Literature review on DTaP based penta- and hexavalent vaccines approved for clinical use in Canada

October 2006

(full PDF version 277 KB)

Prepared by:
Vladimir Gilca, Institut national de santé publique du Québec
Bernard Duval, Institut national de santé publique du Québec

With active collaboration of :
Shelley Deeks, Public Health Agency of Canada
Kevin Laupland, University of Calgary

This review was supported by Public Health Agency of Canada and by l’Institut national de santé publique du Québec.

Table of Contents

• Introduction
• Methods
• Results
  1. Nature and characteristics of immunizing agent
  2. Characteristics of the commercial products
  3. Production capacity and supply Issues
  4. Administration schedule, number of doses,association with other vaccines
  5. Nature and characteristics of immune response
     5. 1 Primary series
     5. 2 Booster vaccination
     5. 3 Mixed schedule: 3, 5, and 11 months vaccination
  6. Immunogenicity in different population groups
  7. Short and long-term vaccine efficacy including reduction of disease and death risks
  8. Effect of the vaccine on transmission of specific and related organisms (i.e. reduction in carriage rate, replacement)
  9. Short and long-term population effectiveness (i.e. impact on reduction of burden of disease, including herd immunity)
  10. Safety: rates and severity of adverse events, contraindications, precautions
  11. Potential interaction with other vaccines
  12. Potential impact of immunization program on resistance to antibiotics and antivirals
• Summary
• Conclusions

Tables

• Table 1.* Composition: Pentacel®, Pediacel®, Infanrix^TM-IPV/Hib, and Infanrix^TM-hexa
• Table 2. Summary of immunogenicity data with Pentacel® (Sanofi Pasteur); Pediacel® (Sanofi Pasteur); Infanrix^TM-IPV/Hib (GSK); and Infanrix^TM-hexa (GSK)
• Table 2a (continuation of Table 2)
• Table 5. Immunogenicity of Infanrixtm-hexa given at age of 3, 5, and 11 months
• Table 6. Immunogenicity of Infanrix^TM-hexa given at age of 2, 4, and 6 months to full-term and pre-term infants, one month after the third dose
• Table 7. Incidence of solicited reports of systemic reactions following any dose of Pentacel® (Sanofi Pasteur); Pediacel® (Sanofi Pasteur); infanrix^TM-IPV/Hib (GSK); and Infanrix^TM-hexa(GSK)
• Table 8. incidence of solicited reports of local reactions following any dose of Pediacel® (Sanofi Pasteur); Infanrix^TM-IPV/Hib(GSK); and Infanrix^TM-hexa(GSK)
• Table 9. incidence of systemic and local reactions by vaccine manufacturer/primary vaccination series
• Table 10. incidence of systemic and local reactions by vaccine manufacturer/booster vaccination:
• Table 11. immunogenicity of penta- and hexavalent vaccines when coadministrated with pneumococcal or pneumococcal and hepatitis B vaccines, or administered separately.
• Table 12. immunogenicity of penta- and hexavalent vaccines when coadministrated with meningococcal vaccines, or administered separately

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Introduction

In Canada, there are two manufacturers, Sanofi Pasteur and GlaxoSmithKline (GSK), that supply three combined pentavalent vaccines against diphtheria, tetanus, acellular pertussis (DTaP), polio and Haemophilus influenzae type b (Hib), and one manufacturer (GSK) that supplies a hexavalent vaccine against the above mentioned infections plus hepatitis B.

Given the specific goal of this report, data on combined DTaP based vaccines approved for use in infants in Canada were analysed. Trade names of vaccines are used to minimize product confusion : Pentacel® (Sanofi Pasteur); Pediacel® (Sanofi Pasteur); Infanrix^TM-IPV/Hib (GSK); and Infanrix^TM-hexa (GSK).

A modified version of the analytical framework for immunization programs in Canada (Erickson L and De Wals P, 2005)¹, section “Vaccine characteristics” was used for the purpose of this report. Issues including the burden of disease, ethical, legal and political considerations, as well as eventual immunization programs in Canada go beyond the objectives of this report. On several occasions, comparisons with similar vaccines not used in Canada, but used in other countries, were done. Data are presented for each antigen of each vaccine.

This report is based on scientific peer-reviewed published data.

References:

1. Erickson LJ, De Wals P, Farand L. An analytical framework for immunization programs in Canada. Vaccine 2005;23(19):2470-6.

Literature review on DTaP based penta- and hexavalent vaccines
approved for clinical use in Canada
(full PDF version 277 KB)