Pediacel (Hansard, 20 October 2004)

§ The Parliamentary Under-Secretary of State, Department of Health (Lord Warner)

Clinical trials conducted with Pediacel have demonstrated that it showed appropriate safety and effectiveness for use in the United Kingdom's primary infant immunisation schedule. The prescribing information (Summary of Product Characteristics) for this vaccine is in the public domain, and contains some clinical trial details of the vaccine's effectiveness and tolerability. Further Pediacel clinical trial data have been published in abstract form:

Miller E, Southern J, Kitchen N, et al. Interaction between different meningococcal C conjugate vaccines and the Hib components of concomitantly administered diphtheria/tetanus/pertussis/Hib vaccines with either whole cell or 86WA acellular pertussis antigens. Poster presentation at 21st European Society for Paediatric Infectious Diseases Meeting, Sicily, 9 to 11 April 2003.

Castaneda, JL, Gonzalez, N, Lavigne, P, and Ortiz, E. Immunogenicity and safety of a fully liquid DTaP-IPV-Hib vaccine with full primary IPV or sequential IPV-OPV in Mexican infants. International Journal of Infectious Diseases 8(Suppl 1), S71. 2004.

A summary of safety data from the UK trial with Pediacel has been submitted to a medical journal for publication. The manuscript for a further Pediacel trial (non-UK data) is in preparation.

The pharmaceutical company also provides to the Medicines and Healthcare Products Regulatory Agency commercially restricted data as part of the licence application. Evidence for the safety and efficacy of Pediacel can also be derived from the experience of the use of a five component acellular pertussis vaccine (called Pentacel) in Canada as part of the routine schedule since 1997. This vaccine contains the same components as Pediacel. Since the introduction of this vaccine, over 10 million doses have been distributed. A number of papers showing the efficacy and safety of this vaccine in Canada have been published as follows.

List of published papers on Pentacel vaccine:

Scheifele D & Halperin SA. Haemophilus influenzae type B disease control using PENTACEL in Canada, 1998–99. Can Commun Dis Rep. 2000 Jun; 1:26(11):93–96.

Moore DL et al. Lack of evidence of encephalopathy related to pertussis vaccine: active surveillance by IMPACT, Canada, 1993–2002. Pediatr Infect Dis J. 2004 Jun; 23(6):568–71.

Le Saux N et al. Decrease in hospital admissions for febrile seizures and reports of hypotonic-hyporesponsive episodes presenting to hospital emergency departments since switching to acellular pertussis vaccine in Canada: a report from IMPACT. Pediatrics. 2003 Nov; 11(5):e348.

Halperin SA. Pertussis control in Canada. CMAJ. 2003 May 27; 168(11):1389–90.

Halperin SA et al. Simultaneous administration of meningococcal C conjugate vaccine and diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenza type b conjugate vaccine in children: a randomised double-blind study. Clin Invest Med. 2002 Dec; 25(6):243–51.