Meningitis, Meningococcal Infection
Conditions
Keywords
Meningococcal Infection, Meningitis, Bacterial, Menactra®
Brief summary
The purpose of this study is to assess the safety and immunogenicity of a single dose of Menactra® vaccine to support registration. Primary Objectives: * To describe the antibody titers measured by serum bactericidal activity using baby rabbit complement (SBA-BR) before and after Menactra® vaccination. * To describe the safety profile of participants after one dose of Menactra®.
Detailed description
Participants will be enrolled in three age cohorts: Children: 2 - 11 years of age; Adolescents: 12 - 17 years of age, and Adults: 18 - 55 years of age to receive a single dose of Menactra®. They will be followed for a duration of 30 days after vaccination.
Interventions
BIOLOGICALMeningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)
0.5 mL, Intramuscular
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
: * Aged 2 to 11 years or Aged 12 to 17 years or Aged 18 to 55 years of age on the day of inclusion * For participants aged 2 to 11 years: Provision of informed consent form signed by the parent(s) or legal representative. * For participants aged 12 to 17 years: Provision of assent form signed by the participant and informed consent form signed by the parent(s) or legal representative. * For participants aged 18 to 55 years: Provision of informed consent form signed by the participant. If the participant or the participant's parents or legally accepted representative (participants aged 2 to 17 years) are illiterate, an independent witness is required to sign the consent form. * Participant and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and comply with all trial procedures * For a woman of child-bearing potential, sexually active, use of a medically acceptable and effective method of contraception for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination (not applicable for participants aged 2 to 17 years' females not of child-bearing potential or not sexually active)
Exclusion criteria
: * For a woman of child-bearing potential sexually active, known or suspected pregnancy or positive serum/urine pregnancy test (not applicable for participants aged 2 to 17 years' females not of child-bearing potential or not sexually active) * Breast-feeding woman * Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination * Planned participation in another clinical trial during the present trial period * Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy * Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances * Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator * Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures * Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response * Receipt or planned receipt of any vaccine (other than influenza vaccine which can be given 2 weeks or more before vaccination) in the 4 weeks preceding or following the trial vaccination * Known Human Immunodeficiency Virus (HIV), Hepatitis B surface (HBs) antigen , or Hepatitis C seropositivity as reported by the participant/parent/guardian and/or based on medical history * History of documented invasive meningococcal disease * Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine * Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination * Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent * Personal or family history of Guillain-Barré Syndrome Temporary contraindications delaying vaccination until resolved: * Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection on the day of vaccination * Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Baseline and 21 days post-vaccination | Antibodies to Menactra vaccine were measured by the Serum bactericidal assay baby rabbit complement (SBA BR) Test. |
| Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Day 0 and Day 30 post-vaccination | Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test. |
| Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination | Day 0 to 30 post-vaccination | Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test. |
| Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Day 0 to 7 post-vaccination | Solicited injection site: Pain, Erythema (Redness), and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia |
Countries
India
Participant flow
Recruitment details
Participants were enrolled from 11 June to 01 October 2010 in 3 clinical centers in India.
