Meningococcal MeningitisPhase 2NCT00310856

Immunogenicity and Safety of MenACWY in Infants (6 & 12 Months)

A Phase 2 study testing MenACWY-CRM, MenC-CRM and DTaP-Hib-IPV in people with Meningococcal Meningitis, run by Novartis Vaccines at 3 sites in Canada.

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

To assess the immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY conjugate vaccine (MenACWY) when administered as a two-dose schedule at 6 and 12 months of age. Read more about this study

Who is it for?: Ages 6 to 12 monthsHealthy volunteers can take part
Conditions the study is for: Meningococcal Meningitis
What is being tested?: MenACWY-CRM, MenC-CRM and DTaP-Hib-IPV
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 175 participants
Where: 3 sitesCanada
Study dates: Jun 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 6 to 12 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Inclusion criteria for Groups I (MenACWY-CRM6-12 M) and II (MenACWY-CRM12 M)
Subjects eligible for enrollment in the study were healthy infants:
who were 6 months old and who were born after full-term pregnancy with an estimated gestational age of 37 weeks or greater and a birth weight 2.5 kg or greater;
who previously received two doses of PC7 and DTaP-Hib-IPV vaccines;
for whom a parent/legal guardian gave written informed consent, after the nature of the study was explained;
who were available for all the visits scheduled in the study;

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who were in good health as determined by medical history, physical examination, and clinical judgment of the investigator.
Inclusion criteria for Group III (MenC-CRM12 MMenACWY-CRM18 M)
Subjects eligible for enrollment in the study were healthy infants:
who were 12 months old;
who previously received three doses of DTaP-Hib-IPV (Pentacel) vaccines;
for whom a parent/legal guardian gave written informed consent, after the nature of the study was explained;
who were available for all the visits scheduled in the study;
who were in good health as determined by medical history, physical examination, and clinical judgment of the investigator.

Who cannot join

Subjects were not to be included in this study if:
their parents/legal guardians were unwilling or unable to give written informed consent to participate in the study;
they previously received any meningococcal vaccine;
they had a previously ascertained or suspected disease caused by Neisseria meningitidis (N meningitidis);
they had a history of any anaphylactic shock, asthma, urticaria, or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
they had experienced significant acute or chronic infection within the previous 7 days or had experienced fever (38.0ºC or greater) within the previous 3 days;

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they had any present or suspected serious acute disease (e.g., leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac failure, renal failure, severe malnutrition, or insulin-dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down's syndrome), or who had a diagnosed cardiac defect or abnormality of hemodynamic significance (e.g., ventricular septal defect, patent ductus arteriosus, or atrial septal defect);
they had a known or suspected autoimmune disease or impairment /alteration of immune function resulting from use of (for example):
any immunosuppressive therapy since birth;
immunostimulants since birth;
any systemic corticosteroid administered for more than 5 days or in a daily dose of greater than 1 mg/kg/day prednisone or equivalent for 5 days or less in the previous 30 days;
they had a suspected or known HIV infection or HIV-related disease;
they had received parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 90 days and were expected to receive it for the full length of the study;
they had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
they had a history of seizure disorder:
febrile seizure;
any other seizure disorder;
they had taken systemic antibiotics (either oral or parenteral) within the previous 14 days (EXCEPTION: subjects who had received an oral or parenteral β-lactam antibiotic [e.g.: penicillin, amoxicillin, ceftriaxone, cefuroxime or cephalexin] could have been enrolled 7 days following the last dose);
their parents/legal guardians were planning to leave the area of the study center before the end of the study period;
they had any condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

Clinical Trials Research Center, Department of Pediatrics, Dalhousie University, IWK Health Center
Halifax, B3K 6R8
Children's Hospital of Eastern Ontario Research Institute
Ottawa, Ontario, K1H 8L1
Herridge Community Health Clinic
Ottawa, Ontario, K1S 0G8

Other trials in Canada

About this study

Official title: A Phase 2, Partially Randomized, Open Label, Multicenter Study to Evaluate the Safety and Immunogenicity After One or Two Doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Young Children

To assess the immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY conjugate vaccine (MenACWY) when administered as a two-dose schedule at 6 and 12 months of age.

Conditions: Meningococcal Meningitis
Being tested: MenACWY-CRM, MenC-CRM, DTaP-Hib-IPV, PC7, MMR
Keywords: meningitis, children, vaccine
Medical subject headings: Meningitis, Meningococcal, Meningitis

What participants receive

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

MenACWY-CRMBiological
Also called Meningococcal ACWY conjugate vaccine
Subjects received the full dose (0.5 mL) of MenACWY-CRM, obtained by extemporaneous mixing of lyophilized MenA powder component and the MenCWY suspension, administered by IM injection into the anterolateral area of the right thigh.
MenC-CRMBiological
Also called Meningococcal C conjugate vaccine
One dose (0.5 mL) of MenC-CRM was obtained by extemporaneous mixing just before injection of the lyophilized MenC component and a saline solvent, administered by IM injection into the arm region.
DTaP-Hib-IPVBiological
Also called Combined vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type B and inactivated polio virus; Pentacel
PC7Biological
Also called Heptavalent conjugate pneumococcal; Prevnar
One dose (0.5 mL) of PC7, supplied in pre-filled syringe, administered by IM injection into the anterolateral area of the left thigh.
MMRBiological
Also called Measles, mumps and rubella
VaricellaBiological

