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)

Phase 2CompletedNCT00551915

Merck Sharp & Dohme LLC756 enrolled

Overview

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.

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

756

Conditions

Bacterial Infections; Virus Diseases

Interventions

AR51 (12, 10)BIOLOGICAL

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

PR51 (3, 10)BIOLOGICAL

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

PR51 (6, 10)BIOLOGICAL

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

PENTACEL™BIOLOGICAL

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

RECOMBIVAX HB™BIOLOGICAL

licensed vaccine for hepatitis, administered open-label

Eligibility

Sex: ALLMin age: 6 WeeksMax age: 9 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Percentage of participants with level of anti-PRP antibodies >1.0 μg/mL at the Postdose 3 time point