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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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The primary objective is to evaluate the persistence of bactericidal antibodies in adolescent subjects who completed study V59P6 in which they received either Novartis Meningococcal (MenACWY) Conjugate Vaccine or Licensed polysaccharide Men ACWY vaccine (Menomune®). The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.
Persistence of antibody response at 5 years after one dose of MenACWY or Menomune
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I: MenACWY-CRM vaccine | Experimental | Subjects had been given one dose of Meningococcal ACWY (MenACWY) vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago. All subjects were given one dose of the Men ACWY in the present study. |
|
| II: Licensed Polysaccharide Meningococcal vaccine | Experimental | Subjects had been given one dose of a licensed MenACWY polysaccharide meningococcal vaccine (Menomune) 5 years ago. All subjects were given one dose of Men ACWY vaccine in the present study. |
|
| III: Meningococcal Naive | Experimental | Subjects were age matched with groups 1 and 2 (age inclusive: 16 years to 23 years) and enrolled at visit 1 and given one dose of Men ACWY vaccine during the present study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novartis Meningococcal (MenACWY-CRM) vaccine | Biological | All subjects will have blood draws at Day 1, Day 8, and Day 29. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination | Persistence of antibody response was measured by the percentage of subjects who showed a serum bactericidal activity with human complement(hSBA) >= 8 [i.e. percentage of subjects with hsBA titer >=8] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y | Day 1 (5 years after primary vaccination) |
| Geometric Mean Titer After Booster Vaccination | Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) and reported as hSBA Geometric mean titer (GMT) in previously vaccinated subjects and in age-matched meningococcal vaccine-naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y | Day 8, Day 29 (5 years after primary vaccination) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination | Persistence was measured by percentage of subjects with serum bactericidal activity with human complement (hSBA) >= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y | Day 1 (5 years after primary vaccination ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rochester | Minnesota | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21177912 | Result | Kimura A, Toneatto D, Kleinschmidt A, Wang H, Dull P. Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine and a quadrivalent meningococcal CRM197 conjugate vaccine against serogroups A, C, W-135, and Y in adults who are at increased risk for occupational exposure to meningococcal isolates. Clin Vaccine Immunol. 2011 Mar;18(3):483-6. doi: 10.1128/CVI.00304-10. Epub 2010 Dec 22. | |
| 23114372 |
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All subjects enrolled were included in the trial.
Participants were enrolled at 3 centers in the USA
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| ID | Title | Description |
|---|---|---|
| FG000 | I: MenACWY-CRM Vaccine | Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago |
| FG001 | II: Licensed Polysaccharide Meningococcal Vaccine | Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago |
| FG002 | III: Meningococcal Naive | Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | I: MenACWY-CRM Vaccine | Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago |
| BG001 | II: Licensed Polysaccharide Meningococcal Vaccine |
| 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 | Percentage of Participants With Serum Bactericidal Activity >=8 at 5 Years After Primary Vaccination | Persistence of antibody response was measured by the percentage of subjects who showed a serum bactericidal activity with human complement(hSBA) >= 8 [i.e. percentage of subjects with hsBA titer >=8] in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y | Full analysis set (all subjects who had no major protocol violation as defined prior to database lock). | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 (5 years after primary vaccination) |
|
safety was assessed up to 28 days after vaccination.
All the AEs reported were solicited post-injection reactions
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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 | I: MenACWY-CRM Vaccine | Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
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| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| D008585 | Meningitis, Meningococcal |
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Geometric Mean Titer at 5 Years After Primary Vaccination | Persistence was measured by serum bactericidal assay with human complement(hSBA) and expressed as hSBA GMT in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y | Day 1 (5 years after primary vaccination ) |
| Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) >= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y. | Day 7, Day 28 post booster (5 years after primary vaccination) |
| Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) >= 8 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y. | Day 7, Day 28 post booster (5 years after primary vaccination) |
