The Long-term Antibody Persistence of MenACWY-TT Vaccine (PF-06866681) Versus Meningitec(Registered) or Mencevax(Registered) ACWY in Healthy Adolescents and Adults and a Booster Dose of MenACWY-TT Administered 10 Years Post Primary Vaccination

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01962207
• Collaborator: (none)
• Enrollment: 243
• Locations: 9
• Arms: 4
• Actual Duration (Months): 56
• Patients Per Site: 27
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the long-term antibody persistence 6, 7, 8, 9 and 10 years after receiving a primary vaccination of meningococcal conjugate vaccine MenACWY-TT versus Meningitec™ or Mencevax™ ACWY, and the safety and immunogenicity of a booster dose of MenACWY-TT administered 10 years after the primary vaccination. All subjects received a primary vaccination at 1 to 10 years of age in study 108658 (NCT00427908). No new subjects will be enrolled in this booster study.

Condition or Disease	Intervention/Treatment	Phase
Infections, Meningococcal	Biological: Meningococcal vaccine GSK134612	Phase 3

Detailed Description

The study aims to evaluate the antibody persistence post primary vaccination with active control, safety and immunogenicity of a booster dose uncontrolled post primary vaccination during different phases:

Persistence phase: Long-term persistence 6, 7, 8, 9 and 10 years after primary vaccination with MenACWY-TT or Meningitec or Mencevax ACWY, in study MenACWY-TT-027.

Booster phase: One month post booster vaccination with MenACWY-TT vaccine ten years after primary vaccination.

The subjects in this study will be allocated to the same groups as in the vaccination study MenACWY-TT-027 (NCT00427908).

Study Design

• Study Type: Interventional
• Actual Enrollment: 243 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A PHASE IIIB, OPEN, MULTI-CENTER STUDY TO EVALUATE THE LONG-TERM ANTIBODY PERSISTENCE AT 6, 7, 8, 9 AND 10 YEARS AFTER THE ADMINISTRATION OF ONE DOSE OF THE MENINGOCOCCAL CONJUGATE VACCINE MENACWY-TT VERSUS ONE DOSE OF MENINGITEC(REGISTERED) VACCINE OR ONE DOSE OF THE MENINGOCOCCAL POLYSACCHARIDE VACCINE MENCEVAX(REGISTERED) ACWY, AND TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A BOOSTER DOSE OF MENACWY-TT VACCINE ADMINISTERED 10 YEARS AFTER PRIMARY VACCINATION OF 1-10 YEAR OLD SUBJECTS WITH MENACWY-TT, MENINGITEC(REGISTERED) OR MENCEVAX(REGISTERED) ACWY.
• Actual Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ACWY<2 Group Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with MenACWY-TT.	Biological: Meningococcal vaccine GSK134612; One dose administered intramuscularly (IM) in the deltoid of the non-dominant arm
Experimental: ACWY≥2 Group Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with MenACWY-TT.	Biological: Meningococcal vaccine GSK134612; One dose administered intramuscularly (IM) in the deltoid of the non-dominant arm
Experimental: MenCCRM Group Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with Meningitec.	Biological: Meningococcal vaccine GSK134612; One dose administered intramuscularly (IM) in the deltoid of the non-dominant arm
Experimental: MenPS Group Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with Mencevax ACWY.	Biological: Meningococcal vaccine GSK134612; One dose administered intramuscularly (IM) in the deltoid of the non-dominant arm

Outcome Measures

Primary Outcome Measures

1. Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination [6 years after primary vaccination (Year 1 of study MENACWY-TT-100)]

   Serogroups included Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY).

2. Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination [7 years after primary vaccination (Year 2 of study MENACWY-TT-100)]

   Serogroups included MenA, MenC, MenW-135 and MenY.

3. Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination [8 years after primary vaccination (Year 3 of study MENACWY-TT-100)]

   Serogroups included MenA, MenC, MenW-135 and MenY.

4. Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination [9 years after primary vaccination (Year 4 of study MENACWY-TT-100)]

   Serogroups included MenA, MenC, MenW-135 and MenY.

5. Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination [10 years after primary vaccination (Year 4 of study MENACWY-TT-100)]

   Serogroups included MenA, MenC, MenW-135 and MenY.

6. Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination [6 Years after primary vaccination (Year 1 of study MENACWY-TT-100)]

   Serogroups included MenA, MenC, MenW-135 and MenY.

7. Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination [7 years after primary vaccination (Year 2 of study MENACWY-TT-100)]

   Serogroups included MenA, MenC, MenW-135 and MenY.

8. Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination [8 years after primary vaccination (Year 3 of study MENACWY-TT-100)]

   Serogroups included MenA, MenC, MenW-135 and MenY.

9. Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination [9 years after primary vaccination (Year 4 of study MENACWY-TT-100)]

   Serogroups included MenA, MenC, MenW-135 and MenY.

10. Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination [10 years after primary vaccination (Year 5 of study MENACWY-TT-100)]

    Serogroups included MenA, MenC, MenW-135 and MenY.

Secondary Outcome Measures

1. Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination [6, 7, 8, 9 and 10 years after primary vaccination (Year 1, 2, 3, 4 and 5 of study MENACWY-TT-100)]

   Serogroups included MenA, MenC, MenW-135 and MenY.

2. Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination [6, 7, 8, 9 and 10 years after primary vaccination (Year 1, 2, 3, 4 and 5 of study MENACWY-TT-100)]

   Serogroups included MenA, MenC, MenW-135 and MenY.

3. Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination [1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)]

   Serogroups included MenA, MenC, MenW-135 and MenY.

4. Booster Phase: Geometric Mean Titers as Measured by rSBA For Each of the 4 Serogroups 1 Month After Booster Vaccination [1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)]

   Serogroups included MenA, MenC, MenW-135 and MenY.

5. Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination [1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)]

   Serogroups included MenA, MenC, MenW-135 and MenY. rSBA booster response to meningococcal antigens (A,C, W-135 and Y) is defined as: rSBA antibody titer >= 1:32 one month after vaccination, and at least 4-fold increase in rSBA titers one month after vaccination.

6. Booster Phase: Percentage of Participants With hSBA Titers >=1:4 and >=1:8 For Each of the 4 Serogroups at 1 Month After Booster Vaccination [1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)]

   Serogroups included MenA, MenC, MenW-135 and MenY.

7. Booster Phase: Geometric Mean Titers Using hSBA For Each of the 4 Serogroups at 1 Month After Booster Vaccination [1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)]

   Serogroups included MenA, MenC, MenW-135 and MenY.

8. Booster Phase: Percentage of Participants With hSBA Booster Response at 1 Month After Booster Vaccination [1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)]

   Serogroups included MenA, MenC, MenW-135 and MenY. hSBA booster response to meningococcal antigens (A,C, W-135 and Y) is defined as: hSBA antibody titer >= 1:8 one month after vaccination, and at least 4-fold increase in hSBA titers one month after vaccination.

9. Persistence Phase: Percentage of Participants With Serious Adverse Events (SAEs) Related to Vaccination or Any Adverse Event (AE) Related to Lack of Vaccine Efficacy [Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination)]

   An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs related to "lack of vaccine efficacy" were as judged by the investigator.

10. Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination [Up to 4 days post booster vaccination]

    Solicited general events: fatigue, gastrointestinal (GI) events (nausea, vomiting, diarrhea and/or abdominal pain, headache (0= normal, 1=mild/easily tolerated, 2=moderate/interfered with normal activity, 3=severe/prevented normal activity) and fever (>=37.5°C for oral/axillary/tympanic route, >=38.0°C for rectal route). Solicited local events: pain (0=none, 1=mild, not interfered/prevented normal activity, 2=moderate, painful when limb moved/interfered with normal activity, 3=severe, significant pain at rest/prevented normal activity), redness and swelling at injection site (record greatest surface diameter in millimeter (mm) as 0 to <=20 mm, >20 to <=50 mm, >50 mm). Participants may be represented in more than 1 category. Only categories with at least 1 participant reported. 'Medical advice' signifies medical advice received to resolve any event. 'Related'=relationship to study vaccine assessed by investigator.

11. Booster Phase: Percentage of Participants With Unsolicited Adverse Events up to 31 Days Post Booster Vaccination [Up to 31 days post booster vaccination]

    An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

12. Booster Phase: Percentage of Participants With Serious Adverse Events (SAEs) Up to 6 Months Post Booster Vaccination [Up to 6 months post booster vaccination]

    An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

13. Booster Phase: Percentage of Participants With New Onset Chronic Illness Up to 6 Months Post Booster Vaccination [Up to 6 months post booster vaccination]

    New onset chronic illness included autoimmune disorders, asthma, type I diabetes, allergies.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects and/or subjects' parent(s)/Legally Acceptable Representative(s) (LARs) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

• A male or female who has received a primary vaccination with the MenACWY-TT, Meningitec or Mencevax ACWY vaccines in study MenACWY-TT-027 (NCT00427908).

• In alignment with local laws and regulations, written informed consent obtained from parents/LAR(s) of the subject and written informed assent obtained from the subject if the subject is less than 15 years of age, or written informed consent obtained from the subject if the subject has achieved the 15th birthday. The subjects ≥15 years of age at the time of enrollment will sign the informed consent form, even if the parent/ LAR previously signed the ICF before the subject reached the legal age of consent.

• Healthy subjects as established by medical history and history-directed physical examination before entering into the study.

All subjects must satisfy the following additional criteria prior to entry of the booster phase:

• Female subjects of non-childbearing potential may be enrolled in the study.

• Non-childbearing potential is defined as pre-menarche, hysterectomy or bilateral ovariectomy.

• Male subjects able to father children and female subjects of childbearing potential (including females who have had tubal ligation) and at risk of pregnancy may be enrolled in the study, if the subject:

• has practiced adequate contraception for 30 days prior to vaccination, and

• has a negative pregnancy test on the day of vaccination (for females only), and

• has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination.

Exclusion Criteria:

• Child in care.

• Previous vaccination with meningococcal polysaccharide or conjugate vaccine outside of study MenACWY-TT-027.

Note: Subjects who were revaccinated with a monovalent MenC conjugate vaccine because of suboptimal response during the persistence phase of the MenACWY-TT-027 study (i.e. MenACWY-TT-028, -029, -030, -031 and -032) are allowed to participate as they will be followed for the persistence of MenA, MenW-135 and MenY.

• History of meningococcal disease due to serogroup A, C, W-135 or Y.

• Previous vaccination with meningococcal B vaccine.

• Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including Human Immunodeficiency Virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).

• Family history of congenital or hereditary immunodeficiency.

• Major congenital defects or serious chronic illness.

• History of chronic alcohol consumption and/or drug abuse.

• Subjects who withdrew consent to be contacted for follow-up studies.

Additional exclusion criteria for booster phase at Month 126 study entry (to be checked at

Month 126) for all subjects:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the follow-up period.

• Administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the booster dose of study vaccine or planned administration within 30 days after vaccination, with the exception of a licensed inactivated influenza vaccine.

• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose . Inhaled and topical steroids are allowed.

• Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination or planned administration during the follow-up period.

• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product .

• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.

• History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.

• Acute disease and/or fever at the time of vaccination.

• Fever is defined as temperature ≥ 37.5°C for oral, axillary, tympanic, or ≥38.0°C for rectal route. The preferred route for recording temperature in this study will be oral.

• Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.

• Pregnant or lactating female.

• Female planning to become pregnant or planning to discontinue contraceptive precautions.

• Male subjects able to father children who are planning to discontinue contraceptive precautions.

• Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Espoo Vaccine Research Clinic	Espoo		Finland	02230
2	South Helsinki Vaccine Research Clinic	Helsinki		Finland	00100
3	Helsinki East Vaccine Research Clinic	Helsinki		Finland	00930
4	Jarvenpaa Vaccine Research Clinic	Jarvenpaa		Finland	04400
5	Tampereen yliopisto/ Oulun rokotetutkimusklinikka	Oulu		Finland	90220
6	Tampereen yliopisto/ Porin rokotetutkimusklinikka	Pori		Finland	28100
7	Tampere Vaccine Research Clinic	Tampere		Finland	33100
8	Tampereen yliopisto/ Turun rokotetutkimusklinikka	Turku		Finland	20520
9	Tampereen yliopisto/ Ita-Vantaan rokotetutkimusklinikka	Vantaa		Finland	01300

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

• Study Protocol - Feb 25, 2016
• Statistical Analysis Plan - Jul 26, 2017

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01962207
• Other Study ID Numbers: MENACWY-TT-100; 2013-001549-15; C0921004; 200171
• First Posted: Oct 14, 2013
• Last Update Posted: Jun 7, 2019
• Last Verified: Mar 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pfizer: 10 years Meningitec; Safety; booster response; Adolescents; Adults; Immunogenicity; Mencevax ACWY
• Additional relevant MeSH terms: Meningococcal Infections

Study Results

Participant Flow

Pre-assignment Detail	In this study, participants from the study MENACWY-TT-027 [NCT00427908] were followed up for assessment of persistence of immune response and safety. And those who consented received booster vaccination and were followed up for another 6 months.

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
Period Title: Persistence Phase (5 Years)
STARTED	76	23	115	29
COMPLETED	47	10	71	17
NOT COMPLETED	29	13	44	12
Period Title: Persistence Phase (5 Years)
STARTED	67	16	77	21
COMPLETED	67	16	77	21
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years	Total
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Total of all reporting groups
Overall Participants	76	23	115	29	243
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	8.2 (0.7)	8.2 (0.7)	12.5 (2.6)	12.1 (2.9)	10.7 (3.0)
Sex: Female, Male (Count of Participants)
Female	40 52.6%	12 52.2%	56 48.7%	14 48.3%	122 50.2%
Male	36 47.4%	11 47.8%	59 51.3%	15 51.7%	121 49.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	76 100%	23 100%	115 100%	29 100%	243 100%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White - Arabic/North African heritage	0 0%	0 0%	1 0.9%	0 0%	1 0.4%
White - Caucasian/European heritage	75 98.7%	22 95.7%	113 98.3%	28 96.6%	238 97.9%
Other	1 1.3%	1 4.3%	1 0.9%	1 3.4%	4 1.6%

Outcome Measures

1. Primary Outcome

Title	Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers >=1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination
Description	Serogroups included Neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY).
Time Frame	6 years after primary vaccination (Year 1 of study MENACWY-TT-100)

Outcome Measure Data

Analysis Population Description

All eligible participants who received primary vaccination with MenACWY-TT, Meningitec, or Mencevax ACWY during study MenACWY-TT-027 and had available assay results for at least 1 tested antigen. Here, "Overall Number of Participants Analyzed" (N) signifies number of participants evaluable for this measure.

