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| ID | Type | Description | Link |
|---|---|---|---|
| C0921003 | Other Identifier | Alias Study Number | |
| 2013-001083-28 | EudraCT Number | ||
| 116892 | Other Identifier | Alias Study Number |
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The purpose of this study is to compare the immediate and long term (up to 5 years) immunogenicity and safety of GSK Biologicals' MenACWY-TT vaccine when given as a single dose or as 2 doses to toddlers aged 12 to 14 months. Also, this study will also assess if co-administration of GSK Biologicals' MenACWY-TT with the booster dose of Pfizer's Prevenar 13 adversely impacts the immunogenicity of either of the vaccines.
The Medicines Control Council (MCC) authorities requested that subjects be screened for HIV testing prior to study enrolment in South Africa to ensure that only HIV negative participants are enrolled. As such, HIV rapid test was added at Visit 1 only for subjects in South Africa. Subjects previously screened HIV positive will be excluded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACWY1d group | Experimental | Subjects will receive 1 dose of the MenACWY-TT vaccine |
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| ACWY2d group | Experimental | Subjects will receive 2 doses of the MenACWY-TT vaccine 2 months apart |
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| Co-ad group | Experimental | Subjects will receive 1 dose of the MenACWY-TT vaccine co-administered with Prevenar 13™ |
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| PCV-13 group | Active Comparator | Subjects will receive 1 dose of Prevenar 13™ and 1 dose of the MenACWY-TT vaccine 2 months later |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meningococcal vaccine GSK134612 | Biological | 1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement Antibody (rSBA) Titers >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups | 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). Percentage of participants with rSBA titers >=1:8 against each serogroup at 1 month after administration of MenACWY-TT are reported. According-to-protocol (ATP) cohort for persistence Year 1 population included all participants who met all eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present with a medical condition or received product leading to exclusion or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1) |
| Percentage of Participants With rSBA Titers >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group | 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). Percentage of participants with rSBA titers >=1:8 against each serogroup at 1 month after administration of 2 doses of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | 1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3) |
| Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1 in the ACWY1d and ACWY2d Groups | 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). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at Year 1 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups | 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). Percentage of participants with hSBA titers >=1:4 and >=1:8 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. |
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Inclusion Criteria:
Exclusion Criteria:
Child in care.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine or planned use during the study period.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the dose of vaccines, with the exception of a licensed inactivated influenza vaccine. Measles, Mumps Rubella (MMR) vaccine or Measles Mumps Rubella and Varicella (MMRV) vaccine can be co-administered with MenACWY-TT and/or Prevenar 13. A DTPa containing vaccine can be administered after the last blood sampling (at Visit 2 or 4 depending on the group).
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 (pharmaceutical product or device).
Previous vaccination against Neisseria meningitidis.
Previous booster vaccination against Streptococcus pneumoniae.
Previous booster vaccination against Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis.
History of meningococcal disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required)*
Family history of congenital or hereditary immunodeficiency.
History of any reaction or hypersensitivity, including to diphtheria toxoid, likely to be exacerbated by any component of the vaccines.
Major congenital defects or serious chronic illness.
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 enrollment.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canberra Hospital | Garran | Australian Capital Territory | 2605 | Australia | ||
| The Childrens Hospital at Westmead |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36621408 | Derived | Cutland CL, Peyrani P, Webber C, Newton R, Cutler M, Perez JL. A phase 3, randomized, controlled, open-label study to evaluate the persistence up to 5 years of 1 or 2 doses of meningococcal conjugate vaccine MenACWY-TT given with or without 13-valent pneumococcal conjugate vaccine in 12-14-month-old children. Vaccine. 2023 Jan 27;41(5):1153-1160. doi: 10.1016/j.vaccine.2022.11.048. Epub 2023 Jan 6. |
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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.
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A total of 803 participants were enrolled and were randomized in 1:1:1:1 ratio to either ACWY1d, ACWY2d, Co-ad and PCV13 groups.