Study groups in NCT00310856
Study group	Role	What they receive
MenACWY-CRM_6-12 M	Experimental	Subjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age) Receives: Biological: MenACWY-CRM; Biological: DTaP-Hib-IPV; Biological: PC7; Biological: MMR; Biological: Varicella
MenACWY-CRM_12 M	Experimental	Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age) Receives: Biological: MenACWY-CRM; Biological: DTaP-Hib-IPV; Biological: PC7; Biological: MMR; Biological: Varicella
MenC-CRM_12 M_MenACWY-CRM_18 M	Experimental	Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age). Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months) Receives: Biological: MenACWY-CRM; Biological: MenC-CRM; Biological: DTaP-Hib-IPV; Biological: PC7; Biological: MMR; Biological: Varicella

What is being measured

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

Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule
Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months (MenACWY-CRM_12 M group)
Measured: Before and 1 month after 2-dose or 1-dose schedule

Secondary outcomes (9)

Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule
The immune response was measured as the hSBA geometric mean titers (GMTs) against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM_12 M group)
Measured: Before and 1 month after 2-dose or 1-dose schedule
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule
Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM_12 M)
Measured: Before and 1 month after 2-dose or 1-dose schedule
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age
Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age
Measured: Before and 1 month after MenC-CRM vaccination at 12 months
Geometric Mean hSBA Titers Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age
The immune response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age
Measured: Before and 1 month after MenC-CRM vaccination at 12 months
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age
Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age
Measured: Before and 1 month after MenACWY-CRM vaccination at 18 months
hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age
The immune response was measured as the hSBA GMTs against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age
Measured: Before and 1 month after MenACWY-CRM vaccination at 18 months
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age
Booster response was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age
Measured: Before and 1 month after MenACWY-CRM vaccination at 18 months
hSBA GMT Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age
Booster response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age
Measured: Before and 1 month after MenACWY-CRM vaccination at 18 months
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination
The safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 following any vaccination of MenACWY-CRM, MenC-CRM and concomitant vaccination
Measured: From day 1 through day 7 after any vaccination

Timeline

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

Jun 2005Nov 2006

First posted5 Apr 2006 (estimated)
Study startJun 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 Meningococcal MeningitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 175 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00310856
Sponsor's protocol ID: V59P9
Status last verified: Sep 2018
First submitted: 3 Apr 2006
Last updated: 9 Oct 2018
Results posted: Yes, on ClinicalTrials.gov

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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Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
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Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
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Active, not recruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 2-6 Years
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All Meningococcal Meningitis 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 2, Partially Randomized, Open Label, Multicenter Study to Evaluate the Safety and Immunogenicity After One or Two Doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Young Children
ClinicalTrials.gov ID: NCT00310856
Acronym / sponsor ID: V59P9
Conditions: Meningococcal Meningitis
Keywords: meningitis, children, vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 175 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Jun 2005
Primary completion: Nov 2006 (actual)
Study completion: Nov 2006 (actual)
First posted: 5 Apr 2006 (estimated)
Results: Posted 1 Nov 2013

Clinical summary

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

To assess the immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY conjugate vaccine (MenACWY) when administered as a two-dose schedule at 6 and 12 months of age.

Study design

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

Arm	Type	Receives
MenACWY-CRM_6-12 M	Experimental	Biological: MenACWY-CRM, Biological: DTaP-Hib-IPV, Biological: PC7, Biological: MMR, Biological: VaricellaSubjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)
MenACWY-CRM_12 M	Experimental	Biological: MenACWY-CRM, Biological: DTaP-Hib-IPV, Biological: PC7, Biological: MMR, Biological: VaricellaSubjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)
MenC-CRM_12 M_MenACWY-CRM_18 M	Experimental	Biological: MenACWY-CRM, Biological: MenC-CRM, Biological: DTaP-Hib-IPV, Biological: PC7, Biological: MMR, Biological: VaricellaSubjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age). Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)

Who may qualify

Ages: 6 to 12 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (14 listed)

Inclusion criteria for Groups I (MenACWY-CRM6-12 M) and II (MenACWY-CRM12 M)
who were 6 months old and who were born after full-term pregnancy with an estimated gestational age of 37 weeks or greater and a birth weight 2.5 kg or greater;
who previously received two doses of PC7 and DTaP-Hib-IPV vaccines;
for whom a parent/legal guardian gave written informed consent, after the nature of the study was explained;
who were available for all the visits scheduled in the study;

Key exclusion criteria (20 listed)

their parents/legal guardians were unwilling or unable to give written informed consent to participate in the study;
they previously received any meningococcal vaccine;
they had a previously ascertained or suspected disease caused by Neisseria meningitidis (N meningitidis);
they had a history of any anaphylactic shock, asthma, urticaria, or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
they had experienced significant acute or chronic infection within the previous 7 days or had experienced fever (38.0ºC or greater) within the previous 3 days;

