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 Adolescents and Young Adults 10 to 40 Years of Age (NCT NCT03433482)

NCT ID: NCT03433482

Last Updated: 2021-02-17

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1707 participants

Primary outcome timeframe

At Day 29

Results posted on

2021-02-17

Participant Flow

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.

Out of the 1707 subjects enrolled in the study (inclusive of phase 1 and 2), 1690 were exposed to the vaccination. Out of the 17 subjects excluded from study, 11 were not randomized, 5 were not administered any study treatment, 1 did not sign the informed consent form.

Participant milestones

Participant milestones
Measure	GSK3536820A ACWY_Liq24 Group 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	ACWY_1 Group Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1.	GSK3536820A ACWY_Liq30 Group 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.	ACWY_2 Group Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
Overall Study STARTED	420	424	427	419
Overall Study COMPLETED	419	424	423	418
Overall Study NOT COMPLETED	1	0	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	GSK3536820A ACWY_Liq24 Group 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	GSK3536820A ACWY_Liq30 Group 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.	ACWY_2 Group Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
Overall Study Lost to Follow-up	1	1	1
Overall Study Withdrawal by Subject	0	1	0
Overall Study Unknown reason	0	2	0

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 Adolescents and Young Adults 10 to 40 Years of Age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSK3536820A ACWY_Liq24 Group n=420 Participants 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	ACWY_1 Group n=424 Participants Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1.	GSK3536820A ACWY_Liq30 Group n=427 Participants 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.	ACWY_2 Group n=419 Participants Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.	Total n=1690 Participants Total of all reporting groups
Age, Continuous	22.5 Years STANDARD_DEVIATION 9.4 • n=5 Participants	22.2 Years STANDARD_DEVIATION 9.6 • n=7 Participants	22.3 Years STANDARD_DEVIATION 9.8 • n=5 Participants	22.0 Years STANDARD_DEVIATION 9.3 • n=4 Participants	22.3 Years STANDARD_DEVIATION 9.5 • n=21 Participants
Sex: Female, Male Female	232 Participants n=5 Participants	242 Participants n=7 Participants	259 Participants n=5 Participants	228 Participants n=4 Participants	961 Participants n=21 Participants
Sex: Female, Male Male	188 Participants n=5 Participants	182 Participants n=7 Participants	168 Participants n=5 Participants	191 Participants n=4 Participants	729 Participants n=21 Participants
Race/Ethnicity, Customized American Indian Or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	13 Participants n=21 Participants
Race/Ethnicity, Customized Black Or African American	26 Participants n=5 Participants	22 Participants n=7 Participants	30 Participants n=5 Participants	26 Participants n=4 Participants	104 Participants n=21 Participants
Race/Ethnicity, Customized Other	58 Participants n=5 Participants	54 Participants n=7 Participants	83 Participants n=5 Participants	84 Participants n=4 Participants	279 Participants n=21 Participants
Race/Ethnicity, Customized White	332 Participants n=5 Participants	343 Participants n=7 Participants	311 Participants n=5 Participants	304 Participants n=4 Participants	1290 Participants n=21 Participants

PRIMARY outcome

Timeframe: At Day 29

Population: Analysis is 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 are calculated in terms of GMTs adjusted for pre-vaccination titer.

Outcome measures

Outcome measures
Measure	GSK3536820A ACWY_Liq24 Group n=363 Participants 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	ACWY_1 Group n=373 Participants Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1.	GSK3536820A ACWY_Liq30 Group n=356 Participants 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.	ACWY_2 Group n=349 Participants Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
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 Titers Interval 319.47 to 467.97	318.34 Titers Interval 264.14 to 383.67	387.06 Titers Interval 322.72 to 464.24	348.89 Titers Interval 290.09 to 419.61

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 serogroup A, C, W and Y.

Outcome measures

Outcome measures
Measure	GSK3536820A ACWY_Liq24 Group n=394 Participants 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	ACWY_1 Group n=398 Participants Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1.	GSK3536820A ACWY_Liq30 Group n=395 Participants 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.	ACWY_2 Group n=392 Participants Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
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	4.39 Titers Interval 3.78 to 5.1	4.21 Titers Interval 3.63 to 4.89	4.14 Titers Interval 3.58 to 4.79	4.19 Titers Interval 3.62 to 4.86
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 29	116.42 Titers Interval 94.03 to 144.15	105.11 Titers Interval 85.17 to 129.71	112.95 Titers Interval 91.55 to 139.34	118.04 Titers Interval 95.27 to 146.25
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	3.01 Titers Interval 2.69 to 3.36	2.91 Titers Interval 2.6 to 3.24	3.34 Titers Interval 2.94 to 3.79	3.16 Titers Interval 2.78 to 3.59
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	388.53 Titers Interval 320.61 to 470.84	319.06 Titers Interval 264.39 to 385.03	394.16 Titers Interval 326.72 to 475.5	349 Titers Interval 288.45 to 422.27
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	8.59 Titers Interval 7.4 to 9.98	7.06 Titers Interval 6.09 to 8.2	9.05 Titers Interval 7.77 to 10.53	8.7 Titers Interval 7.46 to 10.14
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	143.69 Titers Interval 109.13 to 189.2	157.74 Titers Interval 119.39 to 208.42	244.44 Titers Interval 182.2 to 327.96	208.34 Titers Interval 154.96 to 280.11
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	6.23 Titers Interval 5.17 to 7.5	5.8 Titers Interval 4.83 to 6.95	5.69 Titers Interval 4.75 to 6.82	5.74 Titers Interval 4.78 to 6.9
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	62.73 Titers Interval 49.93 to 78.81	63.92 Titers Interval 51.11 to 79.94	80.51 Titers Interval 64.66 to 100.24	73.08 Titers Interval 58.45 to 91.36

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_Liq24 Group n=385 Participants 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	ACWY_1 Group n=390 Participants Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1.	GSK3536820A ACWY_Liq30 Group n=386 Participants 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.	ACWY_2 Group n=377 Participants Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group Meningitis A	130.33 Ratio Interval 105.49 to 161.02	108.39 Ratio Interval 88.14 to 133.3	114.66 Ratio Interval 93.75 to 140.22	106.79 Ratio Interval 87.05 to 131.01
Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group Meningitis C	17.01 Ratio Interval 13.0 to 22.25	21.68 Ratio Interval 16.52 to 28.46	26.69 Ratio Interval 20.22 to 35.22	23.85 Ratio Interval 18.04 to 31.54
Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group Meningitis Y	26.53 Ratio Interval 21.14 to 33.28	25.23 Ratio Interval 20.18 to 31.54	27.18 Ratio Interval 21.66 to 34.1	28.49 Ratio Interval 22.6 to 35.92
Within-group Geometric Mean Ratios (GMRs) of GMTs Against Each of the N.Meningitidis Serogroups A,C,W and Y for Each Vaccine Group Meningitis W	9.81 Ratio Interval 7.84 to 12.27	10.77 Ratio Interval 8.65 to 13.41	13.8 Ratio Interval 11.08 to 17.19	12.48 Ratio Interval 9.98 to 15.61

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 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.

Outcome measures

Outcome measures
Measure	GSK3536820A ACWY_Liq24 Group n=385 Participants 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	ACWY_1 Group n=390 Participants Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1.	GSK3536820A ACWY_Liq30 Group n=386 Participants 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.	ACWY_2 Group n=377 Participants Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
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 Meningitis A	92.29 Percentage of subjects Interval 89.04 to 94.81	90.08 Percentage of subjects Interval 86.59 to 92.92	91.57 Percentage of subjects Interval 88.19 to 94.24	91.69 Percentage of subjects Interval 88.28 to 94.36
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 Meningitis C	62.34 Percentage of subjects Interval 57.29 to 67.2	64.46 Percentage of subjects Interval 59.39 to 69.29	72.61 Percentage of subjects Interval 67.8 to 77.05	69.76 Percentage of subjects Interval 64.85 to 74.36
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 Meningitis Y	71.77 Percentage of subjects Interval 66.95 to 76.25	73.33 Percentage of subjects Interval 68.65 to 77.66	74.35 Percentage of subjects Interval 69.69 to 78.64	77.19 Percentage of subjects Interval 72.62 to 81.33
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 Meningitis W	59.41 Percentage of subjects Interval 54.23 to 64.44	60.57 Percentage of subjects Interval 55.51 to 65.46	66.58 Percentage of subjects Interval 61.55 to 71.34	62.57 Percentage of subjects Interval 57.39 to 67.54

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 are computed for each of the N. meningitidis serogroups A, C, W and Y.

Outcome measures

Outcome measures
Measure	GSK3536820A ACWY_Liq24 Group n=394 Participants 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	ACWY_1 Group n=398 Participants Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1.	GSK3536820A ACWY_Liq30 Group n=395 Participants 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.	ACWY_2 Group n=392 Participants Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
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 Meningitis A, Day 1	12.07 Percentage of subjects Interval 8.98 to 15.77	10.28 Percentage of subjects Interval 7.45 to 13.74	13.53 Percentage of subjects Interval 10.24 to 17.4	12.03 Percentage of subjects Interval 8.91 to 15.77
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 Meningitis A, Day 29	93.65 Percentage of subjects Interval 90.7 to 95.89	92.19 Percentage of subjects Interval 89.03 to 94.67	93.37 Percentage of subjects Interval 90.37 to 95.66	94.01 Percentage of subjects Interval 91.06 to 96.21
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 Meningitis C, Day 1	48.48 Percentage of subjects Interval 43.44 to 53.53	41.52 Percentage of subjects Interval 36.61 to 46.55	50.63 Percentage of subjects Interval 45.59 to 55.67	50.26 Percentage of subjects Interval 45.19 to 55.31
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 Meningitis C, Day 29	77.58 Percentage of subjects Interval 73.1 to 81.63	78.01 Percentage of subjects Interval 73.52 to 82.06	84.17 Percentage of subjects Interval 80.1 to 87.7	82.85 Percentage of subjects Interval 78.67 to 86.51
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 Meningitis W, Day 1	31.66 Percentage of subjects Interval 27.01 to 36.61	28.54 Percentage of subjects Interval 24.14 to 33.26	28.8 Percentage of subjects Interval 24.3 to 33.62	30.05 Percentage of subjects Interval 25.46 to 34.96
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 Meningitis W, Day 29	79.43 Percentage of subjects Interval 75.07 to 83.34	80.87 Percentage of subjects Interval 76.62 to 84.64	85.86 Percentage of subjects Interval 82.0 to 89.17	81.77 Percentage of subjects Interval 77.54 to 85.5
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 Meningitis Y, Day 1	22.82 Percentage of subjects Interval 18.75 to 27.31	21.86 Percentage of subjects Interval 17.9 to 26.25	21.48 Percentage of subjects Interval 17.51 to 25.89	22.34 Percentage of subjects Interval 18.27 to 26.83
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 Meningitis Y, Day 29	87.5 Percentage of subjects Interval 83.77 to 90.64	85.46 Percentage of subjects Interval 81.57 to 88.8	88.04 Percentage of subjects Interval 84.42 to 91.08	87.56 Percentage of subjects Interval 83.85 to 90.69

SECONDARY outcome

Timeframe: At Day 1 and Day 29

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.

Outcome measures

Outcome measures
Measure	GSK3536820A ACWY_Liq24 Group n=394 Participants 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	ACWY_1 Group n=398 Participants Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1.	GSK3536820A ACWY_Liq30 Group n=395 Participants 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.	ACWY_2 Group n=392 Participants Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
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	12.86 Percentage of subjects Interval 9.67 to 16.64	11.57 Percentage of subjects Interval 8.56 to 15.17	15.38 Percentage of subjects Interval 11.89 to 19.43	13.64 Percentage of subjects Interval 10.32 to 17.54
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	93.92 Percentage of subjects Interval 91.01 to 96.1	92.19 Percentage of subjects Interval 89.03 to 94.67	93.37 Percentage of subjects Interval 90.37 to 95.66	94.01 Percentage of subjects Interval 91.06 to 96.21
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	55.84 Percentage of subjects Interval 50.78 to 60.81	48.61 Percentage of subjects Interval 43.58 to 53.66	61.01 Percentage of subjects Interval 56.01 to 65.85	57.14 Percentage of subjects Interval 52.08 to 62.1
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	79.38 Percentage of subjects Interval 75.01 to 83.3	80.37 Percentage of subjects Interval 76.02 to 84.23	84.7 Percentage of subjects Interval 80.67 to 88.17	84.7 Percentage of subjects Interval 80.67 to 88.17
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	32.45 Percentage of subjects Interval 27.76 to 37.42	28.54 Percentage of subjects Interval 24.14 to 33.26	29.32 Percentage of subjects Interval 24.8 to 34.16	30.05 Percentage of subjects Interval 25.46 to 34.96
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	79.43 Percentage of subjects Interval 75.07 to 83.34	80.87 Percentage of subjects Interval 76.62 to 84.64	85.86 Percentage of subjects Interval 82.0 to 89.17	81.77 Percentage of subjects Interval 77.54 to 85.5
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	24.36 Percentage of subjects Interval 20.18 to 28.93	22.86 Percentage of subjects Interval 18.83 to 27.31	21.74 Percentage of subjects Interval 17.75 to 26.16	22.86 Percentage of subjects Interval 18.76 to 27.38
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	88.28 Percentage of subjects Interval 84.63 to 91.32	86.22 Percentage of subjects Interval 82.41 to 89.48	88.3 Percentage of subjects Interval 84.7 to 91.3	87.56 Percentage of subjects Interval 83.85 to 90.69