Study was conducted from 2 October 2013 to 5 December 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | ACWY1d Group | Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0. |
| FG001 | ACWY2d Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 9, 2018 | Sep 7, 2021 |
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| Prevenar 13™ | Biological | 1 dose administered intramuscularly in the right anterolateral thigh or deltoid region |
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| At Year 1 |
| Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1 in the ACWY1d and ACWY2d Groups | Geometric mean titers of antibodies against each serogroup were assessed using rSBA. 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). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | At Year 1 |
| Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 3 in the ACWY1d and ACWY2d Groups | 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). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at Year 3 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 3 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | At Year 3 |
| Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 3 in the ACWY1d and ACWY2d Groups | Geometric mean titers of antibodies against each serogroup were assessed using rSBA. 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). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 3 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | At Year 3 |
| Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 5 in the ACWY1d and ACWY2d Groups | 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). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at Year 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | At Year 5 |
| Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 5 in the ACWY1d and ACWY2d Groups | Geometric mean titers of antibodies against each serogroup were assessed using rSBA. 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). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | At Year 5 |
| Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups | GMCs for anti-pneumococcal antibodies (anti-1, anti-3, anti-4, anti-5, anti-6A, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19A, anti-19F and anti-23F) were measured in microgram per milliliter (mcg/mL). ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2 (Month 1), and had available blood sample at Visit 2 (Month 1) for PCV13 group. | 1 month after administration of Prevnar 13 (i.e. at Month 1) |
| 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1) |
| Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group | 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). Percentage of participants with hSBA titers >=1:4 and >=1:8 against each serogroup at 1 month after administration of 2 doses of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | 1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3) |
| Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups | Geometric mean titers of antibodies against each serogroup were assessed using hSBA. 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). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1) |
| Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group | Geometric mean titers of antibodies against each serogroup were assessed using hSBA. 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). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | 1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3) |
| Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group | 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). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3) |
| Geometric Mean Titers (GMTs) With rSBA Titers for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group | Geometric mean titers of antibodies against each serogroup were assessed using rSBA. 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). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3) |
| Percentage of Participants With rSBA Titers >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups | 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). Percentage of participants with rSBA titers >=1:128 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1) |
| Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in ACWY1d, ACWY2d and Co-ad Groups | Geometric mean titers of antibodies against each serogroup were assessed using rSBA. 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). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1) |
| Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups | 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). Percentage of participants with hSBA titers >=1:4 and >=1:8 against each serogroup at Year 1, 3 and 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | At Year 1, Year 3, Year 5 |
| Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups | Geometric mean titers of antibodies against each serogroup were assessed using hSBA. 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). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | At Year 1, Year 3, Year 5 |
| Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups | 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). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at Year 1, 3 and 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | At Year 1, Year 3, Year 5 |
| Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups | Geometric mean titers of antibodies against each serogroup were assessed using rSBA. 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). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | At Year 1, Year 3, Year 5 |
| Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups | Antibody concentrations were determined for anti-pneumococcal antibodies: anti-1, anti-3, anti-4, anti-5, anti-6A, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19A, anti-19F and anti-23F. Percentage of participants with antibody concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL against each serogroup at 1 month after administration of Prevnar 13 are reported. ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group. | 1 month after administration of Prevnar 13 (i.e. at Month 1) |
| Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups | OPA titers were determined for anti-pneumococcal serotypes: OPSONO-1, OPSONO-3, OPSONO-4, OPSONO-5, OPSONO-6A, OPSONO-6B, OPSONO-7F, OPSONO-9V, OPSONO-14, OPSONO-18C, OPSONO-19A, OPSONO-19F and OPSONO-23F. Percentage of participants with OPA titers >=1:8 against each serogroup at 1 month after administration of Prevnar 13 are reported. ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group. | 1 month after administration of Prevnar 13 (i.e. at Month 1) |
| Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups | OPA titers were determined for anti-pneumococcal serotypes: OPSONO-1, OPSONO-3, OPSONO-4, OPSONO-5, OPSONO-6A, OPSONO-6B, OPSONO-7F, OPSONO-9V, OPSONO-14, OPSONO-18C, OPSONO-19A, OPSONO-19F and OPSONO-23F. OPA titers are expressed as 1/dilution. ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group. | 1 month after administration of Prevnar 13 (i.e. at Month 1) |
| Number of Participants With Solicited Local Reactions Within 4 Days Post Each Vaccination | Solicited local reactions included pain, redness and swelling. Here, '0' in the number analyzed field signifies that no vaccine was administered in the specified group for the specified category. | Within 4 days post each vaccination (vaccination 1 [at Month 0] and vaccination 2 [at Month 2]) |
| Number of Participants With Solicited General Reactions Within 4 Days Post Each Vaccination | Solicited general reactions included drowsiness, irritability/fussiness, loss of appetite and fever. Here, '0' in the number analyzed field signifies that no vaccine was administered in the specified group for the specified category. Post dose 1 for ACWY1d and Co-ad group included reactions occurred after dosing of both MenACWY-TT and Prevenar 13 for Co-ad group and data was collected and summarized collectively. | Within 4 days post each vaccination (vaccination 1 [Dose 1] and vaccination 2 [Dose 2]) |
| Number of Participants With Unsolicited Adverse Events Within 31 Days Post Any Study Vaccination, Classified According to Medical Dictionary for Regulatory Activities (MedDRA) | An adverse event 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 adverse event was an observed adverse event that did not fulfill the conditions prelisted in the case report book (CRB) in terms of symptom and/or onset post-vaccination. | Within 31 days post any vaccination |
| Number of Participants With Serious Adverse Events From Month 0 to Month 9 | An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. | Month 0 to Month 9 |
| Number of Participants With Serious Adverse Events Related to Study Vaccination From First Dose of Study Drug up to End of Study | An adverse event was any untoward medical occurrence in a participant who received study drug. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Related adverse events were those adverse events who were related to the vaccination as judged by the investigator. | Baseline up to end of study (up to 5 years) |
| Number of Participants With Any New Onset of Chronic Illnesses (NOCIs) From Month 0 to Month 9 | New onset chronic illness included autoimmune disorders, asthma, type I diabetes and allergies. | Month 0 to Month 9 |
| Westmead |
| New South Wales |
| 2145 |
| Australia |
| Women's and Children's Hospital | North Adelaide | South Australia | 5006 | Australia |
| Vaccine and Immunization Research Group | Melbourne | Victoria | 3010 | Australia |
| Vaccine Trials Group, Telethon Kids Institute, Perth Children's Hospital | Nedlands | Western Australia | 6009 | Australia |
| The Clinical Research Unit; Children's Hospital Research Institute of Manitoba [CHRIM] | Winnipeg | Manitoba | R3E 3P4 | Canada |
| Canadian Center for Vaccinology - IWK Health Centre | Halifax | Nova Scotia | B3K 6R8 | Canada |
| Medicor Research Inc. | Greater Sudbury | Ontario | P3A 1W8 | Canada |
| Dr. Allen Greenspoon Medicine Professional Corporation | Hamilton | Ontario | L8L 5G8 | Canada |
| CHU de Quebec-Universite Laval | Québec | Quebec | G1E 7G9 | Canada |
| Medicentrum 6 s.r.o | Prague | Vokovice | 160 00 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Benešov | 256 01 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Boletice nad Labem | 40711 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Brandýs nad Labem | 250 01 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Chrastava | 463 31 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Chrudim | 537 01 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Čáslav | 286 01 | Czechia |
| Krajska zdravotni, a.s., Nemocnice Decin | Děčín | 405 01 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Domažlice | 34401 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Holice | 534 01 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Hradec Králové | 500 02 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Hrádek nad Nisou | 463 34 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Hronov | 54931 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Jindřichův Hradec | 377 01 | Czechia |
| Ordinace Praktickeho Lekare Pro Deti A Dorost | Kladno | 272 01 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Krupka | 417 41 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Liberec | 460 07 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Mělník | 276 01 | Czechia |
| Oblastni nemocnice Nachod | Náchod | 547 01 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Neveklov | 257 56 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Nový Jičín | 741 01 | Czechia |
| Ordinace Praktickeho Lekare pro deti a dorost | Odolena Voda | 250 70 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Ostrov | 363 01 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Ostrov | 36301 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Pardubice | 530 03 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Pardubice | 530 09 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Pardubice | 530 12 | Czechia |
| Nemocnice Pardubice | Pardubice | 532 03 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Prague | 130 00 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Prague | 15200 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Smiřice | 503 03 | Czechia |
