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Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005 AM4)

This study has been completed.
Sponsor:
Collaborator:
Sanofi Pasteur MSD
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01337167
First received: April 15, 2011
Last updated: September 26, 2014
Last verified: September 2014
  Purpose

This is a study to assess the safety, tolerability, and immunogenicity of V419 when administered as an infant series at 2, 4, and 6 months of age followed by a toddler dose of DAPTACEL™, Prevnar 13™ and PedvaxHIB™ at 15 months of age. The study will determine whether subjects who receive V419 have a similar immune response to the vaccine compared to subjects who receive licensed component vaccine controls.


Condition Intervention Phase
Bacterial Infections
Virus Diseases
Biological: V419
Biological: DAPTACEL™
Biological: PedvaxHIB™
Biological: Prevnar 13™
Biological: RotaTeq™
Biological: PENTACEL™
Biological: Modified process Hepatitis B vaccine
Biological: ActHIB™
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase III Randomized, Open-Label, Active-Comparator Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V419 in Infants When Given at 2, 4, and 6 Months Concomitantly With Prevnar 13™ and RotaTeq™

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of responders to polyribosylribitol phosphate (PRP) antigen [ Time Frame: Post-dose 3 (Month 7) ] [ Designated as safety issue: No ]
  • Number of responders to hepatitis B surface antigen (HBsAg) [ Time Frame: Post-dose 3 (Month 7) ] [ Designated as safety issue: No ]
  • Number of responders to diphtheria antigen [ Time Frame: Post-dose 3 (Month 7) ] [ Designated as safety issue: No ]
  • Number of responders to tetanus antigen [ Time Frame: Post-dose 3 (Month 7) ] [ Designated as safety issue: No ]
  • Number of responders to pertussis antigens [ Time Frame: Post-dose 3 (Month 7) ] [ Designated as safety issue: No ]
  • Number of responders to inactivated poliovirus (IPV) antigens [ Time Frame: Post-dose 3 (Month 7) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) for the pertussis antigens [ Time Frame: Post-dose 3 (Month 7) ] [ Designated as safety issue: No ]
  • Number of responders to the pertussis antigens [ Time Frame: Post-dose 4 (Month 16) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) for the pertussis antigens [ Time Frame: Post-dose 4 (Month 16) ] [ Designated as safety issue: No ]
  • Number of participants receiving V419 with an IPV antibody titer >1:8 [ Time Frame: Post-dose 3 (Month 7) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of responders to polyribosylribitol phosphate (PRP) antigen [ Time Frame: Post-dose 3 (Month 7) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) for PRP [ Time Frame: Post-dose 3 (Month 7) ] [ Designated as safety issue: No ]
  • Geometric Mean Titers (GMTs) for anti-rotavirus IgA (immunoglobulin A) [ Time Frame: Post-dose 3 (Month 7) ] [ Designated as safety issue: No ]

Enrollment: 1473
Study Start Date: April 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V419
V419 + DAPTACEL™ + PedvaxHIB™ + Prevnar 13™ + RotaTeq™
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, 4, and 6 months of age
Biological: DAPTACEL™
DAPTACEL™ 0.5 mL intramuscular injection at 15 months of age
Biological: PedvaxHIB™
PedvaxHIB™ 0.5 mL intramuscular injection at 15 months of age
Biological: Prevnar 13™
Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age
Biological: RotaTeq™
RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age
Other Name: V260
Active Comparator: Control
PENTACEL™ + modified process hepatitis B vaccine + DAPTACEL™ + ActHIB™ + Prevnar 13™ + RotaTeq™
Biological: DAPTACEL™
DAPTACEL™ 0.5 mL intramuscular injection at 15 months of age
Biological: Prevnar 13™
Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age
Biological: RotaTeq™
RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age
Other Name: V260
Biological: PENTACEL™
PENTACEL™ 0.5 mL intramuscular injection at 2, 4, and 6 months of age
Biological: Modified process Hepatitis B vaccine
Modified process Hepatitis B vaccine 0.5 mL intramuscular injection at 2 and 6 months of age
Biological: ActHIB™
ActHIB™ 0.5 mL intramuscular injection at 15 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 :

  • Participant is a healthy infant
  • Participant has received one dose of monovalent hepatitis B vaccine prior to 1 month of age

Exclusion Criteria :

  • Participant has received more than one dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry
  • Participant has been vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, or any combination of the above
  • Participant has had a fever ≥38.0°C (≥110.4°F) within 24 hours of study enrollment
  • Participant was vaccinated with any non-study vaccine (i.e., inactivated, conjugated, live virus vaccine) within 30 days prior to study enrollment, except for inactivated influenza vaccine which will be permitted 15 days or more prior to enrollment
  • Participant has hepatitis B surface antigen (HBsAg) seropositivity (by medical history)
  • Participant has a history of haemophilus influenzae type B, hepatitis B, diphtheria, tetanus, pertussis, poliomyelitis, rotavirus, or 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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01337167     History of Changes
Other Study ID Numbers: V419-005
Study First Received: April 15, 2011
Last Updated: September 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Diphtheria
Tetanus
Whooping Cough (pertussis)
Poliomyelitis
Hepatitis B infection
Haemophilus influenzae type b infection

Additional relevant MeSH terms:
Bacterial Infections
Communicable Diseases
Infection
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014