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A Study of the Safety and Tolerability of V419 in Healthy Infants at 2,4, 6 and 12 to 14 Months of Age (V419-003)

NCT00551915 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 756

Last updated 2015-10-30

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of 3 formulations of the HR5I vaccine (Haemophilus influenzae type b conjugate, recombinant hepatitis B surface antigen, diphtheria, tetanus, 5-component acellular pertussis, and inactivated poliovirus Types 1, 2, and 3). The primary hypothesis is that at least 1 of the 3 formulations of HR5I administered as a primary series at 2, 4, and 6 months of age will be acceptable (similar to targeted rates) with respect to Postdose 3 antibody responses to all antigens.

Conditions

  • Bacterial Infections; Virus Diseases

Interventions

BIOLOGICAL

AR51 (12, 10)

vaccine formulation containing 12 mcg of PRP-T and 10 mcg of HBsAg

BIOLOGICAL

PR51 (3, 10)

vaccine formulation containing 3 mcg of PRP-OMPC and 10 mcg of HBsAg

BIOLOGICAL

PR51 (6, 10)

vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of HBsAg

BIOLOGICAL

PENTACEL™

licensed vaccine for diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b, administered open-label

BIOLOGICAL

RECOMBIVAX HB™

licensed vaccine for hepatitis, administered open-label

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
9 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-05-31
Primary Completion
2003-01-31
Completion
2003-01-31

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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 NCT00551915 on ClinicalTrials.gov