Meningococcal DiseasePhase 3NCT01274897

A Multi-center, Observer-blind, Placebo-controlled, Randomized Study to Evaluate the Immunogenicity and Safety of MenACWY in Adolescents and Adults in Korea

A Phase 3 study testing Novartis MenACWY-CRM in people with Meningococcal Disease and Meningococcal Meningitis, run by Novartis Vaccines at 8 sites in South Korea.

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 is designed to evaluate the immunogenicity and the safety of a quadrivalent vaccine MenACWY-CRM in healthy subjects from 11 to 55 years of age in Korea. Read more about this study

Who is it for?: Ages 11 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Meningococcal Disease, Meningococcal Meningitis
What is being tested?: Novartis MenACWY-CRM
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 450 participants
Where: 8 sitesSouth Korea
Study dates: Dec 2010to Mar 2011
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
Healthy volunteers accepted
Child, Adult

Who may be able to join

Individuals eligible for enrollment in this study were those:
who were 11-55 years of age inclusive and who, after the nature of the study had been explained:
had given written assent and/or for whom the parent/legal representative had provided written informed consent (11-19 years of age).
had provided written informed consent (20-55 years of age).
who the investigator believed that they or their parents/legal representatives would comply with the requirements of the protocol (e.g., completion of the Diary Card, return for follow-up visit).
who were in good health as determined by

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medical history
physical assessment
clinical judgment of the investigator
who had negative urine pregnancy test for women of childbearing age.

Who cannot join

Individuals not eligible to be enrolled in the study were those:
who were unwilling or unable to give written informed assent or consent to participate in the study.
who were perceived to be unreliable or unavailable for the duration of the study period.
who were planning to leave the area of the study site before the end of the study period.
who had a previous or suspected disease caused by N. meningitidis.
who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment.

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who had previously been immunized with a meningococcal vaccine.
who had received any investigational or non-registered product (drug or vaccine)within 28 days prior to enrollment or who expected to receive an investigational drug or vaccine prior to the completion of the study.
who had received any licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who were planning to receive any vaccine within 30 days from the study vaccines. (Exception: Influenza vaccine was administered up to 15 days prior to study vaccination and at least 15 days after study vaccination)
who had experienced within the 7 days prior to enrollment significant acute or chronic infection (for example requiring systemic antibiotic treatment or antiviral therapy) or had experienced fever (defined as body temperature ≥38°C) within 3 days prior to enrollment.
who had any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, HIV infection or AIDS, or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition).
who had epilepsy or any progressive neurological disease.
who had a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components, including latex allergies.
who had a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
received immunosuppressive therapy within 28 days prior to enrollment(any systemic corticosteroid administered for more than 5 days, or in a daily dose > 1 mg/kg/day prednisone or equivalent during any of 28 days prior to enrollment, or cancer chemotherapy)
received immunostimulants
received parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study
who were known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
who had any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

South Korea8 sites

Department of Pediatrics, Kosin University Gospel Hospital
Busan
Department of Pediatrics, Seoul National University Bundang Hospital
Gyeonggi-do
Deaprtment of Pediatrics, Inha University Hospital
Incheon
Division of Infectious Diseases, Inha University Hospital
Incheon
Pediatrics and Adolescent medicine, Myongji Hospital Kwandong University
Kyunggi
Department of Pediatrics, Ewha Womans University Mokdong Hospital
Seoul
Division of Infection Diseases, Seoul National University Hospital
Seoul
Division of Infectious Diseases, Korea University Guro Hospital
Seoul

Other trials in South Korea

About this study

Official title: A Phase 3, Multi-center, Observer-blind, Placebo-controlled, Randomized Study to Evaluate the Immunogenicity and Safety of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 11 to 55 Years of Age in Korea

This study is designed to evaluate the immunogenicity and the safety of a quadrivalent vaccine MenACWY-CRM in healthy subjects from 11 to 55 years of age in Korea.

Conditions: Meningococcal Disease, Meningococcal Meningitis
Being tested: Novartis MenACWY-CRM, Saline Placebo
Keywords: Meningococcal, ACWY-CRM, Conjugate Vaccine, Meningitis, Adolescents, Persistence, 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.

Novartis MenACWY-CRMBiological
All subjects had blood drawn at Day 1 and Day 29.
Saline PlaceboBiological
All subjects had blood drawn at Day 1 and Day 29.

Study groups in NCT01274897
Study group	Role	What they receive
MenACWY-CRM	Experimental	Subjects received one dose of MenACWY-CRM conjugate vaccine. Receives: Biological: Novartis MenACWY-CRM
Placebo	Placebo comparator	Subjects received the saline placebo. Receives: Biological: Saline Placebo

What is being measured

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

Percentages of Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.
Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y by serum bactericidal assay using human complement, human serum bactericidal assay (hSBA), at day 29 (28 days after MenACWY-CRM vaccination).
Seroresponse is defined as:
1. for subjects with a pre-vaccination hSBA titer < 1:4, a postvaccination hSBA titer ≥ 1:8.
2. for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.
Measured: day 29

Secondary outcomes (3)

Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.
Immunogenicity was assessed as hSBA GMTs and associated 95% CI, measured against N. meningitidis serogroups A, C, W and Y, before the vaccination (baseline, day 1) and at day 29 (28 days after MenACWY-CRM vaccination).
Measured: day 1 and day 29
Percentages of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.
Immunogenicity was measured as the percentage of subjects with hSBA titer ≥1:8 and associated 95% CI, at baseline before vaccination (day 1) and at day 29 (28 days after MenACWY-CRM vaccination).
Measured: day 1 and day 29
Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination
Measured: during 7 days of vaccination

