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

Primary Purpose

Meningitis, Meningococcal

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Meningococcal ACWY Conjugate Vaccine
DTaP-IPV-HBV
Hib
Rotavirus
Pneumococcal 7-valent Conjugate Vaccine
HAV
MMR-V
DTaP
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meningitis, Meningococcal focused on measuring Meningococcal, meningitis, vaccine, infants, Meningococcal meningitis, Meningococcal disease

Eligibility Criteria

2 Months - 2 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Growing Up Pediatrics
  • Alabama Clinical Therapeutics, LLC
  • Growing Up Pediatrics
  • Premier Health Research Center, LLC
  • Kaiser Permanente Oakland
  • Kaiser Permanente Med Group - Vaccine Study Ctr
  • Center for Clinical Trials, LLC
  • Kaiser Permanente Pleasanton
  • Kaiser Permanente Richmond
  • Kaiser Permanente San Francisco
  • Kaiser Permanente Santa Clara
  • UCLA Center for Vaccine Research
  • The Children's Hospital
  • Longmont Medical Research Network
  • Children's Memorial Hospital
  • Kentucky Pediatric/Adult Research Inc.
  • Annapolis Pediatrics
  • Center for Vaccine Development
  • The Pediatric Center
  • Boston University Medical Center
  • Pediatric Associates of Fall River
  • Creighton University
  • Children's Physicians Dundee
  • Dartmouth Hitchcock Medical Center
  • Montefiore Medical Center
  • Akron Children's Hospital
  • Louis P. Brine, Jr., MD, Beeghley Medical Park
  • Senders Pediatric Research at Dr. Senders and Associates
  • Carnegie Pediatrics
  • Children's Health Care - West
  • UPMC/Community Medicine, Inc.
  • Family Healthcare Partners
  • Pennridge Pediatric Associates
  • Pediatric Associates of Latrobe
  • Pediatric Medical Associates
  • Squirrel Hill Office
  • Pediatric Alliance, Greentree Division
  • South Hills Pediatrics
  • Pediatric Alliance, Southwestern
  • Primary Physicians Research, Inc
  • Pediatrics Medical Associates
  • Pennridge Pediatric Associates
  • Laurel Pediatrics
  • CCP - Pittsburgh Pediatrics
  • Goodlettsville Pediatrics
  • Research Across America
  • Mercury Pharma Services
  • Scott and White Hospital
  • Wee Care Pediatrics
  • Utah Valley Pediatrics - Timpanogos
  • Foothill Family Clinic
  • Copperview Medical Center
  • Monroe Medical Foundation
  • CEDEPAP Rio IV
  • Hospitales Materno Neonatal,
  • Hospital Regional Luis Pasteur,
  • Buenos Aires, Argentina
  • CdePAP, Centro De Desarrollo De Proyectos Avanzados Roma 1465,
  • Centro Estudios Infect
  • Siloe
  • Comfenalco
  • Hospital C H Trujillo
  • Corporation Cientifica

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

US1A (MenACWY-CRM + Infant Vaccines)

US1B (MenACWY-CRM + Infant Vaccines)

US2 (Infant Vaccines Only)

US3 (MenACWY-CRM + Infant Vaccines)

US4A (Infant Vaccines Only)

US4B (Infant Vaccines Only)

US4C (Infant Vaccines Only)

LA1A (MenACWY-CRM + Infant Vaccines)

LA1B (MenACWY-CRM + Infant Vaccines)

LA2 (Infant Vaccines Only)

LA3A (MenACWY-CRM + Infant Vaccines)

LA3B (MenACWY-CRM + Infant Vaccines)

LA4 (Infant Vaccines Only)

LA5 (MenACWY-CRM + Infant Vaccines)

LA6A (Infant Vaccines Only)

LA6B (Infant Vaccines Only)

LA6C (Infant Vaccines Only)

Arm Description

Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Received vaccines: MenACWY: 2, 4, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Received vaccines: MenACWY: 2, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Received vaccines: MenACWY: 2, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Received vaccines: MenACWY: 2, 4, 6, and 16 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months

Received vaccines: MenACWY: 2, 4, 6, and 17 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months

Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 15 months Pneumococcal, HAV, and MMR-V: 12 months

Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Received vaccines: MenACWY: 12, and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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) .
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) .
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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.
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.