| Geometric Mean Ratio After Booster Vaccination | Ratios are expressed as geometric mean titer at Day 8: Day 1 and at Day 29:Day 1 | Day 8 and Day 29 (at 5 Years After Primary Vaccination) |
| Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | For a subject with hSBA titer <4 at baseline, seroresponse is defined as a postvaccination hSBA titer >=8; and for a subject with hSBA titer >=4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y. | Day 8, Day 29 (5 years after primary vaccination) |
| Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Local and systemic reactions were solicited to assess safety and tolerability of vaccination | Up to Day 7 |
| Pittsburgh |
| Pennsylvania |
| United States |
| Seattle | Washington | United States |
| Result |
| Jacobson RM, Jackson LA, Reisinger K, Izu A, Odrljin T, Dull PM. Antibody persistence and response to a booster dose of a quadrivalent conjugate vaccine for meningococcal disease in adolescents. Pediatr Infect Dis J. 2013 Apr;32(4):e170-7. doi: 10.1097/INF.0b013e318279ac38. |
| Inappropriate Enrollment |
|
| Unable to Classify |
|
Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago |
| BG002 | III: Meningococcal Naive | Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | II:Licensed Polysacharide Meningococcal Vaccine | Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study. |
| OG002 | III: Meningococcal-naive | Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study. |
|
|
| Primary | Geometric Mean Titer After Booster Vaccination | Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) and reported as hSBA Geometric mean titer (GMT) in previously vaccinated subjects and in age-matched meningococcal vaccine-naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y | Full analysis set | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 8, Day 29 (5 years after primary vaccination) |
|
|
|
|
| Secondary | Percentage of Participants With Serum Bactericidal Activity >=4 at 5 Years After Primary Vaccination | Persistence was measured by percentage of subjects with serum bactericidal activity with human complement (hSBA) >= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y | Full analysis set | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 (5 years after primary vaccination ) |
|
|
|
| Secondary | Geometric Mean Titer at 5 Years After Primary Vaccination | Persistence was measured by serum bactericidal assay with human complement(hSBA) and expressed as hSBA GMT in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y | Full analysis set | Posted | Geometric Mean | 95% Confidence Interval | Titer | Day 1 (5 years after primary vaccination ) |
|
|
|
| Secondary | Percentage of Participants With Serum Bactericidal Activity >=4 After Booster Vaccination | Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) >= 4 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y. | Full Analysis set | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 7, Day 28 post booster (5 years after primary vaccination) |
|
|
|
| Secondary | Percentage of Participants With Serum Bactericidal Activity >=8 After Booster Vaccination | Immunogenicity was measured by serum bactericidal assay with human complement (hSBA) >= 8 in previously vaccinated subjects and in age-matched meningococcal vaccine naive subjects. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y. | Full Analysis set | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 7, Day 28 post booster (5 years after primary vaccination) |
|
|
|
| Secondary | Geometric Mean Ratio After Booster Vaccination | Ratios are expressed as geometric mean titer at Day 8: Day 1 and at Day 29:Day 1 | full analysis set | Posted | Mean | 95% Confidence Interval | Geometric mean ratio | Day 8 and Day 29 (at 5 Years After Primary Vaccination) |
|
|
|
| Secondary | Percentage of Subjects With hSBA Seroresponse After Booster Vaccination | For a subject with hSBA titer <4 at baseline, seroresponse is defined as a postvaccination hSBA titer >=8; and for a subject with hSBA titer >=4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline. Sera was tested against Neisseria meningitidis serogroups A, C, W-135 and Y. | Full analysis set | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 8, Day 29 (5 years after primary vaccination) |
|
|
|
| Secondary | Number of Participants With at Least One Reactogenicity Sign After Booster Vaccination | Local and systemic reactions were solicited to assess safety and tolerability of vaccination | Posted | Number | participants | Up to Day 7 |
|
|
|
| 0 |
| 50 |
| 38 |
| 50 |
| EG001 | II: Licensed Polysaccharide Meningococcal Vaccine | Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago | 0 | 50 | 36 | 50 |
| EG002 | III: Meningococcal Naive | Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive | 0 | 53 | 46 | 53 |
| Chills | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Malaise | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
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| D007239 | Infections |
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |
|
| Day 29, Men A, (N=48, G I) |
|
| Baseline, Men C |
|
| Day 8, Men C |
|
| Day 29, Men C |
|
| Baseline, Men W-135 |
|
| Day 8, Men W-135 |
|
| Day 29, Men W-135 |
|
| Baseline, Men Y |
|
| Day 8, Men Y, (N=48, GI) |
|
| Day 29, Men Y |
|
| ANOVA |
| ratio of titer |
| 0.71 |
| 2-Sided |
| 95 |
| 0.42 |
| 1.2 |
| No |
| Superiority or Other |
