for the first three doses are available for all 13 infant studies; dose 4 data are available for 10 studies; and data for the 6-month follow-up are available for 7 studies. The vaccination schedule and concomitant vaccinations used in these infant trials were consistent with country-specific recommendations and local clinical practice. There were no substantive differences in demographic characteristics between the vaccine groups. By race, 84.0% of subjects were White, 6.0% were Black or African-American, 5.8% were Asian and 3.8% were of 'Other' race (most of these being biracial). Overall, 52.3% of subjects were male infants.

Three studies in the US evaluated the safety of Prevnar 13 when administered concomitantly with routine US pediatric vaccinations at 2, 4, 6, and 12-15 months of age. Solicited local and systemic adverse events were recorded daily by parents/guardians using an electronic diary for 7 consecutive days following each vaccination. For unsolicited adverse events, study subjects were monitored from administration of the first dose until one month after the infant series, and for one month after the administration of the toddler dose. Information regarding unsolicited and serious adverse events, newly diagnosed chronic medical conditions, and hospitalizations since the last visit were collected during the clinic visit for the fourth-study dose and during a scripted telephone interview 6 months after the fourth-study dose. Serious adverse events were also collected throughout the study period. Overall, the safety data show a similar proportion of Prevnar 13 and Prevnar subjects reporting serious adverse events. Among US study subjects, a similar proportion of Prevnar 13 and Prevnar recipients reported solicited local and systemic adverse reactions as well as unsolicited adverse events.

Serious Adverse Events in All Infant and Toddler Clinical Studies

Serious adverse events were collected throughout the study period for all 13 clinical trials. This reporting period is longer than the 30-day post-vaccination period used in some vaccine trials. The longer reporting may have resulted in serious adverse events being reported in a higher percentage of subjects than for other vaccines. Serious adverse events reported following vaccination in infants and toddlers occurred in 8.2% among Prevnar 13 recipients and 7.2% among Prevnar recipients. Serious adverse events observed during different study periods for Prevnar 13 and Prevnar respectively were: 1) 3.7% and 3.5% from dose 1 to the bleed approximately 1 month after the infant series; 2) 3.6% and 2.7% from the bleed after the infant series to the toddler dose; 3) 0.9% and 0.8% from the toddler dose to the bleed approximately 1 month after the toddler dose and 4) 2.5% and 2.8% during the 6 month follow up period after the last dose.

The most commonly reported serious adverse events were in the 'Infections and infestations' system organ class including bronchiolitis (0.9%, 1.1%), gastroenteritis, (0.9%, 0.9%), and pneumonia (0.9%, 0.5%) for Prevnar 13 and Prevnar respectively.

There were 3 (0.063%) deaths among Prevnar 13 recipients, and 1 (0.036%) death in Prevnar recipients, all as a result of sudden infant death syndrome (SIDS). These SIDS rates are consistent with published age specific background rates of SIDS from the year 2000.

Among 6,839 subjects who received at least 1 dose of Prevnar 13 in clinical trials conducted globally, there was 1 hypotonic-hyporesponsive episode adverse reaction reported (0.015%). Among 4,204 subjects who received at least 1 dose of Prevnar in clinical trials conducted globally, there were 3 hypotonic-hyporesponsive episode adverse reactions reported (0.071%). All 4 events occurred in a single clinical trial in Brazil in which subjects received whole cell pertussis vaccine at the same time as Prevnar 13 or Prevnar.

Solicited Adverse Reactions in the Three US Infant and Toddler Studies

A total of 1,907 subjects received at least 1 dose of Prevnar 13 and 701 subjects received at least 1 dose of Prevnar in the three US studies. Most subjects were White (77.3%), 14.2% were Black or African-American, and 1.7% were Asian; 79.1% of subjects were non-Hispanic and non-Latino and 14.6% were Hispanic or Latino. Overall, 53.6% of subjects were male infants.

The incidence and severity of solicited adverse reactions that occurred within 7 days following each dose of Prevnar 13 or Prevnar administered to US infants and toddlers are shown in Tables 3 and 4.

Table 3: Percentage of US Infant and Toddler Subjects Reporting Solicited Local Reactions at the Prevnar 13 or Prevnar Injection Sites Within 7 Days After Each Vaccination at 2, 4, 6, and 12-15 Months of Agea

Graded Local Reaction Dose 1 Dose 2 Dose 3 Dose 4
Prevnar 13
(Nb=1375- 1612)
%
Prevnar
(Nb=516- 606)
%
Prevnar 13
(Nb=1069- 1331)
%
Prevnar
(Nb=405- 510)
%
Prevnar 13
(Nb=998- 1206)
%
Prevnar
(Nb=348- 446)
%
Prevnar 13
(Nb=874- 1060)
%
Prevnar
(Nb=283- 379)
%
Rednessc
  Any 24.3 26.0 33.3 29.7 37.1 36.6 42.3 45.5
  Mild 23.1 25.2 31.9 28.7 35.3 35.3 39.5 42.7
  Moderate 2.2 1.5 2.7 2.2 4.6 5.1 9.6 13.4*
  Severe 0 0 0 0 0 0 0 0
Swellingc
  Any 20.1 20.7 25.2 22.5 26.8 28.4 31.6 36.0*
  Mild 17.2 18.7 23.8 20.5 25.2 27.5 29.4 33.8
  Moderate 4.9 3.9 3.7 4.9 3.8 5.8 8.3 11.2*
  Severe 0 0 0.1 0 0 0 0 0
Tenderness
  Any 62.5 64.5 64.7 62.9 59.2 60.8 57.8 62.5
  Interferes with limb movement 10.4 9.6 9.0 10.5 8.4 9.0 6.9 5.7
* Statistically significant difference p < 0.05. No adjustments for multiplicity.
a Data are from three primary US safety studies (the US phase II infant study [National Clinical Trial (NCT) number NCT00205803], the US noninferiority study [NCT00373958], and the US consistency study [NCT00444457]). All infants received concomitant routine infant immunizations. Concomitant vaccines and pneumococcal conjugate vaccines were administered in different limbs.
b Number of subjects reporting Yes for at least 1 day or No for all days.
c Diameters were measured in caliper units of whole numbers from 1 to 14 or 14+. One caliper unit = 0.5 cm. Measurements were rounded up to the nearest whole number. Intensity of induration and erythema were then characterized as Mild (0.5-2.0 cm), Moderate (2.5-7.0 cm), or Severe ( > 7.0 cm).

Table 4: Percentage of US Infant and Toddler Subjects Reporting Solicited Systemic Adverse Reactions Within 7 Days After Each Vaccination at 2, 4, 6, and 12-15 Months of Agea,b

Graded Systemic Events Dose 1 Dose 2 Dose 3 Dose 4
Prevnar 13
(Na=1360 -1707)
%
Prevnar
(Na=497- 640)
%
Prevnar 13
(Na=1084- 1469)
%
Prevnar
(Na=409- 555)
%
Prevnar 13
(Na=997- 1361)
%
Prevnar
(Na=354- 521)
%
Prevnar 13
(Na=850- 1227)
%
Prevnar
(Na=278- 436)
%
Feverc
  Any 24.3 22.1 36.5 32.8 30.3 31.6 31.9 30.6
  Mild 23.6 21.7 34.9 31.6 29.1 30.2 30.3 30.0
  Moderate 1.1 0.6 3.4 2.8 4.2 3.3 4.4 4.6
  Severe 0.1 0.2 0.1 0.3 0.1 0.7 1.0 0
Decreased appetite 48.3 43.6 47.8 43.6 47.6 47.6 51.0 49.4
Irritability 85.6 83.6 84.8 80.4 79.8 80.8 80.4 77.8
Increased sleep 71.5 71.5 66.6 63.4 57.7 55.2 48.7 55.1
Decreased sleep 42.5 40.6 45.6 43.7 46.5 47.7 45.3 40.3
a Number of subjects reporting Yes for at least 1 day or No for all days.
b Data are from three primary US safety studies (the US phase II infant study [NCT00205803], the US noninferiority study [NCT00373958], and the US consistency study [NCT00444457]). All infants received concomitant routine infant immunizations. Concomitant vaccines and pneumococcal conjugate vaccines were administered in different limbs.
c Fever gradings: Mild ( ≥ 38°C but ≤ 39°C), Moderate ( > 39°C but ≤ 40°C), and Severe ( > 40°C). No other systemic event other than fever was graded. Parents reported the use of antipyretic medication to treat or prevent symptoms in 62 to 75% of subjects after any of the 4 doses. There were no statistical differences between the Prevnar 13 and Prevnar groups.

Unsolicited Adverse Reactions in the Three US Infant and Toddler Safety Studies

The following were determined to be adverse drug reactions based on experience with Prevnar 13 in clinical trials.

Reactions occurring in greater than 1% of infants and toddlers: diarrhea, vomiting, and rash.

Reactions occurring in less than 1% of infants and toddlers: crying, hypersensitivity reaction (including face edema, dyspnea, and bronchospasm), seizures (including febrile seizures), and urticaria or urticaria-like rash.

Safety Assessments in the Catch-Up Studies in Infants and Children

In a catch-up study conducted in Poland, 354 children (7 months through 5 years of age) receiving at least one dose of Prevnar 13 were also monitored for safety. All subjects in this study were White and non-Hispanic. Overall, 49.6% of subjects were male infants. The incidence and severity of solicited adverse reactions that occurred within 4 days following each dose of Prevnar 13 administered to pneumococcal-vaccine na´ve children 7 months through 5 years of age are shown in Tables 5 and 6.

Table 5: Percentage of Subjects 7 Months Through 5 Years of Age Reporting Solicited Local Reactions Within 4 Days After Each Catch-Up Prevnar 13 Vaccination a

Graded Local Reaction 7 through 11 months 12 through 23 months 24 months through 5 years
Dose 1
Nb=86
%
Dose 2
Nb=86-87
%
Dose 3
Nb=78-82
%
Dose 1
Nb=108-110
%
Dose 2
Nb=98-106
%
Dose 1
Nb=147-149
%
Rednessc
  Any 48.8 46.0 37.8 70.0 54.7 50.0
  Mild 41.9 40.2 31.3 55.5 44.7 37.4
  Moderate 16.3 9.3 12.5 38.2 25.5 25.7
  Severe 0.0 0.0 0.0 0.0 0.0 0.0
Swellingc
  Any 36.0 32.2 25.0 44.5 41.0 36.9
  Mild 32.6 28.7 20.5 36.7 36.2 28.2
  Moderate 11.6 14.0 11.3 24.8 12.1 20.3
  Severe 0.0 0.0 0.0 0.0 0.0 0.0
Tenderness
  Any 15.1 15.1 15.2 33.3 43.7 42.3
  Interferes with limb movement 1.2 3.5 6.4 0.0 4.1 4.1
a Study conducted in Poland (NCT00452452).
b Number of subjects reporting Yes for at least 1 day or No for all days.
c Diameters were measured in caliper units of whole numbers from 1 to 14 or 14+. One caliper unit = 0.5 cm. Measurements were rounded up to the nearest whole number. Intensity of redness and swelling were then characterized as Mild (0.5-2.0 cm), Moderate (2.5-7.0 cm), or Severe ( > 7.0 cm).

Table 6: Percentage of Subjects 7 Months Through 5 Years of Age Reporting Solicited Systemic Adverse Reactions Within 4 Days After Each Catch-Up Prevnar 13 Vaccination a

Systemic Reaction 7 through 11 months 12 through 23 months 24 months through 5 years
Dose 1
Nb=86-87
%
Dose 2
Nb=86-87
%
Dose 3
Nb=78-81
%
Dose 1
Nb=108
%
Dose 2
Nb=98-100
%
Dose 1
Nb=147-148
%
Feverc
  Mild 3.4 8.1 5.1 3.7 5.1 0.7
  Moderate 1.2 2.3 1.3 0.9 0.0 0.7
  Severe 0.0 0.0 0.0 0.0 0.0 0.0
Decreased appetite 19.5 17.2 17.5 22.2 25.5 16.3
Irritability 24.1 34.5 24.7 30.6 34.0 14.3
Increased sleep 9.2 9.3 2.6 13.0 10.1 11.6
Decreased sleep 24.1 18.4 15.0 19.4 20.4 6.8
a Study conducted in Poland (NCT00452452).
b Number of subjects reporting Yes for at least 1 day or No for all days.
c Fever gradings: Mild ( ≥ 38°C but ≤ 39°C), Moderate ( > 39°C but ≤ 40°C), and Severe ( > 40°C). No other systemic event other than fever was graded.

