Meningococcal InfectionsPhase 3NCT00450437

A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults

A Phase 3 study testing MenACWY CRM and Meningococcal ACWY Conjugate vaccine in people with Meningococcal Infections and Meningococcal Meningitis, run by Novartis Vaccines at 40 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

This study will evaluate the lot to lot consistency, safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine in healthy US adolescents and adults. Read more about this study

Who is it for?: Ages 11 to 55 years
Conditions the study is for: Meningococcal Infections, Meningococcal Meningitis
What is being tested?: MenACWY CRM and Meningococcal ACWY Conjugate vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,539 participants
Where: 40 sitesUnited States
Study dates: Mar 2007to Jan 2008
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 11 to 55 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Healthy subjects who are 11-55 years of age inclusive and who have given appropriate written assent and/or consent

Who cannot join

Subjects with a previous or suspected disease caused by N. meningitidis
previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
previous or suspected disease caused by N. meningitidis
Any serious acute, chronic or progressive disease
Pregnant or breastfeeding

Trial locations and contacts

40 sites in 1 country.

City, postcode or hospital

40 sites in 1 country

United States40 sites

Study site
Akron, Ohio, 44308
Study site
Annapolis, Maryland, 21401
Study site
Atlanta, Georgia, 30062
Study site
Baltimore, Maryland, 21201
Study site
Bardstown, Kentucky, 40004
Study site
Birmingham, Alabama, 35205, 35244
Study site
Boston, Massachusetts, 02118
Study site
Carnegie, Pennsylvania, 15106
Study site
Chicago, Illinois, 60614
Study site
Cincinnati, Ohio, 45229
Study site
Denver, Colorado, 80218
Study site
Erie, Pennsylvania, 16505
Study site
Fall River, Massachusetts, 02124
Study site
Frederick, Maryland, 21702
Study site
Fremont, California, 94538
Study site
Fresno, California, 93726
Study site
Galveston, Texas, 77555-0371
Study site
Greenville, Pennsylvania, 16125
Study site
Grove City, Pennsylvania, 16127
Study site
Harleyville, Pennsylvania, 19438
Study site
Hayward, California, 94545
Study site
Jefferson Borough, Pennsylvania, 15025
Study site
Latrobe, Pennsylvania, 15650
Study site
Lebanon, New Hampshire, 03756
Study site
Marietta, Georgia, 30062
Study site
Oakland, California, 94612
Study site
Pittsburgh, Pennsylvania, 15217 to 15241
Study site
Roseville, California, 95661
Study site
Sacramento, California, 95817
Study site
Salt Lake City, Utah, 84121
Study site
San Jose, California, 95119
Study site
Seattle, Washington, 98101-1466
Study site
Sellersville, Pennsylvania, 18960
Study site
South Euclid, Ohio, 44121
Study site
Tuscaloosa, Alabama, 35487
Study site
Uniontown, Pennsylvania, 15401
Study site
Upper Saint Clair, Pennsylvania, 15241
Study site
Washington, Pennsylvania, 15301
Study site
Wexford, Pennsylvania, 15090
Study site
Woodstock, Georgia, 30189

Other trials in United States

About this study

Official title: A Phase 3, Multi-center Study to Evaluate Lot to Lot Consistency, Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults and Compare to the Safety and Immune Response to a Licensed Conjugate Meningococcal ACWY Vaccine

This study will evaluate the lot to lot consistency, safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine in healthy US adolescents and adults.

Conditions: Meningococcal Infections, Meningococcal Meningitis
Being tested: MenACWY CRM, Meningococcal ACWY Conjugate vaccine
Keywords: Meningococcal, meningitis, vaccine, adolescents, adults
Medical subject headings: Meningococcal Infections, Meningitis, Meningococcal, Meningitis

What participants receive

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

MenACWY CRMBiological
One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
Meningococcal ACWY Conjugate vaccineBiological
One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.

