A Phase 2 interventional study of AR51 (12, 10) and PR51 (3, 10) in Bacterial Infections; Virus Diseases, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 6 Weeks to 9 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-30.
Sponsored by Merck Sharp & Dohme LLC · Phase 2, Interventional, and Prevention
The purpose of this study is to evaluate the safety, tolerability and immunogenicity of 3 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 3 formulations of HR5I administered as a primary series at 2, 4, and 6 months of age will be acceptable (similar to targeted rates) with respect to Postdose 3 antibody responses to all antigens.
Participants will be randomized into 4 arms:
AR51 (12, 10): arm receiving vaccine formulation containing 12 mcg of polyribosylribitol phosphate (PRP) conjugated 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 polyribosylribitol phosphate 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
PENTACEL™ + RECOMBIVAX HB™: open-label control group receiving PENTACEL™ (licensed vaccine for diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b) and RECOMBIVAX HB™ (licensed vaccine for hepatitis)
658 studies on the registry are indexed under Bacterial Infections; 100 are open to participants now.
This study's enrollment of 756 is above the median of 84 across 405 interventional studies indexed under Bacterial Infections.
Browse Bacterial Infections studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
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Exclusion Criteria:
Participants were vaccinated with 0.5 ml of AR51 (12,10) formulation via intramuscular injection as a primary series at 2, 4, and 6 months of age, and as a booster at 12 to 14 months of age.
Biological: AR51 (12, 10)
Participants were vaccinated with 0.5 ml of PR51 (3,10) formulation via intramuscular injection as a primary series at 2, 4, and 6 months of age, and as a booster at 12 to 14 months of age.
Biological: PR51 (3, 10)
Participants were vaccinated with 0.5 ml of PR51 (6,10) formulation via intramuscular injection as a primary series at 2, 4, and 6 months of age, and as a booster at 12 to 14 months of age.
Biological: PR51 (6, 10)
Participants were vaccinated with 0.5 ml each of PENTACEL™ + RECOMBIVAX HB™ via intramuscular injection as a primary series at 2, 4, and 6 months of age, and with 0.5 ml PENTACEL™ as a booster at 12 to 14 months of age.
Biological: PENTACEL™ · Biological: RECOMBIVAX HB™
vaccine formulation containing 12 mcg of PRP-T and 10 mcg of HBsAg
vaccine formulation containing 3 mcg of PRP-OMPC and 10 mcg of HBsAg
vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of HBsAg
licensed vaccine for diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b, administered open-label
licensed vaccine for hepatitis, administered open-label
Percentage of participants with level of anti-PRP antibodies >1.0 μg/mL at the Postdose 3 time point
Time frame: At 7 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 7 months of age (1 month after 3rd vaccination)
Percentage of participants with a ≥4-fold rise in levels of antibodies to pertussis antigens at the Postdose 3 time point
Time frame: At 7 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 7 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 7 months of age (1 month after 3rd vaccination)
Percentage of participants with neutralizing anti-poliovirus type antibodies at ≥1:8 dilution at the Postdose 3 time point
Time frame: At 7 months of age (1 month after 3rd vaccination)
Percentage of participants with level of anti-PRP antibodies >1.0 μg/mL at the Postdose 2 time point
Time frame: At 6 months of age (2 months after 2nd vaccination)
Percentage of participants with level of anti-HBsAg antibodies ≥10 mIU/L at the Postdose 2 time point
Time frame: At 6 months of age (2 months after 2nd vaccination)
Percentage of participants with a ≥4-fold rise in level of antibodies to pertussis antigens at the Postdose 2 time point
Time frame: At 6 months of age (2 months after 2nd vaccination)
Percentage of participants with level of anti-diphtheria antibodies ≥0.01 IU/mL at the Postdose 2 time point
Time frame: At 6 months of age (2 months after 2nd vaccination)
Percentage of participants with level of anti-tetanus antibodies ≥0.01 IU/mL at the Postdose 2 time point
Time frame: At 6 months of age (2 months after 2nd vaccination)
Percentage of participants with neutralizing anti-poliovirus type antibodies at ≥1:8 dilution at the Postdose 2 time point
Time frame: At 6 months of age (2 months after 2nd vaccination)
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)
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)
No study locations are listed for this record.
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC