A Phase 2 interventional study of MenACWY liquid and MenACWY in Meningitis, Meningococcal, sponsored by GlaxoSmithKline. Completed at 49 sites in 9 countries. Open to participants aged 10 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-17.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Prevention
Among 10 studies in Meningitis, Meningococcal with a site in Spain — none open to participants now, none under way, none of them phase 3. Meningitis, Meningococcal · Spain.
Among the 10 studies in Meningitis, Meningococcal with a site in Spain, this one is the 2nd largest by enrollment, is one of 2 that started in 2018, is one of 3 in phase 2, and was the 9th registered.
125 studies on the registry are indexed under Meningitis, Meningococcal; 10 are open to participants now.
This study's enrollment of 1,707 is above the median of 538 across 113 interventional studies indexed under Meningitis, Meningococcal.
Browse Meningitis, Meningococcal studies →None of the 10 studies in Meningitis, Meningococcal with a site in Spain is open now.
Of the 5 Meningitis, Meningococcal studies recruiting now, 0 (0%) set no upper age limit and 5 (100%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.
This study: 10 Years to 40 Years · all sexes · healthy volunteers too.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 2 started in 2018.
Median enrollment 1,164 across the 10 interventional studies. Of the 10 that completed or were terminated, 10 (100%) have results posted.
10 of 10 have an industry lead sponsor. The 4 most frequent:
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
GlaxoSmithKline has 9 studies filed under Meningitis, Meningococcal — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Meningitis, Meningococcal with a site in Spain, from their registry updates:
Nothing recorded among them since 2026-09-25.
MenACWY (Menveo) is a GSK vaccine intended for protection against disease caused by meningococcal bacteria groups A, C, W and Y in infants, children and adults, licensed in more than 60 countries.
The purpose of this study is to compare the immunogenicity of the currently licensed MenACWY vaccine with the investigational MenACWY liquid vaccine aged for different lengths of time by storage at 2-8ºC.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female subjects of non- may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Exclusion Criteria:
Abnormal function of the immune system resulting from:
Individuals who received any other vaccines within 7 days (for inactivated vaccines) or 14 days prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.*
* In case an emergency mass vaccination for an unforeseen public health threat is organized by the public health authorities, outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine provided it is licensed and used according to its Prescribing Information and according to the local governmental recommendations and provided a written approval of the sponsor is obtained.
Acute disease and/or fever within 3 days prior to study vaccination. Note: enrolment may be postponed/delayed until such transient circumstances have ended.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy subjects receiving a single dose of the investigational MenACWY liquid vaccine formulation aged for approximately 24 months, at Day 1 in the Study Phase1.
Biological: MenACWY liquid
Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1.
Biological: MenACWY
Healthy subjects receiving a single dose of the investigational MenACWY liquid vaccine formulation aged for approximately 30 months, at Day 1 in the Study Phase 2.
Biological: MenACWY liquid
Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
Biological: MenACWY
At visit 1 (day 1), each subject will receive a single dose of the investigational MenACWY liquid vaccine (GSK3536820A) aged for approximately 24 months in Phase 1 of the study (subjects randomized to study arm ACWY_Liq24) or vaccine aged for 30 months in Phase 2 of the study (subjects randomized to study arm ACWY_Liq30), administered by intramuscular injection in the deltoid of the non-dominant arm.
At visit 1 (day 1), each subject will receive a single dose of the MenACWY vaccine in the Phase1 of the study (subjects randomized to study arm ACWY_1) or in phase 2 of the study (subjects randomized to study arm ACWY_2), administered by intramuscular injection in the deltoid of the non-dominant arm.
Also known as: Menveo
Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A for Each Vaccine Group and Between-group Ratios
hSBA titers against N. meningitidis serogroup A are calculated in terms of GMTs adjusted for pre-vaccination titer.
Time frame: At Day 29
hSBA GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Ratios
hSBA titers were calculated in terms of GMTs, at Day 1 and Day 29, against each of the N. meningitidis serogroup A, C, W and Y.
Time frame: At Day 1 and Day 29
Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group
Within-group ratios of hSBA GMTs against each of the N.meningitidis serogroups A, C, W and Y at Day 29 compared to Day 1.
Time frame: At Day 29
Percentages of Subjects With ≥4 Fold Rise in hSBA Antibody Titers for Each of the N.Meningitidis Serogroups A, C,W and Y for Each Vaccine Group and Between-group Differences
The percentages of subjects with a ≥ 4-fold rise in post-vaccination hSBA (at Day 29 compared to Day 1) and associated 2-sided 95% Clopper-Pearson CIs are computed by group and N. meningitidis serogroups A, C, W and Y. A 4-fold rise in the hSBA titers is defined as: - for individuals, whose pre-vaccination titers are \< the LOD (limit of detection), the post-vaccination titers must be ≥ 4-fold the LOD or ≥ the LLOQ (lower limit of quantitation) whichever is greater; - for individuals whose pre-vaccination titers are ≥ the LOD and ≤ the LLOQ, the post-vaccination titers must be at least four times the LLOQ; - for individuals whose pre-vaccination titers are \> the LLOQ, the post-vaccination titers must be at least four times the pre-vaccination titer.
Time frame: At Day 29
Percentages of Subjects With hSBA Antibody Titers ≥8 Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group and Between-group Differences
For each vaccine group the percentage of subjects with hSBA titer ≥8 , and its associated two-sided 95% Clopper-Pearson CIs are computed for each of the N. meningitidis serogroups A, C, W and Y.
Time frame: At Day 1 and Day 29
Percentages of Subjects With hSBA Titers ≥LLOQ Against Each of the N. Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Differences
For each vaccine group the percentages of subjects with hSBA titer ≥LLOQ, and its associated two-sided 95% Clopper-Pearson CIs are computed for each of the N. meningitidis serogroups A, C, W and Y.
Time frame: At Day 1 and Day 29
Number of Subjects Reported With Any Unsolicited Adverse Events (AEs) Within 30 Minutes After Vaccination
An unsolicited adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered with a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment.
Time frame: Within 30 minutes after vaccination at Day 1
Number of Subjects Reported With Solicited Local and Systemic AEs
Assessed solicited local AEs were erythema, induration and pain at injection site. Assessed solicited systemic AEs were Arthralgia, chills, fatigue, fever (body temperature ≥38.0°C), headache, loss of appetite, myalgia and nausea.
Time frame: From Day 1 (6 hours) to Day 7 after vaccination
Number of Subjects Reported With Other Indicators of Reactogenicity
Number of subjects reporting other indicators of reactogenicity such as use of analgesics/antipyretics within 7 days after any vaccination
Time frame: From Day 1 to Day 7 after vaccination
Number of Subjects Reported With Any Unsolicited AEs Within 29 Days After Vaccination
An unsolicited adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered with a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment.
Time frame: From Day 1 to Day 29 after vaccination
Number of Subjects Reported With Serious Adverse Events (SAEs), AEs Leading to Withdrawal and Medically Attended AEs
Medically attended AEs are defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended AE(s) is occurrence of any medically attended AE(s) regardless of intensity grade or relation to vaccination. Serious adverse event is any congenital anomaly/birth defect in the offspring of a study subject or any untoward medical occurrence that results in death or life threatening or requires hospitalization or results in disability or incapacity
Time frame: From Day 1 to Day 181 (during the entire study period)
Enrollment was defined with 2 parallel groups per phase, in a 2-phase staggered design: Subjects in both experimental groups receiving investigational vaccine aged for approximately 24 months and 30 months in phase 1 and phase 2 respectively. Both comparator groups subjects in phase 1 and 2 of the study receiving licensed vaccine.
| Milestone | GSK3536820A ACWY_Liq24 Group | ACWY_1 Group | GSK3536820A ACWY_Liq30 Group | ACWY_2 Group |
|---|---|---|---|---|
| Started | 420 | 424 | 427 | 419 |
| Completed | 419 | 424 | 423 | 418 |
| Not completed | 1 | 0 | 4 | 1 |
| Withdrew: Lost to follow-up | 1 | 0 | 1 | 1 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 0 |
| Withdrew: Unknown reason | 0 | 0 | 2 | 0 |
hSBA titers against N. meningitidis serogroup A are calculated in terms of GMTs adjusted for pre-vaccination titer.
| Titers | GSK3536820A ACWY_Liq24 Group | ACWY_1 Group | GSK3536820A ACWY_Liq30 Group | ACWY_2 Group |
|---|---|---|---|---|
| Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A for Each Vaccine Group and Between-group Ratios | 386.66 (319.47 to 467.97) | 318.34 (264.14 to 383.67) | 387.06 (322.72 to 464.24) | 348.89 (290.09 to 419.61) |
hSBA titers were calculated in terms of GMTs, at Day 1 and Day 29, against each of the N. meningitidis serogroup A, C, W and Y.
