Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001549-15 | EudraCT Number | ||
| C0921004 | Other Identifier | Alias Study Number | |
| 200171 | Other Identifier | Alias Study Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the long-term antibody persistence 6, 7, 8, 9 and 10 years after receiving a primary vaccination of meningococcal conjugate vaccine MenACWY-TT versus Meningitecâ„¢ or Mencevaxâ„¢ ACWY, and the safety and immunogenicity of a booster dose of MenACWY-TT administered 10 years after the primary vaccination. All subjects received a primary vaccination at 1 to 10 years of age in study 108658 (NCT00427908). No new subjects will be enrolled in this booster study.
The study aims to evaluate the antibody persistence post primary vaccination with active control, safety and immunogenicity of a booster dose uncontrolled post primary vaccination during different phases:
Persistence phase: Long-term persistence 6, 7, 8, 9 and 10 years after primary vaccination with MenACWY-TT or Meningitec or Mencevax ACWY, in study MenACWY-TT-027.
Booster phase: One month post booster vaccination with MenACWY-TT vaccine ten years after primary vaccination.
The subjects in this study will be allocated to the same groups as in the vaccination study MenACWY-TT-027 (NCT00427908).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACWY<2 Group | Experimental | Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with MenACWY-TT. |
|
| ACWY≥2 Group | Experimental | Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with MenACWY-TT. |
|
| MenCCRM Group | Experimental | Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with Meningitec. |
|
| MenPS Group | Experimental | Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with Mencevax ACWY. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal vaccine GSK134612 | Biological | One dose administered intramuscularly (IM) in the deltoid of the non-dominant arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination | Serogroups included Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). | 6 years after primary vaccination (Year 1 of study MENACWY-TT-100) |
| Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | 7 years after primary vaccination (Year 2 of study MENACWY-TT-100) |
| Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | 8 years after primary vaccination (Year 3 of study MENACWY-TT-100) |
| Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | 9 years after primary vaccination (Year 4 of study MENACWY-TT-100) |
| Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | 10 years after primary vaccination (Year 4 of study MENACWY-TT-100) |
| Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | 6, 7, 8, 9 and 10 years after primary vaccination (Year 1, 2, 3, 4 and 5 of study MENACWY-TT-100) |
Not provided
Inclusion Criteria:
All subjects must satisfy the following additional criteria prior to entry of the booster phase:
Female subjects of non-childbearing potential may be enrolled in the study.
Male subjects able to father children and female subjects of childbearing potential (including females who have had tubal ligation) and at risk of pregnancy may be enrolled in the study, if the subject:
Exclusion Criteria:
Note: Subjects who were revaccinated with a monovalent MenC conjugate vaccine because of suboptimal response during the persistence phase of the MenACWY-TT-027 study (i.e. MenACWY-TT-028, -029, -030, -031 and -032) are allowed to participate as they will be followed for the persistence of MenA, MenW-135 and MenY.
Additional exclusion criteria for booster phase at Month 126 study entry (to be checked at Month 126) for all subjects:
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the follow-up period.
Administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the booster dose of study vaccine or planned administration within 30 days after vaccination, with the exception of a licensed inactivated influenza vaccine.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose . Inhaled and topical steroids are allowed.
Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination or planned administration during the follow-up period.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product .
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.
Acute disease and/or fever at the time of vaccination.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions.
Male subjects able to father children who are planning to discontinue contraceptive precautions.
Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Espoo Vaccine Research Clinic | Espoo | 02230 | Finland | |||
| South Helsinki Vaccine Research Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32598244 | Derived | Vesikari T, Peyrani P, Webber C, Van Der Wielen M, Cheuvart B, De Schrevel N, Aris E, Cutler M, Li P, Perez JL. Ten-Year Antibody Persistence and Booster Response to MenACWY-TT Vaccine After Primary Vaccination at 1-10 Years of Age. Hum Vaccin Immunother. 2020 Jun 2;16(6):1280-1291. doi: 10.1080/21645515.2020.1746110. |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Not provided
Not provided
Not provided
In this study, participants from the study MENACWY-TT-027 [NCT00427908] were followed up for assessment of persistence of immune response and safety. And those who consented received booster vaccination and were followed up for another 6 months.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MenACWY-TT Vaccine: Less Than (<) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Persistence Phase (5 Years) |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 25, 2016 | Mar 4, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Serogroups included MenA, MenC, MenW-135 and MenY. |
| 6 Years after primary vaccination (Year 1 of study MENACWY-TT-100) |
| Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | 7 years after primary vaccination (Year 2 of study MENACWY-TT-100) |
| Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | 8 years after primary vaccination (Year 3 of study MENACWY-TT-100) |
| Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | 9 years after primary vaccination (Year 4 of study MENACWY-TT-100) |
| Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | 10 years after primary vaccination (Year 5 of study MENACWY-TT-100) |
| Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | 6, 7, 8, 9 and 10 years after primary vaccination (Year 1, 2, 3, 4 and 5 of study MENACWY-TT-100) |
| Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100) |
| Booster Phase: Geometric Mean Titers as Measured by rSBA For Each of the 4 Serogroups 1 Month After Booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100) |
| Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. rSBA booster response to meningococcal antigens (A,C, W-135 and Y) is defined as: rSBA antibody titer >= 1:32 one month after vaccination, and at least 4-fold increase in rSBA titers one month after vaccination. | 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100) |
| Booster Phase: Percentage of Participants With hSBA Titers >=1:4 and >=1:8 For Each of the 4 Serogroups at 1 Month After Booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100) |
| Booster Phase: Geometric Mean Titers Using hSBA For Each of the 4 Serogroups at 1 Month After Booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100) |
| Booster Phase: Percentage of Participants With hSBA Booster Response at 1 Month After Booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. hSBA booster response to meningococcal antigens (A,C, W-135 and Y) is defined as: hSBA antibody titer >= 1:8 one month after vaccination, and at least 4-fold increase in hSBA titers one month after vaccination. | 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100) |
| Persistence Phase: Percentage of Participants With Serious Adverse Events (SAEs) Related to Vaccination or Any Adverse Event (AE) Related to Lack of Vaccine Efficacy | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs related to "lack of vaccine efficacy" were as judged by the investigator. | Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination) |
| Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Solicited general events: fatigue, gastrointestinal (GI) events (nausea, vomiting, diarrhea and/or abdominal pain, headache (0= normal, 1=mild/easily tolerated, 2=moderate/interfered with normal activity, 3=severe/prevented normal activity) and fever (>=37.5°C for oral/axillary/tympanic route, >=38.0°C for rectal route). Solicited local events: pain (0=none, 1=mild, not interfered/prevented normal activity, 2=moderate, painful when limb moved/interfered with normal activity, 3=severe, significant pain at rest/prevented normal activity), redness and swelling at injection site (record greatest surface diameter in millimeter (mm) as 0 to <=20 mm, >20 to <=50 mm, >50 mm). Participants may be represented in more than 1 category. Only categories with at least 1 participant reported. 'Medical advice' signifies medical advice received to resolve any event. 'Related'=relationship to study vaccine assessed by investigator. | Up to 4 days post booster vaccination |
| Booster Phase: Percentage of Participants With Unsolicited Adverse Events up to 31 Days Post Booster Vaccination | An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | Up to 31 days post booster vaccination |
| Booster Phase: Percentage of Participants With Serious Adverse Events (SAEs) Up to 6 Months Post Booster Vaccination | An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Up to 6 months post booster vaccination |
| Booster Phase: Percentage of Participants With New Onset Chronic Illness Up to 6 Months Post Booster Vaccination | New onset chronic illness included autoimmune disorders, asthma, type I diabetes, allergies. | Up to 6 months post booster vaccination |
| Helsinki |
| 00100 |
| Finland |
| Helsinki East Vaccine Research Clinic | Helsinki | 00930 | Finland |
| Jarvenpaa Vaccine Research Clinic | Jarvenpaa | 04400 | Finland |
| Tampereen yliopisto/ Oulun rokotetutkimusklinikka | Oulu | 90220 | Finland |
| Tampereen yliopisto/ Porin rokotetutkimusklinikka | Pori | 28100 | Finland |
| Tampere Vaccine Research Clinic | Tampere | 33100 | Finland |
| Tampereen yliopisto/ Turun rokotetutkimusklinikka | Turku | 20520 | Finland |
| Tampereen yliopisto/ Ita-Vantaan rokotetutkimusklinikka | Vantaa | 01300 | Finland |
| FG001 | MenCCRM (Meningitec) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| FG002 | MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| FG003 | MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Booster Phase (6 Months) |
|
Baseline analysis population included all the participants enrolled in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MenACWY-TT Vaccine: Less Than (<) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| BG001 | MenCCRM (Meningitec) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| BG002 | MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| BG003 | MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination | Serogroups included Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). | All eligible participants who received primary vaccination with MenACWY-TT, Meningitec, or Mencevax ACWY during study MenACWY-TT-027 and had available assay results for at least 1 tested antigen. Here, "Overall Number of Participants Analyzed" (N) signifies number of participants evaluable for this measure. | Posted | Number | 95% Confidence Interval | percentage of participants | 6 years after primary vaccination (Year 1 of study MENACWY-TT-100) |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup titers cut off. | Posted | Number | 95% Confidence Interval | percentage of participants | 7 years after primary vaccination (Year 2 of study MENACWY-TT-100) |
| ||||||||||||||||||||||||||||||||||||
| Primary | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027 and had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. | Posted | Number | 95% Confidence Interval | percentage of participants | 8 years after primary vaccination (Year 3 of study MENACWY-TT-100) |
| ||||||||||||||||||||||||||||||||||||
| Primary | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup titers cut off. | Posted | Number | 95% Confidence Interval | percentage of participants | 9 years after primary vaccination (Year 4 of study MENACWY-TT-100) |
| ||||||||||||||||||||||||||||||||||||
| Primary | Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup titers cut off. | Posted | Number | 95% Confidence Interval | percentage of participants | 10 years after primary vaccination (Year 4 of study MENACWY-TT-100) |
| ||||||||||||||||||||||||||||||||||||
| Primary | Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027 and had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. | Posted | Geometric Mean | 95% Confidence Interval | titers | 6 Years after primary vaccination (Year 1 of study MENACWY-TT-100) |
| ||||||||||||||||||||||||||||||||||||
| Primary | Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup. | Posted | Geometric Mean | 95% Confidence Interval | titers | 7 years after primary vaccination (Year 2 of study MENACWY-TT-100) |
| ||||||||||||||||||||||||||||||||||||
| Primary | Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. | Posted | Geometric Mean | 95% Confidence Interval | titers | 8 years after primary vaccination (Year 3 of study MENACWY-TT-100) |
| ||||||||||||||||||||||||||||||||||||
| Primary | Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup. | Posted | Geometric Mean | 95% Confidence Interval | titers | 9 years after primary vaccination (Year 4 of study MENACWY-TT-100) |
| ||||||||||||||||||||||||||||||||||||
| Primary | Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup. | Posted | Geometric Mean | 95% Confidence Interval | titers | 10 years after primary vaccination (Year 5 of study MENACWY-TT-100) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup titers cut off. | Posted | Number | 95% Confidence Interval | percentage of participants | 6, 7, 8, 9 and 10 years after primary vaccination (Year 1, 2, 3, 4 and 5 of study MENACWY-TT-100) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup. | Posted | Geometric Mean | 95% Confidence Interval | titers | 6, 7, 8, 9 and 10 years after primary vaccination (Year 1, 2, 3, 4 and 5 of study MENACWY-TT-100) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | All eligible participants who received primary vaccination in study MenACWY-TT-027 and booster vaccination in MenACWY-TT-100, had available assay results for 1 month post booster vaccination blood sample. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup titers cut off. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Booster Phase: Geometric Mean Titers as Measured by rSBA For Each of the 4 Serogroups 1 Month After Booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | All eligible participants who received primary vaccination in study MenACWY-TT-027 and booster vaccination in this study (MenACWY-TT-100) and had available assay results for the 1 month post booster vaccination blood sample. "N": number of participants evaluable for this measure. | Posted | Geometric Mean | 95% Confidence Interval | titers | 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. rSBA booster response to meningococcal antigens (A,C, W-135 and Y) is defined as: rSBA antibody titer >= 1:32 one month after vaccination, and at least 4-fold increase in rSBA titers one month after vaccination. | All eligible participants who received primary vaccination in study MenACWY-TT-027 and booster vaccination in this study (MenACWY-TT-100), had available assay results for 1 month post booster vaccination blood sample. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Booster Phase: Percentage of Participants With hSBA Titers >=1:4 and >=1:8 For Each of the 4 Serogroups at 1 Month After Booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | All eligible participants: received primary vaccination in study MenACWY-TT-027, booster vaccination in study MenACWY-TT-100, had available assay results for 1 month post booster vaccination blood sample. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup titers cut off. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Booster Phase: Geometric Mean Titers Using hSBA For Each of the 4 Serogroups at 1 Month After Booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. | All eligible participants: received primary vaccination in study MenACWY-TT-027, booster vaccination in study MenACWY-TT-100, had available assay results for 1 month post booster vaccination blood sample. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup titers cut off. | Posted | Geometric Mean | 95% Confidence Interval | titers | 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Booster Phase: Percentage of Participants With hSBA Booster Response at 1 Month After Booster Vaccination | Serogroups included MenA, MenC, MenW-135 and MenY. hSBA booster response to meningococcal antigens (A,C, W-135 and Y) is defined as: hSBA antibody titer >= 1:8 one month after vaccination, and at least 4-fold increase in hSBA titers one month after vaccination. | All eligible participants: received primary vaccination in study MenACWY-TT-027, booster vaccination in study MenACWY-TT-100, had available assay results for 1 month post booster vaccination blood sample. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Persistence Phase: Percentage of Participants With Serious Adverse Events (SAEs) Related to Vaccination or Any Adverse Event (AE) Related to Lack of Vaccine Efficacy | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs related to "lack of vaccine efficacy" were as judged by the investigator. | All the participants enrolled in the study. | Posted | Number | percentage of participants | Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination | Solicited general events: fatigue, gastrointestinal (GI) events (nausea, vomiting, diarrhea and/or abdominal pain, headache (0= normal, 1=mild/easily tolerated, 2=moderate/interfered with normal activity, 3=severe/prevented normal activity) and fever (>=37.5°C for oral/axillary/tympanic route, >=38.0°C for rectal route). Solicited local events: pain (0=none, 1=mild, not interfered/prevented normal activity, 2=moderate, painful when limb moved/interfered with normal activity, 3=severe, significant pain at rest/prevented normal activity), redness and swelling at injection site (record greatest surface diameter in millimeter (mm) as 0 to <=20 mm, >20 to <=50 mm, >50 mm). Participants may be represented in more than 1 category. Only categories with at least 1 participant reported. 'Medical advice' signifies medical advice received to resolve any event. 'Related'=relationship to study vaccine assessed by investigator. | Analysis population included all participants who received a booster dose of study vaccine MenACWY-TT in the booster stage. "Number analyzed": participants analyzed for specified category. | Posted | Number | percentage of participants | Up to 4 days post booster vaccination |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Booster Phase: Percentage of Participants With Unsolicited Adverse Events up to 31 Days Post Booster Vaccination | An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. | Analysis population included all participants who received a booster dose of study vaccine MenACWY-TT in the booster stage. | Posted | Number | percentage of participants | Up to 31 days post booster vaccination |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Booster Phase: Percentage of Participants With Serious Adverse Events (SAEs) Up to 6 Months Post Booster Vaccination | An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Analysis population included all participants who received a booster dose of study vaccine MenACWY-TT in the booster stage. | Posted | Number | percentage of participants | Up to 6 months post booster vaccination |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Booster Phase: Percentage of Participants With New Onset Chronic Illness Up to 6 Months Post Booster Vaccination | New onset chronic illness included autoimmune disorders, asthma, type I diabetes, allergies. | Analysis population included all participants who received a booster dose of study vaccine MenACWY-TT in the booster stage. | Posted | Number | percentage of participants | Up to 6 months post booster vaccination |
|
For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Persistence Phase: MenACWY-TT Vaccine (Less Than [<] 2 Years) | Participants with <2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027). | 0 | 76 | 0 | 76 | 0 | 76 |
| EG001 | Persistence Phase:MenCCRM (Meningitec) Vaccine(<2 Years) | Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027). | 0 | 23 | 0 | 23 | 0 | 23 |
| EG002 | Persistence Phase: MenACWY-TT Vaccine (>=2 Years) | Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027). | 0 | 115 | 0 | 115 | 0 | 115 |
| EG003 | Persistence Phase: MenPS (Mencevax ACWY) Vaccine (< 2 Years) | Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027). | 0 | 29 | 0 | 29 | 0 | 29 |
| EG004 | Booster Phase: MenACWY-TT Vaccine (Less Than 2 Years) | Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027). Booster phase: Participants received a single 0.5 mL booster dose of MenACWY-TT intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months. | 0 | 67 | 0 | 67 | 53 | 67 |
| EG005 | Booster Phase: MenCCRM (Meningitec) Vaccine (<2 Years) | Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027). Booster phase: Participants received a single 0.5 mL booster dose of MenACWY-TT intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months. | 0 | 16 | 0 | 16 | 12 | 16 |
| EG006 | Booster Phase: MenACWY-TT Vaccine (>= 2 Years) | Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027). Booster phase: Participants received a single 0.5 mL booster dose of MenACWY-TT in this study, 10 years post primary vaccination, and were followed up for 6 months. | 0 | 77 | 1 | 77 | 65 | 77 |
