Meningitis, Meningococcal Infection
Conditions
Keywords
Meningitis, Meningococcal Infection, Menactra®
Brief summary
The purpose of this study is to assess the immunogenicity and safety of Menactra® vaccine given as a two-dose series in infants and toddlers. Primary Objectives: * To assess the seroprotection rate (percentage of subjects with a serum bactericidal assay using human complement \[SBA-HC\] titer ≥ 1:8) 28 days after the second of 2 doses of Menactra® administered 3 to 6 months apart. Secondary Objectives: * To assess the immune responses to meningococcal antigens (serogroups A, C, Y, and W-135) 28 days following the second vaccination with Menactra® using SBA-HC and SBA-BR titers. * To assess the safety profile of Menactra® after each and any vaccination.
Detailed description
Study participants will receive 2 doses on Menactra® vaccine at 3 to 6 months apart and will be monitored for safety and immunogenicity. The planned duration of each subject's participation in the trial will be from 118 to 215 days.
Interventions
BIOLOGICALMeningococcal Diphtheria Toxoid Vaccine
0.5 mL, Intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Months to 17 Months
Healthy volunteers
Yes
Inclusion criteria
* Male and female subjects aged 9 to 17 months on the day of inclusion * Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative(s) (if applicable) * Subject and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
* Participation in the 4 weeks preceding inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. * Receipt of any vaccine in the 4 weeks preceding each trial vaccination or planned receipt of any vaccine in the 4 weeks following each trial vaccination, except for: * (i) influenza vaccination, which may be received at least 2 weeks before study vaccines. * (ii) measles (M) or measles, mumps, rubella (MMR) routine vaccination, which can be administered concomitantly with the first dose of study vaccine as per routine immunization schedule * (iii) for subjects enrolled at Indian sites: oral poliomyelitis vaccine (OPV) received during National Immunization Days (NIDs) and supplementary immunization activity days (SIADs) * Previous vaccination against meningococcal disease with either the study vaccine or another meningococcal vaccine * Receipt of immune globulins, blood or blood-derived products in the past 3 months * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * History of meningococcal diseases, confirmed either clinically, serologically, or microbiologically * At high risk, in the opinion of the Investigator, for meningococcal disease during the trial * Known or suspected systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances * Known thrombocytopenia, contraindicating intramuscular vaccination * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination * In an emergency setting, or hospitalized involuntarily * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion * For subjects enrolled at Indian sites: Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). * For subjects enrolled at Russian sites: Acute disease of any severity on the day of vaccination or febrile illness (axillary temperature ≥ 37.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided. * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw * Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study * Personal history of Guillain-Barré Syndrome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Day 0 (pre-vaccination) and Day 28 post-second vaccination | Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. Seroprotection was defined as antibody titers ≥ 1:8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With At Least Four-Fold Rise in Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Day 0 (pre-vaccination) and Day 28 post-vaccination | Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. |
| Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Day 0 (pre-vaccination) and Day 28 post-vaccination | Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:8. |
| Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Day 0 (pre-vaccination) and Day 28 post-vaccination | Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay. The threshold was defined as antibody titers ≥ 1:8. |
| Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Day 0 (pre-vaccination) and Day 28 post-vaccination | Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:4. |
| Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Day 0 (pre-vaccination) and Day 28 post-vaccination | Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay. The threshold was defined as antibody titers ≥ 1:4. |
| Percentage of Participants With At Least Four-Fold Rise in Threshold Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Day 0 (pre-vaccination) and Day 28 post-vaccination | Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. |
| Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Day 0 (pre-vaccination) and Day 28 post-vaccination | Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:4. |
| Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Day 0 (pre-vaccination) and Day 28 post-vaccination | Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay. |
| Percentage of Participants With At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Baby Rabbit Complement Following Vaccination With Menactra® | Day 0 (pre-vaccination) and Day 28 post-vaccination | Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay. |
| Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Day 0 (pre-vaccination) and Day 28 post-vaccination | Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. |
| Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Day 0 (pre-vaccination) and Day 28 post-vaccination | Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR. |
| Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Day 0 up to Day 7 post-each vaccination | Injection site: Tenderness, Erythema, and Swelling. Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, Irritability. Grade 3 Injection site: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced. Erythema and Swelling, ≥50 mm. Grade 3 Systemic: Fever, \>39.5C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, \>3 hours; Drowsiness, Sleeping most of the time or difficult to wake; Appetite lost, Refuses ≥3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable. |
| Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Following Vaccination With Menactra® | Day 0 (pre-vaccination) and Day 28 post-vaccination | Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. |
Countries
India, Russia
Participant flow
Recruitment details
Study participants were enrolled from 25 June 2013 to 05 November 2013 (Russian Federation) and 24 March 2015 to 17 November 2015 (India) at 4 clinic sites in Russia and 4 clinic sites in India.
Pre-assignment details
A total of 300 participants (100 in Russia and 200 in India) were enrolled. Of the 100 Russians, 2 did not receive the second vaccination. Of the 200 Indians, 1 did not receive the first vaccination and 8 did not receive the second vaccination.
Participants by arm
| Arm | Count |
|---|---|
| Russian Federation Participants in the Russian Federation who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection. | 100 |
| India Participants in India who received 1 dose of Menactra vaccine on Day 0 when 9 to 17 months of age and a second dose of Menactra vaccine no less than 3 months and no more than 6 months after the first injection. | 200 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Protocol Violation | 0 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 8 |
Baseline characteristics
| Characteristic | Russian Federation | India | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 100 Participants | 200 Participants | 300 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous Age Continuous | 13.5 Months STANDARD_DEVIATION 2.7 | 12.9 Months STANDARD_DEVIATION 3 | 13.1 Months STANDARD_DEVIATION 2.9 |
| Region of Enrollment India | 0 Participants | 200 Participants | 200 Participants |
| Region of Enrollment Russia | 100 Participants | 0 Participants | 100 Participants |
| Sex: Female, Male Female | 59 Participants | 69 Participants | 128 Participants |
| Sex: Female, Male Male | 41 Participants | 131 Participants | 172 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 199 |
| other Total, other adverse events | 35 / 100 | 40 / 199 |
| serious Total, serious adverse events | 1 / 100 | 3 / 199 |
Outcome results
Primary
Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. Seroprotection was defined as antibody titers ≥ 1:8.
Time frame: Day 0 (pre-vaccination) and Day 28 post-second vaccination
Population: Seroprotection was assessed in the Per Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Russian Federation | Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup A; Pre vaccination 1 (N=77,169) | 45.5 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup A; Post vaccination 2 (N=77,166) | 98.7 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup C; Pre vaccination 1 (N=77,169) | 6.5 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup C; Post vaccination 2 (N=77,169) | 92.2 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup Y; Pre vaccination 1 (N=77,169) | 5.2 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup Y; Post vaccination 2 (N=77,169) | 96.1 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup W 135; Pre vaccination 1 (N=77,169) | 7.8 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup W 135; Post vaccination 2 (N=77,169) | 100.0 Percentage of participants |
| India | Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup W 135; Post vaccination 2 (N=77,169) | 99.4 Percentage of participants |
| India | Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup A; Pre vaccination 1 (N=77,169) | 55.0 Percentage of participants |
| India | Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup Y; Pre vaccination 1 (N=77,169) | 6.5 Percentage of participants |
| India | Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup A; Post vaccination 2 (N=77,166) | 97.6 Percentage of participants |
| India | Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup W 135; Pre vaccination 1 (N=77,169) | 5.3 Percentage of participants |
| India | Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup C; Pre vaccination 1 (N=77,169) | 4.7 Percentage of participants |
| India | Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup Y; Post vaccination 2 (N=77,169) | 98.2 Percentage of participants |
| India | Percentage of Participants Achieving Seroprotection Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:8 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup C; Post vaccination 2 (N=77,169) | 95.9 Percentage of participants |
Secondary
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay. The threshold was defined as antibody titers ≥ 1:4.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: The threshold was assessed in the Per Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup A; Pre vaccination 1 (N=75,165) | 26.7 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup A; Post vaccination 2 (N=77,161) | 100.0 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup C; Pre vaccination 1 (N=76,166) | 5.3 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup C; Post vaccination 2 (N=77,166) | 97.4 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup Y; Pre vaccination 1 (N=76,166) | 84.2 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup Y; Post vaccination 2 (N=77,164) | 100.0 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup W-135; Pre vaccination 1 (N=76,165) | 27.6 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup W-135; Post vaccination 2 (N=77,163) | 100.0 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup W-135; Post vaccination 2 (N=77,163) | 100.0 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup A; Pre vaccination 1 (N=75,165) | 5.5 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup Y; Pre vaccination 1 (N=76,166) | 84.3 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup A; Post vaccination 2 (N=77,161) | 98.8 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup W-135; Pre vaccination 1 (N=76,165) | 19.4 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup C; Pre vaccination 1 (N=76,166) | 11.4 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup Y; Post vaccination 2 (N=77,164) | 100.0 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup C; Post vaccination 2 (N=77,166) | 94.0 Percentage of participants |
Secondary
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:4.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: The threshold was assessed in the Per Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup A; Pre vaccination 1 (N=77,169) | 88.3 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup A; Post vaccination 2 (N=77,166) | 100.0 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup C; Pre vaccination 1 (N=77,169) | 19.5 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup C; Post vaccination 2 (N=77,169) | 98.7 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup Y; Pre vaccination 1 (N=77,169) | 9.1 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup Y; Post vaccination 2 (N=77,169) | 98.7 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup W-135; Pre vaccination 1 (N=77,169) | 14.3 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup W-135; Post vaccination 2 (N=77,169) | 100.0 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup W-135; Post vaccination 2 (N=77,169) | 100.0 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup A; Pre vaccination 1 (N=77,169) | 97.6 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup Y; Pre vaccination 1 (N=77,169) | 11.8 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup A; Post vaccination 2 (N=77,166) | 99.4 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup W-135; Pre vaccination 1 (N=77,169) | 10.7 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup C; Pre vaccination 1 (N=77,169) | 14.2 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup Y; Post vaccination 2 (N=77,169) | 100.0 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:4 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup C; Post vaccination 2 (N=77,169) | 98.8 Percentage of participants |
Secondary
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay. The threshold was defined as antibody titers ≥ 1:8.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Threshold was assessed in the Per Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup A; Pre vaccination 1 (N=75,165) | 25.3 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup A; Post vaccination 2 (N=77,161) | 100.0 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup C; Pre vaccination 1 (N=76,166) | 5.3 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup C; Post vaccination 2 (N=77,166) | 97.4 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup Y; Pre vaccination 1 (N=76,166) | 84.2 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup Y; Post vaccination 2 (N=77,164) | 100.0 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup W-135; Pre vaccination 1 (N=76,165) | 27.6 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup W-135; Post vaccination 2 (N=77,163) | 100.0 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup W-135; Post vaccination 2 (N=77,163) | 100.0 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup A; Pre vaccination 1 (N=75,165) | 4.8 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup Y; Pre vaccination 1 (N=76,166) | 84.3 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup A; Post vaccination 2 (N=77,161) | 98.8 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup W-135; Pre vaccination 1 (N=76,165) | 18.2 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup C; Pre vaccination 1 (N=76,166) | 10.8 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup Y; Post vaccination 2 (N=77,164) | 100.0 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Baby Rabbit Complement Before and Following Vaccination With Menactra® | Serogroup C; Post vaccination 2 (N=77,166) | 94.0 Percentage of participants |
Secondary
Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:8.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: The threshold was assessed in the Per Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup A; Pre vaccination 1 (N=77,169) | 45.5 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup A; Post vaccination 2 (N=77,166) | 98.7 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup C; Pre vaccination 1 (N=77,169) | 6.5 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup C; Post vaccination 2 (N=77,169) | 92.2 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup Y; Pre vaccination 1 (N=77,169) | 5.2 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup Y; Post vaccination 2 (N=77,169) | 96.1 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup W-135; Pre vaccination 1 (N=77,169) | 7.8 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup W-135; Post vaccination 2 (N=77,169) | 100.0 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup W-135; Post vaccination 2 (N=77,169) | 99.4 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup A; Pre vaccination 1 (N=77,169) | 55.0 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup Y; Pre vaccination 1 (N=77,169) | 6.5 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup A; Post vaccination 2 (N=77,166) | 97.6 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup W-135; Pre vaccination 1 (N=77,169) | 5.3 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup C; Pre vaccination 1 (N=77,169) | 4.7 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup Y; Post vaccination 2 (N=77,169) | 98.2 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers ≥ 1:8 by Serum Bactericidal Assay Using Human Complement Before and Following Vaccination With Menactra® | Serogroup C; Post vaccination 2 (N=77,169) | 95.9 Percentage of participants |
Secondary
Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay. The threshold was defined as antibody titers ≥ 1:4.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: The threshold was assessed in the Per Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Russian Federation | Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup A; Pre vaccination 1 (N=77,169) | 88.3 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup A; Post vaccination 2 (N=77,166) | 100.0 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup C; Pre vaccination 1 (N=77,169) | 19.5 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup C; Post vaccination 2 (N=77,169) | 98.7 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup Y; Pre vaccination 1 (N=77,169) | 9.1 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup Y; Post vaccination 2 (N=77,169) | 98.7 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup W 135; Pre vaccination 1 (N=77,169) | 14.3 Percentage of participants |
| Russian Federation | Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup W 135; Post vaccination 2 (N=77,169) | 100.0 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup W 135; Post vaccination 2 (N=77,169) | 100.0 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup A; Pre vaccination 1 (N=77,169) | 97.6 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup Y; Pre vaccination 1 (N=77,169) | 11.8 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup A; Post vaccination 2 (N=77,166) | 99.4 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup W 135; Pre vaccination 1 (N=77,169) | 10.7 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup C; Pre vaccination 1 (N=77,169) | 14.2 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup Y; Post vaccination 2 (N=77,169) | 100.0 Percentage of participants |
| India | Percentage of Participants Achieving the Threshold Using a Serum Bactericidal Assay Human Complement With Antibody Titers ≥ 1:4 for Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup C; Post vaccination 2 (N=77,169) | 98.8 Percentage of participants |
Secondary
Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra®
Injection site: Tenderness, Erythema, and Swelling. Systemic: Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, Irritability. Grade 3 Injection site: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced. Erythema and Swelling, ≥50 mm. Grade 3 Systemic: Fever, \>39.5C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, \>3 hours; Drowsiness, Sleeping most of the time or difficult to wake; Appetite lost, Refuses ≥3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable.
Time frame: Day 0 up to Day 7 post-each vaccination
Population: Solicited injection site and systemic reactions were assessed in the Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Crying abnormal; Post dose 1; N=100,199 | 0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Inj. site Erythema; Post dose 2; N=98,188 | 16.3 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Drowsiness; Post dose 1; N=100,199 | 14.0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Inj. site Swelling; Post dose 1; N=100,199 | 8.0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Drowsiness; Post dose 1; N=100,199 | 0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Inj. site Erythema; Post dose 2; N=98,188 | 2.0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Appetite lost; Post dose 1; N=100,199 | 14.0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Inj. site Erythema; Post dose 1; N=100,199 | 28.0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Appetite lost; Post dose 1; N=100,199 | 0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Inj. site Swelling; Post dose 2; N=98,188 | 7.1 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Irritability; Post dose 1; N=100,199 | 23.0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Inj. site Swelling; Post dose 2; N=98,188 | 1.0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Irritability; Post dose 1; N=100,199 | 0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Inj. site Swelling; Post dose 1; N=100,199 | 0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Fever; Post dose 2; N=98,185 | 6.1 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Fever; Post dose 1; N=100,197 | 0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Fever; Post dose 2; N=98,185 | 0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Inj. site Tenderness;Post dose 1;N=100,199 | 0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Vomiting; Post dose 2; N=98,188 | 0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Fever; Post dose 1; N=100,197 | 0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Vomiting; Post dose 2; N=98,188 | 0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Inj. site Tenderness; Post dose 2; N=98,188 | 13.3 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Crying abnormal; Post dose 2; N=98,188 | 9.2 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Vomiting; Post dose 1; N=100,199 | 2.0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Crying abnormal; Post dose 2; N=98,188 | 0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Inj. site Erythema; Post dose 1; N=100,199 | 1.0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Drowsiness; Post dose 2; N=98,188 | 11.2 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Vomiting; Post dose 1; N=100,199 | 0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Drowsiness; Post dose 2; N=98,188 | 1.0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Inj. site Tenderness;Post dose 2;N=98,188 | 0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Appetite lost; Post dose 2; N=98,188 | 11.2 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Crying abnormal; Post dose 1; N=100,199 | 8.0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Appetite lost; Post dose 2; N=98,188 | 1.0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Inj. site Tenderness; Post dose 1; N=100,199 | 13.0 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Irritability; Post dose 2; N=98,188 | 12.2 Percentage of participants |
