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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_552 |
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This study will examine the safety and tolerability of octavalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) vaccine formulated with amorphous aluminum hydroxysulfate (AAHS) and ISCOMATRIX™ (IMX). Reviews of safety and tolerability will be used to select the dose(s) of IMX for further studies of the octavalent HPV L1 VLP vaccine.
The study was performed in 2 staggered phases, Phase A and Phase B. In Phase A, participants were randomized to qHPV, Octavalent HPV with 15 mcg IMX/AAHS, or Octavalent HPV with 30 mcg IMX/AAHS. After the safety for Phase A was reviewed, Phase B was initiated. In Phase B, participants were randomized to qHPV, Octavalent HPV with 60 mcg IMX/AAHS or Octavalent HPV with 120 mcg IMX/AAHS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| qHPV (GARDASIL™) - Phase A Control | Active Comparator | Quadrivalent Human Papillomavirus (qHPV) (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™). This is the control for the Octavalent HPV with 15 mcg ISCOMATRIX™ (IMX) / Aluminum Hydroxyphosphate Sulfate (AAHS) and Octavalent HPV with 30 mcg IMX / AAHS during Phase A. |
|
| Octavalent HPV with 15 mcg IMX / AAHS | Experimental | Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg AAHS and 15 mcg IMX. |
|
| Octavalent HPV with 30 mcg IMX / AAHS | Experimental | Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX. |
|
| qHPV (GARDASIL™) - Phase B Control | Active Comparator | Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™). This is the control for the Octavalent HPV with 60 mcg IMX / AAHS and Octavalent HPV with 120 mcg IMX / AAHS during Phase B. |
|
| Octavalent HPV with 60 mcg IMX / AAHS |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octavalent HPV with 15 mcg IMX / AAHS | Biological | 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using a competitive Luminex immunoassay (cLIA) after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent. | 4 weeks postdose 3 (Phase A) |
| Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using cLIA after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent. | 4 weeks postdose 3 (Phase B) |
| Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively. | 4 weeks postdose 3 (Phase A) |
| Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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In Phase A, participants were randomized to quadrivalent Human Papillomavirus (qHPV), Octavalent HPV with 15 mcg ISCOMATRIX™ (IMX) / Aluminum Hydroxyphosphate Sulfate (AAHS), or Octavalent HPV with 30 mcg IMX/AAHS. In Phase B, participants were randomized to qHPV, Octavalent HPV with 60 mcg IMX/AAHS or Octavalent HPV with 120 mcg IMX/AAHS.
158 participants were enrolled. Of the enrolled 158 participants, 8 were screening failures. 150 participants were randomized to the base study (up to 12 months), conducted in 2 phases, Phase A and Phase B. Some participants continued in a voluntary, long-term extension of the study (up to 36 months).
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| ID | Title | Description |
|---|---|---|
| FG000 | qHPV (GARDASIL™) - Phase A Control | Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- controls from Phase A. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6. |
| FG001 | Octavalent HPV With 15 mcg IMX / AAHS |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Base Study (Up to 12 Months) |
|
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| Experimental |
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX. |
|
| Octavalent HPV with 120 mcg IMX / AAHS | Experimental | Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX. |
|
|
| Octavalent HPV with 30 mcg IMX / AAHS | Biological | 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6 |
|
|
| Octavalent HPV with 60 mcg IMX / AAHS | Biological | 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6 |
|
|
| Octavalent HPV with 120 mcg IMX / AAHS | Biological | 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6 |
|
|
| Comparator: Quadrivalent HPV Vaccine (qHPV), (GARDASIL™) | Biological | 0.5-mL intramuscular injection administered at Day 1, Month 2 and Month 6 |
|
|
| 4 weeks postdose 3 (Phase B) |
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™ (IMX). A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6. |
| FG002 | Octavalent HPV With 30 mcg IMX / AAHS | Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6. |
| FG003 | qHPV (GARDASIL™) - Phase B Control | Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- controls from Phase B. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6. |
| FG004 | Octavalent HPV With 60 mcg IMX / AAHS | Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6. |
| FG005 | Octavalent HPV With 120 mcg IMX / AAHS | Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Extension Study (Up to 36 Months) |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | qHPV (GARDASIL™) - Phase A Control | Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- Controls from Phase A. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6. |
| BG001 | Octavalent HPV With 15 mcg IMX / AAHS | Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate(AAHS) and 15 mcg ISCOMATRIX™ (IMX). A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6. |
| BG002 | Octavalent HPV With 30 mcg IMX / AAHS | Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6. |