| Ordinace Praktickeho Lekare pro deti a dorost | Trutnov | 541 01 | Czechia |
| Ordinace praktickeho lekare pro deti a dorost | Týnec nad Sázavou | 257 41 | Czechia |
| Centro Pediatrico America, Consultorios America | Panama City | Panama |
| CEVAXIN Plaza Carolina | Panama City | Panama |
| Consultorios America Via Espana | Panama City | Panama |
| ULAPS Guadalupe | Panama City | Panama |
| Chris Hani Baragwanath Academic Hospital | Soweto | Gauteng | 2013 | South Africa |
| Setshaba Clinical Research | Gauteng | 0152 | South Africa |
| Hacettepe University Faculty of Medicine | Ankara | Sihhiye | 06100 | Turkey (Türkiye) |
| Ege University Hospital Medical Faculty | Izmir | 35100 | Turkey (Türkiye) |
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
| FG002 | Co-ad Group | Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0. |
| FG003 | PCV13 Group | Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2. |
| Vaccinated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Analysis was performed on participants, who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ACWY1d Group | Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0. |
| BG001 | ACWY2d Group | Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2. |
| BG002 | Co-ad Group | Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0. |
| BG003 | PCV13 Group | Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2. |
| 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 | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement Antibody (rSBA) Titers >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups | 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). Percentage of participants with rSBA titers >=1:8 against each serogroup at 1 month after administration of MenACWY-TT are reported. According-to-protocol (ATP) cohort for persistence Year 1 population included all participants who met all eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present with a medical condition or received product leading to exclusion or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for PCV13 reporting group. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1) |
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| Primary | Percentage of Participants With rSBA Titers >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group | 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). Percentage of participants with rSBA titers >=1:8 against each serogroup at 1 month after administration of 2 doses of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d, Co-ad and PCV13 reporting groups. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3) |
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| Primary | Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1 in the ACWY1d and ACWY2d Groups | 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). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at Year 1 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups. | Posted | Number | 95% Confidence Interval | percentage of participants | At Year 1 |
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| Primary | Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1 in the ACWY1d and ACWY2d Groups | Geometric mean titers of antibodies against each serogroup were assessed using rSBA. 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). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups. | Posted | Geometric Mean | 95% Confidence Interval | titers (1/dilution) | At Year 1 |
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| Primary | Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 3 in the ACWY1d and ACWY2d Groups | 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). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at Year 3 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 3 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | Analyzed on ATP cohort for persistence Year 3 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups. | Posted | Number | 95% Confidence Interval | percentage of participants | At Year 3 |
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| Primary | Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 3 in the ACWY1d and ACWY2d Groups | Geometric mean titers of antibodies against each serogroup were assessed using rSBA. 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). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 3 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | Analyzed on ATP cohort for persistence Year 3 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups. | Posted | Geometric Mean | 95% Confidence Interval | titers (1/dilution) | At Year 3 |
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| Primary | Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 5 in the ACWY1d and ACWY2d Groups | 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). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at Year 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | Analyzed on ATP cohort for persistence Year 5 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups. | Posted | Number | 95% Confidence Interval | percentage of participants | At Year 5 |
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| Primary | Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 5 in the ACWY1d and ACWY2d Groups | Geometric mean titers of antibodies against each serogroup were assessed using rSBA. 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). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | Analyzed on ATP cohort for persistence Year 5 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups. | Posted | Geometric Mean | 95% Confidence Interval | titers (1/dilution) | At Year 5 |
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| Primary | Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups | GMCs for anti-pneumococcal antibodies (anti-1, anti-3, anti-4, anti-5, anti-6A, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19A, anti-19F and anti-23F) were measured in microgram per milliliter (mcg/mL). ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2 (Month 1), and had available blood sample at Visit 2 (Month 1) for PCV13 group. | Analyzed on ATP cohort for immunogenicity post dose 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d and ACWY2d reporting groups. | Posted | Geometric Mean | 95% Confidence Interval | mcg/mL | 1 month after administration of Prevnar 13 (i.e. at Month 1) |
