Meningitis, Meningococcal Clinical Trial
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
Verified date | February 2014 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 4545 |
Est. completion date | November 2009 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Months to 2 Months |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Argentina | CEDEPAP Rio IV | Alvear 1439 PB Dpto, rio IV, Cordoba | Cordoba |
Argentina | Buenos Aires, Argentina | Buenos Aires | |
Argentina | Hospitales Materno Neonatal, | Castro Barros 650 - Barrio San Martin, Cordoba | Cordoba |
Argentina | CdePAP, Centro De Desarrollo De Proyectos Avanzados Roma 1465, | Cordoba | |
Argentina | Hospital Regional Luis Pasteur, | Mendoza n°2152, Villa Maria, Cordoba, | Cordoba |
Argentina | Centro Estudios Infect | Scalabrini Ortiz 676, Buenos Aires, Buenos Aires, | |
Colombia | Siloe | Calle 1 #50-51 | Cali |
Colombia | Comfenalco | Calle 6#5-42 | Cali |
Colombia | Hospital C H Trujillo | Calle 72U 28 F-00 | Cali |
Colombia | Corporation Cientifica | Ped Calle 5B5 No.37 BIS-28 | Cali |
United States | Akron Children's Hospital | Akron | Ohio |
United States | Annapolis Pediatrics | Annapolis | Maryland |
United States | The Children's Hospital | Aurora | Colorado |
United States | Center for Vaccine Development | Baltimore | Maryland |
United States | Kentucky Pediatric/Adult Research Inc. | Bardstown | Kentucky |
United States | Growing Up Pediatrics | Bessemer | Alabama |
United States | Alabama Clinical Therapeutics, LLC | Birmingham | Alabama |
United States | Growing Up Pediatrics | Birmingham | Alabama |
United States | Louis P. Brine, Jr., MD, Beeghley Medical Park | Boardman | Ohio |
United States | Boston University Medical Center | Boston | Massachusetts |
United States | Montefiore Medical Center | Bronx | New York |
United States | Carnegie Pediatrics | Carnegie | Pennsylvania |
United States | Children's Memorial Hospital | Chicago | Illinois |
United States | Senders Pediatric Research at Dr. Senders and Associates | Cleveland | Ohio |
United States | Research Across America | Dallas | Texas |
United States | Premier Health Research Center, LLC | Downey | California |
United States | Children's Health Care - West | Erie | Pennsylvania |
United States | Pediatric Associates of Fall River | Fall River | Massachusetts |
United States | The Pediatric Center | Frederick | Maryland |
United States | UPMC/Community Medicine, Inc. | Greenville | Pennsylvania |
United States | Family Healthcare Partners | Grove City | Pennsylvania |
United States | Pennridge Pediatric Associates | Harleyville | Pennsylvania |
United States | Mercury Pharma Services | Houston | Texas |
United States | Pediatric Associates of Latrobe | Latrobe | Pennsylvania |
United States | Wee Care Pediatrics | Layton | Utah |
United States | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire |
United States | Longmont Medical Research Network | Longmont | Colorado |
United States | Goodlettsville Pediatrics | Madison | Tennessee |
United States | Monroe Medical Foundation | Monroe | Wisconsin |
United States | Pediatric Medical Associates | Norristown | Pennsylvania |
United States | Kaiser Permanente Med Group - Vaccine Study Ctr | Oakland | California |
United States | Kaiser Permanente Oakland | Oakland | California |
United States | Children's Physicians Dundee | Omaha | Nebraska |
United States | Creighton University | Omaha | Nebraska |
United States | Utah Valley Pediatrics - Timpanogos | Orem | Utah |
United States | Center for Clinical Trials, LLC | Paramount | California |
United States | Pediatric Alliance, Greentree Division | Pittsburgh | Pennsylvania |
United States | Pediatric Alliance, Southwestern | Pittsburgh | Pennsylvania |
United States | Primary Physicians Research, Inc | Pittsburgh | Pennsylvania |
United States | South Hills Pediatrics | Pittsburgh | Pennsylvania |
United States | Squirrel Hill Office | Pittsburgh | Pennsylvania |
United States | Kaiser Permanente Pleasanton | Pleasanton | California |
United States | Kaiser Permanente Richmond | Richmond | California |
United States | Pediatrics Medical Associates | Rydal | Pennsylvania |
United States | Foothill Family Clinic | Salt Lake City | Utah |
United States | Kaiser Permanente San Francisco | San Francisco | California |
United States | Kaiser Permanente Santa Clara | Santa Clara | California |
United States | Pennridge Pediatric Associates | Sellersville | Pennsylvania |
United States | Copperview Medical Center | South Jordan | Utah |
United States | Scott and White Hospital | Temple | Texas |
United States | UCLA Center for Vaccine Research | Torrence | California |
United States | Laurel Pediatrics | Uniontown | Pennsylvania |
United States | CCP - Pittsburgh Pediatrics | Wexford | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Novartis Vaccines |
United States, Argentina, Colombia,
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): — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Subjects With hSBA Titer >=1:8 - US Subjects | Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age | 13 months of age (one month post-toddler vaccination) | |
Primary | Geometric Mean hSBA Titers - US Subjects | Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age. | 13 months of age (one month post-toddler vaccination) | |
Secondary | Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series | Solicited local and systemic reactions post first vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines. | 7 days after vaccination | |
Secondary | Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series | Solicited local and systemic reactions post second vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines. | 7 days after vaccination | |
Secondary | Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series | Solicited local and systemic reactions post third vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines. | 7 days after vaccination | |
Secondary | Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age | Solicited local and systemic reactions after receiving MenACWY-CRM vaccination at 12 months of age were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines. | 7 days after vaccination | |
Secondary | Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series | Solicited local and systemic reactions post first vaccination of toddler series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines. | 7 days post vaccination | |
Secondary | Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series | Solicited local and systemic reactions post second vaccination of toddler series at 15 months of age. | 7 days post vaccination | |
Secondary | Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series | Solicited local and systemic reactions reported post first vaccination was compared in subjects receiving MenACWY versus Hib Vaccines. | 7 days post-vaccination | |
Secondary | Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series | Solicited local and systemic reactions reported post second vaccination was compared in subjects receiving MenACWY versus Hib Vaccines. | 7 days post-vaccination | |
Secondary | Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series | Solicited local and systemic reactions reported post third vaccination was compared in subjects receiving MenACWY versus Hib Vaccines. | 7 days post-vaccination | |
Secondary | Geometric Mean hSBA Titers Post-infant Series - US Subjects | Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after three doses at 2, 4, and 6 months of age. | 7 months of age (one month post-infant series) | |
Secondary | Geometric Mean hSBA Titers Post-infant Series - LA Subjects | Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 (LA3) months of age. | 7 months of age (one month post-infant series) | |
Secondary | Percentage of Subjects With hSBA Titer >=1:8 - US Subjects | Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age. | 7 months of age (one month post-infant series) | |
Secondary | Percentage of Subjects With hSBA Titer >=1:4 - US Subjects | Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age. | 7 months of age (one month post-infant series) | |
Secondary | Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects | Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) . | 7 months of age (one month post-infant series) | |
Secondary | Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects | Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) . | 7 months of age (one month post-infant series) | |
Secondary | Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects | Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens. | 7 months of age (one month post-infant series) | |
Secondary | Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects | Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens. | 7 months of age (one month post-infant series) | |
Secondary | Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects | Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens. | 7 months of age (one month post-infant series) | |
Secondary | Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects | Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens. | 7 months of age (one month post-infant series) | |
Secondary | Percentage of Subjects With Persistence Antibodies hSBA =1:4 at 12 Months of Age- US Subject | Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) = 1:4, directed against N.meningitidis serogroups A, C, W and Y. | 12 Months of Age (one month pre-toddler vaccination) | |
Secondary | Percentage of Subjects With Persistence Antibodies hSBA =1:8 at 12 Months of Age- US Subject | Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) = 1:8, directed against N.meningitidis serogroups A, C, W and Y. | 12 Months of Age (one month pre-toddler vaccination) | |
Secondary | Persistence Antibodies Geometric Mean Titers - US Subject | Geometric Mean hSBA Titers directed against N. meningitides serogroups A, C, W and Y was measured at 12 Months of Age. | 12 Months of Age (one month pre-toddler vaccination) | |
