occasion [5:<6 months of age who are too young to have received a complete vaccination series. 105 166 During 2009, there were 35 cases of invasive Hib disease and 178 cases caused by unknown serotypes of H. influenzae in US children> <5 years of age. 166 USPHS Advisory Committee on Immunization Practices (ACIP), AAP, and others recommend routine vaccination against Hib in all infants using an appropriate vaccine regimen initiated in early infancy at 2 months of age (minimum age 6 weeks). 105 159 199 Catch-up vaccination recommended by ACIP, AAP, and others for all children> <5 years of age who are unvaccinated or incompletely vaccinated against Hib. 105 159 199 Unvaccinated children> <4 years of age are at increased risk of invasive Hib disease, especially if in prolonged close contact (e.g., household contact) with a child with invasive Hib disease. 105 Other factors associated with increased risk of invasive Hib infection include asplenia, 105 166 sickle cell disease, 105 166 antibody deficiency syndromes, 166 HIV infection, 105 156 166 other immunodeficiency syndromes, 38 105 166 and Hodgkin s disease 79 or other malignancies (especially during chemotherapy). 105 166 Historically, invasive Hib was more common in boys; 105 American Indians (e.g., Apache and Navajo tribes), 45 105 166 Alaskan natives, 40 45 85 105 Hispanics, 166 and blacks; 29 105 166 daycare attendees; 105 166 children living in crowded conditions; 105 166 and children who were not breastfed. 105 (See Limitations of Vaccine Effectiveness under Cautions.) Not labeled by FDA for use in children ≥5 years of age, adolescents, or adults. 77 144 174 223 224 227 Although efficacy data not available on which to base recommendations, ACIP, AAP, and others recommend a single dose of Hib vaccine in children ≥5 years of age † who are unvaccinated or incompletely vaccinated against Hib and are at increased risk for invasive Hib disease because of altered immunocompetence (e.g., sickle cell disease, leukemia, anatomic or function asplenia, HIV infection, IgG 2 deficiency, chemotherapy, hematopoietic stem cell transplantation). 105 134 156 159 166 199 200 These experts also state consider a single dose of Hib vaccine in adults † with sickle cell disease, leukemia, HIV infection, or anatomic or functional asplenia if they have not previously received the vaccine. 134 200 Consider that immune response to the vaccine may be less in immunocompromised individuals. 105 134 (See Individuals with Altered Immunocompetence under Cautions.) Ensure that children with a cochlear implant have received age-appropriate Hib vaccination; 114 cochlear implant recipients may be at increased risk of invasive Hib disease (i.e., meningitis). 114 For internationally adopted children with uncertain immune status, ACIP recommends revaccination with an age-appropriate Hib vaccine regimen. 134 Hib vaccine will not provide protection against other types of H. influenzae (e.g., nonencapsulated [nontypeable] strains associated with otitis media and sinusitis) or against other pathogens that cause meningitis or septicemia. 144 174 Depending on age and vaccination status, Hib vaccine may be given as a monovalent vaccine (ActHIB , PedvaxHIB , Hiberix ) 144 174 223 or a combination vaccine containing Hib and other antigens. 77 174 224 227 ACIP, AAP, and others state a combination vaccine generally preferred over separate injections of the equivalent component vaccines; 134 199 considerations include provider assessment (e.g., number of injections, vaccine availability, likelihood of improved coverage, likelihood of patient return, storage requirements, cost), patient preference, and potential for adverse effects. 134 Hib-HepB (Comvax ): May be used in infants 6 weeks to 15 months of age born to HBsAg-negative women when vaccination against HBV and Hib indicated. 77 Although not labeled by FDA for use in infants born to HBsAg-positive women, 77 ACIP states Hib-HepB (Comvax ) may be used to complete the HBV vaccination series in infants 6 weeks to 15 months of age born to HBsAg-positive women † . 