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CompletedNCT01962207Updated Jun 7, 2019Results posted

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

A Phase 3 interventional study of Meningococcal vaccine GSK134612 in Infections, Meningococcal, sponsored by Pfizer. Completed at 9 sites in Finland. Per ClinicalTrials.gov, last updated 2019-06-07.

Sponsored by Pfizer · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
243
Allocation
Non-randomized
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Infections, Meningococcal

Keywords

  • 10 years Meningitec
  • Safety
  • booster response
  • Adolescents
  • Adults
  • Immunogenicity
  • Mencevax ACWY
03

In context

Meningococcal Infections

219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.

This study's enrollment of 243 is below the median of 450 across 190 interventional studies indexed under Meningococcal Infections.

Browse Meningococcal Infections studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

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.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
243 participants (actual)

Study arms

  • Experimental
    ACWY<2 Group

    Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with MenACWY-TT.

    Biological: Meningococcal vaccine GSK134612

  • Experimental
    ACWY≥2 Group

    Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with MenACWY-TT.

    Biological: Meningococcal vaccine GSK134612

  • Experimental
    MenCCRM Group

    Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with Meningitec.

    Biological: Meningococcal vaccine GSK134612

  • Experimental
    MenPS Group

    Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with Mencevax ACWY.

    Biological: Meningococcal vaccine GSK134612

Interventions

  • BiologicalMeningococcal vaccine GSK134612

    One dose administered intramuscularly (IM) in the deltoid of the non-dominant arm

06

What researchers measure

Primary outcomes

  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

    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)

  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

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

    Time frame: 7 years after primary vaccination (Year 2 of study MENACWY-TT-100)

  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

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

    Time frame: 8 years after primary vaccination (Year 3 of study MENACWY-TT-100)

  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

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

    Time frame: 9 years after primary vaccination (Year 4 of study MENACWY-TT-100)

  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

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

    Time frame: 10 years after primary vaccination (Year 4 of study MENACWY-TT-100)

  6. Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination

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

    Time frame: 6 Years after primary vaccination (Year 1 of study MENACWY-TT-100)

  7. Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination

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

    Time frame: 7 years after primary vaccination (Year 2 of study MENACWY-TT-100)

  8. Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination

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

    Time frame: 8 years after primary vaccination (Year 3 of study MENACWY-TT-100)

  9. Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination

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

    Time frame: 9 years after primary vaccination (Year 4 of study MENACWY-TT-100)

  10. Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination

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

    Time frame: 10 years after primary vaccination (Year 5 of study MENACWY-TT-100)

Secondary outcomes

  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

    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)

  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

    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)

  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

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

    Time frame: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)

  4. Booster Phase: Geometric Mean Titers as Measured by rSBA For Each of the 4 Serogroups 1 Month After Booster Vaccination

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

    Time frame: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)

  5. Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination

    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)

  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

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

    Time frame: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)

  7. Booster Phase: Geometric Mean Titers Using hSBA For Each of the 4 Serogroups at 1 Month After Booster Vaccination

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

    Time frame: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)

  8. Booster Phase: Percentage of Participants With hSBA Booster Response at 1 Month After Booster Vaccination

    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)

  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

    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)

  10. Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events 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.

    Time frame: Up to 4 days post booster vaccination

  11. Booster Phase: Percentage of Participants With Unsolicited Adverse Events 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.

    Time frame: Up to 31 days post booster vaccination

  12. Booster Phase: Percentage of Participants With Serious Adverse Events (SAEs) 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.

    Time frame: Up to 6 months post booster vaccination

  13. Booster Phase: Percentage of Participants With New Onset Chronic Illness Up to 6 Months Post Booster Vaccination

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

    Time frame: Up to 6 months post booster vaccination

07

Results

Posted Jun 7, 2019

Participant flow

Persistence Phase (5 Years)
Participant flow — Persistence Phase (5 Years)
MilestoneMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Started762311529
Completed47107117
Not completed29134412
Withdrew: Lost to follow-up2152
Withdrew: Migrated/moved from study area2040
Withdrew: Withdrawal by subject45184
Withdrew: Eligibility criteria not fulfilled0031
Withdrew: Adverse event0010
Withdrew: Missed at least 1 persistence visit217135
Booster Phase (6 Months)
Participant flow — Booster Phase (6 Months)
MilestoneMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Started67167721
Completed67167721
Not completed0000

Outcome measures

PrimaryPersistence 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

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)
Reported as:
Number · percentage of participants
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
percentage of participantsMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
rSBA-MenA: >=1:851.9 (37.8 to 65.7)18.8 (4.0 to 45.6)79.6 (70.3 to 87.1)12.5 (2.7 to 32.4)
rSBA-MenC: >=1:877.8 (64.4 to 88.0)75.0 (47.6 to 92.7)82.7 (73.7 to 89.6)79.2 (57.8 to 92.9)
rSBA-MenW-135: >=1:833.3 (21.1 to 47.5)12.5 (1.6 to 38.3)73.5 (63.6 to 81.9)12.5 (2.7 to 32.4)
rSBA-MenY: >=1:838.9 (25.9 to 53.1)37.5 (15.2 to 64.6)71.4 (61.4 to 80.1)20.8 (7.1 to 42.2)
rSBA-MenA: >=1:2816.7 (7.9 to 29.3)6.3 (0.2 to 30.2)55.1 (44.7 to 65.2)8.3 (1.0 to 27.0)
rSBA-MenC: >=1:2870.4 (56.4 to 82.0)56.3 (29.9 to 80.2)68.4 (58.2 to 77.4)62.5 (40.6 to 81.2)
rSBA-MenW-135: >=1:2829.6 (18.0 to 43.6)6.3 (0.2 to 30.2)73.5 (63.6 to 81.9)12.5 (2.7 to 32.4)
rSBA-MenY: >=1:2833.3 (21.1 to 47.5)31.3 (11.0 to 58.7)65.3 (55.0 to 74.6)20.8 (7.1 to 42.2)
PrimaryPersistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 7 Years of Primary Vaccination