SECONDARY outcome

Timeframe: Within 30 minutes after vaccination at Day 1

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 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.

Outcome measures

Outcome measures
Measure	GSK3536820A ACWY_Liq24 Group n=420 Participants 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	ACWY_1 Group n=424 Participants Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1.	GSK3536820A ACWY_Liq30 Group n=427 Participants 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.	ACWY_2 Group n=419 Participants Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
Number of Subjects Reported With Any Unsolicited Adverse Events (AEs) Within 30 Minutes After Vaccination	2 Participants	2 Participants	6 Participants	6 Participants

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 solicited adverse events data for the defined period.

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.

Outcome measures

Outcome measures
Measure	GSK3536820A ACWY_Liq24 Group n=418 Participants 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	ACWY_1 Group n=422 Participants Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1.	GSK3536820A ACWY_Liq30 Group n=425 Participants 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.	ACWY_2 Group n=419 Participants Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
Number of Subjects Reported With Solicited Local and Systemic AEs Arthralgia	45 Participants	50 Participants	49 Participants	40 Participants
Number of Subjects Reported With Solicited Local and Systemic AEs Chills	75 Participants	79 Participants	78 Participants	56 Participants
Number of Subjects Reported With Solicited Local and Systemic AEs Fatigue	174 Participants	175 Participants	149 Participants	147 Participants
Number of Subjects Reported With Solicited Local and Systemic AEs Fever (Temperature >= 38 C)	15 Participants	18 Participants	15 Participants	12 Participants
Number of Subjects Reported With Solicited Local and Systemic AEs Headache	164 Participants	151 Participants	169 Participants	157 Participants
Number of Subjects Reported With Solicited Local and Systemic AEs Nausea	54 Participants	48 Participants	42 Participants	46 Participants
Number of Subjects Reported With Solicited Local and Systemic AEs Pain	189 Participants	181 Participants	202 Participants	192 Participants
Number of Subjects Reported With Solicited Local and Systemic AEs Erythema	48 Participants	51 Participants	58 Participants	40 Participants
Number of Subjects Reported With Solicited Local and Systemic AEs Induration	50 Participants	51 Participants	54 Participants	39 Participants
Number of Subjects Reported With Solicited Local and Systemic AEs Loss of Appetite	53 Participants	54 Participants	63 Participants	34 Participants
Number of Subjects Reported With Solicited Local and Systemic AEs Myalgia	60 Participants	59 Participants	58 Participants	65 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 solicited adverse events data for the defined period.

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

Outcome measures

Outcome measures
Measure	GSK3536820A ACWY_Liq24 Group n=418 Participants 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	ACWY_1 Group n=422 Participants Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1.	GSK3536820A ACWY_Liq30 Group n=425 Participants 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.	ACWY_2 Group n=419 Participants Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
Number of Subjects Reported With Other Indicators of Reactogenicity Analgesic/Antipyretic Prevention, No	357 Participants	374 Participants	366 Participants	369 Participants
Number of Subjects Reported With Other Indicators of Reactogenicity Analgesic/Antipyretic Treatment, No	328 Participants	340 Participants	349 Participants	350 Participants
Number of Subjects Reported With Other Indicators of Reactogenicity Analgesic/Antipyretic Treatment, Yes	90 Participants	82 Participants	76 Participants	69 Participants
Number of Subjects Reported With Other Indicators of Reactogenicity Analgesic/Antipyretic Prevention, Yes	61 Participants	48 Participants	59 Participants	50 Participants

