Meningitis, Meningococcal Infection
Conditions
Keywords
Meningitis; Meningococcal Infection
Brief summary
The purpose of this clinical trial is to describe the safety and immunogenicity of one or two doses of Menactra® (TetraMenD) administered in children less than 2 years of age. Primary Objective: To describe the immunogenicity profile of one or two doses of Menactra® (TetraMenD) when administered to subjects aged 9, 12, 15, or 18 months in comparison to the immunogenicity of one dose of Menomune® when administered to children aged 3 years to \<6 years of age.
Detailed description
This is a Phase II, open-label, parallel, exploratory, multi-center study in healthy toddlers.
Interventions
BIOLOGICALMeningococcal Polysaccharide Diphtheria Protein Conjugate (Menactra®)
0.5 mL, Intramuscular (at age 9 and 12 months)
0.5 mL, Subcutaneous (at 3 years to \<6 years of age)
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Months to 5 Years
Healthy volunteers
Yes
Inclusion criteria
: * Aged either 9, 12, 15 or 18 months of age or 3 to \< 6 years of age on the day of inclusion. * Informed consent form that has been approved by the site's Institutional Review Board (IRB) and signed by the parent or legal guardian * Able to attend all scheduled visits and to comply with all trial procedures
Exclusion criteria
: * History of a serious chronic disease that could interfere with trial conduct or completion. * Known or suspected impairment of immunologic function. * Acute medical illness with or without fever within the last 72 hours, or rectal temperature ≥ 100.4°F (≥ 38.0°C) or axillary temperature ≥ 99.4°F (≥ 37.4°C) on the day of inclusion. * History of invasive meningococcal disease (confirmed either clinically, serologically or microbiologically) or previous meningococcal vaccination. * Administration of immune globulin or other blood products within 3 months, or oral or parenteral corticosteroids or other immunosuppressive therapy within the last 6 weeks of the study vaccine. Individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment. * Antibiotic therapy within the 72 hours prior to having any blood sample drawn. * Received or scheduled to receive any vaccine in the 28-day period prior to receipt of either dose of the study vaccine, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 28-day period after receipt of either dose of the study vaccine. Hyposensitization therapy and influenza vaccination may be received up to two weeks before or after receiving the trial vaccine. * Suspected or known hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances. * Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination * Unable to attend one or more of the scheduled visits or to comply with the study procedures. * Participation in another clinical trial in the 4 weeks preceding enrollment. * Planned participation in another clinical trial during the present trial period. * Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Day 0 up to 7 post-vaccination | Solicited local reactions: Redness, Swelling, and Tenderness. Solicited systemic reactions: Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from 10 December 2004 to 14 May 2005 in 15 medical centers in the US
Pre-assignment details
A total of 378 participants that met the inclusion and exclusion criteria were enrolled, 369 were vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Vaccinated at Age 9 and 12 Months Participants received Menactra vaccine at 9 and 12 months of age | 55 |
| Vaccinated at Age 9 and 15 Months Participants received Menactra vaccine at 9 months and 15 months of age | 67 |
| Vaccinated at Age 12 and 15 Months Participants received Menactra vaccine at 12 months and 15 months of age | 68 |
| Vaccinated at Age 15 Months Participants received Menactra vaccine at 15 months of age | 62 |
| Vaccinated at Age 18 Months Participants received Menactra vaccine at 18 months of age | 59 |
| Vaccinated at Age 3 Years to <6 Years Participants received Menomune vaccine at age 3 years to \<6 years of age | 67 |
| Total | 378 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Not Vaccinated | 2 | 2 | 3 | 0 | 2 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 1 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 | 2 | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Vaccinated at Age 9 and 15 Months | Vaccinated at Age 12 and 15 Months | Vaccinated at Age 15 Months | Vaccinated at Age 9 and 12 Months | Vaccinated at Age 18 Months | Vaccinated at Age 3 Years to <6 Years | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 67 Participants | 68 Participants | 62 Participants | 55 Participants | 59 Participants | 67 Participants | 378 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8.9 Months STANDARD_DEVIATION 0.3 | 11.9 Months STANDARD_DEVIATION 0.3 | 14.9 Months STANDARD_DEVIATION 0.3 | 8.9 Months STANDARD_DEVIATION 0.4 | 17.9 Months STANDARD_DEVIATION 0.3 | 48.0 Months STANDARD_DEVIATION 10.3 | 18.7 Months STANDARD_DEVIATION 14.6 |
| Region of Enrollment United States | 67 participants | 68 participants | 62 participants | 55 participants | 59 participants | 67 participants | 378 participants |
| Sex: Female, Male Female | 34 Participants | 34 Participants | 23 Participants | 24 Participants | 34 Participants | 30 Participants | 179 Participants |
| Sex: Female, Male Male | 33 Participants | 34 Participants | 39 Participants | 31 Participants | 25 Participants | 37 Participants | 199 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 37 / 53 | 50 / 65 | 48 / 65 | 34 / 61 | 33 / 57 | 21 / 67 |
| serious Total, serious adverse events | 0 / 53 | 3 / 65 | 4 / 65 | 1 / 61 | 5 / 57 | 3 / 67 |
Outcome results
Primary
Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination.