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| Secondary | Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups | 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). Percentage of participants with hSBA titers >=1:4 and >=1:8 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1) |
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| Secondary | Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group | 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). Percentage of participants with hSBA titers >=1:4 and >=1:8 against each serogroup at 1 month after administration of 2 doses of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d, Co-ad and PCV13 reporting groups. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3) |
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| Secondary | Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups | Geometric mean titers of antibodies against each serogroup were assessed using hSBA. 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). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups. | Posted | Geometric Mean | 95% Confidence Interval | titers (1/dilution) | 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1) |
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| Secondary | Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group | Geometric mean titers of antibodies against each serogroup were assessed using hSBA. 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). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups. | Posted | Geometric Mean | 95% Confidence Interval | titers (1/dilution) | 1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3) |
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| Secondary | Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group | 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). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d, ACWY2d and Co-ad reporting groups. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3) |
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| Secondary | Geometric Mean Titers (GMTs) With rSBA Titers for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group | Geometric mean titers of antibodies against each serogroup were assessed using rSBA. 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). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d, ACWY2d and Co-ad reporting groups. | Posted | Geometric Mean | 95% Confidence Interval | titers (1/dilution) | 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3) |
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| Secondary | Percentage of Participants With rSBA Titers >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups | 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). Percentage of participants with rSBA titers >=1:128 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for PCV13 reporting group. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1) |
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| Secondary | Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in ACWY1d, ACWY2d and Co-ad Groups | Geometric mean titers of antibodies against each serogroup were assessed using rSBA. 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). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for PCV13 reporting group. | Posted | Geometric Mean | 95% Confidence Interval | titers (1/dilution) | 1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1) |
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| Secondary | Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups | 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). Percentage of participants with hSBA titers >=1:4 and >=1:8 against each serogroup at Year 1, 3 and 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | Analyzed on ATP cohort for persistence Year 1, 3 and 5 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups. | Posted | Number | 95% Confidence Interval | percentage of participants | At Year 1, Year 3, Year 5 |
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| Secondary | Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups | Geometric mean titers of antibodies against each serogroup were assessed using hSBA. 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). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | Analyzed on ATP cohort for persistence Year 1, 3 and 5 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups. | Posted | Geometric Mean | 95% Confidence Interval | titers (1/dilution) | At Year 1, Year 3, Year 5 |
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| Secondary | Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups | 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). Percentage of participants with rSBA titers >=1:8 and >=1:128 against each serogroup at Year 1, 3 and 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | Analyzed on ATP cohort for persistence Year 1, 3 and 5 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d and ACWY2d reporting groups. | Posted | Number | 95% Confidence Interval | percentage of participants | At Year 1, Year 3, Year 5 |
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| Secondary | Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups | Geometric mean titers of antibodies against each serogroup were assessed using rSBA. 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). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point. | Analyzed on ATP cohort for persistence Year 1, 3 and 5 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d and ACWY2d reporting groups. | Posted | Geometric Mean | 95% Confidence Interval | titers (1/dilution) | At Year 1, Year 3, Year 5 |
