Trial Outcomes & Findings for A Study to Investigate the Safety and Immunogenicity of Different Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) Administered to Healthy Adults 18 to 40 Years of Age (NCT NCT03652610)

NCT ID: NCT03652610

Last Updated: 2021-02-09

Results Overview

hSBA titers against N.meningitidis serogroup A were calculated in terms of GMTs adjusted for pre-vaccination titer.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

996 participants

Primary outcome timeframe

At Day 29

Results posted on

2021-02-09

Participant Flow

Subjects were enrolled from 8 centers in Australia, 2 in Belgium, 10 in Canada, 6 in Germany and 4 in Italy.Planned age range in this study was 18-40 years.But 1 subject aged 44 years not meeting inclusion criteria was enrolled \& vaccinated in GSK3536820A ACWY\_Liq Group \& therefore was considered for all analyses except per protocol set for immunogenicity analyses

Among 996 enrolled subjects, 16 subjects didn't receive any treatment and ICF documentation was not retrievable for 1 subject.

Participant milestones

Participant milestones
Measure	GSK3536820A ACWY_Liq Group Healthy adults, 18 to 44 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS.	ACWY Group Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).
Overall Study STARTED	490	489
Overall Study COMPLETED	486	484
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK3536820A ACWY_Liq Group Healthy adults, 18 to 44 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS.	ACWY Group Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	3	5

Baseline Characteristics

A Study to Investigate the Safety and Immunogenicity of Different Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) Administered to Healthy Adults 18 to 40 Years of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK3536820A ACWY_Liq Group n=490 Participants Healthy adults, 18 to 44 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS.	ACWY Group n=489 Participants Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).	Total n=979 Participants Total of all reporting groups
Age, Continuous	31.7 Years STANDARD_DEVIATION 5.8 • n=5 Participants	31.9 Years STANDARD_DEVIATION 5.8 • n=7 Participants	31.8 Years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	309 Participants n=5 Participants	305 Participants n=7 Participants	614 Participants n=5 Participants
Sex: Female, Male Male	181 Participants n=5 Participants	184 Participants n=7 Participants	365 Participants n=5 Participants
Race/Ethnicity, Customized American Indian Or Alaska Native	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	40 Participants n=5 Participants	27 Participants n=7 Participants	67 Participants n=5 Participants
Race/Ethnicity, Customized Black Or African American	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian Or Other Pacific Islander	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Other	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized White	427 Participants n=5 Participants	439 Participants n=7 Participants	866 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 29

Population: Analysis was performed on the per protocol set for immunogenicity that includes subjects who received the vaccine, did not have any protocol deviation leading to exclusion, who were not excluded due to other reasons defined prior to unblinding or analysis and had available immuno data for any serogroup and time point considered.

hSBA titers against N.meningitidis serogroup A were calculated in terms of GMTs adjusted for pre-vaccination titer.

Outcome measures

Outcome measures
Measure	GSK3536820A ACWY_Liq Group n=386 Participants Healthy adults, 18 to 44 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS.	ACWY Group n=404 Participants Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).
Adjusted Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers (GMTs) Against N. Meningitidis Serogroup A for Each Vaccine Group, and Between-group Ratios	185.16 Titers Interval 147.9 to 231.81	211.33 Titers Interval 169.61 to 263.32

SECONDARY outcome

Timeframe: At Day 1 and Day 29

hSBA titers were calculated in terms of GMTs, at Day 1 and Day 29, against each of the N. meningitidis serogroups A, C, W and Y.

Outcome measures

Outcome measures
Measure	GSK3536820A ACWY_Liq Group n=459 Participants Healthy adults, 18 to 44 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS.	ACWY Group n=467 Participants Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).
hSBA GMTs Against Each of the N.Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Ratios Meningitis A, Day 1	2.79 Titers Interval 2.52 to 3.1	2.97 Titers Interval 2.68 to 3.29
hSBA GMTs Against Each of the N.Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Ratios Meningitis A, Day 29	182.96 Titers Interval 145.11 to 230.68	213.42 Titers Interval 170.11 to 267.77
hSBA GMTs Against Each of the N.Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Ratios Meningitis C, Day 1	11.41 Titers Interval 9.81 to 13.27	12.05 Titers Interval 10.38 to 14.0
hSBA GMTs Against Each of the N.Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Ratios Meningitis C, Day 29	153.95 Titers Interval 115.03 to 206.04	139.63 Titers Interval 104.56 to 186.47
hSBA GMTs Against Each of the N.Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Ratios Meningitis W, Day 1	9.6 Titers Interval 8.05 to 11.45	10.92 Titers Interval 9.16 to 13.02
hSBA GMTs Against Each of the N.Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Ratios Meningitis W, Day 29	59.74 Titers Interval 47.67 to 74.86	54.12 Titers Interval 43.17 to 67.86
hSBA GMTs Against Each of the N.Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Ratios Meningitis Y, Day 1	4.14 Titers Interval 3.63 to 4.71	4.75 Titers Interval 4.17 to 5.4
hSBA GMTs Against Each of the N.Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Ratios Meningitis Y, Day 29	60.29 Titers Interval 48.67 to 74.68	54.99 Titers Interval 44.44 to 68.06

SECONDARY outcome

Timeframe: At Day 29

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.

