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Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)

NCT01341639 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1250

Last updated 2019-04-30

Study results available
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Summary

This study will determine whether participants who receive the vaccine V419 at 2, 3, 4, and 12 months of age have an acceptable immune response to the vaccine. The study will also determine whether the immune response to V419 is similar to that of participants who receive a licensed vaccine control.

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, 3, 4, and 12 months of age.

BIOLOGICAL

INFANRIX™ hexa

INFANRIX™ hexa 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age.

BIOLOGICAL

RotaTeq

RotaTeq (pentavalent combination live vaccine of 5 human-bovine reassortant rotavirus strains) 2 mL oral dose at 2, 3, and 4 months of age

BIOLOGICAL

Prevenar 13

Prevenar 13 0.5 mL intramuscular injection at 2, 3, 4,and 13 months of age

BIOLOGICAL

ProQuad™

ProQuad™ 0.5 mL subcutaneous injection at 12 and 13 months of age

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-05-26
Primary Completion
2013-03-13
Completion
2013-03-13

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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 NCT01341639 on ClinicalTrials.gov