Time frame: Day 0 (baseline) and Day 28 post-Vaccinations 1 and 2
Population: Serum Bactericidal Assay Human Complement antibody titers to each of the 4 meningococcal serogroups in the vaccine was evaluated in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated at Age 9 and 12 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup Y (Post dose 2) | 95 Percentage of Participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup A (Baseline) | 38 Percentage of Participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup Y (Post dose 1) | 21 Percentage of Participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup W-135 (Post dose 2) | 92 Percentage of Participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup A (Post dose 2) | 89 Percentage of Participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup W-135 (Post dose 1) | 24 Percentage of Participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup C (Baseline) | 5 Percentage of Participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup C (Post dose 1) | 83 Percentage of Participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup W-135 (Baseline) | 3 Percentage of Participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup C (Post dose 2) | 100 Percentage of Participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup A (Post dose 1) | 76 Percentage of Participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup Y (Baseline) | 3 Percentage of Participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup C (Post dose 2) | 100 Percentage of Participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup Y (Baseline) | 0 Percentage of Participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup Y (Post dose 2) | 94 Percentage of Participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup A (Post dose 1) | 67 Percentage of Participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup C (Post dose 1) | 85 Percentage of Participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup C (Baseline) | 2 Percentage of Participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup A (Baseline) | 44 Percentage of Participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup Y (Post dose 1) | 24 Percentage of Participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup W-135 (Post dose 1) | 27 Percentage of Participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup A (Post dose 2) | 89 Percentage of Participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup W-135 (Post dose 2) | 92 Percentage of Participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup W-135 (Baseline) | 0 Percentage of Participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup W-135 (Post dose 1) | 18 Percentage of Participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup A (Post dose 2) | 85 Percentage of Participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup Y (Post dose 2) | 96 Percentage of Participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup C (Baseline) | 0 Percentage of Participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup W-135 (Post dose 2) | 96 Percentage of Participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup W-135 (Baseline) | 0 Percentage of Participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup Y (Baseline) | 2 Percentage of Participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup Y (Post dose 1) | 35 Percentage of Participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup C (Post dose 1) | 85 Percentage of Participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup A (Post dose 1) | 52 Percentage of Participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup A (Baseline) | 33 Percentage of Participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup C (Post dose 2) | 100 Percentage of Participants |
| Vaccinated at Age 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup Y (Post dose 1) | 33 Percentage of Participants |
| Vaccinated at Age 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup A (Baseline) | 40 Percentage of Participants |
| Vaccinated at Age 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup A (Post dose 1) | 76 Percentage of Participants |
| Vaccinated at Age 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup A (Post dose 2) | 0 Percentage of Participants |
| Vaccinated at Age 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup C (Baseline) | 2 Percentage of Participants |
| Vaccinated at Age 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup C (Post dose 1) | 86 Percentage of Participants |
| Vaccinated at Age 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup C (Post dose 2) | 0 Percentage of Participants |
| Vaccinated at Age 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup Y (Baseline) | 2 Percentage of Participants |
| Vaccinated at Age 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup Y (Post dose 2) | 0 Percentage of Participants |
| Vaccinated at Age 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup W-135 (Baseline) | 2 Percentage of Participants |
| Vaccinated at Age 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup W-135 (Post dose 1) | 42 Percentage of Participants |
| Vaccinated at Age 15 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup W-135 (Post dose 2) | 0 Percentage of Participants |
| Vaccinated at Age 18 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup C (Post dose 1) | 77 Percentage of Participants |
| Vaccinated at Age 18 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup A (Post dose 2) | 0 Percentage of Participants |
| Vaccinated at Age 18 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup A (Baseline) | 40 Percentage of Participants |
| Vaccinated at Age 18 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup W-135 (Post dose 2) | 0 Percentage of Participants |
| Vaccinated at Age 18 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup W-135 (Post dose 1) | 36 Percentage of Participants |
| Vaccinated at Age 18 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup C (Baseline) | 4 Percentage of Participants |
| Vaccinated at Age 18 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup A (Post dose 1) | 65 Percentage of Participants |
| Vaccinated at Age 18 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup Y (Post dose 2) | 0 Percentage of Participants |
| Vaccinated at Age 18 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup W-135 (Baseline) | 0 Percentage of Participants |
| Vaccinated at Age 18 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup Y (Baseline) | 8 Percentage of Participants |
| Vaccinated at Age 18 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup Y (Post dose 1) | 47 Percentage of Participants |
| Vaccinated at Age 18 Months | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup C (Post dose 2) | 0 Percentage of Participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup Y (Post dose 1) | 66 Percentage of Participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup C (Post dose 1) | 49 Percentage of Participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup Y (Post dose 2) | 0 Percentage of Participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup C (Baseline) | 8 Percentage of Participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup W-135 (Post dose 2) | 0 Percentage of Participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup W-135 (Baseline) | 10 Percentage of Participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup A (Post dose 2) | 0 Percentage of Participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup A (Post dose 1) | 87 Percentage of Participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup W-135 (Post dose 1) | 61 Percentage of Participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup A (Baseline) | 71 Percentage of Participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup Y (Baseline) | 8 Percentage of Participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants With a ≥8 Antibody Titers as Measured by Serum Bactericidal Assay Human Complement (SBA-HC) After Each Vaccination. | Meningococcal serogroup C (Post dose 2) | 0 Percentage of Participants |
