Meningococcal DiseasePhase 3NCT01345721

Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine

A Phase 3 study testing MenACWY-CRM in people with Meningococcal Disease, run by Novartis Vaccines at 11 sites in Germany.

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

Who is it for?: Ages 22 to 45 months
Conditions the study is for: Meningococcal Disease
What is being tested?: MenACWY-CRM
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 205 participants
Where: 11 sitesGermany
Study dates: May 2011to Sep 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 22 to 45 months
All sexes
No healthy volunteers
Child

Who may be able to join

Children eligible to be enrolled in the study were those
whose parents provide written informed consent;
were in generally good health based on the clinical judgment of the investigators;
subjects were 22-45 months of age at the time of enrollment into V59P22E1;
subject who had participated in the parent V59P22 study.

Who cannot join

Main exclusion criteria:
Subjects with serious, acute, or chronic illnesses
Subjects who had received any other licensed vaccines within 28 days (Exception: Influenza vaccine was allowed up to 14 days prior to and no less than 14 days after the study immunization) prior to enrolment and any study visit
Subjects who had received any Meningococcal vaccine since the study dose of MenACWY or Men C at 12 months of age in V59P22 trial.

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

Germany11 sites

Dr. Johannes Kandzora and Dr. Kathrin Kandzora
Am Teich 11, Neumuenster, 24534
Bogda-Maria Kniese,
Boyneburgstr 7, Eschwege, 37269
Dr Goertz Martin Kimmig
GroBbottwarer Str 47, Oberstenfeld, 71720
Dr med Walter Otto
Heinrichstrasse 16 A, Fulda, 36037
Dr med Kerstin Pscherer
Hellersdorfer Str 237, Berlin, 12627
Dr Renate Mangelsdorf-Taxis
Kirchstrasse 2, Bonnigheim, 74357
Dr. Christoph Wittermann
Murnauer Str 3, Weilheim, 82362
Ute Jessat
Rathausstr 6, Gluecksburg, 24960
Dr med Luise Schroeter
Schoenwalder Str 28, Berlin, 13347
Dr med Ulrich Pfletschinger
Stuttgarter Strasse 74, Stuttgart Feuerbach, 70469
Dr Lothar Maurer
Welschgasse 39, Frankenthal, 67227

Other trials in Germany

About this study

Official title: A Phase IIIb, Open-Label, Controlled, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine

The primary purpose of this study is to evaluate the persistence of bactericidal antibodies in children of approximately 22 to 45 months of age previously enrolled in the V59P22 study (NCT00667602) who received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine. This is measured by percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against Neisseria meningitidis serogroups A, C, W-135, and Y. In addition the response one month post an additional dose of Novartis MenACWY will be measured by percentage of subjects with hSBA titers ≥ 1:8 and GMTs.

Conditions: Meningococcal Disease
Being tested: MenACWY-CRM
Keywords: Meningococcal, ACWY, Conjugate Vaccine, Meningitis, Toddlers, Children, Persistence, Boost
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.

MenACWY-CRMBiological

Study groups in NCT01345721
Study group	Role	What they receive
MenACWY (2 primary + 1 booster dose)	Experimental	Subjects who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study. Receives: Biological: MenACWY-CRM
MenACWY (1 primary + 1 booster dose)	Experimental	Subjects who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study. Receives: Biological: MenACWY-CRM
MenC (1 primary dose)+MenACWY (1 booster dose)	Experimental	Subjects who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study. Receives: Biological: MenACWY-CRM

