A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00474526
• Other study ID #: V59P14
• 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
• 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

Related Conditions & MeSH terms

• Meningitis
• Meningitis, Meningococcal

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)