Clinical trial NCT00474526: A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants
Official title: A Phase 3, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningitis, Meningococcal
Keywords: Meningococcal
meningitis
vaccine
infants
Meningococcal meningitis
Meningococcal disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-05-17
Enrollment: 4545
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants.


Eligibility criteria: Inclusion Criteria:

* Healthy term 2-month-old infants for whom a parent/legal representative has given written informed consent.

Exclusion Criteria:

* Subjects with a previous or suspected disease caused by Neisseria meningitidis, Corynebacterium diphtheriae, Clostridium tetani, Poliovirus, Hepatitis B, Haemophilus influenzae type b (Hib), Pneumococcus or Bordetella pertussis; previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) or prior vaccination with Diptheria, Tetanus, Pertussis (acellular or whole cell), inactivated polio vaccineIPV or oral polio vaccineOPV, H. influenzae type b (Hib) or Pneumococcus; who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W-135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth; Any serious acute, chronic or progressive disease

Primary outcomes:
measure: Percentage of Subjects With hSBA Titer >=1:8 - US Subjects
timeFrame: 13 months of age (one month post-toddler vaccination)
measure: Geometric Mean hSBA Titers - US Subjects
timeFrame: 13 months of age (one month post-toddler vaccination)
Secondary outcomes:
measure: Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series
timeFrame: 7 days after vaccination
measure: Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series
timeFrame: 7 days after vaccination
measure: Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series
timeFrame: 7 days after vaccination
measure: Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age
timeFrame: 7 days after vaccination
measure: Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series
timeFrame: 7 days post vaccination
measure: Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series
timeFrame: 7 days post vaccination
measure: Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series
timeFrame: 7 days post-vaccination
measure: Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series
timeFrame: 7 days post-vaccination
measure: Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series
timeFrame: 7 days post-vaccination
measure: Geometric Mean hSBA Titers Post-infant Series - US Subjects
timeFrame: 7 months of age (one month post-infant series)
measure: Geometric Mean hSBA Titers Post-infant Series - LA Subjects
timeFrame: 7 months of age (one month post-infant series)
measure: Percentage of Subjects With hSBA Titer >=1:8 - US Subjects
timeFrame: 7 months of age (one month post-infant series)
measure: Percentage of Subjects With hSBA Titer >=1:4 - US Subjects
timeFrame: 7 months of age (one month post-infant series)
measure: Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects
timeFrame: 7 months of age (one month post-infant series)
measure: Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects
timeFrame: 7 months of age (one month post-infant series)
measure: Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects
timeFrame: 7 months of age (one month post-infant series)
measure: Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects
timeFrame: 7 months of age (one month post-infant series)
measure: Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects
timeFrame: 7 months of age (one month post-infant series)
measure: Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects
timeFrame: 7 months of age (one month post-infant series)
measure: Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject
timeFrame: 12 Months of Age (one month pre-toddler vaccination)
measure: Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject
timeFrame: 12 Months of Age (one month pre-toddler vaccination)
measure: Persistence Antibodies Geometric Mean Titers - US Subject
timeFrame: 12 Months of Age (one month pre-toddler vaccination)
measure: Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject
timeFrame: 12 or 16 Months of Age (one month pre-toddler vaccination)
measure: Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject
timeFrame: 12 or 16 Months of Age (one month pre-toddler vaccination)
measure: Persistence Antibodies Geometric Mean Titers - LA Subjects
timeFrame: 12 or 16 Months of Age (one month pre-toddler vaccination)
measure: Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects
timeFrame: 13 months of age (one month post-toddler vaccination)
measure: Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects
timeFrame: 13 months of age (one month post-toddler vaccination)
measure: Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects
timeFrame: 13 months of age (one month post-toddler vaccination)
measure: Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects
timeFrame: 13 months of age (one month post-toddler vaccination)
measure: Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects
timeFrame: 13 or 17 Months of Age (one month post-toddler vaccination)
measure: Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects
timeFrame: 13 or 17 Months of Age (one month post-toddler vaccination)
measure: Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects
timeFrame: 13 or 17 Months of Age (one month post-toddler vaccination)
measure: Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects
timeFrame: 13 or 17 Months of Age (one month post-toddler vaccination)
measure: Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects
timeFrame: 13 months of age (one month post-toddler vaccination)
measure: Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects
timeFrame: 13 months of age (one month post-toddler vaccination)
measure: Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects
timeFrame: 13 months of age (one month post-toddler vaccination)
measure: Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects
timeFrame: 13 months of age (one month post-toddler vaccination)
measure: Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects
timeFrame: 17 months of age (one month post-toddler vaccination)
measure: Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects
timeFrame: 17 months of age (one month post-toddler vaccination)
measure: Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects
timeFrame: 12 or 15 months of age (one month post 1st or 2nd toddler vaccination)
measure: Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects
timeFrame: 12 or 15 months of age (one month post 1st or 2nd toddler vaccination)
Other outcomes:
Locations:
city: Bessemer
country: United States
facility: Growing Up Pediatrics
state: Alabama
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics, LLC
state: Alabama
city: Birmingham
country: United States
facility: Growing Up Pediatrics
state: Alabama
city: Downey
country: United States
facility: Premier Health Research Center, LLC
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Oakland
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Med Group - Vaccine Study Ctr
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC
state: California
city: Pleasanton
country: United States
facility: Kaiser Permanente Pleasanton
state: California
city: Richmond
country: United States
facility: Kaiser Permanente Richmond
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente San Francisco
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Santa Clara
state: California
city: Torrence
country: United States
facility: UCLA Center for Vaccine Research
state: California
city: Aurora
country: United States
facility: The Children's Hospital
state: Colorado
city: Longmont
country: United States
facility: Longmont Medical Research Network
state: Colorado
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research Inc.
state: Kentucky
city: Annapolis
country: United States
facility: Annapolis Pediatrics
state: Maryland
city: Baltimore
country: United States
facility: Center for Vaccine Development
state: Maryland
city: Frederick
country: United States
facility: The Pediatric Center
state: Maryland
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: Fall River
country: United States
facility: Pediatric Associates of Fall River
state: Massachusetts
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
city: Omaha
country: United States
facility: Children's Physicians Dundee
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
city: Boardman
country: United States
facility: Louis P. Brine, Jr., MD, Beeghley Medical Park
state: Ohio
city: Cleveland
country: United States
facility: Senders Pediatric Research at Dr. Senders and Associates
state: Ohio
city: Carnegie
country: United States
facility: Carnegie Pediatrics
state: Pennsylvania
city: Erie
country: United States
facility: Children's Health Care - West
state: Pennsylvania
city: Greenville
country: United States
facility: UPMC/Community Medicine, Inc.
state: Pennsylvania
city: Grove City
country: United States
facility: Family Healthcare Partners
state: Pennsylvania
city: Harleyville
country: United States
facility: Pennridge Pediatric Associates
state: Pennsylvania
city: Latrobe
country: United States
facility: Pediatric Associates of Latrobe
state: Pennsylvania
city: Norristown
country: United States
facility: Pediatric Medical Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Squirrel Hill Office
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pediatric Alliance, Greentree Division
state: Pennsylvania
city: Pittsburgh
country: United States
facility: South Hills Pediatrics
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pediatric Alliance, Southwestern
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Primary Physicians Research, Inc
state: Pennsylvania
city: Rydal
country: United States
facility: Pediatrics Medical Associates
state: Pennsylvania
city: Sellersville
country: United States
facility: Pennridge Pediatric Associates
state: Pennsylvania
city: Uniontown
country: United States
facility: Laurel Pediatrics
state: Pennsylvania
city: Wexford
country: United States
facility: CCP - Pittsburgh Pediatrics
state: Pennsylvania
city: Madison
country: United States
facility: Goodlettsville Pediatrics
state: Tennessee
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Houston
country: United States
facility: Mercury Pharma Services
state: Texas
city: Temple
country: United States
facility: Scott and White Hospital
state: Texas
city: Layton
country: United States
facility: Wee Care Pediatrics
state: Utah
city: Orem
country: United States
facility: Utah Valley Pediatrics - Timpanogos
state: Utah
city: Salt Lake City
country: United States
facility: Foothill Family Clinic
state: Utah
city: South Jordan
country: United States
facility: Copperview Medical Center
state: Utah
city: Monroe
country: United States
facility: Monroe Medical Foundation
state: Wisconsin
city: Alvear 1439 PB Dpto, rio IV, Cordoba
country: Argentina
facility: CEDEPAP Rio IV
state: Cordoba
city: Castro Barros 650 - Barrio San Martin, Cordoba
country: Argentina
facility: Hospitales Materno Neonatal,
state: Cordoba
city: Mendoza n°2152, Villa Maria, Cordoba,
country: Argentina
facility: Hospital Regional Luis Pasteur,
state: Cordoba
city: Buenos Aires
country: Argentina
facility: Buenos Aires, Argentina
city: Cordoba
country: Argentina
facility: CdePAP, Centro De Desarrollo De Proyectos Avanzados Roma 1465,
city: Scalabrini Ortiz 676, Buenos Aires, Buenos Aires,
country: Argentina
facility: Centro Estudios Infect
city: Calle 1 #50-51
country: Colombia
facility: Siloe
state: Cali
city: Calle 6#5-42
country: Colombia
facility: Comfenalco
state: Cali
city: Calle 72U 28 F-00
country: Colombia
facility: Hospital C H Trujillo
state: Cali
city: Ped Calle 5B5 No.37 BIS-28
country: Colombia
facility: Corporation Cientifica
state: Cali
Study officials:
affiliation: Novartis Vaccines & Diagnostics
name: Novartis - Vaccines
role: STUDY_CHAIR
References:
citation: Klein NP, Reisinger KS, Johnston W, Odrljin T, Gill CJ, Bedell L, Dull P. Safety and immunogenicity of a novel quadrivalent meningococcal CRM-conjugate vaccine given concomitantly with routine vaccinations in infants. Pediatr Infect Dis J. 2012 Jan;31(1):64-71. doi: 10.1097/INF.0b013e31823dce5c.