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

Completed · Phase 3

Conditions studied: Meningococcal Infections

In brief

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

Key facts

Study ID

NCT00626327

Run by

Novartis Vaccines

People needed

1630

Starts

2008-02-01

Expected to finish

2010-10-01

Last updated by the study team

2013-04-19

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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;

You may not qualify if…

• 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)
• 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

Where it is running

• Site 86 - Southeastern Pediatrics Associate, 364 Honeysuckle Road — Dothan, Alabama, United States
• Site 00 - Veritas Research LLC/ Stabler Clinic, 300 North College Street, — Greenville, Alabama, United States
• Site 42 - Drug Research and Analysis Corporation, 1758 Parkplace, Suite 200 — Montgomery, Alabama, United States
• Site 56 - Children's Investigational Research Program, LLC, 2719 SE I Street — Bentonville, Arkansas, United States
• Site 94 - Central Arkansas Pediatrics, 2425 Dave Ward Dr.; Suite 601 — Conway, Arkansas, United States
• Site 80 - The Children's Clinic of Jonesboro, 800 S. Church St; Suite 400; 4th Fl — Jonesboro, Arkansas, United States
• Site 49 - Arkansas Pediatric Clinical Research, 500 S. University; Suite 200 — Little Rock, Arkansas, United States
• Site 05 - Kaiser Permanente Pediatric Clinic 395 Hickory Blvd. 2nd Floor; Room 265 — Daly City, California, United States
• Site 08 - Kaiser Permanente Pediatric Clinic 4785 N. First Street 3rd Floor — Fresno, California, United States
• Site 70 - Loma Linda University, Department of Pediatrics, 11175 Campus Street; CP A1120 — Loma Linda, California, United States
• Site 71 - LLUHC Moreno Valley Pediatrics, 11401 Heacock Street — Moreno Valley, California, United States
• Site 34 - Children's Hospital and Research Center Oakland (CHRCO), Infectious Diseases Department, 747 52nd Street — Oakland, California, United States
• Site 72 - Children's Hospital of Orange Co. 455 South Main Street — Orange, California, United States
• Site 58 - Center for Clinical Trials, LLC 16660 Paramount Boulevard Suite 301 — Paramount, California, United States
• Site 59 - Center for Clinical Trials, LLC 16415 S. Colorado Avevue Suite 308 — Paramount, California, United States
• Site 04 - Kaiser Permanente Pediatric Clinic, 610 Walnut Street, Room 110 — Redwood City, California, United States
• Site 37 - Kaiser Permanente Pediatric Clinic 901 Nevin Ave. Room 1E24 — Richmond, California, United States
• Site 09 - Kaiser Permanente Pediatric Clinic 1840 Sierra Gardens Vaccine Studies — Roseville, California, United States
• Site 03 - Kaiser Permanente Pediatric Clinic, Point West Medical Offices, 1650 Response Road — Sacramento, California, United States
• Site 48 - Pediatric Infectious Diseases Admin 2516 Stockton Blvd.; Ticon II — Sacramento, California, United States
• Site 10 - Kaiser Permanente Pediatric Clinic 6600 Bruceville Road Pediatric Station C — Sacramento, California, United States
• Site 50 - Kaiser Permanente Pediatric Clinic 3925 Old Redwood Hwy — Santa Rosa, California, United States
• Site 24 - UCLA Center for Vaccine Research 1124 W Carson St. — Torrance, California, United States
• Site 07 - Kaiser Permanente Pediatric Clinic 975 Sereno Drive; 1st Floor MOB Pediatric Station 1 — Vallejo, California, United States
• Site 85 - Birmingham Pediatric Associates, 806 St. Vincent's Drive — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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