Meningitis, Meningococcal Infections
Conditions
Keywords
Menomune® - A/C/Y/W-135, Meningococcal Infections, Meningitis
Brief summary
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
Detailed description
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.
Interventions
BIOLOGICALMeningococcal Polysaccharide Groups A\C\Y\W-135 Combined
0.5 mL, Subcutaneous
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
: * 18 to 55 years of age. * Willing to return for 3 follow-up visits and comply with a 30 day follow-up period. * Signed an informed consent form.
Exclusion criteria
: * Allergy to any component of the vaccine and latex. * Known or suspected immunodeficiency or receipt of immunosuppressive therapy or blood products within the previous two months. * History of serious chronic diseases (such as cardiac or renal disease). * Acute febrile illness at the time of visit. * Pregnancy. * Receipt of any vaccine within the 28 days prior to enrollment. * Receipt of meningococcal vaccine (example in Military) within the past 5 years or history of meningococcal disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers | Baseline to 28 days post vaccination | 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. |
| Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Baseline (Day 0) and Day 28 post-vaccination | GMTs and their 95% confidence interval to the vaccine meningococcal serogroups at Day 0 and Day 28 post-vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Day 0 to 7 days post-vaccination | Participants with solicited local and systemic reactions and intensity within 7 days following vaccination with Menomune® |
Countries
United States
Participant flow
Recruitment details
Study participants were enrolled from 15 through 16 October 2002 in 1 US site
Pre-assignment details
A total of 170 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| 0.5 mL Subcutaneous Menomune® Participants received 0.5 mL Subcutaneous Menomune® | 34 |
| 0.1 mL Subcutaneous Menomune® Participants received 0.1 mL Subcutaneous Menomune® | 34 |
| 0.05 mL Intradermal Menomune® Participants received 0.05 mL Intradermal Menomune® | 34 |
| 0.1 mL Intradermal Menomune® Participants received 0.1 mL Intradermal Menomune® | 34 |
| 0.15 mL Intradermal Menomune® Participants received 0.15 mL Intradermal Menomune® | 34 |
| Total | 170 |
Baseline characteristics
| Characteristic | 0.1 mL Subcutaneous Menomune® | 0.1 mL Intradermal Menomune® | 0.15 mL Intradermal Menomune® | Total | 0.5 mL Subcutaneous Menomune® | 0.05 mL Intradermal Menomune® |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 5 Participants | 1 Participants | 11 Participants | 2 Participants | 2 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 29 Participants | 33 Participants | 159 Participants | 32 Participants | 32 Participants |
| Age, Continuous | 24.3 years STANDARD_DEVIATION 7.1 | 24.5 years STANDARD_DEVIATION 8.46 | 28.9 years STANDARD_DEVIATION 12.85 | 25.6 years STANDARD_DEVIATION 9.42 | 25.8 years STANDARD_DEVIATION 9.68 | 24.4 years STANDARD_DEVIATION 7.64 |
| Region of Enrollment United States | 34 participants | 34 participants | 34 participants | 170 participants | 34 participants | 34 participants |
| Sex: Female, Male Female | 23 Participants | 15 Participants | 17 Participants | 93 Participants | 22 Participants | 16 Participants |
| Sex: Female, Male Male | 11 Participants | 19 Participants | 17 Participants | 77 Participants | 12 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 34 | 9 / 34 | 9 / 34 | 10 / 34 | 18 / 34 |
| serious Total, serious adverse events | 0 / 34 | 1 / 34 | 0 / 34 | 0 / 34 | 0 / 34 |
Outcome results
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.