| Titers | GSK3536820A ACWY_Liq24 Group | ACWY_1 Group | GSK3536820A ACWY_Liq30 Group | ACWY_2 Group |
|---|---|---|---|---|
| Meningitis A, Day 1 | 3.01 (2.69 to 3.36) | 2.91 (2.60 to 3.24) | 3.34 (2.94 to 3.79) | 3.16 (2.78 to 3.59) |
| Meningitis A, Day 29 | 388.53 (320.61 to 470.84) | 319.06 (264.39 to 385.03) | 394.16 (326.72 to 475.50) | 349 (288.45 to 422.27) |
| Meningitis C, Day 1 | 8.59 (7.40 to 9.98) | 7.06 (6.09 to 8.20) | 9.05 (7.77 to 10.53) | 8.7 (7.46 to 10.14) |
| Meningitis C, Day 29 | 143.69 (109.13 to 189.20) | 157.74 (119.39 to 208.42) | 244.44 (182.20 to 327.96) | 208.34 (154.96 to 280.11) |
| Meningitis W, Day 1 | 6.23 (5.17 to 7.50) | 5.8 (4.83 to 6.95) | 5.69 (4.75 to 6.82) | 5.74 (4.78 to 6.90) |
| Meningitis W, Day 29 | 62.73 (49.93 to 78.81) | 63.92 (51.11 to 79.94) | 80.51 (64.66 to 100.24) | 73.08 (58.45 to 91.36) |
| Meningitis Y, Day 1 | 4.39 (3.78 to 5.10) | 4.21 (3.63 to 4.89) | 4.14 (3.58 to 4.79) | 4.19 (3.62 to 4.86) |
| Meningitis Y, Day 29 | 116.42 (94.03 to 144.15) | 105.11 (85.17 to 129.71) | 112.95 (91.55 to 139.34) | 118.04 (95.27 to 146.25) |
Within-group ratios of hSBA GMTs against each of the N.meningitidis serogroups A, C, W and Y at Day 29 compared to Day 1.
| Ratio | GSK3536820A ACWY_Liq24 Group | ACWY_1 Group | GSK3536820A ACWY_Liq30 Group | ACWY_2 Group |
|---|---|---|---|---|
| Meningitis A | 130.33 (105.49 to 161.02) | 108.39 (88.14 to 133.30) | 114.66 (93.75 to 140.22) | 106.79 (87.05 to 131.01) |
| Meningitis C | 17.01 (13.00 to 22.25) | 21.68 (16.52 to 28.46) | 26.69 (20.22 to 35.22) | 23.85 (18.04 to 31.54) |
| Meningitis W | 9.81 (7.84 to 12.27) | 10.77 (8.65 to 13.41) | 13.8 (11.08 to 17.19) | 12.48 (9.98 to 15.61) |
| Meningitis Y | 26.53 (21.14 to 33.28) | 25.23 (20.18 to 31.54) | 27.18 (21.66 to 34.10) | 28.49 (22.60 to 35.92) |
The percentages of subjects with a ≥ 4-fold rise in post-vaccination hSBA (at Day 29 compared to Day 1) and associated 2-sided 95% Clopper-Pearson CIs are computed by group and N. meningitidis serogroups A, C, W and Y. A 4-fold rise in the hSBA titers is defined as: - for individuals, whose pre-vaccination titers are \< the LOD (limit of detection), the post-vaccination titers must be ≥ 4-fold the LOD or ≥ the LLOQ (lower limit of quantitation) whichever is greater; - for individuals whose pre-vaccination titers are ≥ the LOD and ≤ the LLOQ, the post-vaccination titers must be at least four times the LLOQ; - for individuals whose pre-vaccination titers are \> the LLOQ, the post-vaccination titers must be at least four times the pre-vaccination titer.