SECONDARY outcome

Timeframe: From Day 1 to Day 29 after vaccination

Outcome measures

Outcome measures
Measure	GSK3536820A ACWY_Liq24 Group n=420 Participants 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	ACWY_1 Group n=424 Participants Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1.	GSK3536820A ACWY_Liq30 Group n=427 Participants 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.	ACWY_2 Group n=419 Participants Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
Number of Subjects Reported With Any Unsolicited AEs Within 29 Days After Vaccination	77 Participants	91 Participants	101 Participants	97 Participants

SECONDARY outcome

Timeframe: From Day 1 to Day 181 (during the entire study 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_Liq24 Group n=420 Participants 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	ACWY_1 Group n=424 Participants Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1.	GSK3536820A ACWY_Liq30 Group n=427 Participants 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.	ACWY_2 Group n=419 Participants Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
Number of Subjects Reported With Serious Adverse Events (SAEs), AEs Leading to Withdrawal and Medically Attended AEs AEs Leading to withdrawal	0 Participants	0 Participants	0 Participants	0 Participants
Number of Subjects Reported With Serious Adverse Events (SAEs), AEs Leading to Withdrawal and Medically Attended AEs SAEs	4 Participants	1 Participants	4 Participants	4 Participants
Number of Subjects Reported With Serious Adverse Events (SAEs), AEs Leading to Withdrawal and Medically Attended AEs Medically attended AEs	88 Participants	69 Participants	81 Participants	77 Participants

Adverse Events

GSK3536820A ACWY_Liq24 Group

Serious events: 4 serious events

Other events: 312 other events

Deaths: 0 deaths

ACWY_1 Group

Serious events: 1 serious events

Other events: 314 other events

Deaths: 0 deaths

GSK3536820A ACWY_Liq30 Group

Serious events: 4 serious events

Other events: 324 other events

Deaths: 0 deaths

ACWY_2 Group

Serious events: 4 serious events

Other events: 317 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GSK3536820A ACWY_Liq24 Group n=420 participants at risk 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	ACWY_1 Group n=424 participants at risk Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase1.	GSK3536820A ACWY_Liq30 Group n=427 participants at risk 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.	ACWY_2 Group n=419 participants at risk Healthy subjects receiving a single dose of the licensed GSK's MenACWY vaccine formulation (Menveo), at Day 1 in the Study Phase 2.
Reproductive system and breast disorders Adnexa uteri pain	0.00% 0/420 • 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% 0/424 • 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% 0/427 • 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)	0.24% 1/419 • 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)
Reproductive system and breast disorders Ovarian cyst ruptured	0.24% 1/420 • 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% 0/424 • 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% 0/427 • 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% 0/419 • 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)
Congenital, familial and genetic disorders Phimosis	0.00% 0/420 • 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% 0/424 • 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% 0/427 • 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)	0.24% 1/419 • 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)
Gastrointestinal disorders Appendicitis noninfective	0.24% 1/420 • 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% 0/424 • 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% 0/427 • 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% 0/419 • 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 Otitis externa	0.00% 0/420 • 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% 0/424 • 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% 0/427 • 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)	0.24% 1/419 • 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 Tooth abscess	0.24% 1/420 • 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% 0/424 • 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% 0/427 • 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% 0/419 • 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 Post procedural haemorrhage	0.00% 0/420 • 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% 0/424 • 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)	0.23% 1/427 • 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% 0/419 • 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 Soft tissue injury	0.24% 1/420 • 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% 0/424 • 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% 0/427 • 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% 0/419 • 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 Tibia fracture	0.00% 0/420 • 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% 0/424 • 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)	0.23% 1/427 • 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% 0/419 • 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) Malignant melanoma	0.00% 0/420 • 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)	0.24% 1/424 • 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% 0/427 • 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% 0/419 • 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 Tension headache	0.00% 0/420 • 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% 0/424 • 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% 0/427 • 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)	0.24% 1/419 • 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)
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/420 • 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% 0/424 • 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)	0.23% 1/427 • 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% 0/419 • 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 Depression	0.00% 0/420 • 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% 0/424 • 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)	0.23% 1/427 • 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% 0/419 • 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)

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