Haemophilus influenzae Type B Vaccine: Canadian Immunization Guide
Updated: January 2015
- Key Information
- Preparations Authorized for Use in Canada
- Efficacy, Effectiveness and Immunogenicity
- Recommendations for Use
- Vaccine Administration
- Serologic Testing
- Storage Requirements
- Simultaneous Administration with Other Vaccines
- Vaccine Safety and Adverse Events
- Other Considerations
- Selected References
Key Information (Refer to text for details)
- Haemophilus influenzae type b (Hib) occurs worldwide although rates are very low in Canada where the incidence is highest in infants less than one year of age and children one to four years of age. Hib can cause bacterial meningitis and other serious invasive infections in young children.
- In addition to the primary series at 2, 4 and 6 months of age, receipt of a dose of Hib vaccine at or after 12 months of age is critical for sustained protection. Clinical efficacy of Hib vaccination has been estimated at 95% to 100%.
- When the primary series is given and one dose is given at or after 12 months of age, more than 95% of infants develop protective antibody concentrations.
- Injection site reactions, including pain, redness and swelling, occur in 5% to 30% of children immunized with Hib-containing vaccine.
- Hib-containing vaccine is recommended for routine immunization of infants and children 2 to 59 months of age (up to the fifth birthday).
- Hib vaccine is recommended for individuals (5 years of age and older) with: congenital (primary) immunodeficiency; malignant hematologic disorders; HIV; anatomic or functional asplenia, including sickle cell disease; all transplant recipients; and cochlear implant recipients.
- Routine Hib immunization of infants: administer DTaP-IPV-Hib vaccine at 2, 4, 6 and 12 to 23 months of age (generally given at 18 months of age). If infant immunization for hepatitis B is undertaken, DTaP-HB-IPV-Hib vaccine may be used.
- Children beginning immunization after 2 months of age or with incomplete vaccination schedules: assess the number of doses required to complete the series. The number of doses of Hib vaccine required varies by age at first dose. Hib-containing vaccine is not needed in healthy children after 59 months of age (fifth birthday).
- Children 5 years of age and older or adults with chronic conditions with increased risk of invasive Hib disease: administer a single dose of Hib vaccine, even if previously vaccinated when younger, with at least one year from a previous dose.
- Hib-containing vaccines may be administered concomitantly with routine childhood vaccines at different injection sites using separate needles and syringes.
- Hib causes meningitis and bacteremia. It also commonly causes otitis media and pneumonia. The case-fatality rate of Hib meningitis is about 5%.
- Severe neurologic sequelae occur in 10% to 15% of survivors and deafness in 15% to 20%.
Haemophilus influenzae is a gram-negative coccobacillus that is either encapsulated (typeable) or non-encapsulated (non-typeable). Encapsulated strains are divided into serotypes "a" through "f", depending on the antigenic characteristics of their polysaccharide capsule, and are more likely to cause invasive disease, while non-encapsulated strains generally cause milder infections. Haemophilus influenzae serotype b (Hib) is the most pathogenic and caused 95% of invasive disease prior to the introduction of vaccine programs.
Hib is transmitted through the nasopharynx by contact with respiratory droplets or nasal or throat discharges of infected persons. The incubation period is unknown but is probably about 2 to 4 days. Infected persons can transmit disease as long as Hib bacteria are present, which may be for a prolonged period. Hib is no longer communicable 24 to 48 hours after starting effective antibiotic treatment.
Historically, the risk of Hib meningitis was increased among children with splenic dysfunction (e.g., sickle cell disease, asplenia) or antibody deficiency, children attending group child care centres, Inuit children, and persons who had received a cochlear implant.
Spectrum of clinical illness
Before the introduction of Hib vaccines in 1988, Hib was the most common cause of bacterial meningitis and a leading cause of other serious invasive infections in young children. About 55% to 65% of affected children developed meningitis, the remainder suffering from epiglottitis, bacteremia, cellulitis, pneumonia or septic arthritis. Hib also commonly causes otitis media. The case-fatality rate of Hib meningitis was about 5%. Severe neurologic sequelae occurred in 10% to 15% of survivors and deafness in 15% to 20%.
Invasive H. influenzae type b (Hib) disease occurs worldwide, but its incidence has decreased by 94% with the introduction of Hib vaccine in an increasing number of countries. Invasive disease due to non- b H. influenzae now accounts for the majority of invasive H. influenzae disease in Canada. For more information about invasive H. influenzae disease in Canada, refer to Haemophilus influenzae.
Preparations Available For Use in Canada
Haemophilus influenzae type b-containing vaccines
- Act-HIB® (Haemophilus influenzae type b conjugate vaccine [tetanus protein conjugate]), Sanofi Pasteur SA (manufacturer), Sanofi Pasteur Ltd. (distributor). (Hib)
- HIBERIX® (Haemophilus influenzae type b conjugate vaccine [tetanus protein conjugate]), GlaxoSmithKline Inc. (Hib)
- INFANRIX®-IPV/Hib (adsorbed vaccine containing diphtheria and tetanus toxoids, acellular pertussis, inactivated poliomyelitis and conjugated Haemophilus influenzae type b vaccine), GlaxoSmithKline Inc. (DTaP-IPV-Hib)
- INFANRIX hexa™ (adsorbed vaccine containing diphtheria and tetanus toxoids, acellular pertussis, hepatitis B (recombinant), inactivated poliomyelitis and conjugated Haemophilus influenzae type b vaccine (tetanus toxoid conjugate)), GlaxoSmithKline Inc. (DTaP-HB-IPV-Hib)
- PEDIACEL® (adsorbed vaccine containing diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed combined with inactivated poliomyelitis vaccine and Haemophilus influenzae type b conjugate vaccine (tetanus protein conjugate)), Sanofi Pasteur Ltd. (DTaP-IPV-Hib)
The amounts of tetanus protein carriers used in Hib conjugate vaccines should not be considered immunizing agents against tetanus disease.
For complete prescribing information, consult the product leaflet or information contained within Health Canada's authorized product monographs available through the Drug Product Database. Refer to Table 1 in Contents of Immunizing Agents Available in Canada in Part 1 for a list of all vaccines available for use in Canada and their contents.
Efficacy, Effectiveness and Immunogenicity
Efficacy and effectiveness
Clinical efficacy of Hib vaccination has been estimated at 95% to 100%. A significant component of protection of children arises because of herd immunity and so relies upon good vaccination coverage. The efficacy for persons with congenital or acquired immunodeficiency conditions is unknown. Hib vaccine failure occurs rarely and may be associated with immunodeficiency. Therefore, children who develop invasive Hib disease after completing a primary series should be evaluated for evidence of an immunodeficiency condition.
When the primary series is completed and one booster dose is given at or after 12 months of age, more than 95% of infants develop protective antibody concentrations. Higher vaccine response rates (95% to 100%) were observed in studies with a 2, 4 and 6 month schedule as compared with compressed schedules of either 2, 3 and 4 months or 3, 4 and 5 months. The duration of immunity following completion of age-appropriate immunization is unknown, but data suggest that protection is long lasting.
Recommendations for Use
Infants and children (2 months to 4 years of age)
Hib-containing vaccine is recommended for routine infant immunization beginning at 2 months of age. DTaP-IPV-Hib vaccine is authorized for use in children less than 7 years of age. DTaP-HB-IPV-Hib vaccine is authorized for use in children 6 weeks to 23 months of age and may be given to children aged 24 months to less than 7 years, if necessary.
Children and adults (5 years of age and older)
Hib-containing vaccine is not routinely indicated in children 5 years of age and older.
Hib vaccination is recommended for individuals (5 years of age and older) with: congenital (primary) immunodeficiency; malignant hematologic disorders; HIV; anatomic or functional asplenia (including sickle cell disease); all transplant recipients; and cochlear implant recipients (refer to Table 1). Consultation with an infectious disease expert is advised. Refer to Immunization of Immunocompromised Persons and Immunization of Persons with chronic diseases in Part 3 for additional information.
|Condition||5 years of age and older, including ADULTS|
|Asplenia or hyposplenism (including sickle cell disease)||1 dose recommended regardless of Hib immunization historyTable 1 - Footnote *2|
|Cochlear implant||1 dose recommended regardless of Hib immunization historyTable 1 - Footnote *2|
|Congenital (primary) immunodeficiency||1 dose recommended regardless of Hib immunization historyTable 1 - Footnote *2|
|HIV||1 dose recommended regardless of Hib immunization historyTable 1 - Footnote *2|
|HSCT||Post-HSCT: 3 doses|
|Malignant hematologic disorders||1 dose recommended regardless of Hib immunization historyTable 1 - Footnote *2|
|Solid organ transplant||
Pre- transplant: 1 dose recommended regardless of Hib immunization historyTable 1 - Footnote *2
Hib infection does not always confer immunity. Persons who have recovered from Hib should be immunized as appropriate for age and risk factors.