What is being measured

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

Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine
The percentage of subjects with persisting serum bactericidal antibody (hSBA)titers ≥1:8 against Neisseria meningitidis serogroups A,C,W,Y, 13-33 months after receiving either one or two doses of MenACWY-CRM conjugate vaccine or one dose of MenC vaccine in parent study, is reported.
The functional bactericidal antibodies response against N. meningitidis serogroups was measured with the serum bactericidal assay using human complement (hSBA)
Measured: From 13-33 months post last vaccination in parent study (V59P22)
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination
The serum antibody response following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y.
Measured: 1 month post booster
Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination
The serum antibody titers following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, are reported as geometric mean titers (GMTs) against N. meningitidis serogroups A,C, W,Y.
Measured: 1 month post booster vaccination
Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination
The serum antibody response following a dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C, W,Y
Measured: 1 month after vaccination
Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine
The serum antibody titers following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C,W,Y
Measured: 1 month post vaccination

Secondary outcomes (5)

Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine
The persisting serum bactericidal antibody titers in children, 13-33 months after receiving either one or two doses of MenACWY-CRM vaccine or one dose of Men C vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y
Measured: From 13-33 months post last vaccination in parent study (V59P22)
Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine
Comparison of serum antibody responses following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of Men C vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y
Measured: 1 month post vaccination
Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine
Comparison of serum antibody titers following a one dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one dose of the same vaccine or one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C, W,Y
Measured: 1 month post vaccination
Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination
The safety and tolerability of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting solicited local and systemic AEs after MenACWY-CRM vaccine.
Measured: Day 1-7 after vaccination
Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination
The safety of MenACWY-CRM vaccine in children (who had previously received either one or two doses of MenACWY-CRM vaccine or one dose of MenC vaccine in the parent study) is assessed in terms of number of subjects reporting any unsolicited AEs (day 1 to day 7); serious AEs and AEs necessitating medical attention/or premature withdrawal (day 1 to day 28) after MenACWY-CRM vaccine.
Measured: Day 1-28 after vaccination

Timeline

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

May 2011Sep 2011

First posted2 May 2011 (estimated)
Study startMay 2011
Primary completionSep 2011
Study completionSep 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.
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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 205 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01345721
Sponsor's protocol ID: V59P22E1
Status last verified: May 2018
First submitted: 29 Apr 2011
Last updated: 18 Jun 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Giuliani MM, Biolchi A, Keshavan P, Moriondo M, Tomei S, Santini L, Mori E, Brozzi A, Bodini M, Nieddu F, Ricci S, Mzolo T, Costantini M, Azzari C, Pellegrini M. Bactericidal antibodies against hypervirulent Neisseria meningitidis C field strains following MenC-CRM or MenACWY-CRM priming and MenACWY-CRM booster in children. Hum Vaccin Immunother. 2021 May 4;17(5):1442-1449. doi: 10.1080/21645515.2020.1833578. Epub 2020 Dec 16.
PubMed 33325757

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
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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 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIIb, Open-Label, Controlled, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine
ClinicalTrials.gov ID: NCT01345721
Acronym / sponsor ID: V59P22E1
Conditions: Meningococcal Disease
Keywords: Meningococcal, ACWY, Conjugate Vaccine, Meningitis, Toddlers, Children, Persistence, Boost
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 205 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: May 2011
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 2 May 2011 (estimated)
Results: Posted 18 Oct 2013

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
MenACWY (2 primary + 1 booster dose)	Experimental	Biological: MenACWY-CRMSubjects who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
MenACWY (1 primary + 1 booster dose)	Experimental	Biological: MenACWY-CRMSubjects who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
MenC (1 primary dose)+MenACWY (1 booster dose)	Experimental	Biological: MenACWY-CRMSubjects who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.

Who may qualify

Ages: 22 to 45 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Children eligible to be enrolled in the study were those
whose parents provide written informed consent;
were in generally good health based on the clinical judgment of the investigators;
subjects were 22-45 months of age at the time of enrollment into V59P22E1;
subject who had participated in the parent V59P22 study.

Key exclusion criteria (4 listed)

Subjects with serious, acute, or chronic illnesses
Subjects who had received any other licensed vaccines within 28 days (Exception: Influenza vaccine was allowed up to 14 days prior to and no less than 14 days after the study immunization) prior to enrolment and any study visit
Subjects who had received any Meningococcal vaccine since the study dose of MenACWY or Men C at 12 months of age in V59P22 trial.

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	Biological	MenACWY (1 primary + 1 booster dose), MenACWY (2 primary + 1 booster dose), MenC (1 primary dose)+MenACWY (1 booster dose)

Primary outcome

Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine
Time frame: From 13-33 months post last vaccination in parent study (V59P22)
The percentage of subjects with persisting serum bactericidal antibody (hSBA)titers ≥1:8 against Neisseria meningitidis serogroups A,C,W,Y, 13-33 months after receiving either one or two doses of MenACWY-CRM conjugate vaccine or one dose of MenC vaccine in parent study, is reported. The functional bactericidal antibodies response against N. meningitidis serogroups was measured with the serum bactericidal assay using human complement (hSBA)
Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination
Time frame: 1 month post booster
The serum antibody response following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C,W,Y.
Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination
Time frame: 1 month post booster vaccination
The serum antibody titers following a booster dose of MenACWY-CRM conjugate vaccine in children, who had previously received either one or two doses of the same vaccine in the parent study, are reported as geometric mean titers (GMTs) against N. meningitidis serogroups A,C, W,Y.
Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination
Time frame: 1 month after vaccination
The serum antibody response following a dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, is reported as percentage of subjects with hSBA titers ≥1:8 against N. meningitidis serogroups A,C, W,Y
Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine
Time frame: 1 month post vaccination
The serum antibody titers following one dose of MenACWY-CRM conjugate vaccine in children, who had previously received one dose of MenC vaccine in the parent study, are reported as GMTs against N. meningitidis serogroups A,C,W,Y

5 secondary outcomes

Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine
Time frame: From 13-33 months post last vaccination in parent study (V59P22)
Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine
Time frame: 1 month post vaccination
Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine
Time frame: 1 month post vaccination
Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination
Time frame: Day 1-7 after vaccination
Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination
Time frame: Day 1-28 after vaccination

Results and safety

Results posted to the registry on 18 Oct 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 (2 Primary + 1 Booster Dose)	74	74
MenACWY (1 Primary + 1 Booster Dose)	66	66
MenC (1 Primary Dose) + MenACWY (1 Booster Dose)	65	65

Primary outcome: Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine

Time frame: From 13-33 months post last vaccination in parent study (V59P22). Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	MenACWY (2 Primary + 1 Booster Dose) n = 52	MenACWY (1 Primary + 1 Booster Dose) n = 41	MenC (1 Primary Dose) +MenACWY (1 Booster Dose) n = 43
13-33 months persistence (Serogroup A)	13 (6 to 26)	7 (2 to 20)	0 (0 to 8)
13-33 months persistence (Serogroup C)(N=52,40,42)	27 (16 to 41)	25 (13 to 41)	36 (22 to 52)
13-33 months persistence (Serogroup W-135)	50 (36 to 64)	63 (47 to 78)	12 (4 to 25)
13-33 months persistence (Serogroup Y)	40 (27 to 55)	39 (24 to 55)	19 (8 to 33)

Population analysed: The analysis was done on the per-protocol persistence dataset i.e all enrolled subjects who provided evaluable serum samples at day 1 of the study and had no major protocol violation as defined prior to the end of the study.

Primary outcome: Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination

Time frame: 1 month post booster. Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	MenACWY (2 Primary + 1 Booster Dose) n = 52	MenACWY (1 Primary + 1 Booster Dose) n = 41
Pre-booster (Serogroup A)	13 (6 to 26)	7 (2 to 20)
1 month post booster (Serogroup A)	96 (87 to 100)	98 (87 to 100)
Pre-booster (Serogroup C) N=52,40	27 (16 to 41)	25 (13 to 41)
1 month post booster (Serogroup C) N=52,40	100 (93 to 100)	100 (91 to 100)
Pre-booster (Serogroup W-135)	50 (36 to 64)	63 (47 to 78)
1 month post booster (Serogroup W-135)	100 (93 to 100)	100 (91 to 100)
Pre-booster (Serogroup Y)	40 (27 to 55)	39 (24 to 55)
1 month post booster (Serogroup Y)	100 (93 to 100)	100 (91 to 100)

Population analysed: The analysis was done on the per-protocol dataset i.e All enrolled subjects who correctly received the vaccine, provided evaluable serum samples at the relevant time points (Day 28),and had no major protocol violation as defined prior to the end of the study.

