Infections, MeningococcalPhase 3NCT01962207

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 study testing Meningococcal vaccine GSK134612 in people with Infections, Meningococcal, run by Pfizer at 9 sites in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Infections, Meningococcal
What is being tested?: Meningococcal vaccine GSK134612
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 243 participants
Where: 9 sitesFinland
Study dates: Oct 2013to Jun 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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).

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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.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Finland9 sites

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

Other trials in Finland

About this study

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.

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).

Conditions: Infections, Meningococcal
Being tested: Meningococcal vaccine GSK134612
Keywords: 10 years Meningitec, Safety, booster response, Adolescents, Adults, Immunogenicity, Mencevax ACWY
Medical subject headings: Meningococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Meningococcal vaccine GSK134612Biological
One dose administered intramuscularly (IM) in the deltoid of the non-dominant arm

Study groups in NCT01962207
Study group	Role	What they receive
ACWY<2 Group	Experimental	Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with MenACWY-TT. Receives: Biological: Meningococcal vaccine GSK134612
ACWY≥2 Group	Experimental	Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with MenACWY-TT. Receives: Biological: Meningococcal vaccine GSK134612
MenCCRM Group	Experimental	Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with Meningitec. Receives: Biological: Meningococcal vaccine GSK134612
MenPS Group	Experimental	Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with Mencevax ACWY. Receives: Biological: Meningococcal vaccine GSK134612

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 6 years after primary vaccination (Year 1 of study MENACWY-TT-100)
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.
Measured: 7 years after primary vaccination (Year 2 of study MENACWY-TT-100)
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.
Measured: 8 years after primary vaccination (Year 3 of study MENACWY-TT-100)
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.
Measured: 9 years after primary vaccination (Year 4 of study MENACWY-TT-100)
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.
Measured: 10 years after primary vaccination (Year 4 of study MENACWY-TT-100)
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.
Measured: 6 Years after primary vaccination (Year 1 of study MENACWY-TT-100)
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.
Measured: 7 years after primary vaccination (Year 2 of study MENACWY-TT-100)
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.
Measured: 8 years after primary vaccination (Year 3 of study MENACWY-TT-100)
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.
Measured: 9 years after primary vaccination (Year 4 of study MENACWY-TT-100)
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.
Measured: 10 years after primary vaccination (Year 5 of study MENACWY-TT-100)

Secondary outcomes (13)

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.
Measured: 6, 7, 8, 9 and 10 years after primary vaccination (Year 1, 2, 3, 4 and 5 of study MENACWY-TT-100)
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.
Measured: 6, 7, 8, 9 and 10 years after primary vaccination (Year 1, 2, 3, 4 and 5 of study MENACWY-TT-100)
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.
Measured: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)
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.
Measured: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)
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.
Measured: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)
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.
Measured: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)
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.
Measured: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)
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.
Measured: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)
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.
Measured: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination)
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.
Measured: Up to 4 days post booster vaccination
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.
Measured: Up to 31 days post booster vaccination
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.
Measured: Up to 6 months post booster vaccination
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.
Measured: Up to 6 months post booster vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Jun 2018

First posted14 Oct 2013 (estimated)
Study startOct 2013
Primary completionDec 2017
Study completionJun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Infections, MeningococcalStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 243 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01962207
Sponsor's protocol ID: MENACWY-TT-100
Other IDs: 2013-001549-15, C0921004, 200171
Status last verified: Mar 2019
First submitted: 26 Sep 2013
Last updated: 7 Jun 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT01962207
Acronym / sponsor ID: MENACWY-TT-100
Conditions: Infections, Meningococcal
Keywords: 10 years Meningitec, Safety, booster response, Adolescents, Adults, Immunogenicity, Mencevax ACWY
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 243 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Oct 2013 (actual)
Primary completion: Dec 2017 (actual)
Study completion: Jun 2018 (actual)
First posted: 14 Oct 2013 (estimated)
Results: Posted 7 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
ACWY<2 Group	Experimental	Biological: Meningococcal vaccine GSK134612Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with MenACWY-TT.
ACWY≥2 Group	Experimental	Biological: Meningococcal vaccine GSK134612Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with MenACWY-TT.
MenCCRM Group	Experimental	Biological: Meningococcal vaccine GSK134612Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with Meningitec.
MenPS Group	Experimental	Biological: Meningococcal vaccine GSK134612Subjects will receive a dose of MenACWY-TT 10 years after primary vaccination with Mencevax ACWY.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (11 listed)

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:

Key exclusion criteria (25 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Meningococcal vaccine GSK134612One dose administered intramuscularly (IM) in the deltoid of the non-dominant arm	Biological	ACWY<2 Group, ACWY≥2 Group, MenCCRM Group, MenPS Group

