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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1117-7012 | Other Identifier | WHO |
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The purpose of this trial is to describe the safety and antibody response to revaccination with Menactra vaccine in persons who received their first dose at ≥11 years of age.
Primary Objective:
- To evaluate the antibody responses to meningococcal serogroups A, C, Y, and W-135, measured by serum bactericidal assay using human complement (SBA-HC), induced by Menactra vaccine in subjects who were first vaccinated with Menactra 4-6 years ago.
Secondary Objective:
- To evaluate the antibody responses to serogroups A, C, Y, and W-135 in serum specimens collected 6 days post-vaccination in a subset of study population.
Observational Objective:
- To describe the rates of immediate reactions, solicited injection-site and systemic reactions, unsolicited adverse events and serious adverse events following vaccination.
All participants will receive one dose of Menactra vaccine at their first clinic visit. There will be a telephone safety follow-up contact at six months post-vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meningococcal vaccine Group | Experimental | Participants must have received Menactra vaccine 4 to 6 years prior to enrollment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra® | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC) | Day 28 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | 72205 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27642132 | Derived | Robertson CA, Greenberg DP, Hedrick J, Pichichero M, Decker MD, Saunders M. Safety and immunogenicity of a booster dose of meningococcal (groups A, C, W, and Y) polysaccharide diphtheria toxoid conjugate vaccine. Vaccine. 2016 Oct 17;34(44):5273-5278. doi: 10.1016/j.vaccine.2016.09.003. Epub 2016 Sep 15. |
| Label | URL |
|---|---|
| Related Info | View source |
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A total of 834 participants who met all of the inclusion and none of the exclusion criteria were randomized; 831 were vaccinated in this study.
The study participants were enrolled from 26 September 2011 through 21 December 2011 at 15 clinic centers in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Menactra® Vaccine Group | Participants <56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine in this study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination |
| Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point. | Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination |
| Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point. | Day 6 and Day 28 post-vaccination |
| Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point. | Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination |
| Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point. | Day 6 and Day 28 post-vaccination |
| Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Solicited injection-site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection-site reactions: Pain - Significant, prevents daily activity; Erythema and Swelling - >100 mm. Grade 3 systemic reactions: Fever - ≥40˚C or ≥104˚F; Headache, Malaise, Myalgia, and Shivering - Significant, prevents daily activity. | Day 0 up to Day 7 post-vaccination |
| San Diego |
| California |
| 92103 |
| United States |
| Bardstown | Kentucky | 40004 | United States |
| Crestview Hills | Kentucky | 41017 | United States |
| Spokane | Massachusetts | 99202 | United States |
| Woburn | Massachusetts | 01801 | United States |
| Niles | Michigan | 49120 | United States |
| Stevensville | Michigan | 49127 | United States |
| Rochester | New York | 14618 | United States |
| Cleveland | Ohio | 44121 | United States |
| Sellersville | Pennsylvania | 18960 | United States |
| Kingsport | Tennessee | 37660 | United States |
| Layton | Utah | 84041 | United States |
| Orem | Utah | 84057 | United States |
| Midlothian | Virginia | 23113 | United States |
| Safety Analysis Set |
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| Per-Protocol Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Menactra® Vaccine Group | Participants <56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra in this study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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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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| Region of Enrollment | 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 | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC) | SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. | Posted | Number | Participants | Day 28 post-vaccination |
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| Secondary | Number of Participants Achieving Antibody Titers ≥1:4 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point. | SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point. | Posted | Number | Participants | Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination |
|
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| Secondary | Number of Participants Achieving Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point. | SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point. | Posted | Number | Participants | Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination |
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| Secondary | Number of Participants Achieving At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point. | SBA-HC antibody titers were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point. | Posted | Number | Participants | Day 6 and Day 28 post-vaccination |
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| Secondary | Geometric Mean Antibody Titers Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point. | Geometric mean titers (GMTs) were assessed in the Per-protocol Analysis Set. Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC GMTs at this time point. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Day 0 (pre-vaccination), Day 6 and Day 28 post-vaccination |
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| Secondary | Geometric Mean Antibody Titer Ratios Against Meningococcal Serogroups A, C, Y, and W-135 by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Meningococcal antibodies against serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA-HC). Serum samples were collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC antibody titers at this time point. | Geometric mean titers ratios (GMTRs) were assessed in the Per-protocol Analysis Set. Serum samples were also collected from a random subset of vaccinated participants 6 days post-vaccination to assess SBA-HC GMTRs at this time point. | Posted | Geometric Mean | 95% Confidence Interval | Titers ratio | Day 6 and Day 28 post-vaccination |
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| Secondary | Number of Participants Reporting Solicited Injection-Site or Systemic Reactions Following Vaccination With Menactra® | Solicited injection-site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection-site reactions: Pain - Significant, prevents daily activity; Erythema and Swelling - >100 mm. Grade 3 systemic reactions: Fever - ≥40˚C or ≥104˚F; Headache, Malaise, Myalgia, and Shivering - Significant, prevents daily activity. | Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set. | Posted | Number | Participants | Day 0 up to Day 7 post-vaccination |
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Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.
The solicited injection site and systemic reactions were recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
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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 | Menactra® Vaccine Group | Participants <56 years of age who received Menactra 4-6 years previously at age >= 11 years received a single dose of Menactra vaccine | 11 | 831 | 494 | 831 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Serratia infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Injury | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
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| Wound Dehiscence | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
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| Benign hydatidiform mole | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
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| Affective disorder | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Post streptococcal glomerulonephritis | Renal and urinary disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site Pain | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Shivering | General disorders | MedDRA 14.0 | Systematic Assessment |
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Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | RegistryContactUs@sanofipasteur.com |
| ID | Term |
|---|---|
| D008581 | Meningitis |
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D022401 | Meningococcal Vaccines |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Title | Measurements |
|---|---|
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| Serogroup W-135 |
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