A US study evaluated the use of Prevnar 13 in children previously immunized with Prevnar. In this open label trial, 284 healthy children 15 through 59 months of age previously vaccinated with at least 3 doses of Prevnar, received 1 or 2 doses of Prevnar 13. Children 15 months through 23 months of age (group 1) received 2 doses, and children 24 months through 59 months of age (group 2) received one dose. Most subjects were White (75.0%), 15.8% were Black or African-American, and 1.6% were Asian; 86.6% of subjects were non-Hispanic and non-Latino and 13.4% were Hispanic or Latino. Overall, 54.0% of subjects were male infants.

The incidence and severity of solicited adverse reactions that occurred within 7 days following one dose of Prevnar 13 administered to children 15 months through 59 months of age are shown in Tables 7 and 8.

Table 7: Percentage of Subjects 15 Months Through 59 Months of Age, Previously Vaccinated With 3 or 4 Prior Infant Doses of Prevnar, Reporting Solicited Local Reactions Within 7 Days After One Supplemental Prevnar 13 Vaccination

Graded Local Reaction 15 months through 23 monthsa 24 months through 59 monthsb
1 dose Prevnar 13
3 prior Prevnar doses
Nc=28-32
%
1 dose Prevnar 13
4 prior Prevnar doses
Nc=62-76
%
1 dose Prevnar 13
3 or 4 prior Prevnar doses
Nc=138-155
%
Rednessd
  Any 46.9 36.6 34.9
  Mild 31.0 31.4 31.5
  Moderate 22.6 7.9 9.9
  Severe 0.0 0.0 0.0
Swellingd
  Any 35.5 21.2 22.2
  Mild 26.7 18.8 20.3
  Moderate 13.8 7.7 5.7
  Severe 0.0 0.0 0.0
Tenderness
  Any 53.1 50.0 61.9
  Interferes with limb movement 10.3 6.3 10.6
a Dose 2 data not shown.
b The data for this age group are only represented as a single result as 95% of children received 4 doses of Prevnar prior to enrollment.
c Number of subjects reporting Yes for at least 1 day or No for all days.
d Diameters were measured in caliper units of whole numbers from 1 to 14 or 14+. One caliper unit = 0.5 cm. Measurements were rounded up to the nearest whole number. Intensity of redness and swelling were then characterized as Mild (0.5-2.0 cm), Moderate (2.5-7.0 cm), or Severe ( > 7.0 cm).
Note - Clinical trial.gov NCT number is as follows: NCT00761631.

Table 8: Percentage of US Subjects 15 Months Through 59 Months of Age, Previously Vaccinated With 3 or 4 Prior Infant Prevnar Doses, Reporting Solicited Systemic Adverse Reactions Within 7 Days After One Supplemental Prevnar 13 Vaccination

Systemic Reaction 15 through 23 monthsa 24 months through 59 monthsb
1 dose Prevnar 13
3 prior Prevnar doses
Nc=28-33
%
1 dose Prevnar 13
4 prior Prevnar doses
Nc=62-75
%
1 dose Prevnar 13
3 or 4 prior Prevnar doses
Nc=138-151
%
Feverd
  Mild 10.7 18.8 5.1
  Moderate 7.1 3.2 0.7
  Severe 0.0 0.0 0.7
Decreased appetite 56.7 36.2 24.8
Irritability 66.7 57.3 39.7
Increased sleep 30.0 33.8 15.9
Decreased sleep 22.6 22.7 14.0
a Dose 2 data not shown.
b The data for this age group are only represented as a single result as 95% of children received 4 doses of Prevnar prior to enrollment.
c Number of subjects reporting Yes for at least 1 day or No for all days.
d Fever gradings: Mild ( ≥ 38°C but ≤ 39°C), Moderate ( > 39°C but ≤ 40°C), and Severe ( > 40°C). No other systemic event other than fever was graded.
Note - Clinical trial.gov NCT number is as follows: NCT00761631.

