Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this trial is to study the administration of the Menomune vaccine given intradermally and low-dose subcutaneously versus standard subcutaneously. This study will describe the immunogenicity of Menomune® - A/C/Y/W-135 administered subcutaneously (standard dose) versus intradermally over a dose range (1/10th, 2/10th, and 3/10th of standard dose) and a low dose (2/10th of standard dose) subcutaneously.
The secondary objective is to describe the safety of the subcutaneous (SC) and intradermal (ID) routes at different dosages
This trial will provide a proof of concept that a dose range of Menomune given ID can induce an immune response that is comparable to standard dosing by the SC route, and is equivalent or superior to a low dose given SC.
Subjects will be randomized according to a computer-generated randomization schedule to receive the vaccine by SC injection or by ID injection at different dosages.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | 0.5 mL Subcutaneous arm (Menomune® ) |
|
| Group 2 | Experimental | 0.1 mL Subcutaneous arm (Menomune®) |
|
| Group 3 | Experimental | 0.05 mL Intradermal arm (Menomune®) |
|
| Group 4 | Experimental | 0.1 mL Intradermal arm (Menomune®) |
|
| Group 5 | Experimental | 0.15 mL Intradermal arm (Menomune®) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined | Biological | 0.5 mL, Subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers | Percentage of participants with a 4-fold rise in Serum bactericidal assay using baby rabbit complement (SBA-BR) antibody titers to each meningococcal serogroup from baseline to Day 28 post-vaccination. | Baseline to 28 days post vaccination |
| Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | GMTs and their 95% confidence interval to the vaccine meningococcal serogroups at Day 0 and Day 28 post-vaccination. | Baseline (Day 0) and Day 28 post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Participants with solicited local and systemic reactions and intensity within 7 days following vaccination with Menomune® | Day 0 to 7 days post-vaccination |
Not provided
Inclusion Criteria :
Exclusion Criteria :
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Stroudsburg | Pennsylvania | 18301 | United States |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
A total of 170 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.
Study participants were enrolled from 15 through 16 October 2002 in 1 US site
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 0.5 mL Subcutaneous Menomune® | Participants received 0.5 mL Subcutaneous Menomune® |
| FG001 | 0.1 mL Subcutaneous Menomune® | Participants received 0.1 mL Subcutaneous Menomune® |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined | Biological | 0.1 mL, Subcutaneous |
|
|
| Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined | Biological | 0.05 mL, Intradermal |
|
|
| Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined | Biological | 0.1 mL, Intradermal |
|
|
| Meningococcal Polysaccharide Groups A\C\Y\W-135 Combined | Biological | 0.15 mL, Intradermal |
|
|
| FG002 | 0.05 mL Intradermal Menomune® | Participants received 0.05 mL Intradermal Menomune® |
| FG003 | 0.1 mL Intradermal Menomune® | Participants received 0.1 mL Intradermal Menomune® |
| FG004 | 0.15 mL Intradermal Menomune® | Participants received 0.15 mL Intradermal Menomune® |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 0.5 mL Subcutaneous Menomune® | Participants received 0.5 mL Subcutaneous Menomune® |
| BG001 | 0.1 mL Subcutaneous Menomune® | Participants received 0.1 mL Subcutaneous Menomune® |
| BG002 | 0.05 mL Intradermal Menomune® | Participants received 0.05 mL Intradermal Menomune® |
| BG003 | 0.1 mL Intradermal Menomune® | Participants received 0.1 mL Intradermal Menomune® |
| BG004 | 0.15 mL Intradermal Menomune® | Participants received 0.15 mL Intradermal Menomune® |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers | Percentage of participants with a 4-fold rise in Serum bactericidal assay using baby rabbit complement (SBA-BR) antibody titers to each meningococcal serogroup from baseline to Day 28 post-vaccination. | 4-Fold rise analysis was in the per-protocol population with valid serology data | Posted | Number | Percentage of participants | Baseline to 28 days post vaccination |
|
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Participants with solicited local and systemic reactions and intensity within 7 days following vaccination with Menomune® | Posted | Number | Participants | Day 0 to 7 days post-vaccination |
| |||||||||||||||||||||||||||||||||||||||||
| Primary | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | GMTs and their 95% confidence interval to the vaccine meningococcal serogroups at Day 0 and Day 28 post-vaccination. | Geometric mean titers were determined in the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Baseline (Day 0) and Day 28 post-vaccination |
|
Adverse events data were collected from the day of vaccination for 28 days post-vaccination
Not provided
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 | 0.5 mL Subcutaneous Menomune® | Participants received 0.5 mL Subcutaneous Menomune® | 0 | 34 | 8 | 34 | ||
| EG001 | 0.1 mL Subcutaneous Menomune® | Participants received 0.1 mL Subcutaneous Menomune® | 1 | 34 | 9 | 34 | ||
| EG002 | 0.05 mL Intradermal Menomune® | Participants received 0.05 mL Intradermal Menomune® | 0 | 34 | 9 | 34 | ||
| EG003 | 0.1 mL Intradermal Menomune® | Participants received 0.1 mL Intradermal Menomune® | 0 | 34 | 10 | 34 | ||
| EG004 | 0.15 mL Intradermal Menomune® | Participants received 0.15 mL Intradermal Menomune® | 0 | 34 | 18 | 34 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain NOS | Gastrointestinal disorders | MedDRA 6.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site redness | General disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Injection site tenderness | General disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Chills | Musculoskeletal and connective tissue disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 6.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 6.0 | Systematic Assessment |
|
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 |
|---|---|
| D008589 | Meningococcal Infections |
| D008581 | Meningitis |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Meningococcal serogroup C |
|
| Meningococcal serogroup Y |
|
| Meningococcal serogroup W-135 |
|
|
|
Participants received 0.15 mL Intradermal Menomune® |
|
|