Study groups in NCT00450437
Study group	Role	What they receive
Licensed Meningococcal Vaccine	Active comparator	Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine Receives: Biological: Meningococcal ACWY Conjugate vaccine
Novartis MenACWY Conjugate Vaccine	Experimental	Novartis meningococcal ACWY conjugate Vaccine Receives: Biological: MenACWY CRM

What is being measured

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

Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years
The consistency of immune response for the three lots of Meningococcal ACWY (MenACWY), as measured by human serum bactericidal activity (hSBA) geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 18 years of age)
Measured: 28 days after vaccination
Percentage of Seroresponders, Ages 11 to 18 Years
Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age).
Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Measured: 28 days after vaccination
Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years
Safety of Novartis Meningococcal ACWY and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of participants presenting at least one severe systemic reaction during the first 7 days (Days 1-7) following a single vaccination.
Note: severe adverse events: unable to perform normal daily activity
Measured: 6 days after vaccination
Percentage of Seroresponders, Ages 19 to 55 Years
Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroreponse directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 19 to 55 years of Age).
Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Measured: 28 days after vaccination

Secondary outcomes (4)

Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years
The consistency of the immune response for three lots of Meningococcal ACWY, as measured by the percentage of subjects with seroresponse, hSBA titer ≥ 1:4 and ≥ 1:8, directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age).
Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Measured: 28 days after vaccination
Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years
Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age).
Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Measured: 28 days after vaccination
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years
Immunogenicity of a single injection of MenACWY (3 lots combined) to that of a single injection of a licensed meningococcal ACWY conjugate vaccine, as measured by hSBA GMTs directed against N meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 55 years of age).
Measured: 28 days after vaccination
Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years
Safety profile following a single injection of MenACWY (3 lots combined) was to that following a single injection of a licensed meningococcal ACWY conjugate vaccine administered to healthy adolescents or adults (11 to 55 years of age).
Measured: Days 1 to 7

Timeline

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

Mar 2007Jan 2008

First posted22 Mar 2007 (estimated)
Study startMar 2007
Primary completionAug 2007
Study completionJan 2008

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 (2)Papers the sponsor has linked to this study.
Other trials for Meningococcal InfectionsStudies 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 3,539 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00450437
Sponsor's protocol ID: V59P13
Status last verified: Jan 2015
First submitted: 21 Mar 2007
Last updated: 28 Jan 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Jackson LA, Baxter R, Reisinger K, Karsten A, Shah J, Bedell L, Dull PM; V59P13 Study Group. Phase III comparison of an investigational quadrivalent meningococcal conjugate vaccine with the licensed meningococcal ACWY conjugate vaccine in adolescents. Clin Infect Dis. 2009 Jul 1;49(1):e1-10. doi: 10.1086/599117.
PubMed 19476428
Reisinger KS, Baxter R, Block SL, Shah J, Bedell L, Dull PM. Quadrivalent meningococcal vaccination of adults: phase III comparison of an investigational conjugate vaccine, MenACWY-CRM, with the licensed vaccine, Menactra. Clin Vaccine Immunol. 2009 Dec;16(12):1810-5. doi: 10.1128/CVI.00207-09. Epub 2009 Oct 7.
PubMed 19812260

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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Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
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All Meningococcal Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multi-center Study to Evaluate Lot to Lot Consistency, Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In US Adolescents and Adults and Compare to the Safety and Immune Response to a Licensed Conjugate Meningococcal ACWY Vaccine
ClinicalTrials.gov ID: NCT00450437
Acronym / sponsor ID: V59P13
Conditions: Meningococcal Infections, Meningococcal Meningitis
Keywords: Meningococcal, meningitis, vaccine, adolescents, adults
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,539 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: Aug 2007 (actual)
Study completion: Jan 2008 (actual)
First posted: 22 Mar 2007 (estimated)
Results: Posted 24 Sep 2010

Clinical summary

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

This study will evaluate the lot to lot consistency, safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine in healthy US adolescents and adults.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Licensed Meningococcal Vaccine	Active comparator	Biological: Meningococcal ACWY Conjugate vaccineLicensed meningococcal ACWY polysaccharide-protein conjugate vaccine
Novartis MenACWY Conjugate Vaccine	Experimental	Biological: MenACWY CRMNovartis meningococcal ACWY conjugate Vaccine

Who may qualify

Ages: 11 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (1 listed)