137 Hib-MenCY (MenHibrix ): May be used in infants 6 weeks through 18 months of age when vaccination against Hib and meningococcal serogroups C and Y indicated. 162 227 228 Although routine vaccination against meningococcal disease not recommended in infants who are not at increased risk, 105 162 228 ACIP, AAP, and others state Hib-MenCY (MenHibrix ) may be used for primary immunization against Hib in infants 6 weeks through 18 months of age who are at increased risk for meningococcal disease because they have certain chronic medical conditions (e.g., persistent complement component deficiencies or anatomic or functional asplenia, including sickle cell disease) or reside in communities with outbreaks of meningococcal serogroup C or Y. 162 199 228 Does not provide adequate protection for infants and children traveling to or residing in areas with high endemic rates of meningococcal disease (e.g., meningitis belt of sub-Saharan Africa) since it does not provide protection against meningococcal serogroups A and W-135. 162 199 228 Administration in infancy unlikely to provide persistent protection against meningococcal disease until 11 through 12 years of age, the age of recommended routine adolescent meningococcal vaccination. 162 DTaP-IPV/Hib (Pentacel ): May be used in infants and children 6 weeks through 4 years of age when doses of DTaP, IPV, and Hib indicated and there are no contraindications to any of the individual components. 207 224 For prevention of Hib, ACIP states that DTaP-IPV/Hib (Pentacel ) may be used for primary immunization doses and the booster dose at 12 through 15 months of age. 207 Haemophilus b Vaccine Dosage and Administration Administration IM Administration Monovalent Hib vaccines (PRP-T; ActHIB , Hiberix ) (PRP-OMP; PedvaxHIB ): Administer by IM injection. 77 144 174 223 Hib-HepB (Comvax ), Hib-MenCY (MenHibrix ), DTaP-IPV/Hib (Pentacel ): Administer by IM injection. 77 224 227 Do not administer monovalent Hib vaccines or combination vaccines containing Hib and other antigens IV, sub-Q, or intradermally. 77 144 174 223 224 227 Depending on patient age, administer IM into deltoid muscle or anterolateral thigh. 134 144 224 227 In infants and children 6 weeks to 2 years of age, anterolateral thigh is preferred; 134 alternatively, deltoid muscle can be used in those 1 through 2 years of age if muscle mass is adequate. 134 In children ≥3 years of age, deltoid muscle preferred. 134 To ensure delivery into muscle, make IM injections at a 90° angle to the skin using a needle length appropriate for the individual s age and body mass, thickness of adipose tissue and muscle at injection site, and injection technique. 134 208 209 Consider anatomic variability, especially in the deltoid; use clinical judgement to avoid inadvertent underpenetration or overpenetration of muscle. 208 209 Avoid injection into gluteal area or into or near blood vessels or nerves. 77 134 144 174 224 Generally do not administer vaccines into gluteal area or any area where there may be a major nerve trunk. 134 If the gluteal muscle is chosen for infants> <12 months of age because of special circumstances (e.g., physical obstruction of other sites), it is essential that clinician identify anatomical landmarks prior to injection. 134 Syncope (vasovagal or vasodepressor reaction; fainting) may occur following vaccination; 134 223 227 may be accompanied by transient neurologic signs (e.g., visual disturbance, paresthesia, tonic-clonic limb movements). 223 227 Occurs most frequently in adolescents and young adults. 134 Have procedures in place to avoid falling injury and restore cerebral perfusion following syncope. 223 227 Syncope and secondary injuries may be averted if vaccinees sit or lie down during and for 15 minutes after vaccination. 134 If syncope occurs, observe patient until symptoms resolve. 134 May be given simultaneously with other age-appropriate vaccines. 