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The study is designed to determine the safety, tolerability and immunogenicity of a 3-dose regimen of GARDASILâ„¢ 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 GARDASILâ„¢ clinical trials program, and confirm that GARDASILâ„¢ may be administered safely and will induce immune responses in populations from and living in Sub-Saharan Africa, as GARDASILâ„¢ has not previously been studied in this region of the world.
In Phase A of the study, healthy females between 9 and 12 years of age will be randomized (4:1) to receive the 3-dose regimen of GARDASILâ„¢ or placebo, and those between 13 and 26 years old will receive GARDASILâ„¢. In Phase B of the study, participants who received placebo in Phase A will have the option to receive the 3-dose regimen of GARDASILâ„¢.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GARDASILâ„¢ 9 to 12 Years Old | Experimental | GARDASILâ„¢ 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. |
|
| GARDASILâ„¢ 13 to 15 Years Old | Experimental | GARDASILâ„¢ 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. |
|
| GARDASILâ„¢ 16 to 26 Years Old | Experimental | GARDASILâ„¢ 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. |
|
| Placebo 9 to 12 Years Old | Placebo Comparator | Placebo to GARDASILâ„¢ 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 GARDASILâ„¢ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASILâ„¢) | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of Anti-HPV Type 6 Antibody | Anti-HPV Type 6 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 20 milli Merck U/mL. | Month 7 (1 month postdose 3 in study Phase A) |
| GMT of Anti-HPV Type 11 Antibody |
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Inclusion Criteria :
Exclusion Criteria :
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25912475 | Result | 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. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | GARDASIL 9 to 12 Years Old | GARDASILâ„¢ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B. |
| FG001 | GARDASIL 13 to 15 Years Old | GARDASILâ„¢ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B. |
| FG002 | GARDASIL 16 to 26 Years Old | GARDASILâ„¢ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B. |
| FG003 | Placebo 9 to 12 Years Old | Placebo to GARDASILâ„¢ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASILâ„¢ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. Safety evaluation continued to Month 7 of study Phase B (total study duration up to 19 months) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study Phase A |
|
| |||||||||||||||||||||
| Study Phase B |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GARDASIL 9 to 12 Years Old | GARDASILâ„¢ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo. | Posted | Number | Participants | Month 7 (1 month postdose 3 in study Phase A) |
|
Serious adverse events were assessed up to 19 months from study start. Other adverse events were assessed up to 15 days after each vaccination in study Phase A.
The analysis included all participants receiving at least one vaccination and had at least one postvaccination follow-up visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GARDASIL 9 to 12 Years Old | GARDASILâ„¢ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants did not continue to study Phase B. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foetal distress syndrome | Pregnancy, puerperium and perinatal conditions | MedDRA 16.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye pain | Eye disorders | MedDRA 16.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D002583 | Uterine Cervical Neoplasms |
| D014846 | Vulvar Neoplasms |
| D014625 | Vaginal Neoplasms |
| D003218 | Condylomata Acuminata |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D014614 | Vaccines, Synthetic |
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| ID | Term |
|---|---|
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
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| Placebo | Biological |
|
| 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) |
Anti-HPV Type 11 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 16 milli Merck U/mL. |
| Month 7 (1 month postdose 3 in study Phase A) |
| GMT of Anti-HPV Type 16 Antibody | Anti-HPV Type 16 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 20 milli Merck U/mL. | Month 7 (1 month postdose 3 in study Phase A) |
| GMT of Anti-HPV Type 18 Antibody | Anti-HPV Type 18 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 24 milli Merck U/mL. | Month 7 (1 month postdose 3 in study Phase A) |
| Protocol Violation |
|
| Lost to Follow-up |
|
| Completed Vaccinations in Study Phase B |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| GARDASIL 13 to 15 Years Old |
GARDASILâ„¢ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B. |
| BG002 | GARDASIL 16 to 26 Years Old | GARDASILâ„¢ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B. |
| BG003 | Placebo 9 to 12 Years Old | Placebo to GARDASILâ„¢ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASILâ„¢ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. Safety evaluation continued to Month 7 of study Phase B (total study duration up to 19 months) |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Placebo 9 to 12 Years Old |
Placebo to GARDASILâ„¢ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. |
|
|
| Primary | 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. | Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo. | Posted | Number | Participants | Month 7 (1 month postdose 3 in study Phase A) |
|
|
|
| Primary | 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. | Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo. | Posted | Number | Participants | Month 7 (1 month postdose 3 in study Phase A) |
|
|
|
| Primary | 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. | Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo. | Posted | Number | Participants | Month 7 (1 month postdose 3 in study Phase A) |
|
|
|
| Primary | 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 | The analysis included all participants receiving at least 1 vaccination in study Phase A and who had postvaccination follow-up | Posted | Number | Participants | Up to Day 5 after any vaccination in study Phase A |
|
|
|
| Primary | Number of Participants With Elevated Temperature (Oral Temperature >=100 °F) | The analysis included all participants receiving at least 1 vaccination in study Phase A and who had temperature data | Posted | Number | Participants | Up to Day 5 after any vaccination in study Phase A |
|
|
|
| Primary | 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 | The analysis included all participants receiving at least 1 vaccination in study Phase A or B and who had postvaccination follow-up | Posted | Number | Participants | From the time of informed consent is signed through the last study visit (up to 19 months) |
|
|
|
| Secondary | Geometric Mean Titer (GMT) of Anti-HPV Type 6 Antibody | Anti-HPV Type 6 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 20 milli Merck U/mL. | Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo. | Posted | Geometric Mean | 95% Confidence Interval | milli Merck U/mL | Month 7 (1 month postdose 3 in study Phase A) |
|
|
|
| Secondary | GMT of Anti-HPV Type 11 Antibody | Anti-HPV Type 11 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 16 milli Merck U/mL. | Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo. | Posted | Geometric Mean | 95% Confidence Interval | milli Merck U/mL | Month 7 (1 month postdose 3 in study Phase A) |
|
|
|
| Secondary | GMT of Anti-HPV Type 16 Antibody | Anti-HPV Type 16 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 20 milli Merck U/mL. | Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo. | Posted | Geometric Mean | 95% Confidence Interval | milli Merck U/mL | Month 7 (1 month postdose 3 in study Phase A) |
|
|
|
| Secondary | GMT of Anti-HPV Type 18 Antibody | Anti-HPV Type 18 antibodies were measured by cLIA. The seropositive cut-off threshold for this assay is defined as 24 milli Merck U/mL. | Participants analyzed included those who received all 3 vaccinations in study Phase A and provided a sample for Month 7 serology testing. This analysis pooled results for participants receiving GARDASIL and compared these with results for participants receiving placebo. | Posted | Geometric Mean | 95% Confidence Interval | milli Merck U/mL | Month 7 (1 month postdose 3 in study Phase A) |
|
|
|
| 0 |
| 79 |
| 61 |
| 79 |
| EG001 | GARDASIL 13 to 15 Years Old | GARDASILâ„¢ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants did not continue to study Phase B. | 0 | 29 | 22 | 29 |
| EG002 | GARDASIL 16 to 26 Years Old | GARDASILâ„¢ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants did not continue to study Phase B. | 1 | 119 | 103 | 119 |
| EG003 | Placebo 9 to 12 Years Old | Placebo to GARDASILâ„¢ 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 had the option to receive GARDASILâ„¢ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. | 0 | 19 | 15 | 19 |
| Myopia | Eye disorders | MedDRA 16.0 |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.0 |
|
| Injection site erythema | General disorders | MedDRA 16.0 |
|
| Injection site pain | General disorders | MedDRA 16.0 |
|
| Injection site swelling | General disorders | MedDRA 16.0 |
|
| Pyrexia | General disorders | MedDRA 16.0 |
|
| Gastroenteritis | Infections and infestations | MedDRA 16.0 |
|
| Malaria | Infections and infestations | MedDRA 16.0 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.0 |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 |
|
| Dizziness | Nervous system disorders | MedDRA 16.0 |
|
| Headache | Nervous system disorders | MedDRA 16.0 |
|
| Somnolence | Nervous system disorders | MedDRA 16.0 |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 16.0 |
|
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D014845 | Vulvar Diseases |
| D014623 | Vaginal Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D017778 | Vaccines, Combined |
| D053918 | Papillomavirus Vaccines |
| D014765 | Viral Vaccines |