Timeline

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

Dec 2010Mar 2011

First posted12 Jan 2011 (estimated)
Study startDec 2010
Primary completionMar 2011
Study completionMar 2011

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.
Other trials for Meningococcal DiseaseStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 450 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01274897
Sponsor's protocol ID: V59_39
Status last verified: Sep 2012
First submitted: 9 Jan 2011
Last updated: 16 Oct 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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
Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
RecruitingObservational study
A Study to Learn About the Safety of PENBRAYA During Pregnancy
Meningococcal Disease
Active, not recruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 2-6 Years
Epidemic Meningitis, Meningococcal Vaccines

All Meningococcal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multi-center, Observer-blind, Placebo-controlled, Randomized Study to Evaluate the Immunogenicity and Safety of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 11 to 55 Years of Age in Korea
ClinicalTrials.gov ID: NCT01274897
Acronym / sponsor ID: V59_39
Conditions: Meningococcal Disease, Meningococcal Meningitis
Keywords: Meningococcal, ACWY-CRM, Conjugate Vaccine, Meningitis, Adolescents, Persistence, Adults
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 450 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Dec 2010
Primary completion: Mar 2011 (actual)
Study completion: Mar 2011 (actual)
First posted: 12 Jan 2011 (estimated)
Results: Posted 16 Oct 2012

Clinical summary

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

This study is designed to evaluate the immunogenicity and the safety of a quadrivalent vaccine MenACWY-CRM in healthy subjects from 11 to 55 years of age in Korea.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
MenACWY-CRM	Experimental	Biological: Novartis MenACWY-CRMSubjects received one dose of MenACWY-CRM conjugate vaccine.
Placebo	Placebo comparator	Biological: Saline PlaceboSubjects received the saline placebo.

Who may qualify

Ages: 11 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (10 listed)

who were 11-55 years of age inclusive and who, after the nature of the study had been explained:
who the investigator believed that they or their parents/legal representatives would comply with the requirements of the protocol (e.g., completion of the Diary Card, return for follow-up visit).
who were in good health as determined by
who had negative urine pregnancy test for women of childbearing age.

Key exclusion criteria (19 listed)

who were unwilling or unable to give written informed assent or consent to participate in the study.
who were perceived to be unreliable or unavailable for the duration of the study period.
who were planning to leave the area of the study site before the end of the study period.
who had a previous or suspected disease caused by N. meningitidis.
who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment.

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
Novartis MenACWY-CRMAll subjects had blood drawn at Day 1 and Day 29.	Biological	MenACWY-CRM
Saline PlaceboAll subjects had blood drawn at Day 1 and Day 29.	Biological	Placebo

Primary outcome

Percentages of Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.
Time frame: day 29
Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y by serum bactericidal assay using human complement, human serum bactericidal assay (hSBA), at day 29 (28 days after MenACWY-CRM vaccination). Seroresponse is defined as: 1. for subjects with a pre-vaccination hSBA titer < 1:4, a postvaccination hSBA titer ≥ 1:8. 2. for subjects with a pre-vaccination hSBA titer ≥ 1:4, an increase in hSBA titer of at least four times the pre-vaccination titer.

3 secondary outcomes

Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.
Time frame: day 1 and day 29
Percentages of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.
Time frame: day 1 and day 29
Number of Subjects Who Reported Local and Systemic Reactogenicity During 7 Days After MenACWY-CRM Vaccination
Time frame: during 7 days of vaccination

Results and safety

Results posted to the registry on 16 Oct 2012, 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-CRM	297	297
Placebo	153	153

Primary outcome: Percentages of Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination.

Time frame: day 29. Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	MenACWY-CRM n = 296	Placebo n = 152
Serogroup A (N=295,152)	76 (71 to 81)	1 (0 to 5)
Serogroup C (N=293,150)	86 (82 to 90)	1 (0 to 5)
Serogroup W (N=293,151)	28 (23 to 33)	4 (1 to 8)
Serogroup Y (N=294,152)	69 (63 to 74)	2 (0 to 6)

MenACWY-CRM: Lower limit of the two-sided 95% CI: 71 (95% CI 71 to 81), Clopper and Pearson
MenACWY-CRM: Lower limit of the two-sided 95% CI: 82 (95% CI 82 to 90), Clopper and Pearson
MenACWY-CRM: Lower limit of the two-sided 95% CI: 23 (95% CI 23 to 33), Clopper and Pearson

Population analysed: Analysis was done on per protocol (PP) population i.e. the subjects who received the vaccine correctly and provided evaluable serum samples at the relevant time points.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the study period (29 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MenACWY-CRM	0 of 297 (0%)	117 of 297 (39.4%)	Not reported
Placebo	0 of 153 (0%)	50 of 153 (32.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Meningococcal Disease

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
Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
RecruitingObservational study
A Study to Learn About the Safety of PENBRAYA During Pregnancy
Meningococcal Disease
Active, not recruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 2-6 Years
Epidemic Meningitis, Meningococcal Vaccines

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 chair

Novartis Vaccines

8 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 Novartis MenACWY-CRM in people with Meningococcal Disease and Meningococcal Meningitis, run by Novartis Vaccines at 8 sites in South Korea.

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 10 inclusion and 19 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 16 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in South Korea. 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. Some participants in this study may receive a placebo. 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 16 Oct 2012). 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 Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination. (time frame: day 29). 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 NCT01274897.

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 16 Oct 2012.