Meningococcal DiseasePhase 3NCT00329849

Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of Age

A Phase 3 study testing Meningococcal ACWY-CRM conjugate vaccine and Meningococcal ACWY-PS polysaccharide vaccine in people with Meningococcal Disease, run by Novartis Vaccines at 3 sites in Argentina.

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

Safety and immunogenicity of meningococcal ACWY conjugate versus polysaccharide vaccine in children 2 to 10 years of age Read more about this study

Who is it for?: Ages 2 to 10 yearsHealthy volunteers can take part
Conditions the study is for: Meningococcal Disease
What is being tested?: Meningococcal ACWY-CRM conjugate vaccine and Meningococcal ACWY-PS polysaccharide vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,500 participants
Where: 3 sitesArgentina
Study dates: May 2006to Mar 2007
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 10 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy children 2 to 10 years of age inclusive whose parents or legal guardians gave written informed consent at the time of enrollment;
Available for all visits and telephone calls (parents or legal guardians) scheduled for the study;
Good health as determined by the clinical judgment of the investigator.

Who cannot join

Individuals not eligible to be enrolled into the study were those:
whose parent or legal guardian was unwilling or unable to give written informed consent to participate in the study;
whose parent or legal guardian were perceived as unreliable or unavailable for the duration 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;
who had previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational);

Show all 22Show fewer

who had received any investigational agents or vaccines within 90 days prior to enrollment or who expected to receive an investigational agent or vaccine prior to the completion of the study;
who had received any licensed vaccines within one month prior to enrollment or for whom receipt of a licensed vaccine was anticipated within one month after vaccination (Exception: influenza vaccine could be administered up to 15 days prior to study vaccination and no less than 15 days after study vaccination);
who had received a live viral vaccine within 60 days prior to enrollment;
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 axillary 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, Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS), or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition). (Exception: subjects with mild asthma were eligible for enrollment; subjects with moderate or severe asthma requiring routine use of inhaled or systemic corticosteroids were not eligible for enrollment);
who had epilepsy or any progressive neurological disease;
who had a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component;
who had a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
receipt of immunosuppressive therapy within 30 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 30 days prior to enrollment, or cancer chemotherapy);
receipt of immunostimulants;
receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study;
common childhood exanthematous diseases (varicella, mumps, measles, rubella) occurring 6 weeks prior to vaccination;
who were known to have a bleeding diathesis or any condition that could be associated with a prolonged bleeding time;
who had Down syndrome or other known cytogenic disorders;
whose families were planning to leave the area of the study site before the end of the study period;
who had any condition that, in the opinion of the investigator, could interfere with the evaluation of the study objectives.

Trial locations and contacts

3 sites in 1 country.

Argentina3 sites

FUNCEI, French 3085
Buenos Aires
Centro di Desarrollo de Proyectos Avanzados (CEDEPAP) Roma 1464
Córdoba
Hospital de Pediatria "Sor Maria Ludovica", Calle 14 N1631,(1900)
La Plata

Other trials in Argentina

About this study

Official title: A Phase 3, Randomized, Observer-blind, Controlled, Multi-Center Study to Compare the Safety of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With That of a Licensed Meningococcal ACWY Polysaccharide Vaccine (Menomune®) Administered to Healthy Children 2 to 10 Years of Age

Safety and immunogenicity of meningococcal ACWY conjugate versus polysaccharide vaccine in children 2 to 10 years of age

Conditions: Meningococcal Disease
Being tested: Meningococcal ACWY-CRM conjugate vaccine, Meningococcal ACWY-PS polysaccharide vaccine
Keywords: Meningitis, children, vaccine, safety, efficacy
Medical subject headings: Meningococcal Infections, Meningitis

What participants receive

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

Meningococcal ACWY-CRM conjugate vaccineBiological
MenACWY-CRM vaccine was obtained by extemporaneous mixing of the lyophilized MenA component to be resuspended with the liquid MenCWY component. One dose (0.5 mL) was administered by IM injection in the deltoid area of the arm without a BCG scar.
Meningococcal ACWY-PS polysaccharide vaccineBiological
MenACWY-PS vaccine was supplied as a single dose (one vial of vaccine and one vial of diluent). One dose (0.5 mL) of MenACWY-PS vaccine was administered by SC injection in the deltoid area of the arm without a BCG scar.