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

Time frame:
7 years after primary vaccination (Year 2 of study MENACWY-TT-100)
Reported as:
Number · percentage of participants
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
percentage of participantsMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
rSBA-MenA: >=1:858.3 (44.9 to 70.9)9.5 (1.2 to 30.4)74.0 (64.5 to 82.1)18.5 (6.3 to 38.1)
rSBA-MenC: >=1:878.3 (65.8 to 87.9)71.4 (47.8 to 88.7)84.2 (75.6 to 90.7)81.5 (61.9 to 93.7)
rSBA-MenW-135: >=1:826.7 (16.1 to 39.7)9.5 (1.2 to 30.4)73.5 (63.9 to 81.8)11.1 (2.4 to 29.2)
rSBA-MenY: >=1:835.0 (23.1 to 48.4)28.6 (11.3 to 52.2)75.5 (66.0 to 83.5)14.8 (4.2 to 33.7)
rSBA-MenA: >=1:2821.7 (12.1 to 34.2)9.5 (1.2 to 30.4)44.2 (34.5 to 54.3)11.1 (2.4 to 29.2)
rSBA-MenC: >=1:2861.7 (48.2 to 73.9)52.4 (29.8 to 74.3)61.4 (51.2 to 70.9)66.7 (46.0 to 83.5)
rSBA-MenW-135: >=1:2823.3 (13.4 to 36.0)9.5 (1.2 to 30.4)69.6 (59.7 to 78.3)7.4 (0.9 to 24.3)
rSBA-MenY: >=1:2833.3 (21.7 to 46.7)28.6 (11.3 to 52.2)69.6 (59.7 to 78.3)14.8 (4.2 to 33.7)
PrimaryPersistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 8 Years of Primary Vaccination

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

Time frame:
8 years after primary vaccination (Year 3 of study MENACWY-TT-100)
Reported as:
Number · percentage of participants
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
percentage of participantsMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
rSBA-MenA: >=1:847.7 (35.1 to 60.5)4.5 (0.1 to 22.8)70.0 (60.0 to 78.8)24.0 (9.4 to 45.1)
rSBA-MenC: >=1:878.5 (66.5 to 87.7)77.3 (54.6 to 92.2)85.0 (76.5 to 91.4)88.0 (68.8 to 97.5)
rSBA-MenW-135: >=1:829.2 (18.6 to 41.8)13.6 (2.9 to 34.9)76.0 (66.4 to 84.0)20.0 (6.8 to 40.7)
rSBA-MenY: >=1:840.0 (28.0 to 52.9)40.9 (20.7 to 63.6)79.0 (69.7 to 86.5)24.0 (9.4 to 45.1)
rSBA-MenA: >=1:2823.1 (13.5 to 35.2)4.5 (0.1 to 22.8)45.0 (35.0 to 55.3)12.0 (2.5 to 31.2)
rSBA-MenC: >=1:2864.6 (51.8 to 76.1)50.0 (28.2 to 71.8)61.0 (50.7 to 70.6)64.0 (42.5 to 82.0)
rSBA-MenW-135: >=1:2827.7 (17.3 to 40.2)9.1 (1.1 to 29.2)76.0 (66.4 to 84.0)20.0 (6.8 to 40.7)
rSBA-MenY: >=1:2838.5 (26.7 to 51.4)40.9 (20.7 to 63.6)73.0 (63.2 to 81.4)20.0 (6.8 to 40.7)
PrimaryPersistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 9 Years of Primary Vaccination

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

Time frame:
9 years after primary vaccination (Year 4 of study MENACWY-TT-100)
Reported as:
Number · percentage of participants
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
percentage of participantsMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
rSBA-MenA >=1:867.2 (54.3 to 78.4)4.8 (0.1 to 23.8)79.6 (69.9 to 87.2)24.0 (9.4 to 45.1)
rSBA-MenC >=1:881.3 (69.5 to 89.9)85.7 (63.7 to 97.0)86.0 (77.3 to 92.3)84.0 (63.9 to 95.5)
rSBA-MenW-135 >=1:832.8 (21.6 to 45.7)9.5 (1.2 to 30.4)76.1 (66.1 to 84.4)16.0 (4.5 to 36.1)
rSBA-MenY >=1:842.2 (29.9 to 55.2)47.6 (25.7 to 70.2)66.7 (56.1 to 76.1)20.0 (6.8 to 40.7)
rSBA-MenA >=1:2831.3 (20.2 to 44.1)4.8 (0.1 to 23.8)57.0 (46.3 to 67.2)16.0 (4.5 to 36.1)
rSBA-MenC >=1:2865.6 (52.7 to 77.1)57.1 (34.0 to 78.2)64.5 (53.9 to 74.2)68.0 (46.5 to 85.1)
rSBA-MenW-135 >=1:2826.6 (16.3 to 39.1)9.5 (1.2 to 30.4)71.7 (61.4 to 80.6)16.0 (4.5 to 36.1)
rSBA-MenY >=1:2834.4 (22.9 to 47.3)38.1 (18.1 to 61.6)58.1 (47.4 to 68.2)16.0 (4.5 to 36.1)
PrimaryPersistence Phase: Percentage of Participants With rSBA Titers >= 1:8 and >=1:128 For Each of the 4 Serogroups After 10 Years of Primary Vaccination

