Infections, MeningococcalPhase 3NCT01934140

Study to Evaluate the Long-term Antibody Persistence of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine (GSK134612) Versus Mencevax ACWY in Healthy Adolescents and Adults and Booster Response to MenACWY-TT Vaccine Administered at 10 Years Post-primary Vaccination

A Phase 3 study testing Meningococcal vaccine GSK134612 in people with Infections, Meningococcal, run by Pfizer at 2 sites in Philippines.

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

Who is it for?: Ages 17 to 66 yearsHealthy 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: 311 participants
Where: 2 sitesPhilippines
Study dates: Apr 2014to Aug 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 17 to 66 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

All subjects must satisfy the following criteria at study entry to the persistence phase:
Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. Or /and subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
A male or female between and including 17 and 66 years of age at the time of entry into the present study.
Has completed the vaccination phase of the vaccination study MENACWY-TT-015.
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 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday. The subjects ≥18 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.

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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, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
Female subjects of childbearing potential 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, and
has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Who cannot join

Child in care.
Previous vaccination with meningococcal polysaccharide or conjugate vaccine outside of study MENACWY-TT-015.
History of meningococcal disease due to serogroup A, C, W-135 or Y.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including Human Immunodeficiency Virus (HIV) infection, based on medical history and physical examination.
Major congenital defects or serious chronic illness.
Family history of congenital or hereditary immunodeficiency.

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History of chronic alcohol consumption and/or drug abuse.
Additional exclusion criteria for booster phase at Month 120 study entry (to be checked at Month 120) for all subjects
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the follow-up period.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose. Inhaled and topical steroids are allowed.
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 day of vaccination considered Day 0), with the exception of a licensed inactivated influenza vaccine.
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.
Previous vaccination with tetanus toxoids within the last month.
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 enrollment.
Fever is defined as temperature ≥ 37.5°C for oral, axillary or tympanic route, or ≥ 38.0°C for rectal route. The preferred route for recording temperature in this study will be oral.
Subjects with a minor illness 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.

Trial locations and contacts

2 sites in 1 country.

Philippines2 sites

Philippine General Hospital
Manila, 1000
Research Institute for Tropical Medicine
Muntinlupa City, National Capital Region, 1781

Other trials in Philippines

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 MENINGOCOCCAL CONJUGATE VACCINE MENACWY-TT VERSUS ONE DOSE OF 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 11-55 YEAR OLD SUBJECTS WITH MENACWY-TT OR MENCEVAX (REGISTERED) ACWY.

The purpose of this study is to evaluate the long-term antibody persistence from 6, 7, 8, 9 to 10 years post-administration of MenACWY-TT conjugate vaccine as compared to Mencevax ACWY when given to healthy subjects 11 to 55 years of age. In addition, the safety and immunogenicity of a booster dose of MenACWY-TT vaccine administered to all eligible subjects 10 years after the primary vaccination will be evaluated.

All Filipino subjects who received the primary vaccination in the primary vaccination study 107386 (NCT00356369) will be invited to enrol in the long-term follow up and booster phase. No new subjects will be enrolled.

Conditions: Infections, Meningococcal
Being tested: Meningococcal vaccine GSK134612
Keywords: Healthy, Adults, Safety, Neisseria meningitidis, Booster response, Immunogenicity, Adolescents, Serogroups A, C, W-135, and Y, long-term antibody persistence
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
1 dose administered intramuscularly in the non-dominant deltoid region.

Study groups in NCT01934140
Study group	Role	What they receive
ACWY-TT group	Experimental	All subjects vaccinated with MenACWY-TT in study MENACWY-TT-015 will be assigned to this group. At Month 120 after primary vaccination, these subjects will be vaccinated with a booster dose of MenACWY-TT in this study. Receives: Biological: Meningococcal vaccine GSK134612
MenPS group	Active comparator	All subjects vaccinated with Mencevax ACWY in study MENACWY-TT-015 will be assigned to this group. At Month 120 after primary vaccination, these subjects will be vaccinated with a dose of MenACWY-TT in this study. 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 Greater Than or Equal to (>=) 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: After 6 years of primary vaccination
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: After 7 years of primary vaccination
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: After 8 years of primary vaccination
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: After 9 years of primary vaccination
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: After 10 years of primary vaccination
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 percentage (%) reduction of meningococcal colony-forming units.
Measured: After 6 years of primary vaccination
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.
Measured: After 7 years of primary vaccination
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.
Measured: After 8 years of primary vaccination
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.
Measured: After 9 years of primary vaccination
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.
Measured: After 10 years of primary vaccination

Secondary outcomes (11)

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
Booster Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups at 1 Month After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.
Measured: 1 month after booster vaccination
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 vaccine responses for serogroups A, C, W-135 and Y defined as: for initially seronegative participants (pre-vaccination titer below the cut-off of 1:8) had rSBA antibody titers >= 1:32, 1 month after vaccination, and for initially seropositive participants (pre-vaccination titer >= 1:8) had rSBA antibody titers at least 4 times the pre-vaccination antibody titers, 1 month after vaccination. Data reported below is including both seropositive and seronegative participants.
Measured: 1 month after booster vaccination
Booster Phase: Percentage of Participants With Antibodies Against-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL at 1 Month After Booster Vaccination
Tetanus toxoid (TT) was used as carrier in tetravalent meningococcal ACWY conjugate vaccine. Percentage of participants with anti-TT concentration >=0.1 IU/mL, >=1.0 IU/mL were summarized.
Measured: 1 month after booster vaccination
Booster Phase: Geometric Mean Concentrations (GMCs) of Antibodies Against-Tetanus Toxoid (Anti-TT) at 1 Month After Booster Vaccination
TT was used as carrier in tetravalent meningococcal ACWY conjugate vaccine. Percentage of participants with anti-TT concentration >=0.1 IU/mL, >=1.0 IU/mL were summarized.
Measured: 1 month after booster vaccination
Booster Phase: Percentage of Participants With Solicited Local and General Adverse Events up to 4 Days Post Booster Vaccination
Solicited local events:1)pain(Grade [G] : 0=none,1=mild,neither interfered nor prevented normal activities,2=moderate, painful when limb moved; interfered with normal activities,3=severe, significant pain at rest,prevented normal activities),2)redness, and 3)swelling (record greatest surface diameter in millimetre[mm] as 0 to less than or equal to[<=]20 mm, greater than[>]20 to <=50 mm,>50 mm). If to resolve any event medical advice taken, results reported as Medical Advice. Solicited general events: 1) fatigue, 2) gastrointestinal(GI) events(nausea, vomiting, diarrhea and/or abdominal pain,3) headache(G : 0=normal, 1=mild, easily tolerated,2=moderate, interfered with normal activity,3=severe, prevented normal activity), and 4)fever (G: 0=less than[<] 37.5 degree Celsius[°C], 1= 37.5 degree C to 38.0degree C, 2= 38.1 degreeC to 39.0 degree C,3 =>39.0 degree C). 'Related'=relationship to study vaccine assessed by investigator.Medical advice=medical advice received to resolve any event.
Measured: Up to 4 days post booster vaccination
Booster Phase: Percentage of Participants With Unsolicited Adverse Events (AEs) 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) From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Up to 6 months post booster vaccination
Booster Phase: Percentage of Participants With New Onset Chronic Illness From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination)
New onset chronic illness included autoimmune disorders, asthma, type I diabetes, and allergies.
Measured: Up to 6 months post booster vaccination
Booster Phase: Percentage of Participants With Guillain-Barre Syndrome (GBS) From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination)
Guillain-Barre syndrome (GBS) is a rare neurological disorder in which the body's immune system mistakenly attacks part of its peripheral nervous system-the network of nerves located outside of the brain and spinal cord. GBS can range from a very mild case with brief weakness to nearly devastating paralysis, leaving the person unable to breathe independently.
Measured: Up to 6 months post booster vaccination
Booster Phase: Percentage of Participants With Meningococcal Disease From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination)
Meningococcal disease describes infections caused by the bacterium Neisseria meningitidis (also termed meningococcus). It causes two life threatening diseases: meningococcal meningitis and fulminant meningococcemia which often occur together. Meningococcal meningitis is defined as an inflammatory response to bacterial infection of leptomeninges (pia-arachnoid) and the sub-arachnoid space. Meningococcal meningococcemia is meningococcal septicemia when the bacteria circulate and multiply in blood and involve multiple organs. It can cause multi-organ failure and severe disability or death.
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.

