A Study to Test the Safety and Effectiveness of an Investigational Vaccine in Infants (V419-002)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Bacterial Infections; Virus Diseases

Treatments: Biological: PR51 (6, 10); Biological: AR51 (12, 10); Biological: PR51 (6, 15); Biological: PR51 (3, 10)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00551629

V419-002

2007_580 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of 4 different 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 4 formulations of HR5I administered as a primary series at 2, 3, and 4 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) conjugates 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 PRP 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

PR51 (6, 15): arm receiving vaccine formulation containing 6 mcg of PRP-OMPC and 15 mcg of HBsAg

Enrollment: 708 patients

Sex: All

Ages: 6 to 9 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 :

• Documented HIV infection (child or mother)
• Documented HBsAg-seropositivity (child or mother)
• History of invasive Hib disease, hepatitis B, diphtheria, tetanus, pertussis, or poliovirus infection
• History of seizure disorder, developmental delay, or any other neurologic 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 vaccines being administered in this protocol
• Any history or condition that would exclude the child from receiving any vaccine administered under this protocol
• Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

708 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, 3, and 4 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, 3, and 4 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, 3, and 4 months of age, and as a booster at 12 to 14 months of age.

Treatment:

Biological: PR51 (6, 10)

PR51 (6, 15)

Experimental group

Description:

Participants were vaccinated with 0.5 ml of PR51 (6, 15) formulation via intramuscular injection as a primary series at 2, 3, and 4 months of age, and as a booster at 12 to 14 months of age.

Treatment:

Biological: PR51 (6, 15)