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A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)

NCT01340937 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2808

Last updated 2018-11-15

Study results available
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Summary

This study will determine whether three manufacturing lots of V419 (PR5I) induce similar immune responses to all of the antigens contained in V419 when given concomitantly with Prevnar13™ and RotaTeq™.

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) (from one of three lots) 0.5 mL intramuscular injection at 2, 4, and 6 months of age.

BIOLOGICAL

PENTACEL™

PENTACEL™ 0.5 mL intramuscular injection at 15 months of age in the V419 groups and at 2, 4, 6, and 15 months of age in the control group

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

Recombivax HB vaccine

Recombivax HB vaccine 0.5 mL intramuscular injection at 2 and 6 months of age

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-05-10
Primary Completion
2012-12-18
Completion
2013-07-26

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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 NCT01340937 on ClinicalTrials.gov