TdaPBooster. Tetanus, diphtheria and pertussis vaccination of children, adolescents and adults throughout life

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1 TdaPBooster Tetanus, diphtheria and pertussis vaccination of children, adolescents and adults throughout life CONTENTS Statens Serum Institut vaccine production Pertussis in Denmark Pertussis vaccination - not just for kids Safety and immunogenicity trials of TdaPBooster in children in adolescents in adults Product characteristics

2 Statens Serum Institut For more than 1 years Statens Serum Institut s main task has been to secure the preparedness towards infectious diseases and congenital disorders in Denmark. Today Statens Serum Institut is an international research, production and service enterprise with approximately 1,3 employees, developing and manufacturing high-quality innovative vaccines. TdaPBooster* Indicated for booster vaccination from the age of 4 years onwards Safe and immunogenic Highly purified antigens H 2 O 2 inactivated and high dose pertussis toxoid Contains no preservatives Manufactured in Denmark High quality vaccines At Statens Serum Institut we are focused on manufacturing highly purified components for use in our vaccines, thus further reducing side effects and increasing safety. Therefore: Tetanus (T), diphtheria (d) and acellular pertussis (ap) toxoids are manufactured using a technique where purification takes place before inactivation, ensuring optimal purity the acellular pertussis toxin is inactivated by hydrogen peroxide (H 2 O 2 ), resulting in a lower degree of impairment of immunogenic epitopes and thus in a vaccine antigen, which is structurally more related to native pertussis toxin than if inactivated by formaldehyde / glutaraldehyde [1;2] TdaPBooster vaccine from Statens Serum Institut is free from preservatives About the monocomponent pertussis from Statens Serum Institut The clinical development of the monocomponent ap vaccine was initiated by the US National Institute of Health (NIH). Recently Statens Serum Institut acquired the license to manufacture the ap toxoid, and it is today manufactured by Statens Serum Institut at our manufacturing site in Denmark, along with our entire vaccine production. Vaccines containing this pertussis component obtained first regulatory approval in 1996 in Denmark and Sweden, followed by other European countries in 1997 and the USA in The ap vaccine safety and immunogenicity has been demonstrated in infants, children, adolescents and adults. In a Danish cohort study including over 5. children who recieved 3 TDaP doses, the vaccine effectiveness against pertussis requiring hospitalisation was 93%, and 78% against pertussis not requiring hospitalisation [3]. A result showing a higher effectiveness against severe pertussis than against mild pertussis. *TdaPBooster is authorised with other brand names in some countries

3 Pertussis in Denmark - the Danish case Epidemiological facts Age change in pertussis incidences Since the introduction of acellular pertussis vaccination in Denmark in 1997, the only pertussis vaccine used in the country up to 214 is the pertussis vaccine from SSI. The epidemiological profile for pertussis in Denmark is therefore uniquely influenced by one type of vaccine, the monocomponent ap vaccine from SSI. Laboratory confirmed pertussis cases in Denmark 4 35 Cases per 1. inhabitants 3 25 The highest incidence of pertussis is among infants below one year of age. In this group the majority is not yet fully immunized. The incidence curves for adolescents has changed significantly since the 199s, where a shift from around 5 to over 2 cases per 1. has occurred. This trend suggests that lifelong protection against pertussis is not obtained with the childhood vaccinations [9]. The same trend is observed in neighbouring countries and some countries are today recommending pertussis boosting of adolescents and adults for prolonged immunity years years 2 + years Years In addition to the primary DTaP IPV/Act-Hib vaccination given to infants at 3, 5 and 12 months, TdaP IPV booster vaccination was introduced at 5 years of age in 23. Since 1995, only one pertussis epidemic has occurred in Denmark, which was in 22, the year before the booster vaccination at 5 years was introduced. The documented population incidence that year was 36 per Years "" years 1-4 years 5-8 years 9-12 years Years

4 Pertussis vaccination - not just for kids In the mid-2th century, pertussis was generally thought of as a childhood disease that vaccination could easily conquer. However, neither an episode of pertussis nor vaccination against pertussis will confer life long protection against this highly infectious disease. In fact, immunity only lasts approximately 5-1 years [4] and pertussis in adolescents and adults is therefore quite common. The symptoms associated with pertussis in adults can vary from a mild prolonged cough to full characteristic pertussis with as much as three months of frequent coughing spasms accompanied by vomiting. Pertussis in adults is not lifethreatening as it is in infants, but it is widely recognized that the source of pertussis infection to vulnerable nonvaccinated infants is indeed the parents and other family members. In recognition of this, several countries around the world have therefore introduced booster vaccines to adolescents and adults. PERTUSSIS IN ADOLESCENTS AND ADULTS IS QUITE COMMON

5 Safety and immunogenicity trials of TdaPBooster Safety and immunogencity in children TdaPBooster was investigated in a dose-finding clinical trial [8]. The vaccine was given as a booster vaccination to a total of 62 preschool aged children who had previously been vaccinated with ap vaccine in an efficacy trial [5]. TdaPBooster is safe in children No reports of extensive swelling reactions ( 1 cm) 2.4 % experienced injection site redness ( 6 cm) 9.9 % experienced injection site swelling ( 6 cm) 55.6 % experienced injection site pain (of any intensity) TdaPBooster is highly immunogenic in children 97.4 % obtained anti-pertussis toxoid seroconversion ( x4 increase) 99.3 % obtained anti-pertussis toxoid seropositivity (post-vac. conc. 4 IU/mL) The post vaccination anti-pertussis toxoid GMC (General Mean Concentration) was 223 IU/mL Safety and immunogenicity in adolescents TdaPBooster was investigated in 115 Swedish adolescents of years of age, previously primed and boosted with acellular pertussis, in a randomised and controlled clinical trial [6,8]. TdaPBooster is safe in adolescents 2.7 % experienced an extensive swelling reaction.9 % experienced severe injection site pain Frequencies of moderate to severe fatigue of 15.2 % and moderate to severe headache of 17. % TdaPBooster is highly immunogenic in adolescents 95.6 % obtained an anti-pertussis toxoid booster response ( x2 increase & post-vac. conc. 4 IU/mL) The post vaccination anti-pertussis toxoid GMC was 74.2 IU/mL

6 Safety and immunogenicity in adults TdaPBooster and ditebooster from Statens Serum Institut were given as booster vaccinations in a double-blind, randomised and controlled clinical trial [7] to 8 Danish adults of 18 to 55 years of age, all previously primed with whole cell pertussis vaccine (wp). 41 were given TdaPBooster and 399 were given ditebooster. TdaPBooster is safe in adults No difference in frequencies of injection site reactions following TdaPBooster and ditebooster Severe injection site pain was experienced by.7 % TdaPBooster is highly immunogenic in adults Tetanus and diphtheria seroprotection rates after vaccination with TdaPBooster were non-inferior to those after vaccination with ditebooster 92. % obtained an anti-pertussis toxoid booster response 98.3 % obtained anti-pertussis toxoid seropositivity (post-vac. conc. 5 IU/mL) The post-vaccination anti-pertussis GMC was IU/mL Response curves showing the effect of the booster vaccination [7] % Before After 1 Diphtheria Log1 (conc) (IU/ml) % Tetanus Before After Log1 (conc) (IU/ml) % Pertussis Before After Log1 (conc) (IU/ml) Reverse cummulative distribution curves showing the titer of antibodies against tetanus, diphtheria and pertussis before and after booster vaccination. Subjects (%) vs. concentrations (IU/mL). Red curves (TdaPBooster), Black curves (ditebooster). Stipulated horisontal lines=seroprotection limits of.1 IU/mL for diphtheria and tetanus, and seropositivity limit of 5 IU/mL for pertussis. All concentrations are in logarithmic scale.

