Meningococcal DiseasePhase 2NCT00601731

Evaluation of Meningococcal ACWY Immune Response in Children Aged 40 and 60 Months

A Phase 2 study testing MenACWY-CRM197 and Blood test in people with Meningococcal Disease, run by Novartis Vaccines at 3 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

The purpose of this study is to evaluate how well the immuno response against meningococcal serogroups A, C, W and Y lasts in children who were vaccinated with MenACWY as infants. Read more about this study

Who is it for?: Ages 40 to 63 monthsHealthy volunteers can take part
Conditions the study is for: Meningococcal Disease
What is being tested?: MenACWY-CRM197 and Blood test
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 382 participants
Where: 3 sitesin 2 countries
Study dates: Feb 2008to Sep 2010
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 40 to 63 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Follow-on, healthy 40, 60 months old participants who have completed the V59P5 study and are in good health
Control subjects: healthy 60 months old who had received a complete MenC immunization course

Who cannot join

Subjects with any serious, acute or chronic progressive disease

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

Canada2 sites

Clinical Trials Research Center
Halifax
Vaccine Evaluation Center
Vancouver

Other trials in Canada

United Kingdom1 site

Oxford Vaccine Group
Oxford, OX3 7LJ

Other trials in United Kingdom

About this study

Official title: A Phase 2, Open-label, Controlled, Multi-center Study to Evaluate Meningococcal ACWY Antibody Response in Children Aged 40 and 60 Months Who Have Previously Received Novartis MenACWY Conjugate Vaccine as Infants

The purpose of this study is to evaluate how well the immuno response against meningococcal serogroups A, C, W and Y lasts in children who were vaccinated with MenACWY as infants.

Conditions: Meningococcal Disease
Being tested: MenACWY-CRM197, Blood test
Keywords: Prevention of Meningococcal disease
Medical subject headings: Meningococcal Infections

What participants receive

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

MenACWY-CRM197Biological
Blood test, 40-months and 60-months children
Blood testBiological
Blood test, 40-months and 60-months children

Study groups in NCT00601731
Study group	Role	What they receive
Adjuvanted MenACWY vaccine group	Experimental	Blood test Receives: Biological: MenACWY-CRM197
Non-adjuvanted MenACWY vaccine group	Active comparator	Blood test Receives: Biological: Blood test

What is being measured

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

Percentage of Subjects With hSBA ≥1:8
Percentages of subjects with human Serum Bactericidal Assay (hSBA) ≥1:8 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.
Measured: At 40 and 60 months of age

Secondary outcomes (2)

Percentage of Subjects With hSBA ≥1:4
Percentages of subjects with hSBA ≥1:4 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.
Measured: At 40 and 60 months of age
GMTs in Subjects Within Each Site and in Age-Matched Control Subjects
The Geometric Mean Titers (GMTs) as measured by serum bactericidal activity at 40 months and 60 months of age and 95% CIs were calculated for each vaccine group and for each serogroup by exponentiating (base 10) the least square means of the logarithmically transformed (base 10) titers and their 95% CIs obtained from a two-way Analysis of Variance (ANOVA) with factors for vaccine group and center.
Measured: At 40 and 60 months of age

Timeline

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

Feb 2008Sep 2010

First posted28 Jan 2008 (estimated)
Study startFeb 2008
Primary completionJul 2010
Study completionSep 2010

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 2
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 382 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00601731
Sponsor's protocol ID: V59P5E1
Other IDs: 2007-004978-16
Status last verified: Oct 2014
First submitted: 15 Jan 2008
Last updated: 24 Oct 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Khatami A, Snape MD, Davis E, Layton H, John T, Yu LM, Dull PM, Gill CJ, Odrjlin T, Dobson S, Halperin SA, Langley JM, McNeil SA, Pollard AJ. Persistence of the immune response at 5 years of age following infant immunisation with investigational quadrivalent MenACWY conjugate vaccine formulations. Vaccine. 2012 Apr 16;30(18):2831-8. doi: 10.1016/j.vaccine.2012.02.046. Epub 2012 Mar 3.
PubMed 22394992

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
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
Epidemic Meningitis, Meningococcal Vaccines

