Meningococcal Infections
Conditions
Keywords
Meningococcal Meningitis, MenACYW conjugate vaccine, Quadrivalent meningococcal vaccine
Brief summary
This was an open-label, multi-center study to describe the immune persistence of the priming dose and describe the immunogenicity and safety of a booster dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) conjugate vaccine in children in Finland who had been vaccinated 3 years earlier as toddlers with either MenACYW conjugate vaccine or Nimenrix® as part of the MET54 study (NCT03205358). The objectives were: * To describe the antibody persistence of meningococcal serogroups A, C, Y, and W before a booster dose in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers. * To describe the antibody responses to meningococcal serogroups A, C, Y, and W 30 days after a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers. * To describe the antibody responses against tetanus toxoid 30 days after a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers. * To describe the safety profile of a booster dose of MenACYW conjugate vaccine in children who received either MenACYW conjugate vaccine or Nimenrix® 3 years earlier as toddlers.
Detailed description
Healthy children who were vaccinated 3 years earlier at 12 to 23 months of age in study MET54 (NCT03205358) were eligible for enrollment. All participants received a single booster dose of MenACYW conjugate vaccine on Day 0. Immunogenicity was assessed at pre-vaccination and 30 days after vaccination. Safety was assessed throughout the study period, and included solicited injection site and systemic reactions (Day 0 to Day 7 post-vaccination); unsolicited adverse events up to Day 30 (Visit 2), and serious adverse events occurring throughout the trial.
Interventions
BIOLOGICALMenACYW conjugate vaccine
Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
46 Months to 61 Months
Healthy volunteers
Yes
Inclusion criteria
* Participated in and completed (attended Visit 2) study MET54. * Informed consent form had been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness, if required by local regulations). * Participant and parent/legally acceptable representative were able to attend all scheduled visits and complied with all trial procedures. * Covered by health insurance where applicable.
Exclusion criteria
* Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. * Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which might be received at a gap of at least 2 weeks before or after the study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines. If the participant was due to receive vaccination(s) recommended for his/her age by the national immunization schedule at the time of the study, the participant was recommended to complete his/her immunization schedule after Visit 2. * Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B vaccine) with the exception of the single dose of meningococcal vaccine administered as part of study MET54. * Receipt of immune globulins, blood or blood-derived products in the past 3 months. * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). * History of meningococcal infection, confirmed either clinically, serologically, or microbiologically * At high risk for meningococcal infection during the trial (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease). * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances. * Verbal report of thrombocytopenia, contraindicating intramuscular vaccination in the Investigator's opinion. * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination. * Personal history of Guillain-Barré syndrome. * Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine. * Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with trial conduct or completion. * Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature \>= 38.0 degree Celsius \[°C\]). A prospective participant was not included in the study until the condition had resolved or the febrile event had subsided. * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw. * Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Day 0 (pre-vaccination) | Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. |
| Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Day 30 (post-booster vaccination) | Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. |
| Antibody Titers Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Day 0 (pre-vaccination) | Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA. |
| Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Day 30 (post-booster vaccination) | Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA. |
| Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Day 0 (pre-vaccination) and Day 30 (post-priming vaccination) in study MET54, and Day 0 (pre-vaccination) and Day 30 (post-booster vaccination) in study MET62 | Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. |
| Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Day 0 (pre-vaccination) and Day 30 (post-priming vaccination) in study MET54, and Day 0 (pre-vaccination) and Day 30 (post-booster vaccination) in study MET62 | Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA. |
| Antibody Concentrations Against Tetanus Toxoid Before a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Day 0 (pre-vaccination) | Anti-tetanus antibodies were measured by electrochemiluminescent (ECL) assay. |
| Antibody Concentrations Against Tetanus Toxoid After a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Day 30 (post-booster vaccination) | Anti-tetanus antibodies were measured by ECL assay. |
| Number of Participants With Immediate Adverse Event After Vaccination in MET62 | Within 30 minutes after vaccination | Immediate events captured medically relevant unsolicited systemic adverse events (AEs) that occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Systemic AEs were all AEs that were not injection or administration site reactions. |
| Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62 | Within 7 days after vaccination | A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: fever, headache, malaise and, myalgia. |
| Number of Participants With Unsolicited Adverse Event After Vaccination in MET62 | Within 30 days after vaccination | An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination. |
| Number of Participants With a Serious Adverse Event (SAE) After Vaccination in MET62 | Within 30 days after vaccination | A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event. |
Countries
Finland
Participant flow
Recruitment details
The study was conducted at 8 sites in Finland from 27 February 2018 to 10 September 2018.
Pre-assignment details
A total of 91 participants who received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) conjugate vaccine or Nimenrix® vaccine in previous study MET54 (NCT03205358) were enrolled in this study (MET62).
