Canadian Immunization Guide: Part 4 - Active Vaccines


Key Information

What
  • Pertussis (whooping cough) is a highly communicable bacterial illness.
  • Its severity is greatest among infants who are too young to be protected by a complete vaccine series. 
  • Timely primary immunization with four doses of an acellular pertussis-containing vaccine is estimated to be 90% effective in preventing pertussis during the first 4 to 6 years of life.
  • Tdap immunization in pregnancy is estimated to protect approximately 90% of infants less than 3 months of age
  • Acellular pertussis-containing vaccines are only available as combination vaccines.
  • Redness, swelling and pain at the injection site are the most common adverse reactions to acellular pertussis-containing vaccines.
Who
  • Acellular pertussis-containing vaccines are recommended for:
    • routine immunization of infants and children, including an adolescent booster dose
    • immunization of children who missed pertussis immunization on the routine schedule
    • adults who have not previously received a dose of pertussis-containing vaccine in adulthood
How
  • Routine pertussis immunization of infants, children and adolescents: DTaP-IPV-Hib-containing vaccine should be provided at 2, 4, 6 and 12 to 23 months of age (generally given at 18 months of age), followed by a booster dose of either DTaP-IPV or Tdap-IPV vaccine at 4 to 6 years of age (school entry) and a booster dose of Tdap vaccine at 14 to 16 years of age.
  • Routine pertussis immunization of adults: one dose of Tdap vaccine should be provided to all adults 18 years of age and older. One dose of Tdap vaccine should be administered in every pregnancy, ideally between 27 and 32 weeks of gestation.
  • Acellular pertussis-containing vaccines may be administered concomitantly with routine vaccines at different injection sites using separate needles and syringes.
Why
  • In unimmunized or underimmunized individuals, pertussis can result in hospitalization and death
  • Serious complications may include pneumonia, atelectasis, subdural bleeding, conjunctival bleeding, lymphocytosis, seizures, encephalopathy and hernias.

Significant revisions since the last chapter update are highlighted in the Table of Updates

Epidemiology

Disease description

Infectious agent

Pertussis (whooping cough) is caused by the bacterium Bordetella pertussis.

Reservoir

Humans.

Transmission

Pertussis is highly communicable, with high attack rates among susceptible household contacts. Parents (primarily mothers) and siblings are an important source of pertussis transmission to young infants. Transmission is less likely from vaccinated cases and to vaccinated contacts. Pertussis is usually transmitted by the respiratory route through contact with respiratory droplets; indirect spread through contaminated objects occurs rarely, if at all. The incubation period is 9 to 10 days (range, 6 to 20 days), and may rarely be as long as 42 days. Infectiousness is greatest during the catarrhal period and during the first 2 weeks after cough onset. Patients are no longer contagious after 5 days of appropriate antibiotic treatment.

Risk factors

While pertussis can affect individuals of any age, severity and disease complications are greatest among infants who are unimmunized or underimmunized.

Seasonal and temporal patterns

Pertussis is an endemic disease common to children (especially young children) everywhere, regardless of ethnicity, climate or geographic location. In Canada, pertussis peaks occur at two to five year intervals, with cycle activity varying by province and territory.

Spectrum of clinical illness

The clinical course of pertussis is divided into three stages. The initial catarrhal stage is characterized by runny nose, sneezing, low-grade fever, and a mild cough, similar to a cold. After 1 to 2 weeks of gradually worsening cough, the paroxysmal stage begins. The paroxysmal stage is characterized by bursts of rapid coughing, ending with an inspiratory whoop and sometimes post-tussive vomiting. This stage lasts from 1 to 6 weeks but may persist for up to 10 weeks. In the convalescent stage, recovery is gradual and may take weeks to months.

The clinical course varies with age. In young infants, who are at the highest risk, clinical symptoms are frequently atypical. Whoop and post-tussive vomiting may be absent. The presentation may be characterized solely by episodes of apnea. Serious complications occur mainly in infants and may include pneumonia, atelectasis, subdural bleeding, conjunctival bleeding, lymphocytosis, seizures, encephalopathy, hernias and death.

Pertussis may be milder in adolescents and adults, but symptoms can range from asymptomatic infection to a very prolonged, debilitating cough. Pertussis is a common and often unrecognized cause of cough persisting for over 2 weeks in adolescents and adults. Complications in adolescents and adults include sleep disturbance, rib fractures, subconjuctival hemorrhages, rectal prolapse, and urinary incontinence, all from intense and persistent coughing. Adolescents and adults with a cough, and less so in those who are asymptomatic, are a source of infection for those most at risk, namely infants.

Although mortality is rare in high-income countries, it is most often caused by complications of pertussis infection such as pneumonia and central nervous system dysfunction that can lead to respiratory failure and apnea.  One to four deaths related to pertussis occur each year in Canada, particularly in unimmunized or underimmunized infants less than 6 months of age.

Disease distribution

Pertussis is endemic worldwide, even in regions with high vaccination coverage. Despite periodic increases, Canada has experienced an overall decline since the introduction of pertussis vaccination programs. However, infants and children are still at the highest risk for disease, associated complications, and death.  For more information about pertussis distribution in Canada, please refer to the Vaccine Preventable Disease Surveillance Report.

Preparations authorized for use in Canada

Pertussis-containing vaccines

  • ADACEL®(adsorbed vaccine containing tetanus toxoid, reduced diphtheria toxoid and reduced acellular pertussis vaccine), Sanofi Pasteur Ltd. (Tdap)
  • ADACEL®-POLIO (adsorbed vaccine containing tetanus toxoid, reduced diphtheria toxoid and reduced acellular pertussis vaccine combined with inactivated poliomyelitis vaccine), Sanofi Pasteur Ltd. (Tdap-IPV)
  • BOOSTRIX® (adsorbed vaccine containing tetanus toxoid, reduced diphtheria toxoid and reduced acellular pertussis vaccine), GlaxoSmithKline Inc. (Tdap)
  • BOOSTRIX®-POLIO (adsorbed vaccine containing tetanus toxoid, reduced diphtheria toxoid and reduced acellular pertussis vaccine combined with inactivated poliomyelitis vaccine), GlaxoSmithKline Inc. (Tdap-IPV)
  • INFANRIX®-IPV (adsorbed vaccine containing diphtheria and tetanus toxoids, acellular pertussis, inactivated poliomyelitis), GlaxoSmithKline Inc. (DTaP-IPV)
  • 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 hexaTM® (adsorbed vaccine containing combined diphtheria and tetanus toxoids, acellular pertussis, hepatitis B [recombinant], inactivated poliomyelitis and conjugated Haemophilus influenzae type b vaccine), GlaxoSmithKline Inc. (DTaP-HB-IPV-Hib)
  • PEDIACEL® (adsorbed vaccine containing diphtheria and tetanus toxoids and acellular pertussis vaccine combined with inactivated poliomyelitis vaccine and Haemophilus influenzae type b conjugate vaccine), Sanofi Pasteur Ltd. (DTaP-IPV-Hib)
  • QUADRACEL® (adsorbed vaccine containing diphtheria and tetanus toxoids and acellular pertussis vaccine combined with inactivated poliomyelitis vaccine), Sanofi Pasteur Ltd. (DTaP-IPV)

In Canada, pertussis vaccine is only available as an acellular preparation in a combination vaccine. The amount of acellular pertussis antigen present varies by product. Preparations containing higher concentrations of acellular pertussis antigen (designated as "aP") are administered for primary immunization of infants and young children less than 7 years of age (pediatric formulation) and may be administered as a booster for children 4 years to less than 7 years of age. Preparations containing a lower concentration (designated as "ap" and referred to as "reduced") may also be administered as a booster dose to children 4 years to less than 7 years of age and are the recommended product for older children, adolescents and adults (adolescent/adult formulation).

