Meningococcal InfectionsPhase 3NCT00626327

Safety and Immune Response of Novartis MenACWY-CRM Conjugate Vaccine When Given to Healthy Toddlers

A Phase 3 study testing MenACWY-CRM + MMRV, MMRV and MenACWY-CRM in people with Meningococcal Infections, run by Novartis Vaccines at 90 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Safety immune response of Novartis MenACWY-CRM conjugate vaccine when given to healthy toddlers Read more about this study

Who is it for?: Ages 7 months to 1 yearHealthy volunteers can take part
Conditions the study is for: Meningococcal Infections
What is being tested?: MenACWY-CRM + MMRV, MMRV and MenACWY-CRM
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,630 participants
Where: 90 sitesUnited States
Study dates: Feb 2008to Oct 2010
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 7 months to 1 year
All sexes
Healthy volunteers accepted
Child

Who may be able to join

who are healthy 7 to 9 months old or 12 months old (inclusive plus 14 days) and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent;
who have received complete primary vaccination with recommended licensed vaccines;
who are available for all visits and telephone calls scheduled for the study;

Who cannot join

whose parent or legal guardian is unwilling or unable to give written informed assent consent
who had a previous or suspected disease caused by N. meningitidis;
who had previous or suspected infection with measles, mumps, rubella, varicella, and/or herpes zoster;
who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment;
who had household contact with and/or intimate exposure to an individual with measles, mumps, rubella and/or varicella infection within 60 days prior to enrollment;
who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)

Show all 12Show fewer

who have previously received any measles, mumps, rubella or varicella vaccine either alone or in any combination;
who have received any investigational agents or vaccines within 90 days prior to enrollment or who expect to receive an investigational agent or vaccine prior to the completion of the study;
who have any serious acute, chronic or progressive disease such as, cancer, diabetes, heart failure, malnutrition, epilepsy, HIV/AIDS, Guillain Barre Syndrome
who have a history of anaphylaxis, serious vaccine reactions or allergy to any part of the vaccine,
who have a known or suspected impairment/alteration of immune function, either congenital or acquired
who have Down's syndrome or other known cytogenic disorders; bleeding diathesis

Trial locations and contacts

90 sites in 1 country.

