A Study to Test the Safety and Effectiveness of an Investigational Vaccine in Infants (V419-002)
October 29, 2015 updated by: Merck Sharp & Dohme LLC
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
708
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 2 months (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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.
|
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.
|
vaccine formulation containing 6 mcg of PRP-OMPC and 15 mcg of HBsAg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
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
Time Frame: At 5 months of age (1 month after 3rd vaccination)
|
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
Time Frame: At 5 months of age (1 month after 3rd vaccination)
|
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
Time Frame: At 5 months of age (1 month after 3rd vaccination)
|
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
Time Frame: At 5 months of age (1 month after 3rd vaccination)
|
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
Time Frame: At 5 months of age (1 month after 3rd vaccination)
|
At 5 months of age (1 month after 3rd vaccination)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
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
Time Frame: From 1st vaccination up to 14 days following last vaccination (up to 14.5 months)
|
From 1st vaccination up to 14 days following last vaccination (up to 14.5 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2001
Primary Completion (Actual)
March 1, 2003
Study Completion (Actual)
March 1, 2003
Study Registration Dates
First Submitted
October 29, 2007
First Submitted That Met QC Criteria
October 30, 2007
First Posted (Estimate)
October 31, 2007
Study Record Updates
Last Update Posted (Estimate)
October 30, 2015
Last Update Submitted That Met QC Criteria
October 29, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V419-002
- 2007_580 (Other Identifier: Merck Registration Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.