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| Secondary | Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups | Antibody concentrations were determined for anti-pneumococcal antibodies: anti-1, anti-3, anti-4, anti-5, anti-6A, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19A, anti-19F and anti-23F. Percentage of participants with antibody concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL against each serogroup at 1 month after administration of Prevnar 13 are reported. ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group. | Analyzed on ATP cohort for immunogenicity post dose 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d and ACWY2d reporting groups. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month after administration of Prevnar 13 (i.e. at Month 1) |
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| Secondary | Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups | OPA titers were determined for anti-pneumococcal serotypes: OPSONO-1, OPSONO-3, OPSONO-4, OPSONO-5, OPSONO-6A, OPSONO-6B, OPSONO-7F, OPSONO-9V, OPSONO-14, OPSONO-18C, OPSONO-19A, OPSONO-19F and OPSONO-23F. Percentage of participants with OPA titers >=1:8 against each serogroup at 1 month after administration of Prevnar 13 are reported. ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group. | Analyzed on ATP cohort for immunogenicity post dose 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d and ACWY2d reporting groups. | Posted | Number | 95% Confidence Interval | percentage of participants | 1 month after administration of Prevnar 13 (i.e. at Month 1) |
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| Secondary | Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups | OPA titers were determined for anti-pneumococcal serotypes: OPSONO-1, OPSONO-3, OPSONO-4, OPSONO-5, OPSONO-6A, OPSONO-6B, OPSONO-7F, OPSONO-9V, OPSONO-14, OPSONO-18C, OPSONO-19A, OPSONO-19F and OPSONO-23F. OPA titers are expressed as 1/dilution. ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group. | Analyzed on ATP cohort for immunogenicity post dose 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d and ACWY2d reporting groups. | Posted | Geometric Mean | 95% Confidence Interval | titers | 1 month after administration of Prevnar 13 (i.e. at Month 1) |
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| Secondary | Number of Participants With Solicited Local Reactions Within 4 Days Post Each Vaccination | Solicited local reactions included pain, redness and swelling. Here, '0' in the number analyzed field signifies that no vaccine was administered in the specified group for the specified category. | The total vaccinated cohort (TVC) included all participants vaccinated with at least 1 dose of study vaccine. The analysis was performed per vaccine actually administered at Dose 1. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. | Posted | Count of Participants | Participants | Within 4 days post each vaccination (vaccination 1 [at Month 0] and vaccination 2 [at Month 2]) |
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| Secondary | Number of Participants With Solicited General Reactions Within 4 Days Post Each Vaccination | Solicited general reactions included drowsiness, irritability/fussiness, loss of appetite and fever. Here, '0' in the number analyzed field signifies that no vaccine was administered in the specified group for the specified category. Post dose 1 for ACWY1d and Co-ad group included reactions occurred after dosing of both MenACWY-TT and Prevenar 13 for Co-ad group and data was collected and summarized collectively. | The total vaccinated cohort (TVC) included all participants vaccinated with at least 1 dose of study vaccine. The analysis was performed per vaccine actually administered at Dose 1. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and 'number analyzed' signifies participants evaluable for each specified category. | Posted | Count of Participants | Participants | Within 4 days post each vaccination (vaccination 1 [Dose 1] and vaccination 2 [Dose 2]) |
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| Secondary | Number of Participants With Unsolicited Adverse Events Within 31 Days Post Any Study Vaccination, Classified According to Medical Dictionary for Regulatory Activities (MedDRA) | An adverse event 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 adverse event was an observed adverse event that did not fulfill the conditions prelisted in the case report book (CRB) in terms of symptom and/or onset post-vaccination. | The total vaccinated cohort (TVC) included all participants vaccinated with at least 1 dose of study vaccine. The analysis was performed per vaccine actually administered at Dose 1. | Posted | Count of Participants | Participants | Within 31 days post any vaccination |
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| Secondary | Number of Participants With Serious Adverse Events From Month 0 to Month 9 | An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. | The total vaccinated cohort (TVC) included all participants vaccinated with at least 1 dose of study vaccine. The analysis was performed per vaccine actually administered at Dose 1. | Posted | Count of Participants | Participants | Month 0 to Month 9 |
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| Secondary | Number of Participants With Serious Adverse Events Related to Study Vaccination From First Dose of Study Drug up to End of Study | An adverse event was any untoward medical occurrence in a participant who received study drug. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Related adverse events were those adverse events who were related to the vaccination as judged by the investigator. | The total vaccinated cohort (TVC) included all participants vaccinated with at least 1 dose of study vaccine. The analysis was performed per vaccine actually administered at Dose 1. | Posted | Count of Participants | Participants | Baseline up to end of study (up to 5 years) |
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| Secondary | Number of Participants With Any New Onset of Chronic Illnesses (NOCIs) From Month 0 to Month 9 | New onset chronic illness included autoimmune disorders, asthma, type I diabetes and allergies. | The total vaccinated cohort (TVC) included all participants vaccinated with at least 1 dose of study vaccine. The analysis was performed per vaccine actually administered at Dose 1. | Posted | Count of Participants | Participants | Month 0 to Month 9 |
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AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.
