In a Phase 3 active-controlled, modified double-blind clinical trial7 (Study 7) of Prevnar 13 in the US and Sweden, PPSV23 previously vaccinated adults aged ≥70 years who had received one dose of PPSV23 ≥5 years prior were randomly assigned (1:1) to receive either Prevnar 13 or PPSV23. The assay used for this determination was a standardized ELISA involving pre-absorption of the test sera with pneumococcal C-polysaccharide and serotype 22F polysaccharide to reduce non-specific background reactivity. 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. Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention. The data show that 3 doses of acetaminophen (the first dose administered at the time of each vaccination and the subsequent doses at 6 to 8 hour intervals) reduced the antibody response to some serotypes following the third dose of Prevnar 13, compared with responses among infants who received antipyretics only as needed for treatment. 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. 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. In five studies,6–8,10,11 subjects 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 9 where subjects were enrolled if the medical condition was stable for 6 or more weeks before receipt of study vaccine. Medical conditions: Parents of children who were born prematurely or have problems with blood clotting or bleeding, a weakened immune system (due to conditions such as HIV, cancer, spleen problems, or medications that suppress the immune system such as those used for cancer, rheumatoid arthritis, or organ transplants) should discuss with their doctor how this vaccine may affect their child's medical condition, how their child's medical condition may affect the dosing and effectiveness of this vaccine, and whether any special monitoring is needed. mcOPA antibody GMTs for serotype 6A were statistically significantly greater after Prevnar 13 compared with after PPSV23. 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%). Noninferiority was demonstrated for each pneumococcal serotype if the lower limit of the 2-sided 95% CI for the GMT ratio (Prevnar 13 + IIV4 relative to Prevnar 13 alone) was >0.5. Safety Assessments in the Catch-Up Studies in Infants and Children Through 5 Years of Age. Co-primary endpoints included the percentage of subjects with serum pneumococcal anti-capsular polysaccharide IgG ≥0.35 µg/mL measured one month after the third dose and serum pneumococcal anti-capsular polysaccharide IgG geometric mean concentrations (GMCs) one month after the fourth dose. Clinical Trials Conducted in PPSV23 Previously Vaccinated 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. The data following one dose of Prevnar 13 in children 24 months through 59 months of age are shown in Table 21. It is used to prevent pneumonia (lung infection), meningitis (brain lining infection), pleural empyema (pus buildup in the space between the lung and the chest wall), bacteremia (bacterial blood infection) and sepsis (a life-threatening infection causing rapid breathing and heart rate, organ shutdown, and dangerously low blood pressure) caused by various types of pneumococcal bacteria. And after dose 4, fever was reported in 6.3–6.4% on day 1 and 7.3–9.7% on day 2. Help protect yourself against Streptococcus pneumoniae with Prevnar 13, a single-shot* vaccine in adults. Can Commun Dis Rep. 2008;34(ACS-5):1-12. Noninferiority was demonstrated if the lower limit of the 2-sided 95% CI for the HAI GMT ratio (Prevnar 13 + IIV4 relative to IIV4 + Placebo) was >0.5. ©2020 Rexall Pharmacy Group Ltd. This product's label may have been updated. Clinical Trials Experience With Prevnar 13 in Children 5 Through 17 Years of Age. Pneumococcal 13-valent vaccine works by exposing you to a small amount of the bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease. 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%). Immune responses (IgG GMCs) after the first dose of Prevnar 13 were numerically higher for all serotypes compared with baseline. OPA antibody GMTs for serotype 6A were statistically significantly greater after Prevnar 13 compared with after PPSV23 (see Table 25). 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). Mild infections without fever, such as colds, usually do not require delay of the vaccine. In this study, the efficacy of Prevnar against invasive disease due to S. pneumoniae in cases accrued during this period was 100% in both the per-protocol and intent-to-treat analyses (95% confidence interval [CI]: 75.4%, 100% and 81.7%, 100%, respectively). Prevnar 13 was administered to PPSV23 previously vaccinated adults ≥50 years of age concomitantly with a US-licensed inactivated influenza vaccine, quadrivalent (IIV4) (Fluzone Quadrivalent) for the 2014/2015 influenza season (Study 13) [see Adverse Reactions (6.2) and Drug Interactions (7.1)]. A total of 84,496 subjects received either a single dose of Prevnar 13 (42,240) or placebo (42,256) in a 1:1 randomization. In addition, the lower limit of the 95% confidence interval for the mcOPA antibody GMT ratio (Prevnar 13/PPSV23) was greater than 1 for 9 of the serotypes in common. If you miss an appointment to receive the pneumococcal vaccine, contact your doctor as soon as possible to reschedule your appointment. PREVNAR 13 ® should not be given to anyone with a severe allergic reaction to any component of PREVNAR 13 ® or any diphtheria toxoid–containing vaccine. Individuals with Hematopoietic Stem Cell Transplant. Overall across the clinical studies evaluating the immunogenicity of Prevnar 13 in adults, persons 18 through 64 years of age responded at least as well as persons 65 years and older, the age group evaluated in a clinical endpoint efficacy trial. In a US study5 (Study 5), a single dose of Prevnar 13 was administered to children 5 through 9 years of age, who were previously vaccinated with at least one dose of Prevnar, and to pneumococcal vaccine-naïve children 10 through 17 years of age. If Prevnar was previously administered, then at least 8 weeks should elapse before receiving Prevnar 13. 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. Submissions without photos may not be accepted. This statement will supplement previous conjugate pneumococcal statements Footnote from 1-to Footnote 3 and provide information regarding a newly authorized indication for the use of the 13-valent conjugate vaccine against pneumococcal disease, Prevnar®13 (PNEU-C-13): As of January 2012, PNEU-C-13 has been authorized for use in adults aged 50 years … Study 1212 was a randomized double-blind placebo-controlled study conducted in the Netherlands in community-dwelling adults aged 65 years and older with no prior pneumococcal vaccination history. In a study in rabbits, no vaccine-related effects were found regarding reproductive performance including female fertility [see Use in Specific Populations (8.1)]. In addition, the lower limit of the 95% confidence interval for the mcOPA antibody GMT ratio (Prevnar 13/PPSV23) was greater than 1 for 8 of the serotypes in common. A US study5 (Study 5) evaluated the use of Prevnar 13 in children previously immunized with Prevnar. change one of the medications to another, change how you are taking one or both of the medications, or. The first three doses of Prevnar 13 were administered one month apart, followed by a fourth dose of Prevnar 13 six months after the third dose. Among the 84,496 subjects, 58,072 (68.7%) were ≥65 to <75 years of age, 23,481 (27.8%) were ≥75 and <85 years of age, and 2,943 (3.5%) were ≥85 years of age. Serious adverse events were collected throughout the study period for all 13 clinical trials. PREVNAR 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 Protein]) This product information is intended only for residents of the United States. Prefilled Syringe, 1 Dose (1 per package) – NDC 0005-1971-05. Do not freeze. In Study 3, subjects were randomly assigned to receive one of 3 lots of Prevnar 13 or Prevnar in a 2:2:2:1 ratio. This vaccine contains 13 different types of pneumococcal bacteria. You know PREVNAR 13 ® can help protect you from 13 strains of bacteria that cause pneumococcal pneumonia. The pneumococcal conjugate 13-valent (Pneu-C-13) vaccine, Prevnar®13, is authorized for use for the prevention of IPD; specifically for the active immunization against Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. In an open-label, single-arm, descriptive study, 3 doses of Prevnar 13 were administered 6 months apart to HIV-infected adults ≥18 years of age (median age 48 years), with CD4 counts ≥200 cells/µL and serum HIV RNA titer <50,000 copies/mL. What other drugs could interact with this medication? Similarly, in exploratory analyses in PPSV23 previously vaccinated adults ≥70 years of age in Study 7, diminished mcOPA antibody GMTs were observed in those that received Prevnar 13 one year after PPSV23 when compared to those who received Prevnar 13 alone. Pneumococcal vaccine 13-valent (PCV13) is indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F Pneumovax 23: Pneumococcal vaccine belongs to the class of medications called vaccines. In an active-controlled modified1 double-blind clinical trial6 (Study 6) of Prevnar 13 in the US, PPSV23 unvaccinated adults aged 60 through 64 years were randomly assigned (1:1) to receive Prevnar 13 or PPSV23. If S. pneumoniae was isolated, serotyping was performed; the primary endpoint was efficacy against AOM episodes caused by vaccine serotypes in the per-protocol population. Prevnar 13 is a suspension for intramuscular injection available in 0.5 mL single-dose prefilled syringes. Clinical trials have been conducted in the US using a 2, 4, 6, and 12–15 month schedule. Overall, 54.0% of subjects were male infants. The safety of Prevnar 13 was assessed in 7 clinical studies (Studies 6–12) 6–12 conducted in the US and Europe which included 91,593 adults (48,806 received Prevnar 13) ranging in age from 18 through 101 years. Study 66 evaluated the safety and immunogenicity of Prevnar 13 in adults 18 through 64 years of age who had not received a previous dose of pneumococcal vaccine. It is important to remember that vaccination only protects a person from those bacteria that are actually contained in the vaccine. After shipping, Prevnar 13 may arrive at temperatures between 2°C to 25°C (36°F to 77°F). For serotype 6A, which is unique to Prevnar 13, the proportion of subjects with a ≥4-fold increase after Prevnar 13 (88.5%) was statistically significantly greater than after PPSV23 (49.3%) in PPSV23-unvaccinated adults aged 60 through 64 years. Rodriguez R. Safety of pneumococcal revaccination. Fever: A doctor may decide to delay this vaccine if the person receiving the vaccine has an acute infection or fever. Talk to your health care professional if you plan to get ZOSTAVAX ® (Zoster Vaccine Live) at the same time as PNEUMOVAX 23 because it may be better to get these vaccines at least 4 weeks apart. After dose 1, fever was reported in 11.0–12.7% on day 1 and 6.4–6.8% on day 2. Each study included healthy adults and immunocompetent adults with stable underlying conditions including chronic cardiovascular disease, chronic pulmonary disease, renal disorders, diabetes mellitus, chronic liver disease, and medical risk conditions and behaviors (e.g., alcoholism and smoking) that are known to increase the risk of serious pneumococcal pneumonia and invasive pneumococcal disease. PNEUMOCOCCAL VACCINE is a vaccine used to prevent pneumococcus bacterial infections. This medication belongs to a group of medications known as vaccines. In this open label trial, 592 children, including those with asthma, received a single dose of Prevnar 13. In children from 6 weeks to 5 years of age, it helps protect against diseases such as bacteraemic pneumonia (lung infection with bacteria in the blood stream), sepsis or bacteraemia … Streptococcus pneumoniae Immunization. HAI GMTs were evaluated for each IIV4 strain in Study 13. Data are not available to assess the effects of Prevnar 13 on the breastfed infant or on milk production/excretion. The importance of completing the immunization series unless contraindicated. Six Phase 3 or Phase 4 clinical trials6–8,10,11,13 were conducted in the US and Europe evaluating the immunogenicity of Prevnar 13 in different adult age groups, in individuals who were either not previously vaccinated with PPSV23 (PPSV23 unvaccinated) or who had received one dose of PPSV23 (PPSV23 previously vaccinated). Prior receipt of PPSV23 within 1 year results in diminished immune responses to Prevnar 13 compared to PPSV23 naïve individuals [see Clinical Studies (14.3)]. 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. In an open-label, single-arm, descriptive study, 2 doses of Prevnar 13 were administered 6 months apart to children ≥6 to <18 years of age with sickle cell disease who previously received PPSV23 at least 6 months prior to enrollment. 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 11. Previously Unvaccinated Older Infants and Children 7 Months Through 5 Years of Age. In the NCKP trial, the efficacy of Prevnar against otitis media was assessed from the beginning of the trial in October 1995 through April 1998. Functional dOPA antibody responses were elicited for all 13 serotypes, as shown in Table 17. 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. No adverse effects on pre-weaning development were observed. The mcOPA antibody GMTs elicited by Prevnar 13 in adults aged 50 through 59 years were noninferior to the corresponding mcOPA antibody GMTs elicited by Prevnar 13 in adults aged 60 through 64 years for all 13 serotypes (see Table 25). Introduction. When should the Pneumococcal Polysaccharide 23-valent vaccine also be given? In an open-label descriptive study of Prevnar 13 in Poland4 (Study 4), children 7 months through 11 months of age, 12 months through 23 months of age and 24 months through 5 years of age (prior to the 6th birthday) who were naïve to pneumococcal conjugate vaccine, were given 3, 2 or 1 dose of Prevnar 13 respectively, according to the age-appropriate schedules in Table 2. The single antibody reference value was based on pooled efficacy estimates from three placebo-controlled IPD efficacy trials with either Prevnar or the investigational 9-valent CRM197 conjugate pneumococcal polysaccharide vaccine. 100 % din cazurile de boală invazivă la copiii cu vârsta sub cinci ani și cel puțin 50 până la 76 % din cazurile de boală invazivă la adulți, în funcție de țară. 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. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor. 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. In addition, adults aged 18 through 49 years and 50 through 59 years were enrolled and received one dose of Prevnar 13 (open-label). 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. Side effects can be mild or severe, temporary or permanent. Serious Adverse Events in Adult Clinical Studies. A serum anti-capsular polysaccharide antibody concentration of 0.35 µg/mL as measured by ELISA one month after the third dose as a single antibody reference concentration was used to estimate the effectiveness of Prevnar 13 against invasive pneumococcal disease (IPD) in infants and children. The following side effects have been reported by at least 1% of people taking this medication. Immune responses elicited by Prevnar 13 and PPSV23 were measured by a mcOPA antibody assay for the 13 pneumococcal serotypes contained in Prevnar 13. In children and adolescents, data are insufficient to assess the concomitant administration of Prevnar 13 with Human Papillomavirus Vaccine (HPV), Meningococcal Conjugate Vaccine (MCV4) and Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap). Each 0.5 mL dose is to be injected intramuscularly using a sterile needle attached to the supplied prefilled syringe. One clinical safety study9 (Study 9) of Prevnar 13, conducted in PPSV23 previously vaccinated (≥3 years prior to enrollment) adults aged ≥68 years was a single arm study. A post hoc analysis of the immune responses as measured by OPA antibody assay showed the pattern of functional antibody responses to be consistent with IgG responses for each serotype. When preterm infants (<37 weeks gestational age, N=100) were administered 4 doses of Prevnar 13 on a non-US schedule, the serotype-specific IgG antibody responses after the third and fourth dose were lower compared to responses among term infants (≥37 weeks gestational age, N=100) for some serotypes; the effectiveness of Prevnar 13 in preterm infants cannot be established from this study. Are there any other precautions or warnings for this medication?
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