Vaccine Information: GARDASIL (Page 7 of 8)

14.9 Long-Term Follow-Up Studies

The protection of GARDASIL against HPV-related disease continues to be studied over time in populations including adolescents (boys and girls) and women who were enrolled in the Phase 3 studies.

Persistence of Effectiveness

An extension of Study 4 used national healthcare registries in Denmark, Iceland, Norway, and Sweden to monitor endpoint cases of HPV 6-, 11-, 16-, or 18-related CIN (any grade), AIS, cervical cancer, vulvar cancer, or vaginal cancer among 2,650 girls and women 16 through 23 years of age at enrollment who were randomized to vaccination with GARDASIL and consented to be followed in the extension study. An interim analysis of the per-protocol effectiveness population included 1,902 subjects who completed the GARDASIL vaccination series within one year, were naïve to the relevant HPV type through 1 month postdose 3, had no protocol violations, and had follow-up data available. The median follow-up from initial vaccination was 6.7 years with a range of 2.8 to 8.4 years. No cases of HPV 6-, 11-, 16-, or 18-related CIN (any grade), AIS, cervical cancer, vulvar cancer, or vaginal cancer were observed over a total of 5,765 person-years at risk.

An extension of a Phase 3 study (Study 7) in which 614 girls and 565 boys 9 through 15 years of age at enrollment were randomized to vaccination with GARDASIL actively followed subjects for endpoint cases of HPV 6-, 11-, 16-, or 18-related persistent infection, CIN (any grade), AIS, VIN, VaIN, cervical cancer, vulvar cancer, vaginal cancer, and genital lesions from the initiation of sexual activity or age 16 onwards. An interim analysis of the per-protocol effectiveness population included 246 girls and 168 boys who completed the GARDASIL vaccination series within one year, were seronegative to the relevant HPV type at initiation of the vaccination series, and had not initiated sexual activity prior to receiving the third dose of GARDASIL. The median follow-up, from the first dose of vaccine, was 7.2 years with a range of 0.5 to 8.5 years. No cases of persistent infection of at least 12 months’ duration and no cases of HPV 6-, 11-, 16-, or 18-related CIN (any grade), AIS, VIN, VaIN, cervical cancer, vulvar cancer, vaginal cancer, or genital lesions were observed over a total 1,105 person-years at risk. There were 4 cases of HPV 6-, 11-, 16-, or 18-related persistent infection of at least 6 months’ duration, including 3 cases related to HPV 16 and 1 case related to HPV 6, none of which persisted to 12 months’ duration.

Persistence of the Immune Response

The interim reports of the two extension studies described above included analyses of type-specific anti-HPV antibody titers at 9 years postdose 1 for girls and women 16 through 23 years of age at enrollment (range of 1,178 to 1,331 subjects with evaluable data across HPV types) and at 8 years postdose 1 for boys and girls 9 through 15 years of age at enrollment (range of 436 to 440 subjects with evaluable data across HPV types). Anti-HPV 6, 11, 16, and 18 GMTs as measured by cLIA were decreased compared with corresponding values at earlier time points, but the proportions of seropositive subjects ranged from 88.4% to 94.4% for anti-HPV 6, from 89.1% to 95.5% for anti-HPV 11, from 96.8% to 99.1% for anti-HPV 16, and from 60.0% to 64.1% for anti-HPV 18.

14.10 Studies with RECOMBIVAX HB [hepatitis B vaccine (recombinant)]

The safety and immunogenicity of co-administration of GARDASIL with RECOMBIVAX HB [hepatitis B vaccine (recombinant)] (same visit, injections at separate sites) were evaluated in a randomized, double-blind, study of 1871 women aged 16 through 24 years at enrollment. The race distribution of the girls and women in the clinical trial was as follows: 61.6% White; 1.6% Hispanic (Black and White); 23.8% Other; 11.9% Black; 0.8% Asian; and 0.3% American Indian.

Subjects either received GARDASIL and RECOMBIVAX HB (n = 466), GARDASIL and RECOMBIVAX HB-matched placebo (n = 468), RECOMBIVAX HB and GARDASIL-matched placebo (n = 467) or RECOMBIVAX-matched placebo and GARDASIL-matched placebo (n = 470) at Day 1, Month 2 and Month 6. Immunogenicity was assessed for all vaccines 1 month post completion of the vaccination series.

Concomitant administration of GARDASIL with RECOMBIVAX HB [hepatitis B vaccine (recombinant)] did not interfere with the antibody response to any of the vaccine antigens when GARDASIL was given concomitantly with RECOMBIVAX HB or separately.

14.11 Studies with Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] and Adacel [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)]

The safety and immunogenicity of co-administration of GARDASIL with Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] and Adacel [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)] (same visit, injections at separate sites) were evaluated in an open-labeled, randomized, controlled study of 1040 boys and girls 11 through 17 years of age at enrollment. The race distribution of the subjects in the clinical trial was as follows: 77.7% White; 6.8% Hispanic (Black and White); 1.4% Multi-racial; 12.3% Black; 1.2% Asian; 0.2% Indian; and 0.4% American Indian.

One group received GARDASIL in one limb and both Menactra and Adacel, as separate injections, in the opposite limb concomitantly on Day 1 (n = 517). The second group received the first dose of GARDASIL on Day 1 in one limb then Menactra and Adacel, as separate injections, at Month 1 in the opposite limb (n = 523). Subjects in both vaccination groups received the second dose of GARDASIL at Month 2 and the third dose at Month 6. Immunogenicity was assessed for all vaccines 1 month post completion of the vaccination series (1 dose for Menactra and Adacel and 3 doses for GARDASIL).

Concomitant administration of GARDASIL with Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] and Adacel [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)] did not interfere with the antibody response to any of the vaccine antigens when GARDASIL was given concomitantly with Menactra and Adacel or separately.

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-1523

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Inform the patient, parent, or guardian:

  • Vaccination does not eliminate the necessity for women to continue to undergo recommended cervical cancer screening. Women who receive GARDASIL should continue to undergo cervical cancer screening per standard of care.
  • Recipients of GARDASIL should not discontinue anal cancer screening if it has been recommended by a health care provider.
  • GARDASIL has not been demonstrated to provide protection against disease from vaccine and non-vaccine HPV types to which a person has previously been exposed through sexual activity.
  • Since syncope has been reported following vaccination sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended.
  • Vaccine information is required to be given with each vaccination to the patient, parent, or guardian.
  • Information regarding benefits and risks associated with vaccination.
  • GARDASIL is not recommended for use in pregnant women.
  • Importance of completing the immunization series unless contraindicated.
  • Report any adverse reactions to their health care provider.

Manuf. and Dist. by: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

The trademarks depicted herein are owned by their respective companies.

Copyright © 2006, 2009, 2010, 2011 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

uspi-v501-i-1504r021

Printed in USA

USPPI
Patient Information about
GARDASIL® (pronounced “gard-Ah-sill”)
Generic name: [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]

Read this information with care before getting GARDASIL1. You (the person getting GARDASIL) will need 3 doses of the vaccine. It is important to read this leaflet when you get each dose. This leaflet does not take the place of talking with your health care provider about GARDASIL.

What is GARDASIL?

GARDASIL is a vaccine (injection/shot) that is used for girls and women 9 through 26 years of age to help protect against the following diseases caused by Human Papillomavirus (HPV):

  • Cervical cancer
  • Vulvar and vaginal cancers
  • Anal cancer
  • Genital warts
  • Precancerous cervical, vaginal, vulvar, and anal lesions

GARDASIL is used for boys and men 9 through 26 years of age to help protect against the following diseases caused by HPV:

  • Anal cancer
  • Genital warts
  • Precancerous anal lesions
    • The diseases listed above have many causes, and GARDASIL only protects against diseases caused by certain kinds of HPV (called Type 6, Type 11, Type 16, and Type 18). Most of the time, these 4 types of HPV are responsible for the diseases listed above.
    • GARDASIL cannot protect you from a disease that is caused by other types of HPV, other viruses, or bacteria.
    • GARDASIL does not treat HPV infection.
    • You cannot get HPV or any of the above diseases from GARDASIL.

