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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

756 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-05-31

Study Completion Date

2003-01-31

Brief Summary

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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.

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Detailed Description

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Participants will be randomized into 4 arms:

AR51 (12, 10): arm receiving vaccine formulation containing 12 mcg of polyribosylribitol phosphate (PRP) conjugated to tetanus toxoid (PRP-T) and 10 mcg of Hepatitis B surface antigen (HBsAg)

PR51 (3, 10): arm receiving vaccine formulation containing 3 mcg of polyribosylribitol phosphate conjugated to the outer membrane protein complex of Neisseria meningitides (PRP-OMPC) and 10 mcg of HBsAg

PR51 (6, 10): arm receiving vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of HBsAg

PENTACEL™ + RECOMBIVAX HB™: open-label control group receiving PENTACEL™ (licensed vaccine for diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b) and RECOMBIVAX HB™ (licensed vaccine for hepatitis)

Conditions

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Bacterial Infections; Virus Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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AR51 (12, 10)

Participants were vaccinated with 0.5 ml of AR51 (12,10) formulation via intramuscular injection as a primary series at 2, 4, and 6 months of age, and as a booster at 12 to 14 months of age.

Group Type EXPERIMENTAL

AR51 (12, 10)

Intervention Type BIOLOGICAL

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

PR51 (3, 10)

Participants were vaccinated with 0.5 ml of PR51 (3,10) formulation via intramuscular injection as a primary series at 2, 4, and 6 months of age, and as a booster at 12 to 14 months of age.

Group Type EXPERIMENTAL

PR51 (3, 10)

Intervention Type BIOLOGICAL

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

PR51 (6, 10)

Participants were vaccinated with 0.5 ml of PR51 (6,10) formulation via intramuscular injection as a primary series at 2, 4, and 6 months of age, and as a booster at 12 to 14 months of age.

Group Type EXPERIMENTAL

PR51 (6, 10)

Intervention Type BIOLOGICAL

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

PENTACEL™ + RECOMBIVAX HB™

Participants were vaccinated with 0.5 ml each of PENTACEL™ + RECOMBIVAX HB™ via intramuscular injection as a primary series at 2, 4, and 6 months of age, and with 0.5 ml PENTACEL™ as a booster at 12 to 14 months of age.

Group Type ACTIVE_COMPARATOR

PENTACEL™

Intervention Type BIOLOGICAL

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

RECOMBIVAX HB™

Intervention Type BIOLOGICAL

licensed vaccine for hepatitis, administered open-label

Interventions

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AR51 (12, 10)

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

Intervention Type BIOLOGICAL

PR51 (3, 10)

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

Intervention Type BIOLOGICAL

PR51 (6, 10)

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

Intervention Type BIOLOGICAL

PENTACEL™

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

Intervention Type BIOLOGICAL

RECOMBIVAX HB™

licensed vaccine for hepatitis, administered open-label

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy infants 2 months of age who have not received prior vaccinations for Haemophilus influenzae type b (Hib), hepatitis B, Diptheria/Pertussis/Tetanus (DPT), or Polio

Exclusion Criteria

* HIV infection in participant (child/mother)
* Documented HBsAg seropositivity in the participant (child or mother)
* History of invasive Hib disease, hepatitis B, diphtheria, tetanus, pertussis, or poliovirus infection
* History of seizure disorder
* Underlying medical conditions such as inborn errors of metabolism, failure to thrive, or any major congenital abnormalities requiring surgery
* Prior or anticipated receipt of immune globulin, blood, or blood products
* Known hypersensitivity to any component of the investigational or marketed vaccines being administered in this protocol
* Any history or condition that would exclude the participant from receiving any vaccine administered under this protocol based on the contraindications that appear in the package circulars for each component of these vaccines
* Any condition that, in the opinion of the investigator, is not stable or may interfere with the evaluation of the study objectives

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

9 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes