Clinical trial NCT01000311: 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
Official title: A Phase 3, Randomized, Open Label, Controlled Multicenter Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Disease
Keywords: MenACWY conjugate vaccine in infants
Meningococcal vaccine in infants
MenACWY
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-10-23
Enrollment: 529
Sex: ALL
Minimum age (years): 55
Maximum age (years): 89
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 Criteria:

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

   1. medical history
   2. physical assessment
   3. clinical judgment of the investigator

Exclusion Criteria:

1. 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.
2. 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).
3. 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.
4. Subjects who had a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component.
5. 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.
6. Subjects who had any serious acute or chronic disease, neurological disease including seizures, congenital defects, or cytogenic disorders (e.g., Down syndrome).
7. Subjects who had a known or suspected autoimmune disease or persistent impairment/alteration of immune function.
8. Subjects who had a suspected or known HIV infection or were born to a mother known to be HIV positive.
9. Subjects who had ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation (including Hepatitis B immune globulin).
10. Subjects who had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
11. Subjects who with their parents/legal representatives were planning to leave the area of the study site before the end of the study period.
12. Subjects who had any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
13. 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.
14. Subjects who were relatives of site research staff working on this study.

Primary outcomes:
measure: Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
timeFrame: Baseline and one month after fourth-dose of MenACWY-CRM
Secondary outcomes:
measure: hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
timeFrame: Baseline and one month after fourth-dose of MenACWY-CRM
measure: Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
timeFrame: Baseline and one month after third infant dose of MenACWY-CRM
measure: hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM
timeFrame: Baseline and one month after third infant dose of MenACWY-CRM
measure: Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
timeFrame: One month after third dose of routine infant series vaccination
measure: Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone
timeFrame: One month after third dose of routine infant series vaccination
measure: Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone
timeFrame: One month after PCV toddler vaccination
measure: Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone
timeFrame: One month after PCV toddler vaccination
measure: Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination
timeFrame: Baseline and Six months after third infant dose of MenACWY-CRM
measure: Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination
timeFrame: Baseline and Six months after third infant dose of MenACWY-CRM
measure: Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
timeFrame: One month after MenACWY-CRM toddler vaccination
measure: Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
timeFrame: From day 1 to 18 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 37 Alabama Clinical Therapeutics LLC 52 Medical Park East Drive Suite 203
state: Alabama
city: Fayetteville
country: United States
facility: 15 Northwest Arkansas Pediatric Clinic 3383 N. Mana Court Suite 101
state: Arkansas
city: Jonesboro
country: United States
facility: 6 Children's Clinic of Jonesboro AR 800 South Church Street Suite 400 and 204
state: Arkansas
city: Canoga Park
country: United States
facility: 9 San Fernando Valley Research Associates 7111 Winnetka Avenue Suite 14
state: California
city: Fountain Valley
country: United States
facility: 17 Edinger Medical Group Research Center 9900 Talbert Avenue Suite 204
state: California
city: Madera
country: United States
facility: 28 Madera Family Medical Group 1111 West 4th Street
state: California
city: Paramount
country: United States
facility: 38 Center for Clinical Trials LLC 16660 Paramount Blvd Suite 301
state: California
city: Miami
country: United States
facility: 8 Pharmax Research Clinic 7200 NW 7th Street Suite 350
state: Florida
city: Topeka
country: United States
facility: 48 Cotton O'Neil Clinical Research Center 4100 SW 15th Street
state: Kansas
city: Topeka
country: United States
facility: 47 Cotton O'Neil Clinical Research Center 6725 SW 29th Street
state: Kansas
city: Bardstown
country: United States
facility: 29 Kentucky Pediatric/Adult Research 201 South 5th Street
state: Kentucky
city: Louisville
country: United States
facility: 4 Nassim McMonigle Mescia and Associates 5512 Bardstown Road Suite 2
state: Kentucky
city: Louisville
country: United States
facility: 40 Brownsboro Park Pediatrics 5512 Bardstown Road Suite 2
state: Kentucky
city: Louisville
country: United States
facility: 24 University Of Louisville 555 South Floyd Street
state: Kentucky
city: Louisville
country: United States
facility: 26 University Of Louisville 230 East Broadway
state: Kentucky
city: Springfield
country: United States
facility: 30 Kentucky Pediatric/Adult Research 102 West Depot Street
state: Kentucky
city: Haughton
country: United States
facility: 27 Ark-La-Tex Children's Clinic 1025 Highway 80 E
state: Louisiana
city: Shreveport
country: United States
facility: 13 Willis Knighton Physician Network- Portico Pediatrics 7847 Youree Drive
state: Louisiana
city: Niles
country: United States
facility: 35 Southwestern Medical Clinic P.C. 2002 S 11th Street
state: Michigan
city: Kansas City
country: United States
facility: 25 Center for Pharmaceutical Research 1010 Carondelet Drive Suite 426
state: Missouri
city: Cleveland
country: United States
facility: 31 Senders Pediatrics 2054 South Green Road
state: Ohio
city: Dayton
country: United States
facility: 5 Dayton Clinical Research 1100 Salem Ave.
state: Ohio
city: Huber Heights
country: United States
facility: 14 Ohio Pediatrics Research Association 7371 Brandt Pike Suite C
state: Ohio
city: Kettering
country: United States
facility: 22 Ohio Pediatrics Research Association 1775 Delco Park Drive
state: Ohio
city: Tulsa
country: United States
facility: 45 Oklahoma State University Physicians 635 W 11th St
state: Oklahoma
city: Pittsburgh
country: United States
facility: 33 Primary Physicians Research Inc. 1580 McLaughlin Run Road
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 34 Primary Physicians Research Inc. 1580 McLaughlin Run Road
state: Pennsylvania
city: Kingsport
country: United States
facility: 10 Holston Medical Group 105 W. Stone Drive Suite 3B
state: Tennessee
city: Lebanon
country: United States
facility: 23 Focus Research Group 201 Signature Place
state: Tennessee
city: Amarillo
country: United States
facility: 7 Amarillo Children's Clinical Research #17 Care Circle
state: Texas
city: Houston
country: United States
facility: 46 Pediatric Healthcare of Northwest Houston P.A. 12015 Louetta Road Suite 100
state: Texas
city: Tomball
country: United States
facility: 12 Pediatric Healthcare of Northwest Houston P.A. 13406 Medical Complex Drive Suite 200
state: Texas
city: Clinton
country: United States
facility: 16 Westside Medical 1477 North 2000 West
state: Utah
city: Layton
country: United States
facility: 42 Wee Care Pediatrics 934 S. Main Street Suite 8
state: Utah
city: Layton
country: United States
facility: 43 Wee Care Pediatrics 1580 W. Antelope Drive Suite 100
state: Utah
city: Provo
country: United States
facility: 19 Pediatric Care 1675 North Freedom Blvd Building 3
state: Utah
city: Roy
country: United States
facility: 44 Wee Care Pediatrics 5991 S. 3500 W Suite 100 Rock Run Plaza
state: Utah
city: South Jordan
country: United States
facility: 18 Copperview Medical Center 3556 West 9800 South
state: Utah
city: St. George
country: United States
facility: 39 Dixie Pediatrics 1240 E 100 S Suite 14
state: Utah
city: Syracuse
country: United States
facility: 41 Wee Care Pediatrics 1792 W. 1700 S. Suite 102
state: Utah
city: Richmond
country: United States
facility: 36 Dominion Medical Associates 304 East Leigh Street
state: Virginia
city: Charleston
country: United States
facility: 21 CAMC Health Education and Research Institute 3100 McCorkle Ave. S.E. Suite 806
state: West Virginia
city: Randwick
country: Australia
facility: 3 Sydney Children's Hospital Strasser Lab. Level 3 High Street
state: New South Wales
city: Herston
country: Australia
facility: 2 Royal Children's Hospital Herston Road
state: Queensland
city: Carlton
country: Australia
facility: 1 Murdoch Childrens Research Institute C/- School of Population Health The University of Melbourne
state: Victoria
city: Sudbury
country: Canada
facility: 20 Medicor Research Inc 359 Riverside Suite 200
state: Ontario
Study officials:
References: