PACTR202407768096289Not yet recruitingPhase 3
A Phase III, double-blind, randomized, multinational trial to evaluate safety and immunogenicity of INNOVAX Recombinant Human Papillomavirus 9-valent (Types 6/11/16/18/31/33/45/52/58) Vaccine (Escherichia Coli) compared to GARDASIL®9 in a single-dose regimen in healthy girls and young women in Ghana and the Philippines
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- PATH
- Enrollment
- 1,320
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 6 Year(s) to 12 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1. Females between the ages of =9 - <15 years for Cohort 1 and =15 - =20 years for Cohort 2 at time of randomization.
- •2. Healthy as defined by the absence of clinically significant medical condition, either acute or chronic,
- •as determined by medical history and clinical assessment.
- •3. Written informed consent obtained from the participant prior to randomization. For participants below the legal age of consent, written informed consent must be obtained from the participant’s parent(s)/legally authorized representative (LAR), and written informed assent must be obtained from the participant.
- •4. Anticipated ability and willingness to complete all study visits and evaluations.
- •5. Participant must be either of non-childbearing potential or, if of childbearing potential*, not breastfeeding and not pregnant (based on a negative urine pregnancy test at screening and on the day of vaccination), and must have been practicing adequate contraception (defined in Appendix III) for at least 21 days prior to vaccination and agrees to continue such precautions consistently through 2 months after vaccination, and agrees to not become pregnant through other means (e.g., artificial insemination and IVF) through 2 months after vaccination. *Female of childbearing potential is defined as having begun menstruation (achieved menarche) and not permanently infertile (e.g., due to bilateral tubal ligation, occlusion or removal, or post-total
- •hysterectomy, or post-bilateral ovariectomy).
- •6. Living within the catchment area of the study without plans to move during the conduct of the study.
Exclusion Criteria
- •1.Acute medical illnesses (temporary exclusions) should be evaluated, treated, and improved prior to study randomization and vaccination.
- •2.Known history of abnormal cervical cytology, abnormal cervical biopsy results, treatment for genital warts or other HPV-associated disease (prior screening is not required for eligibility assessment).
- •3.Participant reports more than 4 lifetime sexual partners prior to enrollment.
- •4.Current or former participation in HPV vaccine related research.
- •5.Prior receipt of any HPV vaccine, or planned administration of any HPV vaccine other than study vaccines during the study period.
- •6.Received an investigational product within 30 days prior to randomization.
- •7.Currently participating in or planning to participate in another clinical research trial involving investigational product during the conduct of this study.
- •8Received or plans to receive a licensed inactivated vaccine or allergy desensitization injections within 7 days prior to or after study vaccination or a live attenuated vaccine within 28 days prior to or after study vaccination.
- •9Contraindication to intramuscular injections or history of bleeding or coagulation disorder.
- •10.History of anaphylaxis or serious allergic reactions following receipt of any vaccines.
- •11.History of allergy or hypersensitivity to any components of the study vaccine or Gardasil 9 (e.g., yeast, polysorbate 80, aluminum).
- •12.Planned administration or receipt of any immunoglobulins or blood products within 6 months prior to randomization or during the study.
- •13.Immunosuppressive or immunodeficient condition
- •14.Immunosuppressive or immune modulating medications
- •15.Malignancy or autoimmune disease
- •16.Any condition that in the opinion of the investigator would pose a health risk to the participant if enrolled or could interfere with the evaluation of the study vaccine.
- •17.Medical condition that would interfere with or serves as a contraindication to protocol adherence or ability to give informed consent.
Investigators
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