Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT01341639
First received: April 22, 2011
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

This study will determine whether subjects who receive V419 at 2, 3, 4, and 12 months of age have an acceptable immune response to the vaccine. The study will also determine whether the immune response to V419 is similar to that of subjects who receive a licensed vaccine control.


Condition Intervention Phase
Bacterial Infections
Virus Diseases
Biological: V419
Biological: INFANRIX hexa
Biological: RotaTeq
Biological: Prevenar 13
Biological: ProQuad
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Phase III Randomized, Double-Blind, Active-Comparator Controlled Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4, and 12 Months (V419-007-03)

Resource links provided by NLM:


Further study details as provided by Sanofi Pasteur MSD:

Primary Outcome Measures:
  • Number of responders to polyribosylribitol phosphate (PRP) antigen [ Time Frame: Post-dose 3 (5 Months) ] [ Designated as safety issue: No ]
  • Number of responders to diphtheria antigen [ Time Frame: Post-dose 3 (5 Months) ] [ Designated as safety issue: No ]
  • Number of responders to tetanus antigen [ Time Frame: Post-dose 3 (5 Months) ] [ Designated as safety issue: No ]
  • Number of responders to inactivated poliovirus (IPV) antigen [ Time Frame: Post-dose 3 (5 Months) ] [ Designated as safety issue: No ]
  • Number of responders to polyribosylribitol phosphate (PRP) antigen [ Time Frame: Post-dose 4 (13 Months) ] [ Designated as safety issue: No ]
  • Number of responders to diphtheria antigen [ Time Frame: Post-dose 4 (13 Months) ] [ Designated as safety issue: No ]
  • Number of responders to tetanus antigen [ Time Frame: Post-dose 4 (13 Months) ] [ Designated as safety issue: No ]
  • Number of responders to inactivated poliovirus (IPV) antigen [ Time Frame: Post-dose 4 (13 Months) ] [ Designated as safety issue: No ]
  • Number of responders to hepatitis B surface antigen (HBsAg) [ Time Frame: Post-dose 4 (13 Months) ] [ Designated as safety issue: No ]
  • Number of responders to pertussis antigens [ Time Frame: Post-dose 4 (Month 13) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of responders to measles antigen [ Time Frame: Post-dose 4 (13 Months) ] [ Designated as safety issue: No ]
  • Number of responders to mumps antigen [ Time Frame: Post-dose 4 (13 Months) ] [ Designated as safety issue: No ]
  • Number of responders to rubella antigen [ Time Frame: Post-dose 4 (13 Months) ] [ Designated as safety issue: No ]
  • Number of responders to varicella antigen [ Time Frame: Post-dose 4 (13 Months) ] [ Designated as safety issue: No ]

Enrollment: 1250
Study Start Date: May 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V419
V419 + RotaTeq + Prevenar 13 + ProQuad
Biological: V419
V419 (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Outer Membrane Protein Complex], and Hepatitis B [Recombinant] Vaccine) 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age
Biological: RotaTeq
RotaTeq 2 mL oral dose at 2, 3, and 4 months of age
Biological: Prevenar 13
Prevenar 13 0.5 mL intramuscular injection at 2, 3, 4,and 13 months of age
Biological: ProQuad
ProQuad™ 0.5 mL subcutaneous injection at 12 and 13 months of age
Active Comparator: INFANRIX hexa
INFANRIX hexa + RotaTeq + Prevenar 13 + ProQuad
Biological: INFANRIX hexa
INFANRIX™ hexa 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age.
Biological: RotaTeq
RotaTeq 2 mL oral dose at 2, 3, and 4 months of age
Biological: Prevenar 13
Prevenar 13 0.5 mL intramuscular injection at 2, 3, 4,and 13 months of age
Biological: ProQuad
ProQuad™ 0.5 mL subcutaneous injection at 12 and 13 months of age

  Eligibility

Ages Eligible for Study:   46 Days to 74 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Healthy infants able to attend all study visits
  • Parent(s)/legal representative able to read, understand, and complete study questionnaires