Participants by arm
| Arm | Count |
|---|---|
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) Participants who received a single dose of MenACYW conjugate vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62). | 42 |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) Participants who received a single dose of Nimenrix® vaccine 3 years earlier in a previous vaccine study (MET54), received a booster dose of MenACYW conjugate vaccine at Day 0 in this study (MET62). | 49 |
| Total | 91 |
Baseline characteristics
| Characteristic | Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Total |
|---|---|---|---|
| Age, Continuous | 3.9 years STANDARD_DEVIATION 0.35 | 3.9 years STANDARD_DEVIATION 0.33 | 3.9 years STANDARD_DEVIATION 0.34 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 16 Participants | 30 Participants | 46 Participants |
| Sex: Female, Male Male | 26 Participants | 19 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 49 |
| other Total, other adverse events | 36 / 42 | 43 / 49 |
| serious Total, serious adverse events | 0 / 42 | 0 / 49 |
Outcome results
Primary
Antibody Concentrations Against Tetanus Toxoid After a Booster Dose of MenACYW Conjugate Vaccine in MET62
Anti-tetanus antibodies were measured by ECL assay.
Time frame: Day 30 (post-booster vaccination)
Population: Analysis was performed on PPAS.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Concentrations Against Tetanus Toxoid After a Booster Dose of MenACYW Conjugate Vaccine in MET62 | 10.4 IU/mL |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Concentrations Against Tetanus Toxoid After a Booster Dose of MenACYW Conjugate Vaccine in MET62 | 9.36 IU/mL |
Primary
Antibody Concentrations Against Tetanus Toxoid Before a Booster Dose of MenACYW Conjugate Vaccine in MET62
Anti-tetanus antibodies were measured by electrochemiluminescent (ECL) assay.
Time frame: Day 0 (pre-vaccination)
Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Concentrations Against Tetanus Toxoid Before a Booster Dose of MenACYW Conjugate Vaccine in MET62 | 3.12 International unit per milliliter(IU/mL) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Concentrations Against Tetanus Toxoid Before a Booster Dose of MenACYW Conjugate Vaccine in MET62 | 3.02 International unit per milliliter(IU/mL) |
Primary
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.
Time frame: Day 30 (post-booster vaccination)
Population: Analysis was performed on PPAS.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup A | 763 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup C | 5894 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup Y | 2013 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup W | 2656 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup W | 3444 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup A | 659 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup Y | 2806 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup C | 1592 titers (1/dilution) |
Primary
Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.
Time frame: Day 0 (pre-vaccination) and Day 30 (post-priming vaccination) in study MET54, and Day 0 (pre-vaccination) and Day 30 (post-booster vaccination) in study MET62
Population: Analysis in both MET54 and MET62 was performed on Full Analysis Set for Persistence (FASP) which included all participants who had a valid pre-vaccination blood sample result. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup A: Day 0 (MET54) | 3.68 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup A: Day 30 (MET62) | 755 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup Y: Day 0 (MET54) | 2.17 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup Y: Day 30 (MET54) | 105 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup Y: Day 0 (MET62) | 32.5 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup Y: Day 30 (MET62) | 2048 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup W: Day 0 (MET54) | 2.00 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup A: Day 30 (MET54) | 83.3 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup A: Day 0 (MET62) | 11.9 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup C: Day 0 (MET54) | 2.48 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup C: Day 30 (MET54) | 594 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup C: Day 0 (MET62) | 103 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup C: Day 30 (MET62) | 5744 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup W: Day 30 (MET54) | 71.8 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup W: Day 0 (MET62) | 50.0 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup W: Day 30 (MET62) | 2776 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup W: Day 30 (MET62) | 3235 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup A: Day 0 (MET62) | 14.7 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup A: Day 30 (MET62) | 629 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup C: Day 30 (MET62) | 1618 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup W: Day 0 (MET54) | 2.12 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup Y: Day 0 (MET54) | 2.27 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup C: Day 0 (MET54) | 2.30 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup Y: Day 30 (MET54) | 75.8 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup W: Day 0 (MET62) | 21.2 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup Y: Day 0 (MET62) | 18.2 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup C: Day 30 (MET54) | 29.4 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup Y: Day 30 (MET62) | 2710 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup W: Day 30 (MET54) | 40.1 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup A: Day 0 (MET54) | 3.67 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup C: Day 0 (MET62) | 11.6 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup A: Day 30 (MET54) | 49.6 titers (1/dilution) |
Primary
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.
Time frame: Day 30 (post-booster vaccination)
Population: Analysis was performed on PPAS.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup Y | 5499 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup W | 16103 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup A | 4240 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup C | 8629 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup C | 4871 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup Y | 7814 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup A | 5702 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup W | 19793 titers (1/dilution) |
Primary
Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.