Clinical Trials Experience With Prevnar 13 in Adults Aged ≥ 50 years

The safety of Prevnar 13 was assessed in 6 clinical studies conducted in the US and Europe which included 6,198 adults (5,667 received Prevnar 13) ranging in age from 50 through 95 years.

The 5,667 Prevnar 13 recipients included 2,616 adults who were aged 50 through 64 years and 3,051 adults aged 65 years and older. Of the 5,667 Prevnar 13 recipients, 3,751 adults had not previously received PPSV23 (“PPSV23 unvaccinated”) and 1,916 adults were previously vaccinated (“PPSV23 previously vaccinated”) with PPSV23 at least 3 years prior to enrollment.

Two of the 6 clinical studies supporting safety were randomized comparing the safety and immunogenicity of Prevnar 13 with PPSV23 as a single dose in PPSV23 unvaccinated adults aged 50 through 64 years (Study 1) and in adults ≥ 70 years PPSV23 previously vaccinated ( ≥ 5 years prior to enrollment) (Study 2). 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 through 64 years (Study 3). One clinical safety study (Study 4) of Prevnar 13, conducted in PPSV23 previously vaccinated ( ≥ 3 years prior to enrollment) adults aged ≥ 68 years was a single arm study. Two studies, one in the US (Study 5) in adults age 50 through 59 years and the other in Europe (Study 6) in adults aged ≥ 65 years, evaluated the concomitant administration of Prevnar 13 with trivalent inactivated influenza vaccine (Fluarix®, A/H1N1, A/H3N2, and B, Fall 2007/Spring 2008: TIV) in these two age groups in PPSV23 unvaccinated adults.

The total safety population in the 6 studies was 6,198. In 5 of the 6 studies, more females than males were enrolled (50.2% - 61.8%) . Across the 6 studies the racial distribution included : > 91% White; 0.2%-7.5% Black or African American; 0%-1.7% Asian ; < 1%, Native Hawaiian or other Pacific Islander; < 1%, American Indian; and < 1%, Alaskan Native. Ethnicity data were not collected in study 6; in the 5 other studies 0.6%-4.8% were Hispanic or Latino.

In five studies, persons with pre-existing underlying diseases were enrolled if the medical condition was stable (did not require a change in therapy or hospitalization for worsening disease for 12 weeks before receipt of study vaccine) except in study 4 where subjects were enrolled if the medical condition was stable for 6 or more weeks before receipt of study vaccine.

Persons were excluded from study participation due to prior receipt of diphtheria toxoid containing vaccines within 6 months of study vaccine. However, the time of prior receipt of a diphtheria toxoid containing vaccine was not recorded.

Solicited adverse reactions for Prevnar 13 were monitored by subjects recording local adverse reactions and systemic reactions daily using an electronic diary for 14 consecutive days following vaccination. Unsolicited serious and non-serious adverse events were collected for one month after each vaccination. In addition, serious adverse events were collected for an additional 5 months after each vaccination (at the 6-month follow-up phone contact) in all studies except Study 6.

Serious Adverse Events in Adult Clinical Studies

Across the 6 studies, serious adverse events within 1 month of vaccination were reported after an initial study dose in 0.2%-1.4% of 5055 persons vaccinated with Prevnar 13 and in 0.4%-1.7% of 1124 persons vaccinated after an initial study dose of PPSV23. From 1 month to 6 months after an initial study dose , serious adverse events were reported in 1.2%-5.8% of persons vaccinated during the studies with Prevnar 13 and in 2.4%-5.5% of persons vaccinated with PPSV23. One case of erythema multiforme occurred 34 days after receipt of a second dose of Prevnar 13.

Twelve of 5,667 (0.21%) Prevnar 13 recipients and 4 of 1,391 (0.28%) PPSV23 recipients died. 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 with Prevnar 13 and both deaths were in subjects > 65 years of age. One death due to cardiac failure occurred 3 days after receiving Prevnar 13 administered with TIV and 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).

