Prevention of Meningococcal DiseasePhase 2NCT00262028

Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children

A Phase 2 study testing MenACWY-CRM Vaccine and MenACWY-PS Vaccine in people with Prevention of Meningococcal Disease, run by Novartis Vaccines at 1 site 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

The purpose of this study is to evaluate the safety and immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy children ages 1 - 10 years Read more about this study

Who is it for?: Ages 12 months to 10 years
Conditions the study is for: Prevention of Meningococcal Disease
What is being tested?: MenACWY-CRM Vaccine and MenACWY-PS Vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 910 participants
Where: 1 siteUnited States
Study dates: Apr 2005to Nov 2006
Phase: Phase 2
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 12 months to 10 years
All sexes
Child

Who may be able to join

Group 1: Healthy children 2-10 years of age;
Group 2: Healthy toddlers 12-23 months of age; who are up to date with age appropriate immunizations for diphtheria, tetanus, pertussis, polio, hepatitis B, Hemophilus influenzae type b, and pneumococcus.

Who cannot join

Group 1: Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease.
Group 2: Subjects with a previous or suspected disease caused by N. meningitidis or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease.

Trial locations and contacts

1 site in 1 country.

United States1 site

Kaiser Permanente Vaccine Study Center
Oakland, California, 94612

Other trials in United States

About this study

Official title: A Phase 2, Randomized, Single-blind, Controlled, Single-Center Study to Compare the Safety and Immunogenicity of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Children 2-10 Years of Age and an Open-label Study to Assess the Safety and Immunogenicity of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine Administered to Healthy Toddlers 12-23 Months of Age

The purpose of this study is to evaluate the safety and immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy children ages 1 - 10 years

Conditions: Prevention of Meningococcal Disease
Being tested: MenACWY-CRM Vaccine, MenACWY-PS Vaccine

What participants receive

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

MenACWY-CRM VaccineBiological
MenACWY-PS VaccineBiological

Study groups in NCT00262028
Study group	Role	What they receive
MenACWY-CRM (2-10 years)	Experimental	Subjects received one dose of investigational MenACWY-CRM conjugate vaccine Receives: Biological: MenACWY-CRM Vaccine
MenACWY-CRM (12-23 months)	Experimental	Subjects received one dose of investigational MenACWY-CRM conjugate vaccine Receives: Biological: MenACWY-CRM Vaccine
MenACWY-PS (2-10 years)	Active comparator	Subjects received one dose of licensed comparator MenACWY polysaccharide (MenACWY-PS) vaccine Receives: Biological: MenACWY-PS Vaccine
MenACWY-CRM+PnC (12-15 months)	Experimental	Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with PnC Receives: Biological: MenACWY-CRM Vaccine
MenACWY-CRM+DTaP (16-23 months)	Experimental	Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with DTaP Receives: Biological: MenACWY-CRM Vaccine

What is being measured

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

Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Number of subjects (2-10 years of age) achieving with hSBA titers ≥1:4 against Neisseria meningitidis serogroups A,C,W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
Measured: 1 month post vaccination (Day 29)

Secondary outcomes (11)

Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Percentages of subjects (2-5 years of age and 6-10 years of age) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
Measured: 1 month post vaccination (Day 29)
Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine
Percentage of subjects (12-23 months old) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y after receiving one dose of MenACWY-CRM vaccine compared with percentage of subjects (3-5 years old) with hSBA ≥ 1:4 after one dose of licensed MenACWY-PS vaccine.
Measured: 1 month post vaccination (Day 29)
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or the licensed MenACWY-PS vaccine.
Measured: 1 month post vaccination (Day 29)
hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-5 years of age and 6-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or licensed MenACWY-PS vaccine.
Measured: 1 month post vaccination (Day 29)
hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (12-23 months old), one month after receiving one dose of MenACWY-CRM vaccine compared with hSBA GMT in 3-5 year old subjects after receiving one dose of licensed MenACWY-PS vaccine.
Measured: 1 month post vaccination (Day 29)
Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Number of subjects (2-10 years, 2-5 years and 6-10 years old subjects) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, 12 months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
Measured: 12 months post vaccination (Day 360)
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years, 2-5 years and 6-10 years old), twelve months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.
Measured: 12 months post vaccination (Day 360)
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.
Measured: Day 1 to 7 post vaccination
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.
Measured: Day 1 to 7 post vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.
Measured: Day 1- Day 360 (throughout the study)
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.
Measured: Day 1- Day 360 (Throughout the study)