Other Pre-specified
Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination.
Solicited local reactions: Redness, Swelling, and Tenderness. Solicited systemic reactions: Fever (temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.
Time frame: Day 0 up to 7 post-vaccination
Population: Safety analysis was on all enrolled and vaccinated study participants, intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Injection Site Reaction - Dose 2 | 63 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Drowsiness (difficulty to wake up) | 0 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Vomiting (≥ 6 episodes per day) | 4 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Tenderness (cries when inj. limb is moved) | 0 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Swelling (≥ 2 inches) | 0 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Vomiting | 19 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Vomiting | 17 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Systemic Reaction Dose 2 | 83 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Drowsiness | 42 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Systemic Reaction-Any Dose | 89 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Erythema | 29 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Vomiting ≥ 6 episodes per day) | 0 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Irrtability (inconsolable) | 4 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Fever (≥ 39.6 ºC) | 2 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Appetite Lost | 28 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Systemic Reaction Dose 1 | 72 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Solicited Systemic Reaction Dose 2 | 13 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Solicited Injection Site Reaction - Dose 1 | 0 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Irritability (inconsolable) | 10 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Crying Abnormal (> 3 hours) | 6 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Fever | 23 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Solicited Systemic Reaction Dose 1 | 9 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Irritability | 60 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Crying Abnormal | 50 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Swelling | 25 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Erythema (≥ 2 inches) | 0 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Erythema (≥ 2 inches) | 0 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Drowsiness (difficulty to wake up) | 4 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Erythema | 32 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Appetite Lost (refuses ≥ 3 feeds) | 0 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Drowsiness | 40 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Swelling | 23 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Injection Site Reaction-Any Dose | 74 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Fever | 28 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Irritability | 63 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Tenderness (cries when inj. limb is moved) | 2 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Appetite Lost | 31 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Swelling (≥ 2 inches) | 0 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Solicited Injection Site Reaction - Dose 2 | 2 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Crying Abnormal (> 3 hours) | 4 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Injection Site Reaction - Dose 1 | 62 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Fever (≥ 39.6 ºC) | 2 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Tenderness | 52 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Tenderness | 43 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Appetite Lost (refuses ≥ 3 feeds) | 4 Percentage of participants |
| Vaccinated at Age 9 and 12 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Crying Abnormal | 34 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Irritability (inconsolable) | 7 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Irrtability (inconsolable) | 5 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Appetite Lost (refuses ≥ 3 feeds) | 3 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Tenderness | 42 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Injection Site Reaction - Dose 2 | 54 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Swelling (≥ 2 inches) | 3 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Solicited Injection Site Reaction - Dose 2 | 7 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Erythema (≥ 2 inches) | 2 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Erythema | 36 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Swelling | 20 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Erythema (≥ 2 inches) | 2 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Swelling | 8 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Appetite Lost | 32 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Swelling (≥ 2 inches) | 0 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Drowsiness (difficulty to wake up) | 2 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Tenderness | 31 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Injection Site Reaction - Dose 1 | 45 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Tenderness (cries when inj. limb is moved) | 0 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Drowsiness | 25 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Systemic Reaction-Any Dose | 84 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Injection Site Reaction-Any Dose | 69 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Crying Abnormal (> 3 hours) | 2 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Systemic Reaction Dose 1 | 75 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Solicited Systemic Reaction Dose 1 | 8 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Crying Abnormal | 29 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Fever | 17 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Vomiting ≥ 6 episodes per day) | 2 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Fever (≥ 39.6 ºC) | 3 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Solicited Injection Site Reaction - Dose 1 | 2 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Vomiting | 20 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Vomiting | 10 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Vomiting (≥ 6 episodes per day) | 0 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Fever (≥ 39.6 ºC) | 0 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Crying Abnormal | 36 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Irritability | 42 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Crying Abnormal (> 3 hours) | 3 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Fever | 15 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Drowsiness | 38 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Solicited Systemic Reaction Dose 2 | 9 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Drowsiness (difficulty to wake up) | 0 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Erythema | 20 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Appetite Lost | 36 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Systemic Reaction Dose 2 | 56 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Appetite Lost (refuses ≥ 3 feeds) | 2 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Tenderness (cries when inj. limb is moved) | 3 Percentage of participants |
