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

NCT01337167 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1473

Last updated 2018-11-15

Study results available
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Summary

This is a study to assess the safety, tolerability, and immunogenicity of V419 (PR5I) 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.

Conditions

Interventions

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

BIOLOGICAL

PENTACEL™

PENTACEL™ 0.5 mL intramuscular injection at 2, 4, and 6 months of age

BIOLOGICAL

Recombivax HB vaccine

Recombivax HB 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

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
46 Days
Max Age
89 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-19
Primary Completion
2013-05-09
Completion
2013-05-09

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01337167 on ClinicalTrials.gov