Time frame: Baseline (Day 0) and Day 28 post-vaccination
Population: Geometric mean titers were determined in the per-protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 0.5 mL Subcutaneous Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup Y (Day 28) | 1883.0 Titers |
| 0.5 mL Subcutaneous Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup W-135 (Day 28) | 1374.1 Titers |
| 0.5 mL Subcutaneous Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup A (Day 0) | 462.4 Titers |
| 0.5 mL Subcutaneous Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup A (Day 28) | 5496.3 Titers |
| 0.5 mL Subcutaneous Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup C (Day 0) | 48.1 Titers |
| 0.5 mL Subcutaneous Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup C (Day 28) | 2989.0 Titers |
| 0.5 mL Subcutaneous Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup Y (Day 0) | 301.3 Titers |
| 0.5 mL Subcutaneous Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup W-135 (Day 0) | 32.7 Titers |
| 0.1 mL Subcutaneous Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup W-135 (Day 0) | 37.7 Titers |
| 0.1 mL Subcutaneous Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup Y (Day 0) | 166.8 Titers |
| 0.1 mL Subcutaneous Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup A (Day 0) | 320.4 Titers |
| 0.1 mL Subcutaneous Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup W-135 (Day 28) | 856.3 Titers |
| 0.1 mL Subcutaneous Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup Y (Day 28) | 2002.7 Titers |
| 0.1 mL Subcutaneous Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup C (Day 0) | 85.1 Titers |
| 0.1 mL Subcutaneous Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup A (Day 28) | 3662.7 Titers |
| 0.1 mL Subcutaneous Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup C (Day 28) | 1751.3 Titers |
| 0.05 mL Intradermal Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup A (Day 28) | 1775.6 Titers |
| 0.05 mL Intradermal Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup A (Day 0) | 267.0 Titers |
| 0.05 mL Intradermal Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup C (Day 0) | 50.8 Titers |
| 0.05 mL Intradermal Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup Y (Day 0) | 164.7 Titers |
| 0.05 mL Intradermal Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup C (Day 28) | 1478.0 Titers |
| 0.05 mL Intradermal Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup Y (Day 28) | 1390.3 Titers |
| 0.05 mL Intradermal Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup W-135 (Day 0) | 47.7 Titers |
| 0.05 mL Intradermal Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup W-135 (Day 28) | 1390.3 Titers |
| 0.1 mL Intradermal Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup A (Day 0) | 381.6 Titers |
| 0.1 mL Intradermal Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup W-135 (Day 0) | 34.1 Titers |
| 0.1 mL Intradermal Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup A (Day 28) | 3079.0 Titers |
| 0.1 mL Intradermal Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup C (Day 0) | 53.0 Titers |
| 0.1 mL Intradermal Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup C (Day 28) | 1307.8 Titers |
| 0.1 mL Intradermal Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup W-135 (Day 28) | 1307.8 Titers |
| 0.1 mL Intradermal Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup Y (Day 0) | 216.4 Titers |
| 0.1 mL Intradermal Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup Y (Day 28) | 1603.6 Titers |
| 0.15 mL Intradermal Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup W-135 (Day 28) | 2006.7 Titers |
| 0.15 mL Intradermal Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup Y (Day 28) | 1887.6 Titers |
| 0.15 mL Intradermal Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup Y (Day 0) | 189.0 Titers |
| 0.15 mL Intradermal Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup W-135 (Day 0) | 19.4 Titers |
| 0.15 mL Intradermal Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup C (Day 28) | 2780.6 Titers |
| 0.15 mL Intradermal Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup C (Day 0) | 41.5 Titers |
| 0.15 mL Intradermal Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup A (Day 28) | 4013.3 Titers |
| 0.15 mL Intradermal Menomune® | Geometric Mean Titers (GMTs) for Each Meningococcal Serogroup at Baseline and 28 Days Post-vaccination. | Meningococcal serogroup A (Day 0) | 261.6 Titers |
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.