7 Product characteristics This is a shortened version of the approved Summary of Product Characteritics. Registrations and licensing conditions may vary between countries. Please always consult your locally approved prescribing information. For full product information please contact your local supplier, local authorities or contact Statens Serum Institut by Composition One dose of.5 ml contains: Diphtheria toxoid, purified 2 IU Tetanus toxoid, purified 2 IU Pertussis toxoid, purified 2 µg Aluminium hydroxide corr. to.5 mg aluminium Unpreserved Shelf life and storage The shelf life is 3 years. Storage in refrigerator between +2 and + 8 C. Do not freeze. Discard if frozen. Presentation Suspension for injection in pre-filled syringe. Pack sizes: 1 x.5 ml, 5 x.5 ml, 1 x.5 ml and 2 x.5 ml. Some pack sizes may not be marketed. Therapeutic indication Booster vaccination against tetanus, diphtheria and pertussis of individuals from the age of 4 years onwards. Use according to official recommendations. The recommended interval between tetanus and diphtheria booster vaccinations is generally 1 years. The interval between pertussis booster vaccinations is not yet scientifically well-established. Individuals with unknown vaccination history can be vaccinated. However, a booster response is only expected in previously vaccinated or naturally infected individuals. Can be used in individuals with tetanus prone injuries when vaccination against diphtheria and pertussis is also relevant. possible, vaccination should be postponed until immunosuppressive treatment has been finalised. As with any vaccine, a protective immune response is not elicited in all vaccinees. If any of the following adverse events occur in relation to immunisation with a pertussis-containing vaccine, the decision to administer additional doses of pertussis vaccine should be carefully considered: hypotonic-hyporesponsive episode (HHE) within 48 hours of vaccination fever > 4 C within 48 hours of vaccination not due to any other identified cause persistent, inconsolable crying lasting more than 3 hours, within 48 hours of vaccination convulsions with or without fever, within 3 days of vaccination Interactions As it is an inactivated vaccine, it can be administered simultaneously, before or after other live or inactivated vaccines at separate injection sites. Tetanus immunoglobulin can be administered concomitantly. Fertility, pregnancy and lactation Nothing indicates that vaccination has an effect on male or female fertility. Data from a repeated dose toxicity study in animals showed no effect on reproductive organs. As for other inactivated vaccines harm to the fetus is not anticipated. Data from animal studies on reproductive toxicity are limited. Before vaccinating a breast feeding woman, risks and benefits should be assessed. The effects on the breast feeding infant have not been studied. Posology and administration A dose of.5 ml is recommended for all ages and populations. Shake before use. Administer intramuscularly, preferably in the deltoid muscle. Do not administer intravascularly. In individuals at risk of haemorrhage, administer subcutaneously. Contraindications Hypersensitivity to the active substances or any of the excipients or to formaldehyde. Progressive neurological disease. Encephalopathy of unknown aetiology with onset within 7 days after receipt of a previous pertussis vaccination. In this case a tetanus and diphtheria booster vaccination should be administered. Acute severe febrile illness. In this case postpone the booster vaccination. Special warnings and precautions for use Take necessary precautions for treatment of anaphylactic reactions. The vaccine is not intended for primary immunisation. In immunosuppressed or immunodeficient e.g. HIV infected individuals the serologic response may be impaired. Vaccination is, however, still recommended. In individuals receiving immunosuppressive treatment, vaccination can take place, but may result in an impaired serologic response. If Undesirable effects System organ class Immune system disorders Nervous system disorders Skin and subcutaneous tissue disorders Musculoskeletal and connective tissue disorders General disorders and administration site conditions Adverse reaction frequency Very rare (< 1/1,): Hypersensitivity, Anaphylactic reactions Very common ( 1/1): Headache Rare ( 1/1, to < 1/1,): Urticaria Common ( 1/1 to < 1/1): Myalgia Very common ( 1/1): Pain, itching, redness and swelling at the injection site. Fatigue Common ( 1/1 to < 1/1): Fever ( 38 C), Irritability, Malaise Redness or swelling 5 cm Rare ( 1/1, to < 1/1,): Fever (> 4 C), Injection site granuloma, Injection site abscess sterile

8 Reference List [1] Ibsen PH. The effect of formaldehyde, hydrogen peroxide and genetic detoxification of pertussis toxin on epitope recognition by murine monoclonal antibodies. Vaccine 1996 Apr;14(5): [2] Heron I, Chen FM, Fusco J. DTaP vaccines from north american vaccine (NAVA): composition and critical parameters. Biologicals 1999 Jun;27(2):91-6. [3] Hviid A, Stellfeld M, Andersen PH, Wohlfahrt J, Melbye M. Impact of routine vaccination with a pertussis toxoid vaccine in Denmark. Vaccine 24 Sep 9;22(27-28): [4] Wendelboe AM, Van Rie A, Salmaso S, Englund JA. Duration of immunity against pertussis after natural infection or vaccination. Pediatr Infect Dis J. 25 May;24(5 Suppl):S [7] Thierry-Carstensen B, Jordan K, Uhlving HH, et al. A randomised, double-blind, non-inferiority clinical trial on the safety and immunogenicity of a tetanus, diphtheria and monocomponent acellular pertussis (TdaP) vaccine in comparison to a tetanus and diphtheria (Td) vaccine when given as booster vaccinations to healthy adults. Vaccine 212 Aug 1;3(37): [8] Thierry-Carstensen B, Dalby T, Stevner MA, Robbins JB, Schneerson R, Trollfors B. Experience with monocomponent acellular pertussis combination vaccines for infants, children, adolescents and adults a review of safety, immunogenicity, efficacy and effectiveness studies and 15 years of field experience. Vaccine 213, Oct 25;31[45]: [9] Plotkin SA. The Pertussis Problem. Clinical Infectious Diseases 213 Dec 2. [5] Trollfors B, Taranger J, Lagergard T, et al. A placebo-controlled trial of a pertussis-toxoid vaccine. N Engl J Med 1995 Oct 19;333(16): [6] Netterlid E, Hallander HO, Nilsson L, Ljungman M, Gothefors L., Gustafsson L. An immunogenenicity and safety study of combined adsorbed tetanus, low dose diphtheria and acellular partussis vaccine given as a school leaving booster to year olds primed with a five component acellular pertussis vaccine at 3, 5 and 12 months of age and a booster dose at 5½ years of age. Poster session at Nordic Vaccine meeting 5-7 September 212, Copenhagen, Denmark. 212 Sep 5; 212. Scan this code to learn more about SSI s Division of Vaccine or go to ssi.dk/english/vaccines For more information and business enquiries please contact: Statens Serum Institut 5 Artillerivej DK-23 Copenhagen S Denmark T F W ssi.dk

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