Time frame: Day 0 (pre-vaccination) and Day 30 (post-priming vaccination) in study MET54, and Day 0 (pre-vaccination) and Day 30 (post-booster vaccination) in study MET62
Population: Analysis in both MET54 and MET62 was performed on FASP. Here, 'Number analyzed' = participants with available data for each specified category.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup A: Day 30 (MET54) | 3198 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup Y: Day 30 (MET54) | 2667 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup C: Day 30 (MET54) | 2711 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup Y: Day 30 (MET62) | 5553 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup A: Day 30 (MET62) | 4096 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup W: Day 0 (MET54) | 2.00 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup C: Day 0 (MET62) | 94.4 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup W: Day 30 (MET54) | 5793 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup A: Day 0 (MET62) | 124 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup A: Day 0 (MET54) | 12.3 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup C: Day 30 (MET62) | 8474 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup Y: Day 0 (MET62) | 120 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup W: Day 0 (MET62) | 106 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup C: Day 0 (MET54) | 2.21 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup W: Day 30 (MET62) | 15839 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup Y: Day 0 (MET54) | 2.88 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup W: Day 30 (MET62) | 18710 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup A: Day 30 (MET54) | 7633 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup A: Day 0 (MET62) | 239 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup A: Day 30 (MET62) | 5341 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup C: Day 0 (MET54) | 2.15 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup C: Day 30 (MET54) | 414 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup C: Day 0 (MET62) | 11.2 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup C: Day 30 (MET62) | 4817 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup Y: Day 0 (MET54) | 4.29 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup Y: Day 0 (MET62) | 123 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup Y: Day 30 (MET62) | 7498 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup W: Day 0 (MET54) | 2.24 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup W: Day 30 (MET54) | 4214 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup Y: Day 30 (MET54) | 2836 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup W: Day 0 (MET62) | 113 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W After Priming Vaccination in MET54 and Booster Vaccination in MET62 | Serogroup A: Day 0 (MET54) | 4.88 titers (1/dilution) |
Primary
Antibody Titers Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by rSBA.
Time frame: Day 0 (pre-vaccination)
Population: Analysis was performed on PPAS. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup C | 102 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup A | 135 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup Y | 119 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup W | 113 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup W | 126 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup A | 281 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup C | 11.9 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup Y | 126 titers (1/dilution) |
Primary
Antibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.
Time frame: Day 0 (pre-vaccination)
Population: Analysis was performed on Per-Protocol Analysis Set (PPAS) which included all participants who received at least 1 dose of the study vaccine, had a valid post-vaccination blood sample result and had no certain protocol deviations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup A | 12.1 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup W | 48.5 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup C | 106 titers (1/dilution) |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Antibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup Y | 30.9 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup W | 21.9 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup Y | 17.6 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup C | 11.7 titers (1/dilution) |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Antibody Titers Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Before a Booster Dose of MenACYW Conjugate Vaccine in MET62 | Serogroup A | 16.5 titers (1/dilution) |
Primary
Number of Participants With a Serious Adverse Event (SAE) After Vaccination in MET62
A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event.
Time frame: Within 30 days after vaccination
Population: Analysis was performed on safety analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Number of Participants With a Serious Adverse Event (SAE) After Vaccination in MET62 | 0 Participants |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Number of Participants With a Serious Adverse Event (SAE) After Vaccination in MET62 | 0 Participants |
Primary
Number of Participants With Immediate Adverse Event After Vaccination in MET62
Immediate events captured medically relevant unsolicited systemic adverse events (AEs) that occurred within the first 30 minutes after vaccination. An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Systemic AEs were all AEs that were not injection or administration site reactions.
Time frame: Within 30 minutes after vaccination
Population: Analysis was performed on safety analysis set which included participants who had received at least one dose of the study vaccine and had any safety data available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Number of Participants With Immediate Adverse Event After Vaccination in MET62 | 0 Participants |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Number of Participants With Immediate Adverse Event After Vaccination in MET62 | 0 Participants |
Primary
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62
A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. Solicited injection site reactions: pain, erythema, and swelling. Solicited systemic reactions: fever, headache, malaise and, myalgia.
Time frame: Within 7 days after vaccination
Population: Analysis was performed on safety analysis set.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62 | Malaise | 13 Participants |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62 | Erythema | 22 Participants |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62 | Swelling | 16 Participants |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62 | Fever | 3 Participants |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62 | Myalgia | 14 Participants |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62 | Pain | 26 Participants |
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62 | Headache | 8 Participants |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62 | Pain | 35 Participants |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62 | Myalgia | 21 Participants |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62 | Erythema | 27 Participants |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62 | Headache | 14 Participants |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62 | Swelling | 19 Participants |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62 | Fever | 4 Participants |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions in MET62 | Malaise | 15 Participants |
Primary
Number of Participants With Unsolicited Adverse Event After Vaccination in MET62
An unsolicited AE was an observed AE that did not fulfill the conditions pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination.
Time frame: Within 30 days after vaccination
Population: Analysis was performed on safety analysis set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1:MenACYW Conjugate Vaccine(Previous Exposed to MenACYW) | Number of Participants With Unsolicited Adverse Event After Vaccination in MET62 | 22 Participants |
| Group2:MenACYW Conjugate Vaccine(Previous Exposed to Nimenrix) | Number of Participants With Unsolicited Adverse Event After Vaccination in MET62 | 15 Participants |