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 Contents of Immunizing Agents Available in Canada in Part 1 for a list of all vaccines available for use in Canada and their contents.

Immunogenicity, Efficacy and Effectiveness

Immunogenicity

Immunologic correlates of protection against pertussis are not well-defined, but higher levels of anti-pertussis antibodies seem to be associated with greater protection. In general, acellular pertussis-containing combination vaccines have demonstrated good immunogenicity of their component antigens. Consistently high response to pertussis vaccine has been observed after booster vaccination. Early third trimester Tdap vaccination in pregnancy leads to efficient transplacental transfer of vaccine-derived antibodies to the infant which persist until the infant may begin to be immunized at 2 months of age.

Efficacy and effectiveness

The vaccine efficacy following the primary series with acellular pertussis vaccines is estimated to be about 85%, and approximately 90% following booster immunization. Although the duration of protection afforded by acellular pertussis vaccine is unknown, available data suggests that protection does not significantly decline between the first booster (18 months) and second booster (4-6 years) with an acellular pertussis vaccine. However, a progressive decline in protection has been observed following the second booster dose. Tdap immunization in pregnancy is estimated to provide protection against pertussis in 9 of 10 infants less than 3 months of age.

Recommendations for use

Routine schedule

Infants and children (2 months to 6 years of age)

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 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.

DTaP-IPV or Tdap-IPV vaccine should be used as the booster dose for children at 4 to 6 years of age.

Children (7 to 17 years of age)
Tdap vaccine should be administered to adolescents at 14 to 16 years of age as the first 10-year booster dose.
Adults (18 years of age and older)

All adults should receive one dose of Tdap vaccine if they have not previously received pertussis-containing vaccines in adulthood. In particular, adults who have not previously received pertussis-containing vaccines in adulthood, and who anticipate having regular contact with an infant, should receive a dose of Tdap vaccine, ideally administered at least 2 weeks before contact with the infant. Persons who have had pertussis infection should receive pertussis-containing vaccines as recommended because infection does not confer long term immunity.

A Tdap vaccine should be routinely offered to all pregnant women in every pregnancy, irrespective of their immunization history. One dose of Tdap vaccine should ideally be provided between 27 and 32 weeks of gestation. Earlier immunization between 13 and 26 weeks of gestation may also be considered in some situations (e.g. in case of an increased risk of preterm delivery or travel) to allow for longer placental exposure to higher antibody levels and maximization of antibody transfer. While it is preferable that immunization is administered at least 4 weeks before birth to allow optimal transfer of antibodies and direct protection of the infant against pertussis, it should be considered until the end of pregnancy as it has the potential to provide partial protection.

Catch-up and accelerated schedules

Infants and children (up to 17 years 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 as early as 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 on or after 12 months of age for sustained immunity. DTaP-IPV (with or without 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.

Previously unimmunized children less than 7 years of age should receive three doses of DTaP-IPV (with or without Hib) vaccine with an interval of 8 weeks between doses, followed by a dose of DTaP-IPV vaccine 6 to 12 months after the third dose. A booster dose of either DTaP-IPV or Tdap-IPV vaccine should be administered at 4 to 6 years of age (school entry). The booster dose at 4 to 6 years of age is not required if the fourth dose of tetanus-toxoid containing vaccine was administered after the fourth birthday. A booster dose of Tdap vaccine should be administered 10 years after the last dose; Tdap-IPV vaccine should be used if IPV vaccine is also indicated.

Previously unimmunized children 7 years of age and older should receive three doses of Tdap-IPV vaccine, with an interval of 8 weeks between the first two doses, followed by a third dose administered 6 to 12 months after the second dose. A booster dose of Tdap vaccine should be administered 10 years after the last dose; Tdap-IPV vaccine should be used if IPV vaccine is also indicated.

