Vaccine Information: PREVNAR 13
PREVNAR 13- streptococcus pneumoniae type 1 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 3 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 4 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 5 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 6a capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 6b capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 7f capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 9v capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 14 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 18c capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 23f capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 19a capsular polysaccharide diphtheria crm197 protein conjugate antigen and streptococcus pneumoniae type 19f capsular polysaccharide diphtheria crm197 protein conjugate antigen injection, suspension
Wyeth Pharmaceutical Division of Wyeth Holdings LLC
1 INDICATIONS AND USAGE
1.1 Children 6 Weeks Through 5 Years of Age
In children 6 weeks through 5 years of age (prior to the 6th birthday), Prevnar 13® is indicated for:
- •
- active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae s erotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
- •
- active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. No otitis media efficacy data are available for serotypes 1, 3, 5, 6A, 7F, and 19A.
1.2 Children 6 Years Through 17 Years of Age
In children 6 years through 17 years of age (prior to the 18th birthday), Prevnar 13 is indicated for:
- •
- active immunization for the prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
1.3 Adults 18 Years of Age and Older
- In adults 18 years of age and older, Prevnar 13 is indicated for:
- •
- active immunization for the prevention of pneumonia and invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
1.4 Limitations of Prevnar 13 Use and Effectiveness
- •
- Prevnar 13 does not protect against disease caused by S. pneumoniae serotypes that are not in the vaccine.
2 DOSAGE AND ADMINISTRATION
2.1 Preparation for Administration
Since this product is a suspension containing an adjuvant, shake vigorously immediately prior to use to obtain a homogenous, white suspension in the vaccine container. Do not use the vaccine if it cannot be resuspended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration [see Description (11)]. This product should not be used if particulate matter or discoloration is found.
Do not mix Prevnar 13 with other vaccines/products in the same syringe.
2.2 Administration Information
For intramuscular injection only.
Each 0.5 mL dose is to be injected intramuscularly using a sterile needle attached to the supplied prefilled syringe. The preferred sites for injection are the anterolateral aspect of the thigh in infants and the deltoid muscle of the upper arm in toddlers, children and adults. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk and/or blood vessel.
2.3 Vaccination Schedule for Infants and Toddlers
Prevnar 13 is to be administered as a four-dose series at 2, 4, 6, and 12–15 months of age.
Dose | Dose 1 * , † | Dose 2 † | Dose 3 † | Dose 4 ‡ |
---|---|---|---|---|
Age at Dose | 2 months | 4 months | 6 months | 12–15 months |
2.4 Vaccination Schedule for Unvaccinated Children 7 Months Through 5 Years of Age
For children 7 months through 5 years of age who have not received Prevnar® or Prevnar 13, the catch-up schedule in Table 2 applies:
Age at First Dose | Total Number of 0.5 mL Doses |
---|---|
7–11 months of age | 3* |
12–23 months of age | 2† |
24 months through 5 years of age (prior to the 6th birthday) | 1 |
The immune responses induced by this catch-up schedule may result in lower antibody concentrations for some serotypes, compared to antibody concentrations following 4 doses of Prevnar 13 (given at 2, 4, 6, and 12–15 months). In children 24 months through 5 years of age, lower antibody concentrations were observed for some serotypes, compared to antibody concentrations following 3 doses of Prevnar 13 (given at 2, 4, and 6 months).
2.5 Vaccination Schedule for Children 6 Years Through 17 Years of Age
In children 6 years through 17 years of age, Prevnar 13 is administered as single dose. If Prevnar was previously administered, then at least 8 weeks should elapse before receiving Prevnar 13.
2.6 Vaccination Schedule for Adults 18 Years of Age and Older
- Prevnar 13 is administered as a single dose.
3 DOSAGE FORMS AND STRENGTHS
Prevnar 13 is a suspension for intramuscular injection available in 0.5 mL single-dose prefilled syringes.
4 CONTRAINDICATIONS
- Severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 13 or any diphtheria toxoid-containing vaccine [see Description (11)].
5 WARNINGS AND PRECAUTIONS
5.1 Management of Allergic Reactions
Epinephrine and other appropriate agents used to manage immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur following administration of Prevnar 13.
5.2 Altered Immunocompetence
Individuals with altered immunocompetence, including those at higher risk for invasive pneumococcal disease (e.g., individuals with congenital or acquired splenic dysfunction, HIV infection, malignancy, hematopoietic stem cell transplant, nephrotic syndrome), may have reduced antibody responses to immunization with Prevnar 13 [see Use in Specific Populations (8.6)].