Healthy subjects who are 11-55 years of age inclusive and who have given appropriate written assent and/or consent

Key exclusion criteria (5 listed)

Subjects with a previous or suspected disease caused by N. meningitidis
previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
previous or suspected disease caused by N. meningitidis
Any serious acute, chronic or progressive disease
Pregnant or breastfeeding

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
MenACWY CRMOne dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.	Biological	Novartis MenACWY Conjugate Vaccine
Meningococcal ACWY Conjugate vaccineOne dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.	Biological	Licensed Meningococcal Vaccine

Primary outcome

Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years
Time frame: 28 days after vaccination
The consistency of immune response for the three lots of Meningococcal ACWY (MenACWY), as measured by human serum bactericidal activity (hSBA) geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 11 to 18 years of age)
Percentage of Seroresponders, Ages 11 to 18 Years
Time frame: 28 days after vaccination
Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroresponse directed against N meningitidis serogroups A, C, W, and Y (healthy adolescents 11 to 18 years of age). Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years
Time frame: 6 days after vaccination
Safety of Novartis Meningococcal ACWY and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of participants presenting at least one severe systemic reaction during the first 7 days (Days 1-7) following a single vaccination. Note: severe adverse events: unable to perform normal daily activity
Percentage of Seroresponders, Ages 19 to 55 Years
Time frame: 28 days after vaccination
Immunogenicity of a single injection of Meningococcal ACWY (3 lots pooled) to that of a licensed meningococcal ACWY conjugate vaccine, defined as the percentage of subjects with seroreponse directed against N. meningitidis serogroups A, C, W, and Y (healthy subjects 19 to 55 years of Age). Seroresponse to MenACWY: For a subject with hSBA titer <1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer ≥ 1:8; for a subject with hSBA titer ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.

4 secondary outcomes

Lot to Lot Consistency for the Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and ≥ 1:4, Ages 11 to 18 Years
Time frame: 28 days after vaccination
Percentage of Subjects With Seroresponse, Human Serum Bactericidal Activity (hSBA) Titer ≥ 1:8, and hSBA Titer ≥ 1:4, Ages 11 to 55 Years
Time frame: 28 days after vaccination
Human Serum Bactericidal Activity (hSBA) Geometric Mean Titers, Ages 11 to 55 Years
Time frame: 28 days after vaccination
Number of Subjects With Local and Systemic Reactions, Ages 11 to 55 Years
Time frame: Days 1 to 7

Results and safety

Results posted to the registry on 24 Sep 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Novartis MenACWY Vaccine (11 to 18 Years)	1,640	1,594
Licensed Meningococcal Vaccine (11 to 18 Years)	540	524
Novartis MenACWY Vaccine (19 to 55 Years)	1,023	999
Licensed Meningococcal Vaccine (19 to 55 Years)	336	325

Primary outcome: Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years

Time frame: 28 days after vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Novartis MenACWY Lot 1 n = 359	Novartis MenACWY Lot 2 n = 357	Novartis MenACWY Lot 3 n = 359
Serogroup A	29 (23 to 38)	33 (25 to 42)	31 (24 to 40)
Serogroup C (N=499, 493, 491)	77 (58 to 102)	58 (43 to 77)	64 (48 to 86)
Serogroup W (N=340, 341, 343)	87 (70 to 108)	111 (89 to 138)	82 (66 to 102)
Serogroup Y (N=345, 345, 346)	48 (37 to 62)	61 (47 to 79)	53 (41 to 69)

Novartis MenACWY Lot 1 vs Novartis MenACWY Lot 2: hSBA GMT ratios: 0.89 (95% CI 0.68 to 1.16), ANOVA
Novartis MenACWY Lot 1 vs Novartis MenACWY Lot 3: hSBA GMT ratios: 0.95 (95% CI 0.73 to 1.23), ANOVA
Novartis MenACWY Lot 2 vs Novartis MenACWY Lot 3: hSBA GMT ratios: 1.06 (95% CI 0.81 to 1.38), ANOVA

Population analysed: The analysis was performed on the Per Protocol (PP) Population

Primary outcome: Percentage of Seroresponders, Ages 11 to 18 Years

Time frame: 28 days after vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Novartis MenACWY Vaccine n = 1075	Licensed Meninogcoccal Vaccine n = 359
Serogroup A	75 (72 to 77)	66 (61 to 71)
Serogroup C (N= 1483, 501)	75 (73 to 77)	73 (69 to 77)
Serogroup W (N= 1024, 288)	75 (72 to 77)	63 (57 to 68)
Serogroup Y (N= 1036, 294)	68 (65 to 71)	41 (35 to 47)

Novartis MenACWY Vaccine vs Licensed Meninogcoccal Vaccine: Vaccine group difference: 8 (95% CI 3 to 14), ANOVA
Novartis MenACWY Vaccine vs Licensed Meninogcoccal Vaccine: Vaccine group difference: 2 (95% CI -2 to 7), ANOVA
Novartis MenACWY Vaccine vs Licensed Meninogcoccal Vaccine: Vaccine group difference: 12 (95% CI 6 to 18), ANOVA

Population analysed: The analysis set was the per protocol (PP) population.

Primary outcome: Number of Participants With at Least One Severe Systemic Reaction, Ages 11 to 55 Years

Time frame: 6 days after vaccination. Number. Unit: Participants

Measure	Novartis MenACWY Vaccine n = 2649	Licensed Meningococcal Vaccine n = 875
Value	94	24

Novartis MenACWY Vaccine vs Licensed Meningococcal Vaccine: Vaccine group difference: 1 (95% CI -1 to 2), ANOVA

Population analysed: The analysis was performed on the safety set.

Primary outcome: Percentage of Seroresponders, Ages 19 to 55 Years

Time frame: 28 days after vaccination. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Novartis MenACWY Vaccine n = 963	Licensed Meningococcal Vaccine n = 321
Serogroup A	67 (64 to 70)	68 (63 to 73)
Serogroup C (N=961, 318)	67 (64 to 70)	58 (53 to 64)
Serogroup W (N= 484, 292)	50 (46 to 55)	41 (35 to 47)
Serogroup Y (N= 503, 306)	56 (51 to 60)	40 (34 to 46)

Novartis MenACWY Vaccine vs Licensed Meningococcal Vaccine: Vaccine group difference: -1 (95% CI -7 to 5), ANOVA
Novartis MenACWY Vaccine vs Licensed Meningococcal Vaccine: Vaccine group difference: 9 (95% CI 3 to 15), ANOVA
Novartis MenACWY Vaccine vs Licensed Meningococcal Vaccine: Vaccine group difference: 9 (95% CI 2 to 17), ANOVA

Population analysed: The analysis set was the per protocol (PP) population.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events were collected from study day 1 to 180.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Novartis MenACWY Vaccine	23 of 2,649 (0.9%)	1,613 of 2,649 (60.9%)	Not reported
Licensed Meningococcal Vaccine	5 of 875 (0.6%)	572 of 875 (65.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19476428Jackson LA, Baxter R, Reisinger K, Karsten A, Shah J, Bedell L, Dull PM; V59P13 Study Group. Phase III comparison of an investigational quadrivalent meningococcal conjugate vaccine with the licensed meningococcal ACWY conjugate vaccine in adolescents. Clin Infect Dis. 2009 Jul 1;49(1):e1-10. doi: 10.1086/599117.
Results publication: PubMed 19812260Reisinger KS, Baxter R, Block SL, Shah J, Bedell L, Dull PM. Quadrivalent meningococcal vaccination of adults: phase III comparison of an investigational conjugate vaccine, MenACWY-CRM, with the licensed vaccine, Menactra. Clin Vaccine Immunol. 2009 Dec;16(12):1810-5. doi: 10.1128/CVI.00207-09. Epub 2009 Oct 7.

Related trials for Meningococcal Infections

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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 and Diagnostics study director

Novartis

40 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 1 inclusion and 5 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 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 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 24 Sep 2010). 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?

Lot to Lot Consistency of MenACWY as Measured by hSBA GMT Vaccine Group Ratios, Ages 11 to 18 Years (time frame: 28 days after vaccination). The study lists 4 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 NCT00450437, which also lists 2 linked publications.

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 Jan 2015.