Infants and Children 6 Weeks Through 17 Months of Age. Pneumococcal conjugate vaccine (PCV) is a pneumococcal vaccine and a conjugate vaccine used to protect infants, young children, and adults against disease caused by the bacterium Streptococcus pneumoniae (pneumococcus). Solicited Adverse Reactions in Adult Clinical Studies. Prevnar 13 TV Spot, 'Prevención' [Spanish] Submissions should come only from the actors themselves, their parent/legal guardian or casting agency. Prevnar 13 is to be administered as a four-dose series at 2, 4, 6, and 12–15 months of age. Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. 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. Terms and conditions of use. Serum IgG concentrations were measured one month after the final dose in each age group and the data are shown in Table 20. Across the 6 studies the racial distribution included: >85% White; 0.2%–10.7% Black or African American; 0%–1.7% Asian; <1% Native Hawaiian or other Pacific Islander; ≤1%, American Indian or Alaskan Native. Discard if the vaccine has been frozen. PREVNAR 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 Protein]) This product information is intended only for residents of the United States. Submissions without photos may not be accepted. 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. Each serotype is grown in soy peptone broth. The following were determined to be adverse drug reactions based on experience with Prevnar 13 in clinical trials. *The need for revaccination with a subsequent dose of Prevnar 13 has not been established. A US study5 (Study 5) evaluated the use of Prevnar 13 in children previously immunized with Prevnar. What side effects are possible with this medication? Contact your doctor if you experience these side effects and they are severe or bothersome. For current full prescribing information, please visit www.pfizer.com. Physician Prescribing Information ; This vaccine may be given at the same time as other routine vaccinations. 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. These components of bacteria are enough to stimulate the production of a person's own antibodies (cells designed to attack that particular bacteria), which will remain in the body ready to attack any future bacteria that may cause infection. The incidence and severity of solicited adverse reactions that occurred within 7 or 14 days following each dose of Prevnar 13, PPSV23, or placebo administered to adults in 5 studies are shown in Tables 11, 12, 13, and 14. Clinical Trials Experience With Prevnar 13 in Children 5 Through 17 Years of Age. A statistically significantly greater response for Prevnar 13 was defined, for the difference in percentages (Prevnar 13 minus PPSV23) of adults achieving a ≥4-fold increase in anti-6A mcOPA antibody titer, as the lower limit of the 2-sided 95% CI greater than zero. 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). There were no vaccine-related fetal malformations or variations. Your pharmacist may be able to advise you on managing side effects. Medically reviewed by Drugs.com. Prevnar 13, Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM 197 Protein) is a sterile suspension of saccharides of the capsular antigens of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, … This product should not be used if particulate matter or discoloration is found. 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. Although the response to serotypes 6B and 9V did not meet the pre-specified noninferiority criterion, the differences were marginal. The otitis media analysis included 34,146 infants randomized to receive either Prevnar (N=17,070), or the control vaccine (N=17,076), at 2, 4, 6, and 12–15 months of age. 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. 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. There may be an interaction between pneumococcal vaccine and any of the following: If you or your child is taking any of these medications, speak with your doctor or pharmacist. Pneumococcal bacteria can infect the sinuses and inner ear. The assay used for this determination is a standardized ELISA involving pre-absorption of the test sera with pneumococcal C-polysaccharide and serotype 22F polysaccharide to reduce non-specific background reactivity. 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® should not be given to anyone with a history of severe allergic reaction to any component of Prevnar 13® or any diphtheria toxoid–containing vaccine - Children and adults with weakened immune systems (eg, HIV infection, leukemia) may have a reduced immune response - A. Potency of the formulated vaccine is determined by quantification of each of the saccharide antigens and by the saccharide to protein ratios in the individual glycoconjugates. If you have not discussed this with your doctor or are not sure why you are receiving this vaccine, speak to your doctor. 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. No adverse effects on pre-weaning development were observed. PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM Protein]) Suspension for Intramuscular InjectionDESCRIPTION. Prevnar 13: This medication belongs to a group of medications known as vaccines. 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 Study 3, subjects were randomly assigned to receive one of 3 lots of Prevnar 13 or Prevnar in a 2:2:2:1 ratio. 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.