Time frame: Baseline to 28 days post vaccination
Population: 4-Fold rise analysis was in the per-protocol population with valid serology data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.5 mL Subcutaneous Menomune® | Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers | Meningococcal serogroup Y | 64 Percentage of participants |
| 0.5 mL Subcutaneous Menomune® | Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers | Meningococcal serogroup W-135 | 88 Percentage of participants |
| 0.5 mL Subcutaneous Menomune® | Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers | Meningococcal serogroup C | 79 Percentage of participants |
| 0.5 mL Subcutaneous Menomune® | Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers | Meningococcal serogroup A | 85 Percentage of participants |
| 0.1 mL Subcutaneous Menomune® | Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers | Meningococcal serogroup Y | 68 Percentage of participants |
| 0.1 mL Subcutaneous Menomune® | Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers | Meningococcal serogroup A | 61 Percentage of participants |
| 0.1 mL Subcutaneous Menomune® | Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers | Meningococcal serogroup C | 58 Percentage of participants |
| 0.1 mL Subcutaneous Menomune® | Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers | Meningococcal serogroup W-135 | 77 Percentage of participants |
| 0.05 mL Intradermal Menomune® | Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers | Meningococcal serogroup A | 61 Percentage of participants |
| 0.05 mL Intradermal Menomune® | Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers | Meningococcal serogroup Y | 61 Percentage of participants |
| 0.05 mL Intradermal Menomune® | Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers | Meningococcal serogroup W-135 | 73 Percentage of participants |
| 0.05 mL Intradermal Menomune® | Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers | Meningococcal serogroup C | 67 Percentage of participants |
| 0.1 mL Intradermal Menomune® | Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers | Meningococcal serogroup A | 76 Percentage of participants |
| 0.1 mL Intradermal Menomune® | Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers | Meningococcal serogroup C | 70 Percentage of participants |
| 0.1 mL Intradermal Menomune® | Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers | Meningococcal serogroup W-135 | 79 Percentage of participants |
| 0.1 mL Intradermal Menomune® | Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers | Meningococcal serogroup Y | 58 Percentage of participants |
| 0.15 mL Intradermal Menomune® | Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers | Meningococcal serogroup A | 84 Percentage of participants |
| 0.15 mL Intradermal Menomune® | Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers | Meningococcal serogroup Y | 66 Percentage of participants |
| 0.15 mL Intradermal Menomune® | Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers | Meningococcal serogroup C | 88 Percentage of participants |
| 0.15 mL Intradermal Menomune® | Percentage of Participants With ≥ 4-Fold Rise in Antibody Titers | Meningococcal serogroup W-135 | 97 Percentage of participants |
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®
Time frame: Day 0 to 7 days post-vaccination
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Myalgia | 0 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Grade 3 Systemic Reaction | 0 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Tenderness (disabling) | 0 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Diarrhea (≥3 episodes) | 0 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Swelling | 0 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Grade 3 Local Reaction | 0 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Systemic Reaction | 4 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Local Reaction | 8 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Headache (disabling) | 0 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Swelling ( ≥ 2 inchs) | 0 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Headache | 2 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Pain | 1 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Vomiting | 0 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Arthralgia | 1 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Tenderness | 6 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Myalgia (disabling) | 0 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Pain (disabling) | 0 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Malaise (disabling) | 0 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Chills (disabling) | 0 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Malaise | 0 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Nausea (disabling) | 0 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Nausea | 0 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Dizziness | 1 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Diarrhea | 0 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Chills | 1 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Fever (≥ 39.6 ºC) | 0 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Dizziness (disabling) | 0 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Redness | 2 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Vomiting (≥3 episodes) | 0 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Injection site Rash | 1 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Fever | 0 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Arthralgia (disabling) | 0 Participants |
| 0.5 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Redness ( ≥ 2 inchs) | 0 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Vomiting | 1 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Malaise | 2 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Malaise (disabling) | 0 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Local Reaction | 5 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Myalgia | 1 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Nausea (disabling) | 0 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Myalgia (disabling) | 0 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Grade 3 Local Reaction | 0 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Nausea | 3 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Arthralgia (disabling) | 0 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Redness | 2 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Redness ( ≥ 2 inchs) | 0 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Swelling | 1 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Arthralgia | 4 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Swelling ( ≥ 2 inchs) | 0 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Tenderness (disabling) | 0 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Tenderness | 4 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Injection site Rash | 0 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Pain | 0 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Pain (disabling) | 0 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Diarrhea (≥3 episodes) | 1 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Systemic Reaction | 9 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Grade 3 Systemic Reaction | 2 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Fever | 0 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Diarrhea | 2 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Fever (≥ 39.6 ºC) | 0 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Chills | 2 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Chills (disabling) | 0 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Headache | 6 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Vomiting (≥3 episodes) | 0 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Dizziness | 0 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Headache (disabling) | 1 Participants |