Persons with inadequate immunization records
Children and adults lacking adequate documentation of immunization should be considered unimmunized and started on an immunization schedule appropriate for their age and risk factors. Hib vaccine can be given, if indicated, without concern about prior receipt of the vaccine, because adverse events associated with repeated immunization with the vaccine have not been demonstrated. Refer to Immunization of Persons with Inadequate Immunization Records in Part 3 for additional general information.
Infants born prematurely
Premature infants in stable clinical condition should be immunized with a Hib-containing vaccine at the same chronological age and according to the same schedule as full-term infants. Infants born prematurely (especially those weighing less than 1,500 grams at birth) are at higher risk of apnea and bradycardia following vaccination. Hospitalized premature infants should have continuous cardiac and respiratory monitoring for 48 hours after their first immunization. Refer to Immunization of Infants Born Prematurely in Part 3 for additional general information.
Diphtheria-tetanus-pertussis-polio-Hib-containing vaccines may be administered to immunocompromised persons. Immunocompromised children under 5 years of age should receive Hib-containing vaccine according to routine vaccination schedules. Some immunocompromised individuals 5 years of age and older should receive Hib-containing vaccine regardless of prior history of Hib vaccination, and at least 1 year after any previous dose, because of increased susceptibility to invasive Hib disease. Refer to Table 1.
When considering immunization of an immunocompromised person, consultation with the individual's attending physician may be of assistance in addition to the guidance provided below. For complex cases, referral to a physician with expertise in immunization or immunodeficiency is advised.
Refer to Immunization of Immunocompromised Persons in Part 3 for additional information.
Persons with chronic diseases
Hyposplenism or asplenia
Individuals, regardless of age, who have absent or defective splenic function are at increased risk of fulminant bacteremia which is associated with a high mortality rate. Hyposplenic, such as sickle cell disease and other hemoglobinopathies, or asplenic children less than 5 years of age, should receive an age appropriate primary series of Hib-containing vaccine. Hyposplenic or asplenic persons 5 years of age and older should receive one dose of Hib vaccine regardless of prior history of Hib immunization, and at least 1 year after any previous dose. When elective splenectomy is planned, all recommended vaccines should be given at least 2 weeks before surgery. In the case of an emergency splenectomy, vaccines should be given 2 weeks after surgery or before discharge if it is thought that the prospective vaccinee might not return for vaccination after discharge.
People who have received a cochlear implant are at increased risk for meningitis and otitis media. Prior to surgery, they should receive all-age appropriate vaccinations, including Hib-containing vaccine. Individuals 5 years of age and older should receive one dose of Hib vaccine, regardless of prior history of Hib vaccination, and at least 1 year after any previous dose.
Refer to Immunization of Persons with Chronic Diseases in Part 3 for additional general information.
Unimmunized or incompletely immunized travellers should receive diphtheria-tetanus-pertussis-polio-Hib-containing vaccine as appropriate for age. Refer to Diphtheria Toxoid and Poliomyelitis Vaccine in Part 4 for information regarding other components in Hib-containing combination vaccines. Refer to Immunization of Travellers in Part 3 for additional general information.
Persons new to Canada
Health care providers who see persons newly arrived in Canada should review the immunization status and update immunization for these individuals. Many countries do not have routine Hib immunization programs for infants. Review of Hib vaccination status is particularly important for persons identified as having sickle cell disease or other genetic hemoglobinopathies that may predispose to hyposplenia. (refer to Hyposplenism or asplenia). Information on vaccination schedules in other countries can be viewed through the WHO. Refer to Immunization of Persons New to Canada in Part 3 for additional general information.
Chemoprophylaxis is not required for household contacts of cases of invasive Hib infection when the contacts have completed a vaccine series (refer to Table 2). When contacts less than 48 months of age are incompletely immunized, consultation with local public health officials is advised.
Dose, route of administration, and schedule
Each dose of Hib-containing vaccine is 0.5 mL.
Route of administration
Hib-containing vaccines must be administered intramuscularly. Refer to Vaccine Administration Practices in Part 1 for additional information.
Infants and children (2 months to 4 years of age)
Routine Hib immunization of infants: DTaP-IPV-Hib vaccine should be given at 2, 4, 6 and 12 to 23 months of age (generally given at 18 months of age).
If infant immunization for hepatitis B is undertaken, DTaP-HB-IPV-Hib vaccine may be used as an alternative to separately administered hepatitis B and DTaP-IPV-Hib vaccines. DTaP-HB-IPV-Hib vaccine is authorized for use in children 6 weeks to 23 months of age and may be given to children aged 24 months to less than 7 years, if necessary, although Hib vaccine is generally not indicated in those 5 years of age and older. DTaP-HB-IPV-Hib vaccine may be given at 2, 4, 6 and 12 to 23 months of age, but the fourth dose is unlikely to provide significant additional hepatitis B protection and will increase cost. Alternative schedules may be used as follow:
- DTaP-HB-IPV-Hib vaccine (2, 4 and 6 months of age) with DTaP-IPV-Hib vaccine at 12 to 23 months of age
- DTaP-HB-IPV-Hib vaccine (2, 4 and 12 to 23 months of age) with DTaP-IPV-Hib vaccine at 6 months of age.
If rapid protection is required for an infant, the first dose of DTaP-IPV-Hib or DTaP-HB-IPV-Hib vaccine can be given at 6 weeks of age. The first three doses may be administered at intervals of 4 weeks and, optimally, the fourth dose given 12 months after the third dose. The fourth dose may be given at a minimum interval of 6 months after the third dose in certain situations (e.g., travel) but must be administered at or after 12 months of age for sustained immunity.
Children beginning immunization after 2 months of age or with interrupted or incomplete vaccination schedules should be assessed to determine the number of doses of Hib vaccine required to complete the series. The number of doses of Hib vaccine required varies by age at first dose. Because Hib vaccine is given as part of a combination vaccine, the schedule for the other components in the combination vaccine may differ for children starting the vaccine series after 6 months of age, and additional doses may be required to complete the series. Refer to Table 2.
|Age at 1st dose of HibTable 2 - Footnote *1 vaccine||HibTable 2 - Footnote *1 vaccine schedule|
|2 to 6 months|
|7 to 11 months||
2 doses, 2 months apart AND 1 booster doseTable 2 - Footnote *4
|12 to 14 months||
1 dose AND 1 booster doseTable 2 - Footnote *4
|15 to 59 monthsTable 2 - Footnote *2||
Children and adults (5 years of age and older)
Some older children and adults with certain chronic conditions with increased risk of invasive Hib disease should be immunized with Hib vaccine (refer to Table 1). Refer to Immunization of Immunocompromised Persons and Immunization of Persons with Chronic Diseases in Part 3 for details.
Booster doses and re-immunization
Serologic testing is not recommended before or after receiving Hib vaccine. There is no role for serological testing in determining immunity to Hib.
Hib-containing vaccines should be stored in a refrigerator at +2°C to +8°C and not frozen. Reconstituted Hib vaccine should be used immediately. Refer to Storage and Handling of Immunizing Agents in Part 1 for additional general information.
Simultaneous Administration With Other Vaccines
Hib-containing vaccines may be administered concomitantly with routine vaccines at different injection sites using separate needles and syringes. Refer to Timing of Vaccine Administration in Part 1 for additional general information.
Vaccine Safety and Adverse Events
Refer to Vaccine Safety in Part 2 for additional general information. Refer to Diphtheria Toxoid, Tetanus Toxoid, Pertussis Vaccine, Poliomyelitis Vaccine and Hepatitis B Vaccine in Part 4 for additional information regarding other components in Hib-containing combination vaccines.
Common and local adverse events
Injection site reactions, including pain, redness and swelling, occur in 5% to 30% of children immunized with Hib vaccine. These symptoms are mild and usually resolve within 24 hours. Fever has been reported in some infants given Hib vaccine, either alone or in combination with other vaccines.
