Gardasil 9 Adverse Reactions

Clinical Trials Experience: Clinical Trials Experience with HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) and GARDASIL: The safety of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) was evaluated in 7 clinical studies (Protocols 001, 002, 003, 005, 006, 007, 009) that included 15,776 individuals who received at least one dose of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) and had safety follow-up. Protocol 001 and Protocol 009 included 7,378 individuals who received at least one dose of GARDASIL and had safety follow-up. The vaccines were administered on the day of enrollment and the subsequent doses administered approximately 2 and 6 months thereafter. Safety was evaluated using vaccination report card (VRC)-aided surveillance for 14 days after each injection of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) or GARDASIL.
The individuals who were monitored using VRC-aided surveillance included 9,102 girls and women 16 through 26 years of age, 1,394 boys and men 16 through 26 years of age and 5,280 girls and boys 9 through 15 years of age (3,481 girls and 1,799 boys) at enrollment who received HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9); and 7,078 girls and women 16 through 26 years of age and 300 girls 9 through 15 years of age at enrollment who received GARDASIL.
Safety was also evaluated in a clinical trial that included 640 women 27 through 45 years of age and 570 girls and women 16 through 26 years of age who received HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9). The safety profile of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) was comparable between the two age groups.
Systemic and Injection-Site Adverse Reactions in Clinical Trials of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9): The vaccine-related adverse experiences that were observed among recipients of either HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) or GARDASIL at a frequency of at least 1% are shown in Tables 10 and 11. Few individuals [HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) = 0.1% vs. GARDASIL <0.1%] discontinued due to adverse experiences after receiving either vaccine. The safety profile was similar between HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) and GARDASIL in women, men, girls and boys. (See Tables 10 and 11.)

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Solicited Systemic and Injection-Site Adverse Reactions in Clinical Trials of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9): Temperature and injection-site pain, swelling, and erythema were solicited using VRC-aided surveillance for 5 days after each injection of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) during the clinical studies. The incidence and severity of solicited adverse reactions that occurred within 5 days following each dose of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) are shown in Table 12. (See Table 12.)

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Clinical Trials Experience for HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) in Individuals Who Have Been Previously Vaccinated with GARDASIL: A clinical study (Protocol 006) evaluated the safety of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) in 12- through 26-year-old girls and women who had previously been vaccinated with 3 doses of GARDASIL. The time interval between the last injection of GARDASIL and the first injection of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) ranged from approximately 12 to 36 months. Individuals were administered HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) or saline placebo and safety was evaluated using VRC-aided surveillance for 14 days after each injection of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) or saline placebo in these individuals. The individuals who were monitored included 608 individuals who received HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) and 305 individuals who received saline placebo. Few (0.5%) individuals who received HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) discontinued due to adverse reactions. The vaccine-related adverse experiences that were observed among recipients of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) at a frequency of at least 1.0% and also at a greater frequency than that observed among saline placebo recipients are shown in Table 13. Overall, the safety profile was similar between individuals vaccinated with HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) who were previously vaccinated with GARDASIL and those who were naïve to HPV vaccination. (See Table 13.)

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Clinical Trials Experience for Concomitant Administration of HUMAN PAPILLOMAVIRUS 9 VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) with Other Vaccines: The safety of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) when administered concomitantly with other vaccines was evaluated in clinical studies.
There was an increase in injection-site swelling reported at the injection site for HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) when HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) was administered concomitantly with Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) Vaccine, (adsorbed, reduced antigen(s) content) (dTap-IPV) or Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) and Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine as compared to non-concomitant vaccination. The majority of injection-site swelling seen with concomitant administration with other vaccines was reported as being mild to moderate in intensity.
Post-marketing Experience: The post-marketing adverse experiences were reported voluntarily from uncertain size, therefore, it is not possible to reliably estimate their frequency or to establish a causal relationship to vaccine exposure.
The safety profile of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) and GARDASIL are similar. The post-marketing adverse experience with GARDASIL is relevant to HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9) since the vaccines are similar in composition and contain L1 HPV proteins of 4 of the same HPV types.
HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9): In addition to the adverse reactions reported in the clinical studies, the following adverse experiences have been spontaneously reported during post-approval use of HUMAN PAPILLOMAVIRUS 9-VALENT (TYPES 6, 11, 16, 18, 31, 33, 45, 52, 58) RECOMBINANT VACCINE (GARDASIL 9): Nervous system disorders: syncope sometimes accompanied by tonic-clonic movements.
Gastrointestinal disorders: vomiting.
GARDASIL: Additionally, the following post-marketing adverse experiences have been spontaneously reported for GARDASIL: Infections and infestations: cellulitis.
Blood and lymphatic system disorders: idiopathic thrombocytopenic purpura, lymphadenopathy.
Immune system disorders: hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria.
Nervous system disorders: acute disseminated encephalomyelitis, Guillain-Barré syndrome.
Musculoskeletal and connective tissue disorders: arthralgia, myalgia.
General disorders and administration site conditions: asthenia, chills, malaise.