{"id":381,"date":"2024-01-16T22:21:16","date_gmt":"2024-01-16T22:21:16","guid":{"rendered":"https:\/\/www.merckvaccines.com\/pedvaxhib\/?page_id=381"},"modified":"2024-09-30T09:41:33","modified_gmt":"2024-09-30T09:41:33","slug":"frequently-asked-questions","status":"publish","type":"page","link":"https:\/\/www.merckvaccines.com\/pedvaxhib\/frequently-asked-questions\/","title":{"rendered":"FAQs"},"content":{"rendered":"\n\n

Frequently asked questions about PedvaxHIB <\/strong><\/h1><\/div>\n\n\n\n\n
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Find information to commonly asked questions about PedvaxHIB<\/strong><\/h2><\/div>\n\n\n\n
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What are the indications and usage for PedvaxHIB?<\/h4><\/summary>
PedvaxHIB is indicated for routine vaccination against invasive disease caused by Haemophilus influenzae<\/em> type b in infants and children 2 to 71 months of age.<\/span>\n
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PedvaxHIB will not protect against disease caused by Haemophilus influenzae<\/em> other than type b or against other microorganisms that cause invasive disease such as meningitis or sepsis.<\/p>\n\n\n\n

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As with any vaccine, vaccination may not result in a protective antibody response in all individuals given the vaccine.<\/p>\n\n\n\n

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Because of the potential for immune tolerance, PedvaxHIB IS NOT RECOMMENDED FOR USE IN INFANTS YOUNGER THAN 6 WEEKS OF AGE.<\/p>\n\n\n\n

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Revaccination<\/strong><\/p>\n\n\n\n

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Infants completing the primary 2-dose regimen before 12 months of age should receive a booster dose (see Dosage and administration<\/strong><\/a>.)<\/p>\n<\/div><\/details><\/div>\n\n\n\n

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What is the recommended dosing and administration for PedvaxHIB?<\/h4><\/summary>
PedvaxHIB is administered in a 2-dose primary regimen before 14 months of age.<\/span>\n
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Infants 2 to 14 months of age should receive a 0.5 mL dose of vaccine, ideally beginning at 2 months of age, followed by a 0.5 mL dose 2 months later (or as soon as possible thereafter). When the primary 2-dose regimen is completed before 12 months of age, a booster dose (0.5 mL) should be administered at 12 to 15 months, but not earlier than 2 months after the second dose.<\/p>\n\n\n\n

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Infants born prematurely, regardless of birth weight, should be vaccinated at the same chronological age and according to the same schedule and precautions as full-term infants and children.<\/p>\n\n\n\n

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Children 15 months of age and older previously unvaccinated against Hib disease should receive a single 0.5 mL dose of vaccine.<\/p>\n\n\n\n

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PedvaxHIB may be interchanged with other licensed Haemophilus b conjugate vaccines for the primary and booster doses. If PedvaxHIB is given in a series with one of the other products licensed for infants, the recommended number of doses to complete the primary series is determined by the other product and not by PedvaxHIB. PedvaxHIB may be interchanged with other licensed Haemophilus b conjugate vaccines for the booster dose.<\/p>\n\n\n\n

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Before administering PedvaxHIB, please read the accompanying Prescribing information<\/a>.<\/strong><\/p>\n<\/div><\/details><\/div>\n\n\n\n

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What is the Selected Safety Information for PedvaxHIB?<\/h4><\/summary>
PedvaxHIB is contraindicated in patients with hypersensitivity to any component of the vaccine. Persons who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections of the vaccine or the diluent.<\/span>\n
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As for any vaccine, adequate treatment provisions, including epinephrine, should be available for immediate use should an anaphylactoid reaction occur.<\/p>\n\n\n\n

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Use caution when vaccinating latex-sensitive individuals since the vial stopper contains dry natural latex rubber that may cause allergic reactions.<\/p>\n\n\n\n

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As with other vaccines, PedvaxHIB may not induce protective antibody levels immediately following vaccination.<\/p>\n\n\n\n

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There is insufficient evidence that PedvaxHIB given immediately after exposure to natural Haemophilus influenzae<\/em> type b will prevent illness.<\/p>\n\n\n\n

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If PedvaxHIB is used in persons with malignancies or those receiving immunosuppressive therapy or who are otherwise immunocompromised, the expected immune response may not be obtained.<\/p>\n\n\n\n

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Special Populations<\/strong><\/p>\n\n\n\n

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Animal reproduction studies have not been conducted with PedvaxHIB. Liquid PedvaxHIB is not recommended for use in individuals 6 years of age and older.<\/p>\n\n\n\n

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Geriatric use<\/u>: This vaccine is NOT recommended for use in adult populations.<\/p>\n\n\n\n