134 When multiple vaccines are administered during a single health-care visit, give each parenteral vaccine with a different syringe and at different injection site. 134 Separate injection sites by at least 1 inch (if anatomically feasible) to allow appropriate attribution of any local adverse effects that may occur. 134 PRP-OMP (PedvaxHIB ) Do not dilute. 144 Shake well before use; 144 thorough agitation necessary to maintain suspension. 144 Should appear as slightly opaque white suspension. 144 PRP-T (ActHIB ) Reconstitute single-dose vial of lyophilized PRP-T (ActHIB ) by adding entire amount of 0.4% sodium chloride diluent supplied by the manufacturer; agitate thoroughly. 174 Consult manufacturer s labeling for specific information regarding reconstitution. 174 Administer within 24 hours after reconstitution. 174 PRP-T (Hiberix ) Reconstitute single-dose vial of lyophilized PRP-T (Hiberix ) by adding entire amount of 0.9% sodium chloride diluent supplied by the manufacturer; 223 agitate thoroughly. 223 Consult manufacturer s labeling for specific information regarding reconstitution. 223 Administer promptly after reconstitution or store at 2 8°C and administer within 24 hours. 223 Shake vigorously before use. 223 Do not mix with any other vaccine or solution. 223 Hib-HepB (Comvax ) Do not dilute. 77 Shake well before use; 77 thorough agitation necessary to maintain suspension. 77 Should appear as slightly opaque white suspension. 77 Hib-MenCY (MenHibrix ) Reconstitute single-dose vial of lyophilized Hib-MenCY (MenHibrix ) by adding 0.6 mL of 0.9% sodium chloride diluent supplied by the manufacturer; 227 shake well. 227 Consult manufacturer s labeling for specific information regarding reconstitution. 227 Administer immediately after reconstitution. 227 Do not mix with any other vaccine. 227 DTaP-IPV/Hib (Pentacel ) DTaP-IPV/Hib (Pentacel ) is commercially available as a kit containing single-dose vial of fixed-combination vaccine containing diphtheria, tetanus, pertussis, and poliovirus antigens (DTaP-IPV vaccine) and single-dose vial of lyophilized Hib vaccine (PRP-T; ActHIB ). 224 Prior to administration, reconstitute vial of lyophilized PRP-T (ActHIB ) vaccine by adding entire contents of vial of DTaP-IPV vaccine in the kit according to manufacturer s instructions to provide a combination vaccine containing diphtheria, tetanus, pertussis, IPV, and Hib antigens. 224 Gently swirl until cloudy, uniform, white to off-white (yellow tinge) suspension is obtained. 224 Administer immediately after reconstitution. 224 Dosage Dosing schedule varies according to specific vaccine administered and age at which vaccination is started. 144 159 174 223 227 Follow dosage recommendations for the specific preparation used. 144 159 174 223 227 PRP-T (ActHIB ) and PRP-OMP (PedvaxHIB ) monovalent Hib vaccines can be considered interchangeable for both primary and booster immunization. 105 166 If the primary vaccination series included both PRP-T (ActHIB ) and PRP-OMP (PedvaxHIB ), 3 primary doses and a booster dose are needed to complete the series. 166 AAP recommends use of a vaccine preparation that includes PRP-OMP (PedvaxHIB or Comvax ) for the first primary dose in American Indian and Alaskan native children. 105 (See Limitations of Vaccine Effectiveness under Cautions.) Medically stable preterm and low birthweight infants should be vaccinated at the usual chronologic age using usual dosage. 105 144 170 174 (See Pediatric Use under Cautions.) Interruptions resulting in an interval between doses longer than recommended should not interfere with the final immunity achieved; there is no need to administer additional doses or start the vaccination series over. 134 144 174 Pediatric Patients Prevention of Haemophilus influenzae Type b (Hib) Infection Infants 2 through 18 Months of Age (PRP-T; ActHIB ) IM Each dose is 0.5 mL. 174 Routine primary immunization in early infancy consists of a series of 3 doses and a booster dose. 105 174 199 ACIP, AAP, and others recommend that doses be given at 2, 4, 6, and 12 through 15 months of age. 105 199 Initial dose may be given as early as 6 weeks of age. 105 199 Catch-up vaccination using the age-appropriate number of doses indicated below is recommended in those who are unvaccinated or incompletely vaccinated. 199 Previously unvaccinated infants 7 through 11 months of age: Primary immunization consists of a series of 2 doses and a booster dose. 105 174 199 ACIP, AAP, and others recommend a minimum interval of 4 weeks between first and second dose and third (final) dose at 12 through 15 months of age (regardless of Hib vaccine used for first dose). 199 Manufacturer recommends that 2 doses be given 8 weeks apart and a third dose (booster dose) be given at 15 through 18 months of age. 174 Previously unvaccinated infants 12 through 14 months of age: Primary immunization consists of 2 doses given at least 8 weeks apart. 174 199 Previously unvaccinated infants 15 through 18 months of age: Single dose. 105 199 Infants and Children 2 through 71 Months of Age (PRP-OMP; PedvaxHIB ) IM Each dose is 0.5 mL. 144 Routine primary immunization in early infancy consists of a series of 2 doses and a booster dose. 105 144 Manufacturer, ACIP, AAP, and others recommend that doses be given at 2, 4, and 12 through 15 months of age. 105 144 159 Initial dose may be given as early as 6 weeks of age. 105 199 Minimum interval between doses is 2 months. 144 Catch-up vaccination using the age-appropriate number of doses indicated below is recommended in all children up to 71 months of age who are unvaccinated or incompletely vaccinated. 199 Previously unvaccinated infants 7 through 11 months of age: Primary immunization consists of a series of 2 doses and a booster dose. 105 199 ACIP, AAP, and others recommend a minimum interval of 4 weeks between first and second dose with third (final) dose at 12 through 15 months of age (regardless of Hib vaccine used for first dose). 199 Previously unvaccinated infants 12 through 14 months of age: Primary immunization consists of 2 doses given at least 8 weeks apart. 199 Previously unvaccinated infants and children 15 through 71 months of age: Single dose. 105 144 199 Infants and Children 15 Months through 4 Years of Age (PRP-T; Hiberix ) IM A single dose consisting of entire contents of reconstituted vial (approximately 0.5 mL). 223 Used as a booster dose in infants and children 15 months through 4 years of age who received a primary series of an appropriate Hib vaccine (primary series consists of 2 or 3 doses depending on the manufacturer). 223 225 To facilitate timely administration of Hib booster dose for routine or catch-up vaccination, ACIP states that booster dose of PRP-T (Hiberix ) may be given as early as 12 months of age † . 199 225 Do not use for primary immunization. 199 223 225 However, if PRP-T (Hiberix ) is inadvertently given during primary vaccination series, ACIP states that the dose may be counted as a valid PRP-T primary dose if it was administered at an appropriate interval according to the recommended PRP-T primary vaccination schedule. 225 Infants 6 Weeks to 15 Months of Age (Hib-HepB; Comvax ) IM Each dose is 0.5 mL. 77 May be used when primary immunization against Hib and HBV is indicated in infants and children 6 weeks to 15 months of age born to HBsAg-negative women. 77 Primary immunization consists of a series of 3 doses given ideally at 2, 4, and 12 15 months of age. 77 Minimum interval between first 2 doses is 6 weeks; make interval between second and third dose as close to 8 11 months as possible. 77 Infants 6 Weeks through 18 Months of Age (Hib-MenCY; MenHibrix ) IM Each dose is 0.5 mL. 227 Primary immunization in previously unvaccinated infants: Use a series of 4 doses. 162 199 227 228 Give doses at 2, 4, 6, and 12 through 15 months of age. 199 227 228 Initial dose usually given at 2 months of age, but may be given as early as 6 weeks of age. 162 227 228 Fourth dose may be given as late as 18 months of age. 162 227 228 If first dose given at ≥12 months of age, give a series of 2 doses at least 8 weeks apart. 162 228 For those who remain at prolonged increased risk for meningococcal disease, ACIP recommends a dose of meningococcal vaccine (MCV4) 3 years after completion of Hib-MenCY (MenHibrix ) primary immunization series and every 5 years thereafter. 228 Infants and Children 6 Weeks through 4 Years of Age (DTaP-IPV/Hib; Pentacel ) IM Each dose is 0.5 mL. 224 May be used when immunization against diphtheria, tetanus, pertussis, poliovirus, and Hib is indicated in children 6 weeks through 4 years of age. 207 224 Previously unvaccinated: Use a series of 4 doses. 224 Give doses at 2, 4, 6, and 15 through 18 months of age. 224 Initial dose usually given at 2 months of age, but may be given as early as 6 weeks of age. 224 Previously received ≥1 dose of Hib vaccine: Can be used to complete the Hib vaccination series when doses of IPV and DTaP also are indicated and there are no contraindications to any of the individual components. 207 224 To complete recommended primary and booster vaccination series against diphtheria, tetanus, and pertussis in children who received the 4-dose series of DTaP-IPV/Hib (Pentacel ): Give a fifth dose of DTaP (Daptacel ) at 4 through 6 years of age. 224 Do not use DTaP-IPV/Hib (Pentacel ) for booster dose of DTaP indicated at 4 through 6 years of age; however, if dose of DTaP-IPV/Hib (Pentacel ) is inadvertently given to a child ≥5 years of age or older, ACIP states the dose may be counted as a valid dose. 207 To complete recommended vaccination against poliovirus in children who received the 4-dose series of DTaP-IPV/Hib (Pentacel ): Give additional booster dose of age-appropriate vaccine containing IPV (IPOL or Kinrix ) at 4 through 6 years of age. 224 Children 12 through 59 Months of Age with Medical Conditions Associated with Increased Risk of Invasive Hib Disease IM Unvaccinated or previously received 1 dose of Hib vaccine before 12 months of age: AAP recommends 2 doses of Hib vaccine given 2 months apart. 105 Previously received 2 doses of Hib vaccine before 12 months of age: AAP recommends 1 dose of Hib vaccine. 105 Children ≥5 Years of Age with Medical Conditions Associated with Increased Risk of Invasive Hib Disease † IM Unvaccinated or incompletely vaccinated against Hib: ACIP, AAP, and others recommend a single dose in those at increased risk because of sickle cell disease, leukemia, anatomic or functional asplenia, HIV infection, IgG 2 deficiency, chemotherapy, or hematopoietic stem cell transplantation. 105 134 156 159 199 Adults Adults with Medical Conditions Associated with Increased Risk of Invasive Hib Disease † IM Unvaccinated against Hib: ACIP, AAP, and others state consider a single dose in those at increased risk because of sickle cell disease, leukemia, HIV infection, or anatomic or functional asplenia. 134 200 Special Populations Hepatic Impairment No specific dosage recommendations. 144 174 223 227 Renal Impairment No specific dosage recommendations. 144 174 223 227 Cautions for Haemophilus b Vaccine Contraindications PRP-OMP (PedvaxHIB ) and PRP-T (ActHIB ): Hypersensitivity to any vaccine component. 144 174 PRP-T (Hiberix ): Severe allergic reaction (e.g., anaphylaxis) after dose of any Hib vaccine, dose of any vaccine containing tetanus toxoid, or any component in PRP-T (Hiberix ). 223 Hib-HepB (Comvax ): Hypersensitivity to yeast or any vaccine component. 77 Hib-MenCY (MenHibrix ): Severe allergic reaction (e.g., anaphylaxis) to the vaccine, any vaccine component, or any vaccine containing meningococcal, Hib, or tetanus antigens. 227 DTaP-IPV/Hib (Pentacel ): Severe allergic reaction (e.g., anaphylaxis) to any ingredient in the vaccine or after previous dose of the vaccine or any vaccine containing diphtheria, tetanus, pertussis, poliovirus, or Hib antigens. 224 Also contraindicated (because of the pertussis antigen) in individuals who had encephalopathy (e.g., coma, decreased consciousness, prolonged seizures) within 7 days of a dose of pertussis-containing vaccine and in individuals with progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy. 224 Warnings/Precautions Sensitivity Reactions Hypersensitivity Reactions Hypersensitivity reactions (e.g., anaphylaxis, anaphylactoid reaction, angioedema, rash, urticaria) reported. 