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
Measure Participants	54	16	98	24
rSBA-MenA: >=1:8	51.9 68.3%	18.8 81.7%	79.6 69.2%	12.5 43.1%
rSBA-MenC: >=1:8	77.8 102.4%	75.0 326.1%	82.7 71.9%	79.2 273.1%
rSBA-MenW-135: >=1:8	33.3 43.8%	12.5 54.3%	73.5 63.9%	12.5 43.1%
rSBA-MenY: >=1:8	38.9 51.2%	37.5 163%	71.4 62.1%	20.8 71.7%
rSBA-MenA: >=1:28	16.7 22%	6.3 27.4%	55.1 47.9%	8.3 28.6%
rSBA-MenC: >=1:28	70.4 92.6%	56.3 244.8%	68.4 59.5%	62.5 215.5%
rSBA-MenW-135: >=1:28	29.6 38.9%	6.3 27.4%	73.5 63.9%	12.5 43.1%
rSBA-MenY: >=1:28	33.3 43.8%	31.3 136.1%	65.3 56.8%	20.8 71.7%

2. Primary Outcome

Title	Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination
Description	Serogroups included MenA, MenC, MenW-135 and MenY.
Time Frame	7 years after primary vaccination (Year 2 of study MENACWY-TT-100)

Outcome Measure Data

Analysis Population Description

All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup titers cut off.

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
Measure Participants	60	21	104	27
rSBA-MenA: >=1:8	58.3 76.7%	9.5 41.3%	74.0 64.3%	18.5 63.8%
rSBA-MenC: >=1:8	78.3 103%	71.4 310.4%	84.2 73.2%	81.5 281%
rSBA-MenW-135: >=1:8	26.7 35.1%	9.5 41.3%	73.5 63.9%	11.1 38.3%
rSBA-MenY: >=1:8	35.0 46.1%	28.6 124.3%	75.5 65.7%	14.8 51%
rSBA-MenA: >=1:28	21.7 28.6%	9.5 41.3%	44.2 38.4%	11.1 38.3%
rSBA-MenC: >=1:28	61.7 81.2%	52.4 227.8%	61.4 53.4%	66.7 230%
rSBA-MenW-135: >=1:28	23.3 30.7%	9.5 41.3%	69.6 60.5%	7.4 25.5%
rSBA-MenY: >=1:28	33.3 43.8%	28.6 124.3%	69.6 60.5%	14.8 51%

3. Primary Outcome

Title	Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination
Description	Serogroups included MenA, MenC, MenW-135 and MenY.
Time Frame	8 years after primary vaccination (Year 3 of study MENACWY-TT-100)

Outcome Measure Data

Analysis Population Description

All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027 and had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure.

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
Measure Participants	65	22	100	25
rSBA-MenA: >=1:8	47.7 62.8%	4.5 19.6%	70.0 60.9%	24.0 82.8%
rSBA-MenC: >=1:8	78.5 103.3%	77.3 336.1%	85.0 73.9%	88.0 303.4%
rSBA-MenW-135: >=1:8	29.2 38.4%	13.6 59.1%	76.0 66.1%	20.0 69%
rSBA-MenY: >=1:8	40.0 52.6%	40.9 177.8%	79.0 68.7%	24.0 82.8%
rSBA-MenA: >=1:28	23.1 30.4%	4.5 19.6%	45.0 39.1%	12.0 41.4%
rSBA-MenC: >=1:28	64.6 85%	50.0 217.4%	61.0 53%	64.0 220.7%
rSBA-MenW-135: >=1:28	27.7 36.4%	9.1 39.6%	76.0 66.1%	20.0 69%
rSBA-MenY: >=1:28	38.5 50.7%	40.9 177.8%	73.0 63.5%	20.0 69%

4. Primary Outcome

Title	Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination
Description	Serogroups included MenA, MenC, MenW-135 and MenY.
Time Frame	9 years after primary vaccination (Year 4 of study MENACWY-TT-100)

Outcome Measure Data

Analysis Population Description

All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup titers cut off.

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
Measure Participants	64	21	93	25
rSBA-MenA >=1:8	67.2 88.4%	4.8 20.9%	79.6 69.2%	24.0 82.8%
rSBA-MenC >=1:8	81.3 107%	85.7 372.6%	86.0 74.8%	84.0 289.7%
rSBA-MenW-135 >=1:8	32.8 43.2%	9.5 41.3%	76.1 66.2%	16.0 55.2%
rSBA-MenY >=1:8	42.2 55.5%	47.6 207%	66.7 58%	20.0 69%
rSBA-MenA >=1:28	31.3 41.2%	4.8 20.9%	57.0 49.6%	16.0 55.2%
rSBA-MenC >=1:28	65.6 86.3%	57.1 248.3%	64.5 56.1%	68.0 234.5%
rSBA-MenW-135 >=1:28	26.6 35%	9.5 41.3%	71.7 62.3%	16.0 55.2%
rSBA-MenY >=1:28	34.4 45.3%	38.1 165.7%	58.1 50.5%	16.0 55.2%

5. Primary Outcome

Title	Persistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination
Description	Serogroups included MenA, MenC, MenW-135 and MenY.
Time Frame	10 years after primary vaccination (Year 4 of study MENACWY-TT-100)

Outcome Measure Data

Analysis Population Description

All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup titers cut off.

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
Measure Participants	64	17	82	21
rSBA-MenA >=1:8	65.6 86.3%	17.6 76.5%	88.9 77.3%	28.6 98.6%
rSBA-MenC >=1:8	82.8 108.9%	88.2 383.5%	84.1 73.1%	81.0 279.3%
rSBA-MenW-135 >=1:8	31.3 41.2%	0.0 0%	67.1 58.3%	23.8 82.1%
rSBA-MenY >=1:8	43.8 57.6%	35.3 153.5%	65.9 57.3%	23.8 82.1%
rSBA-MenA >=1:28	26.6 35%	5.9 25.7%	49.4 43%	14.3 49.3%
rSBA-MenC >=1:28	64.1 84.3%	58.8 255.7%	65.9 57.3%	66.7 230%
rSBA-MenW-135 >=1:28	28.1 37%	0.0 0%	65.9 57.3%	23.8 82.1%
rSBA-MenY >=1:28	35.9 47.2%	29.4 127.8%	59.8 52%	19.0 65.5%

6. Primary Outcome

Title	Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination
Description	Serogroups included MenA, MenC, MenW-135 and MenY.
Time Frame	6 Years after primary vaccination (Year 1 of study MENACWY-TT-100)

Outcome Measure Data

Analysis Population Description

All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027 and had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure.

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
Measure Participants	54	16	98	24
rSBA-MenA	16.0	5.9	107.3	5.8
rSBA-MenC	161.3	103.1	192.9	98.7
rSBA-MenW-135	18.0	6.2	265.2	7.6
rSBA-MenY	21.5	21.7	136.4	11.6

7. Primary Outcome

Title	Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination
Description	Serogroups included MenA, MenC, MenW-135 and MenY.
Time Frame	7 years after primary vaccination (Year 2 of study MENACWY-TT-100)

Outcome Measure Data

Analysis Population Description

All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup.

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
Measure Participants	60	21	104	27
rSBA-MenA	20.4	6.1	65.3	7.4
rSBA-MenC	104.0	54.3	139.0	101.6
rSBA-MenW-135	13.0	6.8	206.0	6.3
rSBA-MenY	19.9	18.3	152.7	8.2

8. Primary Outcome

Title	Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination
Description	Serogroups included MenA, MenC, MenW-135 and MenY.
Time Frame	8 years after primary vaccination (Year 3 of study MENACWY-TT-100)

Outcome Measure Data

Analysis Population Description

All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure.

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
Measure Participants	65	22	100	25
rSBA-MenA	15.8	4.8	51.3	7.8
rSBA-MenC	110.2	64.0	140.1	121.1
rSBA-MenW-135	15.3	6.4	252.5	11.8
rSBA-MenY	26.1	33.0	181.0	10.9

9. Primary Outcome

Title	Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination
Description	Serogroups included MenA, MenC, MenW-135 and MenY.
Time Frame	9 years after primary vaccination (Year 4 of study MENACWY-TT-100)

Outcome Measure Data

Analysis Population Description

All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup.

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
Measure Participants	64	21	93	25
rSBA-MenA	28.4	5.2	118.8	10.9
rSBA-MenC	166.0	92.0	176.4	164.3
rSBA-MenW-135	17.3	6.6	274.0	9.7
rSBA-MenY	23.1	32.0	106.2	10.0

10. Primary Outcome

Title	Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination
Description	Serogroups included MenA, MenC, MenW-135 and MenY.
Time Frame	10 years after primary vaccination (Year 5 of study MENACWY-TT-100)

Outcome Measure Data

Analysis Population Description

All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup.

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
Measure Participants	64	17	82	21
rSBA-MenA	29.3	5.8	106.0	9.1
rSBA-MenC	132.2	81.7	175.0	105.0
rSBA-MenW-135	16.7	4.0	187.2	14.0
rSBA-MenY	25.8	22.2	90.5	12.7

11. Secondary Outcome

Title	Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Description	Serogroups included MenA, MenC, MenW-135 and MenY.
Time Frame	6, 7, 8, 9 and 10 years after primary vaccination (Year 1, 2, 3, 4 and 5 of study MENACWY-TT-100)

Outcome Measure Data

Analysis Population Description

All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup titers cut off.

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
Measure Participants	64	22	100	27
Year 1 of study MENACWY-TT-100: hSBA-MenA >=1:4	34.1 44.9%	28.6 124.3%	42.2 36.7%	42.9 147.9%
Year 2 of study MENACWY-TT-10: hSBA-MenA >=1:4	26.7 35.1%	14.3 62.2%	26.3 22.9%	26.9 92.8%
Year 3 of study MENACWY-TT-10: hSBA-MenA >=1:4	32.8 43.2%	27.3 118.7%	28.9 25.1%	40.0 137.9%
Year 4 of study MENACWY-TT-10: hSBA-MenA >=1:4	39.7 52.2%	30.0 130.4%	43.0 37.4%	30.4 104.8%
Year 5 of study MENACWY-TT-10: hSBA-MenA >=1:4	31.1 40.9%	25.0 108.7%	34.8 30.3%	33.3 114.8%
Year 1 of study MENACWY-TT-10: hSBA-MenC >=1:4	92.5 121.7%	93.8 407.8%	93.8 81.6%	100.0 344.8%
Year 2 of study MENACWY-TT-10: hSBA-MenC >=1:4	89.8 118.2%	100.0 434.8%	88.5 77%	92.3 318.3%
Year 3 of study MENACWY-TT-10: hSBA-MenC >=1:4	92.2 121.3%	95.5 415.2%	89.6 77.9%	96.0 331%
Year 4 of study MENACWY-TT-10: hSBA-MenC >=1:4	90.5 119.1%	95.0 413%	86.7 75.4%	91.7 316.2%
Year 5 of study MENACWY-TT-10: hSBA-MenC >=1:4	91.9 120.9%	93.8 407.8%	91.1 79.2%	100.0 344.8%
Year 1 of study MENACWY-TT-10: hSBA-MenW-135>=1:4	70.2 92.4%	13.3 57.8%	81.5 70.9%	30.4 104.8%
Year 2 of study MENACWY-TT-10: hSBA-MenW-135>=1:4	60.3 79.3%	20.0 87%	79.6 69.2%	18.5 63.8%
Year 3 of study MENACWY-TT-10: hSBA-MenW-135>=1:4	39.1 51.4%	19.0 82.6%	56.4 49%	12.0 41.4%
Year 4 of study MENACWY-TT-10: hSBA-MenW-135>=1:4	44.8 58.9%	18.8 81.7%	68.4 59.5%	9.5 32.8%
Year 5 of study MENACWY-TT-10: hSBA-MenW-135>=1:4	44.4 58.4%	21.4 93%	61.2 53.2%	26.3 90.7%
Year 1 of study MENACWY-TT-10: hSBA-MenY>=1:4	31.7 41.7%	7.1 30.9%	65.2 56.7%	25.0 86.2%
Year 2 of study MENACWY-TT-10: hSBA-MenY>=1:4	51.8 68.2%	33.3 144.8%	75.0 65.2%	40.7 140.3%
Year 3 of study MENACWY-TT-10: hSBA-MenY>=1:4	50.8 66.8%	38.1 165.7%	72.0 62.6%	34.8 120%
Year 4 of study MENACWY-TT-10: hSBA-MenY>=1:4	32.8 43.2%	26.3 114.3%	67.9 59%	27.3 94.1%
Year 5 of study MENACWY-TT-10: hSBA-MenY>=1:4	41.4 54.5%	40.0 173.9%	72.6 63.1%	44.4 153.1%
Year 1 of study MENACWY-TT-10: hSBA-MenA>=1:8	31.8 41.8%	28.6 124.3%	41.1 35.7%	33.3 114.8%
Year 2 of study MENACWY-TT-10: hSBA-MenA>=1:8	25.0 32.9%	14.3 62.2%	26.3 22.9%	23.1 79.7%
Year 3 of study MENACWY-TT-10: hSBA-MenA>=1:8	32.8 43.2%	27.3 118.7%	28.9 25.1%	36.0 124.1%
Year 4 of study MENACWY-TT-10: hSBA-MenA>=1:8	30.2 39.7%	20.0 87%	43.0 37.4%	26.1 90%
Year 5 of study MENACWY-TT-10: hSBA-MenA>=1:8	26.2 34.5%	18.8 81.7%	33.3 29%	28.6 98.6%
Year 1 of study MENACWY-TT-10: hSBA-MenC>=1:8	92.5 121.7%	93.8 407.8%	93.8 81.6%	100.0 344.8%
Year 2 of study MENACWY-TT-10: hSBA-MenC>=1:8	89.8 118.2%	100.0 434.8%	88.5 77%	92.3 318.3%
Year 3 of study MENACWY-TT-10: hSBA-MenC>=1:8	92.2 121.3%	95.5 415.2%	89.6 77.9%	96.0 331%
Year 4 of study MENACWY-TT-10: hSBA-MenC>=1:8	90.5 119.1%	95.0 413%	85.6 74.4%	91.7 316.2%
Year 5 of study MENACWY-TT-10: hSBA-MenC>=1:8	91.9 120.9%	93.8 407.8%	91.1 79.2%	100.0 344.8%
Year 1 of study MENACWY-TT-10: hSBA-MenW-135 >=1:8	70.2 92.4%	13.3 57.8%	81.5 70.9%	30.4 104.8%
Year 2 of study MENACWY-TT-10: hSBA-MenW-135 >=1:8	60.3 79.3%	20.0 87%	79.6 69.2%	18.5 63.8%
Year 3 of study MENACWY-TT-10: hSBA-MenW-135 >=1:8	39.1 51.4%	19.0 82.6%	56.4 49%	12.0 41.4%
Year 4 of study MENACWY-TT-10: hSBA-MenW-135 >=1:8	44.8 58.9%	18.8 81.7%	67.1 58.3%	9.5 32.8%
Year 5 of study MENACWY-TT-10: hSBA-MenW-135 >=1:8	44.4 58.4%	21.4 93%	61.2 53.2%	26.3 90.7%
Year 1 of study MENACWY-TT-10: hSBA-MenY >=1:8	31.7 41.7%	7.1 30.9%	65.2 56.7%	25.0 86.2%
Year 2 of study MENACWY-TT-10: hSBA-MenY >=1:8	51.8 68.2%	33.3 144.8%	75.0 65.2%	40.7 140.3%
Year 3 of study MENACWY-TT-10: hSBA-MenY >=1:8	50.8 66.8%	38.1 165.7%	72.0 62.6%	34.8 120%
Year 4 of study MENACWY-TT-10: hSBA-MenY >=1:8	32.8 43.2%	26.3 114.3%	67.9 59%	27.3 94.1%
Year 5 of study MENACWY-TT-10: hSBA-MenY >=1:8	41.4 54.5%	40.0 173.9%	72.6 63.1%	44.4 153.1%

