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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 has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
MCM Vaccines B.V.
ClinicalTrials.gov Identifier:
NCT01480258
First received: November 23, 2011
Last updated: February 27, 2017
Last verified: October 2013
  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
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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:


Further study details as provided by MCM Vaccines B.V.:

Primary Outcome Measures:
  • Number of responders to polyribosylribitol phosphate (PRP) antigen [ Time Frame: Post-dose 3 (12 to 13 Months) ]
  • Number of responders to diphtheria antigen [ Time Frame: Post-dose 3 (12 to 13 Months) ]
  • Number of responders to tetanus antigen [ Time Frame: Post-dose 3 (12 to 13 Months) ]
  • Number of responders to inactivated poliovirus (IPV) antigens [ Time Frame: Post-dose 3 (12 to 13 Months) ]
  • Number of responders to hepatitis B surface (HBsAg) antigen [ Time Frame: Post-dose 3 (12 to 13 Months) ]
  • Number of responders to pertussis antigens [ Time Frame: Post-dose 3 (12 to 13 Months) ]

Secondary Outcome Measures:
  • Number of responders to polyribosylribitol phosphate (PRP) antigen [ Time Frame: Post-dose 2 (5 Months) ]
  • Geometric mean titer (GMT) for rotavirus antigens [ Time Frame: Post-dose 2 (5 Months) ]

Enrollment: 1315
Study Start Date: November 2011
Study Completion Date: October 2013
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   (Child)
Sexes Eligible for Study:   All
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
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: NCT01480258

Locations
Finland
SPMSD Investigational Site 0080019
Espoo, Finland
SPMSD Investigational Site 0080005
Helsinki, Finland
SPMSD Investigational site 0080018
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
MCM Vaccines B.V.
Merck Sharp & Dohme Corp.
  More Information

Responsible Party: MCM Vaccines B.V.
ClinicalTrials.gov Identifier: NCT01480258     History of Changes
Other Study ID Numbers: V419-008
2010-021491-28 ( EudraCT Number )
Study First Received: November 23, 2011
Last Updated: February 27, 2017

Keywords provided by MCM Vaccines B.V.:
combination vaccine
diphtheria
pertussis
tetanus
hepatitis B
Hep B
Haemophilus influenzae b
Hib
polio
poliovirus

Additional relevant MeSH terms:
Bacterial Infections
Virus Diseases
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 23, 2017