| EG007 | Booster Phase: MenPS (Mencevax ACWY) Vaccine (<2 Years) | Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027). Booster phase: Participants received a single 0.5 mL booster dose of MenACWY-TT in this study, 10 years post primary vaccination, and were followed up for 6 months. | 0 | 21 | 0 | 21 | 15 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA v21.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymph node pain | Blood and lymphatic system disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Coeliac disease | Gastrointestinal disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Gastrointestinal symptoms | Gastrointestinal disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Fatigue 1 | General disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Injection site erythema (redness) | General disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Injection site hypoaesthesia | General disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Injection site pain (pain at injection site) | General disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Injection site swelling (swelling) | General disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v21.0 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA v21.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v21.0 | Non-systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA v21.0 | Non-systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA v21.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v21.0 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA v21.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v21.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA v21.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v21.0 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA v21.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v21.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v21.0 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA v21.0 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA v21.0 | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA v21.0 | Non-systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Headache 1 | Nervous system disorders | MedDRA v21.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA v21.0 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA v21.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 26, 2017 | Mar 4, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| White - Caucasian/European heritage |
|
| Other |
|
| rSBA-MenC: >=1:8 |
|
| rSBA-MenW-135: >=1:8 |
|
| rSBA-MenY: >=1:8 |
|
| rSBA-MenA: >=1:28 |
|
| rSBA-MenC: >=1:28 |
|
| rSBA-MenW-135: >=1:28 |
|
| rSBA-MenY: >=1:28 |
|
Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG002 | MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG003 | MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
|
|
| OG002 | MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG003 | MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
|
|
Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG002 | MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG003 | MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
|
|
Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG002 | MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG003 | MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
|
|
| OG002 | MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG003 | MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
|
|
Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
| OG002 | MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG003 | MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
|
|
| OG002 | MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG003 | MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
|
|
Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
| OG002 | MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG003 | MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
|
|
Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
| OG002 | MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG003 | MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
|
|
| MenCCRM (Meningitec) Vaccine: Less Than 2 Years |
Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG002 | MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG003 | MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
|
|
Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG002 | MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG003 | MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
|
|
Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG002 | MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG003 | MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
|
|
Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
| OG002 | MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG003 | MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
|
|
| OG001 | MenCCRM (Meningitec) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG002 | MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG003 | MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
|
|
Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG002 | MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG003 | MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
|
|
Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG002 | MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG003 | MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
|
|
| OG001 | MenCCRM (Meningitec) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG002 | MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG003 | MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
|
|
| OG001 |
| MenCCRM (Meningitec) Vaccine: Less Than 2 Years |
Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG002 | MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG003 | MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
|
|
| OG001 | MenCCRM (Meningitec) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG002 | MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG003 | MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
|
|
| OG001 | MenCCRM (Meningitec) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG002 | MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG003 | MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
|
|
| MenCCRM (Meningitec) Vaccine: Less Than 2 Years |
Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG002 | MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG003 | MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
|
|
| OG002 | MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
| OG003 | MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years | Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination. |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|