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-CRMAlso: Meningococcal ACWY conjugate vaccineSubjects received the full dose (0.5 mL) of MenACWY-CRM, obtained by extemporaneous mixing of lyophilized MenA powder component and the MenCWY suspension, administered by IM injection into the anterolateral area of the right thigh.	Biological	MenACWY-CRM_12 M, MenACWY-CRM_6-12 M, MenC-CRM_12 M_MenACWY-CRM_18 M
MenC-CRMAlso: Meningococcal C conjugate vaccineOne dose (0.5 mL) of MenC-CRM was obtained by extemporaneous mixing just before injection of the lyophilized MenC component and a saline solvent, administered by IM injection into the arm region.	Biological	MenC-CRM_12 M_MenACWY-CRM_18 M
DTaP-Hib-IPVAlso: Combined vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type B and inactivated polio virus; Pentacel	Biological	MenACWY-CRM_12 M, MenACWY-CRM_6-12 M, MenC-CRM_12 M_MenACWY-CRM_18 M
PC7Also: Heptavalent conjugate pneumococcal; PrevnarOne dose (0.5 mL) of PC7, supplied in pre-filled syringe, administered by IM injection into the anterolateral area of the left thigh.	Biological	MenACWY-CRM_12 M, MenACWY-CRM_6-12 M, MenC-CRM_12 M_MenACWY-CRM_18 M
MMRAlso: Measles, mumps and rubella	Biological	MenACWY-CRM_12 M, MenACWY-CRM_6-12 M, MenC-CRM_12 M_MenACWY-CRM_18 M
Varicella	Biological	MenACWY-CRM_12 M, MenACWY-CRM_6-12 M, MenC-CRM_12 M_MenACWY-CRM_18 M

Primary outcome

Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule
Time frame: Before and 1 month after 2-dose or 1-dose schedule
Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM_6-12 M group) or 1-dose schedule administered at 12 months (MenACWY-CRM_12 M group)

9 secondary outcomes

Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule
Time frame: Before and 1 month after 2-dose or 1-dose schedule
Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule
Time frame: Before and 1 month after 2-dose or 1-dose schedule
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age
Time frame: Before and 1 month after MenC-CRM vaccination at 12 months
Geometric Mean hSBA Titers Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age
Time frame: Before and 1 month after MenC-CRM vaccination at 12 months
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age
Time frame: Before and 1 month after MenACWY-CRM vaccination at 18 months
hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age
Time frame: Before and 1 month after MenACWY-CRM vaccination at 18 months
Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age
Time frame: Before and 1 month after MenACWY-CRM vaccination at 18 months
hSBA GMT Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age
Time frame: Before and 1 month after MenACWY-CRM vaccination at 18 months
Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination
Time frame: From day 1 through day 7 after any vaccination

Results and safety

Results posted to the registry on 1 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_6-12 M	64	59
MenACWY-CRM_12 M	61	56
MenC-CRM_12 M_MenACWY-CRM_18 M	50	42

Primary outcome: Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule

Time frame: Before and 1 month after 2-dose or 1-dose schedule. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	MenACWY-CRM_6-12 M n = 55	MenACWY-CRM_12 M n = 54
Serogroup A - Prevaccination (N=50,53)	10 (3 to 22)	0 (0 to 7)
Serogroup A - Postvaccination (N=50,53)	88 (76 to 95)	74 (60 to 85)
Serogroup C - Prevaccination	85 (73 to 94)	2 (0.047 to 10)
Serogroup C - Postvaccination	100 (94 to 100)	96 (87 to 100)
Serogroup W - Prevaccination (N=40,41)	85 (70 to 94)	2 (0.062 to 13)
Serogroup W - Postvaccination (N=40,41)	100 (91 to 100)	95 (83 to 99)
Serogroup Y - Prevaccination (N=53,54)	72 (58 to 83)	0 (0 to 7)
Serogroup Y - Postvaccination (N=53,54)	100 (93 to 100)	78 (64 to 88)

Population analysed: Analysis was done on per protocol (PP) population, i.e subjects in the exposed population who received all the relevant doses of vaccines correctly; and provided evaluable serum samples at the relevant time points; and had no major protocol violation as defined prior to unblinding.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MenACWY-CRM_6-12M	3 of 64 (4.7%)	62 of 64 (96.9%)	Not reported
MenACWY-CRM_12M	2 of 61 (3.3%)	58 of 61 (95.1%)	Not reported
MenC-CRM_12M_MenACWY-CRM_18M	2 of 50 (4%)	50 of 50 (100%)	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.

Related trials for Meningococcal Meningitis

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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.

Scott Halperin, Dr. principal investigator

Novartis Vaccines & Diagnostics

Francisco Diaz-Mitoma, Dr. principal investigator

Novartis Vaccines

3 sites 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, MenC-CRM and DTaP-Hib-IPV in people with Meningococcal Meningitis, run by Novartis Vaccines at 3 sites in Canada.

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 14 inclusion and 20 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 Canada. 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 1 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 Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule (time frame: Before and 1 month after 2-dose or 1-dose schedule). 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 NCT00310856.

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.