Meningococcal InfectionsPhase 3NCT00616421
Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children
A Phase 3 study testing MenACWY-CRM and Licensed meningococcal ACWY vaccine in people with Meningococcal Infections, run by Novartis Vaccines at 68 sites in 2 countries.
Trial summary
To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine. Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Infections
- What is being tested?
- MenACWY-CRM and Licensed meningococcal ACWY vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,907 participants
- Where
- 68 sitesin 2 countries
- Study dates
- Mar 2008to Oct 2009
- 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 2-10 years of age children, inclusive and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent
- who are available for all visits and telephone calls scheduled for the study
- who are up-to-date with age-appropriate routine childhood vaccinations
Who cannot join
- whose parent or legal guardian is unwilling or unable to give written informed consent
- who had a previous or suspected disease caused by N. meningitidis;
- who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
- who have received any investigational agents or vaccines within 90 days prior to enrollment
- who have any serious acute, chronic or progressive disease
- who have epilepsy or any progressive neurological disease or history of Guillain Barré Syndrome
Show all 10Show fewer
- who have a history of anaphylaxis, serious vaccine reactions
- who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from
- who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
- who have Down's syndrome or other known cytogenic disorders
Trial locations and contacts
68 sites in 2 countries.
68 sites in 2 countries
United States52 sites
Kaiser Permanente - Aurora
Aurora, Colorado, 80012
Kentucky Pediatric Research Center
Bardstown, Kentucky, 40004
Children's Investigational Reserach Program
Bentonville, Arkansas, 72712
1st Allergy & Clinical Research
Centennial, Colorado, 80112
Dr. Senders and Associates
Cleveland, Ohio, 44121
Jean Brown Research
Clinton, Utah, 84015
Premier Health Research Center
Downey, California, 90241
Duke University Medical Center
Durham, North Carolina, 27704
Durham Pediatrics
Durham, North Carolina, 27704
Regional Pediatric Associates PA
Durham, North Carolina, 27704
Children's Health Care - West
Erie, Pennsylvania, 16505
Odyssey Research
Fargo, North Dakota, 58103
Benchmark Research Ft. Worth
Fort Worth, Texas, 76135
Kaiser Permanente - Fremont
Fremont, California, 94538
Kaiser Permanente - Fresno
Fresno, California, 93726
University Of Pittsburgh Medical Center
Greenville, Pennsylvania, 16125
Calcagno Research & Development
Gresham, Oregon, 97030
Family Healthcare Partners
Grove City, Pennsylvania, 16127
Kaiser Permanente - Hayward
Hayward, California, 94545
Jackson Clinic Professional Association
Jackson, Tennessee, 38305
Pediatric Associates of Latrobe
Latrobe, Pennsylvania, 15650
Wee Care Pediatrics
Layton, Utah, 84041
Arkansas Pediatric Research Group
Little Rock, Arkansas, 72205
Longmont Medical Research Network
Longmont, Colorado, 80501
Benchmark Research
Metairie, Louisiana, 70006
Cottonwood Pediatrics
Murray, Utah, 84107
Kaiser Permanente - Oakland
Oakland, California, 94611
Meridian Clinical Research LLC
Omaha, Nebraska, 68134
Pediatric Alliance PC
Pittsburgh, Pennsylvania, 15217
Pediatric Alliance PC
Pittsburgh, Pennsylvania, 15220
South Hills Pediatrics
Pittsburgh, Pennsylvania, 15227
Pediatric Alliance PC
Pittsburgh, Pennsylvania, 15236
Primary Physicians Research Inc.
Pittsburgh, Pennsylvania, 15237
Primary Physicians Research Inc.