City, postcode or hospital

90 sites in 1 country

United States90 sites

Site 82 - Austintown Pediatrics 107 Javit Court
Austintown, Ohio, 44515
Site 25 - Kentucky Pediatric/ Adult Research 201 South 5th Street Suite 102
Bardstown, Kentucky, 40004
Site 79 - Children's Physicians Bellevue 11507 S. 42nd Street
Bellevue, Nebraska, 68123
Site 56 - Children's Investigational Research Program, LLC, 2719 SE I Street
Bentonville, Arkansas, 72712
Site 85 - Birmingham Pediatric Associates, 806 St. Vincent's Drive
Birmingham, Alabama, 35205
Site 51 - Cincinnati Children's Hosp Med Ctr Gamble Program for Clinical Studies 3333 Burnet Avenue; MLC 6014
Cincinnati, Ohio, 45229
Site 81 - Alpha Clinical Research, LLC 279 Clear Sky Court; Suite C
Clarksville, Tennessee, 37043
Site 62 - Dr. Senders and Assoc., Pediatrics 2054 South Green Road
Cleveland, Ohio, 44121
Site 94 - Central Arkansas Pediatrics, 2425 Dave Ward Dr.; Suite 601
Conway, Arkansas, 72034
Site 52 - Cincinnati Children's Hosp Med Ctr Gamble Program for Clinical Studies 2865 Chancellor Drive
Crestview Hills, Kentucky, 41017
Site 05 - Kaiser Permanente Pediatric Clinic 395 Hickory Blvd. 2nd Floor; Room 265
Daly City, California, 94015
Site 97 - Dayton Clinical Research 1100 Salem Avenue
Dayton, Ohio, 45406
Site 35 - Caro Pediatric Center 111 Turner Road
Dayton, Ohio, 45415
Site 86 - Southeastern Pediatrics Associate, 364 Honeysuckle Road
Dothan, Alabama, 36305
Site 32 - Drexel Hill Pediatrics 5030 State Rd.; Suite 2-900
Drexel Hill, Pennsylvania, 19026
Site 28 - Duke Health Center at Roxboro Road 4020 North Roxboro Road
Durham, North Carolina, 27704
Site 29 - Regional Pediatrics 4022 Freedom Lake Drive
Durham, North Carolina, 27704
Site 30 - Durham Pediatrics 2609 North Duke Street Suite 100
Durham, North Carolina, 27704
Site 93 - ACC Pediatric Research 1025 Highway 80 East
East Haughton, Louisiana, 71037
Site 13 - Children's Health Care- West 4671 West Lake Road
Erie, Pennsylvania, 16505
Site 39 - Pediatric Associates of Fall River, 829 S. Main Street
Fall River, Massachusetts, 02724
Site 69 - University of North Texas Health Science Center 855 Montgomery Street
Fort Worth, Texas, 76107
Site 08 - Kaiser Permanente Pediatric Clinic 4785 N. First Street 3rd Floor
Fresno, California, 93726
Site 00 - Veritas Research LLC/ Stabler Clinic, 300 North College Street,
Greenville, Alabama, 36037
Site 15 - UPMC/ Community Medicine, Inc 90 Shenango Street
Greenville, Pennsylvania, 16125
Site 31 - Calcagno Research and Development 24850 SE Stark Street Suite 150
Gresham, Oregon, 97030
Site 11 - Focus Research Group 242 West Main
Hendersonville, Tennessee, 37075
Site 36 - Pediatric Healthcare of Northwest Houston P.A. 13406 Medical Complex Drive Suite 200
Houston, Texas, 77070
Site 26 - Ohio Pediatrics 7371 Brandt Pike; Suite C
Huber Heights, Ohio, 45424
Site 98 - University Physicians Internal Medicine 1600 Medical Center Drive
Huntington, West Virginia, 25701
Site 73 - University of MS Medical Ctr Pediatric Clinical Research 2500 North State St; 2 East-H255
Jackson, Mississippi, 39216
Site 38 - Jackson Clinic 2683 Highway 45 Bypass North
Jackson, Tennessee, 38305
Site 80 - The Children's Clinic of Jonesboro, 800 S. Church St; Suite 400; 4th Fl
Jonesboro, Arkansas, 72401
Site 27 - Ohio Pediatrics 1775 Delco Park Drive
Kettering, Ohio, 45420
Site 92 - Gundersen Clinic, Ltd. 1836 South Ave.; Mailstop C03-006B
La Crosse, Wisconsin, 54601
Site 19 - Pediatric Associates of Latrobe 210 Welson Street
Latrobe, Pennsylvania, 15650
Site 43 - Wee Care Pediatrics 1580 W. Antelope Drive; Suite 100
Layton, Utah, 84041
Site 45 - Wee Care Pediatrics 934 South Main St.; Suite 8
Layton, Utah, 84041
Site 49 - Arkansas Pediatric Clinical Research, 500 S. University; Suite 200
Little Rock, Arkansas, 72205
Site 70 - Loma Linda University, Department of Pediatrics, 11175 Campus Street; CP A1120
Loma Linda, California, 92350
Site 74 - University of Louisville University Child Health Specialists 230 East Broadway
Louisville, Kentucky, 40202
Site 87 - University of Louisville Children & Youth Project 555 South Floyd Street
Louisville, Kentucky, 40202
Site 88 - University of Louisville Univ. of Child Health Specialist So 9702 Stonestreet Road; Suite 100
Louisville, Kentucky, 40272
Site 57 - Bluegrass Clinical Research, Inc. 5512 Bardstown Rd; Suite 2
Louisville, Kentucky, 40291
Site 76 - Winthrop University Hospital Winthrop Pediatric Associates 120 Mineola Boulevard, Suite 210
Mineola, New York, 11501
Site 64 - Monroe Medical Foundation Monroe Clinic 515 22nd Avenue
Monroe, Wisconsin, 53566
Site 42 - Drug Research and Analysis Corporation, 1758 Parkplace, Suite 200
Montgomery, Alabama, 36106
Site 71 - LLUHC Moreno Valley Pediatrics, 11401 Heacock Street
Moreno Valley, California, 92557
Site 63 - Ochsner Clinic Foundations, 1315 Jefferson Highway
New Orleans, Louisiana, 70121
Site 96 - Southwestern Medical Clinic, PC 2002 South 11th Street
Niles, Michigan, 49120
Site 60 - Norwich Pediatric Group, PC 92 New London Turnpike
Norwich, Connecticut, 06360
Site 34 - Children's Hospital and Research Center Oakland (CHRCO), Infectious Diseases Department, 747 52nd Street
Oakland, California, 94618
Site 66 - Creighton University Department of Pediatrics 601 N. 30th St.; Suite 6820
Omaha, Nebraska, 68131
Site 78 - Children's Physicians Dundee 119 North 51st Street
Omaha, Nebraska, 68132
Site 72 - Children's Hospital of Orange Co. 455 South Main Street
Orange, California, 92868
Site 47 - Department of Clinical Trials 1401Lucerne Terrace; MP141
Orlando, Florida, 32806
Site 84 - Springs Medical Research, PLLC 2200 East Parrish Avenue Suite 101
Owensboro, Kentucky, 42303
Site 58 - Center for Clinical Trials, LLC 16660 Paramount Boulevard Suite 301
Paramount, California, 90723
Site 59 - Center for Clinical Trials, LLC 16415 S. Colorado Avevue Suite 308
Paramount, California, 90723
Site 18 - Squirrel Hill Office 4070 Beechwood Blvd
Pittsburgh, Pennsylvania, 15217
Site 21 - Pediatric Alliance Greentree Div. 969 Greentree Road Suite 100