| BG003 | qHPV (GARDASIL™) - Phase B Control | Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- Controls from Phase B. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6. |
| BG004 | Octavalent HPV With 60 mcg IMX / AAHS | Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6. |
| BG005 | Octavalent HPV With 120 mcg IMX / AAHS | Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase A | The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using a competitive Luminex immunoassay (cLIA) after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent. | Per Protocol Immunogenicity (PPI) population: participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and polymerase chain reaction (PCR)-negative Day 1 through Month 7 for the relevant HPV type(s), had a valid Month 7 serology result collected in the appropriate day range. | Posted | Geometric Mean | 95% Confidence Interval | mMU/mL | 4 weeks postdose 3 (Phase A) |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Geometric Mean Titers (GMTs) to Each of the HPV Types Contained in the Vaccine for Phase B | The quadrivalent HPV (GARDASIL™) vaccine has types 6, 11, 16, 18, and the octavalent HPV has types 6, 11, 16, 18, 31, 45, 52, and 58. Serum antibody titres to the HPV type were obtained using cLIA after vaccination with GARDASIL™ or the octavalent HPV vaccine. GMTs were calculated and are reported as the antibody concentration in milli-Merck Units per milliliter (mMU/mL) of neutralizing monoclonal antibody equivalent. | PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7 for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range. | Posted | Geometric Mean | 95% Confidence Interval | mMU/mL | 4 weeks postdose 3 (Phase B) |
| |||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase A | A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively. | PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7 for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range. | Posted | Number | Participants | 4 weeks postdose 3 (Phase A) |
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Seroconverted to Each of the HPV Types Contained in the Vaccine During Phase B | A vaccinated participant was considered seropositive for a given HPV type if her serum antibody titer by cLIA for the HPV type was greater than the serostatus cutoff. The serostatus cutoffs for HPV Types 6, 11, 16, 18, 31, 45, 52, and 58 were 20, 20, 20, 20, 16, 16, 20, and 16 mMU/mL, respectively. | PPI population: All participants who were not protocol violators, received all 3 vaccinations within acceptable day ranges, were seronegative at Day 1 and PCR-negative Day 1 through Month 7 for the relevant HPV type(s), and had a valid Month 7 serology result collected in the appropriate day range. | Posted | Number | Participants | 4 weeks postdose 3 (Phase B) |
|
All injection site adverse events (AEs) for 5 days following vaccination, all non-injection site AEs for 14 calendar days following vaccination, and all laboratory AEs that occurred at any time during the study are included.
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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 | qHPV (GARDASIL™) - Phase A and Phase B Controls | Quadrivalent Human Papillomavirus (qHPV) (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) combined from Phase A and Phase B. | 0 | 30 | 30 | 30 | ||
| EG001 | Octavalent HPV With 15 mcg IMX / AAHS | Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 15 mcg IMX. | 0 | 30 | 30 | 30 | ||
| EG002 | Octavalent HPV With 30 mcg IMX / AAHS | Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 30 mcg IMX. | 0 | 30 | 30 | 30 | ||
| EG003 | Octavalent HPV With 60 mcg IMX / AAHS | Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 60 mcg IMX. | 0 | 30 | 30 | 30 | ||
| EG004 | Octavalent With 120 mcg IMX / AAHS | Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 120 mcg IMX. | 0 | 30 | 30 | 30 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Injection site mass | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Injection site warmth | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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As this study is part of a multicenter trial, the SPONSOR does not recommend separate publication of individual study site results due to scientific concerns. 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. SPONSOR review can be expedited to meet publication guidelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President,Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D014846 | Vulvar Neoplasms |
| D014625 | Vaginal Neoplasms |
| D003218 | Condylomata Acuminata |
| ID | Term |
|---|---|
| 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 |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014845 | Vulvar Diseases |
| D014623 | Vaginal Diseases |
| D030361 | Papillomavirus Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068857 | Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D053918 | Papillomavirus Vaccines |
| D014765 | Viral Vaccines |
Not provided
Not provided
| Moved |
|
| Male |
|
| Anti-HPV 11 (N=11, N=21, N=22) |
|
| Anti-HPV 16 (N=11, N=23, N=24) |
|
| Anti-HPV 18 (N=11, N=24, N=24) |
|
| Anti-HPV 31(N=11, N=24, N=23) |
|
| Anti-HPV 45 (N=11, N=26, N=25) |
|
| Anti-HPV 52 (N=9, N=23, N=25) |
|
| Anti-HPV 58 (N=10, N=24, N=22) |
|
| Octavalent HPV With 120 mcg IMX / AAHS |
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 120 mcg ISCOMATRIX™ (IMX) |
|
|
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 30 mcg ISCOMATRIX™ (IMX)
|
|
Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 120 mcg ISCOMATRIX™ (IMX)
|
|