Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

Completed · Phase 3

Conditions studied: Meningitis, Meningococcal Infection

In brief

The primary objective of this phase 3b study is to evaluate the safety and tolerability of Novartis MenACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants

Key facts

Study ID

NCT00806195

Run by

Novartis

People needed

7744

Starts

2008-12-01

Expected to finish

2011-11-01

Last updated by the study team

2013-07-09

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• healthy 2-month-old infants (aged 55 - 89 days); babies must have been born after a full-term pregnancy with an estimated gestation age ≥37 weeks and a birth weight ≥2.5 kg
• for whom a parent/legal representative has given written informed consent after the nature of the study has been explained;
• who are available for all visits scheduled in the study;
• who are in good health as determined by medical history and physical assessment.

You may not qualify if…

• who previously received any meningococcal vaccine or D, T, P, IPV or OPV, H influenzae type b (Hib) or Pneumococcus; prior doses of BCG (one) and/or HBV (two) are permitted
• who have 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);
• who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N meningitidis (serogroups A, C, W135, or Y), B pertussis, Hib, C diphtheriae, Polio, or pneumococcal infection at any time since birth;
• who have a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
• who have experienced significant acute or chronic infection within the previous 7 days or have experienced fever (axillary temperature ≥ 38.0°C [100.4°F]) within the previous 3 days;
• who have any present or suspected serious acute (e.g. leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac disease, renal failure, severe malnutrition, or insulin dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down's syndrome);
• who have a known or suspected autoimmune disease or persistent impairment/alteration of immune function resulting from (for example):
• receipt of any immunosuppressive therapy at any time since birth
• receipt of immunostimulants at any time since birth
• receipt of any systemic corticosteroid since birth;
• who have a suspected or known HIV infection or HIV related disease;
• who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation;
• who have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
• who have any history of seizure;
• who with their parents/legal representatives are planning to leave the area of the study site before the end of the study period;
• who have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives;
• who have 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.
• who are relatives of site research staff working on this study.

Where it is running

• 43 Alabama Clinical Therapeutics, LLC 364 Honeysuckle Rd — Dothan, Alabama, United States
• 81 Cholla Pediatrics 2167 West Orange Grove Road — Tuscon, Arizona, United States
• 55 Central Arkansas Pediatric Clinic Pediatric 2301 Springhill Road Suite 200 — Benton, Arkansas, United States
• 21 Northwest Arkansas Pediatric Clinic 3383 N. MANA Court Suite 101 — Fayetteville, Arkansas, United States
• 30 Sparks Pediatric Clinic 1501 S. Waldron Road Suite 100 — Fort Smith, Arkansas, United States
• 14 The Children's Clinic of Jonesboro 800 S. Church Suite 400 — Jonesboro, Arkansas, United States
• 170 Little Rock Children's Clinic P.A. 9600 Lile Dr., Ste 360 — Little Rock, Arkansas, United States
• 3 Arkansas Pediatric Clinic 500 S. University Suite 200 — Little Rock, Arkansas, United States
• 179 Associated Pharmaceutical Research Center, Inc 8615 Knott Avenue Suite 5 — Buena Park, California, United States
• 160 San Fernando Valley Research Associates, Inc. 7111 Winnetka Ave. #14 — Canoga Park, California, United States
• 157 Universal Biopharma Research Institute Inc./Alta Family Health Clinic 888 N. Alta Ave. — Dinuba, California, United States
• 6 Alabama Clinical Therapeutics 806 St. Vincent's Drive, Ste 615 — Birmingham, Alabama, United States
• 43 Alabama Clinical Therapeutics, LLC 364 Honeysuckle Rd — Dothan, Alabama, United States
• 1 Premier Health Research Center, LLC 11525 Brookshire Ave Suite 400 — Downey, California, United States
• 68 Sierra Medical Research 5150 N. Sixth, Suite 156 — Fresno, California, United States
• 129 Citrus Vally Family Practice 1400 Hacienda Blvd — La Puente, California, United States
• 114 Loma Linda University Health 11175 Campus Street Coleman Pavillion A-1120 — Loma Linda, California, United States
• 59 Loma Linda University Health 11175 Campus Street Coleman Pavillion A-1120 — Loma Linda, California, United States
• 153 Health Care Partners Medical Group Health Care Partners Medical Group 4401 Atlantic Ave. — Long Beach, California, United States
• 94 Health Care Partners Medical Group 1025 W. Olympic Blvd. — Los Angeles, California, United States
• 67 Madera Family Medical Group 1111 West 4th Street — Madera, California, United States
• 121 Kaiser Permanente (Oakland) 3505 Broadway 6th floor — Oakland, California, United States
• 63 Kaiser Permanente Vaccine Study Center One Kaiser Plaza 16th Floor — Oakland, California, United States
• 42 Children's Hospital of Orange County 455 S. Main Street — Orange, California, United States
• 6 Alabama Clinical Therapeutics 806 St. Vincent's Drive, Ste 615 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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