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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

Safety and Immunogenicity of a Single Dose of MenACYW Conjugate Vaccine at Least 3 Years Following Initial Vaccination With Either Menomune® Vaccine or MenACYW Conjugate Vaccine in Older Adults

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04142242
Enrollment
471
Registered
2019-10-29
Start date
2019-10-04
Completion date
2022-05-25
Last updated
2025-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meningococcal Infection (Healthy Volunteers)

Brief summary

Primary Objective: To demonstrate sufficiency of the vaccine seroresponse to meningococcal serogroups A, C, W, and Y following administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W 135) Tetanus Toxoid (MenACYW) Conjugate vaccine to Group 1 participants (who received primary vaccination with Menomune vaccine greater than or equal to \[\>= 3\] years earlier at \>= 56 years of age in Study MET49). Secondary Objectives: Secondary Objective 1 - To demonstrate sufficiency of the vaccine seroresponse to meningococcal serogroups A, C, W, and Y following administration of a single dose of MenACYW Conjugate vaccine to Group 2 participants (who received primary vaccination with MenACYW Conjugate vaccine \>= 3 years earlier at \>= 56 years of age in Study MET49). Secondary Objective 2 - To describe vaccine seroresponse rates with respect to serogroups A, C, W, and Y in serum specimens collected 6 days (window, 5-7) post-vaccination in approximately 60 participants from Group 1 (Menomune-primed) and approximately 60 participants from Group 2 (MenACYW Conjugate vaccine-primed). Secondary Objective 3 - To describe antibody persistence \>= 3 years after primary vaccination with Menomune vaccine or MenACYW Conjugate vaccine for participants from all groups.

Detailed description

Study duration per participant in Group 1 and Group 2 was approximately 30 days including: 1 day of screening and vaccination, a phone call and a safety-follow up/end of study visit at Day 8 and Day 30 after vaccine administration, respectively. Study duration per participant in Group 3 and 4 was approximately 2 years and 30 days including: 1 day of screening, 1 day of vaccination 2 years later, a phone call and a safety-follow up/end of study visit at Day 8 and Day 30 after vaccine administration, respectively. Study duration per participant in Group 5 and 6 was 1 day. Safety assessment includes solicited reactions within 7 days after vaccination, unsolicited adverse events (AEs), serious adverse events (SAEs) and adverse event of special interest (AESI)s throughout the study active phase (i.e., period of time from revaccination with MenACYW Conjugate vaccine to the end of the short-term \[i.e., \ 30 days\] follow-up after the vaccination).

Interventions

BIOLOGICALMeningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine

Pharmaceutical form: Solution for injection; Route of administration: Intramuscular

OTHERBlood sample

Blood sample for assessment of antibody persistence.

Sponsors

Sanofi Pasteur, a Sanofi Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
59 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Received primary vaccination in Study MET49 or Study MET44 at \>= 56 years of age with either Menomune vaccine or MenACYW Conjugate vaccine, as assigned by randomization. (\>= 56 years means from the day of the 56th birthday onwards). * Able to attend all scheduled visits and to comply with all study procedures.

Exclusion criteria

* Pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile. * Participation in the 4 weeks preceding study enrollment/vaccination or planned participation during the active phase of the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. Note: Active phase refers to the period of time from revaccination with MenACYW Conjugate vaccine to the end of the short-term (i.e., \ 30 days) follow-up after the vaccination. Accordingly, following the blood draw at Visit 1, participants in Group 3 and Group 4 will have a 2-year inactive phase prior to Visit 2. Prior to Visit 2, participants in Group 3 and Group 4 will have inclusion and

Design outcomes

Primary

MeasureTime frameDescription
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)Day 30 (post-vaccination) in study MEQ00066Antibody 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.

Secondary

MeasureTime frameDescription
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 2Day 6 (post-vaccination) in study MEQ00066Antibody 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.
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)Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MEQ00066GMTs 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.
Stage I: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA: Groups 5 and 6Day 0 (pre-vaccination in MEQ00066)GMTs of antibodies against meningococcal serogroups A, C, W, and Y were measured by hSBA. Titers were expressed in terms of 1/dilution.
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 6Day 0 (pre-vaccination) in study MEQ00066Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA.
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)Day 30 (post-vaccination) in study MEQ00066Antibody 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.
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 45 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49GMTs of antibodies against meningococcal serogroups A, C, W, and Y were measured by rSBA. Titers were expressed in terms of 1/dilution.
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 45 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA.
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 45 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49Antibody titers against meningococcal serogroups A, C, W, and Y were measured by rSBA.
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 45 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49GMTs of antibodies against meningococcal serogroups A, C, W, and Y were measured by hSBA. Titers were expressed in terms of 1/dilution.

Countries

Puerto Rico, United States

Participant flow

Recruitment details

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).

Pre-assignment details

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.

Participants by arm

ArmCount
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 IM dose of MenACYW Conjugate vaccine, at Day 0, during Stage I in the present study (MEQ00066).
139
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).
176
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).
31
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).
39
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).
26
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).
60
Total471

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005
Stage INon-compliance with the protocol100001
Stage IVoluntary withdrawal not due to an adverse event (AE)010000
Stage IILost to Follow-up001200
Stage IINon-compliance with the protocol000200
Stage IIWithdrawal by Subject005900

Baseline characteristics

CharacteristicGroup 6: MenACYW Conjugate Vaccine-primed Participants (MET44)TotalGroup 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)Group 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)Group 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)Group 5: Menomune-primed Participants (MET44)
Age, Continuous71.4 years
STANDARD_DEVIATION 6.28
70.2 years
STANDARD_DEVIATION 7.11
70.6 years
STANDARD_DEVIATION 7.48
69.8 years
STANDARD_DEVIATION 7.43
69.2 years
STANDARD_DEVIATION 7.14
69.7 years
STANDARD_DEVIATION 6.39
70.5 years
STANDARD_DEVIATION 5.69
Race/Ethnicity, Customized
Asian
0 Participants2 Participants0 Participants2 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Black or African American
3 Participants40 Participants11 Participants16 Participants3 Participants7 Participants0 Participants
Race/Ethnicity, Customized
Mixed Origin
0 Participants1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Native American or Alaska Native
0 Participants1 Participants0 Participants0 Participants1 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Not Reported
0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Race/Ethnicity, Customized
White
57 Participants426 Participants127 Participants158 Participants27 Participants32 Participants25 Participants
Sex: Female, Male
Female
42 Participants291 Participants85 Participants111 Participants15 Participants27 Participants11 Participants
Sex: Female, Male
Male
18 Participants180 Participants54 Participants65 Participants16 Participants12 Participants15 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 1510 / 1620 / 270 / 25
other
Total, other adverse events
55 / 15162 / 16210 / 275 / 25
serious
Total, serious adverse events
2 / 1511 / 1620 / 271 / 25

Outcome results

Primary

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)

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.

Time frame: Day 30 (post-vaccination) in study MEQ00066

Population: 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.

ArmMeasureGroupValue (NUMBER)
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 A60.8 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 C55.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 W49.2 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 Y49.2 percentage of participants
Secondary

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)

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.

Time frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MEQ00066

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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)478 titers
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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)377 titers
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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)11.8 titers
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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)568 titers
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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)17.7 titers
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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)14.5 titers
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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)15.5 titers
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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)144 titers
Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)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)8.47 titers
Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)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)7.49 titers
Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)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)6.54 titers
Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)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
Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)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)12.2 titers
Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)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)15.3 titers
Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)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)14.2 titers
Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)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)17.7 titers
Secondary

Stage I: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA: Groups 5 and 6

GMTs of antibodies against meningococcal serogroups A, C, W, and Y were measured by hSBA. Titers were expressed in terms of 1/dilution.

Time frame: Day 0 (pre-vaccination in MEQ00066)

Population: Analysis was performed on Stage I FAS population.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)Stage I: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA: Groups 5 and 6Serogroup A9.64 titers
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)Stage I: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA: Groups 5 and 6Serogroup C7.58 titers
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)Stage I: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA: Groups 5 and 6Serogroup W4.95 titers
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)Stage I: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA: Groups 5 and 6Serogroup Y7.19 titers
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)Stage I: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA: Groups 5 and 6Serogroup Y11.2 titers
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)Stage I: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA: Groups 5 and 6Serogroup A9.00 titers
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)Stage I: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA: Groups 5 and 6Serogroup W11.9 titers
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)Stage I: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA: Groups 5 and 6Serogroup C11.9 titers
Secondary

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

GMTs of antibodies against meningococcal serogroups A, C, W, and Y were measured by hSBA. Titers were expressed in terms of 1/dilution.

Time frame: 5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 4Serogroup A8.72 titers
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 4Serogroup C3.78 titers
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 4Serogroup W4.62 titers
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 4Serogroup Y4.00 titers
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 4Serogroup Y5.25 titers
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 4Serogroup A15.6 titers
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 4Serogroup W7.07 titers
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 4Serogroup C7.25 titers
Secondary

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

GMTs of antibodies against meningococcal serogroups A, C, W, and Y were measured by rSBA. Titers were expressed in terms of 1/dilution.

Time frame: 5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49

Population: 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.

ArmMeasureGroupValue (GEOMETRIC_MEAN)
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 4Serogroup Y4.00 titers
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 4Serogroup A24.0 titers
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 4Serogroup C13.8 titers
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 4Serogroup W9.79 titers
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 4Serogroup W25.0 titers
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 4Serogroup Y34.5 titers
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 4Serogroup C64.0 titers
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 4Serogroup A40.0 titers
Secondary

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

Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA.

Time frame: 5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49

Population: 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.

ArmMeasureGroupValue (NUMBER)
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 4Serogroup Y: >= 1:437.5 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 4Serogroup C: >= 1:820.8 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 4Serogroup A: >= 1:858.3 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 4Serogroup W: >= 1:433.3 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 4Serogroup A: >= 1:479.2 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 4Serogroup W: >= 1:829.2 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 4Serogroup Y: >= 1:829.2 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 4Serogroup C: >= 1:450.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 4Serogroup Y: >= 1:842.9 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 4Serogroup Y: >= 1:450.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 4Serogroup A: >= 1:489.3 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 4Serogroup A: >= 1:878.6 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 4Serogroup C: >= 1:464.3 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 4Serogroup C: >= 1:828.6 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 4Serogroup W: >= 1:464.3 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 4Serogroup W: >= 1:846.4 percentage of participants
Secondary

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

Antibody titers against meningococcal serogroups A, C, W, and Y were measured by rSBA.

Time frame: 5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49

Population: 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.

ArmMeasureGroupValue (NUMBER)
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 4Serogroup Y: >= 1:12812.5 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 4Serogroup C: >= 1:12825.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 4Serogroup A: >= 1:845.8 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 4Serogroup W: >= 1:829.2 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 4Serogroup Y: >= 1:812.5 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 4Serogroup W: >= 1:12829.2 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 4Serogroup C: >= 1:845.8 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 4Serogroup A: >= 1:12841.7 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 4Serogroup Y: >= 1:12850.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 4Serogroup A: >= 1:12850.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 4Serogroup Y: >= 1:850.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 4Serogroup A: >= 1:853.6 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 4Serogroup C: >= 1:875.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 4Serogroup C: >= 1:12853.6 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 4Serogroup W: >= 1:850.0 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 4Serogroup W: >= 1:12846.4 percentage of participants
Secondary

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

Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA.

Time frame: Day 0 (pre-vaccination) in study MEQ00066

Population: 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.