223 227 Prior to administration, take all known precautions to prevent adverse reactions, including a review of the patient s history with respect to possible hypersensitivity to the vaccine or similar vaccines. 144 174 223 227 Epinephrine and other appropriate agents and equipment should be readily available in case an immediate allergic reaction occurs. 144 174 223 227 Do not administer additional doses to individuals with symptoms of hypersensitivity after a previous dose. 144 Latex Sensitivity Stopper on vial of sodium chloride diluent supplied with PRP-T (ActHIB ) contains dry natural latex; 174 stoppers on vials of Hib-HepB (Comvax ) and PRP-OMP (PedvaxHIB ) contain natural rubber latex. 77 144 Some components (i.e., tip cap) of single-dose prefilled syringes of sodium chloride diluent supplied with PRP-T (Hiberix ) contain dry natural latex; 223 rubber plungers of these syringes and stoppers on vials of the lyophilized vaccine are latex-free. 223 Some individuals may be hypersensitive to natural latex proteins. 134 190 192 193 223 Take appropriate precautions if these preparations are administered to individuals with history of latex sensitivity. 77 134 144 174 190 192 193 ACIP states that vaccines supplied in vials or syringes containing dry natural rubber or natural rubber latex may be administered to individuals with latex allergies other than anaphylactic allergies (e.g., history of contact allergy to latex gloves), but should not be used in those with a history of severe (anaphylactic) allergy to latex unless benefits of vaccination outweigh risks of a potential allergic reaction. 134 Contact-type allergy is the most common type of latex sensitivity. 134 Yeast Allergy Hib-HepB (Comvax ): Manufacturing process for HepB vaccine component involves baker s yeast ( Saccharomyces cerevisiae ) and final product contains yeast protein ( 1%). 77 Contraindicated in individuals hypersensitive to yeast. 77 Neomycin and/or Polymyxin B Allergy DTaP-IPV/Hib (Pentacel ): Contains trace amounts of neomycin sulfate ( 4 pg) and polymyxin B ( 4 pg). 224 Neomycin allergy usually results in delayed-type (cell-mediated) hypersensitivity reactions manifested as contact dermatitis. 105 134 ACIP and AAP state that vaccines containing trace amounts of neomycin should not be used in individuals with history of anaphylactic reaction to neomycin, but use may be considered in those with history of delayed-type neomycin hypersensitivity if benefits of vaccination outweigh risks. 105 134 Use of Combination Vaccines Do not administer vaccine containing Hib antigen with any other Hib-containing vaccine. 228 When combination vaccine containing Hib and other antigens ([Hib-HepB; Comvax ], [Hib-MenCY; MenHibrix ], [DTaP-IPV/Hib; Pentacel ]) is used, consider cautions, precautions, and contraindications associated with each antigen. 227 Limitations of Vaccine Effectiveness May not protect all vaccine recipients against Hib. 144 174 Protection against Hib disease may not be provided until 1 2 weeks after primary immunization with 2 or 3 doses of Hib vaccine. 144 148 174 When a complete vaccine series is administered as recommended, regimens that include PRP-T (ActHIB ) or PRP-OMP (PedvaxHIB , Comvax ) are considered equivalent. 105 144 166 There is some evidence that vaccines containing PRP-OMP (PedvaxHIB , Comvax ) result in more rapid seroconversion to protective antibody concentrations within the first 6 months of life compared with vaccines containing PRP-T (ActHIB ). 105 207 This is particularly important in American Indian and Alaskan native children because these children are at increased risk for Hib disease during the first 6 months of life. 105 Although PRP-OMP (PedvaxHIB ) contains Hib antigen conjugated to outer membrane protein complex (OMPC) of Neisseria meningitidis and antibodies to OMPC have been demonstrated in patients who received the vaccine, the clinical relevance of these antibodies not established. 144 PRP-OMP (PedvaxHIB ) is not an immunizing agent against meningococcal disease. 