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Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT01480258
First received: November 23, 2011
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  Purpose

This study will determine whether subjects who receive V419 at 2, 4, and 11 to 12 months of age have an acceptable response to the vaccine. this study will also determine whether the immune response to V419 is similar to that of subjects who received a licensed vaccine control.


Condition Intervention Phase
Bacterial Infections
Virus Diseases
 Biological: V419
Biological: Rotavirus vaccine
Biological: Prevenar 13
Biological: INFANRIX hexa
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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, 4, and 11 to 12 Months

Resource links provided by NLM:

U.S. FDA Resources

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 (12 to 13 Months) ] [ Designated as safety issue: No ]
  • Number of responders to diphtheria antigen [ Time Frame: Post-dose 3 (12 to 13 Months) ] [ Designated as safety issue: No ]
  • Number of responders to tetanus antigen [ Time Frame: Post-dose 3 (12 to 13 Months) ] [ Designated as safety issue: No ]
  • Number of responders to inactivated poliovirus (IPV) antigens [ Time Frame: Post-dose 3 (12 to 13 Months) ] [ Designated as safety issue: No ]
  • Number of responders to hepatitis B surface (HBsAg) antigen [ Time Frame: Post-dose 3 (12 to 13 Months) ] [ Designated as safety issue: No ]
  • Number of responders to pertussis antigens [ Time Frame: Post-dose 3 (12 to 13 Months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of responders to polyribosylribitol phosphate (PRP) antigen [ Time Frame: Post-dose 2 (5 Months) ] [ Designated as safety issue: No ]
  • Geometric mean titer (GMT) for rotavirus antigens [ Time Frame: Post-dose 2 (5 Months) ] [ Designated as safety issue: No ]

Enrollment: 1315
Study Start Date: November 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V419
V419 + Rotavirus vaccine + Prevenar 13
 Biological: 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, 4, and 11 to 12 months of age
Biological: Rotavirus vaccine
Rotarix 1.5 mL oral dose at 2 and 4 months of age (subset 1) or RotaTeq 2 mL oral dose at 2, 4 and 5 months of age (subset 2)
Biological: Prevenar 13
Prevenar 13 0.5 mL intramuscular injection at 2, 4, and 11 to 12 months of age
Biological: INFANRIX hexa
INFANRIX hexa 0.5 mL intramuscular injection at 2, 4 and 11 to 12 months of age
Active Comparator: Infanrix hexa
INFANRIX hexa + rotavirus vaccine + Prevenar 13
 Biological: Rotavirus vaccine
Rotarix 1.5 mL oral dose at 2 and 4 months of age (subset 1) or RotaTeq 2 mL oral dose at 2, 4 and 5 months of age (subset 2)
Biological: Prevenar 13
Prevenar 13 0.5 mL intramuscular injection at 2, 4, and 11 to 12 months of age
Biological: INFANRIX hexa
INFANRIX hexa 0.5 mL intramuscular injection at 2, 4 and 11 to 12 months of age

  Eligibility

Ages Eligible for Study:   46 Days to 89 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy infant able to attend all study visits
  • Parent(s)/legal representative are 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 study entry
  • Vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, Haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal
  • polysaccharide, rotavirus vaccine, or 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 enrolment
  • Has a coagulation disorder
  • Has developmental delay or neurological disorder
  • Participant or his/her mother has a medical history of hepatitis B surface antigens (HBsAg) seropositivity
  • History of Haemophilus influenzae type b, hepatitis B, diphtheria, tetanus, pertussis, poliomyelitis, rotavirus gastroenteritis, or invasive pneumococcal infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01480258

Locations
Finland
SPMSD Investigational Site 0080019
Espoo, Finland
SPMSD Investigational site 0080018
Helsinki, Finland
SPMSD Investigational Site 0080005
Helsinki, Finland
SPMSD Investigational Site 0080003
Jarvenpaa, Finland
SPMSD Investigational Site 0080021
Kokkola, Finland
SPMSD Investigational Site 0080020
Oulu, Finland
SPMSD Investigational Site 0080016
Pori, Finland
SPMSD Investigational Site 0080006
Seinajoki, Finland
SPMSD Investigational Site 0080001
Tampere, Finland
SPMSD Investigational Site 0080002
Turku, Finland
SPMSD Investigational Site 0080017
Vantaa, Finland
Italy
SPMSD Investigational Site 0080024
Chiavari, Italy
SPMSD Investigational Site 0080014
Este, Italy
SPMSD Investigational Site 0080011
Genova, Italy
SPMSD Investigational Site 0080013
Milano, Italy
SPMSD Investigational Site 0080022
Novara, Italy
SPMSD Investigational Site 0080025
Ragusa, Italy
SPMSD Investigational Site 0080023
Roma, Italy
SPMSD Investigational Site 0080012
Sassari, Italy
Sweden
SPMSD Investigational Site 0080009
Linkoeping, Sweden
SPMSD Investigational Site 0080008
Malmo, Sweden
SPMSD Investigational Site 0080007
Orebro, Sweden
SPMSD Investigational Site 0080010
Umea, Sweden
Sponsors and Collaborators
Sanofi Pasteur MSD
Merck
  More Information

No publications provided

Responsible Party: Sanofi Pasteur MSD
ClinicalTrials.gov Identifier: NCT01480258     History of Changes
Other Study ID Numbers: V419-008, 2010-021491-28
Study First Received: November 23, 2011
Last Updated: April 9, 2013
Health Authority: Italy: Ethics Committee
Sweden: Medical Products Agency
Finland: Finnish Medicines Agency

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 May 23, 2013