Outcome measures

Outcome measures
Measure	GSK3536820A ACWY_Liq Group n=452 Participants Healthy adults, 18 to 44 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS.	ACWY Group n=455 Participants Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).
Within-group Geometric Mean Ratios (GMRs) Against Each of the N.Meningitidis Serogroups A, C, W and Y Meningitis A	65.24 Ratio Interval 51.81 to 82.16	73.01 Ratio Interval 58.26 to 91.49
Within-group Geometric Mean Ratios (GMRs) Against Each of the N.Meningitidis Serogroups A, C, W and Y Meningitis C	13.17 Ratio Interval 10.3 to 16.84	11.07 Ratio Interval 8.68 to 14.13
Within-group Geometric Mean Ratios (GMRs) Against Each of the N.Meningitidis Serogroups A, C, W and Y Meningitis W	6.1 Ratio Interval 5.07 to 7.33	4.8 Ratio Interval 3.99 to 5.77
Within-group Geometric Mean Ratios (GMRs) Against Each of the N.Meningitidis Serogroups A, C, W and Y Meningitis Y	14.64 Ratio Interval 11.88 to 18.04	11.48 Ratio Interval 9.33 to 14.13

SECONDARY outcome

Timeframe: At Day 29

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 were computed by group and for each 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 of 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

Outcome measures

Outcome measures
Measure	GSK3536820A ACWY_Liq Group n=452 Participants Healthy adults, 18 to 44 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS.	ACWY Group n=455 Participants Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).
Percentages of Subjects With a ≥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 Meningitis A	79.8 Percentages of subjects Interval 75.4 to 83.7	83.7 Percentages of subjects Interval 79.7 to 87.1
Percentages of Subjects With a ≥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 Meningitis C	56.3 Percentages of subjects Interval 51.5 to 61.0	54.4 Percentages of subjects Interval 49.6 to 59.1
Percentages of Subjects With a ≥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 Meningitis W	44.7 Percentages of subjects Interval 40.0 to 49.5	40.2 Percentages of subjects Interval 35.6 to 44.9
Percentages of Subjects With a ≥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 Meningitis Y	63.3 Percentages of subjects Interval 58.6 to 67.7	58 Percentages of subjects Interval 53.3 to 62.6

SECONDARY outcome

Timeframe: At Day 1 and Day 29

For each vaccine group the percentage of subjects with hSBA titer ≥8, and its associated two-sided 95% Clopper-Pearson CIs were computed for each of the N. meningitidis serogroups A, C, W and Y.

Outcome measures

Outcome measures
Measure	GSK3536820A ACWY_Liq Group n=460 Participants Healthy adults, 18 to 44 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS.	ACWY Group n=467 Participants Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).
Percentages of Subjects With hSBA Titers ≥8 Against Each of the N. Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Differences Meningitis A, Day 1	8.7 Percentages of subjects Interval 6.3 to 11.8	11.2 Percentages of subjects Interval 8.4 to 14.5
Percentages of Subjects With hSBA Titers ≥8 Against Each of the N. Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Differences Meningitis A, Day 29	82.8 Percentages of subjects Interval 78.7 to 86.3	86.4 Percentages of subjects Interval 82.8 to 89.5
Percentages of Subjects With hSBA Titers ≥8 Against Each of the N. Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Differences Meningitis C, Day 1	53.8 Percentages of subjects Interval 49.1 to 58.4	54.4 Percentages of subjects Interval 49.7 to 59.0
Percentages of Subjects With hSBA Titers ≥8 Against Each of the N. Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Differences Meningitis C, Day 29	74.5 Percentages of subjects Interval 70.2 to 78.5	74.9 Percentages of subjects Interval 70.6 to 78.8
Percentages of Subjects With hSBA Titers ≥8 Against Each of the N. Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Differences Meningitis W, Day 1	39.8 Percentages of subjects Interval 35.3 to 44.4	45.7 Percentages of subjects Interval 41.1 to 50.4
Percentages of Subjects With hSBA Titers ≥8 Against Each of the N. Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Differences Meningitis W, Day 29	73.3 Percentages of subjects Interval 69.0 to 77.4	73.1 Percentages of subjects Interval 68.8 to 77.1
Percentages of Subjects With hSBA Titers ≥8 Against Each of the N. Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Differences Meningitis Y, Day 1	22.7 Percentages of subjects Interval 18.9 to 26.8	25.5 Percentages of subjects Interval 21.6 to 29.7
Percentages of Subjects With hSBA Titers ≥8 Against Each of the N. Meningitidis Serogroups A, C, W and Y for Each Vaccine Group, and Between-group Differences Meningitis Y, Day 29	77.2 Percentages of subjects Interval 73.1 to 80.9	76 Percentages of subjects Interval 71.9 to 79.8