Full Information

First Posted
May 16, 2007
Last Updated
February 24, 2014
Sponsor
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT00474526
Brief Title
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

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningitis, Meningococcal
Keywords
Meningococcal, meningitis, vaccine, infants, Meningococcal meningitis, Meningococcal disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4545 (Actual)

8. Arms, Groups, and Interventions

Arm Title
US1A (MenACWY-CRM + Infant Vaccines)
Arm Type
Experimental
Arm Description
Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
Arm Title
US1B (MenACWY-CRM + Infant Vaccines)
Arm Type
Experimental
Arm Description
Received vaccines: MenACWY: 2, 4, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
Arm Title
US2 (Infant Vaccines Only)
Arm Type
Experimental
Arm Description
Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
Arm Title
US3 (MenACWY-CRM + Infant Vaccines)
Arm Type
Experimental
Arm Description
Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
Arm Title
US4A (Infant Vaccines Only)
Arm Type
Experimental
Arm Description
Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
Arm Title
US4B (Infant Vaccines Only)
Arm Type
Experimental
Arm Description
Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
Arm Title
US4C (Infant Vaccines Only)
Arm Type
Experimental
Arm Description
Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
Arm Title
LA1A (MenACWY-CRM + Infant Vaccines)
Arm Type
Experimental
Arm Description
Received vaccines: MenACWY: 2, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
Arm Title
LA1B (MenACWY-CRM + Infant Vaccines)
Arm Type
Experimental
Arm Description
Received vaccines: MenACWY: 2, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
Arm Title
LA2 (Infant Vaccines Only)
Arm Type
Experimental
Arm Description
Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
Arm Title
LA3A (MenACWY-CRM + Infant Vaccines)
Arm Type
Experimental
Arm Description
Received vaccines: MenACWY: 2, 4, 6, and 16 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months
Arm Title
LA3B (MenACWY-CRM + Infant Vaccines)
Arm Type
Experimental
Arm Description
Received vaccines: MenACWY: 2, 4, 6, and 17 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months
Arm Title
LA4 (Infant Vaccines Only)
Arm Type
Experimental
Arm Description
Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 15 months Pneumococcal, HAV, and MMR-V: 12 months
Arm Title
LA5 (MenACWY-CRM + Infant Vaccines)
Arm Type
Experimental
Arm Description
Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
Arm Title
LA6A (Infant Vaccines Only)
Arm Type
Experimental
Arm Description
Received vaccines: MenACWY: 12, and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
Arm Title
LA6B (Infant Vaccines Only)
Arm Type
Experimental
Arm Description
Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
Arm Title
LA6C (Infant Vaccines Only)
Arm Type
Experimental
Arm Description
Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months
Intervention Type
Biological
Intervention Name(s)
Meningococcal ACWY Conjugate Vaccine
Other Intervention Name(s)
Menveo
Intervention Type
Biological
Intervention Name(s)
DTaP-IPV-HBV
Other Intervention Name(s)
Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined
Intervention Type
Biological
Intervention Name(s)
Hib
Other Intervention Name(s)
ActHIB® (Haemophilus influenzae type b Conjugate Vaccine)
Intervention Type
Biological
Intervention Name(s)
Rotavirus
Other Intervention Name(s)
RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent
Intervention Type
Biological
Intervention Name(s)
Pneumococcal 7-valent Conjugate Vaccine
Other Intervention Name(s)
Prevnar®
Intervention Type
Biological
Intervention Name(s)
HAV
Other Intervention Name(s)
Havrix® (Hepatitis A Vaccine, Inactivated)
Intervention Type
Biological
Intervention Name(s)
MMR-V
Other Intervention Name(s)
ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)
Intervention Type
Biological
Intervention Name(s)
DTaP
Other Intervention Name(s)
Infanrix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)
Primary Outcome Measure Information:
Title
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects
Description
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
Time Frame
13 months of age (one month post-toddler vaccination)
Title
Geometric Mean hSBA Titers - US Subjects
Description
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.
Time Frame
13 months of age (one month post-toddler vaccination)
Secondary Outcome Measure Information:
Title
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series
Description
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.
Time Frame
7 days after vaccination
Title
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series
Description
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.
Time Frame
7 days after vaccination
Title
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series
Description
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.
Time Frame
7 days after vaccination
Title
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age
Description
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.
Time Frame
7 days after vaccination
Title
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series
Description
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.
Time Frame
7 days post vaccination
Title
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series
Description
Solicited local and systemic reactions post second vaccination of toddler series at 15 months of age.
Time Frame
7 days post vaccination
Title
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series
Description
Solicited local and systemic reactions reported post first vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
Time Frame
7 days post-vaccination
Title
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series
Description
Solicited local and systemic reactions reported post second vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
Time Frame
7 days post-vaccination
Title
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series
Description
Solicited local and systemic reactions reported post third vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.
Time Frame
7 days post-vaccination
Title
Geometric Mean hSBA Titers Post-infant Series - US Subjects
Description
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.
