Trial Outcomes & Findings for Study to Assess the Safety and Immunogenicity of a Single Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine in Older Adults Who Received a Primary Vaccination (3 or More Years Earlier) in Study MET49 (NCT NCT04142242)
NCT ID: NCT04142242
Last Updated: 2025-09-11
Results Overview
Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titer less than (\<) 1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>= 1:8.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
471 participants
Primary outcome timeframe
Day 30 (post-vaccination) in study MEQ00066
Results posted on
2025-09-11
Participant Flow
Study participants were enrolled from 04-October-2019 to 02-March-2020 at 34 sites in the United States. A total of 471 participants who received Menomune vaccine or Meningococcal Polysaccharide (Serogroups A, C, Y, and W 135) Tetanus Toxoid (MenACYW) Conjugate vaccine in Study MET49 (NCT02842866) or Study MET44 (NCT01732627) were enrolled and randomized/assigned to a study group in the present study (MEQ00066).
Study consisted of two stages: Stage I and Stage II. In Stage I, Groups 1 and 2 participants alone received vaccination and Groups 3 and 4 received no vaccination and only provided blood sample for antibody persistence. Groups 3 and 4 participants continued into Stage II and received vaccination in Stage II of the current study.
Participant milestones
| Measure |
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)
Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single intramuscular (IM) dose of MenACYW Conjugate vaccine, at Day 0, during Stage I in the present study (MEQ00066).
|
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0, during Stage I in the present study (MEQ00066).
|
Group 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)
Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066), followed by receiving a single IM dose of MenACYW Conjugate vaccine at Stage II in the present study (MEQ00066).
|
Group 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066), followed by receiving a single IM dose of MenACYW Conjugate vaccine at Stage II in the present study (MEQ00066).
|
Group 5: Menomune-primed Participants (MET44)
Participants who received a single dose of Menomune vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
|---|---|---|---|---|---|---|
|
Stage I
STARTED
|
139
|
176
|
31
|
39
|
26
|
60
|
|
Stage I
Vaccinated
|
138
|
175
|
0
|
0
|
0
|
0
|
|
Stage I
Stage I Full Analysis Set (FAS)
|
138
|
175
|
31
|
39
|
26
|
59
|
|
Stage I
Safety Analysis Set (SafAS)
|
151
|
162
|
0
|
0
|
0
|
0
|
|
Stage I
COMPLETED
|
138
|
175
|
31
|
39
|
26
|
59
|
|
Stage I
NOT COMPLETED
|
1
|
1
|
0
|
0
|
0
|
1
|
|
Stage II
STARTED
|
0
|
0
|
31
|
39
|
0
|
0
|
|
Stage II
Vaccinated
|
0
|
0
|
25
|
27
|
0
|
0
|
|
Stage II
Stage II FAS for Persistence
|
0
|
0
|
24
|
28
|
0
|
0
|
|
Stage II
Safety Analysis Set
|
0
|
0
|
27
|
25
|
0
|
0
|
|
Stage II
COMPLETED
|
0
|
0
|
25
|
26
|
0
|
0
|
|
Stage II
NOT COMPLETED
|
0
|
0
|
6
|
13
|
0
|
0
|
Reasons for withdrawal
| Measure |
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)
Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single intramuscular (IM) dose of MenACYW Conjugate vaccine, at Day 0, during Stage I in the present study (MEQ00066).
|
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0, during Stage I in the present study (MEQ00066).
|
Group 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)
Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066), followed by receiving a single IM dose of MenACYW Conjugate vaccine at Stage II in the present study (MEQ00066).
|
Group 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066), followed by receiving a single IM dose of MenACYW Conjugate vaccine at Stage II in the present study (MEQ00066).
|
Group 5: Menomune-primed Participants (MET44)
Participants who received a single dose of Menomune vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
|---|---|---|---|---|---|---|
|
Stage I
Non-compliance with the protocol
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Stage I
Voluntary withdrawal not due to an adverse event (AE)
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Stage II
Non-compliance with the protocol
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Stage II
Lost to Follow-up
|
0
|
0
|
1
|
2
|
0
|
0
|
|
Stage II
Withdrawal by Subject
|
0
|
0
|
5
|
9
|
0
|
0
|
Baseline Characteristics
Study to Assess the Safety and Immunogenicity of a Single Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine in Older Adults Who Received a Primary Vaccination (3 or More Years Earlier) in Study MET49
Baseline characteristics by cohort
| Measure |
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)
n=139 Participants
Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine, at Day 0, during Stage I in the present study (MEQ00066).
