Infections, MeningococcalPhase 3NCT01900899

Persistence of Antibodies After Meningococcal Vaccine PF-06866681 in Healthy Children

A Phase 3 study testing Blood Sampling in people with Infections, Meningococcal, run by Pfizer at 10 sites in Finland.

Completed

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

Trial summary

The purpose of this study is to evaluate the long-term antibody persistence as well as safety of GSK Biologicals' MenACWY-TT vaccine versus Meningitec up to 6 years after booster vaccination administered in healthy 5 year old children in the study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (NCT00955682), who were primed with… 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?: Blood Sampling
Type of treatment: Vaccines, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 184 participants
Where: 10 sitesFinland
Study dates: Jul 2013to Nov 2017
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

All subjects must satisfy ALL the following criteria at study entry:
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 who has received primary and booster vaccination with the MenACWY-TT or Meningitec vaccines in studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036), respectively.
Written informed consent obtained from the parent(s)/LAR(s) of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Who cannot join

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
Child in care.
History of meningococcal disease.
Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine outside of studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036).
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Finland10 sites

Espoo Vaccine Research Clinic
Espoo, 02230
Tampereen yliopisto/ Etela-Helsingin rokotetutkimusklinikka
Helsinki, 00100
Helsinki East Vaccine Research Clinic
Helsinki, 00930
Tampereen Yliopisto/ Jarvenpaan rokotetutkimusklinikka
Jarvenpaa, 60100
Tampereen yliopisto/ Oulun rokotetutkimusklinikka
Oulu, 90220
Tampereen yliopisto/ Porin rokotetutkimusklinikka
Pori, 28100
Seinajoki Vaccine Research Clinic
Seinäjoki, 60100
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 III, OPEN, MULTI-CENTRE, CONTROLLED STUDY TO EVALUATE THE LONG-TERM ANTIBODY PERSISTENCE AT 2, 3, 4, 5 AND 6 YEARS AFTER A BOOSTER DOSE OF MENINGOCOCCAL SEROGROUP A, C, W-135, Y- TETANUS TOXOID CONJUGATE VACCINE (MENACWY-TT) OR MENINGITEC (REGISTERED) ADMINISTERED IN HEALTHY 5-YEAR-OLD CHILDREN IN STUDY MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036), WHO WERE PRIMED WITH THE SAME VACCINE IN STUDY MENACWY-TT-039 (109670) AT 12 THROUGH 23 MONTHS OF AGE.

Read the detailed description

The subjects in this study will be allocated to the same groups as in study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (NCT00955682). No vaccine will be administered during this long-term persistence study.

Conditions: Infections, Meningococcal
Being tested: Blood Sampling
Keywords: Healthy, Immunogenicity, Children, Neisseria meningitidis, Long-term antibody persistence, Safety, Serogroups A, C, W-135, and Y
Medical subject headings: Meningococcal Infections

What participants receive

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

Blood SamplingProcedure or surgery
At 2, 3, 4, 5, 6 years after booster vaccination.

Study groups in NCT01900899
Study group	Role	What they receive
ACWY-TT group	Experimental	Subjects primed and boosted with the MenACWY-TT vaccine. Receives: Procedure: Blood Sampling
MenCCRM group	Active comparator	Subjects primed and boosted with the Meningitec vaccine. Receives: Procedure: Blood Sampling

What is being measured

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

Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Measured: 24 months after booster Vaccination
Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Measured: 36 months after booster Vaccination
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Measured: 48 months after booster Vaccination
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Measured: 60 months after booster Vaccination
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Measured: 72 months after booster Vaccination

Secondary outcomes (5)

Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Serogroups included MenA, MenC, MenW-135 and MenY.
Measured: 24, 36, 48, 60 and 72 months after booster Vaccination
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Serogroups included MenA, MenC, MenW-135 and MenY.
Measured: 24, 36, 48, 60 and 72 months after booster Vaccination
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs)
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. Treatment-emergent are events between first dose of study drug and up to 72 months after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state.
Measured: Baseline up to the Month 72 after booster vaccination (up to 6 years)
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Serogroups included MenA, MenC, MenW-135 and MenY.
Measured: 24, 36, 48, 60 and 72 months after booster Vaccination
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Serogroups included MenA, MenC, MenW-135 and MenY.
Measured: 24, 36, 48, 60 and 72 months after booster Vaccination

Timeline

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

Jul 2013Nov 2017

First posted17 Jul 2013 (estimated)
Study startJul 2013
Primary completionNov 2017
Study completionNov 2017

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: Single group
Masking: None (open label)
Enrolment: 184 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01900899
Sponsor's protocol ID: MENACWY-TT-102
Other IDs: C0921001, 2012-005816-25, 200088
Status last verified: Mar 2019
First submitted: 27 Jun 2013
Last updated: 17 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, Forsten A, Laudat F, Li P, Van Der Wielen M, Hezareh M, Perez JL, Webber C. Long-term antibody persistence after a booster dose of quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine in healthy 5-year-old children. Vaccine. 2020 May 8;38(22):3902-3908. doi: 10.1016/j.vaccine.2020.02.030. Epub 2020 Apr 11.
PubMed 32284274

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

Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
RecruitingPhase 3
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
Meningococcal Infection, Healthy Volunteers
RecruitingObservational study
A Study to Learn About the Safety of PENBRAYA During Pregnancy
Meningococcal Disease
RecruitingObservational study
National Bacterial Meningitis Study in Children and Newborns
Meningitis, Children, Only
Active, not recruitingPhase 4
A Study on the Immune Response and Safety of a Vaccine Against N. Meningitidis Serogroup B Infection in Healthy Infants From 2 Months of Age
Meningitis, Meningococcal

All Infections, Meningococcal trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE III, OPEN, MULTI-CENTRE, CONTROLLED STUDY TO EVALUATE THE LONG-TERM ANTIBODY PERSISTENCE AT 2, 3, 4, 5 AND 6 YEARS AFTER A BOOSTER DOSE OF MENINGOCOCCAL SEROGROUP A, C, W-135, Y- TETANUS TOXOID CONJUGATE VACCINE (MENACWY-TT) OR MENINGITEC (REGISTERED) ADMINISTERED IN HEALTHY 5-YEAR-OLD CHILDREN IN STUDY MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036), WHO WERE PRIMED WITH THE SAME VACCINE IN STUDY MENACWY-TT-039 (109670) AT 12 THROUGH 23 MONTHS OF AGE.
ClinicalTrials.gov ID: NCT01900899
Acronym / sponsor ID: MENACWY-TT-102
Conditions: Infections, Meningococcal
Keywords: Healthy, Immunogenicity, Children, Neisseria meningitidis, Long-term antibody persistence, Safety, Serogroups A, C, W-135, and Y
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 184 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jul 2013 (actual)
Primary completion: Nov 2017 (actual)
Study completion: Nov 2017 (actual)
First posted: 17 Jul 2013 (estimated)
Results: Posted 17 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

The subjects in this study will be allocated to the same groups as in study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (NCT00955682). No vaccine will be administered during this long-term persistence study.

Study design

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

Arm	Type	Receives
ACWY-TT group	Experimental	Procedure: Blood SamplingSubjects primed and boosted with the MenACWY-TT vaccine.
MenCCRM group	Active comparator	Procedure: Blood SamplingSubjects primed and boosted with the Meningitec vaccine.

Who may qualify

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

Key inclusion criteria (5 listed)

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 who has received primary and booster vaccination with the MenACWY-TT or Meningitec vaccines in studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036), respectively.
Written informed consent obtained from the parent(s)/LAR(s) of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Key exclusion criteria (6 listed)

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
Child in care.
History of meningococcal disease.
Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine outside of studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036).
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

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
Blood SamplingAt 2, 3, 4, 5, 6 years after booster vaccination.	Procedure or surgery	ACWY-TT group, MenCCRM group

Primary outcome

Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination
Time frame: 24 months after booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination
Time frame: 36 months after booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination
Time frame: 48 months after booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination
Time frame: 60 months after booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination
Time frame: 72 months after booster Vaccination
Serogroups included MenA, MenC, MenW-135 and MenY.

5 secondary outcomes

Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Time frame: 24, 36, 48, 60 and 72 months after booster Vaccination
Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Time frame: 24, 36, 48, 60 and 72 months after booster Vaccination
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs)
Time frame: Baseline up to the Month 72 after booster vaccination (up to 6 years)
Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Time frame: 24, 36, 48, 60 and 72 months after booster Vaccination
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Time frame: 24, 36, 48, 60 and 72 months after booster Vaccination

Results and safety

Results posted to the registry on 17 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	159	150
MenCCRM Vaccine	25	24

Primary outcome: Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination

Time frame: 24 months after booster Vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	MenACWY-TT Vaccine n = 123	MenCCRM Vaccine n = 21
rSBA-MenA	98.4 (94.2 to 99.8)	23.8 (8.2 to 47.2)
rSBA-MenC	97.6 (93.0 to 99.5)	100.0 (83.9 to 100.0)
rSBA-MenW-135	96.7 (91.9 to 99.1)	9.5 (1.2 to 30.4)
rSBA-MenY	100.0 (97.0 to 100.0)	33.3 (14.6 to 57.0)

Population analysed: All eligible participants who received primary and booster vaccination with MenACWY-TT or Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. N (overall number of participants analyzed)=number of participants evaluable for this outcome measure.

Primary outcome: Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination

Time frame: 36 months after booster Vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	MenACWY-TT Vaccine n = 135	MenCCRM Vaccine n = 22
rSBA-MenA	95.6 (90.6 to 98.4)	18.2 (5.2 to 40.3)
rSBA-MenC	88.1 (81.5 to 93.1)	77.3 (54.6 to 92.2)
rSBA-MenW-135	97.8 (93.6 to 99.5)	9.1 (1.1 to 29.2)
rSBA-MenY	94.8 (89.6 to 97.9)	36.4 (17.2 to 59.3)

Population analysed: All eligible participants who received primary and booster vaccination with MenACWY-TT or Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. Here, N signifies number of participants evaluable for this outcome measure.

Primary outcome: Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination

Time frame: 48 months after booster Vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	MenACWY-TT Vaccine n = 139	MenCCRM Vaccine n = 23
rSBA-MenA	95.0 (89.9 to 98.0)	26.1 (10.2 to 48.4)
rSBA-MenC	88.5 (82.0 to 93.3)	100.0 (85.2 to 100.0)
rSBA-MenW-135	87.0 (80.2 to 92.1)	17.4 (5.0 to 38.8)
rSBA-MenY	95.0 (89.9 to 98.0)	43.5 (23.2 to 65.5)

Population analysed: All eligible participants who received primary and booster vaccination with MenACWY-TT/ Meningitec vaccine in studies MENACWY-TT-039 and MENACWY-TT-048 EXT and had available assay results for at least 1 tested antigen. Here, N=number of participants evaluable for this outcome measure.

Primary outcome: Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination

Time frame: 60 months after booster Vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	MenACWY-TT Vaccine n = 137	MenCCRM Vaccine n = 23
rSBA-MenA	89.8 (83.4 to 94.3)	0.0 (0.0 to 14.8)
rSBA-MenC	80.3 (72.6 to 86.6)	78.3 (56.3 to 92.5)
rSBA-MenW-135	88.3 (81.7 to 93.2)	13.0 (2.8 to 33.6)
rSBA-MenY	92.7 (87.0 to 96.4)	26.1 (10.2 to 48.4)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to the Month 72 after booster vaccination (up to 6 years). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MenACWY-TT Vaccine	0 of 159 (0%)	1 of 159 (0.6%)	0 of 159
MenCCRM Vaccine	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32284274Vesikari T, Forsten A, Laudat F, Li P, Van Der Wielen M, Hezareh M, Perez JL, Webber C. Long-term antibody persistence after a booster dose of quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine in healthy 5-year-old children. Vaccine. 2020 May 8;38(22):3902-3908. doi: 10.1016/j.vaccine.2020.02.030. Epub 2020 Apr 11.
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.

Related trials for Infections, Meningococcal

Not yet recruitingPhase 4
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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

10 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 Blood Sampling in people with Infections, Meningococcal, run by Pfizer at 10 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 5 inclusion and 6 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 17 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 10 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 17 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?

Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination (time frame: 24 months after booster Vaccination). The study lists 5 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 NCT01900899, 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 17 Jun 2019; AzTrials last refreshed its copy on 8 Nov 2026.