Apr 2014Aug 2018

First posted4 Sep 2013 (estimated)
Study startApr 2014
Primary completionFeb 2018
Study completionAug 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 311 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01934140
Sponsor's protocol ID: MENACWY-TT-099
Other IDs: 2012-005639-10, C0921002, 116725
Status last verified: Jul 2019
First submitted: 22 Aug 2013
Last updated: 28 Aug 2019
Results posted: Yes, on ClinicalTrials.gov
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

Borja-Tabora CFC, Peyrani P, Webber C, Van der Wielen M, Cheuvart B, De Schrevel N, Bianco V, Aris E, Cutler M, Li P, Perez JL. A phase 2b/3b MenACWY-TT study of long-term antibody persistence after primary vaccination and immunogenicity and safety of a booster dose in individuals aged 11 through 55 years. BMC Infect Dis. 2020 Jun 18;20(1):426. doi: 10.1186/s12879-020-05104-5.
PubMed 32552685

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 28 Aug 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 MENINGOCOCCAL CONJUGATE VACCINE MENACWY-TT VERSUS ONE DOSE OF 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 11-55 YEAR OLD SUBJECTS WITH MENACWY-TT OR MENCEVAX (REGISTERED) ACWY.
ClinicalTrials.gov ID: NCT01934140
Acronym / sponsor ID: MENACWY-TT-099
Conditions: Infections, Meningococcal
Keywords: Healthy, Adults, Safety, Neisseria meningitidis, Booster response, Immunogenicity, Adolescents, Serogroups A, C, W-135, and Y
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 311 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Apr 2014 (actual)
Primary completion: Feb 2018 (actual)
Study completion: Aug 2018 (actual)
First posted: 4 Sep 2013 (estimated)
Results: Posted 28 Aug 2019

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ACWY-TT group	Experimental	Biological: Meningococcal vaccine GSK134612All subjects vaccinated with MenACWY-TT in study MENACWY-TT-015 will be assigned to this group. At Month 120 after primary vaccination, these subjects will be vaccinated with a booster dose of MenACWY-TT in this study.
MenPS group	Active comparator	Biological: Meningococcal vaccine GSK134612All subjects vaccinated with Mencevax ACWY in study MENACWY-TT-015 will be assigned to this group. At Month 120 after primary vaccination, these subjects will be vaccinated with a dose of MenACWY-TT in this study.

Who may qualify

Ages: 17 to 66 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (13 listed)

Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. Or /and subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
A male or female between and including 17 and 66 years of age at the time of entry into the present study.
Has completed the vaccination phase of the vaccination study MENACWY-TT-015.
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 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday. The subjects ≥18 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.

Key exclusion criteria (21 listed)

Child in care.
Previous vaccination with meningococcal polysaccharide or conjugate vaccine outside of study MENACWY-TT-015.
History of meningococcal disease due to serogroup A, C, W-135 or Y.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including Human Immunodeficiency Virus (HIV) infection, based on medical history and physical examination.
Major congenital defects or serious chronic illness.