All Meningococcal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Open-label, Controlled, Multi-center Study to Evaluate Meningococcal ACWY Antibody Response in Children Aged 40 and 60 Months Who Have Previously Received Novartis MenACWY Conjugate Vaccine as Infants
ClinicalTrials.gov ID: NCT00601731
Acronym / sponsor ID: V59P5E1
Conditions: Meningococcal Disease
Keywords: Prevention of Meningococcal disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 382 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Collaborators: Novartis
Study start: Feb 2008
Primary completion: Jul 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 28 Jan 2008 (estimated)
Results: Posted 19 Sep 2012

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 how well the immuno response against meningococcal serogroups A, C, W and Y lasts in children who were vaccinated with MenACWY as infants.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Adjuvanted MenACWY vaccine group	Experimental	Biological: MenACWY-CRM197Blood test
Non-adjuvanted MenACWY vaccine group	Active comparator	Biological: Blood testBlood test

Who may qualify

Ages: 40 to 63 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

Follow-on, healthy 40, 60 months old participants who have completed the V59P5 study and are in good health
Control subjects: healthy 60 months old who had received a complete MenC immunization course

Key exclusion criteria (1 listed)

Subjects with any serious, acute or chronic 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-CRM197Blood test, 40-months and 60-months children	Biological	Adjuvanted MenACWY vaccine group
Blood testBlood test, 40-months and 60-months children	Biological	Non-adjuvanted MenACWY vaccine group

Primary outcome

Percentage of Subjects With hSBA ≥1:8
Time frame: At 40 and 60 months of age
Percentages of subjects with human Serum Bactericidal Assay (hSBA) ≥1:8 as measured by serum bactericidal activity at 40 months and 60 months of age and associated 95% Clopper-Pearson CIs were computed for each of the serogroups within each of the vaccinated groups and in age-matched control subjects.

2 secondary outcomes

Percentage of Subjects With hSBA ≥1:4
Time frame: At 40 and 60 months of age
GMTs in Subjects Within Each Site and in Age-Matched Control Subjects
Time frame: At 40 and 60 months of age

Results and safety

Results posted to the registry on 19 Sep 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
UK Site	143	120
UK Control	43	43
Canada Sites	166	151
Canada Control	30	29

Primary outcome: Percentage of Subjects With hSBA ≥1:8

Time frame: At 40 and 60 months of age. Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	UK2,3,4,12+ n = 33	UK2,4,12+ n = 37	UK2,4C/12+ n = 18	UK2,4,12- n = 34	UK Control n = 42	Ca2,4,6+ n = 28	Ca2,4,6+/12PS n = 25	Ca2,4,12+ n = 27	Ca2,4+/12PS n = 28	Ca2,4,12- n = 25	Ca2,4-/12PS n = 24	Ca Control n = 30
MenA 40mths N=33,37,17,34,0,28,23,27,28,25,24,0	27 (13 to 46)	8 (2 to 22)	29 (10 to 56)	3 (0.074 to 15)	NA (NA to NA)	0 (0 to 12)	4 (0 to 22)	7 (1 to 24)	0 (0 to 12)	8 (1 to 26)	0 (0 to 14)	NA (NA to NA)
MenA 60mths N=33,35,18,31,42,27,25,23,25,23,24,30	9 (2 to 24)	11 (3 to 27)	11 (1 to 35)	3 (0.082 to 17)	0 (0 to 8)	0 (0 to 13)	0 (0 to 14)	4 (0 to 22)	4 (0 to 20)	4 (0 to 22)	0 (0 to 14)	3 (0.084 to 17)
MenC 40mths N=32,36,17,33,0,20,22,26,26,24,24,0	41 (24 to 59)	47 (30 to 65)	71 (44 to 90)	33 (18 to 52)	NA (NA to NA)	20 (6 to 44)	14 (3 to 35)	31 (14 to 52)	35 (17 to 56)	38 (19 to 59)	46 (26 to 67)	NA (NA to NA)
MenC 60mths N=32,34,17,31,42,21,24,22,21,22,24,30	34 (19 to 53)	32 (17 to 51)	59 (33 to 82)	45 (27 to 64)	29 (16 to 45)	14 (3 to 36)	13 (3 to 32)	14 (3 to 35)	24 (8 to 47)	27 (11 to 50)	46 (26 to 67)	53 (34 to 72)
MenW 40mths N=33,36,17,34,0,28,23,27,28,25,24,0	73 (54 to 87)	69 (52 to 84)	71 (44 to 90)	74 (56 to 87)	NA (NA to NA)	29 (13 to 49)	48 (27 to 69)	59 (39 to 78)	43 (24 to 63)	72 (51 to 88)	58 (37 to 78)	NA (NA to NA)
MenW 60mths N=32,34,18,31,42,26,25,23,24,21,24,29	69 (50 to 84)	85 (69 to 95)	78 (52 to 94)	84 (66 to 95)	36 (22 to 52)	31 (14 to 52)	44 (24 to 65)	57 (34 to 77)	42 (22 to 63)	81 (58 to 95)	67 (45 to 84)	34 (18 to 54)
MenY 40mths N=33,36,17,34,0,28,23,27,28,25,24,0	76 (58 to 89)	61 (43 to 77)	76 (50 to 93)	53 (35 to 70)	NA (NA to NA)	32 (16 to 52)	26 (10 to 48)	44 (25 to 65)	21 (8 to 41)	64 (43 to 82)	63 (41 to 81)	NA (NA to NA)
MenY 60mths N=33,34,17,31,42,27,25,23,23,21,23,30	61 (42 to 77)	71 (53 to 85)	71 (44 to 90)	42 (25 to 61)	29 (16 to 45)	30 (14 to 50)	24 (9 to 45)	43 (23 to 66)	22 (7 to 44)	57 (34 to 78)	57 (34 to 77)	10 (2 to 27)