| Percentage of subjects | GSK3536820A ACWY_Liq24 Group | ACWY_1 Group | GSK3536820A ACWY_Liq30 Group | ACWY_2 Group |
|---|---|---|---|---|
| Meningitis A | 92.29 (89.04 to 94.81) | 90.08 (86.59 to 92.92) | 91.57 (88.19 to 94.24) | 91.69 (88.28 to 94.36) |
| Meningitis C | 62.34 (57.29 to 67.20) | 64.46 (59.39 to 69.29) | 72.61 (67.80 to 77.05) | 69.76 (64.85 to 74.36) |
| Meningitis W | 59.41 (54.23 to 64.44) | 60.57 (55.51 to 65.46) | 66.58 (61.55 to 71.34) | 62.57 (57.39 to 67.54) |
| Meningitis Y | 71.77 (66.95 to 76.25) | 73.33 (68.65 to 77.66) | 74.35 (69.69 to 78.64) | 77.19 (72.62 to 81.33) |
For each vaccine group the percentage of subjects with hSBA titer ≥8 , and its associated two-sided 95% Clopper-Pearson CIs are computed for each of the N. meningitidis serogroups A, C, W and Y.
| Percentage of subjects | GSK3536820A ACWY_Liq24 Group | ACWY_1 Group | GSK3536820A ACWY_Liq30 Group | ACWY_2 Group |
|---|---|---|---|---|
| Meningitis A, Day 1 | 12.07 (8.98 to 15.77) | 10.28 (7.45 to 13.74) | 13.53 (10.24 to 17.40) | 12.03 (8.91 to 15.77) |
| Meningitis A, Day 29 | 93.65 (90.70 to 95.89) | 92.19 (89.03 to 94.67) | 93.37 (90.37 to 95.66) | 94.01 (91.06 to 96.21) |
| Meningitis C, Day 1 | 48.48 (43.44 to 53.53) | 41.52 (36.61 to 46.55) | 50.63 (45.59 to 55.67) | 50.26 (45.19 to 55.31) |
| Meningitis C, Day 29 | 77.58 (73.10 to 81.63) | 78.01 (73.52 to 82.06) | 84.17 (80.10 to 87.70) | 82.85 (78.67 to 86.51) |
| Meningitis W, Day 1 | 31.66 (27.01 to 36.61) | 28.54 (24.14 to 33.26) | 28.8 (24.30 to 33.62) | 30.05 (25.46 to 34.96) |
| Meningitis W, Day 29 | 79.43 (75.07 to 83.34) | 80.87 (76.62 to 84.64) | 85.86 (82.00 to 89.17) | 81.77 (77.54 to 85.50) |
| Meningitis Y, Day 1 | 22.82 (18.75 to 27.31) | 21.86 (17.90 to 26.25) | 21.48 (17.51 to 25.89) | 22.34 (18.27 to 26.83) |
| Meningitis Y, Day 29 | 87.5 (83.77 to 90.64) | 85.46 (81.57 to 88.80) | 88.04 (84.42 to 91.08) | 87.56 (83.85 to 90.69) |
For each vaccine group the percentages of subjects with hSBA titer ≥LLOQ, and its associated two-sided 95% Clopper-Pearson CIs are computed for each of the N. meningitidis serogroups A, C, W and Y.
| Percentage of subjects | GSK3536820A ACWY_Liq24 Group | ACWY_1 Group | GSK3536820A ACWY_Liq30 Group | ACWY_2 Group |
|---|---|---|---|---|
| Meningitis A, Day 1 | 12.86 (9.67 to 16.64) | 11.57 (8.56 to 15.17) | 15.38 (11.89 to 19.43) | 13.64 (10.32 to 17.54) |
| Meningitis A, Day 29 | 93.92 (91.01 to 96.10) | 92.19 (89.03 to 94.67) | 93.37 (90.37 to 95.66) | 94.01 (91.06 to 96.21) |
| Meningitis C, Day 1 | 55.84 (50.78 to 60.81) | 48.61 (43.58 to 53.66) | 61.01 (56.01 to 65.85) | 57.14 (52.08 to 62.10) |
| Meningitis C, Day 29 | 79.38 (75.01 to 83.30) | 80.37 (76.02 to 84.23) | 84.7 (80.67 to 88.17) | 84.7 (80.67 to 88.17) |
| Meningitis W, Day 1 | 32.45 (27.76 to 37.42) | 28.54 (24.14 to 33.26) | 29.32 (24.80 to 34.16) | 30.05 (25.46 to 34.96) |
| Meningitis W, Day 29 | 79.43 (75.07 to 83.34) | 80.87 (76.62 to 84.64) | 85.86 (82.00 to 89.17) | 81.77 (77.54 to 85.50) |
| Meningitis Y, Day 1 | 24.36 (20.18 to 28.93) | 22.86 (18.83 to 27.31) | 21.74 (17.75 to 26.16) | 22.86 (18.76 to 27.38) |
| Meningitis Y, Day 29 | 88.28 (84.63 to 91.32) | 86.22 (82.41 to 89.48) | 88.3 (84.70 to 91.30) | 87.56 (83.85 to 90.69) |
An unsolicited adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered with a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment.
