Bacterial MeningitisPhase 3NCT01410474

Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 18 Years in Taiwan

A Phase 3 study testing Meningococcal ACWY conjugate vaccine in people with Bacterial Meningitis, run by Novartis at 3 sites in China.

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 immunogenicity and safety of a single injection of Novartis Meningococcal ACWY conjugate vaccine in healthy subjects from 2 to 18 years in Taiwan. Read more about this study

Who is it for?: Ages 2 to 18 yearsHealthy volunteers can take part
Conditions the study is for: Bacterial Meningitis
What is being tested?: Meningococcal ACWY conjugate vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 341 participants
Where: 3 sitesChina
Study dates: Aug 2011to Jan 2012
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 2 to 18 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Healthy subjects from 2 up to and including 18 years of age
Who are in good health as determined by : medical history, physical exam,clinical judgment of the investigator, who have a negative urine pregnancy test for female subjects ≥11 years of age

Who cannot join

Individuals not eligible to be enrolled in the study were those:
Who had a previous confirmed 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 enrolment.
Who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational).
Who have received any vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 30 days from the study vaccines.
Who have experienced within the 7 days prior to enrolment significant acute infection or have experienced fever within 3 days prior to enrolment.

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Who have any serious acute, chronic or progressive who have epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
Who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components.
Who have a known or suspected impairment/alteration of immune function, either congenital or acquired
Who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Who have Down's syndrome or other known cytogenic disorders.

Trial locations and contacts

3 sites in 1 country.

China3 sites

Mackay Memorial Hospital,
Taipei, Taiwan, 10002
National Taiwan University Hospital
Taipei, Taiwan, 10002
Far Eastern Memorial Hospital,
Taipei, Taiwan, 22060

Other trials in China

About this study

Official title: A Phase 3, Multicenter, Open-label Study to Evaluate Immunogenicity and Safety of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) in Healthy Subjects From 2 to 18 Years in Taiwan

This study will evaluate the immunogenicity and safety of a single injection of Novartis Meningococcal ACWY conjugate vaccine in healthy subjects from 2 to 18 years in Taiwan.

Conditions: Bacterial Meningitis
Being tested: Meningococcal ACWY conjugate vaccine
Keywords: Meningococcal, ACWY, bacterial meningitis, conjugate vaccine, healthy, children, adolescents, Taiwan
Medical subject headings: Meningitis, Bacterial

What participants receive

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

Meningococcal ACWY conjugate vaccineBiological
All subjects received a single dose of Meningococcal ACWY conjugate vaccine and had blood draw at day 1 and day 29.

Study groups in NCT01410474
Study group	Role	What they receive
2-18 years	Experimental	Not described Receives: Biological: Meningococcal ACWY conjugate vaccine

What is being measured

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

Percentage of Overall 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 seroresponse and associated 95% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at 28 days after one vaccination of MenACWY-CRM (day 29).
Seroresponse is defined as:
1. for subjects with a prevaccination hSBA titer <1:4, a postvaccination hSBA titer ≥1:8.
2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
Measured: Day 1 and Day 29

Secondary outcomes (6)

Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group
Immunogenicity was measured as the percentage of subjects with hSBA response and associated 95% CI, directed against N. meningitidis serogroups A, C, W and Y, at Day 29, by age groups.
Seroresponse is defined as:
1. for subjects with a prevaccination hSBA titer <1:4, a postvaccination hSBA titer ≥1:8.
2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
Measured: Day 1 and Day 29
Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, before the vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall.
Measured: Day 1 and 29
Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
Immunogenicity was measured as ratio of postvaccination GMTs to prevaccination GMTs and associated 95% CI, against N. meningitidis serogroups A, C, W and Y, at 28 days after MenACWY-CRM vaccination (Day 29), by age group and overall.
Measured: Day 1 and Day 29
Percentage 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, before vaccination (Day 1) and 28 days after MenACWY-CRM vaccination (Day 29), bye age group and overall.
Measured: Day 1 and 29
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years
Safety was assessed as the number of subjects aged 2 to 5 years who reported solicited local and systemic adverse events (AEs) within days 1 through 7 after MenACWY-CRM vaccination.
Measured: From day 1 through day 7 postvaccination
Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years
Safety was assessed as the number of subjects aged 6 to 18 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination.
Measured: From day 1 through day 7 postvaccination

Timeline

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

Aug 2011Jan 2012

First posted5 Aug 2011 (estimated)
Study startAug 2011
Primary completionJan 2012
Study completionJan 2012

