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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_581 | Other Identifier | Merck Registration Number |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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, 4, and 6 months of age, and as a booster at 12 to 14 months of age. |
|
| 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, 4, and 6 months of age, and as a booster at 12 to 14 months of age. |
|
| 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, 4, and 6 months of age, and as a booster at 12 to 14 months of age. |
|
| PENTACEL™ + RECOMBIVAX HB™ | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR51 (12, 10) | Biological | vaccine formulation containing 12 mcg of PRP-T and 10 mcg of HBsAg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with level of anti-PRP antibodies >1.0 μg/mL at the Postdose 3 time point | 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 | 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 | 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 | 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 | 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 | At 7 months of age (1 month after 3rd vaccination) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with level of anti-PRP antibodies >1.0 μg/mL at the Postdose 2 time point | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21134456 | Result | Diaz-Mitoma F, Halperin SA, Tapiero B, Hoffenbach A, Zappacosta PS, Radley D, Bradshaw S, Martin JC, Boslego JW, Hesley TM, Bhuyan PK, Silber JL. Safety and immunogenicity of three different formulations of a liquid hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine at 2, 4, 6 and 12-14 months of age. Vaccine. 2011 Feb 1;29(6):1324-31. doi: 10.1016/j.vaccine.2010.11.053. Epub 2010 Dec 4. |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C512971 | pentacel |
| C075655 | Recombivax HB |
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| PR51 (3, 10) | Biological | vaccine formulation containing 3 mcg of PRP-OMPC and 10 mcg of HBsAg |
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| PR51 (6, 10) | Biological | vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of HBsAg |
|
| PENTACEL™ | Biological | licensed vaccine for diphtheria, tetanus, pertussis, poliomyelitis, and invasive disease due to Haemophilus influenzae type b, administered open-label |
|
| RECOMBIVAX HB™ | Biological | licensed vaccine for hepatitis, administered open-label |
|
| 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 | 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 | 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 | 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 | At 6 months of age (2 months after 2nd vaccination) |
| 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) |