Meningitis, MeningococcalPhase 3NCT00474526
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants
A Phase 3 study testing Meningococcal ACWY Conjugate Vaccine, DTaP-IPV-HBV and Hib in people with Meningitis, Meningococcal, run by Novartis Vaccines at 63 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 2 to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Meningococcal
- What is being tested?
- Meningococcal ACWY Conjugate Vaccine, DTaP-IPV-HBV and Hib
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,545 participants
- Where
- 63 sitesin 3 countries
- Study dates
- Mar 2007to Nov 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy term 2-month-old infants for whom a parent/legal representative has given written informed consent.
Who cannot join
- 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
Trial locations and contacts
63 sites in 3 countries.
63 sites in 3 countries
United States53 sites
Akron Children's Hospital
Akron, Ohio, 44308
Annapolis Pediatrics
Annapolis, Maryland, 21401
The Children's Hospital
Aurora, Colorado, 80045
Center for Vaccine Development
Baltimore, Maryland, 21201
Kentucky Pediatric/Adult Research Inc.
Bardstown, Kentucky, 40004
Growing Up Pediatrics
Bessemer, Alabama, 35022
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 03523
Growing Up Pediatrics
Birmingham, Alabama, 35242
Louis P. Brine, Jr., MD, Beeghley Medical Park
Boardman, Ohio, 44512
Boston University Medical Center
Boston, Massachusetts, 02118
Carnegie Pediatrics
Carnegie, Pennsylvania, 15106
Children's Memorial Hospital
Chicago, Illinois, 60614-3394
Senders Pediatric Research at Dr. Senders and Associates
Cleveland, Ohio, 44118
Research Across America
Dallas, Texas, 75234
Premier Health Research Center, LLC
Downey, California, 90241
Children's Health Care - West
Erie, Pennsylvania, 16505
Pediatric Associates of Fall River
Fall River, Massachusetts, 02724
The Pediatric Center
Frederick, Maryland, 21702
UPMC/Community Medicine, Inc.
Greenville, Pennsylvania, 16125
Family Healthcare Partners
Grove City, Pennsylvania, 16127
Pennridge Pediatric Associates
Harleyville, Pennsylvania, 19438
Mercury Pharma Services
Houston, Texas, 77024
Pediatric Associates of Latrobe
Latrobe, Pennsylvania, 15650
Wee Care Pediatrics
Layton, Utah, 84041
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Longmont Medical Research Network
Longmont, Colorado, 80501
Goodlettsville Pediatrics
Madison, Tennessee, 37115-2154
Monroe Medical Foundation
Monroe, Wisconsin, 53566
Pediatric Medical Associates
Norristown, Pennsylvania, 19401
Kaiser Permanente Oakland
Oakland, California, 94611
Kaiser Permanente Med Group - Vaccine Study Ctr
Oakland, California, 94612
Creighton University
Omaha, Nebraska, 68131
Children's Physicians Dundee
Omaha, Nebraska, 68132
Utah Valley Pediatrics - Timpanogos
Orem, Utah, 84057
Center for Clinical Trials, LLC
Paramount, California, 90723
Squirrel Hill Office
Pittsburgh, Pennsylvania, 15217
Pediatric Alliance, Greentree Division
Pittsburgh, Pennsylvania, 15220
South Hills Pediatrics
Pittsburgh, Pennsylvania, 15227
Pediatric Alliance, Southwestern
Pittsburgh, Pennsylvania, 15236
Primary Physicians Research, Inc
Pittsburgh, Pennsylvania, 15241
Kaiser Permanente Pleasanton
Pleasanton, California, 94588
Kaiser Permanente Richmond
Richmond, California, 94801
Pediatrics Medical Associates
Rydal, Pennsylvania, 19046
Foothill Family Clinic
Salt Lake City, Utah, 84121
Kaiser Permanente San Francisco
San Francisco, California, 94115
Kaiser Permanente Santa Clara
Santa Clara, California, 95051
Pennridge Pediatric Associates
Sellersville, Pennsylvania, 18960
Copperview Medical Center
South Jordan, Utah, 84095
Scott and White Hospital
Temple, Texas, 76508
Montefiore Medical Center
The Bronx, New York, 10461
UCLA Center for Vaccine Research
Torrence, California, 90502
Laurel Pediatrics
Uniontown, Pennsylvania, 15401
CCP - Pittsburgh Pediatrics
Wexford, Pennsylvania, 15090
Argentina6 sites
CEDEPAP Rio IV
Alvear 1439 PB Dpto, Rio IV, Cordoba, Córdoba Province
Buenos Aires, Argentina
Buenos Aires, C1406DGI
Hospitales Materno Neonatal,
Castro Barros 650 - Barrio San Martin, Cordoba, Córdoba Province
CdePAP, Centro De Desarrollo De Proyectos Avanzados Roma 1465,
Córdoba, Córdoba Province, X5000BJH
Hospital Regional Luis Pasteur,
Mendoza N°2152, Villa Maria, Cordoba,, Córdoba Province
Centro Estudios Infect
Scalabrini Ortiz 676, Buenos Aires, Buenos Aires,
Colombia4 sites
Siloe
Calle 1 #50-51, Cali, 405
Comfenalco
Calle 6#5-42, Cali, 405
Hospital C H Trujillo
Calle 72U 28 F-00, Cali, 405
Corporation Cientifica
Ped Calle 5B5 No.37 Bis-28, Cali, 405
About this study
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
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.
