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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00474526
Other study ID # V59P14
Secondary ID
Status Completed
Phase Phase 3
First received May 16, 2007
Last updated February 24, 2014
Start date March 2007
Est. completion date November 2009

Study information

Verified date February 2014
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Meningococcal ACWY Conjugate Vaccine

DTaP-IPV-HBV

Hib

Rotavirus

Pneumococcal 7-valent Conjugate Vaccine

HAV

MMR-V

DTaP


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Novartis Vaccines

Countries where clinical trial is conducted

United States,  Argentina,  Colombia, 

References & Publications (1)

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

Outcome

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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