Refer to Pregnancy and breastfeeding and Booster doses and re-immunization. Refer to Diphtheria Toxoid, Tetanus Toxoid, Poliomyelitis Vaccine, Haemophilus influenzae type b Vaccine, and Hepatitis B Vaccine in Part 4 for additional information.

Serologic Testing

Serologic testing is not recommended before or after receiving pertussis vaccine.

Vaccination of Specific Populations

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. There are no established serologic correlates for protection against pertussis. Refer to Immunization of Persons with Inadequate Immunization Records in Part 3 for additional general information.

Pregnancy and breastfeeding

Immunization with Tdap to date has been shown to be safe in pregnant women and allows high levels of antibody to be transferred in utero that are protective to newborns during the first two months of life when the morbidity and mortality from pertussis infection is the highest. Therefore Tdap vaccine should be offered to all pregnant women during every pregnancy, irrespective of their immunization history. While the vaccine should be ideally provided between 27 and 32 weeks of gestation, immunization between 13 and 26 weeks of gestation may also be considered in some situations (e.g. in case of an increased risk of preterm delivery or travel). Earlier vaccine administration will allow for longer placental exposure to higher antibody levels and maximization of antibody transfer. Although it is preferable that immunization is administered in sufficient time before birth (i.e. 4 weeks) to allow optimal transfer of antibodies, it should be considered until the end of pregnancy.  Table 1 provides information on the preferred timing of Tdap administration depending on the available evidence on vaccine safety, immunogenicity and effectiveness.  Refer to Immunization in Pregnancy and Breastfeeding in Part 3 for additional general information.

Table 1 - Considerations and decision points for determining optimal timing of maternal Tdap immunization
Options Considerations Decision Points

1. Immunization at 27-32 weeks of gestation

Safety

  • Strong safety data in third trimester

Effectiveness

  • Effectiveness data primarily span vaccination at 27-36 weeks of gestation.

Immunogenicity

  • Peak maternal anti-pertussis antibody levels are achieved approximately 4 weeks following vaccination
  • Placental transfer of maternal antibodies is optimal in third trimester

Feasibility or Acceptability

  • Could be paired with routine prenatal visit during which gestational diabetes screening is offered (24-28 weeks of gestation)

Optimal balance between safety data, clinical opportunities, limited antibody waning potential, efficient antibody formation and placental transfer for term pregnancies.

This option is supported by the strongest safety and effectiveness data of all the options, and allows enough time for the antibody response to fully develop in pregnancy.

Vaccination can be paired with routine maternal visits, but may not provide protection for some preterm births.

2. Immunization at 13-26 weeks of gestation

Safety

  • Fewer safety data in second trimester

Effectiveness

  • Effectiveness data not stratified for immunization in second trimester (includes immunization in both second and third trimester).

Immunogenicity

  • Peak maternal anti-pertussis antibody levels are achieved approximately 4 weeks following vaccination
  • Some reports have shown greater antibody concentrations in infants following vaccination at 13-25 weeks compared to ≥26 weeks
  • Earlier vaccine administration in second trimester has been shown to result in higher antibody avidity (binding)

Feasibility or Acceptability

  • Could be paired with routine prenatal visits, either after detailed anatomical ultrasound is reviewed (typically done between 18-22 weeks of gestation) or when gestational diabetes screening is performed (24-28 weeks of gestation)

Safety data are fewer for second trimester, and effectiveness data are not stratified for immunization during second trimester.

Second trimester vaccination increases clinical opportunities to offer vaccination and ensures optimal antibody formation and transfer for both term and preterm infants. For preterm deliveries, a narrow window of opportunity exists between onset of transplacental antibody transfer at 20 weeks and delivery

3. Immunization before 13 weeks of gestation

Safety

  • Limited safety data in first trimester

Effectiveness

  • No effectiveness data stratified for immunization prior to 13 weeks of gestation

Immunogenicity

  • Maternal antibodies will start to wane prior to term delivery
  • Placental transfer of maternal antibodies is minimal prior to third trimester

Feasibility or Acceptability

  • If vaccine is administered prior to detailed anatomical ultrasound, fetal anomalies and other first trimester pregnancy-related complications may be misattributed to the vaccine
  • The vaccine may not be considered acceptable by patients and clinicians in the first trimester of pregnancy

Safety data are limited before 13 weeks, and effectiveness data are not stratified for first trimester immunization.