12. Secondary Outcome

Title	Persistence Phase: Geometric Mean Titers as Measured by hSBA for Each of the 4 Serogroups After 6, 7, 8, 9 and 10 Years of Primary Vaccination
Description	Serogroups included MenA, MenC, MenW-135 and MenY.
Time Frame	6, 7, 8, 9 and 10 years after primary vaccination (Year 1, 2, 3, 4 and 5 of study MENACWY-TT-100)

Outcome Measure Data

Analysis Population Description

All eligible participants who received primary vaccination with MenACWY-TT, Meningitec or Mencevax ACWY in Study MenACWY-TT-027, had available assay results for at least 1 tested antigen. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup.

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
Measure Participants	64	22	100	27
Year 1 of study MENACWY-TT-100: hSBA-MenA	4.7	3.5	6.5	5.9
Year 2 of study MENACWY-TT-100: hSBA-MenA	3.8	2.8	4.5	4.7
Year 3 of study MENACWY-TT-100: hSBA-MenA	5.0	3.7	4.6	6.7
Year 4 of study MENACWY-TT-100: hSBA-MenA	4.8	3.4	6.6	4.5
Year 5 of study MENACWY-TT-100: hSBA-MenA	4.2	3.1	4.6	5.4
Year 1 of study MENACWY-TT-100: hSBA-MenC	542.5	230.0	427.2	234.8
Year 2 of study MENACWY-TT-100: hSBA-MenC	368.1	223.6	342.7	169.2
Year 3 of study MENACWY-TT-100: hSBA-MenC	378.2	203.4	365.5	273.8
Year 4 of study MENACWY-TT-100: hSBA-MenC	319.0	217.2	190.4	125.7
Year 5 of study MENACWY-TT-100: hSBA-MenC	362.2	112.4	199.3	119.1
Year 1 of study MENACWY-TT-100: hSBA-MenW-135	31.8	3.3	62.5	7.0
Year 2 of study MENACWY-TT-100: hSBA-MenW-135	19.5	4.9	50.5	4.0
Year 3 of study MENACWY-TT-100: hSBA-MenW-135	8.0	4.1	20.4	3.3
Year 4 of study MENACWY-TT-100: hSBA-MenW-135	8.5	3.7	23.1	2.8
Year 5 of study MENACWY-TT-100: hSBA-MenW-135	7.6	3.8	17.4	4.2
Year 1 of study MENACWY-TT-100: hSBA-MenY	7.9	3.1	40.3	7.3
Year 2 of study MENACWY-TT-100: hSBA-MenY	15.8	6.9	54.4	10.5
Year 3 of study MENACWY-TT-100: hSBA-MenY	11.6	8.7	43.7	8.8
Year 4 of study MENACWY-TT-100: hSBA-MenY	7.3	5.8	35.5	6.2
Year 5 of study MENACWY-TT-100: hSBA-MenY	8.6	8.5	36.8	13.9

13. Secondary Outcome

Title	Booster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination
Description	Serogroups included MenA, MenC, MenW-135 and MenY.
Time Frame	1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)

Outcome Measure Data

Analysis Population Description

All eligible participants who received primary vaccination in study MenACWY-TT-027 and booster vaccination in MenACWY-TT-100, had available assay results for 1 month post booster vaccination blood sample. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup titers cut off.

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
Measure Participants	62	16	74	17
rSBA-MenA: >= 1:8	98.4 129.5%	100.0 434.8%	95.9 83.4%	100.0 344.8%
rSBA-MenC: >= 1:8	100.0 131.6%	100.0 434.8%	100.0 87%	100.0 344.8%
rSBA-MenW-135: >= 1:8	100.0 131.6%	100.0 434.8%	100.0 87%	94.1 324.5%
rSBA-MenY >= 1:8	98.4 129.5%	100.0 434.8%	100.0 87%	100.0 344.8%
rSBA-MenA: >= 1:28	98.4 129.5%	100.0 434.8%	95.9 83.4%	100.0 344.8%
rSBA-MenC: >= 1:28	100.0 131.6%	100.0 434.8%	100.0 87%	100.0 344.8%
rSBA-MenW-135: >= 1:28	100.0 131.6%	100.0 434.8%	100.0 87%	94.1 324.5%
rSBA-MenY >= 1:28	98.4 129.5%	100.0 434.8%	100.0 87%	100.0 344.8%

14. Secondary Outcome

Title	Booster Phase: Geometric Mean Titers as Measured by rSBA For Each of the 4 Serogroups 1 Month After Booster Vaccination
Description	Serogroups included MenA, MenC, MenW-135 and MenY.
Time Frame	1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)

Outcome Measure Data

Analysis Population Description

All eligible participants who received primary vaccination in study MenACWY-TT-027 and booster vaccination in this study (MenACWY-TT-100) and had available assay results for the 1 month post booster vaccination blood sample. "N": number of participants evaluable for this measure.

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
Measure Participants	62	16	74	17
rSBA-MenA	5122.3	4871.0	4626.4	6414.2
rSBA-MenC	7163.5	5792.6	4020.0	15101.0
rSBA-MenW-135	25911.2	17970.4	27944.4	10462.5
rSBA-MenY	7660.5	6316.9	7529.7	6959.2

15. Secondary Outcome

Title	Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination
Description	Serogroups included MenA, MenC, MenW-135 and MenY. rSBA booster response to meningococcal antigens (A,C, W-135 and Y) is defined as: rSBA antibody titer >= 1:32 one month after vaccination, and at least 4-fold increase in rSBA titers one month after vaccination.
Time Frame	1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)

Outcome Measure Data

Analysis Population Description

All eligible participants who received primary vaccination in study MenACWY-TT-027 and booster vaccination in this study (MenACWY-TT-100), had available assay results for 1 month post booster vaccination blood sample. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup.

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
Measure Participants	62	16	74	17
rSBA-MenA	90.3 118.8%	100.0 434.8%	87.7 76.3%	94.1 324.5%
rSBA-MenC	82.3 108.3%	93.8 407.8%	75.7 65.8%	94.1 324.5%
rSBA-MenW-135	100.0 131.6%	100.0 434.8%	100.0 87%	88.2 304.1%
rSBA-MenY	95.2 125.3%	87.5 380.4%	93.2 81%	100.0 344.8%

16. Secondary Outcome

Title	Booster Phase: Percentage of Participants With hSBA Titers >=1:4 and >=1:8 For Each of the 4 Serogroups at 1 Month After Booster Vaccination
Description	Serogroups included MenA, MenC, MenW-135 and MenY.
Time Frame	1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)

Outcome Measure Data

Analysis Population Description

All eligible participants: received primary vaccination in study MenACWY-TT-027, booster vaccination in study MenACWY-TT-100, had available assay results for 1 month post booster vaccination blood sample. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup titers cut off.

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
Measure Participants	62	16	74	17
hSBA-MenA: >=1:4	100.0 131.6%	87.5 380.4%	100.0 87%	100.0 344.8%
hSBA-MenC: >=1:4	100.0 131.6%	100.0 434.8%	100.0 87%	94.1 324.5%
hSBA-MenW-135: >=1:4	100.0 131.6%	100.0 434.8%	100.0 87%	100.0 344.8%
hSBA-MenY: >=1:4	100.0 131.6%	93.3 405.7%	100.0 87%	100.0 344.8%
hSBA-MenA: >=1:8	100.0 131.6%	87.5 380.4%	100.0 87%	100.0 344.8%
hSBA-MenC: >=1:8	100.0 131.6%	100.0 434.8%	100.0 87%	94.1 324.5%
hSBA-MenW-135: >=1:8	100.0 131.6%	100.0 434.8%	100.0 87%	100.0 344.8%
hSBA-MenY: >=1:8	100.0 131.6%	93.3 405.7%	100.0 87%	100.0 344.8%

17. Secondary Outcome

Title	Booster Phase: Geometric Mean Titers Using hSBA For Each of the 4 Serogroups at 1 Month After Booster Vaccination
Description	Serogroups included MenA, MenC, MenW-135 and MenY.
Time Frame	1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)

Outcome Measure Data

Analysis Population Description

All eligible participants: received primary vaccination in study MenACWY-TT-027, booster vaccination in study MenACWY-TT-100, had available assay results for 1 month post booster vaccination blood sample. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup titers cut off.

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
Measure Participants	62	16	74	17
hSBA-MenA	1534.2	90.0	1213.0	211.1
hSBA-MenC	33959.8	42559.2	15543.5	44794.4
hSBA-MenW-135	11924.8	258.1	6965.2	199.6
hSBA-MenY	12154.3	407.8	11127.4	453.9

18. Secondary Outcome

Title	Booster Phase: Percentage of Participants With hSBA Booster Response at 1 Month After Booster Vaccination
Description	Serogroups included MenA, MenC, MenW-135 and MenY. hSBA booster response to meningococcal antigens (A,C, W-135 and Y) is defined as: hSBA antibody titer >= 1:8 one month after vaccination, and at least 4-fold increase in hSBA titers one month after vaccination.
Time Frame	1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)

Outcome Measure Data

Analysis Population Description

All eligible participants: received primary vaccination in study MenACWY-TT-027, booster vaccination in study MenACWY-TT-100, had available assay results for 1 month post booster vaccination blood sample. "N": number of participants evaluable for this measure. "Number analyzed": participants analyzed for specified serogroup.

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
Measure Participants	59	15	70	17
hSBA-MenA	98.3 129.3%	93.3 405.7%	100.0 87%	88.2 304.1%
hSBA-MenC	86.0 113.2%	92.9 403.9%	85.7 74.5%	94.1 324.5%
hSBA-MenW-135	100.0 131.6%	90.9 395.2%	96.6 84%	100.0 344.8%
hSBA-MenY	100.0 131.6%	71.4 310.4%	98.5 85.7%	78.6 271%

19. Secondary Outcome

Title	Persistence Phase: Percentage of Participants With Serious Adverse Events (SAEs) Related to Vaccination or Any Adverse Event (AE) Related to Lack of Vaccine Efficacy
Description	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs related to "lack of vaccine efficacy" were as judged by the investigator.
Time Frame	Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination)

Outcome Measure Data

Analysis Population Description

All the participants enrolled in the study.

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
Measure Participants	76	23	115	29
Number [percentage of participants]	0.0 0%	0.0 0%	0.0 0%	0.0 0%

20. Secondary Outcome

Title	Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Description	Solicited general events: fatigue, gastrointestinal (GI) events (nausea, vomiting, diarrhea and/or abdominal pain, headache (0= normal, 1=mild/easily tolerated, 2=moderate/interfered with normal activity, 3=severe/prevented normal activity) and fever (>=37.5°C for oral/axillary/tympanic route, >=38.0°C for rectal route). Solicited local events: pain (0=none, 1=mild, not interfered/prevented normal activity, 2=moderate, painful when limb moved/interfered with normal activity, 3=severe, significant pain at rest/prevented normal activity), redness and swelling at injection site (record greatest surface diameter in millimeter (mm) as 0 to <=20 mm, >20 to <=50 mm, >50 mm). Participants may be represented in more than 1 category. Only categories with at least 1 participant reported. 'Medical advice' signifies medical advice received to resolve any event. 'Related'=relationship to study vaccine assessed by investigator.
Time Frame	Up to 4 days post booster vaccination

Outcome Measure Data

Analysis Population Description

Analysis population included all participants who received a booster dose of study vaccine MenACWY-TT in the booster stage. "Number analyzed": participants analyzed for specified category.