Timeline

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

Apr 2005Nov 2006

First posted6 Dec 2005 (estimated)
Study startApr 2005
Primary completionNov 2006
Study completionNov 2006

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 Prevention of 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Enrolment: 910 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00262028
Sponsor's protocol ID: V59P8
Status last verified: Jan 2016
First submitted: 2 Dec 2005
Last updated: 11 Feb 2016
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

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Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants
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Active, not recruitingPhase 3
Efficacy Study of 4CMenB (Bexsero®) to Prevent Gonorrhoea Infection in Gay and Bisexual Men
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All Prevention of Meningococcal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Single-blind, Controlled, Single-Center Study to Compare the Safety and Immunogenicity of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Children 2-10 Years of Age and an Open-label Study to Assess the Safety and Immunogenicity of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine Administered to Healthy Toddlers 12-23 Months of Age
ClinicalTrials.gov ID: NCT00262028
Acronym / sponsor ID: V59P8
Conditions: Prevention of Meningococcal Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 910 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Apr 2005
Primary completion: Nov 2006 (actual)
Study completion: Nov 2006 (actual)
First posted: 6 Dec 2005 (estimated)
Results: Posted 11 Feb 2016

Clinical summary

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

The purpose of this study is to evaluate the safety and immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy children ages 1 - 10 years

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Number of arms: 5

Arm	Type	Receives
MenACWY-CRM (2-10 years)	Experimental	Biological: MenACWY-CRM VaccineSubjects received one dose of investigational MenACWY-CRM conjugate vaccine
MenACWY-CRM (12-23 months)	Experimental	Biological: MenACWY-CRM VaccineSubjects received one dose of investigational MenACWY-CRM conjugate vaccine
MenACWY-PS (2-10 years)	Active comparator	Biological: MenACWY-PS VaccineSubjects received one dose of licensed comparator MenACWY polysaccharide (MenACWY-PS) vaccine
MenACWY-CRM+PnC (12-15 months)	Experimental	Biological: MenACWY-CRM VaccineSubjects received one dose of MenACWY-CRM vaccine alone or concomitantly with PnC
MenACWY-CRM+DTaP (16-23 months)	Experimental	Biological: MenACWY-CRM VaccineSubjects received one dose of MenACWY-CRM vaccine alone or concomitantly with DTaP

Who may qualify

Ages: 12 months to 10 years
Sex: All
Age groups: Child

Key inclusion criteria (2 listed)

Group 1: Healthy children 2-10 years of age;
Group 2: Healthy toddlers 12-23 months of age; who are up to date with age appropriate immunizations for diphtheria, tetanus, pertussis, polio, hepatitis B, Hemophilus influenzae type b, and pneumococcus.

Key exclusion criteria (2 listed)

Group 1: Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease.
Group 2: Subjects with a previous or suspected disease caused by N. meningitidis or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease.

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-CRM Vaccine	Biological	MenACWY-CRM (12-23 months), MenACWY-CRM (2-10 years), MenACWY-CRM+DTaP (16-23 months), MenACWY-CRM+PnC (12-15 months)
MenACWY-PS Vaccine	Biological	MenACWY-PS (2-10 years)

Primary outcome

Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Time frame: 1 month post vaccination (Day 29)
Number of subjects (2-10 years of age) achieving with hSBA titers ≥1:4 against Neisseria meningitidis serogroups A,C,W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.