Solicited Adverse Reactions in Adult Clinical Studies

The incidence and severity of solicited adverse reactions that occurred within 14 days following each dose of Prevnar 13 or PPSV23 administered to adults in 4 studies are shown in Tables 9, 10, 11, and 12. The commonly reported local adverse reactions after Prevnar 13 vaccination in PPSV23 unvaccinated and PPSV23 previously vaccinated adults were redness, swelling and pain at the injection site, or limitation of arm movement (Tables 9 and 10). The commonly reported systemic adverse reactions in PPSV23 unvaccinated and PPSV23 previously vaccinated adults were fatigue, headache, chills, rash, decreased appetite, or muscle pain and joint pain (Tables 11 and 12).

Table 9 : Percentage of Subjects With Solicited Local Reactions Within 14 Days After Vaccination with Prevnar 13 or PPSV23 in PPSV23 Unvaccinated Adults

Age in Years Study 1 Study 3
50-59 60-64 60-64
Local Reaction Prevnar 13a
Nb=152-322
%
Prevnar 13
Nb=193-331
%
PPSV23
Nb=190-301
%
Prevnar 13
Nb=270-370
%
PPSV23
Nb=134-175
%
Rednessc
  Any 15.8 20.2 14.2 12.2 11.2
  Mild 15.2 15.9 11.2 8.3 9.7
  Moderate 5.0 8.6 4.9 6.4 3.9
  Severe 0.7 1.7 0.0 1.2 0.8
Swellingd
  Any 21.7 19.3 13.1 10.0 10.4
  Mild 20.6 15.6 10.1 8.2 6.1
  Moderate 4.3 8.2 4.4 3.8 7.6
  Severe 0.0 0.6 1.1 0.0 0.0
Paine
  Any 88.8 80.1 73.4 69.2* 58.3
  Mild 85.9 >K 78.6 68.6 66.1* 52.9
  Moderate 39.5 23.3 30.0 20.1 21.7
  Severe 3.6 1.7 8.6* 2.3 0.8
Limitation of arm movemente
  Any 40.7 28.5 30.8 23.5 28.2
  Mild 38.6 26.9 29.3 22.7 26.1
  Moderate 2.9 2.2 3.8 1.2 3.1
  Severe 2.9 1.7 4.3 1.1 2.3
*Statistically significant difference p < 0.05. No adjustments for multiplicity.
a Open label administration of Prevnar 13.
b Number of subjects with known values.
c Diameters were measured in caliper units of whole numbers from 1 to 21 or 21+. One caliper unit = 0.5 cm. Measurements were rounded up to the nearest whole number. Intensity of redness and swelling were then characterized as Mild = 2.5 to 5.0 cm, Moderate = 5.1 to 10.0 cm, and severe is > 10.0 cm.
d Mild = awareness of symptom but easily tolerated, moderate = discomfort enough to cause interference with usual activity, severe = incapacitating with inability to do usual activity.
e 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.
Note - Clinical trial.gov NCT numbers are as follows: Study 1 NCT00427895, Study 3 NCT00574548.

Table 10 : Percentage of Subjects With Solicited Local Reactions Within 14 Days After Vaccination With Prevnar 13 or PPSV23 in PPSV23 Previously Vaccinated Adults

Age in Years Study 2 Study4
≥ 70 ≥ 68
Local Reaction Prevnar 13
Nb=306-362
%
PPSV23
Nb=324-383
%
Prevnar 13
Nb=664-777
%
Rednessc
  Any 10.8 22.2 14.3
  Mild 9.5 13.5 12.6
  Moderate 4.7 11.5 6.5
  Severe 1.7 4.8 1.1
Swellingd
  Any 10.4 23.1* 12.8
  Mild 8.9 14.0* 10.9
  Moderate 4.0 13.6* 5.5
  Severe 0.0 4.8* 0.6
Paine
  Any 51.7 58.5 51.0
  Mild 50.1 54.1 49.4
  Moderate 7.5 23.6* 9.0
  Severe 1.3 2.3 0.2
Limitation of arm movemente
   Any 10.5 27.6* 16.2
  Mild 10.3 25.2* 14.8
  Moderate 0.3 2.6* 1.6
  Severe 0.7 3.0* 1.6
*Statistically significant difference p < 0.05. No adjustments for multiplicity .
a Open label administration of Prevnar 13.
b Num.ber of subjects with known values.
c Diameters were measured in caliper units of whole numbers from 1 to 21 or 21+. One caliper unit = 0.5 cm. Measurements were rounded up to the nearest whole number. Intensity of redness and swelling were then characterized as Mild = 2.5 to 5.0 cm, Moderate = 5.1 to 10.0 cm, and severe is > 10.0 cm.
d Mild = awareness of symptom but easily tolerated, moderate = discomfort enough to cause interference with usual activity, severe = incapacitating with inability to do usual activity.
e 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
Note - Clinical trial.gov NCT numbers are as follows: Study 2 NCT00546572, Study 4 NCT00500266.