Less common and serious or severe adverse events
Serious adverse events are rare following immunization with Hib-containing vaccines and, in most cases, data are insufficient to determine a causal association. A meta-analysis, which included 257,000 infants, reported no serious adverse events following vaccination with Hib vaccine. Anaphylaxis following vaccination with Hib-containing vaccine may occur but is very rare.
Guidance on reporting Adverse Events Following Immunization (AEFI)
Vaccine providers are asked to report, through local public health officials, any serious or unexpected adverse event felt to be temporally related to vaccination. An unexpected AEFI is an event that is not listed in available product information but may be due to the immunization or a change in the frequency of a known. Refer to Reporting Adverse Events Following Immunization (AEFI) in Canada in for additional information about AEFI reporting.
Contraindications and precautions
Hib-containing vaccines are contraindicated in persons with a history of anaphylaxis after previous administration of the vaccine and in persons with proven immediate or anaphylactic hypersensitivity to any component of the vaccine or its container. Refer to Table 1 in Contents of Immunizing Agents Available for Use in Canada in Part 1 for a list of all vaccines available for use in Canada and their contents.
Act-HIB® vaccine should not be given to a person who has had a confirmed anaphylactic reaction to tetanus toxoid vaccine.
Hypersensitivity to yeast is very rare and a personal history of yeast allergy is not generally reliable. In situations of suspected hypersensitivity ornon-anaphylactic allergy to vaccine components, investigation is indicated, which may involve immunization in a controlled setting. Consultation with an allergist is advised.
Administration of Hib-containing vaccine should be postponed in persons with moderate or severe acute illness. Persons with minor acute illness (with or without fever) may be vaccinated.
Refer to Contraindications, Precautions and Concerns in Part 2 for additional general information.
Interchangeability of vaccines
The primary series of Hib-containing vaccine should be completed with an appropriate vaccine from the same manufacturer whenever possible. However, if the original vaccine is unknown or unavailable, an alternative combination vaccine from a different manufacturer may be used to complete the primary series. Refer to Principles of Vaccine Interchangeability in Part 1 for additional general information.
- Anderson E, Decker M, Englund J et al. Interchangeability of conjugated Haemophilus influenzae type b vaccines in infants. JAMA 1995;273(11):849-53.
- Centers for Disease Control and Prevention. The Pink Book: Epidemiology and Prevention of Vaccine Preventable Diseases. Updated 11th ed.; May 2009.Accessed October 2010 at: http://www.cdc.gov/vaccines/pubs/pinkbook/index.html.
- Eskola J. Analysis of Haemophilus influenzae type b conjugate and diphtheria-tetanus-pertussis combination vaccines. J Infect Dis 1996;174(Suppl 3):S302-305.
- Friede A, O'Carroll P, Nicola R et al. Centers for Disease Control and Prevention. CDC prevention guidelines. A guide to action. Baltimore: Williams and Wilkins, 1997:394-492.
- GlaxoSmithKline Inc. Product Monograph - INFANRIX hexa™. July 2008.
- National Advisory Committee on Immunization. Interchangeability of diphtheria,
tetanus, acellular pertussis, polio, Haemophilus influenzae type b combination vaccines presently approved for use in Canada for children < 7 years of age. Can Comm Dis Rep 2005;(ACS-1):1-10.
- National Advisory Committee on Immunization. Statement on the recommended use of pentavalent and hexavalent vaccines. Can Comm Dis Rep 2007;33(ACS-1):1-15.
- Sanofi Pasteur Ltd. Product Monograph - Act-HIB®, July 2006.
- Sanofi Pasteur Ltd. Product Monograph - PEDIACEL®, January 2009.
- Scheifele D. Recent trends in pediatric Haemophilus influenzae type b infections in Canada. Immunization Monitoring Program, ACTive (IMPACT) of the Canadian Paediatric Society and the Laboratory Centre for Disease Control. CMAJ 1996;154(7):1041-47.
- Scheifele D, Halperin S, Law B et al. Invasive Haemophilus influenzae type b infections in vaccinated and unvaccinated children in Canada, 2001-2003. CMAJ 2005;172(1):53-56.
- Swingler G, Fransman D, Hussey G. Conjugate vaccines for preventing Haemophilus influenzae type b infections. Cochrane Database Syst Rev 2003(4):CD001729.
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