5.3 Apnea in Premature Infants
Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including Prevnar 13, to infants born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination.
6 ADVERSE REACTIONS
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.
6.1 Clinical Trials Experience With Prevnar 13 in Children 6 Weeks Through 17 Years of Age
The safety of Prevnar 13 was evaluated in 13 clinical trials in which 4,729 infants (6 weeks through 11 months of age) and toddlers (12 months through 15 months of age) 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 (Studies 1, 2 and 3)1,2,3 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 reactions 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 period 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 blood draw approximately 1 month after the infant series; 2) 3.6% and 2.7% from the blood draw after the infant series to the toddler dose; 3) 0.9% and 0.8% from the toddler dose to the blood draw 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 (Studies 1, 2 and 3)1,2,3. 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.
Dose 1 | Dose 2 | Dose 3 | Dose 4 | |||||
---|---|---|---|---|---|---|---|---|
Graded Local Reaction | Prevnar 13 (N † =1375–1612) % | Prevnar (N † =516–606) % | Prevnar 13 (N † =1069–1331) % | Prevnar (N † =405–510) % | Prevnar 13 (N † =998–1206) % | Prevnar (N † =348–446) % | Prevnar 13 (N † =874–1060) % | Prevnar (N † =283–379) % |
| ||||||||
Redness ‡ | ||||||||
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 |
Swelling ‡ | ||||||||
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 |
Dose 1 | Dose 2 | Dose 3 | Dose 4 | |||||
---|---|---|---|---|---|---|---|---|
Graded Systemic Events | Prevnar 13 (N * =1360 – 1707) % | Prevnar (N * =497–640) % | Prevnar 13 (N * =1084–1469) % | Prevnar (N * =409–555) % | Prevnar 13 (N * =997–1361) % | Prevnar (N * =354–521) % | Prevnar 13 (N * =850–1227) % | Prevnar (N * =278–436) % |
| ||||||||
Fever ‡ | ||||||||
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 |
The incidence rates of any fever (≥38.0°C) were similar on days 1 and 2 following each dose of Prevnar 13 compared to after each dose of Prevnar administered to US infants and toddlers (day 1 = day of vaccination). After dose 1, fever was reported in 11.0–12.7% on day 1 and 6.4–6.8% on day 2. After dose 2, fever was reported in 12.3–13.1% on day 1 and 12.5–12.8% on day 2. After dose 3, fever was reported in 8.0–9.6% on day 1 and 9.1–10.5% on day 2. And after dose 4, fever was reported in 6.3–6.4% on day 1 and 7.3–9.7% on day 2.
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 Through 5 Years of Age
In a catch-up study4 conducted in Poland (Study 4), 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 naïve children 7 months through 5 years of age are shown in Tables 5 and 6.
7 through 11 months | 12 through 23 months | 24 months through 5 years | ||||
---|---|---|---|---|---|---|
Graded Local Reaction | Dose 1 N † =86 % | Dose 2 N † =86–87 % | Dose 3 N † =78–82 % | Dose 1 N † =108–110 % | Dose 2 N † =98–106 % | Dose 1 N † =147–149 % |
| ||||||
Redness ‡ | ||||||
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 |
Swelling ‡ | ||||||
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 |
7 through 11 months | 12 through 23 months | 24 months through 5 years | ||||
---|---|---|---|---|---|---|
Systemic Reaction | Dose 1 N † =86–87 % | Dose 2 N † =86–87 % | Dose 3 N † =78–81 % | Dose 1 N † =108 % | Dose 2 N † =98–100 % | Dose 1 N † =147–148 % |
Fever ‡ | ||||||
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 US study5 (Study 5) evaluated the use of Prevnar 13 in children previously immunized with Prevnar. In this open label trial, 596 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 (74.3%), 14.9% were Black or African-American, and 1.2% were Asian; 89.3% of subjects were non-Hispanic and non-Latino and 10.7% were Hispanic or Latino. Overall, 52.2% of subjects were male.
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.
15 months through 23 months † | 24 months through 59 months ‡ | ||
---|---|---|---|
Graded Local Reaction | 1 dose Prevnar 13 3 prior Prevnar doses N § =67–72 % | 1 dose Prevnar 13 4 prior Prevnar doses N § =154–184 % | 1 dose Prevnar 13 3 or 4 prior Prevnar doses N § =209–238 % |
| |||
Redness ¶ | |||
Any | 26.4 | 28.2 | 35.4 |
Mild | 18.8 | 24.3 | 31.1 |
Moderate | 11.4 | 7.5 | 12.1 |
Severe | 1.5 | 0.0 | 0.0 |
Swelling ¶ | |||
Any | 23.9 | 19.6 | 20.7 |
Mild | 18.6 | 16.4 | 17.2 |
Moderate | 8.8 | 8.1 | 7.5 |
Severe | 0.0 | 0.0 | 0.0 |
Tenderness | |||
Any | 48.6 | 47.3 | 62.6 |
Interferes with limb movement | 5.9 | 6.4 | 10.7 |
15 through 23 months † | 24 months through 59 months ‡ | ||
---|---|---|---|
Systemic Reaction | 1 dose Prevnar 13 3 prior Prevnar doses N § =66–75 % | 1 dose Prevnar 13 4 prior Prevnar doses N § =154–189 % | 1 dose Prevnar 13 3 or 4 prior Prevnar doses N § =209–236 % |
| |||
Fever ¶ | |||
Any | 19.1 | 19.9 | 8.1 |
Mild | 16.2 | 17.4 | 7.6 |
Moderate | 6.1 | 3.9 | 1.9 |
Severe | 0.0 | 0.0 | 0.5 |
Decreased appetite | 44.4 | 39.3 | 28.1 |
Irritability | 73.3 | 65.1 | 45.8 |
Increased sleep | 35.2 | 35.3 | 18.8 |
Decreased sleep | 25.0 | 29.7 | 14.8 |
Clinical Trials Experience With Prevnar 13 in Children 5 Through 17 Years of Age
In a US study5 (Study 5), the safety of Prevnar 13 was evaluated in children 5 through 9 years of age previously immunized with at least one dose of Prevnar, and in children 10 through 17 years of age with no prior pneumococcal vaccination. In this open label trial, 592 children, including those with asthma, received a single dose of Prevnar 13. The percentage of children 5 through 9 years of age who received 3 and 4 prior doses of Prevnar was 29.1% and 54.5% respectively.
Most subjects were White (72.8%), 21.8% were Black or African-American, and 1.5% were Asian; 91.4% of subjects were non-Hispanic and non-Latino and 8.6% were Hispanic or Latino. Overall, 51.2% of subjects were male.
The incidence and severity of solicited adverse reactions that occurred within 7 days following one dose of Prevnar 13 administered to children 5 through 17 years of age are shown in Tables 9 and 10.
Vaccine Group (as Administered) | ||||||
---|---|---|---|---|---|---|
Prevnar 13 (5 Through 9 Years) | Prevnar 13 (10 Through 17 Years) | |||||
Local Reaction | N † | n ‡ | % | N † | n ‡ | % |
| ||||||
Redness | ||||||
Any | 233 | 100 | 42.9 | 232 | 70 | 30.2 |
Mild § | 226 | 63 | 27.9 | 226 | 48 | 21.2 |
Moderate § | 218 | 48 | 22.0 | 221 | 31 | 14.0 |
Severe § | 212 | 7 | 3.3 | 213 | 4 | 1.9 |
Swelling | ||||||
Any | 226 | 85 | 37.6 | 233 | 86 | 36.9 |
Mild § | 220 | 48 | 21.8 | 221 | 50 | 22.6 |
Moderate § | 219 | 48 | 21.9 | 226 | 48 | 21.2 |
Severe § | 211 | 7 | 3.3 | 214 | 4 | 1.9 |
Tenderness | ||||||
Any | 265 | 230 | 86.8 | 283 | 252 | 89.0 |
Significant ¶ | 221 | 43 | 19.5 | 242 | 106 | 43.8 |
Vaccine Group (as Administered) | ||||||
---|---|---|---|---|---|---|
Prevnar 13 (5 Through 9 Years) | Prevnar 13 (10 Through 17 Years) | |||||
Systemic Event | N † | n ‡ | % | N † | n ‡ | % |
| ||||||
Any fever ≥38°C | 214 | 13 | 6.1 | 214 | 12 | 5.6 |
Mild § | 212 | 9 | 4.2 | 214 | 11 | 5.1 |
Moderate § | 212 | 5 | 2.4 | 212 | 1 | 0.5 |
Severe § | 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 |
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