Meningococcal Disease
Conditions
Keywords
meningococcal disease, children, vaccination
Brief summary
Evaluate the immune response and reactogenicity of one dose of Meningococcal ACWY-cross reactive material (CRM) and Meningococcal ACWY-tetanus toxoid (TT) in 12-15 months old healthy toddlers.
Interventions
BIOLOGICALMenACWY-CRM
MenACWY-CRM
BIOLOGICALMenACWY-TT
MenACWY-TT
Sponsors
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 15 Months
Healthy volunteers
Yes
Inclusion criteria
1. Healthy children between 12 months and 15 months old inclusive who were born with an estimated gestational age ≥ 37 weeks. 2. Parent(s)/legal guardian(s) had given written informed consent after the nature of the study had been explained according to local regulatory requirements. 3. Parents/legal guardian available for all the visits and would comply with the requirements of the protocol (e.g., completion of the Diary Cards, availability for study visits / safety phone calls). 4. In good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
Exclusion criteria
1. Previous confirmed or suspected disease caused by N. meningitidis. 2. Previously exposed to clinically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characterization, i.e. possible meningococcal disease. 3. Previously immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational). 4. Received within 90 days prior to enrollment or were expected to receive during the study period any investigational or non-registered product (drug or vaccine). 5. Received or planning to receive any vaccines within 14 days before and 30 days after administration of the study vaccine (Exceptions: Injectable influenza vaccine could be administered up to 14 days prior to study vaccination and at least 14 days after study vaccination). 6. Major congenital defect or a serious chronic disease. 7. History of any anaphylaxis, severe vaccine reactions, or allergy to any vaccine components including diphtheria toxoid (CRM197) or tetanus toxoid (TT) and latex. 8. Required chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the study vaccination. (For corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids were allowed). 9. Receipt of immunoglobulins and/or any blood products within six months prior to study vaccination or who had administration planned during the study period. 10. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. 11. Any bleeding disorder which was considered as a contraindication to intramuscular injection. 12. Moderate or severe acute infection and/or fever (defined as temperature ≥ 38°C) within 3 days prior to enrollment. 13. Systemic antibiotic treatment within 7 days prior to enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With at Least One Severe Solicited Adverse Event (AE) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT. | Day 1 to Day 7 post-vaccination | Reactogenicity of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by number of subjects with at least one severe solicited AE within 7 days after vaccination. Solicited AEs included tenderness, erythema, induration, irritability, sleepiness, change in eating habits, vomiting, diarrhea and fever. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Day 29 and Day 180 post-vaccination | Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with seroresponse defined as for subjects with pre-vaccination hSBA titer \< 4, post-vaccination hSBA titer ≥ 8; for subjects with pre-vaccination hSBA titer ≥ 4, an increase of at least four times the pre-vaccination hSBA directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence immune response was measured by the percentage of subjects with seroresponse at Day 180 after vaccination. |
| hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Day 1, Day 29 and Day 180 post-vaccination | Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by hSBA GMTs directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by hSBA GMTs at Day 180 after vaccination. |
| Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Day 1, Day 29 and Day 180 post-vaccination | Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with rSBA titer ≥ 8 directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by percentages of subjects with rSBA titer ≥ 8 on Day 180 after vaccination. |
| Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Day 1, Day 29 and Day 180 post-vaccination | Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with rSBA titer ≥ 128 directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by percentages of subjects with rSBA titer ≥ 128 on Day 180 after vaccination. |
| Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Day 1, Day 29 and Day 180 post-vaccination | Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with hSBA titer ≥ 8 directed against Neisseria meningitidis (N. meningitidis) serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune responses was measured by the percentages of subjects with hSBA titer ≥ 8 on Day 180 post-vaccination. |
| rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Day 1, Day 29 and Day 180 post-vaccination | Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by rSBA GMTs directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune responses was measured by rSBA GMTs on Day 180. |
| Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Day 1 (6 hours) to Day 7 post-vaccination | Safety was assessed in terms of number of subjects (12 to 15 months old) reporting any and each of solicited local and systemic AEs reported from Day 1 to 7 after vaccination with one dose of either MenACWY-CRM or comparator MenACWY-TT vaccine. |
| Number of Subjects Reporting Unsolicited (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Day 1 to Day 29 or Day 1 to Day 180 post-vaccination | Safety was assessed in terms of number of subjects (12 to 15 months old) reporting unsolicited AEs (day 1 to day 29), SAEs, medically attended AEs, AEs leading to premature study withdrawal (Day 1 to Day 180) after vaccination with one dose of either MenACWY-CRM or comparator MenACWY-TT vaccine. |
| Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Day 29 and Day 180 post-vaccination | Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with four-fold increase in rSBA titer directed against N. meningitides serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by the percentages of subjects with four-fold increase in rSBA titer on Day 180 after vaccination. |
Countries
Italy
Participant flow
Recruitment details
Subjects were enrolled from 4 centers in Italy.