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

Time frame:
10 years after primary vaccination (Year 4 of study MENACWY-TT-100)
Reported as:
Number · percentage of participants
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
percentage of participantsMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
rSBA-MenA >=1:865.6 (52.7 to 77.1)17.6 (3.8 to 43.4)88.9 (80.0 to 94.8)28.6 (11.3 to 52.2)
rSBA-MenC >=1:882.8 (71.3 to 91.1)88.2 (63.6 to 98.5)84.1 (74.4 to 91.3)81.0 (58.1 to 94.6)
rSBA-MenW-135 >=1:831.3 (20.2 to 44.1)0.0 (0.0 to 19.5)67.1 (55.8 to 77.1)23.8 (8.2 to 47.2)
rSBA-MenY >=1:843.8 (31.4 to 56.7)35.3 (14.2 to 61.7)65.9 (54.6 to 76.0)23.8 (8.2 to 47.2)
rSBA-MenA >=1:2826.6 (16.3 to 39.1)5.9 (0.1 to 28.7)49.4 (38.1 to 60.7)14.3 (3.0 to 36.3)
rSBA-MenC >=1:2864.1 (51.1 to 75.7)58.8 (32.9 to 81.6)65.9 (54.6 to 76.0)66.7 (43.0 to 85.4)
rSBA-MenW-135 >=1:2828.1 (17.6 to 40.8)0.0 (0.0 to 19.5)65.9 (54.6 to 76.0)23.8 (8.2 to 47.2)
rSBA-MenY >=1:2835.9 (24.3 to 48.9)29.4 (10.3 to 56.0)59.8 (48.3 to 70.4)19.0 (5.4 to 41.9)
PrimaryPersistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination

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

Time frame:
6 Years after primary vaccination (Year 1 of study MENACWY-TT-100)
Reported as:
Geometric mean · titers
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination
titersMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
rSBA-MenA16.0 (9.8 to 26.1)5.9 (3.1 to 11.3)107.3 (66.0 to 174.3)5.8 (3.5 to 9.6)
rSBA-MenC161.3 (84.7 to 307.1)103.1 (31.9 to 333.3)192.9 (121.0 to 307.5)98.7 (42.2 to 230.7)
rSBA-MenW-13518.0 (9.8 to 32.9)6.2 (3.1 to 12.3)265.2 (154.9 to 454.1)7.6 (3.7 to 15.6)
rSBA-MenY21.5 (11.5 to 40.1)21.7 (5.9 to 79.0)136.4 (82.6 to 225.3)11.6 (4.7 to 28.7)
PrimaryPersistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination

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

Time frame:
7 years after primary vaccination (Year 2 of study MENACWY-TT-100)
Reported as:
Geometric mean · titers
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination
titersMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
rSBA-MenA20.4 (12.1 to 34.4)6.1 (3.3 to 11.4)65.3 (40.5 to 105.4)7.4 (4.0 to 13.8)
rSBA-MenC104.0 (58.0 to 186.3)54.3 (18.5 to 158.9)139.0 (87.8 to 220.0)101.6 (42.1 to 245.0)
rSBA-MenW-13513.0 (7.6 to 22.3)6.8 (3.0 to 15.3)206.0 (120.9 to 350.9)6.3 (3.7 to 10.9)
rSBA-MenY19.9 (11.0 to 36.1)18.3 (5.8 to 57.6)152.7 (96.1 to 242.6)8.2 (4.1 to 16.5)
PrimaryPersistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination

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

Time frame:
8 years after primary vaccination (Year 3 of study MENACWY-TT-100)
Reported as:
Geometric mean · titers
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination
titersMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
rSBA-MenA15.8 (9.8 to 25.6)4.8 (3.3 to 7.2)51.3 (31.5 to 83.4)7.8 (4.2 to 14.3)
rSBA-MenC110.2 (65.9 to 184.3)64.0 (26.0 to 157.4)140.1 (91.3 to 214.9)121.1 (52.2 to 281.1)
rSBA-MenW-13515.3 (9.0 to 26.3)6.4 (3.3 to 12.4)252.5 (154.3 to 413.2)11.8 (4.7 to 29.8)
rSBA-MenY26.1 (14.4 to 47.5)33.0 (9.8 to 111.0)181.0 (115.0 to 284.9)10.9 (4.8 to 24.6)
PrimaryPersistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination

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

Time frame:
9 years after primary vaccination (Year 4 of study MENACWY-TT-100)
Reported as:
Geometric mean · titers
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination
titersMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
rSBA-MenA28.4 (16.5 to 48.9)5.2 (3.0 to 9.0)118.8 (71.1 to 198.6)10.9 (4.5 to 26.2)
rSBA-MenC166.0 (92.3 to 298.7)92.0 (32.7 to 259.1)176.4 (106.8 to 291.3)164.3 (66.5 to 405.8)
rSBA-MenW-13517.3 (9.7 to 30.8)6.6 (3.2 to 13.6)274.0 (155.8 to 481.7)9.7 (4.0 to 23.3)
rSBA-MenY23.1 (13.0 to 41.2)32.0 (10.6 to 96.3)106.2 (61.5 to 183.4)10.0 (4.4 to 22.9)
PrimaryPersistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination

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

Time frame:
10 years after primary vaccination (Year 5 of study MENACWY-TT-100)
Reported as:
Geometric mean · titers
Persistence Phase: Geometric Mean Titers as Measured by rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination
titersMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
rSBA-MenA29.3 (16.8 to 51.3)5.8 (3.2 to 10.6)106.0 (63.7 to 176.4)9.1 (4.0 to 20.7)
rSBA-MenC132.2 (74.5 to 234.6)81.7 (29.2 to 229.2)175.0 (104.7 to 292.4)105.0 (37.2 to 296.4)
rSBA-MenW-13516.7 (9.5 to 29.3)4.0 (NA to NA)187.2 (101.0 to 347.1)14.0 (4.8 to 41.2)
rSBA-MenY25.8 (14.0 to 47.3)22.2 (5.8 to 84.2)90.5 (51.5 to 159.2)12.7 (4.2 to 38.1)
SecondaryPersistence 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

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)
Reported as:
Number · percentage of participants
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
percentage of participantsMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Year 1 of study MENACWY-TT-100: hSBA-MenA >=1:434.1 (20.5 to 49.9)28.6 (8.4 to 58.1)42.2 (31.9 to 53.1)42.9 (21.8 to 66.0)
Year 2 of study MENACWY-TT-10: hSBA-MenA >=1:426.7 (16.1 to 39.7)14.3 (3.0 to 36.3)26.3 (17.9 to 36.1)26.9 (11.6 to 47.8)
Year 3 of study MENACWY-TT-10: hSBA-MenA >=1:432.8 (21.6 to 45.7)27.3 (10.7 to 50.2)28.9 (20.1 to 39.0)40.0 (21.1 to 61.3)
Year 4 of study MENACWY-TT-10: hSBA-MenA >=1:439.7 (27.6 to 52.8)30.0 (11.9 to 54.3)43.0 (32.4 to 54.2)30.4 (13.2 to 52.9)
Year 5 of study MENACWY-TT-10: hSBA-MenA >=1:431.1 (19.9 to 44.3)25.0 (7.3 to 52.4)34.8 (23.7 to 47.2)33.3 (14.6 to 57.0)
Year 1 of study MENACWY-TT-10: hSBA-MenC >=1:492.5 (81.8 to 97.9)93.8 (69.8 to 99.8)93.8 (87.0 to 97.7)100.0 (85.8 to 100.0)
Year 2 of study MENACWY-TT-10: hSBA-MenC >=1:489.8 (79.2 to 96.2)100.0 (83.2 to 100.0)88.5 (80.4 to 94.1)92.3 (74.9 to 99.1)
Year 3 of study MENACWY-TT-10: hSBA-MenC >=1:492.2 (82.7 to 97.4)95.5 (77.2 to 99.9)89.6 (81.7 to 94.9)96.0 (79.6 to 99.9)
Year 4 of study MENACWY-TT-10: hSBA-MenC >=1:490.5 (80.4 to 96.4)95.0 (75.1 to 99.9)86.7 (77.9 to 92.9)91.7 (73.0 to 99.0)
Year 5 of study MENACWY-TT-10: hSBA-MenC >=1:491.9 (82.2 to 97.3)93.8 (69.8 to 99.8)91.1 (82.6 to 96.4)100.0 (83.9 to 100.0)
Year 1 of study MENACWY-TT-10: hSBA-MenW-135>=1:470.2 (55.1 to 82.7)13.3 (1.7 to 40.5)81.5 (72.1 to 88.9)30.4 (13.2 to 52.9)
Year 2 of study MENACWY-TT-10: hSBA-MenW-135>=1:460.3 (46.6 to 73.0)20.0 (5.7 to 43.7)79.6 (70.3 to 87.1)18.5 (6.3 to 38.1)
Year 3 of study MENACWY-TT-10: hSBA-MenW-135>=1:439.1 (27.1 to 52.1)19.0 (5.4 to 41.9)56.4 (45.8 to 66.6)12.0 (2.5 to 31.2)
Year 4 of study MENACWY-TT-10: hSBA-MenW-135>=1:444.8 (31.7 to 58.5)18.8 (4.0 to 45.6)68.4 (56.9 to 78.4)9.5 (1.2 to 30.4)
Year 5 of study MENACWY-TT-10: hSBA-MenW-135>=1:444.4 (30.9 to 58.6)21.4 (4.7 to 50.8)61.2 (48.5 to 72.9)26.3 (9.1 to 51.2)
Year 1 of study MENACWY-TT-10: hSBA-MenY>=1:431.7 (18.1 to 48.1)7.1 (0.2 to 33.9)65.2 (54.3 to 75.0)25.0 (9.8 to 46.7)
Year 2 of study MENACWY-TT-10: hSBA-MenY>=1:451.8 (38.0 to 65.3)33.3 (14.6 to 57.0)75.0 (65.3 to 83.1)40.7 (22.4 to 61.2)
Year 3 of study MENACWY-TT-10: hSBA-MenY>=1:450.8 (37.9 to 63.6)38.1 (18.1 to 61.6)72.0 (61.8 to 80.9)34.8 (16.4 to 57.3)
Year 4 of study MENACWY-TT-10: hSBA-MenY>=1:432.8 (21.3 to 46.0)26.3 (9.1 to 51.2)67.9 (56.8 to 77.6)27.3 (10.7 to 50.2)
Year 5 of study MENACWY-TT-10: hSBA-MenY>=1:441.4 (28.6 to 55.1)40.0 (16.3 to 67.7)72.6 (60.9 to 82.4)44.4 (21.5 to 69.2)
Year 1 of study MENACWY-TT-10: hSBA-MenA>=1:831.8 (18.6 to 47.6)28.6 (8.4 to 58.1)41.1 (30.8 to 52.0)33.3 (14.6 to 57.0)
Year 2 of study MENACWY-TT-10: hSBA-MenA>=1:825.0 (14.7 to 37.9)14.3 (3.0 to 36.3)26.3 (17.9 to 36.1)23.1 (9.0 to 43.6)
Year 3 of study MENACWY-TT-10: hSBA-MenA>=1:832.8 (21.6 to 45.7)27.3 (10.7 to 50.2)28.9 (20.1 to 39.0)36.0 (18.0 to 57.5)
Year 4 of study MENACWY-TT-10: hSBA-MenA>=1:830.2 (19.2 to 43.0)20.0 (5.7 to 43.7)43.0 (32.4 to 54.2)26.1 (10.2 to 48.4)
Year 5 of study MENACWY-TT-10: hSBA-MenA>=1:826.2 (15.8 to 39.1)18.8 (4.0 to 45.6)33.3 (22.4 to 45.7)28.6 (11.3 to 52.2)
Year 1 of study MENACWY-TT-10: hSBA-MenC>=1:892.5 (81.8 to 97.9)93.8 (69.8 to 99.8)93.8 (87.0 to 97.7)100.0 (85.8 to 100.0)
Year 2 of study MENACWY-TT-10: hSBA-MenC>=1:889.8 (79.2 to 96.2)100.0 (83.2 to 100.0)88.5 (80.4 to 94.1)92.3 (74.9 to 99.1)
Year 3 of study MENACWY-TT-10: hSBA-MenC>=1:892.2 (82.7 to 97.4)95.5 (77.2 to 99.9)89.6 (81.7 to 94.9)96.0 (79.6 to 99.9)
Year 4 of study MENACWY-TT-10: hSBA-MenC>=1:890.5 (80.4 to 96.4)95.0 (75.1 to 99.9)85.6 (76.6 to 92.1)91.7 (73.0 to 99.0)
Year 5 of study MENACWY-TT-10: hSBA-MenC>=1:891.9 (82.2 to 97.3)93.8 (69.8 to 99.8)91.1 (82.6 to 96.4)100.0 (83.9 to 100.0)
Year 1 of study MENACWY-TT-10: hSBA-MenW-135 >=1:870.2 (55.1 to 82.7)13.3 (1.7 to 40.5)81.5 (72.1 to 88.9)30.4 (13.2 to 52.9)
Year 2 of study MENACWY-TT-10: hSBA-MenW-135 >=1:860.3 (46.6 to 73.0)20.0 (5.7 to 43.7)79.6 (70.3 to 87.1)18.5 (6.3 to 38.1)
Year 3 of study MENACWY-TT-10: hSBA-MenW-135 >=1:839.1 (27.1 to 52.1)19.0 (5.4 to 41.9)56.4 (45.8 to 66.6)12.0 (2.5 to 31.2)
Year 4 of study MENACWY-TT-10: hSBA-MenW-135 >=1:844.8 (31.7 to 58.5)18.8 (4.0 to 45.6)67.1 (55.6 to 77.3)9.5 (1.2 to 30.4)
Year 5 of study MENACWY-TT-10: hSBA-MenW-135 >=1:844.4 (30.9 to 58.6)21.4 (4.7 to 50.8)61.2 (48.5 to 72.9)26.3 (9.1 to 51.2)
Year 1 of study MENACWY-TT-10: hSBA-MenY >=1:831.7 (18.1 to 48.1)7.1 (0.2 to 33.9)65.2 (54.3 to 75.0)25.0 (9.8 to 46.7)
Year 2 of study MENACWY-TT-10: hSBA-MenY >=1:851.8 (38.0 to 65.3)33.3 (14.6 to 57.0)75.0 (65.3 to 83.1)40.7 (22.4 to 61.2)
Year 3 of study MENACWY-TT-10: hSBA-MenY >=1:850.8 (37.9 to 63.6)38.1 (18.1 to 61.6)72.0 (61.8 to 80.9)34.8 (16.4 to 57.3)
Year 4 of study MENACWY-TT-10: hSBA-MenY >=1:832.8 (21.3 to 46.0)26.3 (9.1 to 51.2)67.9 (56.8 to 77.6)27.3 (10.7 to 50.2)
Year 5 of study MENACWY-TT-10: hSBA-MenY >=1:841.4 (28.6 to 55.1)40.0 (16.3 to 67.7)72.6 (60.9 to 82.4)44.4 (21.5 to 69.2)
SecondaryPersistence 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

