Prevenar 13 ® is funded for children and adults with a medical condition that increases their risk of invasive pneumococcal disease AND is listed on the Pharmaceutical Schedule, identified as 'special groups on the National Immunisation Schedule. 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%). For all vaccine serotypes, anti-pneumococcal opsonophagocytic activity (OPA) geometric mean antibody titers (GMTs) were higher after the first dose compared to pre-vaccination (N=95–131); OPA GMTs following the first and second dose were comparable. During the follow-up period (average of 4 years) for case accumulation there were 3,006 deaths (7.1%) in the Prevnar 13 group and 3,005 deaths (7.1%) in the placebo group. 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. Rodriguez R. Safety of pneumococcal revaccination. The vaccine will be injected into a muscle (preferably in the thigh or upper, outer arm) by a qualified health professional. It is used for the prevention of pneumonia caused by the 23 different types of pneumococci bacteria that are contained in the vaccine. Safety and effectiveness of Prevnar 13 in children below the age of 6 weeks have not been established. The primary otitis media endpoint was efficacy against all otitis media episodes in the per-protocol population. Safety Assessments in the Catch-Up Studies in Infants and Children Through 5 Years of Age. 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 No adverse effects on pre-weaning development were observed. Most subjects were White (69.1%), 19.6% were Black or African-American, and 2.4% were Asian; 82.1% of subjects were non-Hispanic and non-Latino and 17.3% were Hispanic or Latino. This clinical trial demonstrated that in adults aged ≥70 years and previously vaccinated with PPSV23 ≥5 years prior, vaccination with Prevnar 13 elicited noninferior immune responses as compared with re-vaccination with PPSV23 (see Table 26). 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. 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 13 and 14). Prevnar (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM'197 Protein]) was licensed in the US for infants and children in 2000, following a randomized, double-blind clinical trial in a multiethnic population at Northern California Kaiser Permanente (NCKP) from October 1995 through August 20, 1998, in which 37,816 infants were randomized to receive either Prevnar or a control vaccine (an investigational meningococcal group C conjugate vaccine [MnCC]) at 2, 4, 6, and 12–15 months of age. Prevnar 13 is stable at temperatures up to 25°C (77°F) for 4 days. If you are a breast-feeding mother and are taking this vaccine, it may affect your baby. Noninferiority was demonstrated for each IIV4 vaccine strain evaluated in Study 13. Streptococcus pneumoniae Immunization. For example, bacteremia, a blood infection with or without pneumonia, and meningitis, an infection of the lining that covers the brain, are 2 serious infections caused by … The following were determined to be adverse drug reactions based on experience with Prevnar 13 in clinical trials. mcOPA antibody GMTs for serotype 6A were statistically significantly greater after Prevnar 13 compared with after PPSV23. OPA antibody titers are expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50%. Also in Study 8, 266 subjects received Prevnar 13 followed by PPSV23 one year later (Prevnar 13/PPSV23). Pneumococcal 13-valent Conjugate The vaccination schedule and concomitant vaccinations used in these infant trials were consistent with country-specific recommendations and local clinical practice. Data from the NCKP trial accumulated through an extended follow-up period to April 20, 1999, in which a total of 37,866 children were included (18,925 in Prevnar group and 18,941 in MnCC control group), resulted in similar otitis media efficacy estimates for all endpoints. Prevenar 13 este foarte asemănător cu Prevenar, însă conține șase polizaharide suplimentare din serotipurile care cauzează 16 % până la 60 % din … A third study compared immune responses to a single dose of Prevnar 13 to the response to Prevnar 13 administered one year after a dose of PPSV23 in adults aged 60 through 64 years who were PPSV23 unvaccinated at enrollment8 (Study 8). Prevnar 13 ® will only help protect against S. pneumoniae serotypes in the vaccine. Following immunization with the Pneu-C-13 vaccine (Prevnar ® 13), high risk adults aged 50 years and older who meet any of the criteria listed above, should also receive pneumococcal polysaccharide 23-valent (Pneu-P-23) vaccine, or Pneumovax ® 23. Last updated on Oct 1, 2020. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk and/or blood vessel. change one of the medications to another, change how you are taking one or both of the medications, or. Clinical Trials Conducted in PPSV23 Unvaccinated Adults. In addition, after each subsequent dose of Prevnar 13, IgG GMCs for all serotypes were numerically higher than responses after the previous dose. down the sink or in the toilet) or in household garbage. 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. A post-marketing clinical study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Prevnar 13 is for use in children from 6 weeks to 5 years old, and in adults who are 50 and older. From 1 month to 6 months after an initial study dose, serious adverse events were reported in 0.2%–5.8% of subjects vaccinated during the studies with Prevnar 13 and in 2.4%–5.5% of subjects vaccinated with PPSV23. Although OPA antibody responses to Prevnar 13 generally appeared to be slightly lower when Prevnar 13 was administered concomitantly with IIV4 compared to Prevnar 13 administered alone, noninferiority was demonstrated for all Prevnar 13 pneumococcal serotypes evaluated in Study 13. The following adverse events have been reported through passive surveillance since market introduction of Prevnar 13. For the remaining 41,231 Prevnar 13 and 41,250 placebo vaccinated subjects, serious adverse events were collected for 28 days after vaccination. Introduction. In an open-label, single-arm, descriptive study, 3 doses of Prevnar 13 were administered 1 month apart to HIV-infected subjects ≥6 years of age with CD4 counts ≥200 cells/µL, and serum HIV RNA titer <50,000 copies/mL. J Gen Intern Med. identifiers for studies included below: Prefilled Syringe, 1 Dose (10 per package) – NDC 0005-1971-02. 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. For all vaccine serotypes anti-pneumococcal OPA GMTs were numerically higher after the first dose compared to pre-vaccination (N=227–253); OPA GMTs following the first, second and third dose were generally comparable. After dose 3, fever was reported in 8.0–9.6% on day 1 and 9.1–10.5% on day 2. 1. Help protect yourself against Streptococcus pneumoniae with Prevnar 13, a single-shot* vaccine in adults. Table 1: Vaccination Schedule for Infants and Toddlers Dose a,bDose 1 cDose 2 b Dose 3 b Data accumulated through an extended follow-up period to April 20, 1999, resulted in similar efficacy estimates of 97.4% in the per-protocol analysis and 93.9% in the intent-to-treat analysis (95% CI: 82.7%, 99.9% and 79.6%, 98.5%, respectively). One study (Study 13) assessed the concomitant administration of Prevnar 13 with seasonal inactivated Fluzone Quadrivalent (IIV4) in PPSV23 previously vaccinated adults ≥50 years of age in the US. This medication is not intended for children under 6 weeks old. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration [see Description (11)]. It contains purified capsular polysaccharide of pneumococcal serotypes conjugated to a carrier protein to improve antibody response compared to the pneumococcal … Adults previously vaccinated with 23-valent pneumococcal polysaccharide vaccine. Serum IgG concentrations were measured one month after the final dose in each age group and the data are shown in Table 20. Individuals with impaired immune responsiveness due to the use of immunosuppressive therapy (including irradiation, corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents) may not respond optimally to active immunization. OPA antibody GMTs for serotype 6A were statistically significantly greater after Prevnar 13 compared with after PPSV23 (see Table 25). Prevnar 13 helps your body make its own antibodies to help protect you against 13 types of the bacteria Streptococcus pneumoniae. 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), bacteraemia (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. Based on analysis of the primary pre-specified comparison of serotype specific anti-capsular polysaccharide IgG GMCs, noninferiority was met for all serotypes in adults 50–59 years of age and for 12 of 13 serotypes in adults ≥65years of age. Adults 18 through 59 years of age received a single dose of Prevnar 13, and adults 60 through 64 years of age received a single dose of Prevnar 13 or PPSV23. Are there any other precautions or warnings for this medication? For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine. Prevnar 13: This medication belongs to a group of medications known as vaccines. Please include at least one social/website link containing a recent photo of the actor. Product Monograph – Prevnar® 13. Subscribe to newsletters for the latest medication news, new drug approvals, alerts and updates. 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. 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. Nonclinical and clinical data support opsonophagocytic activity, as measured by opsonophagocytic activity (OPA) antibody assay, as a contributor to protection against pneumococcal disease. Apnea following intramuscular vaccination has been observed in some infants born prematurely. Functional antibodies elicited by the vaccine (as measured by a dribble opsonophagocytic activity [dOPA] antibody assay) were also evaluated in infants. If you miss an appointment to receive the pneumococcal vaccine, contact your doctor as soon as possible to reschedule your appointment. Subjects who had a CAP or IPD episode with symptom onset less than 14 days after vaccination were excluded from all analyses. 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)]. For a subset of 2,011 subjects (1,006 Prevnar 13 recipients and 1,005 placebo recipients), solicited adverse reactions were monitored by recording local and systemic events using electronic diaries for 7 days after vaccination; unsolicited adverse events were collected for 28 days after vaccination, and serious adverse events were collected for 6 months after vaccination. PNEUMOVAX 23 may not prevent pneumococcal meningitis in patients with leakage of spinal fluid caused by a cracked or injured skull or a medical operation. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Prevnar 13 and any potential adverse effects on the breastfed child from Prevnar 13 or from the underlying maternal condition. 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. Prefilled Syringe, 1 Dose (1 per package) – NDC 0005-1971-05. Each 0.5 mL dose of the vaccine is formulated to contain approximately 2.2 µg of each of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides, 4.4 μg of 6B saccharides, 34 µg CRM197 carrier protein, 100 µg polysorbate 80, 295 µg succinate buffer and 125 µg aluminum as aluminum phosphate adjuvant. Prevnar 13 is to be administered as a four-dose series at 2, 4, 6, and 12–15 months of age. Responses to diphtheria toxoid, tetanus toxoid, pertussis, polio types 1, 2, and 3, hepatitis B, PRP-T, PRP-OMP, measles, and varicella antigens in Prevnar 13 recipients were similar to those in Prevnar recipients. In adults, an antipolysaccharide binding antibody IgG level to predict protection against invasive pneumococcal disease or non-bacteremic pneumonia has not been defined. After dose 2, fever was reported in 12.3–13.1% on day 1 and 12.5–12.8% on day 2. Adults with pre-existing medical conditions, as well as subjects with a history of smoking were eligible for enrollment. In Study 1212 (subjects 65 years and older), serious adverse events within 1 month of vaccination were reported in 327 of 42,237 (0.8%) Prevnar 13 recipients (352 events) and in 314 of 42,225 (0.7%) placebo recipients (337 events). 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.