Pre-assignment details
A total of 300 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Age 2 to 11 Years Group Participants at age 2 to 11 years on enrollment. | 100 |
| Age 12 to 17 Years Group Participants aged 12 to 17 years at enrollment. | 100 |
| Age 18 to 55 Years Group Participants aged 18 to 55 years at enrollment | 100 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 2 | 0 |
Baseline characteristics
| Characteristic | Age 12 to 17 Years Group | Age 18 to 55 Years Group | Age 2 to 11 Years Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 100 Participants | 0 Participants | 100 Participants | 200 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 100 Participants | 0 Participants | 100 Participants |
| Age Continuous | 14.2 Years STANDARD_DEVIATION 1.4 | 34.8 Years STANDARD_DEVIATION 9.2 | 7.2 Years STANDARD_DEVIATION 3.1 | 18.7 Years STANDARD_DEVIATION 13.1 |
| Region of Enrollment India | 100 Participants | 100 Participants | 100 Participants | 300 Participants |
| Sex: Female, Male Female | 48 Participants | 38 Participants | 53 Participants | 139 Participants |
| Sex: Female, Male Male | 52 Participants | 62 Participants | 47 Participants | 161 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 30 / 100 | 23 / 100 | 38 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 | 0 / 100 |
Outcome results
Primary
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination
Solicited injection site: Pain, Erythema (Redness), and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia
Time frame: Day 0 to 7 post-vaccination
Population: Safety parameters were assessed in the safety analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Age 2 to 11 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Any Solicited malaise | 9 Participants |
| Age 2 to 11 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Grade 3 swelling (≥5 cm [2-11 years] or >10 cm) | 0 Participants |
| Age 2 to 11 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Any Solicited injection site erythema | 7 Participants |
| Age 2 to 11 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Grade 3 headache (significant) | 0 Participants |
| Age 2 to 11 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Any Solicited fever | 11 Participants |
| Age 2 to 11 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Grade 3 pain (Incapacitating) | 0 Participants |
| Age 2 to 11 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Any Solicited headache | 12 Participants |
| Age 2 to 11 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Grade 3 fever (≥ 39.0°C) | 3 Participants |
| Age 2 to 11 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Grade 3 malaise (significant) | 0 Participants |
| Age 2 to 11 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Grade 3 erythema (≥5 cm [2-11 years] or >10 cm) | 0 Participants |
| Age 2 to 11 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Grade 3 myalgia (significant) | 0 Participants |
| Age 2 to 11 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Any Solicited injection site pain | 30 Participants |
| Age 2 to 11 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Any Solicited injection site swelling | 10 Participants |
| Age 2 to 11 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Any Solicited myalgia | 13 Participants |
| Age 12 to 17 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Any Solicited malaise | 13 Participants |
| Age 12 to 17 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Any Solicited injection site pain | 23 Participants |
| Age 12 to 17 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Grade 3 pain (Incapacitating) | 0 Participants |
| Age 12 to 17 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Any Solicited injection site erythema | 1 Participants |
| Age 12 to 17 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Grade 3 erythema (≥5 cm [2-11 years] or >10 cm) | 0 Participants |
| Age 12 to 17 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Any Solicited injection site swelling | 4 Participants |
| Age 12 to 17 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Grade 3 swelling (≥5 cm [2-11 years] or >10 cm) | 0 Participants |
| Age 12 to 17 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Any Solicited fever | 3 Participants |
| Age 12 to 17 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Grade 3 fever (≥ 39.0°C) | 2 Participants |
| Age 12 to 17 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Any Solicited headache | 19 Participants |
| Age 12 to 17 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Grade 3 headache (significant) | 0 Participants |
| Age 12 to 17 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Grade 3 malaise (significant) | 0 Participants |
| Age 12 to 17 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Any Solicited myalgia | 8 Participants |
| Age 12 to 17 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Grade 3 myalgia (significant) | 0 Participants |
| Age 18 to 55 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Any Solicited myalgia | 12 Participants |
| Age 18 to 55 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Grade 3 headache (significant) | 0 Participants |
| Age 18 to 55 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Any Solicited injection site swelling | 0 Participants |
| Age 18 to 55 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Grade 3 erythema (≥5 cm [2-11 years] or >10 cm) | 0 Participants |
| Age 18 to 55 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Any Solicited malaise | 5 Participants |
| Age 18 to 55 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Any Solicited injection site erythema | 0 Participants |
| Age 18 to 55 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Any Solicited injection site pain | 38 Participants |
| Age 18 to 55 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Grade 3 malaise (significant) | 0 Participants |
| Age 18 to 55 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Grade 3 pain (Incapacitating) | 0 Participants |
| Age 18 to 55 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Grade 3 fever (≥ 39.0°C) | 2 Participants |
| Age 18 to 55 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Any Solicited fever | 5 Participants |
| Age 18 to 55 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Grade 3 myalgia (significant) | 0 Participants |
| Age 18 to 55 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Any Solicited headache | 19 Participants |
| Age 18 to 55 Years Group | Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Grade 3 swelling (≥5 cm [2-11 years] or >10 cm) | 0 Participants |
Primary
Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination
Antibodies to Menactra vaccine were measured by the Serum bactericidal assay baby rabbit complement (SBA BR) Test.
Time frame: Baseline and 21 days post-vaccination
Population: Menactra vaccine antibody titers were determined in the immunogenicity analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Age 2 to 11 Years Group | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Serogroup A (Pre-vaccination; N= 100, 100, 100) | 17 Participants |
| Age 2 to 11 Years Group | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Serogroup A (Post-vaccination; N= 99, 97, 98) | 95 Participants |
| Age 2 to 11 Years Group | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Serogroup C (Pre-vaccination; N= 100, 100, 100) | 24 Participants |
| Age 2 to 11 Years Group | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Serogroup C (Post-vaccination; N= 99, 98, 100) | 91 Participants |
| Age 2 to 11 Years Group | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Serogroup Y (Pre-vaccination; N= 100, 100, 100) | 92 Participants |
| Age 2 to 11 Years Group | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Serogroup Y (Post-vaccination; N= 99, 97, 98) | 99 Participants |
| Age 2 to 11 Years Group | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Serogroup W-135 (Pre-vaccination; N=100, 100, 100) | 54 Participants |
| Age 2 to 11 Years Group | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Serogroup W-135 (Post-vaccination; N= 99, 97, 99) | 96 Participants |
| Age 12 to 17 Years Group | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Serogroup C (Pre-vaccination; N= 100, 100, 100) | 43 Participants |
| Age 12 to 17 Years Group | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Serogroup W-135 (Pre-vaccination; N=100, 100, 100) | 68 Participants |
| Age 12 to 17 Years Group | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Serogroup C (Post-vaccination; N= 99, 98, 100) | 95 Participants |
| Age 12 to 17 Years Group | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Serogroup Y (Pre-vaccination; N= 100, 100, 100) | 92 Participants |
| Age 12 to 17 Years Group | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Serogroup Y (Post-vaccination; N= 99, 97, 98) | 97 Participants |
| Age 12 to 17 Years Group | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Serogroup A (Pre-vaccination; N= 100, 100, 100) | 27 Participants |
| Age 12 to 17 Years Group | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Serogroup A (Post-vaccination; N= 99, 97, 98) | 94 Participants |
| Age 12 to 17 Years Group | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Serogroup W-135 (Post-vaccination; N= 99, 97, 99) | 97 Participants |
| Age 18 to 55 Years Group | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Serogroup C (Pre-vaccination; N= 100, 100, 100) | 66 Participants |
| Age 18 to 55 Years Group | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Serogroup A (Post-vaccination; N= 99, 97, 98) | 97 Participants |
| Age 18 to 55 Years Group | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Serogroup A (Pre-vaccination; N= 100, 100, 100) | 23 Participants |
| Age 18 to 55 Years Group | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Serogroup C (Post-vaccination; N= 99, 98, 100) | 99 Participants |
| Age 18 to 55 Years Group | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Serogroup W-135 (Pre-vaccination; N=100, 100, 100) | 52 Participants |
| Age 18 to 55 Years Group | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Serogroup Y (Post-vaccination; N= 99, 97, 98) | 98 Participants |
| Age 18 to 55 Years Group | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Serogroup Y (Pre-vaccination; N= 100, 100, 100) | 89 Participants |
| Age 18 to 55 Years Group | Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Serogroup W-135 (Post-vaccination; N= 99, 97, 99) | 99 Participants |
Primary
Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination
Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.
Time frame: Day 0 to 30 post-vaccination
Population: Four-fold antibody increase were determined in the immunogenicity analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Age 2 to 11 Years Group | Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination | Serogroup A (N = 99, 97, 98) | 85 Percentage of Participants |
| Age 2 to 11 Years Group | Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination | Serogroup C (N = 99, 98, 100) | 88 Percentage of Participants |
| Age 2 to 11 Years Group | Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination | Serogroup Y (N = 99, 97, 98) | 68 Percentage of Participants |
| Age 2 to 11 Years Group | Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination | Serogroup W-135 (N = 99, 97, 99) | 93 Percentage of Participants |
| Age 12 to 17 Years Group | Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination | Serogroup W-135 (N = 99, 97, 99) | 96 Percentage of Participants |
| Age 12 to 17 Years Group | Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination | Serogroup A (N = 99, 97, 98) | 85 Percentage of Participants |
| Age 12 to 17 Years Group | Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination | Serogroup Y (N = 99, 97, 98) | 75 Percentage of Participants |
| Age 12 to 17 Years Group | Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination | Serogroup C (N = 99, 98, 100) | 91 Percentage of Participants |
| Age 18 to 55 Years Group | Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination | Serogroup W-135 (N = 99, 97, 99) | 97 Percentage of Participants |
| Age 18 to 55 Years Group | Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination | Serogroup C (N = 99, 98, 100) | 96 Percentage of Participants |
| Age 18 to 55 Years Group | Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination | Serogroup Y (N = 99, 97, 98) | 89 Percentage of Participants |
| Age 18 to 55 Years Group | Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination | Serogroup A (N = 99, 97, 98) | 96 Percentage of Participants |
Primary
Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination
Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test.
Time frame: Day 0 and Day 30 post-vaccination
Population: Geometric mean titers were determined in the immunogenicity analysis set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Age 2 to 11 Years Group | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Serogroup A (Pre-vaccination; N= 100, 100, 100) | 9.51 1/dilution (1/dil) |
| Age 2 to 11 Years Group | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Serogroup A (Post-vaccination; N= 99, 97, 98) | 1145 1/dilution (1/dil) |
| Age 2 to 11 Years Group | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Serogroup C (Pre-vaccination; N= 100, 100, 100) | 9.92 1/dilution (1/dil) |
| Age 2 to 11 Years Group | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Serogroup C (Post-vaccination; N= 99, 98, 100) | 610 1/dilution (1/dil) |
| Age 2 to 11 Years Group | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Serogroup Y (Pre-vaccination; N= 100, 100, 100) | 355 1/dilution (1/dil) |
| Age 2 to 11 Years Group | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Serogroup Y (Post-vaccination; N= 99, 97, 98) | 1964 1/dilution (1/dil) |
| Age 2 to 11 Years Group | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Serogroup W-135 (Pre-vaccination; N=100, 100, 100) | 31.3 1/dilution (1/dil) |
| Age 2 to 11 Years Group | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Serogroup W-135 (Post-vaccination; N= 99, 97, 99) | 1756 1/dilution (1/dil) |
| Age 12 to 17 Years Group | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Serogroup C (Pre-vaccination; N= 100, 100, 100) | 17.9 1/dilution (1/dil) |
| Age 12 to 17 Years Group | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Serogroup W-135 (Pre-vaccination; N=100, 100, 100) | 47.8 1/dilution (1/dil) |
| Age 12 to 17 Years Group | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Serogroup C (Post-vaccination; N= 99, 98, 100) | 2343 1/dilution (1/dil) |
| Age 12 to 17 Years Group | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Serogroup Y (Pre-vaccination; N= 100, 100, 100) | 309 1/dilution (1/dil) |
| Age 12 to 17 Years Group | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Serogroup Y (Post-vaccination; N= 99, 97, 98) | 3190 1/dilution (1/dil) |
| Age 12 to 17 Years Group | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Serogroup A (Pre-vaccination; N= 100, 100, 100) | 15.0 1/dilution (1/dil) |
| Age 12 to 17 Years Group | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Serogroup A (Post-vaccination; N= 99, 97, 98) | 1324 1/dilution (1/dil) |
| Age 12 to 17 Years Group | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Serogroup W-135 (Post-vaccination; N= 99, 97, 99) | 2538 1/dilution (1/dil) |
| Age 18 to 55 Years Group | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Serogroup C (Pre-vaccination; N= 100, 100, 100) | 56.9 1/dilution (1/dil) |
| Age 18 to 55 Years Group | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Serogroup A (Post-vaccination; N= 99, 97, 98) | 2261 1/dilution (1/dil) |
| Age 18 to 55 Years Group | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Serogroup A (Pre-vaccination; N= 100, 100, 100) | 9.78 1/dilution (1/dil) |
| Age 18 to 55 Years Group | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Serogroup C (Post-vaccination; N= 99, 98, 100) | 7486 1/dilution (1/dil) |
| Age 18 to 55 Years Group | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Serogroup W-135 (Pre-vaccination; N=100, 100, 100) | 28.6 1/dilution (1/dil) |
| Age 18 to 55 Years Group | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Serogroup Y (Post-vaccination; N= 99, 97, 98) | 3926 1/dilution (1/dil) |
| Age 18 to 55 Years Group | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Serogroup Y (Pre-vaccination; N= 100, 100, 100) | 156 1/dilution (1/dil) |
| Age 18 to 55 Years Group | Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Serogroup W-135 (Post-vaccination; N= 99, 97, 99) | 3183 1/dilution (1/dil) |