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)
Reported as:
Geometric mean · titers
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
titersMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Year 1 of study MENACWY-TT-100: hSBA-MenA4.7 (3.2 to 7.1)3.5 (2.1 to 5.8)6.5 (4.8 to 8.8)5.9 (3.0 to 11.7)
Year 2 of study MENACWY-TT-100: hSBA-MenA3.8 (2.9 to 5.2)2.8 (1.8 to 4.2)4.5 (3.4 to 6.0)4.7 (2.4 to 9.0)
Year 3 of study MENACWY-TT-100: hSBA-MenA5.0 (3.5 to 7.1)3.7 (2.2 to 6.1)4.6 (3.4 to 6.0)6.7 (3.2 to 14.0)
Year 4 of study MENACWY-TT-100: hSBA-MenA4.8 (3.5 to 6.6)3.4 (2.2 to 5.2)6.6 (4.8 to 9.0)4.5 (2.4 to 8.8)
Year 5 of study MENACWY-TT-100: hSBA-MenA4.2 (3.1 to 5.9)3.1 (2.0 to 4.8)4.6 (3.4 to 6.2)5.4 (2.5 to 11.7)
Year 1 of study MENACWY-TT-100: hSBA-MenC542.5 (284.8 to 1033.5)230.0 (84.3 to 628.1)427.2 (260.7 to 700.0)234.8 (122.2 to 451.1)
Year 2 of study MENACWY-TT-100: hSBA-MenC368.1 (191.9 to 706.0)223.6 (105.8 to 472.7)342.7 (200.7 to 585.4)169.2 (67.3 to 425.2)
Year 3 of study MENACWY-TT-100: hSBA-MenC378.2 (210.7 to 679.0)203.4 (73.8 to 560.9)365.5 (214.1 to 624.1)273.8 (103.8 to 722.1)
Year 4 of study MENACWY-TT-100: hSBA-MenC319.0 (172.7 to 589.0)217.2 (82.8 to 569.9)190.4 (112.1 to 323.4)125.7 (51.2 to 308.8)
Year 5 of study MENACWY-TT-100: hSBA-MenC362.2 (207.2 to 633.4)112.4 (41.2 to 307.0)199.3 (118.4 to 335.7)119.1 (50.2 to 282.5)
Year 1 of study MENACWY-TT-100: hSBA-MenW-13531.8 (17.5 to 57.8)3.3 (1.6 to 6.8)62.5 (42.0 to 93.1)7.0 (2.9 to 16.9)
Year 2 of study MENACWY-TT-100: hSBA-MenW-13519.5 (11.6 to 32.7)4.9 (1.9 to 12.5)50.5 (34.5 to 74.1)4.0 (2.1 to 7.3)
Year 3 of study MENACWY-TT-100: hSBA-MenW-1358.0 (5.1 to 12.6)4.1 (1.9 to 8.6)20.4 (13.0 to 32.2)3.3 (1.8 to 6.0)
Year 4 of study MENACWY-TT-100: hSBA-MenW-1358.5 (5.3 to 13.5)3.7 (1.6 to 8.4)23.1 (14.7 to 36.1)2.8 (1.7 to 4.4)
Year 5 of study MENACWY-TT-100: hSBA-MenW-1357.6 (4.8 to 11.8)3.8 (1.7 to 8.2)17.4 (10.8 to 28.0)4.2 (2.2 to 8.0)
Year 1 of study MENACWY-TT-100: hSBA-MenY7.9 (4.1 to 15.2)3.1 (1.2 to 7.6)40.3 (23.9 to 68.1)7.3 (2.7 to 19.8)
Year 2 of study MENACWY-TT-100: hSBA-MenY15.8 (9.0 to 27.7)6.9 (2.9 to 16.6)54.4 (35.0 to 84.4)10.5 (4.4 to 25.0)
Year 3 of study MENACWY-TT-100: hSBA-MenY11.6 (7.3 to 18.6)8.7 (3.5 to 21.5)43.7 (27.5 to 69.5)8.8 (3.4 to 22.5)
Year 4 of study MENACWY-TT-100: hSBA-MenY7.3 (4.4 to 11.9)5.8 (2.3 to 15.0)35.5 (21.5 to 58.8)6.2 (2.5 to 15.3)
Year 5 of study MENACWY-TT-100: hSBA-MenY8.6 (5.3 to 14.2)8.5 (2.8 to 25.7)36.8 (22.4 to 60.7)13.9 (4.2 to 46.0)
SecondaryBooster Phase: Percentage of Participants With rSBA Titers >=1:8 and >=1:128 For Each of the 4 Serogroups at 1 Month After Booster Vaccination

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

Time frame:
1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)
Reported as:
Number · percentage of participants
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
percentage of participantsMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
rSBA-MenA: >= 1:898.4 (91.3 to 100.0)100.0 (79.4 to 100.0)95.9 (88.6 to 99.2)100.0 (80.5 to 100.0)
rSBA-MenC: >= 1:8100.0 (94.2 to 100.0)100.0 (79.4 to 100.0)100.0 (95.1 to 100.0)100.0 (80.5 to 100.0)
rSBA-MenW-135: >= 1:8100.0 (94.2 to 100.0)100.0 (78.2 to 100.0)100.0 (95.1 to 100.0)94.1 (71.3 to 99.9)
rSBA-MenY >= 1:898.4 (91.3 to 100.0)100.0 (79.4 to 100.0)100.0 (95.1 to 100.0)100.0 (80.5 to 100.0)
rSBA-MenA: >= 1:2898.4 (91.3 to 100.0)100.0 (79.4 to 100.0)95.9 (88.6 to 99.2)100.0 (80.5 to 100.0)
rSBA-MenC: >= 1:28100.0 (94.2 to 100.0)100.0 (79.4 to 100.0)100.0 (95.1 to 100.0)100.0 (80.5 to 100.0)
rSBA-MenW-135: >= 1:28100.0 (94.2 to 100.0)100.0 (78.2 to 100.0)100.0 (95.1 to 100.0)94.1 (71.3 to 99.9)
rSBA-MenY >= 1:2898.4 (91.3 to 100.0)100.0 (79.4 to 100.0)100.0 (95.1 to 100.0)100.0 (80.5 to 100.0)
SecondaryBooster Phase: Geometric Mean Titers as Measured by rSBA For Each of the 4 Serogroups 1 Month After Booster Vaccination

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

Time frame:
1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)
Reported as:
Geometric mean · titers
Booster Phase: Geometric Mean Titers as Measured by rSBA For Each of the 4 Serogroups 1 Month After Booster Vaccination
titersMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
rSBA-MenA5122.3 (3725.6 to 7042.6)4871.0 (2465.1 to 9624.9)4626.4 (3040.6 to 7039.4)6414.2 (3878.5 to 10607.8)
rSBA-MenC7163.5 (5478.0 to 9367.7)5792.6 (3630.6 to 9242.2)4020.0 (3319.0 to 4869.1)15101.0 (7099.3 to 32121.5)
rSBA-MenW-13525911.2 (19119.7 to 35115.2)17970.4 (11666.4 to 27680.7)27944.4 (22213.8 to 35153.3)10462.5 (3253.5 to 33645.5)
rSBA-MenY7660.5 (5262.9 to 11150.3)6316.9 (3223.8 to 12377.5)7529.7 (5827.5 to 9729.2)6959.2 (3636.7 to 13317.1)
SecondaryBooster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination

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)
Reported as:
Number · percentage of participants
Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination
percentage of participantsMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
rSBA-MenA90.3 (80.1 to 96.4)100.0 (79.4 to 100.0)87.7 (77.9 to 94.2)94.1 (71.3 to 99.9)
rSBA-MenC82.3 (70.5 to 90.8)93.8 (69.8 to 99.8)75.7 (64.3 to 84.9)94.1 (71.3 to 99.9)
rSBA-MenW-135100.0 (94.2 to 100.0)100.0 (78.2 to 100.0)100.0 (95.1 to 100.0)88.2 (63.6 to 98.5)
rSBA-MenY95.2 (86.5 to 99.0)87.5 (61.7 to 98.4)93.2 (84.9 to 97.8)100.0 (80.5 to 100.0)
SecondaryBooster Phase: Percentage of Participants With hSBA Titers >=1:4 and >=1:8 For Each of the 4 Serogroups at 1 Month After Booster Vaccination