SECONDARY outcome

Timeframe: At Day 1 and Day 29

For each vaccine group the percentage of subjects with hSBA titer ≥LLOQ, and its associated two-sided 95% Clopper-Pearson CIs were computed for each of the N. meningitidis serogroups A, C, W and Y.

Outcome measures

Outcome measures
Measure	GSK3536820A ACWY_Liq Group n=460 Participants Healthy adults, 18 to 44 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS.	ACWY Group n=467 Participants Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).
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 Meningitis A, Day 1	10.5 Percentages of subjects Interval 7.8 to 13.8	13.5 Percentages of subjects Interval 10.4 to 17.0
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 Meningitis A, Day 29	82.8 Percentages of subjects Interval 78.7 to 86.3	86.7 Percentages of subjects Interval 83.1 to 89.8
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 Meningitis C, Day 1	61.2 Percentages of subjects Interval 56.6 to 65.7	62.3 Percentages of subjects Interval 57.7 to 66.7
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 Meningitis C, Day 29	76.5 Percentages of subjects Interval 72.3 to 80.4	76.5 Percentages of subjects Interval 72.2 to 80.3
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 Meningitis W, Day 1	41.3 Percentages of subjects Interval 36.8 to 46.0	47.3 Percentages of subjects Interval 42.6 to 52.0
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 Meningitis W, Day 29	73.3 Percentages of subjects Interval 69.0 to 77.4	73.5 Percentages of subjects Interval 69.2 to 77.5
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 Meningitis Y, Day 1	23.8 Percentages of subjects Interval 20.0 to 28.0	26.3 Percentages of subjects Interval 22.4 to 30.6
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 Meningitis Y, Day 29	77.8 Percentages of subjects Interval 73.7 to 81.5	77.3 Percentages of subjects Interval 73.2 to 81.1

SECONDARY outcome

Timeframe: From Day 1 (6 hours) to Day 7 after vaccination

Population: Analysis was performed on the solicited safety set that includes all enrolled subjects who received a study vaccination and reported any solicited adverse events data for the defined period.

Number of subjects with solicited local and systemic AEs during the 7-days period (including the day of vaccination) after the vaccination.

Outcome measures

Outcome measures
Measure	GSK3536820A ACWY_Liq Group n=489 Participants Healthy adults, 18 to 44 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS.	ACWY Group n=487 Participants Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).
Number of Subjects Reported With Solicited Local and Systemic AEs Erythema	28 Participants	28 Participants
Number of Subjects Reported With Solicited Local and Systemic AEs Induration	25 Participants	24 Participants
Number of Subjects Reported With Solicited Local and Systemic AEs Pain	200 Participants	182 Participants
Number of Subjects Reported With Solicited Local and Systemic AEs Arthralgia	43 Participants	46 Participants
Number of Subjects Reported With Solicited Local and Systemic AEs Chills	42 Participants	40 Participants
Number of Subjects Reported With Solicited Local and Systemic AEs Fatigue	159 Participants	159 Participants
Number of Subjects Reported With Solicited Local and Systemic AEs Fever (Temperature >= 38 C)	7 Participants	10 Participants
Number of Subjects Reported With Solicited Local and Systemic AEs Headache	158 Participants	165 Participants
Number of Subjects Reported With Solicited Local and Systemic AEs Loss of Appetite	31 Participants	40 Participants
Number of Subjects Reported With Solicited Local and Systemic AEs Myalgia	58 Participants	58 Participants
Number of Subjects Reported With Solicited Local and Systemic AEs Nausea	49 Participants	50 Participants

SECONDARY outcome

Timeframe: From Day 1 to Day 7 after vaccination

Population: Analysis was performed on the solicited safety set that includes all enrolled subjects who received a study vaccination and reported any indicators of reactogenicity data for the defined period.