| Russian Federation | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Irritability; Post dose 2; N=98,188 | 0 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Irritability; Post dose 2; N=98,188 | 9.0 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Irritability; Post dose 2; N=98,188 | 0 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Inj. site Swelling; Post dose 2; N=98,188 | 2.7 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Inj. site Tenderness; Post dose 1; N=100,199 | 14.6 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Inj. site Tenderness;Post dose 1;N=100,199 | 0.5 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Inj. site Erythema; Post dose 1; N=100,199 | 4.5 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Inj. site Erythema; Post dose 1; N=100,199 | 0.5 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Inj. site Swelling; Post dose 1; N=100,199 | 3.5 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Inj. site Swelling; Post dose 1; N=100,199 | 0.5 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Inj. site Tenderness; Post dose 2; N=98,188 | 10.1 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Inj. site Tenderness;Post dose 2;N=98,188 | 0 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Inj. site Erythema; Post dose 2; N=98,188 | 2.1 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Inj. site Erythema; Post dose 2; N=98,188 | 0 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Inj. site Swelling; Post dose 2; N=98,188 | 0 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Fever; Post dose 1; N=100,197 | 7.1 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Fever; Post dose 1; N=100,197 | 0.5 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Vomiting; Post dose 1; N=100,199 | 9.5 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Vomiting; Post dose 1; N=100,199 | 0 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Crying abnormal; Post dose 1; N=100,199 | 12.6 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Crying abnormal; Post dose 1; N=100,199 | 0 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Drowsiness; Post dose 1; N=100,199 | 9.5 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Drowsiness; Post dose 1; N=100,199 | 0 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Appetite lost; Post dose 1; N=100,199 | 17.1 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Appetite lost; Post dose 1; N=100,199 | 1.5 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Irritability; Post dose 1; N=100,199 | 14.6 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Irritability; Post dose 1; N=100,199 | 0.5 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Fever; Post dose 2; N=98,185 | 7.0 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Fever; Post dose 2; N=98,185 | 0.5 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Vomiting; Post dose 2; N=98,188 | 7.4 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Vomiting; Post dose 2; N=98,188 | 0 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Crying abnormal; Post dose 2; N=98,188 | 9.6 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Crying abnormal; Post dose 2; N=98,188 | 0 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Drowsiness; Post dose 2; N=98,188 | 3.7 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Drowsiness; Post dose 2; N=98,188 | 0 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Any Appetite lost; Post dose 2; N=98,188 | 9.6 Percentage of participants |
| India | Percentage of Participants Reporting Solicited Injection Site or Systemic Reactions Following Each Vaccination With Menactra® | Grade 3 Appetite lost; Post dose 2; N=98,188 | 0.5 Percentage of participants |
Secondary
Percentage of Participants With At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Baby Rabbit Complement Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Seroprotection was assessed in the Per Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Russian Federation | Percentage of Participants With At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Baby Rabbit Complement Following Vaccination With Menactra® | Serogroup A (N=75,158) | 96.0 Percentage of participants |
| Russian Federation | Percentage of Participants With At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Baby Rabbit Complement Following Vaccination With Menactra® | Serogroup C (N=76,163) | 94.7 Percentage of participants |
| Russian Federation | Percentage of Participants With At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Baby Rabbit Complement Following Vaccination With Menactra® | Serogroup Y (N=76,161) | 68.4 Percentage of participants |
| Russian Federation | Percentage of Participants With At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Baby Rabbit Complement Following Vaccination With Menactra® | Serogroup W 135 (N=76,159) | 96.1 Percentage of participants |
| India | Percentage of Participants With At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Baby Rabbit Complement Following Vaccination With Menactra® | Serogroup W 135 (N=76,159) | 96.2 Percentage of participants |
| India | Percentage of Participants With At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Baby Rabbit Complement Following Vaccination With Menactra® | Serogroup A (N=75,158) | 96.8 Percentage of participants |
| India | Percentage of Participants With At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Baby Rabbit Complement Following Vaccination With Menactra® | Serogroup Y (N=76,161) | 66.5 Percentage of participants |
| India | Percentage of Participants With At Least Four-Fold Rise in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Baby Rabbit Complement Following Vaccination With Menactra® | Serogroup C (N=76,163) | 92.0 Percentage of participants |
Secondary
Percentage of Participants With At Least Four-Fold Rise in Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: The threshold was assessed in the Per Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Russian Federation | Percentage of Participants With At Least Four-Fold Rise in Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup A (N=77,166) | 90.9 Percentage of participants |
| Russian Federation | Percentage of Participants With At Least Four-Fold Rise in Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup C (N=77,169) | 76.6 Percentage of participants |
| Russian Federation | Percentage of Participants With At Least Four-Fold Rise in Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup Y (N=77,169) | 90.9 Percentage of participants |
| Russian Federation | Percentage of Participants With At Least Four-Fold Rise in Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup W 135 (N=77,169) | 90.9 Percentage of participants |
| India | Percentage of Participants With At Least Four-Fold Rise in Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup W 135 (N=77,169) | 97.0 Percentage of participants |
| India | Percentage of Participants With At Least Four-Fold Rise in Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup A (N=77,166) | 84.9 Percentage of participants |
| India | Percentage of Participants With At Least Four-Fold Rise in Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup Y (N=77,169) | 92.3 Percentage of participants |
| India | Percentage of Participants With At Least Four-Fold Rise in Threshold in Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup C (N=77,169) | 92.3 Percentage of participants |
Secondary
Percentage of Participants With At Least Four-Fold Rise in Threshold Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: The threshold was assessed in the Per Protocol Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Russian Federation | Percentage of Participants With At Least Four-Fold Rise in Threshold Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup A (N=77,166) | 90.9 Percentage of participants |
| Russian Federation | Percentage of Participants With At Least Four-Fold Rise in Threshold Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup C (N=77,169) | 76.6 Percentage of participants |
| Russian Federation | Percentage of Participants With At Least Four-Fold Rise in Threshold Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup Y (N=77,169) | 90.9 Percentage of participants |
| Russian Federation | Percentage of Participants With At Least Four-Fold Rise in Threshold Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup W 135 (N=77,169) | 90.9 Percentage of participants |
| India | Percentage of Participants With At Least Four-Fold Rise in Threshold Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup W 135 (N=77,169) | 97.0 Percentage of participants |
| India | Percentage of Participants With At Least Four-Fold Rise in Threshold Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup A (N=77,166) | 84.9 Percentage of participants |
| India | Percentage of Participants With At Least Four-Fold Rise in Threshold Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup Y (N=77,169) | 92.3 Percentage of participants |
| India | Percentage of Participants With At Least Four-Fold Rise in Threshold Meningococcal Serogroups A, C, Y, and W-135 Antibody Titers by Serum Bactericidal Assay Using Human Complement Following Vaccination With Menactra® | Serogroup C (N=77,169) | 92.3 Percentage of participants |
Secondary
Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR assay.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Geometric mean titer ratios were assessed in the Per Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Russian Federation | Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup A (N=75,158) | 305 Titer ratios |
| Russian Federation | Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup C (N=76,163) | 140 Titer ratios |
| Russian Federation | Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup Y (N=76,161) | 8.45 Titer ratios |
| Russian Federation | Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup W 135 (N=76,159) | 223 Titer ratios |
| India | Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup W 135 (N=76,159) | 246 Titer ratios |
| India | Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup A (N=75,158) | 540 Titer ratios |
| India | Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup Y (N=76,161) | 8.50 Titer ratios |
| India | Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup C (N=76,163) | 240 Titer ratios |
Secondary
Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-BR.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Geometric mean titers were assessed in the Per Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Russian Federation | Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup A; Pre vaccination 1 (N=75,165) | 6.47 Titers (1/dil) |
| Russian Federation | Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup A; Post vaccination 2 (N=77,161) | 1940 Titers (1/dil) |
| Russian Federation | Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup C; Pre vaccination 1 (N=76,166) | 2.38 Titers (1/dil) |