Pittsburgh, Pennsylvania, 15241
Kaiser Permanente - Pleasanton
Pleasanton, California, 94566
Legacy Pediatrics
Rochester, New York, 14618
J. Lewis Research Inc.
Salt Lake City, Utah, 84109
J. Lewis Research Inc.
Salt Lake City, Utah, 84121
Jean Brown Research
Salt Lake City, Utah, 84124
Benchmark Research San Angelo
San Angelo, Texas, 76904
Kaiser Permanente - San Francisco
San Francisco, California, 94115
Kaiser Permanente - San Jose
San Jose, California, 95119
Copperview Medical Center
South Jordan, Utah, 84095
Rockwood Clinic
Spokane, Washington, 99202
Rockwood Clinic North
Spokane, Washington, 99218
Physicians to Children & Adolescents
Springfield, Kentucky, 40004
St. Louis University School of Medicine
St Louis, Missouri, 63104
1st Allergy & Clinical Research
Thornton, Colorado, 80233
Laurel Pediatrics
Uniontown, Pennsylvania, 15401
Family Practice Medical Associates South
Upper Saint Clair, Pennsylvania, 15241
Kaiser Permanente - Westminister
Westminister, Colorado, 80234
Children's Community Pediatrics
Wexford, Pennsylvania, 15090
Canada16 sites
Queen Elizabeth Hospital
Charlottetown, Prince Edward Island, C1A 8T5
Albion Finch Medical Centre
Etobicoke, Ontario, M9V 4B4
Medicor Research Inc.
Greater Sudbury, Ontario, P3E 1H5
Clinical Trials Research Center
Halifax, Nova Scotia, B3K 6R8
Children's Hospital of Western Ontario
London, Ontario, N6A 1V2
Commonwealth Medical Clinic
Mount Pearl, A1N 1W7
SKDS Research In.
Newmarket, Ontario, L3Y 5G8
Herridge Community Health Clinic
Ottawa, Ontario, K1S 0G8
Sarnia Institute of Clinical Research
Sarnia, Ontario, N7T 4X3
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
White Hills Medical Clinic
St. John's, A1A 3R5
TASC Research Services Inc.
Surrey, British Columbia, V3R 8P8
Resolve Research Solutions
Toronto, Ontario, M5G 1N8
Resolve Research Solutions
Toronto, Ontario, M5M 1B2
Colchester Regional Hospital
Truro, Nova Scotia, B2N 1L2
Manitoba Clinic
Winnipeg, Manitoba, R3A 1M3
About this study
Official title: A Phase 3, Randomized, Observer-blind, Multi-Center Study to Compare the Safety and Immunogenicity of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Conjugate Vaccine Administered to Healthy Children 2-10 Years of Age
To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.
- Conditions
- Meningococcal Infections
- Being tested
- MenACWY-CRM, Licensed meningococcal ACWY vaccine
- Keywords
- vaccine, children, healthy, meningitis, meningococcal, prevention of meningococcal disease serogroups ACWY, Menveo
- 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
Also called Menveo
1 injection of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly
MenACWY-CRMBiological
Also called Menveo
2 injections of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly to children 2 to 5 years of age
Licensed meningococcal ACWY vaccineBiological
Also called Menactra
1 injection of the licensed meningococcal ACWY was administered intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| MenACWY-CRM (1 dose) | Experimental | 1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study day 1. Receives: Biological: MenACWY-CRM |
| Licensed polysaccharide vaccine | Active comparator | 1 injection of a licensed meningococcal MenACWY polysaccharide-protein conjugate vaccine administered by intramuscular (IM) injection on study day 1 Receives: Biological: Licensed meningococcal ACWY vaccine |
| MenACWY-CRM (2 doses) | Experimental | 2 injections of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study days 1 and 61. Receives: Biological: MenACWY-CRM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.
Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Measured: 1 month postvaccination
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age.
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenatages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.
Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Measured: 1 month postvaccination
Secondary outcomes (11)
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age.
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.
Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Measured: 1 month postvaccination
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.
Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Measured: 1 month postvaccination
Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age.
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bactericidal Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y.
Measured: 1 month postvaccination
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age.
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenategs of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.
Measured: 1 month postvaccination
Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age.
The immunogenicity of a single dose of the Novartis MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bacterial Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y.
Measured: 1 month postvaccination
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose)
The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y.
Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Measured: 1 month postvaccination
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)
The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y.
Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Measured: 1 month postvaccination
GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)
The immunogenicity of two doses of the Novartis MenACWY-CRM vaccine, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM vaccine, in terms of hSBA (human Serum Bactericidal Activity) GMTs (Geometric Mean Titers) against N. meningitidis serogroups A, C, W-135, and Y.
ANOVA model used for the analysis of this outcome is different compare to ANOVA model used for the other outcome. The computed model components vary according to the variance observed due to the different datasets.
Measured: 1 month postvaccination
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.
Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group, after 1 dose treatment.