Primary outcome: Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination

Time frame: 1 month post booster vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	MenACWY (2 Primary + 1 Booster Dose) n = 52	MenACWY (1 Primary + 1 Booster Dose) n = 41
Pre-booster (Serogroup A)	2.82 (2.35 to 3.38)	2.52 (2.05 to 3.09)
1 month post booster (Serogroup A)	182 (118 to 281)	214 (131 to 350)
Pre-booster (Serogroup C) N=52,40	3.92 (2.92 to 5.26)	3.91 (2.79 to 5.48)
1 month post booster (Serogroup C) N=52,40	541 (399 to 733)	968 (682 to 1372)
Pre-booster (Serogroup W-135)	9.37 (6.3 to 14)	12 (7.51 to 18)
1 month post booster (Serogroup W-135)	799 (564 to 1133)	1267 (854 to 1879)
Pre-booster (Serogroup Y)	6.79 (4.86 to 9.5)	6.04 (4.13 to 8.82)
1 month post booster (Serogroup Y)	650 (448 to 941)	676 (444 to 1027)

Population analysed: The analysis was done on the per-protocol dataset.

Primary outcome: Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination

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

Measure	MenC (1 Primary Dose) +MenACWY (1 Booster Dose) n = 41
Pre-vaccination (Serogroup A)	0 (0 to 9)
1 month post vaccination (Serogroup A)	61 (45 to 76)
Pre-vaccination (Serogroup C) N=39	36 (21 to 53)
1 month post vaccination (Serogroup C) N=39	100 (91 to 100)
Pre-vaccination (Serogroup W-135)	12 (4 to 26)
1 month post vaccination (Serogroup W-135)	95 (83 to 99)
Pre-vaccination (Serogroup Y)	20 (9 to 35)
1 month post vaccination (Serogroup Y)	95 (83 to 99)

Population analysed: The analysis was done on the per-protocol dataset.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited and unsolicited AEs were collected from Day 1-7 after vaccination. SAEs and AEs necessitating medical attention/premature withdrawal were collected from Day 1-28.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MenACWY (2 Primary + 1 Booster Dose)	0 of 53 (0%)	33 of 53 (62.3%)	Not reported
MenACWY (1 Primary + 1 Booster Dose)	0 of 44 (0%)	31 of 44 (70.5%)	Not reported
MenC (1 Primary Dose) + MenACWY (1 Booster Dose)	0 of 43 (0%)	30 of 43 (69.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33325757Giuliani MM, Biolchi A, Keshavan P, Moriondo M, Tomei S, Santini L, Mori E, Brozzi A, Bodini M, Nieddu F, Ricci S, Mzolo T, Costantini M, Azzari C, Pellegrini M. Bactericidal antibodies against hypervirulent Neisseria meningitidis C field strains following MenC-CRM or MenACWY-CRM priming and MenACWY-CRM booster in children. Hum Vaccin Immunother. 2021 May 4;17(5):1442-1449. doi: 10.1080/21645515.2020.1833578. Epub 2020 Dec 16.

Related trials for 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.

The record lists no contact. Use the official record to reach the sponsor.

11 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 MenACWY-CRM in people with Meningococcal Disease, run by Novartis Vaccines at 11 sites in Germany.

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 5 inclusion and 4 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 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Germany. 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 18 Oct 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 Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine (time frame: From 13-33 months post last vaccination in parent study (V59P22)). The study lists 5 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 NCT01345721, 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 18 Jun 2018.