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
Measure Participants	67	16	77	21
All pain	59.7 78.6%	56.3 244.8%	59.5 51.7%	61.9 213.4%
Pain: Grade 1	43.3 57%	37.5 163%	40.5 35.2%	42.9 147.9%
Pain: Grade 2	16.4 21.6%	18.8 81.7%	16.2 14.1%	19.0 65.5%
Severe pain: Grade 3	0.0 0%	0.0 0%	2.7 2.3%	0.0 0%
All redness	35.8 47.1%	43.8 190.4%	36.5 31.7%	23.8 82.1%
Redness: 0 to <=20 mm	28.4 37.4%	25.0 108.7%	31.1 27%	14.3 49.3%
Redness: >20 to <=50 mm	1.5 2%	18.8 81.7%	2.7 2.3%	0.0 0%
Redness: >50 mm	6.0 7.9%	0.0 0%	2.7 2.3%	9.5 32.8%
All swelling	17.9 23.6%	6.3 27.4%	23.0 20%	14.3 49.3%
Swelling: 0 to <=20 mm	14.9 19.6%	0.0 0%	16.2 14.1%	0.0 0%
Swelling: >20 to <=50 mm	1.5 2%	6.3 27.4%	1.4 1.2%	4.8 16.6%
Swelling: >50 mm	1.5 2%	0.0 0%	5.4 4.7%	9.5 32.8%
All fatigue	31.3 41.2%	12.5 54.3%	29.7 25.8%	23.8 82.1%
Fatigue: Grade 1	20.9 27.5%	12.5 54.3%	16.2 14.1%	14.3 49.3%
Fatigue: Grade 2	9.0 11.8%	0.0 0%	6.8 5.9%	9.5 32.8%
Fatigue: Grade 3	1.5 2%	0.0 0%	6.8 5.9%	0.0 0%
Fatigue: Related fatigue	31.3 41.2%	12.5 54.3%	29.7 25.8%	23.8 82.1%
Fatigue: Grade 3 Related	1.5 2%	0.0 0%	6.8 5.9%	0.0 0%
All fever	1.5 2%	0.0 0%	0.0 0%	0.0 0%
Fever: Grade 1	1.5 2%	0.0 0%	0.0 0%	0.0 0%
Fever: Grade 2	0.0 0%	0.0 0%	0.0 0%	0.0 0%
Fever: Grade 3	0.0 0%	0.0 0%	0.0 0%	0.0 0%
Fever: Related	1.5 2%	0.0 0%	0.0 0%	0.0 0%
Fever: Grade 3 related	0.0 0%	0.0 0%	0.0 0%	0.0 0%
All gastrointestinal event (GI)	9.0 11.8%	0.0 0%	17.6 15.3%	14.3 49.3%
GI: Grade 1	7.5 9.9%	0.0 0%	13.5 11.7%	4.8 16.6%
GI: Grade 2	1.5 2%	0.0 0%	2.7 2.3%	9.5 32.8%
GI: Grade 3	0.0 0%	0.0 0%	1.4 1.2%	0.0 0%
GI: Related	7.5 9.9%	0.0 0%	17.6 15.3%	14.3 49.3%
GI: Grade 3 related	0.0 0%	0.0 0%	1.4 1.2%	0.0 0%
All headache	20.9 27.5%	31.3 136.1%	27.0 23.5%	23.8 82.1%
Headache: Grade 1	14.9 19.6%	18.8 81.7%	18.9 16.4%	19.0 65.5%
Headache: Grade 2	6.0 7.9%	12.5 54.3%	6.8 5.9%	4.8 16.6%
Headache: Grade 3	0.0 0%	0.0 0%	1.4 1.2%	0.0 0%
Headache: Related	17.9 23.6%	31.3 136.1%	24.3 21.1%	23.8 82.1%
Headache: Grade 3 related	0.0 0%	0.0 0%	1.4 1.2%	0.0 0%
Headache: Medical advice	0.0 0%	0.0 0%	1.4 1.2%	0.0 0%

21. Secondary Outcome

Title	Booster Phase: Percentage of Participants With Unsolicited Adverse Events up to 31 Days Post Booster Vaccination
Description	An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE covers any untoward medical occurrence in a clinical investigation participant temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time Frame	Up to 31 days post booster vaccination

Outcome Measure Data

Analysis Population Description

Analysis population included all participants who received a booster dose of study vaccine MenACWY-TT in the booster stage.

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
Measure Participants	67	16	77	21
Number [percentage of participants]	23.9 31.4%	31.3 136.1%	35.1 30.5%	52.4 180.7%

22. Secondary Outcome

Title	Booster Phase: Percentage of Participants With Serious Adverse Events (SAEs) Up to 6 Months Post Booster Vaccination
Description	An AE was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame	Up to 6 months post booster vaccination

Outcome Measure Data

Analysis Population Description

Analysis population included all participants who received a booster dose of study vaccine MenACWY-TT in the booster stage.

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
Measure Participants	67	16	77	21
Number [percentage of participants]	0.0 0%	0.0 0%	1.3 1.1%	0.0 0%

23. Secondary Outcome

Title	Booster Phase: Percentage of Participants With New Onset Chronic Illness Up to 6 Months Post Booster Vaccination
Description	New onset chronic illness included autoimmune disorders, asthma, type I diabetes, allergies.
Time Frame	Up to 6 months post booster vaccination

Outcome Measure Data

Analysis Population Description

Analysis population included all participants who received a booster dose of study vaccine MenACWY-TT in the booster stage.

Arm/Group Title	MenACWY-TT Vaccine: Less Than (<) 2 Years	MenCCRM (Meningitec) Vaccine: Less Than 2 Years	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Arm/Group Description	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 milliliter (mL) dose of meningococcal serogroups A, C, W 135, Y tetanus toxoid conjugate (MenACWY-TT) vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100), they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long-term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.	Persistence phase was followed up by booster phase. Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study (MENACWY-TT-100) they were evaluated for long term persistence (of immune response and safety) for 5 years (6, 7, 8, 9 and 10 years post primary vaccination). Booster phase: Participants who provided consent, received a single 0.5 mL booster dose of MenACWY-TT vaccine intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months after booster vaccination.
Measure Participants	67	16	77	21
Number [percentage of participants]	0.0 0%	0.0 0%	1.3 1.1%	4.8 16.6%