Pittsburgh, Pennsylvania, 15220
Site 20 - South Hill Pediatrics 4411 Stilley Road
Pittsburgh, Pennsylvania, 15227
Site 17 - Pediatric Alliance, Southwestern, 850 Clairton Blvd
Pittsburgh, Pennsylvania, 15236
Site 83 - Pediatric Alliance, PC Arcadia Division 9000 Perry Hwy; Suite 120
Pittsburgh, Pennsylvania, 15237
Site 12 - Pediatric Alliance St. Clair 1580 McLaughlin Run Road
Pittsburgh, Pennsylvania, 15241
Site 04 - Kaiser Permanente Pediatric Clinic, 610 Walnut Street, Room 110
Redwood City, California, 94063
Site 37 - Kaiser Permanente Pediatric Clinic 901 Nevin Ave. Room 1E24
Richmond, California, 94801
Site 67 - Virginia Commonwealth Univ. 1001 East Marshall Street Room P008
Richmond, Virginia, 23219
Site 09 - Kaiser Permanente Pediatric Clinic 1840 Sierra Gardens Vaccine Studies
Roseville, California, 95661
Site 44 - Wee Care Pediatrics 5991 South 3500 West; Suite 100 Rock Run Plaza
Roy, Utah, 84067
Site 03 - Kaiser Permanente Pediatric Clinic, Point West Medical Offices, 1650 Response Road
Sacramento, California, 95815
Site 48 - Pediatric Infectious Diseases Admin 2516 Stockton Blvd.; Ticon II
Sacramento, California, 95817
Site 10 - Kaiser Permanente Pediatric Clinic 6600 Bruceville Road Pediatric Station C
Sacramento, California, 95823
Site 50 - Kaiser Permanente Pediatric Clinic 3925 Old Redwood Hwy
Santa Rosa, California, 95403
Site 55 - Children's Hosp. & Regional Med Ctr 4800 Sand Point Way NE; MS 5441
Seattle, Washington, 98105
Site 53 - Copperview Medical Center 3556 West 9800 South Suite 101
South Jordan, Utah, 84095
Site 06 - Rockwood Clinic, P.S. 400 East Fifth Avenue
Spokane, Washington, 99202
Site 46 - Rockwood Clinic North 9001 N. Country Homes Blvd
Spokane, Washington, 99218
Site 68 - Physicians to Children/ Adolescents 102 West Depot Street
Springfield, Kentucky, 40069
Site 89 - Southwestern Medical Clinic 5515 Cleveland Ave.; Suite 1
Stevensville, Michigan, 49127
Site 91 - SUNY Upstate Medical University 750 East Adams St,; Suite 5400
Syracuse, New York, 13210
Site 77 - Montefiore Medical Center 111 East 210th Street Rosenthall Building; 4th Floor
The Bronx, New York, 10467
Site 40 - 1st Allergy and Asthma Center 3260 E. 104th Ave.; Suite C
Thornton, Colorado, 80233
Site 41 - 1st Immunology & Clinical Research 3260 East 104th Avenue
Thornton, Colorado, 80233
Site 24 - UCLA Center for Vaccine Research 1124 W Carson St.
Torrance, California, 90502
Site 90 - OK State Univ-Ctr for Health Scienc Houston Parke Physicians 635 W. 11th StreetOklahoma State University - Center for Health Sciences
Tulsa, Oklahoma, 74127
Site 16 - Laurel Pediatrics 140 Wayland Smith Drive
Uniontown, Pennsylvania, 15401
Site 07 - Kaiser Permanente Pediatric Clinic 975 Sereno Drive; 1st Floor MOB Pediatric Station 1
Vallejo, California, 94589
Site 02 - Kaiser Permanente Pediatric Clinic, 1425 S. Main Street; MOB2, 4th Floor; Station 2
Walnut Creek, California, 94596
Site 14 - CCP - Pittsburgh Pediatrics 6000 Brooktree Road Suite 207
Wexford, Pennsylvania, 15090

