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)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Bacterial Infections; Virus Diseases

Treatments: Biological: PR51 (3, 10); Biological: RECOMBIVAX HB™; Biological: PENTACEL™; Biological: PR51 (6, 10); Biological: AR51 (12, 10)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00551915

V419-003

2007_581 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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)

Enrollment: 756 patients

Sex: All

Ages: 6 to 9 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

756 participants in 4 patient groups

AR51 (12, 10)

Experimental group

Description:

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.

Treatment:

Biological: AR51 (12, 10)

PR51 (3, 10)

Experimental group

Description:

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.

Treatment:

Biological: PR51 (3, 10)

PR51 (6, 10)

Experimental group

Description:

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.

Treatment:

Biological: PR51 (6, 10)

PENTACEL™ + RECOMBIVAX HB™

Active Comparator group

Description:

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.

Treatment:

Biological: PENTACEL™

Biological: RECOMBIVAX HB™