Number of subjects reporting other indicators of reactogenicity such as use of analgesics/antipyretics within 7 days after vaccination

Outcome measures

Outcome measures
Measure	GSK3536820A ACWY_Liq Group n=489 Participants Healthy adults, 18 to 44 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS.	ACWY Group n=487 Participants Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).
Number of Subjects Reported With Other Indicators of Reactogenicity Analgesic/Antipyretic Prevention, Yes	36 Participants	40 Participants
Number of Subjects Reported With Other Indicators of Reactogenicity Analgesic/Antipyretic Prevention, No	453 Participants	447 Participants
Number of Subjects Reported With Other Indicators of Reactogenicity Analgesic/Antipyretic Treatment, Yes	80 Participants	79 Participants
Number of Subjects Reported With Other Indicators of Reactogenicity Analgesic/Antipyretic Treatment, No	409 Participants	408 Participants

SECONDARY outcome

Timeframe: From Day 1 to Day 29 after vaccination

Population: Analysis was performed on the unsolicited safety set that includes all enrolled subjects who received a study vaccination and reported unsolicited adverse events data for the defined period.

An 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.

Outcome measures

Outcome measures
Measure	GSK3536820A ACWY_Liq Group n=489 Participants Healthy adults, 18 to 44 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS.	ACWY Group n=489 Participants Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).
Number of Subjects Reported With Any Unsolicited AEs Within 29 Days After Vaccination	117 Participants	111 Participants

SECONDARY outcome

Timeframe: From Day 1 to Day 181 (during the entire study period)

Population: Analysis was performed on the unsolicited safety set that includes all enrolled subjects who received a study vaccination and reported any adverse events data in the defined period.

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

Outcome measures

Outcome measures
Measure	GSK3536820A ACWY_Liq Group n=489 Participants Healthy adults, 18 to 44 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS.	ACWY Group n=489 Participants Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).
Number of Subjects Reported With AEs Leading to Withdrawal, Medically Attended AEs and Serious Adverse Events (SAEs) Aes leading to withdrawal	0 Participants	0 Participants
Number of Subjects Reported With AEs Leading to Withdrawal, Medically Attended AEs and Serious Adverse Events (SAEs) MAEs	79 Participants	84 Participants
Number of Subjects Reported With AEs Leading to Withdrawal, Medically Attended AEs and Serious Adverse Events (SAEs) SAEs	6 Participants	9 Participants

SECONDARY outcome

Timeframe: Within 30 minutes after vaccination at Day 1

Outcome measures

Outcome measures
Measure	GSK3536820A ACWY_Liq Group n=489 Participants Healthy adults, 18 to 44 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS.	ACWY Group n=489 Participants Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).
Number of Subjects Reported With Any Unsolicited Adverse Events (AEs) Within 30 Minutes After Vaccination	5 Participants	5 Participants

Adverse Events

GSK3536820A ACWY_Liq Group

Serious events: 6 serious events

Other events: 336 other events

Deaths: 0 deaths

ACWY Group

Serious events: 9 serious events

Other events: 335 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	GSK3536820A ACWY_Liq Group n=490 participants at risk Healthy adults, 18 to 44 years of age, receiving at Day 1 a single dose of investigational MenACWY liquid vaccine (GSK3536820A) formulation with approximately 30% Men A FS.	ACWY Group n=489 participants at risk Healthy adults, 18 to 40 years of age, receiving at Day 1 a single dose of licensed GSK's MenACWY vaccine formulation (Menveo).
Cardiac disorders Atrial flutter	0.00% 0/490 • 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)	0.20% 1/489 • Number of events 1 • 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)
Endocrine disorders Hyperthyroidism	0.00% 0/490 • 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)	0.20% 1/489 • Number of events 1 • 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)
General disorders Hernia	0.00% 0/490 • 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)	0.20% 1/489 • Number of events 1 • 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)
Hepatobiliary disorders Biliary colic	0.00% 0/490 • 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)	0.20% 1/489 • Number of events 1 • 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)
Infections and infestations Dengue fever	0.20% 1/490 • Number of events 1 • 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)	0.20% 1/489 • Number of events 1 • 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)
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/490 • 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)	0.20% 1/489 • Number of events 1 • 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)
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/490 • 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)	0.20% 1/489 • Number of events 1 • 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)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine cancer	0.00% 0/490 • 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)	0.20% 1/489 • Number of events 1 • 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)
Nervous system disorders Hemiplegic migraine	0.20% 1/490 • Number of events 1 • 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)	0.00% 0/489 • 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)
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.20% 1/490 • Number of events 1 • 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)	0.00% 0/489 • 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)
Pregnancy, puerperium and perinatal conditions Abortion spontaneous incomplete	0.20% 1/490 • Number of events 1 • 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)	0.00% 0/489 • 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)
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.00% 0/490 • 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)	0.20% 1/489 • Number of events 1 • 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)
Psychiatric disorders Suicide attempt	0.20% 1/490 • Number of events 1 • 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)	0.00% 0/489 • 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)
Reproductive system and breast disorders Ovarian cyst ruptured	0.20% 1/490 • Number of events 1 • 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)	0.00% 0/489 • 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)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.20% 1/490 • Number of events 1 • 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)	0.00% 0/489 • 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)