NCT00551629

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
708

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2001

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2007

Completed
Last Updated

October 30, 2015

Status Verified

October 1, 2015

Enrollment Period

1.8 years

First QC Date

October 29, 2007

Last Update Submit

October 29, 2015

Conditions

Bacterial Infections; Virus Diseases

Outcome Measures

Primary Outcomes (6)

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

    At 5 months of age (1 month after 3rd vaccination)

  • Percentage of participants with level of anti-HBsAg antibodies ≥10 mIU/L at the Postdose 3 time point

    At 5 months of age (1 month after 3rd vaccination)

  • 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

    At 5 months of age (1 month after 3rd vaccination)

  • Percentage of participants with level of anti-diphtheria antibodies ≥0.01 IU/mL at the Postdose 3 time point

    At 5 months of age (1 month after 3rd vaccination)

  • Percentage of participants with level of anti-tetanus antibodies ≥0.01 IU/mL at the Postdose 3 time point

    At 5 months of age (1 month after 3rd vaccination)

  • Percentage of participants with neutralizing anti-poliovirus antibodies (Types 1, 2, and 3) at ≥1:8 dilution at the Postdose 3 time point

    At 5 months of age (1 month after 3rd vaccination)

Secondary Outcomes (2)

  • Number of participants with at least 1 adverse event (AE)

    From 1st vaccination up to 14 days following last vaccination (up to 14.5 months)

  • Number of participants who discontinued study treatment due to an AE

    From 1st vaccination up to 14 days following last vaccination (up to 14.5 months)

Study Arms (4)

AR51 (12, 10)

EXPERIMENTAL

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)

PR51 (3, 10)

EXPERIMENTAL

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)

PR51 (6, 10)

EXPERIMENTAL

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)

PR51 (6, 15)

EXPERIMENTAL

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)

Interventions

AR51 (12, 10)BIOLOGICAL

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

AR51 (12, 10)
PR51 (3, 10)BIOLOGICAL

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

PR51 (3, 10)
PR51 (6, 10)BIOLOGICAL

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

PR51 (6, 10)
PR51 (6, 15)BIOLOGICAL

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

PR51 (6, 15)

Eligibility Criteria

Age6 Weeks - 9 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 19124057RESULT

MeSH Terms

Conditions

Bacterial InfectionsVirus Diseases

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2007

First Posted

October 31, 2007

Study Start

May 1, 2001

Primary Completion

March 1, 2003

Study Completion

March 1, 2003

Last Updated

October 30, 2015

Record last verified: 2015-10