11 secondary outcomes

Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine
Time frame: 1 month post vaccination (Day 29)
Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine
Time frame: 1 month post vaccination (Day 29)
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Time frame: 1 month post vaccination (Day 29)
hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Time frame: 1 month post vaccination (Day 29)
hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine
Time frame: 1 month post vaccination (Day 29)
Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Time frame: 12 months post vaccination (Day 360)
hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine
Time frame: 12 months post vaccination (Day 360)
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years
Time frame: Day 1 to 7 post vaccination
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Time frame: Day 1 to 7 post vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years
Time frame: Day 1- Day 360 (throughout the study)
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months
Time frame: Day 1- Day 360 (Throughout the study)

Results and safety

Results posted to the registry on 11 Feb 2016, 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 (2-5 Years Old)	152	128
MenACWY-PS (2-5 Years Old)	153	126
MenACWY (6-10 Years Old)	157	137
MenACWY-PS (6-10 Years Old)	157	134
MenACWY (12-15 Months Old)	74	62
MenACWY+PnC (12-15 Months)	73	60
MenACWY (16-23 Months)	71	59
MenACWY+DTaP (16-23 Months)	73	55
MenACWY-PS (3-5 Years Old)	100	81

Primary outcome: Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine

Time frame: 1 month post vaccination (Day 29). Number. Unit: Subjects

Measure	MenACWY-CRM (2-10 Years Old) n = 284	MenACWY-PS (2-10 Years) n = 285
Serogroup A (Day 1), N=280, 281	6	1
Serogroup A (Day 29), N=280, 281	228	125
Serogroup C (Day 1)	80	81
Serogroup C (Day 29)	232	181
Serogroup W (Day 1), N=279, 282	111	108
Serogroup W (Day 29), N=279, 282	263	202
Serogroup Y (Day 1), N=280, 282	61	68
Serogroup Y (Day 29), N=280, 282	254	167

MenACWY-CRM (2-10 Years Old) vs MenACWY-PS (2-10 Years): Vaccine group difference: 37 (95% CI 29 to 44)
MenACWY-CRM (2-10 Years Old) vs MenACWY-PS (2-10 Years): Vaccine group difference: 19 (95% CI 12 to 26)
MenACWY-CRM (2-10 Years Old) vs MenACWY-PS (2-10 Years): Vaccine group difference: 23 (95% CI 17 to 29)

Population analysed: Analysis was done on per protocol population i.e. all subjects who received one dose of vaccine and provided serum samples at the relevant time points (day 1, day 29 and day 360) and had no major protocol deviation.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MenACWY (2-5 Years Old)	2 of 151 (1.3%)	82 of 151 (54.3%)	Not reported
MenACWY-PS (2-5 Years Old)	1 of 153 (0.7%)	69 of 153 (45.1%)	Not reported
MenACWY (6-10 Years Old)	0 of 157 (0%)	81 of 157 (51.6%)	Not reported
MenACWY-PS (6-10 Years Old)	0 of 157 (0%)	64 of 157 (40.8%)	Not reported
MenACWY (12-15 Months Old)	2 of 74 (2.7%)	64 of 74 (86.5%)	Not reported
MenACWY-PnC (12-15 Months Old)	3 of 71 (4.2%)	61 of 71 (85.9%)	Not reported
MenACWY (16-23 Months Old)	3 of 71 (4.2%)	62 of 71 (87.3%)	Not reported
MenACWY+DTaP (16-23 Months Old)	2 of 73 (2.7%)	59 of 73 (80.8%)	Not reported
MenACWY-PS (3-5 Years Old)	1 of 100 (1%)	40 of 100 (40%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Prevention of Meningococcal Disease

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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 & Diagnostics

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MenACWY-CRM Vaccine and MenACWY-PS Vaccine in people with Prevention of Meningococcal Disease, run by Novartis Vaccines at 1 site in United States.

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 2 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 11 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 11 Feb 2016). 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 (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine (time frame: 1 month post vaccination (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 NCT00262028.

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 11 Feb 2016.