Primary outcome

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

13 secondary outcomes

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
Time frame: 6, 7, 8, 9 and 10 years after primary vaccination (Year 1, 2, 3, 4 and 5 of study MENACWY-TT-100)
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
Time frame: 6, 7, 8, 9 and 10 years after primary vaccination (Year 1, 2, 3, 4 and 5 of study MENACWY-TT-100)
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
Time frame: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)
Booster Phase: Geometric Mean Titers as Measured by rSBA For Each of the 4 Serogroups 1 Month After Booster Vaccination
Time frame: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)
Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination
Time frame: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)
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
Time frame: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)
Booster Phase: Geometric Mean Titers Using hSBA For Each of the 4 Serogroups at 1 Month After Booster Vaccination
Time frame: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)
Booster Phase: Percentage of Participants With hSBA Booster Response at 1 Month After Booster Vaccination
Time frame: 1 month after booster vaccination (approximately Year 5.5 of study MENACWY-TT-100)
Persistence Phase: Percentage of Participants With Serious Adverse Events (SAEs) Related to Vaccination or Any Adverse Event (AE) Related to Lack of Vaccine Efficacy
Time frame: Through 5 years (6, 7, 8, 9 and 10 years post primary vaccination)
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Time frame: Up to 4 days post booster vaccination
Booster Phase: Percentage of Participants With Unsolicited Adverse Events up to 31 Days Post Booster Vaccination
Time frame: Up to 31 days post booster vaccination
Booster Phase: Percentage of Participants With Serious Adverse Events (SAEs) Up to 6 Months Post Booster Vaccination
Time frame: Up to 6 months post booster vaccination
Booster Phase: Percentage of Participants With New Onset Chronic Illness Up to 6 Months Post Booster Vaccination
Time frame: Up to 6 months post booster vaccination

Results and safety

Results posted to the registry on 7 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MenACWY-TT Vaccine: Less Than (<) 2 Years	76	47
MenCCRM (Meningitec) Vaccine: Less Than 2 Years	23	10
MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years	115	71
MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years	29	17

Primary outcome: 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

Time frame: 6 years after primary vaccination (Year 1 of study MENACWY-TT-100). Number (95% Confidence Interval). Unit: percentage of participants

Measure	MenACWY-TT Vaccine: Less Than (<) 2 Years n = 54	MenCCRM (Meningitec) Vaccine: Less Than 2 Years n = 16	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years n = 98	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years n = 24
rSBA-MenA: >=1:8	51.9 (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: >=1:8	77.8 (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: >=1:8	33.3 (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: >=1:8	38.9 (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: >=1:28	16.7 (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: >=1:28	70.4 (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: >=1:28	29.6 (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: >=1:28	33.3 (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)

Population analysed: 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.

Primary outcome: 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

Time frame: 7 years after primary vaccination (Year 2 of study MENACWY-TT-100). Number (95% Confidence Interval). Unit: percentage of participants

Measure	MenACWY-TT Vaccine: Less Than (<) 2 Years n = 60	MenCCRM (Meningitec) Vaccine: Less Than 2 Years n = 21	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years n = 104	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years n = 27
rSBA-MenA: >=1:8	58.3 (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: >=1:8	78.3 (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: >=1:8	26.7 (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: >=1:8	35.0 (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: >=1:28	21.7 (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: >=1:28	61.7 (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: >=1:28	23.3 (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: >=1:28	33.3 (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)

Population analysed: 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.

Primary outcome: 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

Time frame: 8 years after primary vaccination (Year 3 of study MENACWY-TT-100). Number (95% Confidence Interval). Unit: percentage of participants

Measure	MenACWY-TT Vaccine: Less Than (<) 2 Years n = 65	MenCCRM (Meningitec) Vaccine: Less Than 2 Years n = 22	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years n = 100	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years n = 25
rSBA-MenA: >=1:8	47.7 (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: >=1:8	78.5 (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: >=1:8	29.2 (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: >=1:8	40.0 (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: >=1:28	23.1 (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: >=1:28	64.6 (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: >=1:28	27.7 (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: >=1:28	38.5 (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)

Population analysed: 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.

Primary outcome: 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

Time frame: 9 years after primary vaccination (Year 4 of study MENACWY-TT-100). Number (95% Confidence Interval). Unit: percentage of participants

Measure	MenACWY-TT Vaccine: Less Than (<) 2 Years n = 64	MenCCRM (Meningitec) Vaccine: Less Than 2 Years n = 21	MenACWY-TT Vaccine: Greater Than or Equal to (>=) 2 Years n = 93	MenPS (Mencevax ACWY) Vaccine: Less Than 2 Years n = 25
rSBA-MenA >=1:8	67.2 (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 >=1:8	81.3 (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 >=1:8	32.8 (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 >=1:8	42.2 (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 >=1:28	31.3 (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 >=1:28	65.6 (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 >=1:28	26.6 (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 >=1:28	34.4 (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)

13 secondary outcomes are reported in the full results.

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. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Persistence Phase: MenACWY-TT Vaccine (Less Than [<] 2 Years)	0 of 76 (0%)	0 of 76 (0%)	0 of 76
Persistence Phase:MenCCRM (Meningitec) Vaccine(<2 Years)	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Persistence Phase: MenACWY-TT Vaccine (>=2 Years)	0 of 115 (0%)	0 of 115 (0%)	0 of 115
Persistence Phase: MenPS (Mencevax ACWY) Vaccine (< 2 Years)	0 of 29 (0%)	0 of 29 (0%)	0 of 29
Booster Phase: MenACWY-TT Vaccine (Less Than 2 Years)	0 of 67 (0%)	53 of 67 (79.1%)	0 of 67
Booster Phase: MenCCRM (Meningitec) Vaccine (<2 Years)	0 of 16 (0%)	12 of 16 (75%)	0 of 16
Booster Phase: MenACWY-TT Vaccine (>= 2 Years)	1 of 77 (1.3%)	65 of 77 (84.4%)	0 of 77
Booster Phase: MenPS (Mencevax ACWY) Vaccine (<2 Years)	0 of 21 (0%)	15 of 21 (71.4%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32598244Vesikari 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Meningococcal vaccine GSK134612 in people with Infections, Meningococcal, run by Pfizer at 9 sites in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 6 years after primary vaccination (Year 1 of study MENACWY-TT-100)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01962207, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019.