Pre-assignment details
All enrolled subjects were included in the trial.
Participants by arm
| Arm | Count |
|---|---|
| MenACWY-CRM (12 to 15 Months Old) Subjects received one dose of investigational MenACWY-CRM vaccine. | 100 |
| MenACWY-TT (12 to 15 Months Old) Subjects received one dose of comparator MenACWY-TT vaccine. | 102 |
| Total | 202 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 3 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | MenACWY-CRM (12 to 15 Months Old) | MenACWY-TT (12 to 15 Months Old) | Total |
|---|---|---|---|
| Age, Continuous | 12.8 Months STANDARD_DEVIATION 1 | 12.7 Months STANDARD_DEVIATION 0.9 | 12.7 Months STANDARD_DEVIATION 0.9 |
| Region of Enrollment Italy | 100 Subjects | 102 Subjects | 202 Subjects |
| Sex: Female, Male Female | 48 Participants | 46 Participants | 94 Participants |
| Sex: Female, Male Male | 52 Participants | 56 Participants | 108 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 83 / 99 | 87 / 101 |
| serious Total, serious adverse events | 8 / 99 | 3 / 101 |
Outcome results
Primary
Number of Subjects With at Least One Severe Solicited Adverse Event (AE) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT.
Reactogenicity of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by number of subjects with at least one severe solicited AE within 7 days after vaccination. Solicited AEs included tenderness, erythema, induration, irritability, sleepiness, change in eating habits, vomiting, diarrhea and fever.
Time frame: Day 1 to Day 7 post-vaccination
Population: Analysis was done on the solicited safety data set (all subjects in the exposed set who provided post vaccination reactogenicity data: MenACWY-CRM 99; MenACWY-TT 101).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MenACWY-CRM (12 to 15 Months Old) | Number of Subjects With at Least One Severe Solicited Adverse Event (AE) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT. | 4 Number of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Number of Subjects With at Least One Severe Solicited Adverse Event (AE) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT. | 2 Number of Subjects |
Secondary
hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by hSBA GMTs directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by hSBA GMTs at Day 180 after vaccination.