When given early in pregnancy antibody may wane before term delivery.

There is a risk of adverse events in pregnancy being misattributed to vaccination.

4. Immunization after 32 weeks of gestation

Safety

  • Strong safety data in third trimester

Effectiveness

  • Effectiveness data primarily span vaccination at 27-36 weeks of gestation.

Immunogenicity

  • Placental transfer of maternal antibodies is optimal in third trimester.
  • Peak maternal anti-pertussis antibody levels are achieved approximately 4 weeks following vaccination.

Feasibility or Acceptability

  • Clinical opportunities for vaccination exist with frequent routine prenatal visits towards the end of pregnancy.

The strongest safety and effectiveness data are from the third trimester.
This option may not allow sufficient time (i.e. 4 weeks) for the development and transfer of maternal antibodies before delivery. Late immunization will not provide protection for most preterm births.
There may be fewer clinical opportunities to offer vaccination in late pregnancy compared to earlier vaccination.

Infants born prematurely

Premature infants in stable clinical condition should be immunized with pertussis-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.

Patients/residents in health care institutions

Residents of long-term care facilities should receive all routine immunizations appropriate for their age and risk factors, including acellular pertussis-containing vaccine. Refer to Immunization of Patients in Health Care Institutions in Part 3 for additional general information.

Immunocompromised persons
Diphtheria-tetanus-pertussis-polio-Hib-containing vaccines may be administered to immunocompromised persons. When considering immunization of an immunocompromised person, consultation with the individual's attending physician may be of assistance in addition to the guidance provided in the Immunocompromised persons sections in Diphtheria Toxoid and Haemophilus influenzae type b Vaccine in Part 4. 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 general information.

Persons with chronic diseases

Neurologic disorders
People with neurological disorders are at risk of added morbidity and mortality from pertussis disease. Persons with neurological disorders with onset preceding immunization should receive all routinely recommended immunizations, including pertussis-containing vaccine.

Refer to Immunization of Persons with Chronic Diseases in Part 3 for additional general information.

Travellers

Unimmunized or incompletely immunized travellers should receive diphtheria-tetanus-pertussis-polio-Hib-containing vaccine as appropriate for age. Refer to Pregnancy and breastfeeding for more information about women who may be travelling while pregnant. Refer to Diphtheria Toxoid and Poliomyelitis Vaccine in Part 4 for information regarding other components in acellular pertussis-containing combination vaccines. Refer to Immunization of Travellers in Part 3 for additional general information.

Persons new to Canada

Health care providers who see people newly arrived in Canada should review the immunization status and update immunization for these individuals. Children who have received one or more doses of diphtheria-tetanus-whole cell pertussis (DPT) vaccine before arriving in Canada should have their vaccine series completed with acellular pertussis- containing vaccine (DTaP or Tdap) as appropriate for age. Refer to Immunization of Persons New to Canada in Part 3 for additional general information.

Workers

All health care and child care workers, regardless of age, should receive a single dose of Tdap vaccine for pertussis protection if this vaccine was not previously administered in adulthood, even if the person is not due for a tetanus and diphtheria booster. Refer to Immunization of Workers in Part 3 for additional general information.

Outbreak control

Acellular pertussis vaccine has been used for the control of pertussis outbreaks in defined populations, such as in schools or hospitals, although data supporting its effectiveness are lacking. Children exposed to a case of pertussis should have their immunization status reviewed and updated as required.