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 GSK1346121 dose administered intramuscularly in the non-dominant deltoid region.	Biological	ACWY-TT group, MenPS group

Primary outcome

Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers Greater Than or Equal to (>=) 1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination
Time frame: 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).
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: After 7 years of primary vaccination
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: After 8 years of primary vaccination
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: After 9 years of primary vaccination
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: After 10 years of primary vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 6 Years of Primary Vaccination
Time frame: After 6 years of primary vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 percentage (%) reduction of meningococcal colony-forming units.
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 7 Years of Primary Vaccination
Time frame: After 7 years of primary vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 8 Years of Primary Vaccination
Time frame: After 8 years of primary vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 9 Years of Primary Vaccination
Time frame: After 9 years of primary vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.
Persistence Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups After 10 Years of Primary Vaccination
Time frame: After 10 years of primary vaccination
Serogroups included MenA, MenC, MenW-135 and MenY. rSBA titers expressed as the reciprocal of the highest serum last dilution resulting in at least 50 % reduction of meningococcal colony-forming units.

11 secondary outcomes

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
Booster Phase: Geometric Mean Titers With rSBA for Each of the 4 Serogroups at 1 Month After Booster Vaccination
Time frame: 1 month after booster vaccination
Booster Phase: Percentage of Participants With rSBA Booster Response at 1 Month After Booster Vaccination
Time frame: 1 month after booster vaccination
Booster Phase: Percentage of Participants With Antibodies Against-Tetanus Toxoid (Anti-TT) Concentrations >=0.1 International Units Per Millilitre (IU/mL), >=1.0 IU/mL at 1 Month After Booster Vaccination
Time frame: 1 month after booster vaccination
Booster Phase: Geometric Mean Concentrations (GMCs) of Antibodies Against-Tetanus Toxoid (Anti-TT) at 1 Month After Booster Vaccination
Time frame: 1 month after booster 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 (AEs) 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) From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination)
Time frame: Up to 6 months post booster vaccination
Booster Phase: Percentage of Participants With New Onset Chronic Illness From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination)
Time frame: Up to 6 months post booster vaccination
Booster Phase: Percentage of Participants With Guillain-Barre Syndrome (GBS) From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination)
Time frame: Up to 6 months post booster vaccination
Booster Phase: Percentage of Participants With Meningococcal Disease From Booster Vaccination up to End of Study (6 Months Post Booster Vaccination)
Time frame: Up to 6 months post booster vaccination

Results and safety

Results posted to the registry on 28 Aug 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
ACWY-TT Group	235	152
MenPS Group	76	51

Primary outcome: Persistence Phase: Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Titers Greater Than or Equal to (>=) 1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination

Time frame: After 6 years of primary vaccination

Population analysed: Data was not collected and analyzed for this outcome measure because approval was not obtained from the authorities for Year 6 activities.

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: After 7 years of primary vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	ACWY-TT Group n = 206	MenPS Group n = 65
rSBA-MenA: >=1:8	88.3 (83.2 to 92.4)	67.7 (54.9 to 78.8)
rSBA-MenC: >=1:8	82.5 (76.6 to 87.4)	76.9 (64.8 to 86.5)
rSBA-MenW-135: >=1:8	60.7 (53.7 to 67.4)	23.1 (13.5 to 35.2)
rSBA-MenY: >=1:8	80.1 (74.0 to 85.3)	46.2 (33.7 to 59.0)
rSBA-MenA: >=1:128	73.8 (67.2 to 79.7)	46.2 (33.7 to 59.0)
rSBA-MenC: >=1:128	61.7 (54.6 to 68.3)	61.5 (48.6 to 73.3)
rSBA-MenW-135: >=1:128	52.4 (45.4 to 59.4)	16.9 (8.8 to 28.3)
rSBA-MenY: >=1:128	76.7 (70.3 to 82.3)	38.5 (26.7 to 51.4)

Population analysed: All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 \[NCT00356369\], 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 8 Years of Primary Vaccination

Time frame: After 8 years of primary vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	ACWY-TT Group n = 208	MenPS Group n = 67
rSBA-MenA: >=1:8	76.0 (69.6 to 81.6)	56.7 (44.0 to 68.8)
rSBA-MenC: >=1:8	86.3 (80.8 to 90.7)	80.6 (69.1 to 89.2)
rSBA-MenW-135: >=1:8	66.2 (59.3 to 72.6)	23.9 (14.3 to 35.9)
rSBA-MenY: >=1:8	76.2 (69.8 to 81.9)	40.3 (28.5 to 53.0)
rSBA-MenA: >=1:128	60.6 (53.6 to 67.3)	40.3 (28.5 to 53.0)
rSBA-MenC: >=1:128	68.1 (61.3 to 74.5)	64.2 (51.5 to 75.5)
rSBA-MenW-135: >=1:128	60.9 (53.9 to 67.6)	16.4 (8.5 to 27.5)
rSBA-MenY: >=1:128	70.9 (64.2 to 77.0)	37.3 (25.8 to 50.0)

Population analysed: All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 \[NCT00356369\], had available assay results for at least 1 tested antigen. Here, "N" signifies number of participants evaluable for this measure and "Number analyzed" (n): participants analyzed for specified serogroup.

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: After 9 years of primary vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	ACWY-TT Group n = 190	MenPS Group n = 61
rSBA-MenA: >=1:8	82.6 (76.5 to 87.7)	65.6 (52.3 to 77.3)
rSBA-MenC: >=1:8	89.5 (84.2 to 93.5)	90.2 (79.8 to 96.3)
rSBA-MenW-135: >=1:8	55.8 (48.4 to 63.0)	9.8 (3.7 to 20.2)
rSBA-MenY: >=1:8	89.5 (84.2 to 93.5)	57.4 (44.1 to 70.0)
rSBA-MenA: >=1:128	75.3 (68.5 to 81.2)	59.0 (45.7 to 71.4)
rSBA-MenC: >=1:128	66.8 (59.7 to 73.5)	67.2 (54.0 to 78.7)
rSBA-MenW-135: >=1:128	50.5 (43.2 to 57.8)	9.8 (3.7 to 20.2)
rSBA-MenY: >=1:128	86.3 (80.6 to 90.9)	50.8 (37.7 to 63.9)

Population analysed: All eligible participants who received primary vaccination with MenACWY-TT or Mencevax ACWY during study 107386 \[NCT00356369\], had available assay results for at least 1 tested antigen. Here, "N" signifies number of participants evaluable for this measure.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: For persistence phase: Through 4 years (7, 8, 9 and 10 years post primary vaccination) Non-SAEs were not collected for persistence phase; Booster phase: up to 6 months after booster vaccination; Local and General reactions: Recorded by participants in e-diary up to 4 days post booster vaccination.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Persistence Phase: ACWY-TT Group	0 of 235 (0%)	0 of 0	0 of 235
Persistence Phase: MenPS Group	0 of 76 (0%)	0 of 0	0 of 76
Booster Phase: ACWY-TT Group	0 of 164 (0%)	66 of 164 (40.2%)	0 of 164
Booster Phase: MenPS Group	0 of 56 (0%)	20 of 56 (35.7%)	0 of 56

Limitations and caveats (from the sponsor): Enrollment for this study (MENACWY-TT-99) started at Year 6. However, Study visit for Year 6 was not done because approval was not obtained from the authorities until after the end of the Year 6. Hence, no planned activities were done for Year 6.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32552685Borja-Tabora CFC, Peyrani P, Webber C, Van der Wielen M, Cheuvart B, De Schrevel N, Bianco V, Aris E, Cutler M, Li P, Perez JL. A phase 2b/3b MenACWY-TT study of long-term antibody persistence after primary vaccination and immunogenicity and safety of a booster dose in individuals aged 11 through 55 years. BMC Infect Dis. 2020 Jun 18;20(1):426. doi: 10.1186/s12879-020-05104-5.
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

2 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 2 sites in Philippines.

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 13 inclusion and 21 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 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Philippines. 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 28 Aug 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 Greater Than or Equal to (>=) 1:8 and >=1:128 For Each of the 4 Serogroups After 6 Years of Primary Vaccination (time frame: After 6 years of primary vaccination). 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 NCT01934140, 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 28 Aug 2019.