Trial · NCT04707391
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentages of Participants With a 4-fold Rise in Human Serum Bactericidal Assay (hSBA) Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline | At 1 month after vaccination schedule (i.e., Day 211 for ABCWY group and Day 31 for ACWY group) compared to Day 1 (Baseline) | Four-fold rise is defined as: - a post-vaccination hSBA titer equal to or higher than (\>=) 16 for participants with a pre-vaccination hSBA titer \<4; - a post-vaccination hSBA titer \>= 4 times the LLOQ for participants with a pre vaccination hSBA titer \>= limit of detection (LOD) but \< LLOQ; and - a post-vaccination hSBA titer \>= 4 times the pre-vaccination titer for participants with a pre-vaccination hSBA titer \>= LLOQ. |
| Primary | Percentages of Participants With a 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline | At 1 month after the first vaccination (i.e., Day 31) compared to Day 1 (Baseline) | Four-fold rise is defined as: - a post-vaccination hSBA titer equal to or higher than (\>=) 16 for participants with a pre-vaccination hSBA titer \<4; - a post-vaccination hSBA titer \>= 4 times the LLOQ for participants with a pre vaccination hSBA titer \>= limit of detection (LOD) but \< LLOQ; and - a post-vaccination hSBA titer \>= 4 times the pre-vaccination titer for participants with a pre-vaccination hSBA titer \>= LLOQ. |
| Primary | Number of Participants With Solicited Administration Site Events Following Vaccination at Day 1 for ABCWY Group and ACWY Group | During the 7 days (including day of vaccination) following vaccination at day 1 for ABCWY group and ACWY group | Assessed solicited administration site events include injection site pain, erythema, swelling, induration. Any pain = occurrence of the symptom regardless of intensity grade and any erythema, swelling and induration are defined as a symptom with a surface diameter equal to or greater than 25 millimeters. |
| Primary | Number of Participants With Solicited Administration Site Events Following Vaccination at Day 181 for ABCWY Group | During the 7 days (including day of vaccination) following vaccination at Day 181 for ABCWY group | Assessed solicited administration site events include injection site pain, erythema, swelling, induration. Any pain = occurrence of the symptom regardless of intensity grade and any erythema, swelling and induration are defined as a symptom with a surface diameter equal to or greater than 25 millimeters. |
| Primary | Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group | During the 7 days (including day of vaccination) following vaccination at day 1 for the ABCWY group and ACWY group | Assessed solicited systemic events include fever \[body temperature \>= 38.0°C (celsius) /100.4°F (Fahrenheit)\], nausea, fatigue, myalgia, arthralgia, headache. |
| Primary | Number of Participants With Solicited Systemic Events Following Vaccination at Day 181 for the ABCWY Group | During the 7 days (including day of vaccination) following vaccination at day 181 for the ABCWY group | Assessed solicited systemic events include fever \[body temperature \>= 38.0°C/100.4°F\], nausea, fatigue, myalgia, arthralgia, headache. |
| Primary | Number of Participants With Any Unsolicited Adverse Events (AEs) (Including All Serious Adverse Events [SAEs], AEs Leading to Withdrawal, AEs of Special Interest [AESIs] and Medically Attended AEs) | During the 30 days (including day of vaccination) following vaccination at day 1 for ABCWY group and ACWY group | Unsolicited AE-AE not solicited using an eDiary and spontaneously communicated by a participant/participant's parent(s)/Legally acceptable representative(s) who has signed informed consent. SAEs-events that result in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect in the offspring of a study participant/results in abnormal pregnancy outcomes. AESIs-predefined AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it. An MAE is defined as an unsolicited AE for which the participant received medical attention such as hospitalization, or an emergency room visit, or visit to/by a health care provider. |
| Primary | Number of Participants With Any Unsolicited Adverse Events (AEs) (Including All Serious Adverse Events [SAEs], AEs Leading to Withdrawal, AEs of Special Interest [AESIs] and Medically Attended AEs) Following Vaccination at Day 181 for ABCWY Group | During the 30 days (including day of vaccination) following vaccination at day 181 for ABCWY group | Any AE-untoward medical occurrence in a patient/clinical investigation participant, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AE-AE not solicited using an eDiary and spontaneously communicated by a participant/participant's parent(s)/Legally acceptable representative(s) who has signed informed consent. SAEs-events that result in death, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is congenital anomaly/birth defect in the offspring of a study participant/results in abnormal pregnancy outcomes. AESIs-predefined AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it. |
| Primary | Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs | From Day 1 to Day 361 (throughout the study period) | SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were assessed throughout the study period are reported in this outcome measure. |
| Secondary | Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | At Day 1 (pre-vaccination) and 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group) | The immune response to MenABCWY vaccine after the first dose and single dose of MenACWY vaccine was evaluated by measuring the percentage of participants with hSBA titers \>= LLOQ against each of the serogroups A, C, W and Y. |
| Secondary | Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination | 1 month after the vaccination schedule (i.e., Day 211 for ABCWY group [second dose]) | The immune response to MenABCWY vaccine after the second dose was evaluated by measuring the percentage of participants with hSBA titers \>= LLOQ against each of the serogroups A, C, W and Y. |
| Secondary | hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | At Day 1 and 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group) | The immune response to MenABCWY after first dose and single dose of MenACWY vaccine was evaluated by measuring the human serum bactericidal activity against each of the serogroups A, C, W and Y in terms of GMTs. For each serogroup, the GMTs with their associated 2-sided 95% confidence intervals were calculated. |
| Secondary | hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination | 1 month after the vaccination schedule (i.e., Day 211 for ABCWY group [second dose]) | The immune response to MenABCWY after second dose was evaluated by measuring the human serum bactericidal activity against each of the serogroups A, C, W and Y in terms of GMTs. For each serogroup, the GMTs with their associated 2-sided 95% confidence intervals were calculated. |
| Secondary | Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination | At 1 month after the vaccination schedule (i.e., Day 31 for ABCWY group [first dose] and ACWY group) compared to baseline (Day 1) | The immune response to MenABCWY vaccine after first and single dose of MenACWY vaccine are evaluated by measuring the human serum bactericidal activity against each of the serogroups A, C, W and Y, compared to baseline (Day 1) and expressed as GMRs. Within group GMRs was calculated as ratio of GMTs in the post-vaccination timepoint to the pre-vaccination timepoint. |
| Secondary | Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After Second MenABCWY Vaccination | At 1 month after the vaccination schedule (i.e., Day 211 for ABCWY group [second dose]) compared to baseline (Day 1) | The immune response to MenABCWY vaccine after second dose are evaluated by measuring the human serum bactericidal activity against each of the serogroups A, C, W and Y, compared to baseline (Day 1) and expressed as GMRs. Within group GMRs was calculated as ratio of GMTs in the post-vaccination timepoint to the pre-vaccination timepoint. |
| Secondary | Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination | At Day 1 and at Day 211 | The immune response to MenABCWY vaccine after second dose was evaluated by measuring bactericidal activity against each (individual response) and all (composite response) N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively). |
| Secondary | Percentages of Participants With 4-fold Rise in hSBA Titers Against Each N. Meningitidis Serogroup B Indicator Strains at 1 Month After the Second MenABCWY Vaccination | At Day 211 compared to baseline (Day 1) | The immune response to MenABCWY after second dose is evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B test strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively). compared to baseline (day 1) in terms of 4-fold rise in hSBA titers. For each of the serogroup B indicator strains, the 4-fold rise is defined as: a post-vaccination hSBA titer \>=16 for participants with a pre-vaccination hSBA titer \<4; . a post-vaccination hSBA titer \>= 4 times the LLOQ for participants with a prevaccination hSBA titer \>= limit of detection (LOD) but \< LLOQ; and, a post-vaccination hSBA titer \>= 4 times the pre-vaccination titer for participants with a pre-vaccination hSBA titer \>= LLOQ. |
| Secondary | GMTs Against Each Serogroup B Indicator Strains at Day 1 and at 1 Month After Second MenABCWY Vaccination | At Day 1 and at Day 211 | The immune response to MenABCWY vaccine after the second dose was evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively) in terms of GMTs at baseline (Day 1) and 1 month after second MenABCWY vaccination. |
| Secondary | GMRs Against Each Serogroup B Indicator Strains at 1 Month After Second Dose of MenABCWY Vaccination | At Day 211 compared to baseline (Day 1) | The immune response to MenABCWY vaccine after second dose was evaluated by measuring the human serum bactericidal activity against each of the N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively) compared to baseline (Day 1) and expressed as GMRs. Within group GMRs was calculated as ratio of GMTs in the post-vaccination timepoint to the pre-vaccination timepoint. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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