• The effectiveness of maternal immunization against pertussis in the first 3 months of life has been estimated to be >90%. Pivotal studies conducted with ADACEL provide serology follow-up data at 3, 5 and 10 years, in individuals previously immunized with a single booster dose of ADACEL. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400309. Limited data indicate that maternal antibodies may reduce the magnitude of the immune response to some vaccines in infants born to women vaccinated with REPEVAX during pregnancy. Active immunization against diphtheria, tetanus, pertussis and poliomyelitis in persons from 3 years of age as a booster following primary immunization. One month post-vaccination ≥ 98.5% of study participants achieved seroprotective antibody levels (≥ 0.1 IU/ml) for diphtheria and tetanus, and ≥ 84% achieved booster responses to the pertussis antigens. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Toute reproduction ou représentation totale ou partielle de ce site par quelque procédé que ce soit, sans … In a subsequent study, robust immune responses were observed following a single dose of REPEVAX in UK children 3.5 to 4.0 years of age previously primed with either an acellular pertussis combination vaccine (DTaP-IPV-Hib) or whole cell pertussis combination vaccine (DTwP//Hib) and OPV. Il est présent dans les selles des personnes contaminées. 0.5 mL of suspension in pre-filled syringe (glass) with a plunger stopper (chlorobromobutyl or bromobutyl or chlorobutyl elastomer), without attached needle, with a tip-cap (chlorobromobutyl elastomer or synthetic isoprene-bromobutyl elastomer ) and 1 or 2 separate needles - pack size of 1 or 10. Nevertheless, as REPEVAX contains toxoids or inactivated antigens, no risk to the breastfed infant should be expected. REPEVAX should not be administered into the gluteal area; intradermal or subcutaneous routes should not be used (in exceptional cases the subcutaneous route may be considered, see section 4.4). Talk with your doctor and family members or friends about deciding to join a study. REPEVAX peut être administré simultanément avec une dose de vaccin contre l'Hépatite B. REPEVAX peut être administré simultanément avec une dose de vaccin papillomavirus humain recombinant, sans interférence clinique significative avec la réponse en anticorps vis-à … Healthcare professionals are asked to report any suspected adverse reactions via the Medicines and Healthcare products Regulatory Agency (MHRA), Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. The immunogenicity of ADACEL following repeat vaccination 10 years after a previous dose of ADACEL or REPEVAX, has been evaluated. Légiférer sans passer par le Parlement. Because post-marketing adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. For the full list of excipients, see section 6.1. Intramuscular injections should be given with care in patients on anticoagulant therapy or suffering from coagulation disorders because of the risk of haemorrhage. REPEVAX should not be used for primary immunization. diphtheria, tetanus, polio, pneumococcal, meningococcal) in infants born to women vaccinated with REPEVAX during pregnancy. The safety and immunogenicity of REPEVAX in adults and adolescents was shown to be comparable to that observed with a single booster dose of Td adsorbed or Td Polio adsorbed vaccines containing a similar amount of tetanus and diphtheria toxoids and inactivated poliovirus types 1, 2 and 3. (A pertussis booster response was defined as a post-vaccination antibody concentration ≥ 4 times the LLOQ if the pre-vaccination level was < LLOQ; ≥ 4 times the pre-vaccination level if that was ≥ LLOQ but < 4 times LLOQ; or ≥ 2 times the pre-vaccination level if that was ≥ 4 times the LLOQ). Regarding the interval between a booster dose of REPEVAX and preceding booster doses of diphtheria and/or tetanus containing vaccines, the official recommendations should generally be followed. Choosing to participate in a study is an important personal decision. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. After administration of two additional doses of diphtheria- tetanus- and polio-containing vaccine to 316 subjects, one and six months after the first dose, the seroprotection rates against diphtheria were 94.6% and 100% (≥0.1 and ≥ 0.01 IU/mL, respectively), against tetanus 100% (≥0.1 IU/mL), and against polio (types 1, 2 and 3) 100% (≥1:8 dilution) (see Table 4). This site uses cookies. La contamination se fait principalement par voie digestive, lors de la consommation d'eau contaminée, d'aliments souillés (crudités, par exemple), ou par les mains sales. The number and schedule of doses should be determined according to local recommendations. L’ordonnance, prévue à l’article 38 de la Constitution, peut être assimilée à un contournement de cette règle. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. In adolescents and adults with an unknown or incomplete diphtheria or tetanus vaccination status against diphtheria or tetanus, one dose of REPEVAX® can be administered as part of a vaccination series to protect against pertussis and poliomyelitis and in most cases also against tetanus and diphtheria. Comme le repevax contient des germes inactifs, il peut être injecté, simultanément avec une dose de vaccin contre : La grippe, à condition que le médicament contient des germes inactifs. Table 2: Immune responses 4 weeks after vaccinationAntigen, † Primed with DTaP at 3 and 5 months with a booster at 12 months of age, ‡ Primed with DTwP at 2, 3 and 4 months of age. • Maternal antibody directed against pertussis antigens persists for 2 to 4 months after birth and may be associated with blunting of the infant immune response to active immunization against pertussis (see section 4.4). Tetanus, diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine after placebo. Transient severe swelling of the injected upper arm was reported in <1% of children aged 5 to 6 years. Continue typing to refine. La vaccination contre la diphtérie, le tétanos et la poliomyélite (DTP) est obligatoire ou simplement recommandée selon l'âge et la situation de la personne. REPEVAX, suspension injectable en seringue préremplie. REPEVAX peut être administré simultanément avec une dose de vaccin contre l'Hépatite B. REPEVAX peut être administré simultanément avec une dose de vaccin papillomavirus humain recombinant, sans interférence clinique significative avec la réponse en anticorps vis-à … Table 4: Serological immune status (seroprotection/seroresponse rates and GMC/GMT) before vaccination and after each dose of a 3 dose-vaccination schedule including REPEVAX® (Dose 1) followed by 2 doses of REVAXIS® 1 and 6 months later (Dose 2 and 3) in subjects vaccinated according to protocol (FAS), GMC: Geometric mean of antibody concentrations; GMT: Geometric mean of antibody titres; CI: Confidence Interval; SN: seroneutralisation; ELISA: Enzyme Linked Immunoassay; dil: dilution. Adverse reactions are ranked under headings of frequency using the following convention: cannot be estimated from the available data. To describe the safety of Td-IPV vaccine (REVAXIS®) or Placebo administered to healthy adults. Start typing to retrieve search suggestions. A single injection of one dose (0.5 mL) of REPEVAX should be administered intramuscularly. REPEVAX (Tdap-IPV) is indicated for: Active immunization against diphtheria, tetanus, pertussis and poliomyelitis in persons from 3 years of age as a booster following primary immunization. Syncope (fainting) can occur following, or even before, administration of injectable vaccines, including REPEVAX. What you need to know before REPEVAX is given to you or your child 3. However, a trend of lower anti-HPV GMTs was observed in the concomitant group. Il a été développé par le laboratoire Wyeth (racheté depuis par Pfizer), et est commercialisé sous le nom de Pristiq.La desvenlafaxine correspond à l'un des métabolites de la venlafaxine (vendue sous le nom d'Effexor). As with other inactivated vaccines, it is not expected that vaccination with REPEVAX during any trimester would harm the fetus. Persistence of seroprotection to diphtheria and tetanus, and seropositivity to pertussis is summarised in Table 3. REPEVAX has not been evaluated in fertility studies. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). In adolescents and adults with an unknown or incomplete diphtheria or tetanus vaccination status against diphtheria or … For general information, Learn About Clinical Studies. • 82.4% and 92.7% were seroprotected against diphtheria at a threshold ≥0.1 and ≥0.01 IU/mL, respectively. Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company ). In clinical trials REPEVAX was given to a total of 1,384 persons including 390 children 3 through 6 years of age and 994 adolescent and adults. • 98.5% and 99.7% were seroprotected against tetanus at a threshold ≥0.1 and ≥0.01 IU/mL, respectively. Date of first authorisation/renewal of the authorisation. The rates and severity of adverse events in recipients of tetanus toxoid antigen are influenced by the number of prior doses and level of pre-existing antitoxins. If Guillain-Barré syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give any vaccine containing tetanus toxoid, including REPEVAX should be based on careful consideration of the potential benefits and possible risks. Ce document intitulé « REPEVAX - Indications, posologie et effets