Time Frame
7 months of age (one month post-infant series)
Title
Geometric Mean hSBA Titers Post-infant Series - LA Subjects
Description
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.
Time Frame
7 months of age (one month post-infant series)
Title
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects
Description
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.
Time Frame
7 months of age (one month post-infant series)
Title
Percentage of Subjects With hSBA Titer >=1:4 - US Subjects
Description
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.
Time Frame
7 months of age (one month post-infant series)
Title
Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects
Description
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) .
Time Frame
7 months of age (one month post-infant series)
Title
Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects
Description
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) .
Time Frame
7 months of age (one month post-infant series)
Title
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects
Description
Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.
Time Frame
7 months of age (one month post-infant series)
Title
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects
Description
Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.
Time Frame
7 months of age (one month post-infant series)
Title
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects
Description
Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.
Time Frame
7 months of age (one month post-infant series)
Title
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects
Description
Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.
Time Frame
7 months of age (one month post-infant series)
Title
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject
Description
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.
Time Frame
12 Months of Age (one month pre-toddler vaccination)
Title
Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject
Description
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.
Time Frame
12 Months of Age (one month pre-toddler vaccination)
Title
Persistence Antibodies Geometric Mean Titers - US Subject
Description
Geometric Mean hSBA Titers directed against N. meningitides serogroups A, C, W and Y was measured at 12 Months of Age.
Time Frame
12 Months of Age (one month pre-toddler vaccination)
Title
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject
Description
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.
Time Frame
12 or 16 Months of Age (one month pre-toddler vaccination)
Title
Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject
Description
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.
Time Frame
12 or 16 Months of Age (one month pre-toddler vaccination)
Title
Persistence Antibodies Geometric Mean Titers - LA Subjects
Description
Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured at 12 or 16 Months of Age.
Time Frame
12 or 16 Months of Age (one month pre-toddler vaccination)
Title
Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects
Description
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.
Time Frame
13 months of age (one month post-toddler vaccination)
Title
Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects
Description
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.
Time Frame
13 months of age (one month post-toddler vaccination)
Title
Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects
Description
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.
Time Frame
13 months of age (one month post-toddler vaccination)
Title
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects
Description
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.
Time Frame
13 months of age (one month post-toddler vaccination)
Title
Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects
Description
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.
Time Frame
13 or 17 Months of Age (one month post-toddler vaccination)
Title
Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects
Description
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.
Time Frame
13 or 17 Months of Age (one month post-toddler vaccination)
Title
Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects
Description
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.
Time Frame
13 or 17 Months of Age (one month post-toddler vaccination)
Title
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects
Description
Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.
Time Frame
13 or 17 Months of Age (one month post-toddler vaccination)
Title
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects
Description
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.
Time Frame
13 months of age (one month post-toddler vaccination)
Title
Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects
Description
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.
Time Frame
13 months of age (one month post-toddler vaccination)
Title
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects
Description
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.
Time Frame
13 months of age (one month post-toddler vaccination)
Title
Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects
Description
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
Time Frame
13 months of age (one month post-toddler vaccination)
Title
Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects
Description
Immunogenicity as measured by antibody GMCs/GMTs, directed against DTaP and Hib Antigens
Time Frame
17 months of age (one month post-toddler vaccination)
Title
Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects
Description
Immunogenicity as measured by Percentage of Subjects with predefined seroprotective antibody titers against DTaP and Hib Antigens
Time Frame
17 months of age (one month post-toddler vaccination)
Title
Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects
Description
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.
Time Frame
12 or 15 months of age (one month post 1st or 2nd toddler vaccination)
Title
Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects
Description
Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.
Time Frame
12 or 15 months of age (one month post 1st or 2nd toddler vaccination)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis - Vaccines
Organizational Affiliation
