A Phase 3b, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
A Phase 3b, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
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
Inclusion Criteria:
Exclusion Criteria:
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):
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.
Birmingham, Alabama 35205, United States
Tuscon, Arizona 85741, United States
Benton, Arkansas 72019, United States
Fayetteville, Arkansas 72703, United States
Jonesboro, Arkansas 72401, United States
Little Rock, Arkansas 72205, United States
Buena Park, California 90620, United States
Canoga Park, California 91306, United States
Dinuba, California 93618, United States
Downey, California 90241-4982, United States
Loma Linda, California 92354, United States
Loma Linda, California 92354, United States
Long Beach, California 90807, United States
Los Angeles, California 90015, United States
Oakland, California 94611, United States
Paramount, California 90723, United States
Pleasanton, California 94588, United States
San Francisco, California 94115, United States
Torrance, California 90502, United States
Torrance, California 90503, United States
West Covina, California 91790, United States
Orlando, Florida 32806, United States
Palm Beach Gardens, Florida 33410, United States
Dalton, Georgia 30721, United States
Marietta, Georgia 30062, United States
Woodstock, Georgia 30189, United States
Honolulu, Hawaii 96819, United States
Newton, Kansas 67114, United States
Louisville, Kentucky 40291, United States
Louisville, Kentucky 40291, United States
Ouisville, Kentucky 40202, United States
Springfield, Kentucky 40069, United States
Boston, Massachusetts 02130, United States
Fall River, Massachusetts 02724, United States
North Andover, Massachusetts 01845, United States
Woburn, Massachusetts 01801, United States
Stevensville, Michigan 49127, United States
Mineola, New York 11501, United States
Syracuse, New York 13210, United States
Raleigh, North Carolina 27609, United States
Raleigh, North Carolina 27612, United States
Winston-Salem, North Carolina 27103, United States
Barberton, Ohio 44203, United States
Youngstown, Ohio 44514, United States
Tulsa, Oklahoma 74127, United States
Beaverton, Oregon 97006, United States
Pittsburgh, Pennsylvania 15217, United States
Pittsburgh, Pennsylvania 15237, United States
Pittsburgh, Pennsylvania 15241, United States
Charleston, South Carolina 29406, United States
Ste C Clarksville, Tennessee 37043, United States
Fort Worth, Texas 76107, United States
Galveston, Texas 77555-0351, United States
San Antonio, Texas 78205, United States
San Antonio, Texas 78229, United States
George, Utah 84790, United States
Salt Lake City, Utah 84121, United States
South Jordan, Utah 84095, United States
Charlottesville, Virginia 22902, United States
Richmond, Virginia 23219, United States
Vancouver, Washington 98664, United States
Vancouver, Washington 98684, United States
Vancouver, Washington 98686, United States
Wenatchee, Washington 98801, United States
Kweishan, Taoyuan 333, Taiwan, China
Taipei, Taiwan 100, China
Taipei, Taiwan 104, China
Taipei, Taiwan, China
San José, Costa Rica, Costa Rica
San José, Costa Rica, Costa Rica
San José, Costa Rica, Costa Rica
San Vicente de Paul, Heredia, Costa Rica, Costa Rica
Guatemala City, Departamento de Guatemala CP 01011, Guatemala
Vista Hermosa I, Guatemala CP 01015, Guatemala
Guatemala City, Guatemala CP. 01011, Guatemala
Guatemala City, Guatemala Cp01010, Guatemala
Guatemala City, Guatemala Cp01010, Guatemala
Guatemala City, Guatemala. CP 01007, Guatemala
Chiriquí, Panama
Panama City, Panama
Via Cincuentenario, Panama
Lima Cercado, Lima 01, Peru
Huascar, San Juan de Lurigancho, Lima 36, Peru
Lima, Peru