Administration Practices

Dose and route of administration

Dose

Each dose of pertussis-containing vaccine is 0.5 mL

Route of administration

Pertussis-containing vaccines must be administered intramuscularly. Refer to Vaccine Administration Practices in Part 1 for additional information.

Storage Requirements

Pertussis-containing vaccines should be stored in a refrigerator at +2°C to +8°C and should not be frozen.

Refer to Storage and Handling of Immunizing Agents in Part 1 for additional general information.

Simultaneous Administration with Other Vaccines

Pertussis-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.

Safety and Adverse Events

Refer to Vaccine Safety in Part 2 for additional general information. Refer to Diphtheria Toxoid, Tetanus Toxoid, Poliomyelitis Vaccine, Haemophilus influenzae type b Vaccine and Hepatitis B Vaccine in Part 4 for additional information regarding other components in pertussis-containing combination vaccines.

Common adverse events (affect 1% or more of vaccinees)

  • Local reactions at and near the site of injection: 10-40% (refer to Tetanus Toxoid)
  • Extensive limb swelling: 2-6% of children; more commonly associated with the 4th or 5th dose but resolve spontaneously (refer to Tetanus Toxoid)
  • Fever, irritability and/or fussiness: 8 – 29%  (refer to Tetanus Toxoid)
  • Drowsiness: 40-52% (refer to Tetanus Toxoid)

Uncommon (0.1-<1% of vaccinees) and rare (<0.1% of vaccinees) adverse events

  • Anaphylaxis following vaccination with pertussis-containing vaccine may occur, but is very rare
  • Severe arthus-type injection site reactions  (refer to Tetanus Toxoid)
  • Hypotonic hyporesponsive episodes (HHE): The case definition of HHE includes sudden onset of hypotonia (muscle limpness), hyporesponsiveness (reduced responsiveness or unresponsiveness), and pallor or cyanosis. However, there is evidence that there are no adverse consequences to these events and the adverse consequences of being incompletely immunized have been well documented.
  • High fever with or without seizure: High fever and convulsions, both febrile and afebrile, are rarely reported and are not contraindications to further immunization with acellular pertussis-containing vaccine.

Other safety issues

Epidemiological studies do not support allegations of a causal relationship between pertussis-containing vaccines and either permanent neurological injury or Type 1 diabetes.

Cases of Guillain Barré Syndrome (GBS) have been reported very rarely following administration of a tetanus toxoid-containing vaccine. Refer to Tetanus Toxoid in Part 4 for additional information.

Guidance on reporting Adverse Events Following Immunization (AEFI)

To ensure the ongoing safety of vaccines in Canada, reporting of AEFIs by vaccine providers and other clinicians is critical, and in some jurisdictions, reporting is mandatory under the law.

Vaccine providers are asked to report AEFIs through local public health officials and to check for specific AEFI reporting requirements in their province or territory. In general, any serious or unexpected adverse event felt to be temporally related to vaccination should be reported.

For pertussis containing vaccines, the following AEFIs are also of particular interest: HHE in children less than 2 years of age and extensive limb swelling. 

For additional information about AEFI reporting, please refer to Vaccine Safety in Part 2.

Contraindications and precautions

Pertussis-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.

With respect to Infanrix hexa®, hypersensitivity to yeast is very rare and a personal history of yeast allergy is not generally reliable. In situations of suspected hypersensitivity or non-anaphylactic allergy to vaccine components, investigation is indicated, which may involve immunization in a controlled setting. Consultation with an allergist is advised.

It is prudent to not administer further doses of tetanus-toxoid containing vaccine to persons who develop Guillain-Barre Syndrome (GBS) within 6 weeks of receiving such vaccine. Those who develop GBS outside the 6 week interval may receive subsequent doses of tetanus toxoid-containing vaccine. If there is a history of both Campylobacter infection (which has been associated with GBS) and receipt of a tetanus and diphtheria toxoid-containing vaccine within the 6 weeks before the onset of GBS, consultation with an infectious disease specialist is advised. Refer to Tetanus Toxoid in Part 4 for additional information.