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

Time frame:
1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)
Reported as:
Number · percentage of participants
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
percentage of participantsMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
hSBA-MenA: >=1:4100.0 (94.2 to 100.0)87.5 (61.7 to 98.4)100.0 (95.1 to 100.0)100.0 (80.5 to 100.0)
hSBA-MenC: >=1:4100.0 (93.9 to 100.0)100.0 (78.2 to 100.0)100.0 (94.9 to 100.0)94.1 (71.3 to 99.9)
hSBA-MenW-135: >=1:4100.0 (94.2 to 100.0)100.0 (75.3 to 100.0)100.0 (95.1 to 100.0)100.0 (78.2 to 100.0)
hSBA-MenY: >=1:4100.0 (94.1 to 100.0)93.3 (68.1 to 99.8)100.0 (95.1 to 100.0)100.0 (80.5 to 100.0)
hSBA-MenA: >=1:8100.0 (94.2 to 100.0)87.5 (61.7 to 98.4)100.0 (95.1 to 100.0)100.0 (80.5 to 100.0)
hSBA-MenC: >=1:8100.0 (93.9 to 100.0)100.0 (78.2 to 100.0)100.0 (94.9 to 100.0)94.1 (71.3 to 99.9)
hSBA-MenW-135: >=1:8100.0 (94.2 to 100.0)100.0 (75.3 to 100.0)100.0 (95.1 to 100.0)100.0 (78.2 to 100.0)
hSBA-MenY: >=1:8100.0 (94.1 to 100.0)93.3 (68.1 to 99.8)100.0 (95.1 to 100.0)100.0 (80.5 to 100.0)
SecondaryBooster Phase: Geometric Mean Titers Using hSBA For Each of the 4 Serogroups at 1 Month After Booster Vaccination

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

Time frame:
1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)
Reported as:
Geometric mean · titers
Booster Phase: Geometric Mean Titers Using hSBA For Each of the 4 Serogroups at 1 Month After Booster Vaccination
titersMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
hSBA-MenA1534.2 (1112.1 to 2116.6)90.0 (35.7 to 227.1)1213.0 (993.9 to 1480.5)211.1 (130.9 to 340.3)
hSBA-MenC33959.8 (23890.2 to 48273.5)42559.2 (20106.2 to 90086.2)15543.5 (11734.9 to 20588.3)44794.4 (10111.6 to 198440.4)
hSBA-MenW-13511924.8 (8715.6 to 16315.7)258.1 (155.7 to 427.8)6965.2 (5274.3 to 9198.3)199.6 (101.0 to 394.7)
hSBA-MenY12154.3 (9660.9 to 15291.1)407.8 (129.9 to 1280.3)11127.4 (8909.2 to 13898.0)453.9 (214.6 to 959.8)
SecondaryBooster Phase: Percentage of Participants With hSBA Booster Response at 1 Month After Booster Vaccination

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)
Reported as:
Number · percentage of participants
Booster Phase: Percentage of Participants With hSBA Booster Response at 1 Month After Booster Vaccination
percentage of participantsMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
hSBA-MenA98.3 (90.9 to 100.0)93.3 (68.1 to 99.8)100.0 (94.1 to 100.0)88.2 (63.6 to 98.5)
hSBA-MenC86.0 (74.2 to 93.7)92.9 (66.1 to 99.8)85.7 (75.3 to 92.9)94.1 (71.3 to 99.9)
hSBA-MenW-135100.0 (93.2 to 100.0)90.9 (58.7 to 99.8)96.6 (88.3 to 99.6)100.0 (76.8 to 100.0)
hSBA-MenY100.0 (93.6 to 100.0)71.4 (41.9 to 91.6)98.5 (91.7 to 100.0)78.6 (49.2 to 95.3)
SecondaryPersistence Phase: Percentage of Participants With Serious Adverse Events (SAEs) Related to Vaccination or Any Adverse Event (AE) Related to Lack of Vaccine Efficacy

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)
Reported as:
Number · percentage of participants
Persistence Phase: Percentage of Participants With Serious Adverse Events (SAEs) Related to Vaccination or Any Adverse Event (AE) Related to Lack of Vaccine Efficacy
percentage of participantsMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Persistence Phase: Percentage of Participants With Serious Adverse Events (SAEs) Related to Vaccination or Any Adverse Event (AE) Related to Lack of Vaccine Efficacy0.00.00.00.0
SecondaryBooster Phase: Percentage of Participants With Solicited Local and General Adverse Events 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.

Time frame:
Up to 4 days post booster vaccination
Reported as:
Number · percentage of participants
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
percentage of participantsMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
All pain59.756.359.561.9
Pain: Grade 143.337.540.542.9
Pain: Grade 216.418.816.219.0
Severe pain: Grade 30.00.02.70.0
All redness35.843.836.523.8
Redness: 0 to <=20 mm28.425.031.114.3
Redness: >20 to <=50 mm1.518.82.70.0
Redness: >50 mm6.00.02.79.5
All swelling17.96.323.014.3
Swelling: 0 to <=20 mm14.90.016.20.0
Swelling: >20 to <=50 mm1.56.31.44.8
Swelling: >50 mm1.50.05.49.5
All fatigue31.312.529.723.8
Fatigue: Grade 120.912.516.214.3
Fatigue: Grade 29.00.06.89.5
Fatigue: Grade 31.50.06.80.0
Fatigue: Related fatigue31.312.529.723.8
Fatigue: Grade 3 Related1.50.06.80.0
All fever1.50.00.00.0
Fever: Grade 11.50.00.00.0
Fever: Grade 20.00.00.00.0
Fever: Grade 30.00.00.00.0
Fever: Related1.50.00.00.0
Fever: Grade 3 related0.00.00.00.0
All gastrointestinal event (GI)9.00.017.614.3
GI: Grade 17.50.013.54.8
GI: Grade 21.50.02.79.5
GI: Grade 30.00.01.40.0
GI: Related7.50.017.614.3
GI: Grade 3 related0.00.01.40.0
All headache20.931.327.023.8
Headache: Grade 114.918.818.919.0
Headache: Grade 26.012.56.84.8
Headache: Grade 30.00.01.40.0
Headache: Related17.931.324.323.8
Headache: Grade 3 related0.00.01.40.0
Headache: Medical advice0.00.01.40.0
SecondaryBooster Phase: Percentage of Participants With Unsolicited Adverse Events 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.

Time frame:
Up to 31 days post booster vaccination
Reported as:
Number · percentage of participants
Booster Phase: Percentage of Participants With Unsolicited Adverse Events up to 31 Days Post Booster Vaccination
percentage of participantsMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Booster Phase: Percentage of Participants With Unsolicited Adverse Events up to 31 Days Post Booster Vaccination23.931.335.152.4
SecondaryBooster Phase: Percentage of Participants With Serious Adverse Events (SAEs) 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.