Other trials in United States

About this study

Official title: A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity of MMRV Vaccine When Administered Concomitantly With Novartis Meningococcal ACWY Conjugate Vaccine to Healthy Toddlers

Safety immune response of Novartis MenACWY-CRM conjugate vaccine when given to healthy toddlers

Conditions: Meningococcal Infections
Being tested: MenACWY-CRM + MMRV, MMRV, MenACWY-CRM
Keywords: vaccine, toddlers, healthy, meningitis, meningococcal, measles, mumps, rubella, varicella, Prevention of Meningococcal disease types ACWY
Medical subject headings: Meningococcal Infections, Meningitis, Measles, Mumps, Rubella, Chickenpox

What participants receive

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

MenACWY-CRM + MMRVBiological
One injection of MenACWY-CRM vaccine at 7-9 months of age; the second injection of MenACWY-CRM vaccine concomitantly administered with MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age.
MMRVBiological
one injection of MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age
MenACWY-CRMBiological
Two injections of MenACWY-CRM at 7-9 months and 12 months of age; one injection of MMRV (Measles, Mumps, Rubella and Varicella) at 13.5 months of age

Study groups in NCT00626327
Study group	Role	What they receive
MenACWY-CRM+ MMRV	Experimental	Not described Receives: Biological: MenACWY-CRM + MMRV
MMRV	Active comparator	Not described Receives: Biological: MMRV
MenACWY-CRM	Experimental	Not described 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 a Seroresponse to Measles, Mumps, Rubella and Varicella Following Concomitant Administration of MMRV Vaccine With MenACWY-CRM Vaccine
Percentages of subjects with seroresponses to measles, mumps, rubella and varicella after one dose of MMRV vaccine (at 12 months) when given concomitantly with MenACWY-CRM vaccine compared to when MMRV vaccine was given alone, are reported.
Seroresponse was defined as the percentage of initially seronegative subjects who show seroconversion to measles (≥255 mIU/mL), mumps (≥10 ELISA Ab units), rubella (≥10 IU/mL) and the percentage of initially seronegative subjects who show seroprotection (≥5 gp ELISA units/mL) for varicella.
Immunogenicity to measles, mumps, rubella and varicella at 6 weeks after vaccination with one dose of MMRV given concomitantly with MenACWY-CRM was considered non-inferior to immunogenicity of MMRV administered alone if the lower limit of two-sided 95% CI of the difference in the percentage of subjects with seroconversion for measles, mumps, and rubella, and seroprotection for varicella was greater than -5% (measles, mumps and rubella) and -10% (varicella).
Measured: 6 weeks post vaccination
Percentages of Subjects With Serum Bactericidal Titers ≥1:8 Following Concomitant Administration of MenACWY-CRM Vaccine With MMRV Vaccine.
Percentages of subjects with hSBA ≥1:8, against N.meningitidis serogroups A, C, W-135, and Y following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months) when concomitantly administered with MMRV vaccine (12 months) compared to when MenACWY-CRM vaccine was given alone, are reported.
The serum bactericidal antibodies directed against N.meningitidis serogroups A, C, W-135, and Y, were measured by human complement Serum Bactericidal Assay (hSBA).
The immune response of MenACWY-CRM given concomitantly with MMRV was considered non-inferior to the immunogenicity of MenACWY-CRM administered alone if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12-month old toddlers {P MMRV+MenACWY minus P MenACWY} was greater than -10% for each serogroup.
Measured: 6 weeks post second dose
Percentages of Subjects With hSBA ≥1:8 Following Two Doses of MenACWY-CRM Vaccine
The antibody response following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months) was considered adequate if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA ≥1:8, at 6 weeks following the second dose of MenACWY-CRM, was greater than 85% for serogroups C, W-135, or Y and greater than 65% for serogroup A.
Measured: 6 weeks post vaccine dose 2

Secondary outcomes (8)

Percentages of Subjects With hSBA ≥1:4 After Two Doses of MenACWY-CRM Vaccine
The percentages of subjects with hSBA ≥1:4 directed against N. meningitidis serogroups A, C, W-135, and Y following two doses of MenACWY-CRM vaccine (at 7-9 and 12 months of age) when given concomitantly with MMRV vaccine (at 12 months) compared to when MenACWY-CRM vaccine was given alone, are reported.
Measured: 6 weeks post vaccine dose 2
Geometric Mean Titers Against Serogroups A, C, W-135 and Y, Following Two Doses of MenACWY-CRM Vaccine
The geometric mean titers (GMTs) directed against N.meningitidis serogroups A, C, W-135 and Y, following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months of age), when given concomitantly with MMRV vaccine (at 12 months) compared to when MenACWY-CRM vaccine was given alone, are reported.
Measured: 6 weeks post vaccine dose 2
Geometric Mean Titers Against Measles, Mumps, Rubella and Varicella Following One Dose of MMRV Vaccine.
The GMTs directed against measles, mumps, rubella and varicella, following one dose of MMRV vaccine (at 12 months) when given concomitantly with MenACWY-CRM vaccine compared to when MMRV vaccine was given alone, are reported.
Measured: 6 weeks post vaccination
Percentages of Subjects Showing Seroconversion Response to Varicella Following Concomitant Administration of MMRV With MenACWY-CRM Vaccine.
The percentages of subjects showing seroconversion response to varicella after concomitant administration of MMRV vaccine (at 12 months) with MenACWY-CRM vaccine compared to when MMRV vaccine is given alone, is reported .
Seroconversion for varicella is defined as percentage of subjects who show pre-vaccination antibody titer <1.25 gp ELISA units/mL to a post-vaccination antibody titer ≥1.25 gp ELISA units/mL.
Measured: 6 weeks post vaccination
Percentages of Subjects With hSBA ≥1:4 and hSBA ≥1:8 Following One Dose of MenACWY-CRM Vaccine
The percentages of subjects with hSBA ≥1:4 and hSBA ≥1:8 after one dose of MenACWY-CRM vaccine (at 7-9 months), are reported
Measured: 1 month post vaccine dose 1
Geometric Mean Titers After One Dose of MenACWY-CRM Vaccine
The immunogenicity of one dose of MenACWY-CRM vaccine given at 7 to 9 months of age was assessed in terms of GMTs directed against N.meningitidis serogroups A, C, W-135, and Y.
Measured: 1 month post vaccine dose 1
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination
Safety and tolerability of MenACWY-CRM and MMRV vaccines when given concomitantly compared to when either MenACWY-CRM or MMRV vaccine was administered alone is reported in terms of the number of subjects with local and systemic adverse events after vaccination.
Systemic reactions including axillary temperature reported during 28 days after vaccination at 12 months of age. These included the following systemic reactions: Measles-like rash, Rubella-like rash, Varicellalike rash, injection site rash, Mumps-like symptoms and axillary temperature.
Measured: upto 7 days after any vaccination
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination
The safety profile of MenACWY-CRM and MMRV vaccines when given concomitantly as compared to when MenACWY-CRM or MMRV was given alone is reported in terms of number of subjects reporting unsolicited adverse events (AEs), medically significant adverse events and serious adverse events (SAEs) after vaccination.
Measured: Day 1- Day 180 (Through out the study)

Timeline

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

Feb 2008Oct 2010

First posted29 Feb 2008 (estimated)
Study startFeb 2008
Primary completionJul 2010
Study completionOct 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.
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: Single group
Masking: None (open label)
Enrolment: 1,630 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00626327
Sponsor's protocol ID: V59P21
Other IDs: BB-IND 11278
Status last verified: Apr 2013
First submitted: 20 Feb 2008
Last updated: 19 Apr 2013
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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All Meningococcal Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity of MMRV Vaccine When Administered Concomitantly With Novartis Meningococcal ACWY Conjugate Vaccine to Healthy Toddlers
ClinicalTrials.gov ID: NCT00626327
Acronym / sponsor ID: V59P21
Conditions: Meningococcal Infections
Keywords: vaccine, toddlers, healthy, meningitis, meningococcal, measles, mumps, rubella
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,630 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Jul 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 29 Feb 2008 (estimated)
Results: Posted 15 Mar 2013

Clinical summary

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

Safety immune response of Novartis MenACWY-CRM conjugate vaccine when given to healthy toddlers

Study design

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

Arm	Type	Receives
MenACWY-CRM+ MMRV	Experimental	Biological: MenACWY-CRM + MMRV
MMRV	Active comparator	Biological: MMRV
MenACWY-CRM	Experimental	Biological: MenACWY-CRM

Who may qualify

Ages: 7 months to 1 year
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

who are healthy 7 to 9 months old or 12 months old (inclusive plus 14 days) and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent;
who have received complete primary vaccination with recommended licensed vaccines;
who are available for all visits and telephone calls scheduled for the study;

Key exclusion criteria (12 listed)

whose parent or legal guardian is unwilling or unable to give written informed assent consent
who had a previous or suspected disease caused by N. meningitidis;
who had previous or suspected infection with measles, mumps, rubella, varicella, and/or herpes zoster;
who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment;
who had household contact with and/or intimate exposure to an individual with measles, mumps, rubella and/or varicella infection within 60 days prior to enrollment;

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 + MMRVOne injection of MenACWY-CRM vaccine at 7-9 months of age; the second injection of MenACWY-CRM vaccine concomitantly administered with MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age.	Biological	MenACWY-CRM+ MMRV
MMRVone injection of MMRV (Measles, Mumps, Rubella and Varicella) vaccine at 12 months of age	Biological	MMRV
MenACWY-CRMTwo injections of MenACWY-CRM at 7-9 months and 12 months of age; one injection of MMRV (Measles, Mumps, Rubella and Varicella) at 13.5 months of age	Biological	MenACWY-CRM

