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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_512 | Other Grant/Funding Number | Merck Registration Number |
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This study will evaluate whether co-administration of the first dose of V503 and REPEVAXâ„¢ is well tolerated and causes a non-inferior immune response when compared to administration of REPEVAXâ„¢ one month following the first dose of V503.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concomitant Vaccination | Experimental | V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevaxâ„¢ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1 |
|
| Non-concomitant Vaccination | Experimental | V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevaxâ„¢ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V503 Vaccine | Biological | V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were measured using a competitive Luminex immunoassay. Titers are reported in milli Merck Units/mL. | 4 weeks following Month 6 vaccination |
| Percentage of Participants With a V503 Injection-site Adverse Experience | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an AE. Only injection-site AEs in the arm that received V503 vaccination were reported for this endpoint. | Day 1 through Day 5 following Day 1 vaccination |
| Percentage of Participants With a Repevaxâ„¢ Injection-site Adverse Experience | For the Concomitant Vaccination group, injection-site AEs are reported following Day 1 vaccination; for the Non-concomitant Vaccination group, injection-site AEs are reported following Month 1 vaccination. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an AE. Only injection-site AEs in the arm that received Repevaxâ„¢ vaccination were reported for this endpoint. | Day 1 through Day 5 following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination |
| Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent) | For the Concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Seroconvert for Each of the HPV Types | Blood was drawn at Month 7 and assayed to determine whether or not a participant had achieved seroconversion for the HPV types. The lower limit of the titer (milli Merck U/mL) considered seropositive was as follows: HPV Type 6: >=30, HPV Type 11: >=16; HPV Type 16: >=20, HPV Type 18: >=24, HPV Type 31: >=10, HPV Type 33: >=8, HPV Type 45: >=8, HPV Type 52: >=8, and HPV Type 58: >=8. |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25831420 | Result | Kosalaraksa P, Mehlsen J, Vesikari T, Forsten A, Helm K, Van Damme P, Joura EA, Ciprero K, Maansson R, Luxembourg A, Sobanjo-ter Meulen A. An open-label, randomized study of a 9-valent human papillomavirus vaccine given concomitantly with diphtheria, tetanus, pertussis and poliomyelitis vaccines to healthy adolescents 11-15 years of age. Pediatr Infect Dis J. 2015 Jun;34(6):627-34. doi: 10.1097/INF.0000000000000694. | |
| 27422279 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| ID | Title | Description |
|---|---|---|
| FG000 | Concomitant Vaccination | V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevaxâ„¢ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1 |
| FG001 | Non-concomitant Vaccination | V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevaxâ„¢ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Concomitant Vaccination | V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevaxâ„¢ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1 |
| BG001 | Non-concomitant Vaccination |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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) of the Antibody Response to Each of the Human Papillomavirus (HPV) Types Contained in V503 | Serum antibody titers for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 were measured using a competitive Luminex immunoassay. Titers are reported in milli Merck Units/mL. | The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint | Posted | Geometric Mean | Full Range | milli Merck Units/mL | 4 weeks following Month 6 vaccination |
|
Serious adverse events: up to Month 7; Other adverse events: Day 1 through Day 5 following any vaccination for injection-site AEs and Day 1 through Day 15 following any vaccination for non-injection-site AEs
Adverse events were collected for all participants who received at least one dose of V503 and Repevaxâ„¢
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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 | Concomitant Vaccination | V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevaxâ„¢ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Day 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-cardiac chest pain | General disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders |
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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 |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| REPEVAXâ„¢ (Concomitant) | Biological | REPEVAXâ„¢ given as a single 0.5 mL intramuscular injection at Day 1 |
|
| REPEVAXâ„¢ (Non-concomitant) | Biological | REPEVAXâ„¢ given as a single 0.5 mL intramuscular injection at Month 1 |
|
| Up to 5 days following the Day 1 and Month 1 vaccination / visit |
| Percentage of Participants With a Systemic Adverse Experience | For the Concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 vaccination. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body that is temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an adverse experience. A systemic AE was an AE that was not associated with the injection site. | Up to 15 days following the Day 1 and Month 1 vaccination / visit |
| Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody | For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to diphtheria toxin were measured using a cell-based Diphtheria Micrometabolic Inhibition assay. Serum titers of neutralizing antibody to tetanus toxin were measured using an enzyme immunoassay. The lower limits of quantitation of the assays was 0.01 International Units (IU)/mL and 0.04 IU/mL, respectively. Acceptable titers refer to the World Health Organization-defined protective titer of >=0.1 IU/mL. | 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination |
| Geometric Mean Titers of Pertussis Antibody Responses | For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA), anti-pertactin (PRN), and anti-fimbriae 2/3 (FM 2/3) antibodies were measured using enzyme-linked immunosorbent assays. Titers are expressed as enzyme-linked immunoassay units/mL (ELU/mL). | 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination |
| Percentage of Participants Who Achieve Acceptable Titers of Anti-Poliovirus Antibody | For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to poliovirus type 1, 2, and 3 were measured using a microneutralization assay. Serial dilutions of sera were incubated with type-specific standard poliovirus and sensitive cells. Neutralization of the virus was measured by cell staining. Acceptable titers were defined as neutralization at >=1:8 dilution of serum. | 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination |
| Month 7 |
| Result |
| Moreira ED Jr, Block SL, Ferris D, Giuliano AR, Iversen OE, Joura EA, Kosalaraksa P, Schilling A, Van Damme P, Bornstein J, Bosch FX, Pils S, Cuzick J, Garland SM, Huh W, Kjaer SK, Qi H, Hyatt D, Martin J, Moeller E, Ritter M, Baudin M, Luxembourg A. Safety Profile of the 9-Valent HPV Vaccine: A Combined Analysis of 7 Phase III Clinical Trials. Pediatrics. 2016 Aug;138(2):e20154387. doi: 10.1542/peds.2015-4387. Epub 2016 Jul 15. |
V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevaxâ„¢ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Non-concomitant Vaccination | V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevaxâ„¢ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1 |
|
|
|
| Primary | Percentage of Participants With a V503 Injection-site Adverse Experience | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an AE. Only injection-site AEs in the arm that received V503 vaccination were reported for this endpoint. | The population analyzed included all vaccinated participants with follow-up | Posted | Number | Percentage of participants | Day 1 through Day 5 following Day 1 vaccination |
|
|
|
| Primary | Percentage of Participants With a Repevaxâ„¢ Injection-site Adverse Experience | For the Concomitant Vaccination group, injection-site AEs are reported following Day 1 vaccination; for the Non-concomitant Vaccination group, injection-site AEs are reported following Month 1 vaccination. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an AE. Only injection-site AEs in the arm that received Repevaxâ„¢ vaccination were reported for this endpoint. | The population analyzed included all vaccinated participants with follow-up | Posted | Number | Percentage of participants | Day 1 through Day 5 following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination |
|
|
|
| Primary | Percentage of Participants With Maximum Temperature >=37.8 °C (>=100.0 °F) (Oral or Oral Equivalent) | For the Concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, temperatures were collected after the Day 1 vaccination and the Month 1 vaccination. | The population analyzed included all vaccinated participants with follow-up | Posted | Number | Percentage of participants | Up to 5 days following the Day 1 and Month 1 vaccination / visit |
|
|
|
| Primary | Percentage of Participants With a Systemic Adverse Experience | For the Concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 visit; for the Non-concomitant Vaccination group, systemic AEs were collected after the Day 1 vaccination and the Month 1 vaccination. An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body that is temporally associated with the use of the study vaccine, whether or not considered related to the use of the vaccine. Any worsening of a preexisting condition which is temporally associated with the use of the vaccine is also an adverse experience. A systemic AE was an AE that was not associated with the injection site. | The population analyzed included all vaccinated participants with follow-up | Posted | Number | Percentage of participants | Up to 15 days following the Day 1 and Month 1 vaccination / visit |
|
|
|
| Primary | Percentage of Participants Who Achieve Acceptable Titers of Anti-Diphtheria and Anti-Tetanus Antibody | For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to diphtheria toxin were measured using a cell-based Diphtheria Micrometabolic Inhibition assay. Serum titers of neutralizing antibody to tetanus toxin were measured using an enzyme immunoassay. The lower limits of quantitation of the assays was 0.01 International Units (IU)/mL and 0.04 IU/mL, respectively. Acceptable titers refer to the World Health Organization-defined protective titer of >=0.1 IU/mL. | The per-protocol population included participants who received vaccination and had serum samples available for evaluation of the endpoint | Posted | Number | 95% Confidence Interval | Percentage of participants | 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination |
|
|
|
|
| Primary | Geometric Mean Titers of Pertussis Antibody Responses | For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA), anti-pertactin (PRN), and anti-fimbriae 2/3 (FM 2/3) antibodies were measured using enzyme-linked immunosorbent assays. Titers are expressed as enzyme-linked immunoassay units/mL (ELU/mL). | The per-protocol population included participants who received vaccination and had serum samples available for evaluation of the endpoint | Posted | Geometric Mean | 95% Confidence Interval | ELU/mL | 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination |
|
|
|
|
| Primary | Percentage of Participants Who Achieve Acceptable Titers of Anti-Poliovirus Antibody | For the Concomitant Vaccination group, serum samples were collected 4 weeks after the Day 1 vaccination; for the Non-concomitant Vaccination group, serum samples were collected 4 weeks after the Month 1 vaccination. Titers of neutralizing antibody to poliovirus type 1, 2, and 3 were measured using a microneutralization assay. Serial dilutions of sera were incubated with type-specific standard poliovirus and sensitive cells. Neutralization of the virus was measured by cell staining. Acceptable titers were defined as neutralization at >=1:8 dilution of serum. | The per-protocol population included participants who received vaccination and had serum samples available for evaluation of the endpoint | Posted | Number | 95% Confidence Interval | Percentage of participants | 4 weeks following Day 1 (Concomitant) or Month 1 (Non-concomitant) vaccination |
|
|
|
|
| Secondary | Percentage of Participants Who Seroconvert for Each of the HPV Types | Blood was drawn at Month 7 and assayed to determine whether or not a participant had achieved seroconversion for the HPV types. The lower limit of the titer (milli Merck U/mL) considered seropositive was as follows: HPV Type 6: >=30, HPV Type 11: >=16; HPV Type 16: >=20, HPV Type 18: >=24, HPV Type 31: >=10, HPV Type 33: >=8, HPV Type 45: >=8, HPV Type 52: >=8, and HPV Type 58: >=8. | The per-protocol population included participants who received all study vaccinations, were seronegative to HPV on Day 1, and had serum samples available for evaluation of the endpoint | Posted | Number | Percentage of participants | Month 7 |
|
|
|
| 9 |
| 525 |
| 509 |
| 525 |
| EG001 | Non-concomitant Vaccination | V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevaxâ„¢ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1 | 7 | 527 | 505 | 527 |
| Appendiceal abscess | Infections and infestations |
|
| Appendicitis | Infections and infestations |
|
| Dengue fever | Infections and infestations |
|
| Pyelonephritis | Infections and infestations |
|
| Pyelonephritis acute | Infections and infestations |
|
| Viral pharyngitis | Infections and infestations |
|
| Forearm fracture | Injury, poisoning and procedural complications |
|
| Road traffic accident | Injury, poisoning and procedural complications |
|
| Thermal burn | Injury, poisoning and procedural complications |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders |
|
| Syncope | Nervous system disorders |
|
| Eating disorder | Psychiatric disorders |
|
| Nausea | Gastrointestinal disorders |
|
| Injection-site erythema | General disorders |
|
| Injection-site pain | General disorders |
|
| Injection-site pruritus | General disorders |
|
| Injection-site swelling | General disorders |
|
| Pyrexia | General disorders |
|
| Nasopharyngitis | Infections and infestations |
|
| Upper respiratory tract infection | Infections and infestations |
|
| Headache | Nervous system disorders |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders |
|
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 |
Anti-tetanus titer >=0.1 IU/mL |
| Miettinen and Nurminen |
| <0.001 |
| Difference in percentage |
| 0.0 |
| 2-Sided |
| 95 |
| -1.1 |
| 1.2 |
| Non-Inferiority or Equivalence |
Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the percentage difference is greater than -10 |
| Anti-PRN: n=505, 474 |
|
| Anti-FIM 2/3: n=505, 474 |
|
Anti-FHA |
| ANOVA |
| <0.001 |
| Fold difference in GMT |
| 0.99 |
| 2-Sided |
| 95 |
| 0.90 |
| 1.08 |
| Non-Inferiority or Equivalence |
Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.67 |
| Anti-PRN | ANOVA | <0.001 | Difference in GMT | 0.94 | 2-Sided | 95 | 0.80 | 1.09 | Non-Inferiority or Equivalence | Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.67 |
| Anti-FIM 2/3 | ANOVA | 0.005 | Difference in GMT | 0.89 | 2-Sided | 95 | 0.72 | 1.11 | Non-Inferiority or Equivalence | Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the lower limit of the 95% confidence interval for the fold difference is >0.67 |
| Poliovirus type 3: n=505, 474 |
|
Poliovirus type 2 |
| Miettinen and Nurminen |
| <0.001 |
| Difference in percentage |
| -0.2 |
| 2-Sided |
| 95 |
| -1.2 |
| 0.8 |
| Non-Inferiority or Equivalence |
Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the difference is statistically less than 10 percentage points |
| Poliovirus type 3 | Miettinen and Nurminen | <0.001 | Difference in percentage | 0.0 | 2-Sided | 95 | -0.8 | 0.8 | Non-Inferiority or Equivalence | Noninferiority of concomitant versus non-concomitant vaccination is demonstrated if the difference is statistically less than 10 percentage points |
| Anti-HPV 16: n=489, 479 |
|
| Anti-HPV 18: n=486, 475 |
|
| Anti-HPV 31: n=485, 473 |
|
| Anti-HPV 33: n=487, 478 |
|
| Anti-HPV 45: n=489, 478 |
|
| Anti-HPV 52: n=490, 479 |
|
| Anti-HPV 58: n=484, 469 |
|