Study groups in NCT00329849
Study group	Role	What they receive
MenACWY-CRM	Experimental	Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM) Receives: Biological: Meningococcal ACWY-CRM conjugate vaccine
MenACWY-PS	Active comparator	Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide (PS) vaccine (MenACWY-PS) Receives: Biological: Meningococcal ACWY-PS polysaccharide vaccine

What is being measured

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

Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Immunogenicity was measured as the percentage of subjects with hSBA seroresponse, directed against each of meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), one month after vaccination (day 29)with MenACWY-CRM or MenACWY-PS vaccine.
Seroresponse was 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: 1 month after vaccination (day 29)
Number of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination
Safety was assessed in terms of the number of subjects who reported at least one severe systemic reaction after vaccination with MenACWY-CRM or MenACWY-PS from day 1 to day 7 after vaccination.
Measured: Day 1 to 7 postvaccination

Secondary outcomes (5)

Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month (day 29)after one vaccination with MenACWY-CRM or MenACWY-PS.
Measured: Day 1 and 29
The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
The immune response was measured as the hSBA geometric mean titers (GMTs) directed against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month(day 29) after one vaccination with MenACWY-CRM or MenACWY-PS.
Measured: Day 1 and 29
Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
The persistence of immune response was measured as the percentage of subjects with hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at day 181 after vaccination with MenACWY-CRM or MenACWY-PS.
Measured: Day 181
The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
The persistence of immune response was measured in terms of the hSBA GMTs persisting at day 181 against each of four meningococcal serogroups A, C, W and Y after vaccination with MenACWY-CRM or MenACWY-PS
Measured: Day 181
Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
Safety was assessed as the number of subjects who reported local and systemic reactions and axillary temperature during day 1 to day 7 after vaccination with MenACWY-CRM or MenACWY-PS.
Measured: Day 1 to 7 postvaccination

Timeline

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

May 2006Mar 2007

First posted25 May 2006 (estimated)
Study startMay 2006
Primary completionMar 2007
Study completionMar 2007

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 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: Single blind
Who is masked: Participant
Enrolment: 1,500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00329849
Sponsor's protocol ID: V59P10
Status last verified: Sep 2018
First submitted: 23 May 2006
Last updated: 9 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Black S, Klein NP, Shah J, Bedell L, Karsten A, Dull PM. Immunogenicity and tolerability of a quadrivalent meningococcal glycoconjugate vaccine in children 2-10 years of age. Vaccine. 2010 Jan 8;28(3):657-63. doi: 10.1016/j.vaccine.2009.10.104. Epub 2009 Nov 4.
PubMed 19895922

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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Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
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Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
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All Meningococcal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Observer-blind, Controlled, Multi-Center Study to Compare the Safety of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With That of a Licensed Meningococcal ACWY Polysaccharide Vaccine (Menomune®) Administered to Healthy Children 2 to 10 Years of Age
ClinicalTrials.gov ID: NCT00329849
Acronym / sponsor ID: V59P10
Conditions: Meningococcal Disease
Keywords: Meningitis, children, vaccine, safety, efficacy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,500 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: May 2006
Primary completion: Mar 2007 (actual)
Study completion: Mar 2007 (actual)
First posted: 25 May 2006 (estimated)
Results: Posted 5 Nov 2013

Clinical summary

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

Safety and immunogenicity of meningococcal ACWY conjugate versus polysaccharide vaccine in children 2 to 10 years of age

Study design

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

Arm	Type	Receives
MenACWY-CRM	Experimental	Biological: Meningococcal ACWY-CRM conjugate vaccineSubjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
MenACWY-PS	Active comparator	Biological: Meningococcal ACWY-PS polysaccharide vaccineSubjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide (PS) vaccine (MenACWY-PS)

Who may qualify

Ages: 2 to 10 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Healthy children 2 to 10 years of age inclusive whose parents or legal guardians gave written informed consent at the time of enrollment;
Available for all visits and telephone calls (parents or legal guardians) scheduled for the study;
Good health as determined by the clinical judgment of the investigator.

Key exclusion criteria (22 listed)

whose parent or legal guardian was unwilling or unable to give written informed consent to participate in the study;
whose parent or legal guardian were perceived as unreliable or unavailable for the duration 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;
who had previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational);

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-CRM conjugate vaccineMenACWY-CRM vaccine was obtained by extemporaneous mixing of the lyophilized MenA component to be resuspended with the liquid MenCWY component. One dose (0.5 mL) was administered by IM injection in the deltoid area of the arm without a BCG scar.	Biological	MenACWY-CRM
Meningococcal ACWY-PS polysaccharide vaccineMenACWY-PS vaccine was supplied as a single dose (one vial of vaccine and one vial of diluent). One dose (0.5 mL) of MenACWY-PS vaccine was administered by SC injection in the deltoid area of the arm without a BCG scar.	Biological	MenACWY-PS

Primary outcome

Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Time frame: 1 month after vaccination (day 29)
Immunogenicity was measured as the percentage of subjects with hSBA seroresponse, directed against each of meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), one month after vaccination (day 29)with MenACWY-CRM or MenACWY-PS vaccine. Seroresponse was 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.
Number of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination
Time frame: Day 1 to 7 postvaccination
Safety was assessed in terms of the number of subjects who reported at least one severe systemic reaction after vaccination with MenACWY-CRM or MenACWY-PS from day 1 to day 7 after vaccination.

5 secondary outcomes

Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Time frame: Day 1 and 29
The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Time frame: Day 1 and 29
Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Time frame: Day 181
The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Time frame: Day 181
Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
Time frame: Day 1 to 7 postvaccination

Results and safety

Results posted to the registry on 5 Nov 2013, 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	950	944
MenACWY-PS	550	546

Primary outcome: Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS

Time frame: 1 month after vaccination (day 29). Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	MenACWY-CRM n = 148	MenACWY-PS n = 148
Serogroup A	93 (87 to 96)	55 (46 to 63)
Serogroup C (N=147,144)	82 (74 to 88)	52 (44 to 60)
Serogroup W (N=143,142)	74 (66 to 81)	46 (37 to 54)
Serogroup Y (N=146,146)	82 (74 to 87)	63 (55 to 71)

MenACWY-CRM vs MenACWY-PS: Group difference: 38 (95% CI 29 to 47), Chi-squared
MenACWY-CRM vs MenACWY-PS: Group difference: 30 (95% CI 19 to 40), Chi-squared
MenACWY-CRM vs MenACWY-PS: Group difference: 28 (95% CI 17 to 39), Chi-squared

Population analysed: Analysis was done on the per-protocol (PP) dataset of primary vaccination, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at one month after vaccination; and had no major protocol violations as defined in the analysis plan.

Primary outcome: Number of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination

Time frame: Day 1 to 7 postvaccination. Number. Unit: Number of subjects

Measure	MenACWY-CRM n = 950	MenACWY-PS n = 550
Value	11	1

MenACWY-CRM vs MenACWY-PS: Group Ratio: 6.37 (95% CI 0.82 to 49.2), Risk ratio(MenACWY-CRM/MenACWY-PS)

Population analysed: Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MenACWY-CRM	9 of 950 (0.9%)	409 of 950 (43.1%)	Not reported
MenACWY-PS	1 of 550 (0.2%)	271 of 550 (49.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19895922Black S, Klein NP, Shah J, Bedell L, Karsten A, Dull PM. Immunogenicity and tolerability of a quadrivalent meningococcal glycoconjugate vaccine in children 2-10 years of age. Vaccine. 2010 Jan 8;28(3):657-63. doi: 10.1016/j.vaccine.2009.10.104. Epub 2009 Nov 4.

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
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Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
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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 & Diagnostics study chair

Novartis Vaccines & Diagnostics

3 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 3 inclusion and 22 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 9 Oct 2018. 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 Argentina. 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 5 Nov 2013). 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 Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS (time frame: 1 month after vaccination (day 29)). The study lists 2 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 NCT00329849, 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 9 Oct 2018.