| Day 1, Men A, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 1.68 | 2-Sided | 95 | 0.98 | 2.9 | No | Superiority or Other |
| Day 8, Men A, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 1.31 | 2-Sided | 95 | 0.59 | 2.91 | No | Superiority or Other |
| Day 8, Men A, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 24 | 2-Sided | 95 | 11 | 52 | No | Superiority or Other |
| Day 8, Men A, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 31 | 2-Sided | 95 | 14 | 69 | No | Superiority or Other |
| Day 29, Men A, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 1.3 | 2-Sided | 95 | 0.7 | 2.42 | No | Superiority or Other |
| Day 29, Men A, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 5.56 | 2-Sided | 95 | 3.01 | 10 | No | Superiority or Other |
| Day 29, Men A, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 7.22 | 2-Sided | 95 | 3.86 | 13 | No | Superiority or Other |
| Day 1, Men C, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 2.64 | 2-Sided | 95 | 1.4 | 4.99 | No | Superiority or Other |
| Day 1, Men C, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 1.05 | 2-Sided | 95 | 0.56 | 1.97 | No | Superiority or Other |
| Day 1, Men C, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 2.78 | 2-Sided | 95 | 1.47 | 5.27 | No | Superiority or Other |
| Day 8, Men C, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 0.52 | 2-Sided | 95 | 0.23 | 1.13 | No | Superiority or Other |
| Day 8, Men C, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 45 | 2-Sided | 95 | 21 | 97 | No | Superiority or Other |
| Day 8, Men C, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 23 | 2-Sided | 95 | 10 | 51 | No | Superiority or Other |
| Day 29, Men C, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 0.4 | 2-Sided | 95 | 0.2 | 0.82 | No | Superiority or Other |
| Day 29, Men C, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 24 | 2-Sided | 95 | 12 | 48 | No | Superiority or Other |
| Day 29, Men C, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 9.61 | 2-Sided | 95 | 4.69 | 20 | No | Superiority or Other |
| Day 1, Men W-135, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 1.11 | 2-Sided | 95 | 0.55 | 2.21 | No | Superiority or Other |
| Day 1, Men W-135, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 2.51 | 2-Sided | 95 | 1.27 | 4.96 | No | Superiority or Other |
| Day 1, Men W-135, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 2.77 | 2-Sided | 95 | 1.38 | 5.57 | No | Superiority or Other |
| Day 8, Men W-135, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 0.54 | 2-Sided | 95 | 0.28 | 1.04 | No | Superiority or Other |
| Day 8, Men W-135, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 50 | 2-Sided | 95 | 26 | 94 | No | Superiority or Other |
| Day 8, Men W-135, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 27 | 2-Sided | 95 | 14 | 52 | No | Superiority or Other |
| Day 29, Men W-135, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 0.6 | 2-Sided | 95 | 0.34 | 1.04 | No | Superiority or Other |
| Day 29, Men W-135, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 35 | 2-Sided | 95 | 20 | 60 | No | Superiority or Other |
| Day 29, Men W-135, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 21 | 2-Sided | 95 | 12 | 36 | No | Superiority or Other |
| Day 1, Men Y, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 0.9 | 2-Sided | 95 | 0.48 | 1.69 | No | Superiority or Other |
| Day 1, Men Y, Pairwise comparison of geometric mean titer | ratio of titer | 3.61 | 2-Sided | 95 | 1.94 | 6.74 | No | Superiority or Other |
| Day 1, Men Y, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 3.24 | 2-Sided | 95 | 1.71 | 6.13 | No | Superiority or Other |
| Day 8, Men Y, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 0.33 | 2-Sided | 95 | 0.16 | 0.66 | No | Superiority or Other |
| Day 8, Men Y, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 121 | 2-Sided | 95 | 61 | 241 | No | Superiority or Other |
| Day 8, Men Y, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 40 | 2-Sided | 95 | 20 | 80 | No | Superiority or Other |
| Day 29, Men Y, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 0.58 | 2-Sided | 95 | 0.32 | 1.05 | No | Superiority or Other |
| Day 29, Men Y, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 33 | 2-Sided | 95 | 18 | 60 | No | Superiority or Other |
| Day 29, Men Y, Pairwise comparison of geometric mean titer | ANOVA | ratio of titer | 19 | 2-Sided | 95 | 10 | 35 | No | Superiority or Other |
|
| Men W-135 |
|
| Men Y |
|
|
| Men W-135 |
|
| Men Y |
|
|
| Day 7 post booster, Men C |
|
| Day 28 post booster, Men C |
|
| Day 7 post booster, Men W-135 |
|
| Day 28 post booster, Men W-135 |
|
| Day 7 post booster, Men Y |
|
| Day 28 post booster, Men Y |
|
|
| Day 7 post booster, Men C |
|
| Day 28 post booster, Men C |
|
| Day 7 post booster, Men W-135 |
|
| Day 28 post booster, Men W-135 |
|
| Day 7 post booster, Men Y |
|
| Day 28 post booster, Men Y |
|
|
| Men C (Day 8:1) |
|
| Men C (Day 29:1) |
|
| Men W-135 (Day 8:1) |
|
| Men W-135 (Day 29:1) |
|
| Men Y (Day 8:1), N=48, N=49, N=50 |
|
| Men Y (Day 29:1) |
|
|
| Men C, Day 8 |
|
| Men C, Day 29 |
|
| Men W-135, Day 8 |
|
| Men W-135, Day 29 |
|
| Men Y, Day 8, (N=48, G I) |
|
| Men Y, Day 29 |
|
|
| Erythema (any) |
|
| Induration (any) |
|
| Sytemic Reactions (any-total) |
|
| Chills (any) |
|
| Nausea (any) |
|
| Malaise (any) |
|
| Myalgia (any) |
|
| Arthalgia (any) |
|
| Headache (any) |
|
| Fever >= 38C |
|
| Stayed at home |
|
| Analgesic antipyretic medication used |
|