A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months
NCT ID: NCT01000311
Last Updated: 2014-04-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
529 participants
INTERVENTIONAL
2009-11-30
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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MenACWY-CRM + Routine Vaccines
Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months of age.
Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
MenACWY-CRM
One dose (0.5 mL) of MenACWY conjugate vaccine supplied as an extemporaneous mixing just before injection of the lyophilized component (MenA) reconstituted with the liquid component (MenCWY) was administered at 2, 4, 6 and 12 months of age as IM injections in the anterolateral area of the thigh.
DTaP-IPV/Hib
IM injections of 3 doses of 0.5 mL each of DTaP-IPV/Hib supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh.
HBV
IM injections of 3 doses of 0.5 mL each of HBV supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh.
PCV
IM injections of 4 doses of 0.5 mL each of PCV supplied in prefilled vial were administered at 2, 4, 6 and 12 months of age in the anterolateral area of the thigh.
MMR
Subcutaneous (SC) injection of 1 dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 12 months of age in the anterolateral area of the thigh.
Routine Vaccines
Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
In addition subjects were offered a dose of MenACWY-CRM at 18 months as a benefit of participating in this study. However, blood was not drawn for immunogenicity analysis after this dose.
DTaP-IPV/Hib
IM injections of 3 doses of 0.5 mL each of DTaP-IPV/Hib supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh.
HBV
IM injections of 3 doses of 0.5 mL each of HBV supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh.
PCV
IM injections of 4 doses of 0.5 mL each of PCV supplied in prefilled vial were administered at 2, 4, 6 and 12 months of age in the anterolateral area of the thigh.
MMR
Subcutaneous (SC) injection of 1 dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 12 months of age in the anterolateral area of the thigh.
Interventions
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MenACWY-CRM
One dose (0.5 mL) of MenACWY conjugate vaccine supplied as an extemporaneous mixing just before injection of the lyophilized component (MenA) reconstituted with the liquid component (MenCWY) was administered at 2, 4, 6 and 12 months of age as IM injections in the anterolateral area of the thigh.
DTaP-IPV/Hib
IM injections of 3 doses of 0.5 mL each of DTaP-IPV/Hib supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh.
HBV
IM injections of 3 doses of 0.5 mL each of HBV supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh.
PCV
IM injections of 4 doses of 0.5 mL each of PCV supplied in prefilled vial were administered at 2, 4, 6 and 12 months of age in the anterolateral area of the thigh.
MMR
Subcutaneous (SC) injection of 1 dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 12 months of age in the anterolateral area of the thigh.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Documented written informed consent provided by the parent/legal representative after the nature of the study had been explained.
3. Parent/legal representative was available for all visits scheduled in the study.
4. Subjects were in good health as determined by:
1. medical history
2. physical assessment
3. clinical judgment of the investigator
Exclusion Criteria
2. Subjects who had a previous confirmed or suspected disease caused by N. meningitidis, C. diphtheriae, C. tetani, poliovirus, Hepatitis B, Hib, pneumococcus or B. pertussis (history of laboratory confirmed, or clinical condition of paroxysmal cough for a period of longer than or equal to 2 weeks associated with apnea or whooping).
3. Subjects who had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis, B. pertussis, Hib, C. diphtheriae, polio, or pneumococcal infection at any time since birth.
4. Subjects who had a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component.
5. Subjects who had experienced significant acute or chronic infection within the previous 7 days or have experienced fever (temperature ≥ 38.0°C \[100.4°F\]) within the previous 3 days.
6. Subjects who had any serious acute or chronic disease, neurological disease including seizures, congenital defects, or cytogenic disorders (e.g., Down syndrome).
7. Subjects who had a known or suspected autoimmune disease or persistent impairment/alteration of immune function.
8. Subjects who had a suspected or known HIV infection or were born to a mother known to be HIV positive.
9. Subjects who had ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation (including Hepatitis B immune globulin).
10. Subjects who had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
11. Subjects who with their parents/legal representatives were planning to leave the area of the study site before the end of the study period.
12. Subjects who had any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
13. Subjects who received any investigational agents or vaccines since birth or who expect to receive an investigational agent or vaccine prior to the completion of the study.