|
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)
n=176 Participants
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0, during Stage I in the present study (MEQ00066).
|
Group 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)
n=31 Participants
Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066), followed by receiving a single IM dose of MenACYW Conjugate vaccine at Stage II in the present study (MEQ00066).
|
Group 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)
n=39 Participants
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0), during Stage I in the present study (MEQ00066), followed by receiving a single IM dose of MenACYW Conjugate vaccine at Stage II in the present study (MEQ00066).
|
Group 5: Menomune-primed Participants (MET44)
n=26 Participants
Participants who received a single dose of Menomune vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)
n=60 Participants
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
Total
n=471 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
70.6 years
STANDARD_DEVIATION 7.48 • n=5 Participants
|
69.8 years
STANDARD_DEVIATION 7.43 • n=7 Participants
|
69.2 years
STANDARD_DEVIATION 7.14 • n=5 Participants
|
69.7 years
STANDARD_DEVIATION 6.39 • n=4 Participants
|
70.5 years
STANDARD_DEVIATION 5.69 • n=21 Participants
|
71.4 years
STANDARD_DEVIATION 6.28 • n=10 Participants
|
70.2 years
STANDARD_DEVIATION 7.11 • n=115 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
42 Participants
n=10 Participants
|
291 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
18 Participants
n=10 Participants
|
180 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
White
|
127 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
57 Participants
n=10 Participants
|
426 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
40 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Native American or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Mixed Origin
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Day 30 (post-vaccination) in study MEQ00066Population: Stage I Day 30 Per-Protocol Analysis Set (PPAS) population: participants of Groups 1 and 2 who received 1 dose of vaccine in MEQ00066 and had valid serology result for at least 1 serogroup from a blood sample provided 30 days (+14) post-vaccination with no relevant protocol deviations. 'Number analyzed'=participants with available data for each specified category. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, 4, 5 and 6 as pre-specified in protocol.
Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titer less than (\<) 1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>= 1:8.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)
n=130 Participants
Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine, at Day 0, during Stage I in the present study (MEQ00066).
|
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0, during Stage I in the present study (MEQ00066).
|
Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)
Included all participants of Groups 1 and 3 who received a single dose of Menomune vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 1 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
|
Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)
Included all participants of Groups 2 and 4 who received a single dose of MenACYW Conjugate vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 2 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
|
Group 5: Menomune-primed Participants (MET44)
Participants who received a single dose of Menomune vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
|---|---|---|---|---|---|---|
|
Stage I: Percentage of Participants With Seroresponse for Meningococcal Serogroups A, C, W & Y Measured by Serum Bactericidal Assay Using Human Complement (hSBA) After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Group 1 (Menomune-primed)
Serogroup A
|
60.8 percentage of participants
Interval 51.8 to 69.2
|
—
|
—
|
—
|
—
|
—
|
|
Stage I: Percentage of Participants With Seroresponse for Meningococcal Serogroups A, C, W & Y Measured by Serum Bactericidal Assay Using Human Complement (hSBA) After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Group 1 (Menomune-primed)
Serogroup C
|
55.0 percentage of participants
Interval 46.0 to 63.8
|
—
|
—
|
—
|
—
|
—
|
|
Stage I: Percentage of Participants With Seroresponse for Meningococcal Serogroups A, C, W & Y Measured by Serum Bactericidal Assay Using Human Complement (hSBA) After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Group 1 (Menomune-primed)
Serogroup W
|
49.2 percentage of participants
Interval 40.4 to 58.1
|
—
|
—
|
—
|
—
|
—
|
|
Stage I: Percentage of Participants With Seroresponse for Meningococcal Serogroups A, C, W & Y Measured by Serum Bactericidal Assay Using Human Complement (hSBA) After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Group 1 (Menomune-primed)
Serogroup Y
|
49.2 percentage of participants
Interval 40.4 to 58.1
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 30 (post-vaccination) in study MEQ00066Population: Analysis was performed on Stage I Day 30 PPAS population. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, 4, 5 and 6 as pre-specified in the protocol.
Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \>= 1:16 for participants with pre-vaccination hSBA titer \< 1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>= 1:8.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)
n=145 Participants
Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine, at Day 0, during Stage I in the present study (MEQ00066).
|
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0, during Stage I in the present study (MEQ00066).
|
Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)
Included all participants of Groups 1 and 3 who received a single dose of Menomune vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 1 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
|
Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)
Included all participants of Groups 2 and 4 who received a single dose of MenACYW Conjugate vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 2 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
|
Group 5: Menomune-primed Participants (MET44)
Participants who received a single dose of Menomune vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
|---|---|---|---|---|---|---|
|
Stage I: Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Group 2 (MenACYW Conjugate Vaccine-primed Participants)
Serogroup A
|
79.3 percentage of participants
Interval 71.8 to 85.6
|
—
|
—
|
—
|
—
|
—
|
|
Stage I: Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Group 2 (MenACYW Conjugate Vaccine-primed Participants)
Serogroup C
|
93.1 percentage of participants
Interval 87.7 to 96.6
|
—
|
—
|
—
|
—
|
—
|
|
Stage I: Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Group 2 (MenACYW Conjugate Vaccine-primed Participants)
Serogroup W
|
90.3 percentage of participants
Interval 84.3 to 94.6
|
—
|
—
|
—
|
—
|
—
|
|
Stage I: Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Group 2 (MenACYW Conjugate Vaccine-primed Participants)
Serogroup Y
|
92.4 percentage of participants
Interval 86.8 to 96.2
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 6 (post-vaccination) in study MEQ00066Population: Analysis was performed on Stage I Day 6 PPAS which included participants of Groups 1 and 2 who had received the study MEQ00066 vaccine and had a valid serology result for at least 1 serogroup from a blood sample provided 6 days (window, 5 to 7) post-vaccination with no relevant protocol deviations. For this outcome measure, data were not planned to be collected and analyzed for Groups 3, 4, 5 and 6 as pre-specified in the protocol.
Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \>= 1:16 for participants with pre-vaccination hSBA titer \< 1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>= 1:8.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)
n=62 Participants
Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine, at Day 0, during Stage I in the present study (MEQ00066).
|
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)
n=58 Participants
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0, during Stage I in the present study (MEQ00066).
|
Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)
Included all participants of Groups 1 and 3 who received a single dose of Menomune vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 1 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
|
Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)
Included all participants of Groups 2 and 4 who received a single dose of MenACYW Conjugate vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 2 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
|
Group 5: Menomune-primed Participants (MET44)
Participants who received a single dose of Menomune vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
|---|---|---|---|---|---|---|
|
Stage I: Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, W, and Y Measured by hSBA at Day 6 After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Groups 1 and 2
Serogroup A
|
8.1 percentage of participants
Interval 2.7 to 17.8
|
36.2 percentage of participants
Interval 24.0 to 49.9
|
—
|
—
|
—
|
—
|
|
Stage I: Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, W, and Y Measured by hSBA at Day 6 After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Groups 1 and 2
Serogroup C
|
8.1 percentage of participants
Interval 2.7 to 17.8
|
77.6 percentage of participants
Interval 64.7 to 87.5
|
—
|
—
|
—
|
—
|
|
Stage I: Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, W, and Y Measured by hSBA at Day 6 After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Groups 1 and 2
Serogroup W
|
6.5 percentage of participants
Interval 1.8 to 15.7
|
70.7 percentage of participants
Interval 57.3 to 81.9
|
—
|
—
|
—
|
—
|
|
Stage I: Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, W, and Y Measured by hSBA at Day 6 After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Groups 1 and 2
Serogroup Y
|
8.1 percentage of participants
Interval 2.7 to 17.8
|
72.4 percentage of participants
Interval 59.1 to 83.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MEQ00066Population: Analysis was performed on the Stage I Full Analysis Set (FAS) population for persistence which included Groups 1, 2, 3, 4, 5 and 6 participants who had a valid serology result for at least 1 serogroup from a pre-vaccination blood sample. Here, 'number analyzed' = participants with available data for each specified category.
GMTs of antibodies against meningococcal serogroups A, C, W, and Y 135 were measured by hSBA. Titers are expressed in terms of 1/dilution. At Baseline, Group 1 was equivalent to Group 3 (both groups were Menomune-primed in MET49) and Group 2 was equivalent to Group 4 (both groups were MenACYW Conjugate Vaccine-primed in MET49), therefore it was planned to collect and present pooled data of Groups 1 and 3 and Groups 2 and 4 for Day 0 (pre-vaccination) in this outcome measure. Here, "0" in the number analyzed field for Day 30 signifies that data were not planned to be collected and analyzed for Groups 3 and 4 participants as pre-specified in the protocol.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)
n=138 Participants
Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine, at Day 0, during Stage I in the present study (MEQ00066).
|
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)
n=175 Participants
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0, during Stage I in the present study (MEQ00066).
|
Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)
n=169 Participants
Included all participants of Groups 1 and 3 who received a single dose of Menomune vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 1 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
|
Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)
n=214 Participants
Included all participants of Groups 2 and 4 who received a single dose of MenACYW Conjugate vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 2 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
|
Group 5: Menomune-primed Participants (MET44)
Participants who received a single dose of Menomune vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
|---|---|---|---|---|---|---|
|
Stage I: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Before and After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066 (Groups 1 to 4)
Serogroup A: Day 0 (pre-vaccination)
|
11.6 titers
Interval 9.4 to 14.3
|
11.8 titers
Interval 9.77 to 14.4
|
11.6 titers
Interval 9.53 to 14.1
|
12.2 titers
Interval 10.2 to 14.6
|
—
|
—
|
|
Stage I: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Before and After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066 (Groups 1 to 4)
Serogroup A: Day 30 (post-vaccination)
|
57.6 titers
Interval 42.8 to 77.6
|
144 titers
Interval 110.0 to 188.0
|
—
|
—
|
—
|
—
|
|
Stage I: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Before and After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066 (Groups 1 to 4)
Serogroup C: Day 0 (pre-vaccination)
|
8.85 titers
Interval 6.87 to 11.4
|
17.7 titers
Interval 14.0 to 22.5
|
8.47 titers
Interval 6.76 to 10.6
|
17.7 titers
Interval 14.3 to 21.9
|
—
|
—
|
|
Stage I: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Before and After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066 (Groups 1 to 4)
Serogroup C: Day 30 (post-vaccination)
|
56.7 titers
Interval 40.7 to 78.9
|
568 titers
Interval 447.0 to 721.0
|
—
|
—
|
—
|
—
|
|
Stage I: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Before and After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066 (Groups 1 to 4)
Serogroup W: Day 0 (pre-vaccination)
|
6.68 titers
Interval 5.24 to 8.5
|
14.5 titers
Interval 11.5 to 18.3
|
6.54 titers
Interval 5.28 to 8.11
|
14.2 titers
Interval 11.6 to 17.4
|
—
|
—
|
|
Stage I: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Before and After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066 (Groups 1 to 4)
Serogroup W: Day 30 (post-vaccination)
|
31.5 titers
Interval 23.1 to 42.9
|
377 titers
Interval 290.0 to 490.0
|
—
|
—
|
—
|
—
|
|
Stage I: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Before and After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066 (Groups 1 to 4)
Serogroup Y: Day 0 (pre-vaccination)
|
8.08 titers
Interval 5.91 to 11.0
|
15.5 titers
Interval 12.2 to 19.7
|
7.49 titers
Interval 5.72 to 9.82
|
15.3 titers
Interval 12.3 to 19.1
|
—
|
—
|
|
Stage I: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Before and After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066 (Groups 1 to 4)
Serogroup Y: Day 30 (post-vaccination)
|
41.8 titers
Interval 30.2 to 57.7
|
478 titers
Interval 371.0 to 617.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination in MEQ00066)Population: Analysis was performed on Stage I FAS population.
GMTs of antibodies against meningococcal serogroups A, C, W, and Y were measured by hSBA. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)
n=26 Participants
Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine, at Day 0, during Stage I in the present study (MEQ00066).
|
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)
n=59 Participants
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0, during Stage I in the present study (MEQ00066).
|
Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)
Included all participants of Groups 1 and 3 who received a single dose of Menomune vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 1 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
|
Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)
Included all participants of Groups 2 and 4 who received a single dose of MenACYW Conjugate vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 2 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
|
Group 5: Menomune-primed Participants (MET44)
Participants who received a single dose of Menomune vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
|---|---|---|---|---|---|---|
|
Stage I: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA: Groups 5 and 6
Serogroup A
|
9.64 titers
Interval 5.18 to 17.9
|
9.00 titers
Interval 6.44 to 12.6
|
—
|
—
|
—
|
—
|
|
Stage I: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA: Groups 5 and 6
Serogroup C
|
7.58 titers
Interval 4.11 to 14.0
|
11.9 titers
Interval 7.67 to 18.5
|
—
|
—
|
—
|
—
|
|
Stage I: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA: Groups 5 and 6
Serogroup W
|
4.95 titers
Interval 3.39 to 7.22
|
11.9 titers
Interval 7.97 to 17.8
|
—
|
—
|
—
|
—
|
|
Stage I: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA: Groups 5 and 6
Serogroup Y
|
7.19 titers
Interval 4.09 to 12.6
|
11.2 titers
Interval 7.24 to 17.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) in study MEQ00066Population: Analysis was performed on Stage I FAS population. At Baseline, Group 1 was equivalent to Group 3 (both groups were Menomune-primed in MET49) and Group 2 was equivalent to Group 4 (both groups were MenACYW Conjugate Vaccine-primed in MET49), therefore it was planned to collect and present pooled data of Groups 1 and 3 and Groups 2 and 4 for Day 0 (pre-vaccination) in this outcome measure.
Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)
n=138 Participants
Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine, at Day 0, during Stage I in the present study (MEQ00066).
|
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)
n=175 Participants
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0, during Stage I in the present study (MEQ00066).
|
Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)
n=169 Participants
Included all participants of Groups 1 and 3 who received a single dose of Menomune vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 1 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
|
Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)
n=214 Participants
Included all participants of Groups 2 and 4 who received a single dose of MenACYW Conjugate vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 2 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
|
Group 5: Menomune-primed Participants (MET44)
n=26 Participants
Participants who received a single dose of Menomune vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)
n=59 Participants
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
|---|---|---|---|---|---|---|
|
Stage I: Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 1 to 6
Serogroup A: >= 1:4
|
86.2 percentage of participants
Interval 79.3 to 91.5
|
89.1 percentage of participants
Interval 83.6 to 93.3
|
85.8 percentage of participants
Interval 79.6 to 90.7
|
87.9 percentage of participants
Interval 82.7 to 91.9
|
84.6 percentage of participants
Interval 65.1 to 95.6
|
81.4 percentage of participants
Interval 69.1 to 90.3
|
|
Stage I: Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 1 to 6
Serogroup A: >= 1:8
|
65.2 percentage of participants
Interval 56.6 to 73.1
|
65.1 percentage of participants
Interval 57.6 to 72.2
|
65.7 percentage of participants
Interval 58.0 to 72.8
|
65.0 percentage of participants
Interval 58.2 to 71.3
|
50.0 percentage of participants
Interval 29.9 to 70.1
|
55.9 percentage of participants
Interval 42.4 to 68.8
|
|
Stage I: Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 1 to 6
Serogroup C: >= 1:4
|
71.0 percentage of participants
Interval 62.7 to 78.4
|
89.1 percentage of participants
Interval 83.6 to 93.3
|
69.8 percentage of participants
Interval 62.3 to 76.6
|
89.7 percentage of participants
Interval 84.8 to 93.4
|
73.1 percentage of participants
Interval 52.2 to 88.4
|
79.7 percentage of participants
Interval 67.2 to 89.0
|
|
Stage I: Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 1 to 6
Serogroup C: >= 1:8
|
49.3 percentage of participants
Interval 40.7 to 57.9
|
74.3 percentage of participants
Interval 67.1 to 80.6
|
47.9 percentage of participants
Interval 40.2 to 55.7
|
73.4 percentage of participants
Interval 66.9 to 79.2
|
42.3 percentage of participants
Interval 23.4 to 63.1
|
59.3 percentage of participants
Interval 45.7 to 71.9
|
|
Stage I: Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 1 to 6
Serogroup W: >= 1:4
|
64.5 percentage of participants
Interval 55.9 to 72.4
|
81.1 percentage of participants
Interval 74.5 to 86.6
|
64.5 percentage of participants
Interval 56.8 to 71.7
|
83.2 percentage of participants
Interval 77.5 to 87.9
|
61.5 percentage of participants
Interval 40.6 to 79.8
|
79.7 percentage of participants
Interval 67.2 to 89.0
|
|
Stage I: Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 1 to 6
Serogroup W: >= 1:8
|
40.6 percentage of participants
Interval 32.3 to 49.3
|
66.9 percentage of participants
Interval 59.4 to 73.8
|
39.6 percentage of participants
Interval 32.2 to 47.4
|
66.8 percentage of participants
Interval 60.1 to 73.1
|
38.5 percentage of participants
Interval 20.2 to 59.4
|
66.1 percentage of participants
Interval 52.6 to 77.9
|
|
Stage I: Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 1 to 6
Serogroup Y: >= 1:4
|
53.6 percentage of participants
Interval 44.9 to 62.1
|
81.1 percentage of participants
Interval 74.5 to 86.6
|
53.3 percentage of participants
Interval 45.4 to 61.0
|
79.4 percentage of participants
Interval 73.4 to 84.6
|
57.7 percentage of participants
Interval 36.9 to 76.6
|
71.2 percentage of participants
Interval 57.9 to 82.2
|
|
Stage I: Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 1 to 6
Serogroup Y: >= 1:8
|
42.0 percentage of participants
Interval 33.7 to 50.7
|
69.1 percentage of participants
Interval 61.7 to 75.9
|
40.8 percentage of participants
Interval 33.3 to 48.6
|
68.2 percentage of participants
Interval 61.5 to 74.4
|
46.2 percentage of participants
Interval 26.6 to 66.6
|
59.3 percentage of participants
Interval 45.7 to 71.9
|
SECONDARY outcome
Timeframe: 5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49Population: Analysis was performed on Stage II FAS for persistence that included participants in Groups 3 and 4 who had a valid serology result for at least 1 serogroup from pre-vaccination blood sample (5-year antibody persistence). Data for this outcome measure was not planned to be collected and analyzed for Groups 1, 2, 5 and 6 as pre-specified in the protocol.
GMTs of antibodies against meningococcal serogroups A, C, W, and Y were measured by hSBA. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)
n=24 Participants
Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine, at Day 0, during Stage I in the present study (MEQ00066).
|
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)
n=28 Participants
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0, during Stage I in the present study (MEQ00066).
|
Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)
Included all participants of Groups 1 and 3 who received a single dose of Menomune vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 1 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
|
Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)
Included all participants of Groups 2 and 4 who received a single dose of MenACYW Conjugate vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 2 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
|
Group 5: Menomune-primed Participants (MET44)
Participants who received a single dose of Menomune vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
|---|---|---|---|---|---|---|
|
Stage II: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4
Serogroup A
|
8.72 titers
Interval 5.42 to 14.0
|
15.6 titers
Interval 9.48 to 25.7
|
—
|
—
|
—
|
—
|
|
Stage II: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4
Serogroup C
|
3.78 titers
Interval 2.59 to 5.5
|
7.25 titers
Interval 3.68 to 14.3
|
—
|
—
|
—
|
—
|
|
Stage II: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4
Serogroup W
|
4.62 titers
Interval 2.5 to 8.56
|
7.07 titers
Interval 4.17 to 12.0
|
—
|
—
|
—
|
—
|
|
Stage II: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4
Serogroup Y
|
4.00 titers
Interval 2.35 to 6.81
|
5.25 titers
Interval 3.32 to 8.31
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49Population: Analysis was performed on Stage II FAS for persistence. Data for this outcome measure was not planned to be collected and analyzed for Groups 1, 2, 5 and 6 as pre-specified in the protocol.
GMTs of antibodies against meningococcal serogroups A, C, W, and Y were measured by rSBA. Titers were expressed in terms of 1/dilution.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)
n=24 Participants
Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine, at Day 0, during Stage I in the present study (MEQ00066).
|
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)
n=28 Participants
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0, during Stage I in the present study (MEQ00066).
|
Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)
Included all participants of Groups 1 and 3 who received a single dose of Menomune vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 1 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
|
Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)
Included all participants of Groups 2 and 4 who received a single dose of MenACYW Conjugate vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 2 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
|
Group 5: Menomune-primed Participants (MET44)
Participants who received a single dose of Menomune vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
|---|---|---|---|---|---|---|
|
Stage II: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by rSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4
Serogroup A
|
24.0 titers
Interval 6.93 to 83.0
|
40.0 titers
Interval 12.4 to 129.0
|
—
|
—
|
—
|
—
|
|
Stage II: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by rSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4
Serogroup C
|
13.8 titers
Interval 5.16 to 37.2
|
64.0 titers
Interval 24.7 to 166.0
|
—
|
—
|
—
|
—
|
|
Stage II: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by rSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4
Serogroup W
|
9.79 titers
Interval 3.37 to 28.4
|
25.0 titers
Interval 8.48 to 73.6
|
—
|
—
|
—
|
—
|
|
Stage II: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by rSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4
Serogroup Y
|
4.00 titers
Interval 1.84 to 8.7
|
34.5 titers
Interval 10.9 to 109.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49Population: Analysis was performed on Stage II FAS for persistence. Data for this outcome measure was not planned to be collected and analyzed for Groups 1, 2, 5 and 6 as pre-specified in the protocol.
Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)
n=24 Participants
Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine, at Day 0, during Stage I in the present study (MEQ00066).
|
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)
n=28 Participants
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0, during Stage I in the present study (MEQ00066).