Secondary | Percentage of Subjects With Persistence Antibodies hSBA =1:4 at 12 or 16 Months of Age- LA Subject | Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) = 1:4, directed against N.meningitidis serogroups A, C, W and Y. | 12 or 16 Months of Age (one month pre-toddler vaccination) | |
Secondary | Percentage of Subjects With Persistence Antibodies hSBA =1:8 at 12 or 16 Months of Age- LA Subject | Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) = 1:8, directed against N.meningitidis serogroups A, C, W and Y. | 12 or 16 Months of Age (one month pre-toddler vaccination) | |
Secondary | Persistence Antibodies Geometric Mean Titers - LA Subjects | Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured at 12 or 16 Months of Age. | 12 or 16 Months of Age (one month pre-toddler vaccination) | |
Secondary | Percentage of Subjects (95% CI) With hSBA = 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects | Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) = 1:4 , directed against N.meningitidis serogroups A, C, W and Y. | 13 months of age (one month post-toddler vaccination) | |
Secondary | Percentage of Subjects (95% CI) With hSBA = 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects | Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) = 1:8 , directed against N.meningitidis serogroups A, C, W and Y. | 13 months of age (one month post-toddler vaccination) | |
Secondary | Percentage of Subjects (95% CI) With hSBA = 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects | Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) = 1:16 , directed against N.meningitidis serogroups A, C, W and Y. | 13 months of age (one month post-toddler vaccination) | |
Secondary | Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects | Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age. | 13 months of age (one month post-toddler vaccination) | |
Secondary | Percentage of Subjects (95% CI) With hSBA =1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects | Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) = 1:4, directed against N. meningitidis serogroups A, C, W and Y. | 13 or 17 Months of Age (one month post-toddler vaccination) | |
Secondary | Percentage of Subjects (95% CI) With hSBA =1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects | Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) = 1:8, directed against N. meningitidis serogroups A, C, W and Y. | 13 or 17 Months of Age (one month post-toddler vaccination) | |
Secondary | Percentage of Subjects With hSBA = 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects | Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) = 1:16, directed against N. meningitidis serogroups A, C, W and Y. | 13 or 17 Months of Age (one month post-toddler vaccination) | |
Secondary | Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects | Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y. | 13 or 17 Months of Age (one month post-toddler vaccination) | |
Secondary | Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects | Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F. | 13 months of age (one month post-toddler vaccination) | |
Secondary | Percentage of Subjects With Pneumococcal Antibody GMCs =1.0 µg/mL at 1 Month After Toddler Vaccination - US Subjects | Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs =1.0 µg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F. | 13 months of age (one month post-toddler vaccination) | |
Secondary | Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects | Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F. | 13 months of age (one month post-toddler vaccination) | |
Secondary | Percentage of Subjects With Pneumococcal Antibody Concentration =1.0 µg/mL at 1 Month After Toddler Vaccination - LA Subjects | Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs =1.0 µg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F | 13 months of age (one month post-toddler vaccination) | |
Secondary | Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects | Immunogenicity as measured by antibody GMCs/GMTs, directed against DTaP and Hib Antigens | 17 months of age (one month post-toddler vaccination) | |
Secondary | Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects | Immunogenicity as measured by Percentage of Subjects with predefined seroprotective antibody titers against DTaP and Hib Antigens | 17 months of age (one month post-toddler vaccination) | |
Secondary | Percentage of Subjects With hSBA =1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects | Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) = 1:8, directed against N.meningitidis serogroups A, C, W and Y. | 12 or 15 months of age (one month post 1st or 2nd toddler vaccination) | |
Secondary | Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects | Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y. | 12 or 15 months of age (one month post 1st or 2nd toddler vaccination) |
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