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In clinical trials, the most frequently reported (>1%) adverse reactions, without regard to causality, were fever (\u2265101\u00b0F), irritability, sleepiness, injection-site pain\/soreness, injection-site erythema (\u22642.5 cm diameter), injection-site swelling\/induration (\u22642.5 cm diameter), unusual high-pitched crying, prolonged crying (>4 hours), diarrhea, vomiting, crying, pain, otitis media, rash, and upper respiratory infection.<\/p>\n\n\n\n

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The following additional adverse reactions have been reported with the use of the marketed vaccine: lymphadenopathy; rarely, angioedema; febrile seizures; sterile injection-site abscess.<\/p>\n<\/div><\/details><\/div>\n\n\n\n

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Where is PedvaxHIB administered?<\/h4><\/summary>
PedvaxHIB administration should be done by injecting 0.5 mL intramuscularly, preferably into the outer front of the thigh (anterolateral) or the outside of the upper arm. The buttocks should not be used for active vaccination of infants and children, because of the potential risk of injury to the sciatic nerve. Discard vial after use.<\/span><\/div><\/details><\/div>\n\n\n\n
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What are the storage and preparation guidelines for PedvaxHIB?<\/h4><\/summary>
Refrigerate immediately on arrival; store vaccine at 2\u00b0C to 8\u00b0C (36\u00b0F to 46\u00b0F); DO NOT FREEZE.<\/span>\n
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Shake well before withdrawal and use. Thorough agitation is necessary to maintain suspension of the vaccine.<\/p>\n\n\n\n

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The vaccine should be used as supplied; no reconstitution is necessary.<\/p>\n\n\n\n

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Parenteral drug products should be inspected visually for extraneous particulate matter and discoloration prior to administration whenever solution and container permit. The vaccine is a slightly opaque, white suspension.<\/p>\n\n\n\n

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How is PedvaxHIB supplied?<\/h4><\/summary>
Liquid PedvaxHIB is supplied as a box of 10 single-dose vials of liquid vaccine,\u00a0NDC 0006-4897-00.<\/span><\/div><\/details><\/div>\n\n\n\n
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What are the clinical data for PedvaxHIB?<\/h4><\/summary>
The protective efficacy of lyophilized PedvaxHIB was determined in the Protective Efficacy Study.<\/span>\n
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View efficacy study data.<\/strong><\/a><\/p>\n\n\n\n

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As with any vaccine, vaccination with Liquid PedvaxHIB may not result in a protective antibody response in all individuals given the vaccine.<\/p>\n<\/div><\/details><\/div>\n\n\n\n

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What is the CPT code for PedvaxHIB?<\/h4><\/summary>
PedvaxHIB product CPT code is 90647.1<\/sup><\/span>\n
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CPT, Current Procedural Terminology. CPT is a registered trademark of the American Medical Association.<\/p>\n<\/div><\/details><\/div>\n\n\n\n

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At what age should PedvaxHIB be given?<\/h4><\/summary>
PedvaxHIB is indicated for infants and children 2 to 71 months of age.<\/span>\n
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ACIP recommends: 3-dose series (2-dose primary series at age 2 and 4 months, followed by a booster dose at age 12\u201315 months).2<\/sup><\/p>\n<\/div><\/details><\/div>\n\n\n\n

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References<\/strong><\/h4><\/div>\n\n\n\n\n
  1. Immunization Information Systems (IIS): CPT codes mapped to CVX codes. Centers for Disease Control and Prevention. Last reviewed January 31, 2024. Accessed March 7, 2024. https:\/\/www2a.cdc.gov\/vaccines\/iis\/iisstandards\/vaccines.asp?rpt=cpt<\/span><\/li>
  2. Advisory Committee on Immunization Practices (ACIP). Recommended Child and adolescent immunization schedule. Last updated November 16, 2023. Accessed January 9, 2024. https:\/\/www.cdc.gov\/vaccines\/schedules\/downloads\/child\/0-18yrs-child-combined-schedule.pdf<\/span><\/li><\/ol><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":665,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_trash_the_other_posts":false,"editor_notices":[],"footnotes":""},"ga4_page_audience":[],"ga4_page_birn_id":[],"ga4_page_branding":[267],"ga4_page_businessunit":[275],"ga4_page_campaign":[],"ga4_page_content_purpose":[314],"ga4_page_customer_journey_stage":[334],"ga4_page_customer_specialty":[381],"ga4_page_experience":[],"ga4_page_indication":[409],"ga4_page_material_intent":[522],"ga4_page_product":[561],"ga4_page_region":[790],"ga4_page_therapeuticarea":[844],"class_list":["post-381","page","type-page","status-publish"],"yoast_head":"\nFrequently Asked Questions About PedvaxHIB\u00ae [Haemophilus b Conjugate Vaccine 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