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GARDASIL®9▼ (Human Papillomavirus 9 valent Vaccine)

GARDASIL9▼ (Human Papillomavirus 9 valent Vaccine) GARDASIL9▼ (Human Papillomavirus 9 valent Vaccine)

Updated on 21/02/2019

VACCINES

GARDASIL® 9 helps to protect against 9 strains of Human Papillomavirus (HPV) disease.1

GARDASIL® 9 is indicated for active immunisation of individuals from the age of 9 years against the following HPV diseases:1

  • Premalignant lesions and cancers affecting the cervix, vulva, vagina and anus caused by vaccines HPV types.
  • Genital warts (Condyloma acuminata) caused by specific HPV types.

The use of GARDASIL 9 should be in accordance with official recommendations.

GARDASIL 9 helps to protect against 9 strains of Human Papillomavirus (HPV) disease. Some patients may be suitable for vaccination against certain HPV-related cancers and diseases* but are not eligible to be immunised within the HPV national immunisation programme.

  • This is often due to their age and also, the national immunisation programme does not currently immunise males.
  • GARDASIL 9 is not the vaccine used in the national immunisation programme.

*Cervical, vulval, vaginal, anal cancer and precancerous lesions, and genital warts

What HPV types does GARDASIL 9 help protect against?1,2

GARDASIL 9 combines

Immunogenicity and efficacy

GARDASIL 9 provides

*Efficacy assessed in a per protocol population of women aged 16-25 years [N=7099], having received 3 doses of GARDASIL 9 (0, 2, 6 months) after a follow-up of up to 67 months after Dose 3 (median follow-up 43 months after Dose 3). The PPE population consisted of individuals who received all 3 vaccinations within one year one year of enrolment, did not have major deviations from the study protocol were naïve (PCR negative and seronegative) to the relevant HPV type(s) (types 31, 33, 45, 52, and 58) prior to Dose 1, and who remained PCR negative to the relevant HPV types(s) through one month post-Dose 3 (month 7).

Event rate = 1/5, 015 in the GARDASIL 9 group vs. 38/6, 017 the GARDASIL group.

CIN: Cervical Intraepithelial Neoplasia; AIS: Adenocarcinoma in Situ; VIN: Vulval Intraepithelial Neoplasia; VaIN: Vaginal Intraepithelial Neoplasia.

GARDASIL 9 is not the vaccine in the national HPV vaccination programme.

Posology/dosing1

Please refer to the Summary of Product Characteristics for full prescribing information.

The use of GARDASIL 9 should be in accordance with official recommendations.

Posology/dosing

*If the second vaccine dose is administered earlier than 6 months after the first dose, a third dose should always be administered.

The second dose should be administered at least one month after the first dose and the third dose should be administered at least 3 months after the second dose. All three doses should be given within a 1-year period.

Contraindications1

Please refer to the Summary of Product Characteristics for full prescribing information.

Hypersensitivity to the active substances or to any of the excipients. Individuals with hypersensitivity after previous administration of GARDASIL 9 or GARDASIL/Silgard should not receive GARDASIL 9.

Interactions with other medicinal products1

Please refer to the Summary of Product Characteristics for full prescribing information.

Safety and immunogenicity in individuals who have received immunoglobulin or blood-derived products during the 3 months prior to vaccination have not been studied in clinical trials.

Use with other vaccines

GARDASIL 9 may be administered oncomitantly with a combined booster vaccine containing diphtheria (d) and tetanus (T) with either pertussis [acellular, component] (ap) and/or poliomyelitis [inactivated] (IPV) (dTap, dT-IPV, dTap-IPV vaccines) with no significant interference with antibody response to any of the components of either vaccine. This is based on the results from a clinical trial in which a combined dTap-IPV vaccine was administered concomitantly with the first dose of GARDASIL 9.

Use with hormonal contraceptives

In clinical studies, 60.2% of women aged 16 through 26 years who received GARDASIL 9 used hormonal contraceptives during the vaccination period of the clinical studies. Use of hormonal contraceptives did not appear to affect the type specific immune responses to GARDASIL 9.

Adverse events 1

Please refer to the Summary of Product Characteristics for full prescribing information.

Many people have no problems after their vaccination, but some people may experience side effects. The side effects of the vaccine generally don't last for very long and are similar to those seen with other vaccines.

Adverse events

A full list of side effects can be found in the Summary of Product Characteristics and Patient Information Leaflet.

Useful links

HPVWise
HPVWise is a website developed and provided by MSD.

References

  1. Gardasil 9 Summary of Product Characteristics.
  2. Hartwig S et al. Estimation of the epidemiological burden of HPV-related anogenital cancers, precancerous lesions, and genital warts in women and men in Europe: potential additional benefit of a nine-valent second generation HPV vaccine compared to first generation HPV vaccines. Papillomavirus Res 2015; 1:90–100.
    a) With data from: Cervical cancer: Sanjose S et al. Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study.
    Lancet Oncol. 2010;11(11):1048–1056. Anal cancer: Alemany L et al. Human papillomavirus DNA prevalence and type distribution in anal carcinomas worldwide. Int J Cancer. 2015;136(1):98–107.
    Vaginal cancer: Alemany L et al. Large contribution of human papillomavirus in vaginal neoplastic lesions: a worldwide study in 597 samples. Eur J Cancer. 2014;50(16):2846–2854.
    Vulvar cancer: de Sanjose S et al. Worldwide human p papillomavirus genotype attribution in over 2000 cases of intraepithelial and invasive lesions of the vulva. Eur J Cancer. 2013;49(16):3450–3461
    b) Method for the calculation for precancerous lesions: Based on the data from five countries (France, Denmark, Iceland, Norway, and Sweden) incidence rate ranges were estimated for CIN2+ by age groups, which were then extrapolated to the combined female population of the 32 included countries. The estimates for VIN2/3 and VaIN2/3 were extrapolated from data from Nygard study (2014) from Denmark, Iceland, and Norway from the period 2004 2006. For the estimation of AIN2/3, sex-specific, age-standardised incidence rates from the Danish Registry of Pathology were used, extrapolated to the female and the male population, respectively, of all 32 European countries.

Supporting documentation

Prescribing Information | Summary of Product Characteristics | Patient Information Leaflet

GB-GSL-00009 | Date of Preparation: February 2019