Exclusion Criteria

  • History of congenital or acquired immunodeficiency
  • Received or is expected to receive immunosuppressive agents or systemic immunomodulatory steroids
  • History of leukemia, lymphoma, malignant melanoma, or myeloproliferative disorder
  • Hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or concomitant study vaccines
  • Has any chronic illness that could interfere with study conduct or completion
  • Received any immune globulin, blood, or blood-derived products since birth
  • Received a dose of hepatitis B vaccine prior to the study
  • Vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines,Haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, measles, mumps, rubella, or varicella vaccines, or any combination thereof
  • Fever within 24 hours prior to enrollment
  • Received any non-study vaccine within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 14 days or more prior to enrollment
  • Has a coagulation disorder
  • Has developmental delay or neurological disorder
  • Participant or his/her mother has a medical history of hepatitis B surface antigen (HBsAg)seropositivity
  • History of measles, mumps, rubella, varicella, Haemophilus influenzae type B, hepatitis B, diphtheria, tetanus, pertussis, rotavirus, invasive pneumococcal, or poliomyelitis infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01341639

Locations
Belgium
SPMSD Investigational Site 0070001
Antwerpen, Belgium
SPMSD Investigational Site 0070002
Hasselt, Belgium
Finland
SPMSD Investigational Site 0070011
Espoo, Finland
SPMSD Investigational Site 0070010
Helsinki, Finland
SPMSD Investigational Site 0070008
Helsinki, Finland
SPMSD Investigational Site 0070006
Jarvenpaa, Finland
SPMSD Investigational Site 0070045
Kokkola, Finland
SPMSD Investigational Site 0070007
Lahti, Finland
SPMSD Investigational Site 0070012
Oulu, Finland
SPMSD Investigational Site 0070005
Pori, Finland
SPMSD Investigational Site 0070013
Seinajoki, Finland
SPMSD Investigational Site 0070003
Tampere, Finland
SPMSD Investigational Site 0070004
Turku, Finland
SPMSD Investigational Site 0070009
Vantaa, Finland
Germany
SPMSD Investigational Site 0070051
Aalen, Germany
SPMSD Investigational Site 0070016
Alsfeld, Germany
SPMSD Investigational Site 0070036
Aschaffenburg, Germany
SPMSD Investigational Site 0070018
Baunatal, Germany
SPMSD Investigational Site 0070039
Berlin, Germany
SPMSD Investigational Site 0070015
Bochum, Germany
SPMSD Investigational Site 0070033
Bonnigheim, Germany
SPMSD Investigational Site 0070014
Bramsche, Germany
SPMSD Investigational Site 0070029
Bretten, Germany
SPMSD Investigational Site 0070038
Datteln, Germany
SPMSD Investigational Site 0070024
Erfurt, Germany
SPMSD Investigational Site 0070048
Fulda, Germany
SPMSD Investigational Site 0070049
Hagen, Germany
SPMSD Investigational Site 0070026
Hamburg, Germany
SPMSD Investigational Site 0070020
Herbolzheim, Germany
SPMSD Investigational Site 0070052
Herford, Germany
SPMSD Investigational Site 0070019
Karlsruhe, Germany
SPMSD Investigational Site 0070041
Kleve-Materborn, Germany
SPMSD Investigational Site 0070034
Mannheim, Germany
SPMSD Investigational Site 0070042
Marbach, Germany
SPMSD Investigational Site 0070030
Monchengladbach, Germany
SPMSD Investigational Site 0070022
Monchengladbach, Germany
SPMSD Investigational Site 0070050
Neumunster, Germany
SPMSD Investigational Site 0070031
Oberhausen, Germany
SPMSD Investigational Site 0070053
Schwäbisch Hall, Germany
SPMSD Investigational Site 0070023
Solingen, Germany
SPMSD Investigational Site 0070025
Stockelsdorf, Germany
SPMSD Investigational Site 0070035
Stuttgart, Germany
SPMSD Investigational Site 0070032
Tuttlingen, Germany
SPMSD Investigational Site 0070037
Welzheim, Germany
Sponsors and Collaborators
Sanofi Pasteur MSD
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Sanofi Pasteur MSD
ClinicalTrials.gov Identifier: NCT01341639     History of Changes
Other Study ID Numbers: V419-007, 2010-021490-37
Study First Received: April 22, 2011
Last Updated: April 9, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Finland: Finnish Medicines Agency
Germany: Paul-Ehrlich-Institut

Keywords provided by Sanofi Pasteur MSD:
combination vaccine
diphtheria
pertussis
tetanus
hepatitis B
Hep B
Haemophilus influenzae b
Hib
polio
poliovirus

Additional relevant MeSH terms:
Bacterial Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014