secondaires » issu de Journal des Femmes (sante-medecine.journaldesfemmes.fr) est soumis au droit d'auteur. Le vaccin contre l'hépatite B (en anglais, Hepatitis B vaccine ou HBV) prévient la contamination par le virus de l'hépatite B depuis 1982. Non-clinical data revealed no special hazard for humans based on conventional studies of repeated doses toxicity. The use of REPEVAX in children aged 3 to 5 years is based upon studies in which REPEVAX was given as the fourth dose (first booster) of diphtheria, tetanus, pertussis and poliomyelitis vaccines. Prior known hypersensitivity reaction to any diphtheria and/or tetanus and/or poliomyelitis and/or pertussis containing vaccine, Any current (≤ 3 days) significant underlying disease or acute febrile illness (oral temperature ≥37.5°C), Any long-term (≥ 14 days) non steroid anti-inflammatory therapy given daily within the previous 30 days, Known history of severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, Any previous (≤ 90 days) administration of blood-derived products or immunoglobulins or scheduled to be administered through Visit 3, Any recent administration (≤ 30 days) of a vaccine or scheduled vaccination. Les interactions du repevax avec d’autres médicaments ou vaccins. How and when REPEVAX is given 4. 2Age at which subjects received a dose of ADACEL, 3Percentage of subjects with antibodies ≥ 4 EU/mL for PT, FHA and PRN, and ≥ 17 EU/mL for FIM for the 3 year follow-up; ≥ 4 EU/mL for PT, FIM and PRN, and ≥ 3 EU/mL for FHA for the 5-year and 10-year follow-up. Keep the container in the outer carton in order to protect from light. Precautions to be taken before handling or administering the medicinal product. Premier site institutionnel sur la vaccination en direction du grand public, vaccination-info-service apporte des informations factuelles, pratiques et scientifiquement validées, pour répondre aux questions du public sur la vaccination. Passive protection of neonates and infants against pertussis. Pharmacotherapeutic Group: Vaccine against diphtheria, tetanus, pertussis and poliomyelitis. Les antibiotiques sont donnés sans ordonnance. It is recommended to postpone the vaccination until the end of such disease or treatment if practical. pour demander que le vaccin DT Polio simple et sans aluminium soit de nouveau disponible en France. Ce vaccin n'est pas indiqué en primo-vaccination, ni pour les enfants de moins de 3 ans. Sans objet. Based on the serology follow-up and repeat vaccination data, REPEVAX can be used instead of a dT vaccine or dT-IPV vaccine to boost immunity to pertussis in addition diphtheria, tetanus and polio. REPEVAX should not be administered to individuals with a progressive or unstable neurological disorder, uncontrolled epilepsy or progressive encephalopathy until a treatment regimen has been established and the condition has stabilized. In both studies the rates of most systemic adverse events within 7 to 10 days following vaccination were less than 10%. REPEVAX should be used in accordance with official recommendations. injection sites reactions and systemic events during the 7 day-safety period post-vaccination with TdaP-IPV vaccine. Parenteral products should be inspected visually for extraneous particulate matter and/or discoloration prior to administration. Ces informations sont destinées aux professionnels de santé et aux patients. The clinical significance of this observation is not known. • REPEVAX should not be administered to persons who experienced an encephalopathy of unknown origin within 7 days of previous immunization with a pertussis-containing vaccine. Table 5: Vaccine effectiveness (VE) against pertussis disease in young infants born to mothers vaccinated during pregnancy with REPEVAX or ADACEL in 3 retrospective studies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Enfants âgés de 3 à 5 ans (150 sujets) Cent cinquante enfants ayant reçu une primovaccination à 2, 3 et 4 mois avec un vaccin combiné diphtérique, tétanique et coquelucheux germes entiers (sans dose additionnelle dans la seconde année de vie) ont été vaccinés avec REPEVAX à l’âge de 3 à 5 ans. Continue, 2. - One hundred and fifty children primed at 2, 3, and 4 months of age with a DTwP vaccine (with no additional dose in the second year of life) received REPEVAX at 3 to 5 years of age. Safety data from 4 randomized controlled trials (310 pregnancy outcomes), 2 prospective observational studies (2670 pregnancy outcomes), 4 retrospective observational studies (81,701 pregnancy outcomes), and from passive surveillance of women who received REPEVAX or ADACEL (Tdap component of REPEVAX; containing the same amounts of diphtheria, tetanus and pertussis antigens) during the 2nd or 3rd trimester have shown no vaccine-related adverse effect on pregnancy or on the health of the fetus/newborn child. REPEVAX appears as a uniform, cloudy, white suspension. It allows continued monitoring of the benefit/risk balance of the medicinal product. REPEVAX can be used in the management of tetanus prone injuries with or without concomitant administration of Tetanus Immunoglobulin according to official recommendations. - to any residual substances carried over from manufacture (formaldehyde, glutaraldehyde, streptomycin, neomycin, polymyxin B and bovine serum albumin), which may be present in undetectable trace amounts. Plusieurs chaînes de pharmacies, notamment au Caire, sont ouvertes 24h/24. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Immunogenicity following repeat vaccination. Serological correlates for protection against pertussis have not been established. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. REPEVAX est indiqué pour : - l'immunisation active contre la diphtérie, le tétanos, la coqueluche et la poliomyélite chez les sujets à partir de l'âge de 3 ans en rappel après primovaccination. Reporting suspected adverse reactions after authorisation of the medicinal product is important. In the case of immunosuppressive therapy please refer to Section 4.4. As with any vaccine, a protective immune response may not be elicited in all vaccines (see section 5.1). Nevertheless, vaccination of HIV infected persons or persons with chronic immunodeficiency, such as AIDS, is recommended even if the antibody response might be limited. La desvenlafaxine (ou O-desméthylvenlafaxine) est un antidépresseur inhibiteur de la recapture de la sérotonine-noradrénaline (IRSNa). Please remove one or more studies before adding more. REPEVAX is a vaccine containing low-dose diphtheria toxoid plus tetanus toxoid in combination with pertussis and polio antigens for booster vaccinations. There was a trend for higher rates of local and systemic reactions in adolescents than in adults. Passive protection against pertussis in early infancy following maternal immunization during pregnancy (see sections 4.2, 4.4, 4.6 and 5.1). Safety of REPEVAX® Given One Month After REVAXIS® The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. A single injection of one (0.5 mL) dose is recommended in all indicated age groups. 410, Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK. Qualitative and quantitative composition, 4.2 Posology and method of administration, 4.4 Special warnings and precautions for use, 4.5 Interaction with other medicinal products and other forms of interaction, 4.7 Effects on ability to drive and use machines, 6.6 Special precautions for disposal and other handling, 9. REPEVAX may be administered concomitantly with a dose of inactivated influenza vaccine, based on the results of a clinical trial conducted in persons 60 years of age and older. No teratogenic effect of vaccines containing diphtheria or tetanus toxoids, or inactivated poliovirus has been observed following use in pregnant women. REPEVAX may contain traces of formaldehyde, glutaraldehyde, streptomycin, neomycin, polymyxin B and bovine serum albumin, which are used during the manufacturing process (see sections 4.3 and 4.4). Plus ou moins intenses, de durée variable, ces douleurs peuvent être très handicapantes au … Contents of the pack and other information 1. The immunogenicity of the vaccine could be reduced by immunosuppressive treatment or immunodeficiency. • REPEVAX should not be administered to persons with known hypersensitivity, - to diphtheria, tetanus, pertussis or poliomyelitis vaccines, - to any other component of the vaccine (see Section 6.1). This information is intended for use by health professionals, REPEVAX, suspension for injection, in pre-filled syringe, Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine (adsorbed, reduced antigen(s) content), Diphtheria Toxoid ...........................................................Not less than 2 IU* (2 Lf), Pertussis Toxoid ............................................................2.5 micrograms, Filamentous Haemagglutinin .........................................5 micrograms, Pertactin ........................................................................3 micrograms, Fimbriae Types 2 and 3 .................................................5 micrograms, Type 1 ............................................................................40 D antigen units, Type 2 ............................................................................8 D antigen units, Type 3 ............................................................................32 D antigen units, Adsorbed on aluminium phosphate ................................1.5 mg (0.33 mg aluminium). Source : Base de données du Ministère des Affaires Sociales et de la Santé, medicaments.gouv.fr Recevez chaque jour des conseils d'experts pour prendre soin de vous. The benefits versus the risks of administering REPEVAX during pregnancy should be evaluated. diphtheria, tetanus, pertussis (acellular) and poliomyelitis (inactivated). To email a medicine you must sign up and log in. Prevenar ® est un vaccin administré aux adultes, aux adolescents et aux nourrissons en vue d'immuniser contre certaines infections, otites et pneumonies dues à la bactérie Streptococcus pneumoniae. The benefits versus the risk of administering REPEVAX to breastfeeding women should be evaluated by the health-care providers. However, in most of the cases, the antibody concentrations remain above the thresholds established as protective. Vaccination should be preceded by a review of the person's medical history (in particular previous vaccinations and possible adverse events). In the absence of compatibility studies, REPEVAX must not be mixed with other medicinal products. Extensive limb swelling which may extend from the injection site beyond one or both joints and is frequently associated with erythema, and sometimes with blisters has been reported following administration of REPEVAX. REVAXIS® at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28). As with all injectable vaccines, appropriate medical treatment and supervision should be readily available for immediate use in case of a rare anaphylactic reaction following the administration of the vaccine. To describe the safety profile of a Tetanus, Diphtheria, Poliomyelitis and Pertussis vaccine (REPEVAX®) when administered as a pertussis booster 1 month after a Tetanus, Diphtheria, Poliomyelitis vaccine (REVAXIS®) as compared to the safety profile of REPEVAX® administered one month after Placebo. 0.5 mL of suspension in pre-filled syringe (glass) with a plunger stopper (chlorobromobutyl or bromobutyl or chlorobutyl elastomer), without attached needle, with a tip-cap (chlorobromobutyl elastomer or synthetic isoprene-bromobutyl elastomer) - pack size of 1, 10 or 20. The highest frequency from either study is presented. Table 1 presents adverse reactions observed in clinical trials and also includes additional adverse events which have been spontaneously reported during the post-marketing use of REPEVAX worldwide. The presence of a minor infection (e.g., mild upper respiratory infection) is not a contraindication. Placebo at Visit 1 (Day 0) and REPEVAX®) at Visit 2 (Day 28). What REPEVAX is and what it is used for 2. Clinical data in adults have demonstrated that there was no clinically relevant difference in rates of adverse reactions associated with administration of REPEVAX as early as 4 weeks, compared to at least 5 years after a preceding dose of tetanus and diphtheria-containing vaccine. Discard the vaccine if it has been frozen. FAS: Full Analysis Set – includes all subjects who received the study vaccine dose and for whom the post-vaccination immunogenicity evaluation was available. In addition, irritability was reported in more than 10% of subjects 3 to 5 years of age. However, in accordance with commonly accepted immunization guidelines, since REPEVAX is an inactivated product it may be administered concomitantly with other vaccines or immunoglobulins at separate injection sites. In serology follow-up studies conducted with REPEVAX, seroprotective antibody levels (≥1:8 dilution) for each poliovirus (type1, 2 and 3) were maintained in 95% to 100% of the children, adolescents and adults at the 5-year follow-up time point, and in 100% of the adolescents at the 10-year follow-up time point. Suspension for injection in pre-filled syringe. No studies on the effects on the ability to drive or use machines have been performed. In persons who have a history of serious or severe reaction within 48 hours of a previous injection with a vaccine containing similar components, administration of REPEVAX vaccine must be carefully considered. The majority of these reactions appeared within 48 hours of vaccination and spontaneously resolved over an average of 4 days without sequelae. COVID-19 is an emerging, rapidly evolving situation. How to store REPEVAX 6. In these situations and following official recommendations the administration of REPEVAX by deep subcutaneous injection may be considered, although there is a risk of increased local reactions. Le vaccin ne guérit pas les porteurs chroniques, mais il est efficace de 90 à 95 % pour prévenir l'apparition de cet état. The clinical relevance of this observation is unknown. • and ≥98.8% were seroprotected against polio (types 1, 2 and 3) at a threshold ≥1:8 dilution.