What important information about GARDASIL should I know?

  • You should continue to get routine cervical cancer screening.
  • GARDASIL may not fully protect everyone who gets the vaccine.
  • GARDASIL will not protect against HPV types that you already have.

Who should not get GARDASIL?

You should not get GARDASIL if you have, or have had:

  • an allergic reaction after getting a dose of GARDASIL.
  • a severe allergic reaction to yeast, amorphous aluminum hydroxyphosphate sulfate, polysorbate 80.

What should I tell my health care provider before getting GARDASIL?

Tell your health care provider if you:

  • are pregnant or planning to get pregnant. GARDASIL is not recommended for use in pregnant women.
  • have immune problems, like HIV infection, cancer, or you take medicines that affect your immune system.
  • have a fever over 100°F (37.8°C).
  • had an allergic reaction to another dose of GARDASIL.
  • take any medicines, even those you can buy over the counter.

Your health care provider will help decide if you should get the vaccine.

How is GARDASIL given?

GARDASIL is a shot that is usually given in the arm muscle. You will need 3 shots given on the following schedule:

  • Dose 1: at a date you and your health care provider choose.
  • Dose 2: 2 months after Dose 1.
  • Dose 3: 6 months after Dose 1.

Fainting can happen after getting GARDASIL. Sometimes people who faint can fall and hurt themselves. For this reason, your health care provider may ask you to sit or lie down for 15 minutes after you get GARDASIL. Some people who faint might shake or become stiff. This may require evaluation or treatment by your health care provider.

Make sure that you get all 3 doses on time so that you get the best protection. If you miss a dose, talk to your health care provider.

Can other vaccines and medications be given at the same time as GARDASIL?

GARDASIL can be given at the same time as RECOMBIVAX HB®1 [hepatitis B vaccine (recombinant)] or Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] and Adacel [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)].

What are the possible side effects of GARDASIL?

The most common side effects with GARDASIL are:

  • pain, swelling, itching, bruising, and redness at the injection site
  • headache
  • fever
  • nausea
  • dizziness
  • vomiting
  • fainting

There was no increase in side effects when GARDASIL was given at the same time as RECOMBIVAX HB [hepatitis B vaccine (recombinant)].

There was more injection-site swelling at the injection site for GARDASIL when GARDASIL was given at the same time as Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] and Adacel [Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap)].

Tell your health care provider if you have any of the following problems because these may be signs of an allergic reaction:

  • difficulty breathing
  • wheezing (bronchospasm)
  • hives
  • rash

Tell your health care provider if you have:

  • swollen glands (neck, armpit, or groin)
  • joint pain
  • unusual tiredness, weakness, or confusion
  • chills
  • generally feeling unwell
  • leg pain
  • shortness of breath
  • chest pain
  • aching muscles
  • muscle weakness
  • seizure
  • bad stomach ache
  • bleeding or bruising more easily than normal
  • skin infection

Contact your health care provider right away if you get any symptoms that concern you, even several months after getting the vaccine.

For a more complete list of side effects, ask your health care provider.

What are the ingredients in GARDASIL?

The ingredients are proteins of HPV Types 6, 11, 16, and 18, amorphous aluminum hydroxyphosphate sulfate, yeast protein, sodium chloride, L-histidine, polysorbate 80, sodium borate, and water for injection.

This leaflet is a summary of information about GARDASIL. If you would like more information, please talk to your health care provider or visit www.gardasil.com.

Manufactured and Distributed by: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Whitehouse Station, NJ 08889, USA

Issued April 2011

9883616

1 Registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Copyright © 2006, 2009 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. All rights reserved

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