Table 11 : Percentage of Subjects With Solicited Systemic Events Within 14 Days After Vaccination With Prevnar 13 or PPSV23 in PPSV23 Unvaccinated Adults

Age in Years Study 1 Study 3
50-59 60-64 60-64
Prevnar 13
Nb=137-248
%
Prevnar 13
Nb=180-277
%
PPSV23
Nb=185-273
%
Prevnar 13
Nb=263-324
%
PPSV23
Nb=127-173
%
Systemic Event
Fever          
   ≥ 100.4°F 1.5 4.0 1.1 4.2 1.6
  100.4°F to 101.1°F 1.5 4.0 1.1 3.8 0.8
  101.2°F to 102.0°F 0.0 0.6 0.0 0.8 0.0
  102.1°F to 104.0°F 0.0 0.0 0.0 0.4 0.8
   > 104.0°F 0.0 0.0 0.0 0.0 0.0
Fatigue 63.3 63.2 61.5 50.5 49.1
Headache 65.9 54.0 54.4 49.7 46.1
Chills 19.6 23.5 24.1 19.9 26.9
Rash 14.2 16.5 13.0 8.6 13.4
Vomiting 6.9 3.9 5.4 3.1 3.1
Decreased appetite 25.3 21.3 21.7 14.7 23.0*
Generalized new muscle pain 61.8 56.2 57.8 46.9 51.5
Generalized aggravated muscle pain 39.9 32.6 37.3 22.0 32.5*
Generalized new joint pain 31.5 24.4 30.1 15.5 23.8*
Generalized aggravated joint pain 25.6 24.9 21.4 14.0 21.1
* Statistically significant difference p < 0.05. No adjustments for multiplicity.
a Open label administration of Prevnar 13.
b Number of subjects with known values.
Note - Clinical trial.gov NCT numbers are as follows: Study 1 NCT00427892, Study 3 NCT00574548

Table 12 : Percentage of Subjects With Systemic Events Within 14 Days After Vaccination With Prevnar 13 or PPSV23 in PPSV23 Previously Vaccinated Adults

Age in Years Study2 Study 4
≥ 70 ≥ 68
Prevnar 13
Nb=299-350
%
PPSV23
Nb=304-367
%
Prevnar 13a
Nb=638-733
%
Systemic Event
Fever      
   ≥ 100.4°F 1.0 2.3 1.1
  100.4°F to 101.1°F 1.0 2.0 0.8
  101.2°F to 102.0°F 0.0 0.0 0.0
  102.1°F to 104.0°F 0.0 0.3 0.3
   > 104.0°F 0.0 0.0 0.0
Fatigue 34.0 43.3* 34.4
Headache 23.7 26.0 26.1
Chills 7.9 11.2 7.5
Rash 7.3 16.4* 8.4
Vomiting 1.7 1.3 0.9
Decreased appetite 10.4 11.5 11.2
Generalized new muscle pain 36.8 44.7* 25.3
Generalized aggravated muscle pain 20.6 27.5* 12.3
Generalized new joint pain 12.6 14.9 12.8
Generalized aggravated joint pain 11.6 16.5 9.7
*Statistically significant difference p < 0.05. No adjustments for multiplicity.
a Open label administration of Prevnar 13.
b Number of subjects with known values.
Note - Clinical trial.gov NCT numbers are as follows: Study 2 NCT00546572, Study 4 NCT00500266

Solicited Adverse Reactions in Adult Clinical Studies of Concomitant Administration of Prevnar 13 and TIV (Fluarix)

The safety of concomitant administration of Prevnar 13 with TIV was assessed in 2 studies in PPSV23 unvaccinated adults aged 50 through 59 years (Study 5) and aged ≥ 65 years (Study 6).