| Vaccinated at Age 9 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Irritability | 61 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Appetite Lost | 28 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Vomiting (≥ 6 episodes per day) | 0 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Injection Site Reaction-Any Dose | 65 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Fever (≥ 39.6 ºC) | 0 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Erythema | 34 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Tenderness | 37 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Irrtability (inconsolable) | 3 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Crying Abnormal | 28 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Swelling | 11 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Drowsiness (difficulty to wake up) | 0 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Fever | 10 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Swelling (≥ 2 inches) | 2 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Solicited Injection Site Reaction - Dose 2 | 0 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Crying Abnormal (> 3 hours) | 2 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Tenderness | 37 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Irritability | 49 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Swelling | 15 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Appetite Lost | 29 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Appetite Lost (refuses ≥ 3 feeds) | 5 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Drowsiness | 31 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Irritability (inconsolable) | 5 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Solicited Systemic Reaction Dose 2 | 5 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Swelling (≥ 2 inches) | 0 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Erythema (≥ 2 inches) | 0 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Irritability | 44 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Tenderness (cries when inj. limb is moved) | 0 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Solicited Systemic Reaction Dose 1 | 5 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Crying Abnormal | 27 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Drowsiness (difficulty to wake up) | 0 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Fever | 11 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Systemic Reaction Dose 1 | 60 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Vomiting ≥ 6 episodes per day) | 0 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Appetite Lost (refuses ≥ 3 feeds) | 0 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Crying Abnormal (> 3 hours) | 2 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Erythema (≥ 2 inches) | 2 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Fever (≥ 39.6 ºC) | 0 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Systemic Reaction Dose 2 | 53 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Systemic Reaction-Any Dose | 72 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Vomiting | 8 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Injection Site Reaction - Dose 1 | 57 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Erythema | 23 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Vomiting | 11 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Solicited Injection Site Reaction - Dose 1 | 2 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Injection Site Reaction - Dose 2 | 48 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Tenderness (cries when inj. limb is moved) | 0 Percentage of participants |
| Vaccinated at Age 12 and 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Drowsiness | 18 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Swelling | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Injection Site Reaction-Any Dose | 53 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Injection Site Reaction - Dose 1 | 53 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Solicited Injection Site Reaction - Dose 1 | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Erythema | 37 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Erythema (≥ 2 inches) | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Swelling | 15 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Swelling (≥ 2 inches) | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Tenderness | 35 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Tenderness (cries when inj. limb is moved) | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Systemic Reaction-Any Dose | 75 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Systemic Reaction Dose 1 | 75 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Solicited Systemic Reaction Dose 1 | 12 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Fever | 18 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Fever (≥ 39.6 ºC) | 3 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Vomiting | 8 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Vomiting (≥ 6 episodes per day) | 3 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Crying Abnormal | 30 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Crying Abnormal (> 3 hours) | 2 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Drowsiness | 35 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Drowsiness (difficulty to wake up) | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Appetite Lost | 37 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Appetite Lost (refuses ≥ 3 feeds) | 5 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Irritability | 57 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Irrtability (inconsolable) | 3 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Injection Site Reaction - Dose 2 | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Solicited Injection Site Reaction - Dose 2 | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Erythema | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Erythema (≥ 2 inches) | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Swelling (≥ 2 inches) | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Tenderness | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Tenderness (cries when inj. limb is moved) | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Systemic Reaction Dose 2 | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Solicited Systemic Reaction Dose 2 | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Fever | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Fever (≥ 39.6 ºC) | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Vomiting | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Vomiting ≥ 6 episodes per day) | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Crying Abnormal | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Crying Abnormal (> 3 hours) | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Drowsiness | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Drowsiness (difficulty to wake up) | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Appetite Lost | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Appetite Lost (refuses ≥ 3 feeds) | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Irritability | 0 Percentage of participants |
