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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00551629
First received: October 29, 2007
Last updated: October 30, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Bacterial Infections; Virus Diseases
Biological: AR51 (12, 10)
Biological: PR51 (3, 10)
Biological: PR51 (6, 10)
Biological: PR51 (6, 15)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Safety, Tolerability, and Immunogenicity of Four Different Formulations of a Liquid Hexavalent Combination Vaccine, HR5I (Haemophilus Influenzae Type b Conjugate, Recombinant Hepatitis B Surface Antigen, Diphtheria Toxoid, Tetanus Toxoid, 5-Component Acellular Pertussis Vaccine, and Inactivated Poliovirus Type 1, 2, and 3), When Administered to Healthy Hepatitis B Vaccine-Naïve Infants at 2, 3, 4, and 12 to 14 Months of Age

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percentage of participants with level of anti-PRP antibodies >1.0 μg/mL at the Postdose 3 time point [ Time Frame: At 5 months of age (1 month after 3rd vaccination) ] [ Designated as safety issue: No ]
  • Percentage of participants with level of anti-HBsAg antibodies ≥10 mIU/L at the Postdose 3 time point [ Time Frame: At 5 months of age (1 month after 3rd vaccination) ] [ Designated as safety issue: No ]
  • Percentage of participants with a ≥4-fold rise in levels of antibodies to pertussis antigens (toxoid [PTxd], Filamentous Hemagglutinin [FHA], Fimbria 2 & Fimbria 3 [FIM], and Pertactin [PRN]) at the Postdose 3 time point [ Time Frame: At 5 months of age (1 month after 3rd vaccination) ] [ Designated as safety issue: No ]
  • Percentage of participants with level of anti-diphtheria antibodies ≥0.01 IU/mL at the Postdose 3 time point [ Time Frame: At 5 months of age (1 month after 3rd vaccination) ] [ Designated as safety issue: No ]
  • Percentage of participants with level of anti-tetanus antibodies ≥0.01 IU/mL at the Postdose 3 time point [ Time Frame: At 5 months of age (1 month after 3rd vaccination) ] [ Designated as safety issue: No ]
  • Percentage of participants with neutralizing anti-poliovirus antibodies (Types 1, 2, and 3) at ≥1:8 dilution at the Postdose 3 time point [ Time Frame: At 5 months of age (1 month after 3rd vaccination) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with at least 1 adverse event (AE) [ Time Frame: From 1st vaccination up to 14 days following last vaccination (up to 14.5 months) ] [ Designated as safety issue: Yes ]
  • Number of participants who discontinued study treatment due to an AE [ Time Frame: From 1st vaccination up to 14 days following last vaccination (up to 14.5 months) ] [ Designated as safety issue: Yes ]

Enrollment: 708
Study Start Date: May 2001
Study Completion Date: March 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Biological: AR51 (12, 10)
vaccine formulation containing 12 mcg of PRP-T and 10 mcg of HBsAg
Experimental: 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.
Biological: PR51 (3, 10)
vaccine formulation containing 3 mcg of PRP-OMPC and 10 mcg of HBsAg
Experimental: 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.
Biological: PR51 (6, 10)
vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of HBsAg
Experimental: 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.
Biological: PR51 (6, 15)
vaccine formulation containing 6 mcg of PRP-OMPC and 15 mcg of HBsAg

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

  Eligibility

Ages Eligible for Study:   6 Weeks to 9 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551629

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00551629     History of Changes
Other Study ID Numbers: V419-002, 2007_580
Study First Received: October 29, 2007
Last Updated: October 30, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Bacterial Infections
Virus Diseases

ClinicalTrials.gov processed this record on August 04, 2015