Frequencies of local reactions within 14 days postvaccination in adults aged 50 through 59 years and in adults aged ≥ 65 years were similar after Prevnar 13 was administered with TIV compared to Prevnar 13 administered alone, with the exception of mild redness at the injection site, which was increased when Prevnar 13 was administered concomitantly with TIV.

An increase in some solicited systemic reactions within 14 days postvaccination was noted when Prevnar 13 was administered concomitantly with TIV compared with TIV given alone (headache, chills, rash, decreased appetite, muscle and joint pain) or with Prevnar 13 given alone (fatigue, headache, chills, decreased appetite, and joint pain).

Clinical Trials Experience With Prevnar in Infants and Toddlers

The safety experience with Prevnar is relevant to Prevnar 13 because the two vaccines share common components.

Generally, the adverse reactions reported in clinical trials with Prevnar 13 were also reported in clinical trials with Prevnar.

Overall, the safety of Prevnar was evaluated in a total of five clinical studies in the U.S. in which 18,168 infants and children received a total of 58,699 doses of vaccine at 2, 4, 6, and 12- 15 months of age.

Adverse events reported in clinical trials with Prevnar that occurred within 3 days of vaccination in infants and toddlers and resulted in emergency room visits or hospitalizations, but were not presented in Section 6.1 as adverse reactions for Prevnar 13 are listed below; Bronchiolitis, UTI, acute gastroenteritis, asthma, aspiration, breath holding, influenza, inguinal hernia repair, viral syndrome, URI, croup, thrush, wheezing, choking, conjunctivitis, pharyngitis, colic, colitis, congestive heart failure, roseola, sepsis.

Post-marketing Experience With Prevnar in Infants and Toddlers

The following adverse events have been reported through passive surveillance since market introduction of Prevnar and therefore, are considered adverse events for Prevnar 13 as well. Because these events 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 the vaccine.

Administration site conditions: Injection-site dermatitis, injection-site pruritus, injection-site urticaria

Blood and lymphatic system disorders: Lymphadenopathy localized to the region of the injection site

Immune system disorders: Anaphylactic/anaphylactoid reaction including shock

Skin and subcutaneous tissue disorders: Angioneurotic edema, erythema multiforme

Respiratory: Apnea

Post-marketing Safety Study

The safety of Prevnar given concomitantly with other vaccines as part of routine care was assessed in a three-year observational study performed at Northern California Kaiser Permanente (NCKP) in which 65,927 children received three doses of Prevnar in the first year of life. Primary safety outcomes analyses included an evaluation of pre-defined adverse events occurring in temporal relationship to immunization. Rates of adverse events occurring within various time periods post-vaccination (e.g., 0-2, 0-7, 0-14, and 0-30 days) were compared to the rates of those events occurring within a control time window (i.e., 31-60 days). Secondary safety outcomes analyses included comparisons to a historical control population of infants (1995-1996, N=40,223) prior to the introduction of Prevnar. In addition, the study included extended follow-up of subjects originally enrolled in the NCKP efficacy trial (N=37,866).

The primary safety outcomes analyses did not demonstrate a consistently elevated risk of healthcare utilization for croup, gastroenteritis, allergic reactions, seizures, wheezing diagnoses, or breath-holding across doses, healthcare settings, or multiple time windows. As in prelicensure trials, fever was associated with Prevnar administration. In analyses of secondary safety outcomes, the adjusted relative risk of hospitalization for reactive airways disease was 1.23 (95% CI: 1.11, 1.35). Potential confounders, such as differences in concomitantly administered vaccines, yearly variation in respiratory infections, or secular trends in reactive airways disease incidence, could not be controlled. Extended follow-up of subjects originally enrolled in the NCKP efficacy trial revealed no increased risk of reactive airways disease among Prevnar recipients. In general, the study results support the previously described safety profile of Prevnar.

Read the entire FDA prescribing information for Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein] Suspension for Intramuscular Injection) »

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