Meningococcal MeningitisPhase 3NCT00474487

A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Healthy Adults

A Phase 3 study testing Meningococcal ACWY Polysaccharide Vaccine, MenACWY CRM (19 to 55 years) and Meningococcal ACWY Conjugate Vaccine in people with Meningococcal Meningitis and Meningococcal Infections, run by Novartis Vaccines at 2 sites in 2 countries.

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 safety and immune response of Novartis Meningococcal ACWY conjugate vaccine in healthy adolescents and adults. Read more about this study

Who is it for?: Ages 19 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Meningococcal Meningitis, Meningococcal Infections
What is being tested?: Meningococcal ACWY Polysaccharide Vaccine, MenACWY CRM (19 to 55 years) 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: 2,831 participants
Where: 2 sitesin 2 countries
Study dates: May 2007to Feb 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 19 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

individuals who are 19-65 years of age inclusive and who, after the nature of the study has been explained have provided written informed consent
individuals who are available for all visits and telephone calls scheduled for the study;
individuals who are in good health

Who cannot join

individuals with a previous or suspected disease caused by N. meningitidis
individuals with previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
individuals with previous or suspected disease caused by N. meningitidis
individuals with any serious acute, chronic or progressive disease
individuals who are pregnant or breastfeeding

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Argentina1 site

Buenos Aires, Argentina
Buenos Aires, C1406DGI

Other trials in Argentina

Colombia1 site

Cali, Colombia; Bogota, Colombia
Cali; Bogota

Other trials in Colombia

About this study

Official title: A Phase 3, Multi-center Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adults and Compare to the Safety and Immune Response of a Licensed Conjugate Meningococcal ACWY Vaccine in Subjects Aged 19-55 Years of Age and to a Licensed Polysaccharide Vaccine in Subjects Aged 56-65 Years of Age.

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

Conditions: Meningococcal Meningitis, Meningococcal Infections
Being tested: Meningococcal ACWY Polysaccharide Vaccine, MenACWY CRM (19 to 55 years), Meningococcal ACWY Conjugate Vaccine, Novartis MenACWY Vaccine (56 to 65 Years)
Keywords: Meningococcal, meningitis, vaccine, adolescents, adults
Medical subject headings: Meningitis, Meningococcal, Meningococcal Infections, Meningitis

What participants receive

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

Meningococcal ACWY Polysaccharide VaccineBiological
One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered by subcutaneous injection.
MenACWY CRM (19 to 55 years)Biological
One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection to subjects 19 years to 55 years of age.
Meningococcal ACWY Conjugate VaccineBiological
One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered by intramuscular injection.
Novartis MenACWY Vaccine (56 to 65 Years)Biological
One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection administered to subjects 56 years to 65 years of age.

Study groups in NCT00474487
Study group	Role	What they receive
Novartis MenACWY Vaccine (19 to 55 Years)	Experimental	Novartis meningococcal ACWY conjugate vaccine administered to subjects 19 years to 55 years Receives: Biological: MenACWY CRM (19 to 55 years)
Licensed polysaccharide vaccine	Active comparator	Licensed meningococcal ACWY polysaccharide vaccine Receives: Biological: Meningococcal ACWY Polysaccharide Vaccine
Licensed Conjugate Vaccine	Active comparator	Licensed meningococcal ACWY polysaccharide-protein conjugate vaccine Receives: Biological: Meningococcal ACWY Conjugate Vaccine
Novartis MenACWY Vaccine (56 to 65 Years)	Experimental	Novartis meningococcal ACWY conjugate vaccine administered to subjects 56 years to 65 years Receives: Biological: Novartis MenACWY Vaccine (56 to 65 Years)

What is being measured

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

Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years
Safety of the Novartis MenACWY conjugate vaccine and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of subjects presenting at least one severe systemic reaction during the first 7 days following a single vaccination in healthy subjects.
Measured: Days 1 to 7

Secondary outcomes (6)

Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population
Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 19 to 55 years).
Seroresponse: 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: 1 month postvaccination
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population
Immunogenicity of the MenACWY vaccine and of a licensed meningococcal ACWY conjugate vaccine, defined as percentage of subjects with seroresponse, human Serum Bactericidal Activity (hSBA) ≥ 1:8 directed against N meningitidis serogroups A, C, W, and Y (healthy subjects aged 56 to 65 years).
Seroresponse: 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: 1 month postvaccination
Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population
Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 19 to 55 years of age.
Measured: 1 month postvaccination
Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population
Immunogenicity of a single dose of MenACWY and of a single dose of the licensed meningococcal ACWY conjugate vaccine, as measured by serum bactericidal activity geometric mean titer (GMT) response using human complement (hSBA GMTs) directed against N meningitidis serogroups A, C, W-135, and Y at 1 month after vaccination, when administered to healthy subjects 56 to 65 years of age.
Measured: 1 month postvaccination
Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years
Safety profile following a single vaccination of MenACWY CRM vaccine and of a single vaccination of a licensed meningococcal ACWY conjugate vaccine administered to healthy subjects (ages 19 to 55 years).
Measured: Days 1 to 7
Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years
Safety profile following a single vaccination of MenACWY vaccine and of a single vaccination of a licensed meninococcal ACWY polysaccharide vaccine administered to healthy subjects (ages 56 to 65 years).
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.

May 2007Feb 2008

First posted17 May 2007 (estimated)
Study startMay 2007
Primary completionAug 2007
Study completionFeb 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 (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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 2,831 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00474487
Sponsor's protocol ID: V59P17
Status last verified: Apr 2014
First submitted: 16 May 2007
Last updated: 21 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Stamboulian D, Lopardo G, Lopez P, Cortes-Barbosa C, Valencia A, Bedell L, Karsten A, Dull PM. Safety and immunogenicity of an investigational quadrivalent meningococcal CRM(197) conjugate vaccine, MenACWY-CRM, compared with licensed vaccines in adults in Latin America. Int J Infect Dis. 2010 Oct;14(10):e868-75. doi: 10.1016/j.ijid.2010.03.017. Epub 2010 Jul 22.
PubMed 20655261

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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All Meningococcal Meningitis trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multi-center Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adults and Compare to the Safety and Immune Response of a Licensed Conjugate Meningococcal ACWY Vaccine in Subjects Aged 19-55 Years of Age and to a Licensed Polysaccharide Vaccine in Subjects Aged 56-65 Years of Age.
ClinicalTrials.gov ID: NCT00474487
Acronym / sponsor ID: V59P17
Conditions: Meningococcal Meningitis, Meningococcal Infections
Keywords: Meningococcal, meningitis, vaccine, adolescents, adults
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,831 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: May 2007
Primary completion: Aug 2007 (actual)
Study completion: Feb 2008 (actual)
First posted: 17 May 2007 (estimated)
Results: Posted 4 Aug 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 safety and immune response of Novartis Meningococcal ACWY conjugate vaccine in healthy adolescents and adults.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Novartis MenACWY Vaccine (19 to 55 Years)	Experimental	Biological: MenACWY CRM (19 to 55 years)Novartis meningococcal ACWY conjugate vaccine administered to subjects 19 years to 55 years
Licensed polysaccharide vaccine	Active comparator	Biological: Meningococcal ACWY Polysaccharide VaccineLicensed meningococcal ACWY polysaccharide vaccine
Licensed Conjugate Vaccine	Active comparator	Biological: Meningococcal ACWY Conjugate VaccineLicensed meningococcal ACWY polysaccharide-protein conjugate vaccine
Novartis MenACWY Vaccine (56 to 65 Years)	Experimental	Biological: Novartis MenACWY Vaccine (56 to 65 Years)Novartis meningococcal ACWY conjugate vaccine administered to subjects 56 years to 65 years

Who may qualify

Ages: 19 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

individuals who are 19-65 years of age inclusive and who, after the nature of the study has been explained have provided written informed consent
individuals who are available for all visits and telephone calls scheduled for the study;
individuals who are in good health