|
Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)
Included all participants of Groups 1 and 3 who received a single dose of Menomune vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 1 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
|
Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)
Included all participants of Groups 2 and 4 who received a single dose of MenACYW Conjugate vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 2 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
|
Group 5: Menomune-primed Participants (MET44)
Participants who received a single dose of Menomune vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
|---|---|---|---|---|---|---|
|
Stage II: Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4
Serogroup A: >= 1:4
|
79.2 percentage of participants
Interval 57.8 to 92.9
|
89.3 percentage of participants
Interval 71.8 to 97.7
|
—
|
—
|
—
|
—
|
|
Stage II: Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4
Serogroup A: >= 1:8
|
58.3 percentage of participants
Interval 36.6 to 77.9
|
78.6 percentage of participants
Interval 59.0 to 91.7
|
—
|
—
|
—
|
—
|
|
Stage II: Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4
Serogroup C: >= 1:4
|
50.0 percentage of participants
Interval 29.1 to 70.9
|
64.3 percentage of participants
Interval 44.1 to 81.4
|
—
|
—
|
—
|
—
|
|
Stage II: Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4
Serogroup C: >= 1:8
|
20.8 percentage of participants
Interval 7.1 to 42.2
|
28.6 percentage of participants
Interval 13.2 to 48.7
|
—
|
—
|
—
|
—
|
|
Stage II: Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4
Serogroup W: >= 1:4
|
33.3 percentage of participants
Interval 15.6 to 55.3
|
64.3 percentage of participants
Interval 44.1 to 81.4
|
—
|
—
|
—
|
—
|
|
Stage II: Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4
Serogroup W: >= 1:8
|
29.2 percentage of participants
Interval 12.6 to 51.1
|
46.4 percentage of participants
Interval 27.5 to 66.1
|
—
|
—
|
—
|
—
|
|
Stage II: Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4
Serogroup Y: >= 1:4
|
37.5 percentage of participants
Interval 18.8 to 59.4
|
50.0 percentage of participants
Interval 30.6 to 69.4
|
—
|
—
|
—
|
—
|
|
Stage II: Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4
Serogroup Y: >= 1:8
|
29.2 percentage of participants
Interval 12.6 to 51.1
|
42.9 percentage of participants
Interval 24.5 to 62.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49Population: Analysis was performed on Stage II FAS for persistence. Data for this outcome measure was not planned to be collected and analyzed for Groups 1, 2, 5 and 6 as pre-specified in the protocol.
Antibody titers against meningococcal serogroups A, C, W, and Y were measured by rSBA.
Outcome measures
| Measure |
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)
n=24 Participants
Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine, at Day 0, during Stage I in the present study (MEQ00066).
|
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)
n=28 Participants
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0, during Stage I in the present study (MEQ00066).
|
Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)
Included all participants of Groups 1 and 3 who received a single dose of Menomune vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 1 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
|
Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)
Included all participants of Groups 2 and 4 who received a single dose of MenACYW Conjugate vaccine in a previous study MET49. Participants in each group provided a blood sample for assessment of antibody persistence at enrollment (Day 0) in the present study (MEQ00066). In addition, Group 2 participants received a single IM dose of MenACYW Conjugate vaccine at Day 0 in the present study (MEQ00066).
|
Group 5: Menomune-primed Participants (MET44)
Participants who received a single dose of Menomune vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).
|
|---|---|---|---|---|---|---|
|
Stage II: Percentage of Participants With Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4
Serogroup Y: >= 1:8
|
12.5 percentage of participants
Interval 2.7 to 32.4
|
50.0 percentage of participants
Interval 30.6 to 69.4
|
—
|
—
|
—
|
—
|
|
Stage II: Percentage of Participants With Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4
Serogroup A: >= 1:8
|
45.8 percentage of participants
Interval 25.6 to 67.2
|
53.6 percentage of participants
Interval 33.9 to 72.5
|
—
|
—
|
—
|
—
|
|
Stage II: Percentage of Participants With Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4
Serogroup A: >= 1:128
|
41.7 percentage of participants
Interval 22.1 to 63.4
|
50.0 percentage of participants
Interval 30.6 to 69.4
|
—
|
—
|
—
|
—
|
|
Stage II: Percentage of Participants With Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4
Serogroup C: >= 1:8
|
45.8 percentage of participants
Interval 25.6 to 67.2
|
75.0 percentage of participants
Interval 55.1 to 89.3
|
—
|
—
|
—
|
—
|
|
Stage II: Percentage of Participants With Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4
Serogroup C: >= 1:128
|
25.0 percentage of participants
Interval 9.8 to 46.7
|
53.6 percentage of participants
Interval 33.9 to 72.5
|
—
|
—
|
—
|
—
|
|
Stage II: Percentage of Participants With Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4
Serogroup W: >= 1:8
|
29.2 percentage of participants
Interval 12.6 to 51.1
|
50.0 percentage of participants
Interval 30.6 to 69.4
|
—
|
—
|
—
|
—
|
|
Stage II: Percentage of Participants With Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4
Serogroup W: >= 1:128
|
29.2 percentage of participants
Interval 12.6 to 51.1
|
46.4 percentage of participants
Interval 27.5 to 66.1
|
—
|
—
|
—
|
—
|
|
Stage II: Percentage of Participants With Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4
Serogroup Y: >= 1:128
|
12.5 percentage of participants
Interval 2.7 to 32.4
|
50.0 percentage of participants
Interval 30.6 to 69.4
|
—
|
—
|
—
|
—
|
Adverse Events
Stage I - Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)
Serious events: 2 serious events
Other events: 55 other events
Deaths: 0 deaths
Stage I - Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)
Serious events: 1 serious events
Other events: 62 other events
Deaths: 0 deaths
Stage II - Group 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Stage II - Group 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stage I - Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)
n=151 participants at risk
Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine, at Day 0, during Stage I in the present study (MEQ00066).
|
Stage I - Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)
n=162 participants at risk
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0, during Stage I in the present study (MEQ00066).
|
Stage II - Group 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)
n=27 participants at risk
Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066), followed by receiving a single IM dose of MenACYW Conjugate vaccine at Stage II in the present study (MEQ00066).
|
Stage II - Group 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)
n=25 participants at risk
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0, Stage I) in the present study (MEQ00066), followed by receiving a single IM dose of MenACYW Conjugate vaccine at Stage II in the present study (MEQ00066).
|
|---|---|---|---|---|
|
Infections and infestations
Diverticulitis
|
0.66%
1/151 • Number of events 1 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
0.00%
0/162 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
0.00%
0/27 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
0.00%
0/25 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/151 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
0.00%
0/162 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
0.00%
0/27 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
4.0%
1/25 • Number of events 1 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epithelioid Mesothelioma
|
0.00%
0/151 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
0.62%
1/162 • Number of events 1 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
0.00%
0/27 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
0.00%
0/25 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.66%
1/151 • Number of events 1 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
0.00%
0/162 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
0.00%
0/27 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
0.00%
0/25 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
Other adverse events
| Measure |
Stage I - Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)
n=151 participants at risk
Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine, at Day 0, during Stage I in the present study (MEQ00066).
|
Stage I - Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)
n=162 participants at risk
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0, during Stage I in the present study (MEQ00066).
|
Stage II - Group 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)
n=27 participants at risk
Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066), followed by receiving a single IM dose of MenACYW Conjugate vaccine at Stage II in the present study (MEQ00066).
|
Stage II - Group 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)
n=25 participants at risk
Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0, Stage I) in the present study (MEQ00066), followed by receiving a single IM dose of MenACYW Conjugate vaccine at Stage II in the present study (MEQ00066).
|
|---|---|---|---|---|
|
General disorders
Injection Site Erythema
|
7.3%
11/151 • Number of events 11 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
3.7%
6/162 • Number of events 6 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
7.4%
2/27 • Number of events 2 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
4.0%
1/25 • Number of events 1 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
|
General disorders
Injection Site Pain
|
21.2%
32/151 • Number of events 33 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
16.7%
27/162 • Number of events 27 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
22.2%
6/27 • Number of events 6 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
12.0%
3/25 • Number of events 3 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
|
General disorders
Malaise
|
14.6%
22/151 • Number of events 22 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
13.6%
22/162 • Number of events 22 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
14.8%
4/27 • Number of events 4 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
4.0%
1/25 • Number of events 1 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
19.9%
30/151 • Number of events 30 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
21.6%
35/162 • Number of events 35 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
18.5%
5/27 • Number of events 5 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
16.0%
4/25 • Number of events 4 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
|
Nervous system disorders
Headache
|
13.9%
21/151 • Number of events 21 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
18.5%
30/162 • Number of events 31 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
18.5%
5/27 • Number of events 5 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
8.0%
2/25 • Number of events 2 • Unsolicited adverse event (AE) data were collected from Day 0 (pre-vaccination) up to Day 30 (post-vaccination). The solicited reactions (SR) were collected within 7 days post-vaccination. Serious AEs data were collected throughout the study (i.e., up to 30 days post-vaccination for Groups 1 and 2; and 2 years post-vaccination for Groups 3 and 4 in the current study)
Analysis performed on SafAS population. Safety data were planned to be collected and reported for participants revaccinated with MenACYW conjugate vaccine (i.e., participants in Groups 1 and 2 during Stage I, and participants in Groups 3 and 4 during Stage II). Since participants in Groups 5 and 6 were not vaccinated in MEQ00066 as pre-specified in the protocol, safety data were not planned to be collected and reported for Groups 5 and 6.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable participant matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER