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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_093 |
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Data from this study are expected to demonstrate that Gardasil (V501, Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine), when administered concomitantly with a combined diphtheria, tetanus, pertussis, and poliomyelitis vaccine in adolescents remains immunogenic and well-tolerated and it does not impair the immunogenicity of the concomitant vaccines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Concomitant/CMF |
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| Group 2 | Experimental | Non-Concomitant/CMF |
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| Group 3 | Experimental | Concomitant/FMF |
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| Group 4 | Experimental | Non-Concomitant/FMF |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Current Manufacturing Facility (CMF) | Biological | GARDASILâ„¢ (quadrivalent human papillomavirus [types 6, 11, 16, 18] virus-like particle [VLP] vaccine, referred to as qHPV vaccine) made at the current manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) for Anti-HPV 6 at Month 7 (4 Weeks Postdose 3) | Serum antibodies to HPV Type 6 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAXâ„¢ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAXâ„¢ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction. | Up to 7 Months (4 Weeks Postdose 3) |
| Geometric Mean Titers (GMTs) for Anti-HPV 11 at Month 7 (4 Weeks Postdose 3) | Serum antibodies to HPV Type 11 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAXâ„¢ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAXâ„¢ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction. | Up to 7 Months (4 Weeks Postdose 3) |
| Geometric Mean Titers (GMTs) for Anti-HPV 16 at Month 7 (4 Weeks Postdose 3) | Serum antibodies to HPV Type 16 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAXâ„¢ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAXâ„¢ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction. | Up to 7 Months (4 Weeks Postdose 3) |
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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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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19952980 | Result | Vesikari T, Van Damme P, Lindblad N, Pfletschinger U, Radley D, Ryan D, Vuocolo S, Haupt RM, Guris D. An open-label, randomized, multicenter study of the safety, tolerability, and immunogenicity of quadrivalent human papillomavirus (types 6/11/16/18) vaccine given concomitantly with diphtheria, tetanus, pertussis, and poliomyelitis vaccine in healthy adolescents 11 to 17 years of age. Pediatr Infect Dis J. 2010 Apr;29(4):314-8. doi: 10.1097/INF.0b013e3181c177fb. |
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The study enrolled healthy participants, 11-17 years old, with 0 lifetime sexual partners, vaccinated against diphtheria, tetanus, pertussis and polio but had not received the vaccine in the past 5 years or any prior human papillomavirus (HPV) vaccine. Additional inclusion and exclusion criteria applied.
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| ID | Title | Description |
|---|---|---|
| FG000 | qHPV Vaccine + REPEVAXâ„¢ (Concomitant) | Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAXâ„¢ administered on Day 1 at different injection sites. |
| FG001 | qHPV Vaccine + REPEVAXâ„¢ (Non-Concomitant) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) Vaccine from Future Manufacturing Facility (FMF) | Biological | GARDASILâ„¢ (quadrivalent human papillomavirus [types 6, 11, 16, 18] virus-like particle [VLP] vaccine, referred to as qHPV vaccine) made at the future manufacturing facility was administered as 0.5-mL intramuscular dose at Day 1, Month 2, and Month 6. |
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| Comparator: REPEVAXâ„¢ (Concomitant) | Biological | REPEVAXâ„¢ (diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Day 1 in a limb opposite that of quadrivalent HPV injection. |
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| Comparator: REPEVAXâ„¢ (Non-Concomitant) | Biological | REPEVAXâ„¢ (diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] vaccine, Sanofi Pasteur, Swiftwater, PA U.S.A) was administered as a single 0.5-mL intramuscular dose at Month 1 in a limb opposite that of quadrivalent HPV injection. |
|
| Geometric Mean Titers (GMTs) for Anti-HPV 18 at Month 7 (4 Weeks Postdose 3) | Serum antibodies to HPV Type 18 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAXâ„¢ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAXâ„¢ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction. | Up to 7 Months (4 Weeks Postdose 3) |
| Number of Participants Who Seroconverted for HPV Type 6 (HPV 6 ≥20 mMU/mL) by Month 7 (4 Weeks Postdose 3) | Seroconversion to HPV Type 6 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥20 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine. | Up to 7 Months (4 Weeks Postdose 3) |
| Number of Participants Who Seroconverted for HPV Type 11 (HPV 11 ≥16 mMU/mL) by Month 7 (4 Weeks Postdose 3) | Seroconversion to HPV Type 11 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥16 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine. | Up to 7 Months (4 Weeks Postdose 3) |