ArmMeasureGroupValue (NUMBER)
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 6Serogroup C: >= 1:471.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 6Serogroup A: >= 1:865.2 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 6Serogroup W: >= 1:840.6 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 6Serogroup Y: >= 1:453.6 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 6Serogroup C: >= 1:849.3 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 6Serogroup Y: >= 1:842.0 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 6Serogroup A: >= 1:486.2 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 6Serogroup W: >= 1:464.5 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 6Serogroup Y: >= 1:869.1 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 6Serogroup C: >= 1:874.3 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 6Serogroup W: >= 1:481.1 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 6Serogroup A: >= 1:489.1 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 6Serogroup A: >= 1:865.1 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 6Serogroup W: >= 1:866.9 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 6Serogroup C: >= 1:489.1 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 6Serogroup Y: >= 1:481.1 percentage of participants
Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)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 6Serogroup C: >= 1:469.8 percentage of participants
Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)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 6Serogroup Y: >= 1:453.3 percentage of participants
Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)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 6Serogroup W: >= 1:464.5 percentage of participants
Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)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 6Serogroup C: >= 1:847.9 percentage of participants
Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)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 6Serogroup Y: >= 1:840.8 percentage of participants
Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)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 6Serogroup A: >= 1:485.8 percentage of participants
Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)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 6Serogroup W: >= 1:839.6 percentage of participants
Pooled Groups 1 and 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)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 6Serogroup A: >= 1:865.7 percentage of participants
Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)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 6Serogroup Y: >= 1:868.2 percentage of participants
Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)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 6Serogroup W: >= 1:866.8 percentage of participants
Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)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 6Serogroup C: >= 1:873.4 percentage of participants
Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)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 6Serogroup A: >= 1:487.9 percentage of participants
Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)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 6Serogroup A: >= 1:865.0 percentage of participants
Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)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 6Serogroup C: >= 1:489.7 percentage of participants
Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)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 6Serogroup Y: >= 1:479.4 percentage of participants
Pooled Groups 2 and 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)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 6Serogroup W: >= 1:483.2 percentage of participants
Group 5: Menomune-primed Participants (MET44)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 6Serogroup Y: >= 1:846.2 percentage of participants
Group 5: Menomune-primed Participants (MET44)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 6Serogroup C: >= 1:842.3 percentage of participants
Group 5: Menomune-primed Participants (MET44)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 6Serogroup A: >= 1:484.6 percentage of participants
Group 5: Menomune-primed Participants (MET44)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 6Serogroup A: >= 1:850.0 percentage of participants
Group 5: Menomune-primed Participants (MET44)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 6Serogroup C: >= 1:473.1 percentage of participants
Group 5: Menomune-primed Participants (MET44)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 6Serogroup W: >= 1:461.5 percentage of participants
Group 5: Menomune-primed Participants (MET44)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 6Serogroup W: >= 1:838.5 percentage of participants
Group 5: Menomune-primed Participants (MET44)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 6Serogroup Y: >= 1:457.7 percentage of participants
Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)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 6Serogroup W: >= 1:479.7 percentage of participants
Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)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 6Serogroup C: >= 1:479.7 percentage of participants
Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)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 6Serogroup Y: >= 1:859.3 percentage of participants
Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)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 6Serogroup Y: >= 1:471.2 percentage of participants
Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)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 6Serogroup A: >= 1:855.9 percentage of participants
Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)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 6Serogroup A: >= 1:481.4 percentage of participants
Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)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 6Serogroup C: >= 1:859.3 percentage of participants
Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)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 6Serogroup W: >= 1:866.1 percentage of participants
Secondary

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)

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.

Time frame: Day 30 (post-vaccination) in study MEQ00066

Population: 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.

ArmMeasureGroupValue (NUMBER)
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 A79.3 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 C93.1 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 W90.3 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 Y92.4 percentage of participants
Secondary

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

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.

Time frame: Day 6 (post-vaccination) in study MEQ00066

Population: 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.

ArmMeasureGroupValue (NUMBER)
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 2Serogroup A8.1 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 2Serogroup C8.1 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 2Serogroup W6.5 percentage of participants
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)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 2Serogroup Y8.1 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 2Serogroup Y72.4 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 2Serogroup A36.2 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 2Serogroup W70.7 percentage of participants
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)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 2Serogroup C77.6 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026