| Participants | GSK3536820A ACWY_Liq24 Group | ACWY_1 Group | GSK3536820A ACWY_Liq30 Group | ACWY_2 Group |
|---|---|---|---|---|
| Number of Subjects Reported With Any Unsolicited Adverse Events (AEs) Within 30 Minutes After Vaccination | 2 | 2 | 6 | 6 |
Assessed solicited local AEs were erythema, induration and pain at injection site. Assessed solicited systemic AEs were Arthralgia, chills, fatigue, fever (body temperature ≥38.0°C), headache, loss of appetite, myalgia and nausea.
| Participants | GSK3536820A ACWY_Liq24 Group | ACWY_1 Group | GSK3536820A ACWY_Liq30 Group | ACWY_2 Group |
|---|---|---|---|---|
| Arthralgia | 45 | 50 | 49 | 40 |
| Chills | 75 | 79 | 78 | 56 |
| Erythema | 48 | 51 | 58 | 40 |
| Fatigue | 174 | 175 | 149 | 147 |
| Fever (Temperature >= 38 C) | 15 | 18 | 15 | 12 |
| Headache | 164 | 151 | 169 | 157 |
| Induration | 50 | 51 | 54 | 39 |
| Loss of Appetite | 53 | 54 | 63 | 34 |
| Myalgia | 60 | 59 | 58 | 65 |
| Nausea | 54 | 48 | 42 | 46 |
| Pain | 189 | 181 | 202 | 192 |
Number of subjects reporting other indicators of reactogenicity such as use of analgesics/antipyretics within 7 days after any vaccination
| Participants | GSK3536820A ACWY_Liq24 Group | ACWY_1 Group | GSK3536820A ACWY_Liq30 Group | ACWY_2 Group |
|---|---|---|---|---|
| Analgesic/Antipyretic Prevention, No | 357 | 374 | 366 | 369 |
| Analgesic/Antipyretic Prevention, Yes | 61 | 48 | 59 | 50 |
| Analgesic/Antipyretic Treatment, No | 328 | 340 | 349 | 350 |
| Analgesic/Antipyretic Treatment, Yes | 90 | 82 | 76 | 69 |
An unsolicited adverse event (AE) is defined as any untoward medical occurrence in a subject or clinical investigation subject administered with a pharmaceutical product at any dose that does not necessarily have to have a causal relationship with this treatment.
| Participants | GSK3536820A ACWY_Liq24 Group | ACWY_1 Group | GSK3536820A ACWY_Liq30 Group | ACWY_2 Group |
|---|---|---|---|---|
| Number of Subjects Reported With Any Unsolicited AEs Within 29 Days After Vaccination | 77 | 91 | 101 | 97 |
Medically attended AEs are defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any medically attended AE(s) is occurrence of any medically attended AE(s) regardless of intensity grade or relation to vaccination. Serious adverse event is any congenital anomaly/birth defect in the offspring of a study subject or any untoward medical occurrence that results in death or life threatening or requires hospitalization or results in disability or incapacity
| Participants | GSK3536820A ACWY_Liq24 Group | ACWY_1 Group | GSK3536820A ACWY_Liq30 Group | ACWY_2 Group |
|---|---|---|---|---|
| AEs Leading to withdrawal | 0 | 0 | 0 | 0 |
| SAEs | 4 | 1 | 4 | 4 |
| Medically attended AEs | 88 | 69 | 81 | 77 |
Collected over Solicited AEs were collected from Day 1 to Day 7 after vaccination and Unsolicited AEs from Day 1 to Day 29 after vaccination. SAEs were collected from Day 1 to Day 181 (during the entire study period). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GSK3536820A ACWY_Liq24 Group | 0/420 (0%) | 4/420 (1%) | 312/420 (74.3%) |
| ACWY_1 Group | 0/424 (0%) | 1/424 (0.2%) | 314/424 (74.1%) |
| GSK3536820A ACWY_Liq30 Group | 0/427 (0%) | 4/427 (0.9%) | 324/427 (75.9%) |