| Number of Participants Who Seroconverted for HPV Type 16 (HPV 16 ≥20 mMU/mL) by Month 7 (4 Weeks Postdose 3) | Seroconversion to HPV Type 16 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥20 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine. | Up to 7 Months (4 Weeks Postdose 3) |
| Number of Participants Who Seroconverted for HPV Type 18 (HPV 18 ≥24 mMU/mL) by Month 7 (4 Weeks Postdose 3) | Seroconversion to HPV Type 18 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥24 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine. | Up to 7 Months (4 Weeks Postdose 3) |
| Number of Participants Who Achieved Acceptable Levels of Titers to Diphtheria (Diphtheria ≥0.1 IU/mL) One Month Post-vaccination With REPEVAX™ | Diphtheria antitoxin titers were measured using a neutralization assay in Vero cell culture that compares the antitoxin level in the serum of participants with the World Health Organization International Standard for Diphtheria Antitoxin. An acceptable level of response was defined as ≥0.1 International Units (IU)/milliliter (mL). Response levels of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine. | Up to 1 Month (1 Month Postdose 1) |
| Number of Participants Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥0.1 IU/mL) One Month Post-vaccination With REPEVAX™ | Tetanus antitoxin titers were measured using an indirect, non-competitive enzyme immunoassay (EIA) that compares the antitoxin level in the serum of participants with the World Health Organization International Standard for Tetanus Immunoglobulin. An acceptable level of response was defined as ≥0.1 International Units (IU)/milliliter (mL). Response levels of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine. | Up to 1 Month (1 Month Postdose 1) |
| Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 1 (Poliovirus Type 1 ≥1:8) One Month Postvaccination With REPEVAX™ | Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine. | Up to 1 Month (1 Month Postdose 1) |
| Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 2 (Poliovirus Type 2 ≥1:8) One Month Postvaccination With REPEVAX™ | Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine. | Up to 1 Month (1 Month Postdose 1) |
| Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 3 (Poliovirus Type 3 ≥1:8) One Month Postvaccination With REPEVAX™ | Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine. | Up to 1 Month (1 Month Postdose 1) |
| Geometric Mean Titers (GMTs) For Pertussis (Anti-PT) One Month Postvaccination With REPEVAXâ„¢ | Serum antibodies to Pertussis Toxoid Antibody (anti-PT) were measured with an enzyme-linked immunosorbent assay (ELISA). Titers were reported in ELISA units/mL (ELU/mL) and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAXâ„¢ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAXâ„¢ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction. | Up to 1 Month (1 Month Postdose 1) |
| Geometric Mean Titers (GMTs) For Pertussis (Anti-FHA) One Month Postvaccination With REPEVAXâ„¢ | Serum antibodies to Pertussis Filamentous Haemagglutin Antibody (anti-FHA) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 3.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAXâ„¢ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAXâ„¢ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction. | Up to 1 Month (1 Month Postdose 1) |
| Geometric Mean Titers (GMTs) For Pertussis (Anti-PRN) One Month Postvaccination With REPEVAXâ„¢ | Serum antibodies to Pertussis Pertactin (anti-PRN) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAXâ„¢ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAXâ„¢ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction. | Up to 1 Month (1 Month Postdose 1) |
| Geometric Mean Titers (GMTs) For Pertussis (Anti-FIM) One Month Postvaccination With REPEVAXâ„¢ | Serum antibodies to Pertussis Fimbrial Agglutinogens Antibody (anti-FIM) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAXâ„¢ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAXâ„¢ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV Type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction. | Up to 1 Month (1 Month Postdose 1) |
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAXâ„¢ administered at Month 1. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | qHPV Vaccine + REPEVAXâ„¢ (Concomitant) | Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAXâ„¢ administered on Day 1 at different injection sites. |
| BG001 | qHPV Vaccine + REPEVAXâ„¢ (Non-Concomitant) | Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAXâ„¢ administered at Month 1. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Geometric Mean Titers (GMTs) for Anti-HPV 6 at Month 7 (4 Weeks Postdose 3) | Serum antibodies to HPV Type 6 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAXâ„¢ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAXâ„¢ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction. | Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. | Posted | Mean | 95% Confidence Interval | milliMerck units/mL | Up to 7 Months (4 Weeks Postdose 3) |
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| Primary | Geometric Mean Titers (GMTs) for Anti-HPV 11 at Month 7 (4 Weeks Postdose 3) | Serum antibodies to HPV Type 11 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAXâ„¢ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAXâ„¢ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction. | Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. | Posted | Mean | 95% Confidence Interval | milliMerck units/mL | Up to 7 Months (4 Weeks Postdose 3) |
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| Primary | Geometric Mean Titers (GMTs) for Anti-HPV 16 at Month 7 (4 Weeks Postdose 3) | Serum antibodies to HPV Type 16 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAXâ„¢ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAXâ„¢ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction. | Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. | Posted | Mean | 95% Confidence Interval | milliMerck units/mL | Up to 7 Months (4 Weeks Postdose 3) |
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| Primary | Geometric Mean Titers (GMTs) for Anti-HPV 18 at Month 7 (4 Weeks Postdose 3) | Serum antibodies to HPV Type 18 were measured with a Competitive Luminex Immunoassay. Titers were reported in milli Merck Units (mMU)/milliliter (mL). GMTs from participants who received qHPV vaccine and REPEVAXâ„¢ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAXâ„¢ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction. | Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. | Posted | Mean | 95% Confidence Interval | milliMerck units/mL | Up to 7 Months (4 Weeks Postdose 3) |
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| Primary | Number of Participants Who Seroconverted for HPV Type 6 (HPV 6 ≥20 mMU/mL) by Month 7 (4 Weeks Postdose 3) | Seroconversion to HPV Type 6 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥20 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine. | Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. | Posted | Number | participants | Up to 7 Months (4 Weeks Postdose 3) |
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| Primary | Number of Participants Who Seroconverted for HPV Type 11 (HPV 11 ≥16 mMU/mL) by Month 7 (4 Weeks Postdose 3) | Seroconversion to HPV Type 11 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥16 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine. | Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. | Posted | Number | participants | Up to 7 Months (4 Weeks Postdose 3) |
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| Primary | Number of Participants Who Seroconverted for HPV Type 16 (HPV 16 ≥20 mMU/mL) by Month 7 (4 Weeks Postdose 3) | Seroconversion to HPV Type 16 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥20 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine. | Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. | Posted | Number | participants | Up to 7 Months (4 Weeks Postdose 3) |
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| Primary | Number of Participants Who Seroconverted for HPV Type 18 (HPV 18 ≥24 mMU/mL) by Month 7 (4 Weeks Postdose 3) | Seroconversion to HPV Type 18 was defined as changing serostatus from seronegative to seropositive as measured by GMT. The cutoff value for HPV seropositivity was ≥24 mMU/mL. Seroconversion of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to seroconversion of participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared seroconversion for each HPV type using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine. | Per-protocol population: participants must have no major protocol violations, must be seronegative at baseline to the relevant HPV type, and must have post-vaccination data. | Posted | Number | participants | Up to 7 Months (4 Weeks Postdose 3) |
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| Primary | Number of Participants Who Achieved Acceptable Levels of Titers to Diphtheria (Diphtheria ≥0.1 IU/mL) One Month Post-vaccination With REPEVAX™ | Diphtheria antitoxin titers were measured using a neutralization assay in Vero cell culture that compares the antitoxin level in the serum of participants with the World Health Organization International Standard for Diphtheria Antitoxin. An acceptable level of response was defined as ≥0.1 International Units (IU)/milliliter (mL). Response levels of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine. | Per-protocol population: participants must have no major protocol violations and must have post-vaccination data. | Posted | Number | participants | Up to 1 Month (1 Month Postdose 1) |
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| Primary | Number of Participants Who Achieved Acceptable Levels of Titers to Tetanus (Tetanus ≥0.1 IU/mL) One Month Post-vaccination With REPEVAX™ | Tetanus antitoxin titers were measured using an indirect, non-competitive enzyme immunoassay (EIA) that compares the antitoxin level in the serum of participants with the World Health Organization International Standard for Tetanus Immunoglobulin. An acceptable level of response was defined as ≥0.1 International Units (IU)/milliliter (mL). Response levels of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) were compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine. | Per-protocol population: participants must have no major protocol violations and must have post-vaccination data. | Posted | Number | participants | Up to 1 Month (1 Month Postdose 1) |
