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Influenzae type b disease following vaccination with VAXELIS. Apnea following intramuscular vaccination has been observed in some infants born prematurely. If VAXELIS is administered diwawin to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained. A review by the Institute of Medicine (IOM) found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome. Do not administer VAXELIS to anyone with a history of progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy until a treatment regimen has been established and the condition has stabilized. Do not administer VAXELIS to anyone with a history of encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine, that is not attributable to another identifiable cause.
This article was reviewed by Candace Gasper and by wikiHow staff writer, Aimee Payne, MFA. Package information is not reviewed or updated separately by VxLabels.com. VxLabels.com provides trustworthy package insert and label information about marketed drugs and vaccines as submitted by manufacturers to the U.S. The incidence and severity of solicited injection site and systemic adverse reactions (i.e., vaccine-related adverse events) that occurred within 5 days following each dose of VAXELIS or Control vaccines at 2, 4, and 6 months of age in studies 005 and 006 are shown in Table 2. Information on solicited adverse events was recorded daily by parents or guardians on vaccination report cards. The vaccination schedules of VAXELIS, Control vaccines, and concomitantly administered vaccines used in these studies are provided in Table 1. Two of these (study 005 and 006) were controlled clinical studies conducted in the US, in which a total of 3,380 infants 46 to 89 days of age at enrollment received at least 1 dose of VAXELIS. The safety of VAXELIS was evaluated in 6 clinical studies, in which a total of 5,251 infants 43 to 99 days of age at enrollment received at least 1 dose of VAXELIS.
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VAXELIS may be used to complete the hepatitis B vaccination series following 1 or 2 doses of other hepatitis B vaccines, in infants and children born of HBsAg-negative mothers and who are also scheduled to receive the other antigens in VAXELIS. A 3-dose series of VAXELIS may be administered to infants born to HBsAg-negative mothers, and who have received a dose of any hepatitis B vaccine, prior to or at 1 month of age. A 3-dose series of VAXELIS does not constitute a primary immunization series against pertussis; an additional dose of pertussis-containing vaccine is needed to complete the primary series. Merck does not endorse and is not responsible for the accuracy, content, practices, or standards of any non-Merck site. VAXELIS is approved for use as a 3-dose series in children 6 weeks through 4 years of age (prior to the 5th birthday). VAXELIS is to be administered as a 3-dose series at 2, 4, and 6 months of age.
Vaccination Schedule for VAXELIS:
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