Pertussis Vaccine Adsorbed, Tetanus Toxoid, Reduced Serious adverse events were collected throughout the study period (up to 6 months post-vaccination). Adacel is administered as a single 0.5 mL intramuscular injection. Do not use after expiration date shown on the label. Tetanus Toxoid, Reduced In a clinical study, individuals 65 years of age and older received a single dose of Adacel. A total of 76% of the adolescents and 1.1% of the adults reported a history of receiving 5 previous doses of diphtheria-tetanus-pertussis containing vaccines. In addition, the ability of Adacel to elicit a booster response (defined as rise in antibody concentration after vaccination) to the tetanus, diphtheria and pertussis antigens following vaccination was evaluated. In the Sweden I Efficacy Trial, three doses of DAPTACEL vaccine were shown to confer a protective efficacy of 84.9% (95% CI: 80.1%, 88.6%) against WHO defined pertussis (21 days of paroxysmal cough with laboratory-confirmed B pertussis infection or epidemiological link to a confirmed case). (See Table 6.) had Guillain-Barré syndrome, a nerve disease causing severe muscle weakness, after getting a vaccine. Pain at the injection site was the most common adverse reaction in 62.9% to 77.8% of all vaccinees. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Among adults, the rates of pain after receipt of Adacel or Td vaccine did not significantly differ. Data are not available to assess the effect of administration of Adacel on breast-fed infants or on milk production/excretion. Pregnancy is a precaution for YF vaccine administration, compared with most other live vaccines, which are contraindicated in pregnancy. Use: Active immunization against diphtheria and tetanus in children from 6 weeks to 6 years. The tip caps of the prefilled syringes may contain natural rubber latex. This summary is not intended to take the place of talking with your healthcare provider. have a brain disorder or brain disease that is not stable. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. – Pregnancy and breast-feeding: no contra-indication. Safety data were collected from all participants who received the study vaccine (N = 999 for the Adacel group; N = 328 for the Td group). CDC recommends a single dose of Tdap for healthcare personnel who have never received Tdap regardless of the time since their most recent Td vaccination. Diphtheria Toxoid and corynebacterium diphtheriae toxoid antigen. Adacel is approved for use in individuals 10 through 64 years of age. The most common side effects of Adacel vaccine are. For FIM, non-inferiority was not demonstrated as the lower bound of the 95% CI of the difference in booster response rates (-5.96%) did not meet the predefined criterion (>-5% when the booster response in the older age group was >95%). Tell your healthcare provider if you or your child: Fainting can occur around the time of vaccination with Adacel or other vaccines. Use perferably the conjugate tetanus-diphtheria (Td) vaccine for the prevention of tetanus in children over 7 years, adolescents and adults. Pregnant women should get the Tdap vaccine between 27 and 36 weeks of each pregnancy, preferably during the earlier part of this period. Protection against disease is due to the development of neutralizing antibodies to tetanus toxin. Td is usually given as a booster dose every 10 years, but it can also be given earlier after a severe and dirty wound or burn.. Another vaccine, called Tdap, that protects against pertussis, also known as “whooping cough,” in addition to tetanus and diphtheria, may be used instead of Td. You may ask your healthcare provider for a list of side effects that is available to healthcare professionals. Usual Pediatric Dose for Tetanus Prophylaxis. were told you have an "encephalopathy," which is a kind of brain disease or malfunction, after receiving a previous dose of a pertussis vaccine. You can get tetanus through a cut or wound. The protective efficacy against mild pertussis (defined as at least one day of cough with laboratory-confirmed B pertussis infection) was 77.9% (95% CI: 72.6%, 82.2%). Discard unused portion in vial. Similar rates of immediate, solicited and unsolicited adverse reactions were reported in each of the two age cohorts. Unsolicited adverse events and serious adverse events were collected for 28 days post-vaccination. Adacel vaccine does not contain preservatives. Diphtheria Toxoid and Acellular and Acellular PT is detoxified with glutaraldehyde, FHA is treated with formaldehyde, and the residual aldehydes are removed by ultrafiltration. Among the 543 pregnancies with known outcomes, the timing of Adacel vaccination was not known for 126 of the pregnancies. (Td or Tdap) at least 4 weeks later, and dose #3 (Td or Tdap) 6–12 months after dose #2. Toxoid and Acellular One group received Adacel and Hep B vaccines concurrently (N = 206). A lower pertactin (PRN) GMC was observed when Adacel was administered concomitantly with TIV compared to separate administration. Most joint complaints were mild in intensity with a mean duration of 1.8 days. %%EOF Sera were obtained before and approximately 35 days after vaccination. Women who receive Adacel during pregnancy are encouraged to contact directly, or have their healthcare professional contact, Sanofi Pasteur Inc. at 1-800-822-2463 (1-800-VACCINE). (See Data). R�bŃ��@���:"�@\=aR�$vHpE��2@�M !�M�$� Administration of Adacel to persons with an unstable or progressive neurologic disorder may result in diagnostic confusion between manifestations of the underlying illness and possible adverse effects of vaccination. Data sources include IBM Watson Micromedex (updated 1 Oct 2020), Cerner Multum™ (updated 1 Oct 2020), Wolters Kluwer™ (updated 30 Sep 2020) and others. In both vaccine groups, greater than 94% of subjects identified as white and 99% as non-Hispanic or Latino. -The first dose may be given at 6 weeks of age. Three of the studies were conducted in the U.S. and 2 were conducted in Canada. Before administration of Adacel, healthcare providers should inform the patient, parent or guardian of the benefits and risks of the vaccine and the importance of receiving recommended booster dose unless a contraindication to further immunization exists. When Adacel is administered concomitantly with other injectable vaccines or Tetanus Immune Globulin, they should be given with separate syringes and at different injection sites. %���� Outcomes among these prospectively followed pregnancies included 5 infants with major birth defects and 25 cases of miscarriage. h�b```f``Z������� �� @1V�wc��10��ŀX��n>����ں�"��;'�/������ @5�jP�������ˀ�˃E2�� 2��9eD*��M� ], The concomitant use of Adacel (first vaccination) and trivalent inactivated influenza vaccine (TIV, Fluzone®, manufactured by Sanofi Pasteur Inc., Swiftwater, PA) was evaluated in a multi-center, open-labeled, randomized, controlled study conducted in 720 adults, 19-64 years of age inclusive. If you have questions or would like more information, please talk with your healthcare provider. Local and systemic adverse events were monitored for 14 days post-vaccination using a diary card. Rates of moderate and severe pain in adolescents did not significantly differ between the Adacel and Td vaccine groups. Adacel may be administered for tetanus prophylaxis for wound management. There were no spontaneous reports of extensive limb swelling of the injected limb in study Td506, nor in the other three studies which also contributed to the safety database for Adacel. Adacel induced pertussis antibody levels that were non-inferior to those of Swedish infants who received three doses of DAPTACEL vaccine (Sweden I Efficacy Study). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The healthcare provider should provide the Vaccine Information Statements (VISs) that are required by the National Childhood Vaccine Injury Act of 1986 to be given with each immunization. had a tetanus, diphtheria, or pertussis vaccine within the last 5 years. had a severe allergic reaction to a previous tetanus vaccine, diphtheria vaccine, pertussis vaccine, or any component of Adacel vaccine. Sera were obtained before and approximately 35 days after vaccination.

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