- Conditions
- Meningitis, Meningococcal
- Being tested
- Meningococcal ACWY Conjugate Vaccine, DTaP-IPV-HBV, Hib, Rotavirus, Pneumococcal 7-valent Conjugate Vaccine
- Keywords
- Meningococcal, meningitis, vaccine, infants, Meningococcal meningitis, Meningococcal disease
- Medical subject headings
- Meningitis, Meningococcal, Meningitis, Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal ACWY Conjugate VaccineBiological
Also called Menveo
DTaP-IPV-HBVBiological
Also called Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined
HibBiological
Also called ActHIB® (Haemophilus influenzae type b Conjugate Vaccine)
RotavirusBiological
Also called RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent
Pneumococcal 7-valent Conjugate VaccineBiological
Also called Prevnar®
HAVBiological
Also called Havrix® (Hepatitis A Vaccine, Inactivated)
MMR-VBiological
Also called ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)
DTaPBiological
Also called Infanrix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)
| Study group | Role | What they receive |
|---|---|---|
| US1A (MenACWY-CRM + Infant Vaccines) | Experimental | 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 Receives: Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V |
| US1B (MenACWY-CRM + Infant Vaccines) | Experimental | 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 Receives: Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V |
| US2 (Infant Vaccines Only) | Experimental | 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 Receives: Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V |
| US3 (MenACWY-CRM + Infant Vaccines) | Experimental | 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 Receives: Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V |
| US4A (Infant Vaccines Only) | Experimental | 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 Receives: Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: HAV; Biological: MMR-V |
| US4B (Infant Vaccines Only) | Experimental | 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 Receives: Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V |
| US4C (Infant Vaccines Only) | Experimental | 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 Receives: Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V |
| LA1A (MenACWY-CRM + Infant Vaccines) | Experimental | 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 Receives: Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V |
| LA1B (MenACWY-CRM + Infant Vaccines) | Experimental | 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 Receives: Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V |
| LA2 (Infant Vaccines Only) | Experimental | 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 Receives: Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V |
| LA3A (MenACWY-CRM + Infant Vaccines) | Experimental | 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 Receives: Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V; Biological: DTaP |
| LA3B (MenACWY-CRM + Infant Vaccines) | Experimental | 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 Receives: Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V; Biological: DTaP |
| LA4 (Infant Vaccines Only) | Experimental | 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 Receives: Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V; Biological: DTaP |
| LA5 (MenACWY-CRM + Infant Vaccines) | Experimental | 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 Receives: Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V |
| LA6A (Infant Vaccines Only) | Experimental | 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 Receives: Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V |
| LA6B (Infant Vaccines Only) | Experimental | 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 Receives: Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV; Biological: MMR-V |
| LA6C (Infant Vaccines Only) | Experimental | 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 Receives: Biological: Meningococcal ACWY Conjugate Vaccine; Biological: DTaP-IPV-HBV; Biological: Hib; Biological: Rotavirus; Biological: Pneumococcal 7-valent Conjugate Vaccine; Biological: HAV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 13 months of age (one month post-toddler vaccination)
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.
Measured: 13 months of age (one month post-toddler vaccination)
Secondary outcomes (41)
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.
Measured: 7 days after vaccination
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.
Measured: 7 days after vaccination
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.
Measured: 7 days after vaccination
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.
Measured: 7 days after vaccination
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.
Measured: 7 days post vaccination
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.
Measured: 7 days post vaccination
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.
Measured: 7 days post-vaccination
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.
Measured: 7 days post-vaccination
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.
Measured: 7 days post-vaccination
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.
Measured: 7 months of age (one month post-infant series)
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.
Measured: 7 months of age (one month post-infant series)
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.
Measured: 7 months of age (one month post-infant series)
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.
Measured: 7 months of age (one month post-infant series)
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) .
Measured: 7 months of age (one month post-infant series)
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) .