Measured: Study days 1 to 7
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.
Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group after 1 dose treatment.
Measured: Study days 1 to 7
Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment.
Safety was assessed in terms of the percentage of subjects with unsolicited AEs occurring throughout the entire study period, after 1 dose treatment.
Measured: day 1 to study termination (day 240)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionApr 2009
- Study completionOct 2009
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 InfectionsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,907 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines and Diagnostics, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616421
- Sponsor's protocol ID
- V59P20
- Other IDs
- 11278
- Status last verified
- Jan 2016
- First submitted
- 31 Jan 2008
- Last updated
- 15 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Halperin SA, Gupta A, Jeanfreau R, Klein NP, Reisinger K, Walter E, Bedell L, Gill C, Dull PM. Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age. Vaccine. 2010 Nov 23;28(50):7865-72. doi: 10.1016/j.vaccine.2010.09.092. Epub 2010 Oct 29.
PubMed 20943209
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Observer-blind, Multi-Center Study to Compare the Safety and Immunogenicity of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Conjugate Vaccine Administered to Healthy Children 2-10 Years of Age
- ClinicalTrials.gov ID
- NCT00616421
- Acronym / sponsor ID
- V59P20
- Conditions
- Meningococcal Infections
- Keywords
- vaccine, children, healthy, meningitis, meningococcal, prevention of meningococcal disease serogroups ACWY, Menveo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,907 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Posted 9 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MenACWY-CRM (1 dose) | Experimental | Biological: MenACWY-CRM1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study day 1. |
| Licensed polysaccharide vaccine | Active comparator | Biological: Licensed meningococcal ACWY vaccine1 injection of a licensed meningococcal MenACWY polysaccharide-protein conjugate vaccine administered by intramuscular (IM) injection on study day 1 |
| MenACWY-CRM (2 doses) | Experimental | Biological: MenACWY-CRM2 injections of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study days 1 and 61. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- healthy 2-10 years of age children, inclusive and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent
- who are available for all visits and telephone calls scheduled for the study
- who are up-to-date with age-appropriate routine childhood vaccinations
Key exclusion criteria (10 listed)
- whose parent or legal guardian is unwilling or unable to give written informed consent
- who had a previous or suspected disease caused by N. meningitidis;
- who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
- who have received any investigational agents or vaccines within 90 days prior to enrollment
- who have any serious acute, chronic or progressive disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MenACWY-CRMAlso: Menveo1 injection of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly | Biological | MenACWY-CRM (1 dose) |
| MenACWY-CRMAlso: Menveo2 injections of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly to children 2 to 5 years of age | Biological | MenACWY-CRM (2 doses) |
| Licensed meningococcal ACWY vaccineAlso: Menactra1 injection of the licensed meningococcal ACWY was administered intramuscularly | Biological | Licensed polysaccharide vaccine |
Primary outcome
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age
Time frame: 1 month postvaccination
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age.
Time frame: 1 month postvaccination
The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenatages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y. Seroresponse: For a subject with hSBA <1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
11 secondary outcomes
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age.
Time frame: 1 month postvaccination
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age
Time frame: 1 month postvaccination
Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age.
Time frame: 1 month postvaccination
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age.
Time frame: 1 month postvaccination
Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age.
Time frame: 1 month postvaccination
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose)
Time frame: 1 month postvaccination
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)
Time frame: 1 month postvaccination
GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)
Time frame: 1 month postvaccination
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.
Time frame: Study days 1 to 7
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.
Time frame: Study days 1 to 7
Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment.
Time frame: day 1 to study termination (day 240)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20943209Halperin SA, Gupta A, Jeanfreau R, Klein NP, Reisinger K, Walter E, Bedell L, Gill C, Dull PM. Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age. Vaccine. 2010 Nov 23;28(50):7865-72. doi: 10.1016/j.vaccine.2010.09.092. Epub 2010 Oct 29.
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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 and Diagnostics study director
Novartis
68 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MenACWY-CRM and Licensed meningococcal ACWY vaccine in people with Meningococcal Infections, run by Novartis Vaccines at 68 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 3 inclusion and 10 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 15 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in United States, 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 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 9 Jun 2011). 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?
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (time frame: 1 month postvaccination). 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 NCT00616421, 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 15 Feb 2016.