Time frame:
Up to 6 months post booster vaccination
Reported as:
Number · percentage of participants
Booster Phase: Percentage of Participants With Serious Adverse Events (SAEs) Up to 6 Months Post Booster Vaccination
percentage of participantsMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Booster Phase: Percentage of Participants With Serious Adverse Events (SAEs) Up to 6 Months Post Booster Vaccination0.00.01.30.0
SecondaryBooster Phase: Percentage of Participants With New Onset Chronic Illness Up to 6 Months Post Booster Vaccination

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

Time frame:
Up to 6 months post booster vaccination
Reported as:
Number · percentage of participants
Booster Phase: Percentage of Participants With New Onset Chronic Illness Up to 6 Months Post Booster Vaccination
percentage of participantsMenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 Years
Booster Phase: Percentage of Participants With New Onset Chronic Illness Up to 6 Months Post Booster Vaccination0.00.01.34.8

Adverse events

Collected over 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. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Persistence Phase: MenACWY-TT Vaccine (Less Than [<] 2 Years)0/76 (0%)0/76 (0%)0/76 (0%)
Persistence Phase:MenCCRM (Meningitec) Vaccine(<2 Years)0/23 (0%)0/23 (0%)0/23 (0%)
Persistence Phase: MenACWY-TT Vaccine (>=2 Years)0/115 (0%)0/115 (0%)0/115 (0%)
Persistence Phase: MenPS (Mencevax ACWY) Vaccine (< 2 Years)0/29 (0%)0/29 (0%)0/29 (0%)
Booster Phase: MenACWY-TT Vaccine (Less Than 2 Years)0/67 (0%)0/67 (0%)53/67 (79.1%)
Booster Phase: MenCCRM (Meningitec) Vaccine (<2 Years)0/16 (0%)0/16 (0%)12/16 (75%)
Booster Phase: MenACWY-TT Vaccine (>= 2 Years)0/77 (0%)1/77 (1.3%)65/77 (84.4%)
Booster Phase: MenPS (Mencevax ACWY) Vaccine (<2 Years)0/21 (0%)0/21 (0%)15/21 (71.4%)
Most frequent serious events
Most frequent serious events
EventPersistence 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)
Abdominal painGastrointestinal disorders0/760/230/1150/290/670/161/770/21
Most frequent other events
Showing 10 of 52
Most frequent other events
EventPersistence 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)
Injection site pain (pain at injection site)General disorders0/760/230/1150/2940/679/1644/7713/21
Injection site erythema (redness)General disorders0/760/230/1150/2924/677/1627/775/21
Fatigue 1General disorders0/760/230/1150/2921/672/1622/775/21
Headache 1Nervous system disorders0/760/230/1150/2914/675/1620/775/21
Injection site swelling (swelling)General disorders0/760/230/1150/2912/671/1617/773/21
Gastrointestinal symptomsGastrointestinal disorders0/760/230/1150/296/670/1613/773/21
PyrexiaGeneral disorders0/760/230/1150/292/672/161/770/21
Upper respiratory tract infectionInfections and infestations0/760/230/1150/291/671/167/772/21
FatigueGeneral disorders0/760/230/1150/290/671/160/771/21
Injection site pruritusGeneral disorders0/760/230/1150/291/671/161/770/21

Baseline characteristics

Baseline analysis population included all the participants enrolled in the study.

Age, Continuous
Age, Continuous(years)MenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 YearsTotal
Mean8.2 ± 0.78.2 ± 0.712.5 ± 2.612.1 ± 2.910.7 ± 3.0
Sex: Female, Male
Sex: Female, Male(Participants)MenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 YearsTotal
Female40125614122
Male36115915121
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)MenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 YearsTotal
Hispanic or Latino00000
Not Hispanic or Latino762311529243
Unknown or Not Reported00000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)MenACWY-TT Vaccine: Less Than (<) 2 YearsMenCCRM (Meningitec) Vaccine: Less Than 2 YearsMenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 YearsMenPS (Mencevax ACWY) Vaccine: Less Than 2 YearsTotal
White - Arabic/North African heritage00101
White - Caucasian/European heritage752211328238
Other11114
08

Study locations

9 sites
  • Espoo Vaccine Research Clinic
    Espoo, 02230, Finland
  • South Helsinki Vaccine Research Clinic
    Helsinki, 00100, Finland
  • Helsinki East Vaccine Research Clinic
    Helsinki, 00930, Finland
  • Jarvenpaa Vaccine Research Clinic
    Jarvenpaa, 04400, Finland
  • Tampereen yliopisto/ Oulun rokotetutkimusklinikka
    Oulu, 90220, Finland
  • Tampereen yliopisto/ Porin rokotetutkimusklinikka
    Pori, 28100, Finland
  • Tampere Vaccine Research Clinic
    Tampere, 33100, Finland
  • Tampereen yliopisto/ Turun rokotetutkimusklinikka
    Turku, 20520, Finland
  • Tampereen yliopisto/ Ita-Vantaan rokotetutkimusklinikka
    Vantaa, 01300, Finland
09

References and documents

Publications

  • Vesikari T, Peyrani P, Webber C, Van Der Wielen M, Cheuvart B, De Schrevel N, Aris E, Cutler M, Li P, Perez JL. Ten-Year Antibody Persistence and Booster Response to MenACWY-TT Vaccine After Primary Vaccination at 1-10 Years of Age. Hum Vaccin Immunother. 2020 Jun 2;16(6):1280-1291. doi: 10.1080/21645515.2020.1746110. PubMed 32598244 ↗

Study documents

  • Study protocol · Feb 25, 2016
  • Statistical analysis plan · Jul 26, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01962207
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Oct 14, 2013
Start date
Oct 2013
Primary completion
Dec 2017
Completion
Jun 2018
Results posted
Jun 7, 2019
Last update
Jun 7, 2019

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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