Measured: 7 months of age (one month post-infant series)
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.
Measured: 7 months of age (one month post-infant series)
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.
Measured: 7 months of age (one month post-infant series)
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.
Measured: 7 months of age (one month post-infant series)
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.
Measured: 7 months of age (one month post-infant series)
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.
Measured: 12 Months of Age (one month pre-toddler vaccination)
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.
Measured: 12 Months of Age (one month pre-toddler vaccination)
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.
Measured: 12 Months of Age (one month pre-toddler vaccination)
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.
Measured: 12 or 16 Months of Age (one month pre-toddler vaccination)
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.
Measured: 12 or 16 Months of Age (one month pre-toddler vaccination)
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.
Measured: 12 or 16 Months of Age (one month pre-toddler vaccination)
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.
Measured: 13 months of age (one month post-toddler vaccination)
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.
Measured: 13 months of age (one month post-toddler vaccination)
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.
Measured: 13 months of age (one month post-toddler vaccination)
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.
Measured: 13 months of age (one month post-toddler vaccination)
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.
Measured: 13 or 17 Months of Age (one month post-toddler vaccination)
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.
Measured: 13 or 17 Months of Age (one month post-toddler vaccination)
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.
Measured: 13 or 17 Months of Age (one month post-toddler vaccination)
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.
Measured: 13 or 17 Months of Age (one month post-toddler vaccination)
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.
Measured: 13 months of age (one month post-toddler vaccination)
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.
Measured: 13 months of age (one month post-toddler vaccination)
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.
Measured: 13 months of age (one month post-toddler vaccination)
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
Measured: 13 months of age (one month post-toddler vaccination)
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
Measured: 17 months of age (one month post-toddler vaccination)
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
Measured: 17 months of age (one month post-toddler vaccination)
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.
Measured: 12 or 15 months of age (one month post 1st or 2nd toddler vaccination)
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.
Measured: 12 or 15 months of age (one month post 1st or 2nd toddler vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2007 (estimated)
- Study startMar 2007
- Primary completionSep 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meningitis, MeningococcalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,545 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis - Vaccines, Study chair, Novartis Vaccines & Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00474526
- Sponsor's protocol ID
- V59P14
- Status last verified
- Feb 2014
- First submitted
- 16 May 2007
- Last updated
- 24 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 22094635
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00474526
- Acronym / sponsor ID
- V59P14
- Conditions
- Meningitis, Meningococcal
- Keywords
- Meningococcal, meningitis, vaccine, infants, Meningococcal meningitis, Meningococcal disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,545 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 17 May 2007 (estimated)
- Results
- Posted 24 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 17
| Arm | Type | Receives |
|---|---|---|
| US1A (MenACWY-CRM + Infant Vaccines) | Experimental | Biological: Meningococcal ACWY Conjugate Vaccine, Biological: DTaP-IPV-HBV, Biological: Hib, Biological: Rotavirus, Biological: Pneumococcal 7-valent Conjugate Vaccine, Biological: HAV, Biological: MMR-VReceived 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 |
| US1B (MenACWY-CRM + Infant Vaccines) | Experimental | Biological: Meningococcal ACWY Conjugate Vaccine, Biological: DTaP-IPV-HBV, Biological: Hib, Biological: Rotavirus, Biological: Pneumococcal 7-valent Conjugate Vaccine, Biological: HAV, Biological: MMR-VReceived 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 |
| US2 (Infant Vaccines Only) | Experimental | Biological: Meningococcal ACWY Conjugate Vaccine, Biological: DTaP-IPV-HBV, Biological: Hib, Biological: Rotavirus, Biological: Pneumococcal 7-valent Conjugate Vaccine, Biological: HAV, Biological: MMR-VReceived 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 |
| US3 (MenACWY-CRM + Infant Vaccines) | Experimental | Biological: Meningococcal ACWY Conjugate Vaccine, Biological: DTaP-IPV-HBV, Biological: Hib, Biological: Rotavirus, Biological: Pneumococcal 7-valent Conjugate Vaccine, Biological: HAV, Biological: MMR-VReceived 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 |
| US4A (Infant Vaccines Only) | Experimental | Biological: Meningococcal ACWY Conjugate Vaccine, Biological: DTaP-IPV-HBV, Biological: Hib, Biological: Rotavirus, Biological: HAV, Biological: MMR-VReceived 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 |
| US4B (Infant Vaccines Only) | Experimental | Biological: Meningococcal ACWY Conjugate Vaccine, Biological: DTaP-IPV-HBV, Biological: Hib, Biological: Rotavirus, Biological: Pneumococcal 7-valent Conjugate Vaccine, Biological: HAV, Biological: MMR-VReceived 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 |
| US4C (Infant Vaccines Only) | Experimental | Biological: Meningococcal ACWY Conjugate Vaccine, Biological: DTaP-IPV-HBV, Biological: Hib, Biological: Rotavirus, Biological: Pneumococcal 7-valent Conjugate Vaccine, Biological: HAV, Biological: MMR-VReceived 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 |
| LA1A (MenACWY-CRM + Infant Vaccines) | Experimental | Biological: Meningococcal ACWY Conjugate Vaccine, Biological: DTaP-IPV-HBV, Biological: Hib, Biological: Rotavirus, Biological: Pneumococcal 7-valent Conjugate Vaccine, Biological: HAV, Biological: MMR-VReceived 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 |
| LA1B (MenACWY-CRM + Infant Vaccines) | Experimental | Biological: Meningococcal ACWY Conjugate Vaccine, Biological: DTaP-IPV-HBV, Biological: Hib, Biological: Rotavirus, Biological: Pneumococcal 7-valent Conjugate Vaccine, Biological: HAV, Biological: MMR-VReceived 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 |
| LA2 (Infant Vaccines Only) | Experimental | Biological: Meningococcal ACWY Conjugate Vaccine, Biological: DTaP-IPV-HBV, Biological: Hib, Biological: Rotavirus, Biological: Pneumococcal 7-valent Conjugate Vaccine, Biological: HAV, Biological: MMR-VReceived 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 |
| LA3A (MenACWY-CRM + Infant Vaccines) | Experimental | Biological: Meningococcal ACWY Conjugate Vaccine, Biological: DTaP-IPV-HBV, Biological: Hib, Biological: Rotavirus, Biological: Pneumococcal 7-valent Conjugate Vaccine, Biological: HAV, Biological: MMR-V, Biological: DTaPReceived 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 |
| LA3B (MenACWY-CRM + Infant Vaccines) | Experimental | Biological: Meningococcal ACWY Conjugate Vaccine, Biological: DTaP-IPV-HBV, Biological: Hib, Biological: Rotavirus, Biological: Pneumococcal 7-valent Conjugate Vaccine, Biological: HAV, Biological: MMR-V, Biological: DTaPReceived 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 |
| LA4 (Infant Vaccines Only) | Experimental | Biological: Meningococcal ACWY Conjugate Vaccine, Biological: DTaP-IPV-HBV, Biological: Hib, Biological: Rotavirus, Biological: Pneumococcal 7-valent Conjugate Vaccine, Biological: HAV, Biological: MMR-V, Biological: DTaPReceived 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 |
| LA5 (MenACWY-CRM + Infant Vaccines) | Experimental | Biological: Meningococcal ACWY Conjugate Vaccine, Biological: DTaP-IPV-HBV, Biological: Hib, Biological: Rotavirus, Biological: Pneumococcal 7-valent Conjugate Vaccine, Biological: HAV, Biological: MMR-VReceived 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 |
| LA6A (Infant Vaccines Only) | Experimental | Biological: Meningococcal ACWY Conjugate Vaccine, Biological: DTaP-IPV-HBV, Biological: Hib, Biological: Rotavirus, Biological: Pneumococcal 7-valent Conjugate Vaccine, Biological: HAV, Biological: MMR-VReceived 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 |
| LA6B (Infant Vaccines Only) | Experimental | Biological: Meningococcal ACWY Conjugate Vaccine, Biological: DTaP-IPV-HBV, Biological: Hib, Biological: Rotavirus, Biological: Pneumococcal 7-valent Conjugate Vaccine, Biological: HAV, Biological: MMR-VReceived 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 |
| LA6C (Infant Vaccines Only) | Experimental | Biological: Meningococcal ACWY Conjugate Vaccine, Biological: DTaP-IPV-HBV, Biological: Hib, Biological: Rotavirus, Biological: Pneumococcal 7-valent Conjugate Vaccine, Biological: HAVReceived 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 |
Who may qualify
- Ages
- 2 to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy term 2-month-old infants for whom a parent/legal representative has given written informed consent.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meningococcal ACWY Conjugate VaccineAlso: Menveo | Biological | 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), 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) |
| DTaP-IPV-HBVAlso: Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined | Biological | 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), 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) |
| HibAlso: ActHIB® (Haemophilus influenzae type b Conjugate Vaccine) | Biological | 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), 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) |
| RotavirusAlso: RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent | Biological | 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), 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) |
| Pneumococcal 7-valent Conjugate VaccineAlso: Prevnar® | Biological | 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), US1A (MenACWY-CRM + Infant Vaccines), US1B (MenACWY-CRM + Infant Vaccines), US2 (Infant Vaccines Only), US3 (MenACWY-CRM + Infant Vaccines), US4B (Infant Vaccines Only), US4C (Infant Vaccines Only) |
| HAVAlso: Havrix® (Hepatitis A Vaccine, Inactivated) | Biological | 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), 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) |
| MMR-VAlso: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine) | Biological | 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), 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) |
| DTaPAlso: Infanrix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) | Biological | LA3A (MenACWY-CRM + Infant Vaccines), LA3B (MenACWY-CRM + Infant Vaccines), LA4 (Infant Vaccines Only) |
Primary outcome
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects
Time frame: 13 months of age (one month post-toddler vaccination)
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
Time frame: 13 months of age (one month post-toddler vaccination)
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.
41 secondary outcomes
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series
Time frame: 7 days after vaccination
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series
Time frame: 7 days after vaccination
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series
Time frame: 7 days after vaccination
Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age
Time frame: 7 days after vaccination
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series
Time frame: 7 days post vaccination
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series
Time frame: 7 days post vaccination
Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series
Time frame: 7 days post-vaccination
Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series
Time frame: 7 days post-vaccination
Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series
Time frame: 7 days post-vaccination
Geometric Mean hSBA Titers Post-infant Series - US Subjects
Time frame: 7 months of age (one month post-infant series)
Geometric Mean hSBA Titers Post-infant Series - LA Subjects
Time frame: 7 months of age (one month post-infant series)
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects
Time frame: 7 months of age (one month post-infant series)
Percentage of Subjects With hSBA Titer >=1:4 - US Subjects
Time frame: 7 months of age (one month post-infant series)
Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects
Time frame: 7 months of age (one month post-infant series)
Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects
Time frame: 7 months of age (one month post-infant series)
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects
Time frame: 7 months of age (one month post-infant series)
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects
Time frame: 7 months of age (one month post-infant series)
Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects
Time frame: 7 months of age (one month post-infant series)
Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects
Time frame: 7 months of age (one month post-infant series)
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject
Time frame: 12 Months of Age (one month pre-toddler vaccination)
Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject
Time frame: 12 Months of Age (one month pre-toddler vaccination)
Persistence Antibodies Geometric Mean Titers - US Subject
Time frame: 12 Months of Age (one month pre-toddler vaccination)
Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject
Time frame: 12 or 16 Months of Age (one month pre-toddler vaccination)
Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject
Time frame: 12 or 16 Months of Age (one month pre-toddler vaccination)
Persistence Antibodies Geometric Mean Titers - LA Subjects
Time frame: 12 or 16 Months of Age (one month pre-toddler vaccination)
Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects
Time frame: 13 months of age (one month post-toddler vaccination)
Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects
Time frame: 13 months of age (one month post-toddler vaccination)
Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects
Time frame: 13 months of age (one month post-toddler vaccination)
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects
Time frame: 13 months of age (one month post-toddler vaccination)
Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects
Time frame: 13 or 17 Months of Age (one month post-toddler vaccination)
Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects
Time frame: 13 or 17 Months of Age (one month post-toddler vaccination)
Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects
Time frame: 13 or 17 Months of Age (one month post-toddler vaccination)
Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects
Time frame: 13 or 17 Months of Age (one month post-toddler vaccination)
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects
Time frame: 13 months of age (one month post-toddler vaccination)
Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects
Time frame: 13 months of age (one month post-toddler vaccination)
Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects
Time frame: 13 months of age (one month post-toddler vaccination)
Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects
Time frame: 13 months of age (one month post-toddler vaccination)
Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects
Time frame: 17 months of age (one month post-toddler vaccination)
Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects
Time frame: 17 months of age (one month post-toddler vaccination)
Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects
Time frame: 12 or 15 months of age (one month post 1st or 2nd toddler vaccination)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22094635Klein 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.
Related trials for Meningitis, Meningococcal
Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
Epidemic Meningitis, Meningococcal Vaccines
Active, not recruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 2-6 Years
Epidemic Meningitis, Meningococcal Vaccines
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 12-23 Months
Epidemic Meningitis, Meningococcal Vaccines
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis - Vaccines study chair
Novartis Vaccines & Diagnostics
63 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meningococcal ACWY Conjugate Vaccine, DTaP-IPV-HBV and Hib in people with Meningitis, Meningococcal, run by Novartis Vaccines at 63 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 63 sites in United States, Argentina, Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects With hSBA Titer >=1:8 - US Subjects (time frame: 13 months of age (one month post-toddler vaccination)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00474526, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2014.