E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Papillomavirus Infections |
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E.1.1.1 | Medical condition in easily understood language |
Papillomavirus Infections |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10047438 |
E.1.2 | Term | Viral infectious disorders |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10063001 |
E.1.2 | Term | Human papilloma virus infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10071146 |
E.1.2 | Term | Human papilloma virus immunisation |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- To estimate percent seroconversion for the vaccine HPV types (6, 11, 16, 18, 31, 33, 45, 52 and 58) at Month 7 in Japanese boys aged 9 to 15 years who received 3 doses of the 9vHPV vaccine
- To estimate percent seroconversion for the vaccine HPV types (6, 11, 16, 18, 31, 33, 45, 52 and 58) at Month 7 in Japanese boys aged 9 to 14 years who received 2 doses of the 9vHPV vaccine
- To estimate percent seroconversion for the vaccine HPV types (6, 11, 16, 18, 31, 33, 45, 52 and 58) at Month 7 in Japanese girls aged 9 to 14 years who received 2 doses of the 9vHPV vaccine
- To evaluate the safety and tolerability of the 9vHPV vaccine in Japanese boys aged 9 to 15 years who received 3 doses and Japanese boys and girls aged 9 to 14 years who received 2 doses of the 9vHPV vaccine |
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E.2.2 | Secondary objectives of the trial |
- To estimate the immune response for the vaccine HPV types (6, 11, 16, 18, 31, 33, 45, 52 and 58) at Month 7 including geometric mean titers (GMTs) in Japanese boys aged 9 to 15 years who received 3 doses of the 9vHPV vaccine
- To estimate the immune response for the vaccine HPV types (6, 11, 16, 18, 31, 33, 45, 52 and 58) at Month 7 including GMTs in Japanese boys aged 9 to 14 years who received 2 doses of the 9vHPV vaccine
- To estimate the immune response for the vaccine HPV types (6, 11, 16, 18, 31, 33, 45, 52 and 58) at Month 7 including GMTs in Japanese girls aged 9 to 14 years who received 2 doses of the 9vHPV vaccine |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Is Japanese male or female. Is aged at the time of providing the documented informed consent (inclusive): (3-dose boy arm) male from 9 years to 15 years old, (2-dose boy arm) male from 9 years to 14 years old, or (2-dose girl arm) female from 9 years to 14 years old. Has a legally acceptable representative who can read, understand and complete the vaccination report card (VRC). Has not yet had coitarche and does not plan on becoming sexually active during the Day 1 through Month 7 |
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E.4 | Principal exclusion criteria |
Has a fever (defined as oral temperature ≥37.5°C) within the 24-hour period prior to the Day 1 visit. Has a history of severe allergic reaction that required medical intervention. Is allergic to any vaccine component, including aluminum, yeast, or Benzonase™. Has known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections. Is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other auto immune condition. Has a history of splenectomy. Has a history of genital warts or positive test for human papillomavirus (HPV). Is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within 12 months) of drug or alcohol abuse or dependence at the discretion of the investigator. . Has received within 12 months prior to enrollment, is receiving, or plans to receive during Day 1 through Month 7 of the study, any study-prohibited concomitant immunosuppressive therapy . Has received within the 3 months prior to the Day 1 vaccination, is receiving, or plans to receive during Day 1 through Month 7 of the study, any immune globulin product or blood-derived product other than intravenous gamma globulin (IVIG). Has received inactivated or recombinant vaccines within 14 days prior to Day 1 vaccination or receipt of live vaccines within 28 days prior to Day 1 vaccination. Has previously received a marketed HPV vaccine or has participated in a clinical trial for any HPV vaccine (receiving either active agent or placebo). Is concurrently enrolled in other clinical studies of investigational agents. Is unlikely to adhere to the study procedures, keep appointments, or is planning to permanently relocate from the area prior to the completion of the study or to leave for an extended period when study visits would need to be scheduled. Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Seroconversion Percentages for the HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
2. Percentage of Participants With at Least 1 Solicited Injection-site Adverse Event
3. Percentage of Participants With at Least 1 Systemic Adverse Event
4. Percentage of Participants With at Least 1 Serious Adverse Event
5. Percentage of Participants With at Least 1 Vaccine-related Serious Adverse Event
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. 4 weeks post last vaccination (Month 7)
2. Up to 5 days post vaccination
3. Up to 15 days post vaccination
4. Up to ~Month 30
5. Up to ~Month 30 |
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E.5.2 | Secondary end point(s) |
1. Geometric Mean Titers of Anti-HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. 4 weeks post last vaccination (Month 7) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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For purposes of analysis and reporting, the overall study ends when the Sponsor receives the last laboratory result or at the time of final contact with the last participant, whichever comes last. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial months | 40 |
E.8.9.2 | In all countries concerned by the trial days | 0 |