| ACWY_2 Group | 0/419 (0%) | 4/419 (1%) | 317/419 (75.7%) |
| Event | GSK3536820A ACWY_Liq24 Group | ACWY_1 Group | GSK3536820A ACWY_Liq30 Group | ACWY_2 Group |
|---|---|---|---|---|
| PhimosisCongenital, familial and genetic disorders | 0/420 | 0/424 | 0/427 | 1/419 |
| Otitis externaInfections and infestations | 0/420 | 0/424 | 0/427 | 1/419 |
| Tension headacheNervous system disorders | 0/420 | 0/424 | 0/427 | 1/419 |
| Adnexa uteri painReproductive system and breast disorders | 0/420 | 0/424 | 0/427 | 1/419 |
| Appendicitis noninfectiveGastrointestinal disorders | 1/420 | 0/424 | 0/427 | 0/419 |
| Tooth abscessInfections and infestations | 1/420 | 0/424 | 0/427 | 0/419 |
| Soft tissue injuryInjury, poisoning and procedural complications | 1/420 | 0/424 | 0/427 | 0/419 |
| Ovarian cyst rupturedReproductive system and breast disorders | 1/420 | 0/424 | 0/427 | 0/419 |
| Malignant melanomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/420 | 1/424 | 0/427 | 0/419 |
| Post procedural haemorrhageInjury, poisoning and procedural complications | 0/420 | 0/424 | 1/427 | 0/419 |
| Event | GSK3536820A ACWY_Liq24 Group | ACWY_1 Group | GSK3536820A ACWY_Liq30 Group | ACWY_2 Group |
|---|---|---|---|---|
| Injection site painGeneral disorders | 190/420 | 182/424 | 205/427 | 194/419 |
| HeadacheNervous system disorders | 168/420 | 155/424 | 178/427 | 162/419 |
| FatigueGeneral disorders | 175/420 | 175/424 | 150/427 | 147/419 |
| ChillsGeneral disorders | 77/420 | 79/424 | 78/427 | 56/419 |
| MyalgiaMusculoskeletal and connective tissue disorders | 63/420 | 62/424 | 58/427 | 65/419 |
| Decreased appetiteMetabolism and nutrition disorders | 54/420 | 54/424 | 63/427 | 34/419 |
| Injection site erythemaGeneral disorders | 50/420 | 51/424 | 59/427 | 42/419 |
| NauseaGastrointestinal disorders | 54/420 | 48/424 | 43/427 | 46/419 |
| Injection site indurationGeneral disorders | 52/420 | 51/424 | 54/427 | 39/419 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 50/420 | 53/424 | 49/427 | 40/419 |
| Age, Continuous(Years) | GSK3536820A ACWY_Liq24 Group | ACWY_1 Group | GSK3536820A ACWY_Liq30 Group | ACWY_2 Group | Total |
|---|---|---|---|---|---|
| Mean | 22.5 ± 9.4 | 22.2 ± 9.6 | 22.3 ± 9.8 | 22.0 ± 9.3 | 22.3 ± 9.5 |
| Sex: Female, Male(Participants) | GSK3536820A ACWY_Liq24 Group | ACWY_1 Group | GSK3536820A ACWY_Liq30 Group | ACWY_2 Group | Total |
|---|---|---|---|---|---|
| Female | 232 | 242 | 259 | 228 | 961 |
| Male | 188 | 182 | 168 | 191 | 729 |
| Race/Ethnicity, Customized(Participants) | GSK3536820A ACWY_Liq24 Group | ACWY_1 Group | GSK3536820A ACWY_Liq30 Group | ACWY_2 Group | Total |
|---|---|---|---|---|---|
| American Indian Or Alaska Native | 0 | 1 | 1 | 2 | 4 |
| Asian | 4 | 4 | 2 | 3 | 13 |
| Black Or African American | 26 | 22 | 30 | 26 | 104 |
| Other | 58 | 54 | 83 | 84 | 279 |
| White | 332 | 343 | 311 | 304 | 1290 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from Aug 2018 to primary completion in Jul 2019, 10 months.
Results were first posted in Feb 2021, 1 year 6 months after primary completion. A results delay was requested in Jun 2020.
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