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 Bacterial 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: Single group
Masking: None (open label)
Enrolment: 341 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01410474
Sponsor's protocol ID: V59_49
Status last verified: Sep 2014
First submitted: 3 Aug 2011
Last updated: 22 Sep 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Huang LM, Chiu NC, Yeh SJ, Bhusal C, Arora AK. Immunogenicity and safety of a single dose of a CRM-conjugated meningococcal ACWY vaccine in children and adolescents aged 2-18 years in Taiwan: results of an open label study. Vaccine. 2014 Sep 8;32(40):5177-84. doi: 10.1016/j.vaccine.2014.07.063. Epub 2014 Jul 27.
PubMed 25075804

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 Bacterial Meningitis trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Multicenter, Open-label Study to Evaluate Immunogenicity and Safety of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) in Healthy Subjects From 2 to 18 Years in Taiwan
ClinicalTrials.gov ID: NCT01410474
Acronym / sponsor ID: V59_49
Conditions: Bacterial Meningitis
Keywords: Meningococcal, ACWY, bacterial meningitis, conjugate vaccine, healthy, children, adolescents, Taiwan
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 341 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Collaborators: Novartis Vaccines
Study start: Aug 2011
Primary completion: Jan 2012 (actual)
Study completion: Jan 2012 (actual)
First posted: 5 Aug 2011 (estimated)
Results: Posted 22 Sep 2014

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 immunogenicity and safety of a single injection of Novartis Meningococcal ACWY conjugate vaccine in healthy subjects from 2 to 18 years in Taiwan.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
2-18 years	Experimental	Biological: Meningococcal ACWY conjugate vaccine

Who may qualify

Ages: 2 to 18 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (2 listed)

Healthy subjects from 2 up to and including 18 years of age
Who are in good health as determined by : medical history, physical exam,clinical judgment of the investigator, who have a negative urine pregnancy test for female subjects ≥11 years of age

Key exclusion criteria (11 listed)

Who had a previous confirmed 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 enrolment.
Who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational).
Who have received any vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 30 days from the study vaccines.
Who have experienced within the 7 days prior to enrolment significant acute infection or have experienced fever within 3 days prior to enrolment.

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 conjugate vaccineAll subjects received a single dose of Meningococcal ACWY conjugate vaccine and had blood draw at day 1 and day 29.	Biological	2-18 years

Primary outcome

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

6 secondary outcomes

Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group
Time frame: Day 1 and Day 29
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 29
Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination
Time frame: Day 1 and Day 29
Percentage 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 29
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years
Time frame: From day 1 through day 7 postvaccination
Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years
Time frame: From day 1 through day 7 postvaccination

Results and safety

Results posted to the registry on 22 Sep 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
2-10 Years	173	173
11-18 Years	168	167

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

Time frame: Day 1 and Day 29. Number (95% Confidence Interval). Unit: Percentages of Subjects

Measure	Overall (2 to 18 Years) n = 336
MenA (N=335)	83 (79 to 87)
MenC (N=333)	93 (90 to 96)
MenW (N=334)	50 (45 to 55)
MenY (N=333)	65 (60 to 70)

Population analysed: Analysis was done on modified intention-to-treat (MITT) population i.e subjects in the exposed population who provided evaluable serum samples whose assay results were available for at least one serogroup on day 1 and/or day 29.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the study period (from day 1 through day 29). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2-10 Years	1 of 173 (0.6%)	110 of 173 (63.6%)	Not reported
11-18 Years	0 of 167 (0%)	98 of 167 (58.7%)	Not reported
Overall (2 to 18 Years)	1 of 340 (0.3%)	208 of 340 (61.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25075804Huang LM, Chiu NC, Yeh SJ, Bhusal C, Arora AK. Immunogenicity and safety of a single dose of a CRM-conjugated meningococcal ACWY vaccine in children and adolescents aged 2-18 years in Taiwan: results of an open label study. Vaccine. 2014 Sep 8;32(40):5177-84. doi: 10.1016/j.vaccine.2014.07.063. Epub 2014 Jul 27.

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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.

Li Min Huang, Dr. principal investigator

Dr. Li Min Huang, National Taiwan University Hospital

Nan Chang Chiu, Dr. principal investigator

Mackay Memorial Hospital

Shu Jen Yeh, Dr. principal investigator

Far Eastern Memorial Hospital

3 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 Meningococcal ACWY conjugate vaccine in people with Bacterial Meningitis, run by Novartis at 3 sites in China.

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 2 inclusion and 11 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 22 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. 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 22 Sep 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?

Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination (time frame: Day 1 and 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 NCT01410474, 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 22 Sep 2014.