Same event may appear as both an adverse event and serious adverse events. 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 | ACWY1d Group | Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0. | 0 | 203 | 12 | 203 | 199 | 203 |
| EG001 | ACWY2d Group | Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2. | 0 | 197 | 11 | 197 | 196 | 197 |
| EG002 | Co-ad Group | Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0. | 1 | 201 | 13 | 201 | 197 | 201 |
| EG003 | PCV13 Group | Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2. | 1 | 201 | 16 | 201 | 197 | 201 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
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| Anaphylactic shock | Immune system disorders | MedDRA v23.0 | Non-systematic Assessment |
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| Abscess limb | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
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| Bronchiolitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
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| Croup infectious | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Gastroenteritis rotavirus | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
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| Gastroenteritis salmonella | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
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| Laryngitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
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| Meningitis aseptic | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
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| Myringitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
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| Pneumonia pneumococcal | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
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| Pneumonia viral | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
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| Staphylococcal scalded skin syndrome | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
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| Burns first degree | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
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| Burns second degree | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
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| Petroleum distillate poisoning | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
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| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Marasmus | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v23.0 | Non-systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Adenoidal hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Ear disorder | Ear and labyrinth disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Corneal erosion | Eye disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Eye inflammation | Eye disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Abnormal faeces | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Coeliac disease | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Faeces soft | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Teething | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Crying | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Injection site mass | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Swelling face | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Vaccination site bruising | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Vaccination site pain | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Immunisation reaction | Immune system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Coxsackie viral infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dermatitis infected | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Erythema infectiosum | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Eyelid infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Gastrointestinal bacterial infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Herpangina | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Infected bite | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Measles | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Otosalpingitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Roseola | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Skin bacterial infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Tinea infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Tinea versicolour | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Soft tissue injury | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Body temperature | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Body temperature increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Polydipsia | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Poor quality sleep | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Autism spectrum disorder | Psychiatric disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Fear | Psychiatric disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Initial insomnia | Psychiatric disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Balanoposthitis | Reproductive system and breast disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Genital labial adhesions | Reproductive system and breast disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Genital rash | Reproductive system and breast disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Vulvovaginal adhesion | Reproductive system and breast disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Catarrh | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Nasal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Nasal mucosal discolouration | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Respiratory symptom | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Intertrigo | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Rash morbilliform | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v23.0 | Systematic Assessment | Number of participants evaluable for this local reaction. |
|
| Redness | General disorders | MedDRA v23.0 | Systematic Assessment | Number of participants evaluable for this local reaction. |
|
| Swelling | General disorders | MedDRA v23.0 | Systematic Assessment | Number of participants evaluable for this local reaction. |
|
| Drowsiness | General disorders | MedDRA v23.0 | Systematic Assessment | Number of participants evaluable for this general reaction. |
|
| Irritability/Fussiness | General disorders | MedDRA v23.0 | Systematic Assessment | Number of participants evaluable for this general reaction. |
|
| Loss Of Appetite | General disorders | MedDRA v23.0 | Systematic Assessment | Number of participants evaluable for this general reaction. |
|
| Temperature/(Rectal) (°C) | General disorders | MedDRA v23.0 | Systematic Assessment | Number of participants evaluable for this general reaction. |
|
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 | Nov 11, 2016 | Sep 7, 2021 | 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
| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| rSBA-MenC |
|
|
| rSBA-MenW-135 |
|
|
| rSBA-MenY |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
|
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
|
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
|
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.
|
|
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2. |
|
|
| ACWY2d Group |
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2. |
|
|
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2. |
|
|
| OG001 | ACWY2d Group | Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 | ACWY2d Group | Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| OG001 |
| ACWY2d Group |
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2. |
| OG002 | Co-ad Group | Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0. |
|
|
| OG001 | ACWY2d Group | Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2. |
| OG002 | Co-ad Group | Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0. |
|
|
| ACWY2d Group |
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2. |
|
|
| ACWY2d Group |
Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2. |
|
|
| PCV13 Group |
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2. |
|
|
| PCV13 Group |
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2. |
|
|
| OG001 | PCV13 Group | Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2. |
|
|
| OG001 | PCV13 Group | Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2. |
|
|
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2. |
|
|
| OG003 | PCV13 Group | Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2. |
|
|
| OG002 |
| Co-ad Group |
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0. |
| OG003 | PCV13 Group | Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2. |
|
|
| OG003 | PCV13 Group | Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2. |
|
|
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.
| OG003 | PCV13 Group | Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2. |
|
|
| OG002 |
| Co-ad Group |
Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0. |
| OG003 | PCV13 Group | Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2. |
|
|
Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.
|
|
|
|
|
|
|
|
|
|
| Title | Measurements |
|---|---|
|
|
|
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|