Adverse Events

Time Frame	For persistence phase: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination); Booster phase: up to 6 months after booster vaccination
Adverse Event Reporting Description	Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Arm/Group Title	Persistence Phase: MenACWY-TT Vaccine (Less Than [<] 2 Years)		Persistence Phase:MenCCRM (Meningitec) Vaccine(<2 Years)		Persistence Phase: MenACWY-TT Vaccine (>=2 Years)		Persistence Phase: MenPS (Mencevax ACWY) Vaccine (< 2 Years)		Booster Phase: MenACWY-TT Vaccine (Less Than 2 Years)		Booster Phase: MenCCRM (Meningitec) Vaccine (<2 Years)		Booster Phase: MenACWY-TT Vaccine (>= 2 Years)		Booster Phase: MenPS (Mencevax ACWY) Vaccine (<2 Years)
Arm/Group Description	Participants with <2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027).		Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027).		Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027).		Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027).		Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027). Booster phase: Participants received a single 0.5 mL booster dose of MenACWY-TT intramuscularly in this study, 10 years post primary vaccination in MENACWY-TT-027, and were followed up for 6 months.		Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of Meningitec vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027). Booster phase: Participants received a single 0.5 mL booster dose of MenACWY-TT intramuscularly in this study, 10 years post primary vaccination, and were followed up for 6 months.		Persistence phase: Participants with >=2 years of age, received a single 0.5 mL dose of MenACWY-TT vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long-term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027). Booster phase: Participants received a single 0.5 mL booster dose of MenACWY-TT in this study, 10 years post primary vaccination, and were followed up for 6 months.		Persistence phase: Participants with <2 years of age, received a single 0.5 mL dose of MencevaxACWY vaccine intramuscularly, as primary vaccination in study MENACWY-TT-027. Then, in this study they were evaluated for long term persistence for a maximum duration of 5 years (6, 7, 8, 9 and 10 years post primary vaccination in MENACWY-TT-027). Booster phase: Participants received a single 0.5 mL booster dose of MenACWY-TT in this study, 10 years post primary vaccination, and were followed up for 6 months.
All Cause Mortality
	Persistence Phase: MenACWY-TT Vaccine (Less Than [<] 2 Years)		Persistence Phase:MenCCRM (Meningitec) Vaccine(<2 Years)		Persistence Phase: MenACWY-TT Vaccine (>=2 Years)		Persistence Phase: MenPS (Mencevax ACWY) Vaccine (< 2 Years)		Booster Phase: MenACWY-TT Vaccine (Less Than 2 Years)		Booster Phase: MenCCRM (Meningitec) Vaccine (<2 Years)		Booster Phase: MenACWY-TT Vaccine (>= 2 Years)		Booster Phase: MenPS (Mencevax ACWY) Vaccine (<2 Years)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		0/77 (0%)		0/21 (0%)
Serious Adverse Events
	Persistence Phase: MenACWY-TT Vaccine (Less Than [<] 2 Years)		Persistence Phase:MenCCRM (Meningitec) Vaccine(<2 Years)		Persistence Phase: MenACWY-TT Vaccine (>=2 Years)		Persistence Phase: MenPS (Mencevax ACWY) Vaccine (< 2 Years)		Booster Phase: MenACWY-TT Vaccine (Less Than 2 Years)		Booster Phase: MenCCRM (Meningitec) Vaccine (<2 Years)		Booster Phase: MenACWY-TT Vaccine (>= 2 Years)		Booster Phase: MenPS (Mencevax ACWY) Vaccine (<2 Years)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		1/77 (1.3%)		0/21 (0%)
Gastrointestinal disorders
Abdominal pain	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		1/77 (1.3%)		0/21 (0%)
Other (Not Including Serious) Adverse Events
	Persistence Phase: MenACWY-TT Vaccine (Less Than [<] 2 Years)		Persistence Phase:MenCCRM (Meningitec) Vaccine(<2 Years)		Persistence Phase: MenACWY-TT Vaccine (>=2 Years)		Persistence Phase: MenPS (Mencevax ACWY) Vaccine (< 2 Years)		Booster Phase: MenACWY-TT Vaccine (Less Than 2 Years)		Booster Phase: MenCCRM (Meningitec) Vaccine (<2 Years)		Booster Phase: MenACWY-TT Vaccine (>= 2 Years)		Booster Phase: MenPS (Mencevax ACWY) Vaccine (<2 Years)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		53/67 (79.1%)		12/16 (75%)		65/77 (84.4%)		15/21 (71.4%)
Blood and lymphatic system disorders
Lymph node pain	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		1/77 (1.3%)		0/21 (0%)
Lymphadenitis	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		0/77 (0%)		1/21 (4.8%)
Gastrointestinal disorders
Abdominal pain upper	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		1/67 (1.5%)		0/16 (0%)		0/77 (0%)		0/21 (0%)
Coeliac disease	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		0/77 (0%)		1/21 (4.8%)
Gastrointestinal symptoms	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		6/67 (9%)		0/16 (0%)		13/77 (16.9%)		3/21 (14.3%)
Vomiting	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		1/77 (1.3%)		0/21 (0%)
General disorders
Axillary pain	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		1/67 (1.5%)		0/16 (0%)		0/77 (0%)		1/21 (4.8%)
Fatigue 1	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		21/67 (31.3%)		2/16 (12.5%)		22/77 (28.6%)		5/21 (23.8%)
Fatigue	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		1/16 (6.3%)		0/77 (0%)		1/21 (4.8%)
Injection site bruising	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		2/67 (3%)		0/16 (0%)		0/77 (0%)		0/21 (0%)
Injection site erythema (redness)	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		24/67 (35.8%)		7/16 (43.8%)		27/77 (35.1%)		5/21 (23.8%)
Injection site hypoaesthesia	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		1/77 (1.3%)		0/21 (0%)
Injection site pain (pain at injection site)	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		40/67 (59.7%)		9/16 (56.3%)		44/77 (57.1%)		13/21 (61.9%)
Injection site pruritus	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		1/67 (1.5%)		1/16 (6.3%)		1/77 (1.3%)		0/21 (0%)
Injection site swelling (swelling)	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		12/67 (17.9%)		1/16 (6.3%)		17/77 (22.1%)		3/21 (14.3%)
Pyrexia	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		2/67 (3%)		2/16 (12.5%)		1/77 (1.3%)		0/21 (0%)
Immune system disorders
Drug hypersensitivity	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		1/77 (1.3%)		0/21 (0%)
Infections and infestations
Conjunctivitis	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		1/67 (1.5%)		0/16 (0%)		0/77 (0%)		0/21 (0%)
Ear infection	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		1/77 (1.3%)		0/21 (0%)
Gastroenteritis	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		2/77 (2.6%)		1/21 (4.8%)
Hand-foot-and-mouth disease	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		1/77 (1.3%)		0/21 (0%)
Infectious mononucleosis	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		1/77 (1.3%)		0/21 (0%)
Nasopharyngitis	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		1/16 (6.3%)		1/77 (1.3%)		1/21 (4.8%)
Otitis media	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		1/77 (1.3%)		0/21 (0%)
Respiratory tract infection	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		1/16 (6.3%)		0/77 (0%)		1/21 (4.8%)
Rhinitis	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		2/67 (3%)		0/16 (0%)		0/77 (0%)		1/21 (4.8%)
Sinusitis	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		1/77 (1.3%)		0/21 (0%)
Skin infection	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		0/77 (0%)		1/21 (4.8%)
Tonsillitis	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		1/77 (1.3%)		0/21 (0%)
Upper respiratory tract infection	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		1/67 (1.5%)		1/16 (6.3%)		7/77 (9.1%)		2/21 (9.5%)
Injury, poisoning and procedural complications
Foot fracture	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		1/16 (6.3%)		0/77 (0%)		0/21 (0%)
Hand fracture	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		1/67 (1.5%)		0/16 (0%)		0/77 (0%)		0/21 (0%)
Joint dislocation	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		1/67 (1.5%)		0/16 (0%)		0/77 (0%)		0/21 (0%)
Musculoskeletal and connective tissue disorders
Muscle tightness	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		1/77 (1.3%)		0/21 (0%)
Musculoskeletal pain	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		1/77 (1.3%)		1/21 (4.8%)
Neck pain	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		0/77 (0%)		1/21 (4.8%)
Pain in extremity	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		1/67 (1.5%)		0/16 (0%)		0/77 (0%)		1/21 (4.8%)
Nervous system disorders
Dizziness	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		1/67 (1.5%)		0/16 (0%)		0/77 (0%)		0/21 (0%)
Headache 1	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		14/67 (20.9%)		5/16 (31.3%)		20/77 (26%)		5/21 (23.8%)
Headache	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		4/67 (6%)		1/16 (6.3%)		3/77 (3.9%)		0/21 (0%)
Hypoaesthesia	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		1/77 (1.3%)		0/21 (0%)
Migraine	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		0/77 (0%)		1/21 (4.8%)
Paraesthesia	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		1/67 (1.5%)		0/16 (0%)		0/77 (0%)		0/21 (0%)
Psychiatric disorders
Insomnia	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		1/77 (1.3%)		0/21 (0%)
Sleep disorder	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		0/77 (0%)		1/21 (4.8%)
Reproductive system and breast disorders
Dysmenorrhoea	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		1/67 (1.5%)		0/16 (0%)		2/77 (2.6%)		0/21 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		1/77 (1.3%)		0/21 (0%)
Cough	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		0/67 (0%)		0/16 (0%)		1/77 (1.3%)		0/21 (0%)
Nasal congestion	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		1/67 (1.5%)		0/16 (0%)		0/77 (0%)		0/21 (0%)
Oropharyngeal pain	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		1/67 (1.5%)		0/16 (0%)		2/77 (2.6%)		0/21 (0%)
Throat irritation	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		1/67 (1.5%)		0/16 (0%)		0/77 (0%)		0/21 (0%)
Skin and subcutaneous tissue disorders
Acne	0/76 (0%)		0/23 (0%)		0/115 (0%)		0/29 (0%)		1/67 (1.5%)		0/16 (0%)		0/77 (0%)		0/21 (0%)

Limitations/Caveats

[Not Specified]

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Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.