| Russian Federation | Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup C; Post vaccination 2 (N=77,166) | 326 Titers (1/dil) |
| Russian Federation | Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup Y; Pre vaccination 1 (N=76,166) | 87.3 Titers (1/dil) |
| Russian Federation | Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup Y; Post vaccination 2 (N=77,164) | 734 Titers (1/dil) |
| Russian Federation | Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup W 135; Pre vaccination 1 (N=76,165) | 5.66 Titers (1/dil) |
| Russian Federation | Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup W 135; Post vaccination 2 (N=77,163) | 1260 Titers (1/dil) |
| India | Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup W 135; Post vaccination 2 (N=77,163) | 1134 Titers (1/dil) |
| India | Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup A; Pre vaccination 1 (N=75,165) | 2.55 Titers (1/dil) |
| India | Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup Y; Pre vaccination 1 (N=76,166) | 95.2 Titers (1/dil) |
| India | Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup A; Post vaccination 2 (N=77,161) | 1426 Titers (1/dil) |
| India | Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup W 135; Pre vaccination 1 (N=76,165) | 4.44 Titers (1/dil) |
| India | Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup C; Pre vaccination 1 (N=76,166) | 3.27 Titers (1/dil) |
| India | Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup Y; Post vaccination 2 (N=77,164) | 805 Titers (1/dil) |
| India | Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup C; Post vaccination 2 (N=77,166) | 781 Titers (1/dil) |
Secondary
Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Geometric mean titer ratios were assessed in the Per Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Russian Federation | Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Following Vaccination With Menactra® | Serogroup A (N=77,166) | 29.8 Titer ratios |
| Russian Federation | Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Following Vaccination With Menactra® | Serogroup C (N=77,169) | 20.0 Titer ratios |
| Russian Federation | Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Following Vaccination With Menactra® | Serogroup Y (N=77,169) | 23.4 Titer ratios |
| Russian Federation | Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Following Vaccination With Menactra® | Serogroup W 135 (N=77,169) | 44.2 Titer ratios |
| India | Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Following Vaccination With Menactra® | Serogroup W 135 (N=77,169) | 82.2 Titer ratios |
| India | Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Following Vaccination With Menactra® | Serogroup A (N=77,166) | 13.9 Titer ratios |
| India | Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Following Vaccination With Menactra® | Serogroup Y (N=77,169) | 41.9 Titer ratios |
| India | Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titer Ratios of Meningococcal Serogroups A, C, Y, and W-135 Following Vaccination With Menactra® | Serogroup C (N=77,169) | 51.3 Titer ratios |
Secondary
Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra®
Functional antibody activity against the meningococcal serogroups A, C, Y, and W-135 antigens contained in Menactra vaccine was measured using a SBA-HC assay.
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Population: Geometric mean titers were assessed in the Per Protocol Analysis Set.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Russian Federation | Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup A; Pre vaccination 1 (N=77,169) | 5.73 Titers (1/dil) |
| Russian Federation | Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup A; Post vaccination 2 (N=77,166) | 171 Titers (1/dil) |
| Russian Federation | Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup C; Pre vaccination 1 (N=77,169) | 2.46 Titers (1/dil) |
| Russian Federation | Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup C; Post vaccination 2 (N=77,169) | 49.3 Titers (1/dil) |
| Russian Federation | Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup Y; Pre vaccination 1 (N=77,169) | 2.35 Titers (1/dil) |
| Russian Federation | Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup Y; Post vaccination 2 (N=77,169) | 54.9 Titers (1/dil) |
| Russian Federation | Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup W 135; Pre vaccination 1 (N=77,169) | 2.57 Titers (1/dil) |
| Russian Federation | Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup W 135; Post vaccination 2 (N=77,169) | 114 Titers (1/dil) |
| India | Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup W 135; Post vaccination 2 (N=77,169) | 201 Titers (1/dil) |
| India | Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup A; Pre vaccination 1 (N=77,169) | 6.82 Titers (1/dil) |
| India | Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup Y; Pre vaccination 1 (N=77,169) | 2.49 Titers (1/dil) |
| India | Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup A; Post vaccination 2 (N=77,166) | 95.2 Titers (1/dil) |
| India | Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup W 135; Pre vaccination 1 (N=77,169) | 2.45 Titers (1/dil) |
| India | Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup C; Pre vaccination 1 (N=77,169) | 2.50 Titers (1/dil) |
| India | Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup Y; Post vaccination 2 (N=77,169) | 104 Titers (1/dil) |
| India | Serum Bactericidal Assay Using Human Complement Antibody Geometric Mean Titers of Meningococcal Serogroups A, C, Y, and W-135 Before and Following Vaccination With Menactra® | Serogroup C; Post vaccination 2 (N=77,169) | 128 Titers (1/dil) |