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| Primary | Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 1 (Poliovirus Type 1 ≥1:8) One Month Postvaccination With REPEVAX™ | Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine. | Per-protocol population: participants must have no major protocol violations and must have post-vaccination data. | Posted | Number | participants | Up to 1 Month (1 Month Postdose 1) |
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| Primary | Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 2 (Poliovirus Type 2 ≥1:8) One Month Postvaccination With REPEVAX™ | Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine. | Per-protocol population: participants must have no major protocol violations and must have post-vaccination data. | Posted | Number | participants | Up to 1 Month (1 Month Postdose 1) |
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| Primary | Number of Participants Who Achieved Acceptable Levels of Titers to Poliovirus Type 3 (Poliovirus Type 3 ≥1:8) One Month Postvaccination With REPEVAX™ | Poliovirus antibody was measured using a poliovirus neutralization assay that assesses the ability of serial dilutions of participant sera to neutralize known amounts of type-specific Sabin poliovirus strains (Types 1, 2, and 3). An acceptable level of response was defined as participants who achieve detectable serum neutralizing antibodies at a ≥1:8 dilution of sera. The response of participants who received qHPV vaccine and REPEVAX™ together at Day 1 (concomitant) was compared to participants who received qHPV vaccine at Day 1 followed by REPEVAX™ 1 month later (non-concomitant). An analysis of non-inferiority compared response levels using methods developed by Miettinen and Nurminen adjusting for manufacturing facility for qHPV vaccine. | Per-protocol population: participants must have no major protocol violations and must have post-vaccination data. | Posted | Number | participants | Up to 1 Month (1 Month Postdose 1) |
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| Primary | Geometric Mean Titers (GMTs) For Pertussis (Anti-PT) One Month Postvaccination With REPEVAXâ„¢ | Serum antibodies to Pertussis Toxoid Antibody (anti-PT) were measured with an enzyme-linked immunosorbent assay (ELISA). Titers were reported in ELISA units/mL (ELU/mL) and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAXâ„¢ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAXâ„¢ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction. | Per-protocol population: participants must have no major protocol violations and must have post-vaccination data. | Posted | Mean | 95% Confidence Interval | ELISA units/mL | Up to 1 Month (1 Month Postdose 1) |
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| Primary | Geometric Mean Titers (GMTs) For Pertussis (Anti-FHA) One Month Postvaccination With REPEVAXâ„¢ | Serum antibodies to Pertussis Filamentous Haemagglutin Antibody (anti-FHA) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 3.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAXâ„¢ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAXâ„¢ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction. | Per-protocol population: participants must have no major protocol violations and must have post-vaccination data. | Posted | Mean | 95% Confidence Interval | ELISA units/mL | Up to 1 Month (1 Month Postdose 1) |
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| Primary | Geometric Mean Titers (GMTs) For Pertussis (Anti-PRN) One Month Postvaccination With REPEVAXâ„¢ | Serum antibodies to Pertussis Pertactin (anti-PRN) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAXâ„¢ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAXâ„¢ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction. | Per-protocol population: participants must have no major protocol violations and must have post-vaccination data. | Posted | Mean | 95% Confidence Interval | ELISA units/mL | Up to 1 Month (1 Month Postdose 1) |
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| Primary | Geometric Mean Titers (GMTs) For Pertussis (Anti-FIM) One Month Postvaccination With REPEVAXâ„¢ | Serum antibodies to Pertussis Fimbrial Agglutinogens Antibody (anti-FIM) were measured with an ELISA. Titers were reported in ELU/mL and the lower limit of quantitation for the assay was 5.0 ELU/mL. GMTs from participants who received qHPV vaccine and REPEVAXâ„¢ together at Day 1 (concomitant) were compared to GMTs from participants who received qHPV vaccine at Day 1 followed by REPEVAXâ„¢ 1 month later (non-concomitant). An analysis of non-inferiority compared GMTs for each HPV Type using an ANOVA model with a response of log individual titers and fixed effects for treatment group, manufacturing facility, study site, and the treatment-by-site interaction. | Per-protocol population: participants must have no major protocol violations and must have post-vaccination data. | Posted | Mean | 95% Confidence Interval | ELISA units/mL | Up to 1 Month (1 Month Postdose 1) |
|
Adverse events (AEs) were collected from Day 1 until Month 7.
AEs were collected on participants who received ≥1 dose of study vaccine (qHPV or Repevax). Fevers and injection-site AEs were reported for Days 1-5 and all other AEs for Days 1-15. Injection-site AEs are reported separately for those associated with qHPV (AE term-qHPV) and those that are associated with Repevax (AE term-Repevax).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | qHPV Vaccine + REPEVAXâ„¢ (Concomitant) | Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAXâ„¢ administered on Day 1 at different injection sites. | 1 | 420 | 405 | 420 | ||
| EG001 | qHPV Vaccine + REPEVAXâ„¢ (Non-Concomitant) | Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAXâ„¢ administered at Month 1. | 3 | 423 | 406 | 423 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Systematic Assessment |
| |
| Ligament disorder | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site bruising-qHPV | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site erythema-qHPV | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site haematoma-qHPV | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site induration-qHPV | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site pain-qHPV | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site pruritus-qHPV | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site swelling-qHPV | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site bruising-Repevax | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site erythema-Repevax | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site haematoma-Repevax | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site induration-Repevax | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site irritation-Repevax | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site pain-Repevax | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site pruritus-Repevax | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site swelling-Repevax | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site warmth-Repevax | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Motion sickness | Ear and labyrinth disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Lip swelling | Gastrointestinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Teething | Gastrointestinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Photophobia | Eye disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Ocular discomfort | Eye disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Hypochromasia | Blood and lymphatic system disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Feeling of body temperature change | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Local swelling | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Vessel puncture site pain | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Acute tonsillitis | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Blister infected | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Lice infestation | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Sialoadenitis | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Viral tonsillitis | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Systematic Assessment |
| |
| Brain contusion | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Systematic Assessment |
| |
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA Version 10.1 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Coccydynia | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Growing pains | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Sensation of heaviness | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 10.1 | Systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Syncope vasovagal | Nervous system disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Eating disorder | Psychiatric disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Listless | Psychiatric disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Metrorrhagia | Reproductive system and breast disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Subcutaneous nodule | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site irritation-qHPV | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site warmth-qHPV | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site anaesthesia-Repevax | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site discolouration-qHPV | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site discolouration-Repevax | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site haemorrhage-qHPV | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site haemorrhage-Repevax | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site mass-Repevax | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site movement impairment-qHPV | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site movement impairment-Repevax | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site nodule-qHPV | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site nodule-Repevax | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site papule-Repevax | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site rash-Repevax | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site reaction-qHPV | General disorders | MedDRA Version 10.1 | Systematic Assessment |
| |
| Injection site reaction-Repevax | General disorders | MedDRA Version 10.1 | Systematic Assessment |
|
Safety results have been previously reported in the literature.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
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