14. Subjects who were relatives of site research staff working on this study.
55 Days
89 Days
ALL
Yes
Sponsors
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Novartis Vaccines
INDUSTRY
Responsible Party
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Locations
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37 Alabama Clinical Therapeutics LLC 52 Medical Park East Drive Suite 203
Birmingham, Alabama, United States
15 Northwest Arkansas Pediatric Clinic 3383 N. Mana Court Suite 101
Fayetteville, Arkansas, United States
6 Children's Clinic of Jonesboro AR 800 South Church Street Suite 400 and 204
Jonesboro, Arkansas, United States
9 San Fernando Valley Research Associates 7111 Winnetka Avenue Suite 14
Canoga Park, California, United States
17 Edinger Medical Group Research Center 9900 Talbert Avenue Suite 204
Fountain Valley, California, United States
28 Madera Family Medical Group 1111 West 4th Street
Madera, California, United States
38 Center for Clinical Trials LLC 16660 Paramount Blvd Suite 301
Paramount, California, United States
8 Pharmax Research Clinic 7200 NW 7th Street Suite 350
Miami, Florida, United States
48 Cotton O'Neil Clinical Research Center 4100 SW 15th Street
Topeka, Kansas, United States
47 Cotton O'Neil Clinical Research Center 6725 SW 29th Street
Topeka, Kansas, United States
29 Kentucky Pediatric/Adult Research 201 South 5th Street
Bardstown, Kentucky, United States
4 Nassim McMonigle Mescia and Associates 5512 Bardstown Road Suite 2
Louisville, Kentucky, United States
40 Brownsboro Park Pediatrics 5512 Bardstown Road Suite 2
Louisville, Kentucky, United States
24 University Of Louisville 555 South Floyd Street
Louisville, Kentucky, United States
26 University Of Louisville 230 East Broadway
Louisville, Kentucky, United States
30 Kentucky Pediatric/Adult Research 102 West Depot Street
Springfield, Kentucky, United States
27 Ark-La-Tex Children's Clinic 1025 Highway 80 E
Haughton, Louisiana, United States
13 Willis Knighton Physician Network- Portico Pediatrics 7847 Youree Drive
Shreveport, Louisiana, United States
35 Southwestern Medical Clinic P.C. 2002 S 11th Street
Niles, Michigan, United States
25 Center for Pharmaceutical Research 1010 Carondelet Drive Suite 426
Kansas City, Missouri, United States
31 Senders Pediatrics 2054 South Green Road
Cleveland, Ohio, United States
5 Dayton Clinical Research 1100 Salem Ave.
Dayton, Ohio, United States
14 Ohio Pediatrics Research Association 7371 Brandt Pike Suite C
Huber Heights, Ohio, United States
22 Ohio Pediatrics Research Association 1775 Delco Park Drive
Kettering, Ohio, United States
45 Oklahoma State University Physicians 635 W 11th St
Tulsa, Oklahoma, United States
33 Primary Physicians Research Inc. 1580 McLaughlin Run Road
Pittsburgh, Pennsylvania, United States
34 Primary Physicians Research Inc. 1580 McLaughlin Run Road
Pittsburgh, Pennsylvania, United States
10 Holston Medical Group 105 W. Stone Drive Suite 3B
Kingsport, Tennessee, United States
23 Focus Research Group 201 Signature Place
Lebanon, Tennessee, United States
7 Amarillo Children's Clinical Research #17 Care Circle
Amarillo, Texas, United States
46 Pediatric Healthcare of Northwest Houston P.A. 12015 Louetta Road Suite 100
Houston, Texas, United States
12 Pediatric Healthcare of Northwest Houston P.A. 13406 Medical Complex Drive Suite 200
Tomball, Texas, United States
16 Westside Medical 1477 North 2000 West
Clinton, Utah, United States
42 Wee Care Pediatrics 934 S. Main Street Suite 8
Layton, Utah, United States
43 Wee Care Pediatrics 1580 W. Antelope Drive Suite 100
Layton, Utah, United States
19 Pediatric Care 1675 North Freedom Blvd Building 3
Provo, Utah, United States
44 Wee Care Pediatrics 5991 S. 3500 W Suite 100 Rock Run Plaza
Roy, Utah, United States
18 Copperview Medical Center 3556 West 9800 South
South Jordan, Utah, United States
39 Dixie Pediatrics 1240 E 100 S Suite 14
St. George, Utah, United States
41 Wee Care Pediatrics 1792 W. 1700 S. Suite 102
Syracuse, Utah, United States
36 Dominion Medical Associates 304 East Leigh Street
Richmond, Virginia, United States
21 CAMC Health Education and Research Institute 3100 McCorkle Ave. S.E. Suite 806
Charleston, West Virginia, United States
3 Sydney Children's Hospital Strasser Lab. Level 3 High Street
Randwick, New South Wales, Australia
2 Royal Children's Hospital Herston Road
Herston, Queensland, Australia
1 Murdoch Childrens Research Institute C/- School of Population Health The University of Melbourne
Carlton, Victoria, Australia
20 Medicor Research Inc 359 Riverside Suite 200
Greater Sudbury, Ontario, Canada
Countries
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Other Identifiers
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V59_33
Identifier Type: -
Identifier Source: org_study_id
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