| 0.1 mL Subcutaneous Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Dizziness (disabling) | 0 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Systemic Reaction | 7 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Diarrhea | 0 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Injection site Rash | 1 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Nausea (disabling) | 0 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Fever | 0 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Redness | 8 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Malaise (disabling) | 0 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Grade 3 Local Reaction | 0 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Headache (disabling) | 0 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Fever (≥ 39.6 ºC) | 0 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Arthralgia (disabling) | 0 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Dizziness | 1 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Nausea | 0 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Myalgia (disabling) | 0 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Dizziness (disabling) | 0 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Chills (disabling) | 0 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Chills | 0 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Vomiting (≥3 episodes) | 0 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Tenderness (disabling) | 0 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Tenderness | 1 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Diarrhea (≥3 episodes) | 0 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Swelling ( ≥ 2 inchs) | 0 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Local Reaction | 9 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Pain | 0 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Vomiting | 0 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Pain (disabling) | 0 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Swelling | 4 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Headache | 3 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Myalgia | 2 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Arthralgia | 2 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Redness ( ≥ 2 inchs) | 0 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Malaise | 1 Participants |
| 0.05 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Grade 3 Systemic Reaction | 0 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Swelling | 5 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Headache (disabling) | 0 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Local Reaction | 10 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Grade 3 Local Reaction | 0 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Redness | 9 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Redness ( ≥ 2 inchs) | 0 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Swelling ( ≥ 2 inchs) | 0 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Tenderness | 1 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Tenderness (disabling) | 0 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Pain | 1 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Pain (disabling) | 0 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Systemic Reaction | 4 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Grade 3 Systemic Reaction | 0 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Fever | 0 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Fever (≥ 39.6 ºC) | 0 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Chills | 1 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Chills (disabling) | 0 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Headache | 2 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Dizziness | 0 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Dizziness (disabling) | 0 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Malaise | 1 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Malaise (disabling) | 0 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Myalgia | 0 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Myalgia (disabling) | 0 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Nausea | 1 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Nausea (disabling) | 0 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Vomiting | 0 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Vomiting (≥3 episodes) | 0 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Diarrhea | 0 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Diarrhea (≥3 episodes) | 0 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Arthralgia | 2 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Arthralgia (disabling) | 0 Participants |
| 0.1 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Injection site Rash | 0 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Dizziness | 0 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Injection site Rash | 1 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Vomiting | 0 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Headache (disabling) | 0 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Headache | 1 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Chills (disabling) | 0 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Arthralgia (disabling) | 0 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Vomiting (≥3 episodes) | 0 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Chills | 0 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Fever | 0 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Grade 3 Systemic Reaction | 0 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Fever (≥ 39.6 ºC) | 0 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Diarrhea | 0 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Systemic Reaction | 3 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Pain (disabling) | 0 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Tenderness (disabling) | 0 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Pain | 0 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Diarrhea (≥3 episodes) | 0 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Swelling ( ≥ 2 inchs) | 0 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Swelling | 10 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Redness ( ≥ 2 inchs) | 0 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Tenderness | 3 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Arthralgia | 1 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Redness | 18 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Grade 3 Local Reaction | 0 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Nausea | 1 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Myalgia (disabling) | 0 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Myalgia | 0 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Malaise (disabling) | 0 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Local Reaction | 18 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Nausea (disabling) | 0 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Any Malaise | 1 Participants |
| 0.15 mL Intradermal Menomune® | Number and Intensity of Solicited Local and Systemic Reactions Post-vaccination. | Grade 3 Dizziness (disabling) | 0 Participants |