GARDASIL™ Study in Healthy Females Between 9 and 26 Years of Age in Sub-Saharan Africa (V501-046)

NCT01245764 | Completed Phase 3 Results

• 1 other identifier: V501-046
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is designed to determine the safety, tolerability and immunogenicity of a 3-dose regimen of GARDASIL™ administered to healthy females between 9 and 26 years of age, in Sub-Saharan Africa. Data from the current study are needed in order to complement existing extensive safety data from the GARDASIL™ clinical trials program, and confirm that GARDASIL™ may be administered safely and will induce immune responses in populations from and living in Sub-Saharan Africa, as GARDASIL™ has not previously been studied in this region of the world.

Conditions

Papillomavirus Infections

Keywords

Cervical cancer; vulvar cancer; vaginal cancer; genital warts; human papillomavirus

Outcome Measures

Primary Outcomes (7)

• Number of Participants Who Seroconvert to Human Papillomavirus (HPV) Type 6

  Seroconversion was defined as achieving an anti-HPV Type 6 competitive Luminex Immunoassay (cLIA) level of \>=20 milli Merck U/mL. The dilution-corrected limit of detection for the Type 6 cLIA was 4.2 milli Merck U/mL.

  Month 7 (1 month postdose 3 in study Phase A)

• Number of Participants Who Seroconvert to HPV Type 11

  Seroconversion was defined as achieving an anti-HPV Type 11 cLIA level of \>=16 milli Merck U/mL. The dilution-corrected limit of detection for the Type 11 cLIA was 3.9 milli Merck U/mL.

  Month 7 (1 month postdose 3 in study Phase A)

• Number of Participants Who Seroconvert to HPV Type 16

  Seroconversion was defined as achieving an anti-HPV Type 16 cLIA level of \>=20 milli Merck U/mL. The dilution-corrected limit of detection for the Type 16 cLIA was 9.7 milli Merck U/mL.

  Month 7 (1 month postdose 3 in study Phase A)

• Number of Participants Who Seroconvert to HPV Type 18

  Seroconversion was defined as achieving an anti-HPV Type 18 cLIA level of \>=24 milli Merck U/mL. The dilution-corrected limit of detection for the Type 18 cLIA was 5.8 milli Merck U/mL.

  Month 7 (1 month postdose 3 in study Phase A)

• Number of Participants With Injection-site Adverse Experiences

  Participants were prompted to report injection-site experiences of pain, erythema, or swelling and were also asked to report any other injection-site adverse experiences

  Up to Day 5 after any vaccination in study Phase A

• Number of Participants With Elevated Temperature (Oral Temperature >=100 °F)

  Up to Day 5 after any vaccination in study Phase A

• Number of Participants With Serious Adverse Experiences

  A serious adverse experience is any adverse experience that results in death, is life threatening, results in persistent or significant disability/incapacity, results in or prolongs existing inpatient hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is another important medical event that may jeopardize the participant and may require medical or surgical intervention

  From the time of informed consent is signed through the last study visit (up to 19 months)

Secondary Outcomes (4)

• Geometric Mean Titer (GMT) of Anti-HPV Type 6 Antibody

  Month 7 (1 month postdose 3 in study Phase A)

• GMT of Anti-HPV Type 11 Antibody

  Month 7 (1 month postdose 3 in study Phase A)

• GMT of Anti-HPV Type 16 Antibody

  Month 7 (1 month postdose 3 in study Phase A)

• GMT of Anti-HPV Type 18 Antibody

  Month 7 (1 month postdose 3 in study Phase A)

Study Arms (4)

GARDASIL™ 9 to 12 Years Old

EXPERIMENTAL

GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants will not continue to study Phase B.

Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)

GARDASIL™ 13 to 15 Years Old

EXPERIMENTAL

GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants will not continue to study Phase B.

Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)

GARDASIL™ 16 to 26 Years Old

EXPERIMENTAL

GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants will not continue to study Phase B.

Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)

Placebo 9 to 12 Years Old

PLACEBO COMPARATOR

Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. After database lock and unblinding for study Phase A, participants will have the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B.

Biological: Placebo

Interventions

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) BIOLOGICAL

GARDASIL™ 13 to 15 Years Old; GARDASIL™ 16 to 26 Years Old; GARDASIL™ 9 to 12 Years Old

Placebo BIOLOGICAL

Placebo 9 to 12 Years Old

Eligibility Criteria

• Age: 9 Years - 26 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy subjects who are native to and living in a participating Sub-Saharan African country.
• Subject agrees to provide study personnel with a primary telephone number as well as an alternate telephone number for follow-up purposes. If potential subject does not have a telephone number, the subject must provide an address at which he or she may be contacted.
• Post-pubertal female subjects must not be pregnant
• Subjects who are sexually active must agree to use effective contraception or remain abstinent through Month 7 of the study.
• Subjects who have not yet had sexual intercourse must either agree to remain abstinent through Month 7 of the study, or if they become sexually active during the vaccination phase of the study, to use effective contraception through Month 7.
• Subjects who have had sexual intercourse in the two weeks prior to enrollment must have been using effective contraception as defined above. (Emergency contraception is not considered effective contraception for enrollment in the study.)

You may not qualify if:

• Subject is pregnant as determined by a positive pregnancy test
• Subject has had a temperature ≥ 37.8 °C or ≥ 100 °F within 24 hours prior to the first injection.
• Subject is currently enrolled in another clinical study of an investigational agent or agents.
• Subject has a history of known prior vaccination with a HPV vaccine, or was previously enrolled in an HPV vaccine study and received either active agent or placebo.
• Subject has received any inactivated vaccine within 14 days prior to enrollment or any live vaccine within 21 days prior to enrollment.
• Subject has a history of severe allergic reaction to any agent (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention.
• Subject has known allergy to any vaccine component, including aluminum, yeast or BENZONASE™ (nuclease, Nycomed™ \[used to remove residual nucleic acids from this and other vaccines\]).
• Subject has received any immune globulin preparation or blood-derived products within the 6 months prior to the first injection, or plans to receive any such products during the course of the study.
• Subject has a history of splenectomy, known autoimmune disorder (e.g., systemic lupus erythematosus, rheumatoid arthritis), or is receiving immunosuppressives (e.g., substances or treatments known to diminish immune response such as radiation therapy, administration of antimetabolites, antilymphocytic sera, systemic corticosteroids). Individuals who have received periodic treatments with immunosuppressives, defined as at least 3 courses of systemic corticosteroids each lasting at least 1 week in duration for the year prior to enrollment, will be excluded. Subjects using topical steroids (i.e., inhaled or nasal) will be eligible for vaccination.
• Subject is immunocompromised or has been diagnosed as having Human Immunodeficiency Virus (HIV) infection
• Subject has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
• Subject has known sickle cell anemia disease, active malaria or active tuberculosis.
• Subject has any condition which in the opinion of the investigator might interfere with the evaluation of the study objectives.
• Subject has a history of recent or ongoing alcohol or other drug abuse.
• Female subject has a prior history of abnormal Pap test showing squamous intraepithelial lesion (SIL), atypical squamous cells of undetermined significance (ASC-US), atypical squamous cells, cannot rule out a high grade lesion (ASC-H), or biopsy showing cervical intraepithelial neoplasia (CIN) or worse.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Mugo N, Ansah NA, Marino D, Saah A, Garner EI. Evaluation of safety and immunogenicity of a quadrivalent human papillomavirus vaccine in healthy females between 9 and 26 years of age in Sub-Saharan Africa. Hum Vaccin Immunother. 2015;11(6):1323-30. doi: 10.1080/21645515.2015.1008877.

  PMID: 25912475 RESULT

MeSH Terms

Conditions

Papillomavirus Infections; Uterine Cervical Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms; Condylomata Acuminata

Interventions

Vaccines, Synthetic; Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Vulvar Diseases; Vaginal Diseases; Warts; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; Antigens; Biological Factors; Vaccines, Combined; Papillomavirus Vaccines; Viral Vaccines

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2010
• First Posted: November 22, 2010
• Study Start: March 21, 2011
• Primary Completion: April 15, 2013
• Study Completion: April 15, 2013
• Last Updated: November 14, 2018
• Results First Posted: June 3, 2014

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share