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

Completed · Phase 3

Conditions studied: Meningococcal Disease

In brief

This Phase 3 study is designed to demonstrate the safety and immunogenicity of MenACWY and non-interference of concomitant routine vaccines by MenACWY in an infant age group.

Key facts

Study ID: NCT01000311
Run by: Novartis Vaccines
People needed: 529
Starts: 2009-11-01
Expected to finish: 2011-11-01
Last updated by the study team: 2014-04-21

Who can join

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

You may qualify if…

Two month-old infants, born after a full-term pregnancy with an estimated gestational age ≥37 weeks and a birth weight ≥2.5 kg.
Documented written informed consent provided by the parent/legal representative after the nature of the study had been explained.
Parent/legal representative was available for all visits scheduled in the study.
Subjects were in good health as determined by:
medical history
physical assessment
clinical judgment of the investigator

You may not qualify if…

Subjects who previously received any meningococcal vaccines or vaccines against diphtheria, tetanus, pertussis, polio (IPV or OPV), H. influenzae type b (Hib) or pneumococcus. Exceptions: prior doses HBV vaccination (one or two doses) are permitted.
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).
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.
Subjects who had a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component.
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.
Subjects who had any serious acute or chronic disease, neurological disease including seizures, congenital defects, or cytogenic disorders (e.g., Down syndrome).
Subjects who had a known or suspected autoimmune disease or persistent impairment/alteration of immune function.
Subjects who had a suspected or known HIV infection or were born to a mother known to be HIV positive.
Subjects who had ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation (including Hepatitis B immune globulin).
Subjects who had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Subjects who with their parents/legal representatives were planning to leave the area of the study site before the end of the study period.
Subjects who had any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
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.
Subjects who were relatives of site research staff working on this study.

Where it is running

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

Full record on ClinicalTrials.gov

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