Status:
COMPLETED
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
Lead Sponsor:
Novartis Vaccines
Conditions:
Meningococcal Disease
Eligibility:
All Genders
55-89 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
529 Patients enrolled
Trial Details
Trial ID
NCT01000311
Start Date
November 1 2009
End Date
November 1 2011
Last Update
April 21 2014
Active Locations (46)
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1
37 Alabama Clinical Therapeutics LLC 52 Medical Park East Drive Suite 203
Birmingham, Alabama, United States, 35235
2
15 Northwest Arkansas Pediatric Clinic 3383 N. Mana Court Suite 101
Fayetteville, Arkansas, United States, 72703
3
6 Children's Clinic of Jonesboro AR 800 South Church Street Suite 400 and 204
Jonesboro, Arkansas, United States, 72401
4
9 San Fernando Valley Research Associates 7111 Winnetka Avenue Suite 14
Canoga Park, California, United States, 91306