Population analysed: Immunogenicity was evaluated in the Modified Intent To Treat (MITT) population that included subjects who provided at least one evaluable blood sample. Thus, the difference in the number of subjects entered here versus the number of subjects in the participant flow and baseline characteristics (i.e., enrolled subjects) module.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 37 months overall (11 months of enrollment and 26 months of individual subject participation).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
UK2,3,4,12+	1 of 33 (3%)	5 of 33 (15.2%)	Not reported
UK2,4,12+	1 of 33 (3%)	3 of 33 (9.1%)	Not reported
UK2,4C/12+	0 of 16 (0%)	3 of 16 (18.8%)	Not reported
UK2,4,12-	3 of 29 (10.3%)	2 of 29 (6.9%)	Not reported
UK Control	0 of 26 (0%)	0 of 26 (0%)	Not reported
Ca2,4,6+	1 of 28 (3.6%)	1 of 28 (3.6%)	Not reported
Ca2,4,6+/12PS	0 of 25 (0%)	1 of 25 (4%)	Not reported
Ca2,4,12+	0 of 24 (0%)	3 of 24 (12.5%)	Not reported
Ca2,4+/12PS	0 of 26 (0%)	1 of 26 (3.8%)	Not reported
Ca2,4,12-	0 of 22 (0%)	2 of 22 (9.1%)	Not reported
Ca2,4-/12PS	1 of 25 (4%)	1 of 25 (4%)	Not reported
Ca Control	0 of 23 (0%)	0 of 23 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22394992Khatami A, Snape MD, Davis E, Layton H, John T, Yu LM, Dull PM, Gill CJ, Odrjlin T, Dobson S, Halperin SA, Langley JM, McNeil SA, Pollard AJ. Persistence of the immune response at 5 years of age following infant immunisation with investigational quadrivalent MenACWY conjugate vaccine formulations. Vaccine. 2012 Apr 16;30(18):2831-8. doi: 10.1016/j.vaccine.2012.02.046. Epub 2012 Mar 3.

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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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

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MenACWY-CRM197 and Blood test in people with Meningococcal Disease, run by Novartis Vaccines at 3 sites in 2 countries.

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 1 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 24 Oct 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 Canada, United Kingdom. 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 19 Sep 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?

Percentage of Subjects With hSBA ≥1:8 (time frame: At 40 and 60 months of age). 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 NCT00601731, 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 24 Oct 2014.