Novartis Vaccines & Diagnostics
Official's Role
Study Chair
Facility Information:
Facility Name
Growing Up Pediatrics
City
Bessemer
State/Province
Alabama
ZIP/Postal Code
35022
Country
United States
Facility Name
Alabama Clinical Therapeutics, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
03523
Country
United States
Facility Name
Growing Up Pediatrics
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
Premier Health Research Center, LLC
City
Downey
State/Province
California
ZIP/Postal Code
90241
Country
United States
Facility Name
Kaiser Permanente Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Kaiser Permanente Med Group - Vaccine Study Ctr
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
Center for Clinical Trials, LLC
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Kaiser Permanente Pleasanton
City
Pleasanton
State/Province
California
ZIP/Postal Code
94588
Country
United States
Facility Name
Kaiser Permanente Richmond
City
Richmond
State/Province
California
ZIP/Postal Code
94801
Country
United States
Facility Name
Kaiser Permanente San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser Permanente Santa Clara
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
UCLA Center for Vaccine Research
City
Torrence
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
The Children's Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Longmont Medical Research Network
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Children's Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614-3394
Country
United States
Facility Name
Kentucky Pediatric/Adult Research Inc.
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Annapolis Pediatrics
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Center for Vaccine Development
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
The Pediatric Center
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Pediatric Associates of Fall River
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02724
Country
United States
Facility Name
Creighton University
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Children's Physicians Dundee
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68132
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
Louis P. Brine, Jr., MD, Beeghley Medical Park
City
Boardman
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Facility Name
Senders Pediatric Research at Dr. Senders and Associates
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44118
Country
United States
Facility Name
Carnegie Pediatrics
City
Carnegie
State/Province
Pennsylvania
ZIP/Postal Code
15106
Country
United States
Facility Name
Children's Health Care - West
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16505
Country
United States
Facility Name
UPMC/Community Medicine, Inc.
City
Greenville
State/Province
Pennsylvania
ZIP/Postal Code
16125
Country
United States
Facility Name
Family Healthcare Partners
City
Grove City
State/Province
Pennsylvania
ZIP/Postal Code
16127
Country
United States
Facility Name
Pennridge Pediatric Associates
City
Harleyville
State/Province
Pennsylvania
ZIP/Postal Code
19438
Country
United States
Facility Name
Pediatric Associates of Latrobe
City
Latrobe
State/Province
Pennsylvania
ZIP/Postal Code
15650
Country
United States
Facility Name
Pediatric Medical Associates
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
Facility Name
Squirrel Hill Office
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15217
Country
United States
Facility Name
Pediatric Alliance, Greentree Division
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15220
Country
United States
Facility Name
South Hills Pediatrics
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15227
Country
United States
Facility Name
Pediatric Alliance, Southwestern
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Primary Physicians Research, Inc
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Pediatrics Medical Associates
City
Rydal
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Pennridge Pediatric Associates
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
Facility Name
Laurel Pediatrics
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
CCP - Pittsburgh Pediatrics
City
Wexford
State/Province
Pennsylvania
ZIP/Postal Code
15090
Country
United States
Facility Name
Goodlettsville Pediatrics
City
Madison
State/Province
Tennessee
ZIP/Postal Code
37115-2154
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Mercury Pharma Services
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Wee Care Pediatrics
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Utah Valley Pediatrics - Timpanogos
City
Orem
State/Province
Utah
ZIP/Postal Code
84057
Country
United States
Facility Name
Foothill Family Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
Copperview Medical Center
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Monroe Medical Foundation
City
Monroe
State/Province
Wisconsin
ZIP/Postal Code
53566
Country
United States
Facility Name
CEDEPAP Rio IV
City
Alvear 1439 PB Dpto, rio IV, Cordoba
State/Province
Cordoba
Country
Argentina
Facility Name
Hospitales Materno Neonatal,
City
Castro Barros 650 - Barrio San Martin, Cordoba
State/Province
Cordoba
Country
Argentina
Facility Name
Hospital Regional Luis Pasteur,
City
Mendoza n°2152, Villa Maria, Cordoba,
State/Province
Cordoba
Country
Argentina
Facility Name
Buenos Aires, Argentina
City
Buenos Aires
ZIP/Postal Code
C1406DGI
Country
Argentina
Facility Name
CdePAP, Centro De Desarrollo De Proyectos Avanzados Roma 1465,
City
Cordoba
ZIP/Postal Code
X5000BJH
Country
Argentina
Facility Name
Centro Estudios Infect
City
Scalabrini Ortiz 676, Buenos Aires, Buenos Aires,
Country
Argentina
Facility Name
Siloe
City
Calle 1 #50-51
State/Province
Cali
ZIP/Postal Code
405
Country
Colombia
Facility Name
Comfenalco
City
Calle 6#5-42
State/Province
Cali
ZIP/Postal Code
405
Country
Colombia
Facility Name
Hospital C H Trujillo
City
Calle 72U 28 F-00
State/Province
Cali
ZIP/Postal Code
405
Country
Colombia
Facility Name
Corporation Cientifica
City
Ped Calle 5B5 No.37 BIS-28
State/Province
Cali
ZIP/Postal Code
405
Country
Colombia

12. IPD Sharing Statement

Citations:
PubMed Identifier
22094635
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. Erratum In: Pediatr Infect Dis J. 2012 Oct;31(10):1105.
Results Reference
result

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

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