Key exclusion criteria (5 listed)

individuals with a previous or suspected disease caused by N. meningitidis
individuals with previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
individuals with previous or suspected disease caused by N. meningitidis
individuals with any serious acute, chronic or progressive disease
individuals who are 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
Meningococcal ACWY Polysaccharide VaccineOne dose of the licensed meningococcal ACWY polysaccharide vaccine was administered by subcutaneous injection.	Biological	Licensed polysaccharide vaccine
MenACWY CRM (19 to 55 years)One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection to subjects 19 years to 55 years of age.	Biological	Novartis MenACWY Vaccine (19 to 55 Years)
Meningococcal ACWY Conjugate VaccineOne dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered by intramuscular injection.	Biological	Licensed Conjugate Vaccine
Novartis MenACWY Vaccine (56 to 65 Years)One dose of the Novartis meningococcal ACWY conjugate vaccine was administered by intramuscular injection administered to subjects 56 years to 65 years of age.	Biological	Novartis MenACWY Vaccine (56 to 65 Years)

Primary outcome

Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years
Time frame: Days 1 to 7
Safety of the Novartis MenACWY conjugate vaccine and of a licensed meningococcal ACWY conjugate vaccine as measured by the number of subjects presenting at least one severe systemic reaction during the first 7 days following a single vaccination in healthy subjects.

6 secondary outcomes

Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 19 to 55 Years), PP Population
Time frame: 1 month postvaccination
Percentage of Subjects With Seroresponse and hSBA ≥ 1:8 (Ages 56 to 65 Years), PP Population
Time frame: 1 month postvaccination
Summary of hSBA GMTs (Ages 19 to 55 Years), PP Population
Time frame: 1 month postvaccination
Summary of hSBA GMTs (Ages 56 to 65 Years), PP Population
Time frame: 1 month postvaccination
Number of Subjects With Local and Systemic Reactions, Ages 19 to 55 Years
Time frame: Days 1 to 7
Number of Subjects With Local and Systemic Reactions, Ages 56 to 65 Years
Time frame: Days 1 to 7

Results and safety

Results posted to the registry on 4 Aug 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 (19 to 55 Years)	1,606	1,576
Novartis MenACWY Vaccine (56 to 65 Years)	217	215
Licensed Conjugate Vaccine (19 to 55 Years)	899	885
Licensed Polysaccharide Vaccine (56 to 65 Years)	109	109

Primary outcome: Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years

Time frame: Days 1 to 7. Number. Unit: Subjects

Measure	Novartis MenACWY Vaccine n = 1588	Licensed Conjugate Vaccine n = 882
Value	95	46

Population analysed: The analysis was performed on the safety set. The number of subjects in the safety set is less than the randomized set due to premature withdrawals.

6 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 (19 to 55 Years)	11 of 1,588 (0.7%)	955 of 1,588 (60.1%)	Not reported
Novartis MenACWY Vaccine (56 to 65 Years)	1 of 216 (0.5%)	124 of 216 (57.4%)	Not reported
Licensed Conjugate Vaccine (19 to 55 Years)	8 of 882 (0.9%)	561 of 882 (63.6%)	Not reported
Licensed Polysaccharide Vaccine (56 to 65 Years)	1 of 109 (0.9%)	62 of 109 (56.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20655261Stamboulian D, Lopardo G, Lopez P, Cortes-Barbosa C, Valencia A, Bedell L, Karsten A, Dull PM. Safety and immunogenicity of an investigational quadrivalent meningococcal CRM(197) conjugate vaccine, MenACWY-CRM, compared with licensed vaccines in adults in Latin America. Int J Infect Dis. 2010 Oct;14(10):e868-75. doi: 10.1016/j.ijid.2010.03.017. Epub 2010 Jul 22.

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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

2 sites in 2 countries: 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 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 21 Apr 2014. 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 Argentina, Colombia. 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 4 Aug 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?

Number of Subjects With at Least One Severe Systemic Reaction, Ages 19 to 55 Years (time frame: Days 1 to 7). 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 NCT00474487, 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 21 Apr 2014.