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

NCT ID: NCT00551629

Last Updated: 2015-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 708 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-05-31
• Study Completion Date: 2003-03-31

Brief Summary

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.

Detailed 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

Conditions

Bacterial Infections; Virus Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

AR51 (12, 10)

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.

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, 3, and 4 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, 3, and 4 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

PR51 (6, 15)

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.

Group Type: EXPERIMENTAL

PR51 (6, 15)

Intervention Type: BIOLOGICAL

vaccine formulation containing 6 mcg of PRP-OMPC and 15 mcg of HBsAg

Interventions

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

PR51 (6, 15)

vaccine formulation containing 6 mcg of PRP-OMPC and 15 mcg of HBsAg

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 9 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Halperin SA, Tapiero B, Diaz-Mitoma F, Law BJ, Hoffenbach A, Zappacosta PS, Radley D, McCarson BJ, Martin JC, Brackett LE, Boslego JW, Hesley TM, Bhuyan PK, Silber JL. Safety and immunogenicity of a hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine at 2, 3, 4, and 12-14 months of age. Vaccine. 2009 Apr 28;27(19):2540-7. doi: 10.1016/j.vaccine.2008.11.115. Epub 2009 Jan 3.

Reference Type: RESULT

PMID: 19124057 (View on PubMed)

Other Identifiers

2007_580

Identifier Type: OTHER

Identifier Source: secondary_id

V419-002

Identifier Type: -

Identifier Source: org_study_id