Administration of pertussis-containing vaccine should be postponed in persons suffering from severe acute illness. Immunization should not be delayed because of minor acute illness, with or without fever. Refer to Contraindications, Precautions and Concerns in Part 2 for additional general information.

Other Considerations

Interchangeability of vaccines

The primary series of three doses of pertussis-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. On the basis of expert opinion, an appropriate product from any manufacturer can be used for all booster doses. Refer to Principles of Vaccine Interchangeability in Part 1 for additional general information.

Selected References

  • Centers for Disease Control and Prevention. The Pink Book: Epidemiology and Prevention of Vaccine Preventable Diseases. Updated 13th ed.; 2015. Accessed October 2017 at: https://www.cdc.gov/vaccines/pubs/pinkbook/index.html
  • Centers for Disease Control and Prevention. DTaP ACIP Recommendations. Accessed October 2017 at: https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/dtap.html
  • Centers for Disease Control and Prevention. Tdap/Td ACIP Recommendations. Accessed October 2017: https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/tdap-td.html
  • GlaxoSmithKline Inc. Product Monograph - BOOSTRIX®, March 2017.
  • GlaxoSmithKline Inc. Product Monograph - BOOSTRIX®-POLIO, March 2017.
  • GlaxoSmithKline Inc. Product Monograph - INFANRIX hexa®, April 2016.
  • GlaxoSmithKline Inc. Product Monograph - INFANRIX®.-IPV, September 2014.
  • GlaxoSmithKline Inc. Product Monograph - INFANRIX®.-IPV/Hib, May 2017.
  • National Advisory Committee on Immunization. Update on immunization in pregnancy with tetanus toxoid, reduced diphtheria toxoid and reduced acellular pertussis (Tdap) vaccine. March 2018. Accessed March 2018 from: https://www.canada.ca/en/public-health/services/publications/healthy-living/update-immunization-pregnancy-tdap-vaccine.html
  • National Advisory Committee on Immunization. Literature review on immunization in pregnancy with tetanus toxoid, reduced diphtheria toxoid and reduced acellular pertussis (Tdap) vaccine: Safety, immunogenicity and effectiveness. March 2018. March 2018 from: https://www.canada.ca/en/public-health/services/publications/healthy-living/executive-summary-literature-review-update-immunization-pregnancy-tdap-vaccine.html
  • National Advisory Committee on Immunization. Prevention of pertussis in adolescents and adults. Can Commun Dis Rep 2003;29(ACS-5):1-9.
  • National Advisory Committee on Immunization. Statement on adult/adolescent formulation of combined acellular pertussis, tetanus, and diphtheria vaccine. Can Commun Dis Rep 2000;26(ACS-1):1-8.
  • National Advisory Committee on Immunization. Statement on the booster for 4-6 year-olds for protection against pertussis. Can Commun Dis Rep 2014; 40
  • 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.
  • National Advisory Committee on Immunization. Statement on pertussis vaccine. Can Commun Dis Rep 1997;23(ACS-3):1-16.
  • National Advisory Committee on Immunization. Update on pertussis vaccination in pregnancy. Can Commun Dis Rep 2014;40.
  • Public Health Agency of Canada. Vaccine Preventable Disease: Surveillance Report to December 31, 2015. Available at: https://www.canada.ca/en/public-health/services/publications/healthy-living/vaccine-preventable-disease-surveillance-report-december-31-2015.html
  • Sanofi Pasteur Ltd. Product Monograph - ADACEL®, June 2012.
  • Sanofi Pasteur Ltd. Product Monograph - ADACEL®-POLIO, July 2013.
  • Sanofi Pasteur Ltd. Product Monograph - PEDIACEL®, November 2011.
  • Sanofi Pasteur Ltd. Product Monograph - QUADRACEL®, August 2011.
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