159 Although PRP-T (Hiberix ) and Hib-MenCY (MenHibrix ) contain Hib antigen conjugated to tetanus toxoid, these vaccines are not a substitute for routine immunization against tetanus. 223 227 Individuals with Altered Immunocompetence May be administered to individuals immunosuppressed as the result of disease or immunosuppressive therapy. 77 105 134 144 156 174 Consider possibility that the immune response to the vaccine may be reduced in individuals with altered immunocompetence (e.g., HIV infection, immunoglobulin deficiency, stem cell transplant recipients, cancer patients receiving chemotherapy). 77 105 134 144 174 223 227 Immune responses have been obtained following administration of Hib vaccine in patients with sickle cell disease, leukemia, or HIV infection, and in those who have undergone splenectomies; 166 response in HIV-infected individuals varies with the degree of immunocompromise. 166 Manufacturer of PRP-T (Hiberix ) and Hib-MenCY (MenHibrix ) states that safety and efficacy not evaluated in immunosuppressed children. 223 227 AAP states that children who have received the usual age-appropriate regimen of Hib vaccine (primary and booster doses) and have decreased or absent splenic function do not need additional doses of the vaccine; 105 however, those who are scheduled for splenectomy (e.g., for Hodgkin s disease, spherocytosis, immune thrombocytopenia, hypersplenism) may benefit from an additional dose of a Hib vaccine given at least 7 10 days before surgery. 105 Although children with HIV infection or IgG 2 deficiency or those receiving chemotherapy are at increased risk of invasive Hib disease, it is unclear whether these children would benefit from additional doses of Hib vaccine after completion of the usual age-appropriate vaccination regimen. 105 Concomitant Illness Delay administration in individuals with acute febrile illness until symptoms have subsided. 134 ACIP states that minor illness (with or without fever) generally does not preclude vaccination. 134 Guillain-Barré Syndrome If Guillain-Barré syndrome (GBS) occurred within 6 weeks of receipt of a vaccine containing tetanus toxoid, base a decision to administer a dose of a vaccine containing tetanus toxoid, including PRP-T (Hiberix ) or Hib-MenCY (MenHibrix ), on careful consideration of potential benefits and possible risks. 223 227 Individuals with Bleeding Disorders Advise individuals who have bleeding disorders or are receiving anticoagulant therapy and/or their family members about the risk of hematoma from IM injections. 134 ACIP states that vaccines may be given IM to such individuals if a clinician familiar with the patient s bleeding risk determines that the preparation can be administered with reasonable safety. 134 In these cases, use a fine needle (23 gauge or smaller) to administer the vaccine and apply firm pressure to the injection site (without rubbing) for ≥2 minutes. 134 If patient is receiving therapy for hemophilia, administer the IM vaccine shortly after a scheduled dose of such therapy. 134 Improper Storage and Handling Improper storage or handling of vaccines may reduce vaccine potency resulting in reduced or inadequate immune responses in vaccinees. 134 Inspect all vaccines upon delivery and monitor during storage to ensure that the appropriate temperature is maintained. 134 (See Storage under Stability.) Do not administer monovalent Hib vaccines or combination vaccines containing Hib and other antigens that have been mishandled or have not been stored at the recommended temperature. 77 134 144 174 If there are concerns about mishandling, contact the manufacturer or state or local immunization or health departments for guidance on whether the vaccine is usable. 134 Specific Populations Pregnancy Category C. 77 144 174 223 227 Not labeled by FDA for use in adults 144 174 223 227 and not usually recommended for this age group. 93 105 170 Lactation Not labeled by FDA for use in adults 144 174 223 227 and not usually recommended for this age group. 93 105 144 170 174 200 Pediatric Use PRP-OMP (PedvaxHIB ): Safety and efficacy not established in infants> <6 weeks of age or in children ≥6 years of age. 144 PRP-T (ActHIB ): Safety and efficacy not established in infants> <6 weeks of age or in infants or children >18 months of age. 174 PRP-T (Hiberix ): Safety and efficacy not established in infants> <15 months of age or in children ≥5 years of age. 223 Safety and efficacy for use in infants 15 through 18 months of age established based on clinical studies in this age group; 223 safety and efficacy in infants and children 19 months through 4 years of age supported by evidence in children 15 through 18 months of age. 223 Hib-HepB (Comvax ): Safety and efficacy not established in infants> <6 weeks of age or in infants or children >15 months of age. 77 Hib-MenCY (MenHibrix ): Safety and efficacy not established in infants> <6 weeks of age or in infants and children >18 months of age. 227 DTaP-IPV/Hib (Pentacel ): Safety and efficacy not established in infants> <6 weeks of age or in children ≥5 years of age. 224 Do not administer Hib vaccine to infants> <6 weeks of age; 77 144 limited data indicate that infants who receive Hib vaccine before 6 weeks of age may develop immunologic tolerance resulting in reduced response to subsequent doses of the vaccine. 166 Apnea reported following IM administration of vaccines in some infants born prematurely. 224 227 Base decisions regarding when to administer an IM vaccine in premature infants on consideration of the individual infant's medical status and potential benefits and possible risks of vaccination. 224 227 Geriatric Use Not labeled by FDA for use in adults, including geriatric adults;, 77 144 174 223 224 227 not usually recommended for this age group. 93 105 170 200 Common Adverse Effects PRP-T (ActHIB ) or PRP-OMP (PedvaxHIB ): Injection site reactions (pain, erythema, swelling), fever, irritability, lethargy. 144 174 PRP-T (Hiberix ): Injection site reactions (e.g., redness, pain, swelling) and systemic effects (e.g., fever, fussiness, loss of appetite, restlessness, sleepiness, diarrhea, vomiting) when given concomitantly with a combination vaccine containing diphtheria, tetanus, pertussis, hepatitis B, and poliovirus antigens (DTaP-HBV-IPV) administered at a different site. 223 Hib-HepB (Comvax ): Adverse effects similar in type and frequency to those reported in infants who receive monovalent PRP-OMP (PedvaxHIB ) vaccine and monovalent HepB vaccine (Recombivax HB ) simultaneously at separate sites. 77 Hib-MenCY (MenHibrix ): Injection site reactions (e.g., pain, redness, swelling), systemic effects (e.g., fever, irritability, drowsiness, loss of appetite). 227 DTaP-IPV/Hib (Pentacel ): Injection site reactions (tenderness, redness, swelling), systemic effects (fever, decreased activity/lethargy, inconsolable crying, fussiness/irritability). 224 Interactions for Haemophilus b Vaccine Other Vaccines Simultaneous administration with other age-appropriate vaccines, including live virus vaccines, toxoids, or inactivated or recombinant vaccines, during the same health-care visit is not expected to affect immunologic responses or adverse reactions to any of the preparations. 105 134 174 Immunization against Hib can be integrated with immunization against diphtheria, tetanus, pertussis, hepatitis B, influenza, pneumococcal disease, poliovirus, rotavirus, measles, mumps, rubella, and varicella. 77 105 159 174 Each parenteral vaccine should be administered using a different syringe and different injection site. 105 134 Specific Drugs and Laboratory Tests Drug Interaction Comments Diphtheria and tetanus toxoids and pertussis vaccine adsorbed (DTaP) Hib-MenCY (MenHibrix ): Concurrent administration with DTaP-HepB-IPV (Pediarix ) and pneumococcal 7-valent conjugate vaccine (PCV7; (Prevnar ; no longer commercially available in US) in infants at 2, 4, and 6 months of age did not reduce antibody response to DTaP or the other antigens 227 H understand
reduce Haemophilus b Vaccine a fairly large
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