| Vaccinated at Age 15 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Irritability (inconsolable) | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Solicited Systemic Reaction Dose 1 | 7 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Appetite Lost | 35 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Appetite Lost (refuses ≥ 3 feeds) | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Crying Abnormal | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Fever | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Systemic Reaction Dose 1 | 72 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Injection Site Reaction-Any Dose | 61 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Systemic Reaction-Any Dose | 72 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Irritability | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Crying Abnormal (> 3 hours) | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Crying Abnormal | 19 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Systemic Reaction Dose 2 | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Tenderness (cries when inj. limb is moved) | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Vomiting (≥ 6 episodes per day) | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Erythema | 39 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Drowsiness | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Fever (≥ 39.6 ºC) | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Tenderness | 49 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Drowsiness (difficulty to wake up) | 4 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Swelling (≥ 2 inches) | 2 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Injection Site Reaction - Dose 1 | 61 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Drowsiness (difficulty to wake up) | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Tenderness (cries when inj. limb is moved) | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Vomiting | 11 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Swelling | 23 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Drowsiness | 37 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Solicited Injection Site Reaction - Dose 1 | 2 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Appetite Lost | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Vomiting | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Erythema (≥ 2 inches) | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Appetite Lost (refuses ≥ 3 feeds) | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Fever (≥ 39.6 ºC) | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Erythema | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Solicited Systemic Reaction Dose 2 | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Irritability (inconsolable) | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Swelling | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Fever | 21 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Solicited Injection Site Reaction - Dose 2 | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Irritability | 51 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Injection Site Reaction - Dose 2 | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Erythema (≥ 2 inches) | 2 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Swelling (≥ 2 inches) | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Vomiting ≥ 6 episodes per day) | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Tenderness | 0 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Irrtability (inconsolable) | 5 Percentage of participants |
| Vaccinated at Age 18 Months | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Crying Abnormal (> 3 hours) | 2 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Irritability | 22 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Tenderness | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Appetite Lost (refuses ≥ 3 feeds) | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Tenderness (cries when inj. limb is moved) | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Appetite Lost | 13 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Drowsiness (difficulty to wake up) | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Systemic Reaction Dose 2 | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Drowsiness | 18 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Solicited Systemic Reaction Dose 2 | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Crying Abnormal (> 3 hours) | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Crying Abnormal | 13 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Appetite Lost (refuses ≥ 3 feeds) | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Fever | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Vomiting (≥ 6 episodes per day) | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Solicited Injection Site Reaction - Dose 1 | 8 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Fever (≥ 39.6 ºC) | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Vomiting | 5 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Fever (≥ 39.6 ºC) | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Vomiting | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Fever | 3 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Injection Site Reaction - Dose 1 | 55 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Vomiting ≥ 6 episodes per day) | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Solicited Systemic Reaction Dose 1 | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Systemic Reaction Dose 1 | 31 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Irritability (inconsolable) | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Crying Abnormal | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Systemic Reaction-Any Dose | 31 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Crying Abnormal (> 3 hours) | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Tenderness (cries when inj. limb is moved) | 6 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Tenderness | 48 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Irritability | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Drowsiness | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Swelling (≥ 2 inches) | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Drowsiness (difficulty to wake up) | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Swelling | 12 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Erythema (≥ 2 inches) | 2 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Injection Site Reaction-Any Dose | 55 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Appetite Lost | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Erythema (≥ 2 inches) | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Erythema | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Solicited Injection Site Reaction - Dose 2 | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Swelling | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Solicited Injection Site Reaction - Dose 2 | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Swelling (≥ 2 inches) | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Grade 3 Irrtability (inconsolable) | 0 Percentage of participants |
| Vaccinated at Age 3 Years to <6 Years | Percentage of Participants Reporting Solicited Local and Systemic Reactions Within Days 0 to 7 Post-Vaccination. | Any Erythema | 33 Percentage of participants |