Meningococcal MeningitisPhase 3NCT01148017

Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate Vaccine

A Phase 3 study testing Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in people with Meningococcal Meningitis, run by Novartis Vaccines at 19 sites in United States.

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 37 to 63 monthsHealthy volunteers can take part
Conditions the study is for: Meningococcal Meningitis
What is being tested?: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 433 participants
Where: 19 sitesUnited States
Study dates: Jul 2010to Apr 2013
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 37 to 63 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Children eligible to be enrolled in the study are those whose parents provide written informed consent, and are in generally good health based on the clinical judgment of the investigators.
Group 1 and 2 (Follow up) subjects must be 40 +/- 3 months of age at the time of enrollment and participated in the original V59P14 study (NCT00474526).
Group 3 and 4 (Naïve) subjects must be healthy, meningococcal vaccine-naïve children ages 40 +/- 3 months (Group 3) or 60 +/-3 months (Group 4) at the time of enrollment, respectively.

Who cannot join

Serious, acute, or chronic illnesses are reasons for exclusion.
Subjects who have received any vaccine (excluding influenza vaccines) 28 days preceding enrollment visit. Influenza vaccines (including FluMist®) are excluded for the 14 days prior to the enrollment visit.
Subjects who have received any meningococcal vaccine since birth (Groups 3 \& 4 -naive) or last study dose in V59P14 (NCT00474526) trial (Groups 1 \& 2 - follow on).

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

28 Annapolis Pediatrics, 200 Forbes Street, Suite 200
Annapolis, Maryland, 21401
Kentucky Pediatric/Adult Research 201 South Fifth Street, Suite 102
Bardstown, Kentucky, 40004
Alabama Clinical Therapeutics 806 St. Vincent's Drive, Suite 615
Birmingham, Alabama, 35205
Children's Memorial Hospital 2300 Children's Plaza, Box 155
Chicago, Illinois, 60614
Senders Pediatrics 2054 South Green Road
Cleveland, Ohio, 44121
Premier Health Research 9317 Firestone Blvd.
Downey, California, 90241
Pediatric Medical Associates 160 West Germantown Pike Suite D2
East Norriton, Pennsylvania, 19402
Children's Health Care 2501 West 12th Street
Erie, Pennsylvania, 16505
Pennridge Pediatric Associates 270 Main Street
Harleysville, Pennsylvania, 19438
Kid's Way Pediatrics 3068 Innovation Way
Hermitage, Pennsylvania, 16148
Kaiser Permanente Oakland 3505 Broadway, 6th Floor, Room 624
Oakland, California, 94611
Center for Clinical Trials, LLC 16415 S. Colorado Ave., Suite 308
Paramount, California, 90723
Center for Clinical Trials, LLC 16660 Paramount Blvd., Suite 301
Paramount, California, 90723
Kaiser Permanente Pleasanton 7601 Stoneridge Drive, Second Floor
Pleasanton, California, 94588
Pediatric Medical Associates 1077 Rydal Road Suite 300
Rydal, Pennsylvania, 19046
Kaiser Permanente San Francisco 2200 O'Farrell St., Sixth Floor
San Francisco, California, 94115
Kaiser Permanente Santa Clara 710 Lawrence Expressway, Pediatric Clinic Department
Santa Clara, California, 95051
Pennridge Pediatric Associates 711 Lawn Avenue
Sellersville, Pennsylvania, 18960
PEAK Research 2859 Washington Rd., Ste. 412B
Upper Saint Clair, Pennsylvania, 15241

Other trials in United States

About this study

Official title: A Phase IIIb, Open-Label, Controlled, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine

The primary objective was to evaluate the persistence of bactericidal antibodies in children 40 and 60 months of age previously enrolled in the V59P14 (NCT00474526) study who received Novartis MenACWY Conjugate Vaccine. The study also enrolled age-matched subjects who have never received any meningococcal vaccine (naïve subjects) to serve as a control group. In addition, the response of a booster dose at 60 months was evaluated.

Conditions: Meningococcal Meningitis
Being tested: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
Keywords: Meningococcal, ACWY, Conjugate Vaccine, Meningitis, Children, Persistence, Booster dose
Medical subject headings: Meningitis, Meningococcal, Meningitis

What participants receive

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

Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccineBiological

Study groups in NCT01148017
Study group	Role	What they receive
ACWY - 4	Experimental	Subjects who had previously received 4 doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in the parent study during their first year of life are administered one booster dose of the same vaccine at 60 months of age. Receives: Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
ACWY - 2	Experimental	Subjects who had previously received 1 or 2 doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age. Receives: Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
Naïve - 40	Other	Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine. Receives: Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
Naïve - 60	Active comparator	Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine. Receives: Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine

What is being measured

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

Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y
The persistence of the antibody response in subjects of 40 months of age, previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.
Measured: Visit 9 (continuation from the parent study), 40-month visit.
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y
The persistence of the antibody response in subjects of 60 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentages of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.
Measured: Visit 10, 60 months of age

Secondary outcomes (8)

Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age
The persistence of the antibody response in subjects of 40 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:4 directed against N. meningitidis serogroups A, C, W-135, and Y.
Measured: Visit 9, 40 months of age.
Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y Subjects of 60 Months of Age
The persistence of the antibody response in subjects of 60 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:4 directed against N. meningitidis serogroups A, C, W-135, and Y.
Measured: Visit 10, 60 months of age.
hSBA Geometric Mean Titers (GMTs) Directed Against N. Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age
The persistence of the antibody response in children of 40 months of age previously vaccinated with MenACWY-CRM in study V59P14 (NCT00474526), and baseline antibody levels in age-matched naive subjects, is measured by the hSBA GMTs directed against N meningitidis serogroups A, C, W-135, and Y.
Measured: Visit 9 (continuation from the parent study), 40-months of age.
hSBA GMTs Directed Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 60 Months of Age
The persistence of the antibody response in children of 60 months of age previously vaccinated with MenACWY-CRM in study V59P14 (NCT00474526), and baseline antibody levels in age-matched naive subjects is measured by the hSBA GMTs directed against N meningitidis serogroups A, C, W-135, and Y.
Measured: Visit 10, 60 months of age.
Percentages of Subjects With hSBA Titers ≥ 1:8, and ≥ 1:4 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y, at 1 Month Post-vaccination
The antibody response to one booster dose of MenACWY-CRM in children of 60 months of age who had previously received at least one dose of MenACWY-CRM in the parent study compared to the antibody response to one dose of MenACWY-CRM in meningococcal vaccine-naïve subjects, is measured by the percentage of subjects with hSBA titers ≥ 1:8 and ≥1:4 directed against N. meningitidis serogroups A, C, W-135, and Y, at 1 month post-vaccination.
Measured: Visit 11, 1 month after vaccination.
Percentage of Subjects With Seroresponse at 1 Month Post-vaccination
The antibody response to one booster dose of MenACWY-CRM in children of 60 months of age who had previously received at least one dose of MenACWY-CRM in the parent study, compared to the antibody response to one dose of MenACWY-CRM in meningococcal vaccine-naïve subjects, is measured by the percentage of subjects with seroresponse at 1 month post-vaccination.
Seroresponse is defined as hSBA ≥ 1:8 for subjects with pre-vaccination hSBA titer ≤1:4, and as at least a four-fold rise in hSBA for subjects with pre-vaccination hSBA titer ≥ 1:4.
Measured: Visit 11, 1 month after vaccination.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity
Number of subjects reporting solicited local and systemic Adverse Events (AEs) and other indicators of reactogenicity after receiving study vaccination.
Note: solicited AEs were not recorded for naive subjects at 40 months of age, but only SAEs and medically attended AEs.
Measured: From day 1 to 7 after vaccination.
Number of Subjects Reporting Unsolicited AEs and SAEs
Number of subjects reporting unsolicited AEs, serious adverse events (SAEs) and medically attended AEs after receiving study vaccination.
Measured: Day 1 to 7 after vaccination for any unsolicited AEs, day 1 to study termination for SAEs and medically attended AEs (for the naive-40 group), day 8 to study termination for SAEs and medically attended AEs (for the other groups).

Timeline

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

Jul 2010Apr 2013

First posted22 Jun 2010 (estimated)
Study startJul 2010
Primary completionApr 2013
Study completionApr 2013

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 Meningococcal MeningitisStudies of the same condition, open and under way.
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: 433 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01148017
Sponsor's protocol ID: V59P14E1
Status last verified: Jul 2017
First submitted: 16 Jun 2010
Last updated: 14 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Klein NP, Block SL, Essink B, Barbi S, Smolenov I, Keshavan P. Antibody persistence and booster response following MenACWY-CRM vaccination in children as assessed by two different assay methods. Vaccine. 2019 Jul 26;37(32):4460-4467. doi: 10.1016/j.vaccine.2019.06.076. Epub 2019 Jul 3.
PubMed 31279564

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 14 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIIb, Open-Label, Controlled, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine
ClinicalTrials.gov ID: NCT01148017
Acronym / sponsor ID: V59P14E1
Conditions: Meningococcal Meningitis
Keywords: Meningococcal, ACWY, Conjugate Vaccine, Meningitis, Children, Persistence, Booster dose
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 433 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Collaborators: GlaxoSmithKline
Study start: Jul 2010
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 22 Jun 2010 (estimated)
Results: Posted 14 May 2014

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

Arm	Type	Receives
ACWY - 4	Experimental	Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccineSubjects who had previously received 4 doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in the parent study during their first year of life are administered one booster dose of the same vaccine at 60 months of age.
ACWY - 2	Experimental	Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccineSubjects who had previously received 1 or 2 doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
Naïve - 40	Other	Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccineControl subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.
Naïve - 60	Active comparator	Biological: Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccineControl subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.

Who may qualify

Ages: 37 to 63 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Children eligible to be enrolled in the study are those whose parents provide written informed consent, and are in generally good health based on the clinical judgment of the investigators.
Group 1 and 2 (Follow up) subjects must be 40 +/- 3 months of age at the time of enrollment and participated in the original V59P14 study (NCT00474526).
Group 3 and 4 (Naïve) subjects must be healthy, meningococcal vaccine-naïve children ages 40 +/- 3 months (Group 3) or 60 +/-3 months (Group 4) at the time of enrollment, respectively.

Key exclusion criteria (3 listed)

Serious, acute, or chronic illnesses are reasons for exclusion.
Subjects who have received any vaccine (excluding influenza vaccines) 28 days preceding enrollment visit. Influenza vaccines (including FluMist®) are excluded for the 14 days prior to the enrollment visit.
Subjects who have received any meningococcal vaccine since birth (Groups 3 \& 4 -naive) or last study dose in V59P14 (NCT00474526) trial (Groups 1 \& 2 - follow on).

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 (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine	Biological	ACWY - 2, ACWY - 4, Naïve - 40, Naïve - 60

Primary outcome

Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y
Time frame: Visit 9 (continuation from the parent study), 40-month visit.
The persistence of the antibody response in subjects of 40 months of age, previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.
Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y
Time frame: Visit 10, 60 months of age
The persistence of the antibody response in subjects of 60 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentages of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.

8 secondary outcomes

Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age
Time frame: Visit 9, 40 months of age.
Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y Subjects of 60 Months of Age
Time frame: Visit 10, 60 months of age.
hSBA Geometric Mean Titers (GMTs) Directed Against N. Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age
Time frame: Visit 9 (continuation from the parent study), 40-months of age.
hSBA GMTs Directed Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 60 Months of Age
Time frame: Visit 10, 60 months of age.
Percentages of Subjects With hSBA Titers ≥ 1:8, and ≥ 1:4 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y, at 1 Month Post-vaccination
Time frame: Visit 11, 1 month after vaccination.
Percentage of Subjects With Seroresponse at 1 Month Post-vaccination
Time frame: Visit 11, 1 month after vaccination.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity
Time frame: From day 1 to 7 after vaccination.
Number of Subjects Reporting Unsolicited AEs and SAEs
Time frame: Day 1 to 7 after vaccination for any unsolicited AEs, day 1 to study termination for SAEs and medically attended AEs (for the naive-40 group), day 8 to study termination for SAEs and medically attended AEs (for the other groups).

Results and safety

Results posted to the registry on 14 May 2014, 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 - 4	214	134
ACWY - 2	121	87
Naïve - 40	53	53
Naïve - 60	45	45

Primary outcome: Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y

Time frame: Visit 9 (continuation from the parent study), 40-month visit.. Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	ACWY - 4 n = 206	ACWY - 2 n = 117	Naïve - 40 n = 51
Men A	10 (6 to 15)	35 (26 to 44)	2 (0.05 to 10)
Men C (N=206, 116, 51)	34 (28 to 41)	51 (41 to 60)	12 (4 to 24)
Men W-135 (N=204, 115, 51)	76 (70 to 82)	83 (74 to 89)	47 (33 to 62)
Men Y (N=205, 116, 51)	67 (60 to 73)	71 (62 to 79)	22 (11 to 35)

Population analysed: Analysis was done on the Per Protocol Set 40-month persistence (PPS 40-month persistence), ie, all subjects in the enrolled population who provided an evaluable serum sample at the 40-months of age visit and had no major protocol deviation.

Primary outcome: Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y

Time frame: Visit 10, 60 months of age. Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	ACWY - 4 n = 123	ACWY - 2 n = 80	Naïve - 60 n = 45
Men A	6 (2 to 11)	25 (16 to 36)	2 (0.056 to 12)
Men C	27 (19 to 36)	43 (32 to 54)	22 (11 to 37)
Men W-135 (N=121, 78, 45)	69 (60 to 77)	74 (63 to 84)	40 (26 to 56)
Men Y (N=122, 80, 44)	56 (46 to 65)	69 (57 to 79)	25 (13 to 40)

Population analysed: Analysis was done on the Per Protocol Set 60-Month persistence (PPS 60-Month persistence), ie, all subjects in the enrolled population who provided an evaluable serum sample at the 60-month of age visit and had no major protocol deviation.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited and unsolicited AEs were collected from day 1 to day 7 after vaccination. Serious AEs were collected from day 1 to study termination for the naive-40 group, and from day 8 to study termination for the other groups.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ACWY - 4	0 of 132 (0%)	86 of 132 (65.2%)	Not reported
ACWY - 2	0 of 87 (0%)	57 of 87 (65.5%)	Not reported
Naïve - 40	0 of 11 (0%)	3 of 11 (27.3%)	Not reported
Naïve - 60	0 of 50 (0%)	39 of 50 (78%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31279564Klein NP, Block SL, Essink B, Barbi S, Smolenov I, Keshavan P. Antibody persistence and booster response following MenACWY-CRM vaccination in children as assessed by two different assay methods. Vaccine. 2019 Jul 26;37(32):4460-4467. doi: 10.1016/j.vaccine.2019.06.076. Epub 2019 Jul 3.

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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.

Novartis Vaccines study chair

Novartis Vaccines

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

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 3 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 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. 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 14 May 2014). 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?

Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y (time frame: Visit 9 (continuation from the parent study), 40-month visit.). The study lists 2 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 NCT01148017, 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 14 Aug 2017.