Primary outcome

Percentages of Subjects With a Seroresponse to Measles, Mumps, Rubella and Varicella Following Concomitant Administration of MMRV Vaccine With MenACWY-CRM Vaccine
Time frame: 6 weeks post vaccination
Percentages of subjects with seroresponses to measles, mumps, rubella and varicella after one dose of MMRV vaccine (at 12 months) when given concomitantly with MenACWY-CRM vaccine compared to when MMRV vaccine was given alone, are reported. Seroresponse was defined as the percentage of initially seronegative subjects who show seroconversion to measles (≥255 mIU/mL), mumps (≥10 ELISA Ab units), rubella (≥10 IU/mL) and the percentage of initially seronegative subjects who show seroprotection (≥5 gp ELISA units/mL) for varicella. Immunogenicity to measles, mumps, rubella and varicella at 6 weeks after vaccination with one dose of MMRV given concomitantly with MenACWY-CRM was considered non-inferior to immunogenicity of MMRV administered alone if the lower limit of two-sided 95% CI of the difference in the percentage of subjects with seroconversion for measles, mumps, and rubella, and seroprotection for varicella was greater than -5% (measles, mumps and rubella) and -10% (varicella).
Percentages of Subjects With Serum Bactericidal Titers ≥1:8 Following Concomitant Administration of MenACWY-CRM Vaccine With MMRV Vaccine.
Time frame: 6 weeks post second dose
Percentages of subjects with hSBA ≥1:8, against N.meningitidis serogroups A, C, W-135, and Y following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months) when concomitantly administered with MMRV vaccine (12 months) compared to when MenACWY-CRM vaccine was given alone, are reported. The serum bactericidal antibodies directed against N.meningitidis serogroups A, C, W-135, and Y, were measured by human complement Serum Bactericidal Assay (hSBA). The immune response of MenACWY-CRM given concomitantly with MMRV was considered non-inferior to the immunogenicity of MenACWY-CRM administered alone if the lower limit of the two-sided 95% CI around the difference of the percentage of subjects with hSBA ≥1:8 at 6 weeks after the second dose of MenACWY-CRM given to 12-month old toddlers {P MMRV+MenACWY minus P MenACWY} was greater than -10% for each serogroup.
Percentages of Subjects With hSBA ≥1:8 Following Two Doses of MenACWY-CRM Vaccine
Time frame: 6 weeks post vaccine dose 2
The antibody response following two doses of MenACWY-CRM vaccine (at 7-9 months and 12 months) was considered adequate if the lower limit of the two-sided 95% CI for the percentage of subjects with hSBA ≥1:8, at 6 weeks following the second dose of MenACWY-CRM, was greater than 85% for serogroups C, W-135, or Y and greater than 65% for serogroup A.

8 secondary outcomes

Percentages of Subjects With hSBA ≥1:4 After Two Doses of MenACWY-CRM Vaccine
Time frame: 6 weeks post vaccine dose 2
Geometric Mean Titers Against Serogroups A, C, W-135 and Y, Following Two Doses of MenACWY-CRM Vaccine
Time frame: 6 weeks post vaccine dose 2
Geometric Mean Titers Against Measles, Mumps, Rubella and Varicella Following One Dose of MMRV Vaccine.
Time frame: 6 weeks post vaccination
Percentages of Subjects Showing Seroconversion Response to Varicella Following Concomitant Administration of MMRV With MenACWY-CRM Vaccine.
Time frame: 6 weeks post vaccination
Percentages of Subjects With hSBA ≥1:4 and hSBA ≥1:8 Following One Dose of MenACWY-CRM Vaccine
Time frame: 1 month post vaccine dose 1
Geometric Mean Titers After One Dose of MenACWY-CRM Vaccine
Time frame: 1 month post vaccine dose 1
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination
Time frame: upto 7 days after any vaccination
Number of Subjects Reporting Unsolicited Adverse Events After Vaccination
Time frame: Day 1- Day 180 (Through out the study)

Results and safety

Results posted to the registry on 15 Mar 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+ MMRV	504	426
MMRV	616	557
MenACWY-CRM	510	422

Primary outcome: Percentages of Subjects With a Seroresponse to Measles, Mumps, Rubella and Varicella Following Concomitant Administration of MMRV Vaccine With MenACWY-CRM Vaccine

Time frame: 6 weeks post vaccination. Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	MenACWY-CRM+ MMRV n = 370	MMRV n = 515
Measles (N=350,467)	98 (96 to 99)	99 (98 to 100)
Mumps (N=365,499)	98 (96 to 99)	96 (94 to 98)
Rubella	95 (93 to 97)	97 (95 to 98)
Varicella (N=337,459)	96 (94 to 98)	98 (96 to 99)

MenACWY-CRM+ MMRV vs MMRV: Difference % (MenACWY-CRM+MMRV-MMRV): -1 (95% CI -3.4 to 0.5)
MenACWY-CRM+ MMRV vs MMRV: Difference % (MenACWY-CRM+MMRV - MMRV ): 1 (95% CI -1 to 3.7)
MenACWY-CRM+ MMRV vs MMRV: Difference% (MenACWY-CRM+MMRV-MMRV): -2 (95% CI -4.5 to 0.8)

Population analysed: The analysis was performed on the MMRV per-protocol population

Primary outcome: Percentages of Subjects With Serum Bactericidal Titers ≥1:8 Following Concomitant Administration of MenACWY-CRM Vaccine With MMRV Vaccine.

Time frame: 6 weeks post second dose. Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	MenACWY-CRM+ MMRV n = 384	MenACWY-CRM n = 379
Serogroup A	88 (84 to 91)	88 (84 to 91)
Seroroup C (N=204,195)	100 (98 to 100)	100 (98 to 100)
Sergroup W-135 (N=204,196)	100 (97 to 100)	98 (96 to 100)
Serogroup Y (N=200,198)	98 (95 to 99)	96 (93 to 99)

MenACWY-CRM+ MMRV vs MenACWY-CRM: Difference% (MenACWY-CRM+MMRV-MenACWY): 0 (95% CI -4.7 to 4.5)
MenACWY-CRM+ MMRV vs MenACWY-CRM: Difference% (MenACWY-CRM+MMRV-MenACWY): 0 (95% CI -1.8 to 1.9)
MenACWY-CRM+ MMRV vs MenACWY-CRM: Difference% (MenACWY-CRM+MMRV-MenACWY): 1 (95% CI -1.3 to 3.9)

Population analysed: The analysis was performed on the MenACWY per-protocol population

Primary outcome: Percentages of Subjects With hSBA ≥1:8 Following Two Doses of MenACWY-CRM Vaccine

Time frame: 6 weeks post vaccine dose 2. Number (95% Confidence Interval). Unit: Percentages of subjects

Measure	MenACWY-CRM n = 379
Serogroup A	88 (84 to 91)
Serogroup C (N=195)	100 (98 to 100)
Serogroup W-135 (N=196)	98 (96 to 100)
Serogroup Y (N=198)	96 (93 to 99)

Population analysed: The analysis was performed on the MenACWY per-protocol population

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (Day 1-Day 180).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MenACWY-CRM+ MMRV	18 of 500 (3.6%)	433 of 500 (86.6%)	Not reported
MMRV	9 of 597 (1.5%)	482 of 597 (80.7%)	Not reported
MenACWY-CRM	19 of 500 (3.8%)	442 of 500 (88.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

90 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 + MMRV, MMRV and MenACWY-CRM in people with Meningococcal Infections, run by Novartis Vaccines at 90 sites in United States.

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 12 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 19 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 sites in United States. 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 15 Mar 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?

Percentages of Subjects With a Seroresponse to Measles, Mumps, Rubella and Varicella Following Concomitant Administration of MMRV Vaccine With MenACWY-CRM Vaccine (time frame: 6 weeks post vaccination). The study lists 3 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 NCT00626327.

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 19 Apr 2013.