Trial · NCT04707391
Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine
NCT04707391, Phase 3, Completed, GlaxoSmithKline; results first posted 2024-07-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine. Trials, record NCT04707391. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04707391
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine
- NCT number
- NCT04707391
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,250 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Meningitis, Meningococcal
- Interventions
- MenABCWY vaccine, Placebo, MenACWY vaccine, MenB vaccine
- First posted
- 2021-01-13
- Last updated
- 2024-07-03
- Other registries' IDs
- eudract:2019-004982-42
- Results first posted
- 2024-07-03
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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) | Analysis was performed on Per Protocol Set (PPS), which included participants who received at least 1 dose of the study intervention to which they were randomized and had post-vaccination data available at the specified timepoint minus participants with protocol deviations that led to exclusion from the PPS. | Percentage of Participants | NUMBER |
| 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) | Analysis was performed on Per Protocol Set (PPS), which included participants who received at least 1 dose of the study intervention to which they were randomized and had post-vaccination data available at the specified timepoint minus participants with protocol deviations that led to exclusion from the PPS. | Percentage of Participants | NUMBER |
| 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 | Analysis was performed on Solicited Safety Set (SSS),which included participants who received at least 1 dose of the study intervention and had solicited administration data available during the specified period. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Analysis was performed on Solicited Safety Set (SSS), which included participants who received at least 2 dose of the study intervention and had solicited data available during the specified period. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Analysis was performed on Solicited Safety Set (SSS), which included participants who received at least 1 dose of the study intervention and had solicited systemic data available during the specified period. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Analysis was performed on Solicited Safety Set (SSS),which included participants who received at least 2 dose of the study intervention and had solicited systemic data available during the specified period. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Analysis was performed on the Unsolicited Safety Set (USS), which included participants who received at least 1 dose of the study intervention and had unsolicited AEs during the specific period. | Participants | COUNT_OF_PARTICIPANTS |
| 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 | Analysis was performed on the Unsolicited Safety Set (USS), which included participants who received at least 1 dose of the study intervention and had unsolicited AEs during the specific period. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | Analysis was performed on the Unsolicited Safety Set (USS), which included participants who received at least 1 dose of the study intervention and had unsolicited AEs during the specific period. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | Analysis was performed on the Full Analysis Set (FAS), which included participants who received at least 1 dose of the study intervention and had post-vaccination immunogenicity data for the specified analysis at the specified time points. | Percentage of Participants | NUMBER |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group135
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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 | ABCWY Group | Meningitis A | 95.3 | 95% Confidence Interval 90.89 to 97.93 | Percentage of Participants |
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 | ACWY Group | Meningitis A | 95.0 | 95% Confidence Interval 92.78 to 96.77 | Percentage of Participants |
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 | ABCWY Group | Meningitis C | 94.5 | 95% Confidence Interval 90.07 to 97.32 | Percentage of Participants |
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 | ACWY Group | Meningitis C | 94.0 | 95% Confidence Interval 91.62 to 95.80 | Percentage of Participants |
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 | ABCWY Group | Meningitis W | 95.6 | 95% Confidence Interval 91.48 to 98.07 | Percentage of Participants |
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 | ACWY Group | Meningitis W | 93.9 | 95% Confidence Interval 91.59 to 95.79 | Percentage of Participants |
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 | ABCWY Group | Meningitis Y | 95.0 | 95% Confidence Interval 90.72 to 97.69 | Percentage of Participants |
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 | ACWY Group | Meningitis Y | 94.4 | 95% Confidence Interval 92.12 to 96.20 | Percentage of Participants |
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 | ABCWY Group | Meningitis A | 92.5 | 95% Confidence Interval 89.90 to 94.66 | Percentage of Participants |
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 | ACWY Group | Meningitis A | 95.0 | 95% Confidence Interval 92.78 to 96.77 | Percentage of Participants |
1 to 10 of 135Source ClinicalTrials.gov
See all 135 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ABCWY Group | 626 | |
| Overall Study | STARTED | ACWY Group | 621 | |
| Overall Study | COMPLETED | ABCWY Group | 541 | |
| Overall Study | COMPLETED | ACWY Group | 542 | |
| Overall Study | NOT COMPLETED | ABCWY Group | 85 | |
| Overall Study | NOT COMPLETED | ACWY Group | 79 |
Source ClinicalTrials.gov
Adverse events658
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abscess limb | Infections and infestations | ABCWY Group | 1 | 626 | 1 |
| other | Abscess limb | Infections and infestations | ACWY Group | 0 | 621 | 0 |
| other | Acute sinusitis | Infections and infestations | ABCWY Group | 3 | 626 | 3 |
| other | Acute sinusitis | Infections and infestations | ACWY Group | 6 | 621 | 6 |
| other | Atypical pneumonia | Infections and infestations | ABCWY Group | 1 | 626 | 1 |
| other | Atypical pneumonia | Infections and infestations | ACWY Group | 1 | 621 | 1 |
| other | Bacterial vaginosis | Infections and infestations | ABCWY Group | 3 | 626 | 3 |
| other | Bacterial vaginosis | Infections and infestations | ACWY Group | 0 | 621 | 0 |
| other | Bronchitis | Infections and infestations | ABCWY Group | 1 | 626 | 1 |
| other | Bronchitis | Infections and infestations | ACWY Group | 2 | 621 | 3 |
1 to 10 of 658Source ClinicalTrials.gov
See all 658 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ABCWY Group | 1 | 626 |
| Total, all-cause mortality | ACWY Group | 1 | 621 |
| Total, other adverse events | ABCWY Group | 583 | 626 |
| Total, other adverse events | ACWY Group | 552 | 621 |
| Total, serious adverse events | ABCWY Group | 18 | 626 |
| Total, serious adverse events | ACWY Group | 7 | 621 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39722560 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
ABCWY Group vs ACWY Group: 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) | Trial comparisons |
| ABCWY Group vs ACWY Group: deaths from any cause | Trial comparisons |
| ABCWY Group vs ACWY Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04707391
GET https://conductscience.org/api/trials/v1/NCT04707391/results?page=2