Time frame: Day 1, Day 29 and Day 180 post-vaccination
Population: Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-CRM (12 to 15 Months Old) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 29 (N=94,97) | 30 Titers |
| MenACWY-CRM (12 to 15 Months Old) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 180 (N=92,95) | 16 Titers |
| MenACWY-CRM (12 to 15 Months Old) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 29 (N=84,87) | 9.34 Titers |
| MenACWY-CRM (12 to 15 Months Old) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 1 (N=92,93) | 2.44 Titers |
| MenACWY-CRM (12 to 15 Months Old) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 29 (N=91,97) | 41 Titers |
| MenACWY-CRM (12 to 15 Months Old) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 180 (N=88,89) | 21 Titers |
| MenACWY-CRM (12 to 15 Months Old) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 180 (N=97,96) | 13 Titers |
| MenACWY-CRM (12 to 15 Months Old) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 1 (N=81,78) | 2.58 Titers |
| MenACWY-CRM (12 to 15 Months Old) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 180 (N=96,95) | 24 Titers |
| MenACWY-CRM (12 to 15 Months Old) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 29 (N=87,91) | 5.89 Titers |
| MenACWY-CRM (12 to 15 Months Old) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 1 (N=84,84) | 2.23 Titers |
| MenACWY-CRM (12 to 15 Months Old) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 1 (N=89,92) | 2.19 Titers |
| MenACWY-TT (12 to 15 Months Old) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 1 (N=84,84) | 2.16 Titers |
| MenACWY-TT (12 to 15 Months Old) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 180 (N=97,96) | 4.67 Titers |
| MenACWY-TT (12 to 15 Months Old) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 29 (N=94,97) | 20 Titers |
| MenACWY-TT (12 to 15 Months Old) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 1 (N=81,78) | 2.4 Titers |
| MenACWY-TT (12 to 15 Months Old) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 29 (N=84,87) | 14 Titers |
| MenACWY-TT (12 to 15 Months Old) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 180 (N=88,89) | 56 Titers |
| MenACWY-TT (12 to 15 Months Old) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 29 (N=87,91) | 8.20 Titers |
| MenACWY-TT (12 to 15 Months Old) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 180 (N=92,95) | 26 Titers |
| MenACWY-TT (12 to 15 Months Old) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 1 (N=89,92) | 2.04 Titers |
| MenACWY-TT (12 to 15 Months Old) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 29 (N=91,97) | 30 Titers |
| MenACWY-TT (12 to 15 Months Old) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 1 (N=92,93) | 2.24 Titers |
| MenACWY-TT (12 to 15 Months Old) | hSBA Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 180 (N=96,95) | 41 Titers |
Secondary
Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
Safety was assessed in terms of number of subjects (12 to 15 months old) reporting any and each of solicited local and systemic AEs reported from Day 1 to 7 after vaccination with one dose of either MenACWY-CRM or comparator MenACWY-TT vaccine.
Time frame: Day 1 (6 hours) to Day 7 post-vaccination
Population: Analysis was done on solicited safety data set. MedDRA version v.3.0 was used for the analyses (in the AEs section, MedDRA version v.17.01 was used, leading to a different terminology to describe some of the events reported in this outcome).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Erythema (N=97,100) | 4 Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Change in eating habits (N=96,100) | 22 Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Any Systemic | 56 Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Vomiting (N=96,99) | 6 Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Tenderness (N=97,100) | 29 Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Diarrhea (N=96,99) | 17 Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Irritability (N=96,99) | 30 Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Fever (≥ 38.0°C; N=99,100)) | 14 Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Induration (N=97,101) | 6 Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Prophylatic use of analg./antipyr. (N=97,100) | 1 Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Sleepiness (N=96,98) | 23 Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Therapeutic use of analg./antipyr. (N=98,100) | 13 Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Any Local | 34 Subjects |
| MenACWY-TT (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Therapeutic use of analg./antipyr. (N=98,100) | 13 Subjects |
| MenACWY-TT (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Any Local | 29 Subjects |
| MenACWY-TT (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Tenderness (N=97,100) | 26 Subjects |
| MenACWY-TT (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Erythema (N=97,100) | 2 Subjects |
| MenACWY-TT (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Induration (N=97,101) | 4 Subjects |
| MenACWY-TT (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Any Systemic | 57 Subjects |
| MenACWY-TT (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Irritability (N=96,99) | 39 Subjects |
| MenACWY-TT (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Sleepiness (N=96,98) | 26 Subjects |
| MenACWY-TT (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Change in eating habits (N=96,100) | 26 Subjects |
| MenACWY-TT (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Vomiting (N=96,99) | 9 Subjects |
| MenACWY-TT (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Diarrhea (N=96,99) | 18 Subjects |
| MenACWY-TT (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Fever (≥ 38.0°C; N=99,100)) | 13 Subjects |
| MenACWY-TT (12 to 15 Months Old) | Number of Subjects Reporting Solicited Adverse Events (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Prophylatic use of analg./antipyr. (N=97,100) | 4 Subjects |
Secondary
Number of Subjects Reporting Unsolicited (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
Safety was assessed in terms of number of subjects (12 to 15 months old) reporting unsolicited AEs (day 1 to day 29), SAEs, medically attended AEs, AEs leading to premature study withdrawal (Day 1 to Day 180) after vaccination with one dose of either MenACWY-CRM or comparator MenACWY-TT vaccine.
Time frame: Day 1 to Day 29 or Day 1 to Day 180 post-vaccination
Population: Analysis was done on unsolicited safety data set ie, all subjects in the exposed set who had post-vaccination unsolicited adverse event records.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM (12 to 15 Months Old) | Number of Subjects Reporting Unsolicited (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | AEs leading to premature withdrawal | 0 Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Number of Subjects Reporting Unsolicited (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Medically attended AEs | 73 Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Number of Subjects Reporting Unsolicited (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | SAEs | 8 Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Number of Subjects Reporting Unsolicited (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Death | 0 Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Number of Subjects Reporting Unsolicited (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Any unsolicited AEs | 73 Subjects |
| MenACWY-TT (12 to 15 Months Old) | Number of Subjects Reporting Unsolicited (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Death | 0 Subjects |
| MenACWY-TT (12 to 15 Months Old) | Number of Subjects Reporting Unsolicited (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Any unsolicited AEs | 71 Subjects |
| MenACWY-TT (12 to 15 Months Old) | Number of Subjects Reporting Unsolicited (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | AEs leading to premature withdrawal | 0 Subjects |
| MenACWY-TT (12 to 15 Months Old) | Number of Subjects Reporting Unsolicited (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | SAEs | 3 Subjects |
| MenACWY-TT (12 to 15 Months Old) | Number of Subjects Reporting Unsolicited (AEs) After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Medically attended AEs | 68 Subjects |
Secondary
Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with four-fold increase in rSBA titer directed against N. meningitides serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by the percentages of subjects with four-fold increase in rSBA titer on Day 180 after vaccination.
Time frame: Day 29 and Day 180 post-vaccination
Population: Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 29 (rabbit; N=61,57) | 87 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 180 (rabbit; N=60,61) | 97 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 180 (rabbit; N=58,58) | 55 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 180 (rabbit; N=64,63) | 20 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 29 (rabbit; N=61,59) | 87 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 29 (rabbit; N=63,61) | 100 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 180 (rabbit; N=61,59) | 72 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 29 (rabbit; N=64,62) | 75 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 180 (rabbit; N=61,59) | 56 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 180 (rabbit; N=60,61) | 84 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 29 (rabbit; N=64,62) | 65 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 180 (rabbit; N=64,63) | 30 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 29 (rabbit; N=61,57) | 89 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 180 (rabbit; N=58,58) | 66 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 29 (rabbit; N=61,59) | 88 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Four-fold Increase in rSBA Titers Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 29 (rabbit; N=63,61) | 93 percentage of Subjects |
Secondary
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with hSBA titer ≥ 8 directed against Neisseria meningitidis (N. meningitidis) serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune responses was measured by the percentages of subjects with hSBA titer ≥ 8 on Day 180 post-vaccination.
Time frame: Day 1, Day 29 and Day 180 post-vaccination
Population: Analysis was done on Full Analysis Set (FAS) Day 29 (subjects who received the vaccine and provided immunogenicity data at Day 29: MenACWY-CRM 95; MenACWT-TT 97). Persistence of immune responses at Day 180 was analysed on FAS Day 180 (subjects who received the vaccine and provided immunogenicity data at Day 180: MenACWY-CRM 98; MenACWT-TT 97).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 180 (N=92,95) | 78 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 180 (N=97,96) | 65 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 1 (N=92,93) | 3 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 29 (N=84,87) | 62 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 1 (N=89,92) | 2 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 29 (N=94,97) | 96 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 180 (N=96,95) | 88 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 1 (N=81,78) | 6 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 180 (N=88,89) | 88 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 1 (N=84,84) | 4 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 29 (N=87,91) | 41 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 29 (N=91,97) | 90 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 1 (N=81,78) | 4 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 29 (N=91,97) | 88 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 29 (N=94,97) | 86 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 180 (N=97,96) | 30 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 29 (N=87,91) | 56 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 1 (N=92,93) | 1 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 180 (N=96,95) | 95 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 29 (N=84,87) | 72 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 1 (N=84,84) | 2 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 180 (N=92,95) | 98 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 180 (N=88,89) | 100 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titer ≥ 8 Against (N. Meningitidis) Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 1 (N=89,92) | 0 percentage of Subjects |
Secondary
Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with rSBA titer ≥ 8 directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by percentages of subjects with rSBA titer ≥ 8 on Day 180 after vaccination.
Time frame: Day 1, Day 29 and Day 180 post-vaccination
Population: Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 180 (rabbit; N=74,75) | 100 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 29 (rabbit; N=70,69) | 90 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 29 (rabbit; N=74,74) | 92 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 180 (rabbit; N=73,70) | 71 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 29 (rabbit; N=73,74) | 100 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 180 (rabbit; N=77,76) | 64 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 1 (rabbit; N=61,59) | 10 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 1 (rabbit; N=64,62) | 3 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 29 (rabbit; N=70,70) | 90 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 1 (rabbit; N=61,57) | 7 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 180 (rabbit; N=74,71) | 80 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 1 (rabbit; N=63,61) | 24 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 180 (rabbit; N=74,71) | 82 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 29 (rabbit; N=73,74) | 100 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 180 (rabbit; N=74,75) | 93 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 1 (rabbit; N=64,62) | 0 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 29 (rabbit; N=74,74) | 97 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 180 (rabbit; N=77,76) | 71 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 1 (rabbit; N=61,57) | 5 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 29 (rabbit; N=70,69) | 91 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 180 (rabbit; N=73,70) | 87 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 1 (rabbit; N=63,61) | 31 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 1 (rabbit; N=61,59) | 15 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titer ≥ 8 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 29 (rabbit; N=70,70) | 89 percentage of Subjects |
Secondary
Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with rSBA titer ≥ 128 directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune response was measured by percentages of subjects with rSBA titer ≥ 128 on Day 180 after vaccination.
Time frame: Day 1, Day 29 and Day 180 post-vaccination
Population: Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 1 (rabbit; N=63,61) | 22 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 29 (rabbit; N=74,74) | 78 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 29 (rabbit; N=73,74) | 100 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 29 (rabbit; N=70,69) | 90 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 180 (rabbit; N=74,75) | 100 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 1 (rabbit; N=61,59) | 10 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 1 (rabbit; N=61,57) | 7 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 1 (rabbit; N=64,62) | 3 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 180 (rabbit; N=73,70) | 62 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 29 (rabbit; N=70,70) | 89 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 180 (rabbit; N=74,71) | 73 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 180 (rabbit; N=77,76) | 25 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 180 (rabbit; N=74,71) | 62 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 1 (rabbit; N=64,62) | 0 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 29 (rabbit; N=74,74) | 65 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 1 (rabbit; N=61,57) | 5 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 1 (rabbit; N=61,59) | 12 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 29 (rabbit; N=70,70) | 86 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 1 (rabbit; N=63,61) | 31 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 29 (rabbit; N=73,74) | 100 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 180 (rabbit; N=77,76) | 33 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 29 (rabbit; N=70,69) | 90 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 180 (rabbit; N=73,70) | 66 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With rSBA Titer ≥ 128 Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 180 (rabbit; N=74,75) | 91 percentage of Subjects |
Secondary
Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by the percentages of subjects with seroresponse defined as for subjects with pre-vaccination hSBA titer \< 4, post-vaccination hSBA titer ≥ 8; for subjects with pre-vaccination hSBA titer ≥ 4, an increase of at least four times the pre-vaccination hSBA directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence immune response was measured by the percentage of subjects with seroresponse at Day 180 after vaccination.
Time frame: Day 29 and Day 180 post-vaccination
Population: Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 29 (N=89,92) | 88 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 29 (N=81,78) | 54 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 180 (N=95,92) | 62 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 29 (N=92,93) | 95 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 180 (N=94,92) | 85 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 180 (N=83,81) | 83 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 29 (N=84,84) | 39 percentage of Subjects |
| MenACWY-CRM (12 to 15 Months Old) | Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 180 (N=88,87) | 74 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 29 (N=92,93) | 84 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 29 (N=89,92) | 87 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 180 (N=83,81) | 99 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 29 (N=81,78) | 73 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 180 (N=88,87) | 95 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 180 (N=94,92) | 93 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 180 (N=95,92) | 29 percentage of Subjects |
| MenACWY-TT (12 to 15 Months Old) | Percentages of Subjects With Seroresponse Against N. Meningitidis Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 29 (N=84,84) | 54 percentage of Subjects |
Secondary
rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine.
Immunogenicity of one dose of MenACWY-CRM and comparator MenACWY-TT vaccine was assessed in subjects (12 to 15 months old) as measured by rSBA GMTs directed against N. meningitidis serogroups A, C, W, and Y on Day 29 after vaccination. Persistence of immune responses was measured by rSBA GMTs on Day 180.
Time frame: Day 1, Day 29 and Day 180 post-vaccination
Population: Analysis at Day 29 was done on FAS set at Visit Day 29. Persistence of immune responses at Day 180 was analysed on FAS at Visit Day 180.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY-CRM (12 to 15 Months Old) | rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 1 (rabbit; N=63,61) | 6.62 Titers |
| MenACWY-CRM (12 to 15 Months Old) | rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 180 (rabbit; N=77,76) | 20 Titers |
| MenACWY-CRM (12 to 15 Months Old) | rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 180 (rabbit; N=74,75) | 2815 Titers |
| MenACWY-CRM (12 to 15 Months Old) | rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 29 (rabbit; N=70,69) | 1092 Titers |
| MenACWY-CRM (12 to 15 Months Old) | rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 180 (rabbit; N=73,70) | 91 Titers |
| MenACWY-CRM (12 to 15 Months Old) | rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 1 (rabbit; N=64,62) | 2.46 Titers |
| MenACWY-CRM (12 to 15 Months Old) | rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 1 (rabbit; N=61,59) | 3.46 Titers |
| MenACWY-CRM (12 to 15 Months Old) | rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 29 (rabbit; N=73,74) | 5698 Titers |
| MenACWY-CRM (12 to 15 Months Old) | rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 29 (rabbit; N=70,70) | 756 Titers |
| MenACWY-CRM (12 to 15 Months Old) | rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 29 (rabbit; N=74,74) | 171 Titers |
| MenACWY-CRM (12 to 15 Months Old) | rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 180 (rabbit; N=74,71) | 248 Titers |
| MenACWY-CRM (12 to 15 Months Old) | rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 1 (rabbit; N=61,57) | 3.1 Titers |
| MenACWY-TT (12 to 15 Months Old) | rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 180 (rabbit; N=74,71) | 140 Titers |
| MenACWY-TT (12 to 15 Months Old) | rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 1 (rabbit; N=61,57) | 3.17 Titers |
| MenACWY-TT (12 to 15 Months Old) | rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 1 (rabbit; N=63,61) | 12 Titers |
| MenACWY-TT (12 to 15 Months Old) | rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 29 (rabbit; N=73,74) | 2827 Titers |
| MenACWY-TT (12 to 15 Months Old) | rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | A Day 180 (rabbit; N=74,75) | 950 Titers |
| MenACWY-TT (12 to 15 Months Old) | rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 1 (rabbit; N=64,62) | 2.07 Titers |
| MenACWY-TT (12 to 15 Months Old) | rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 29 (rabbit; N=74,74) | 142 Titers |
| MenACWY-TT (12 to 15 Months Old) | rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | C Day 180 (rabbit; N=77,76) | 22 Titers |
| MenACWY-TT (12 to 15 Months Old) | rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 29 (rabbit; N=70,69) | 1060 Titers |
| MenACWY-TT (12 to 15 Months Old) | rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | W Day 180 (rabbit; N=73,70) | 142 Titers |
| MenACWY-TT (12 to 15 Months Old) | rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 1 (rabbit; N=61,59) | 4.22 Titers |
| MenACWY-TT (12 to 15 Months Old) | rSBA GMT Against N. Meningitidis Against Serogroups A, C, W, and Y After Receiving One Dose of Either MenACWY-CRM Vaccine or MenACWY-TT Vaccine. | Y Day 29 (rabbit; N=70,70) | 624 Titers |