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| ID | Type | Description | Link |
|---|---|---|---|
| 2007_580 | Other Identifier | Merck Registration Number |
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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.
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
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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, 3, and 4 months of age, and as a booster at 12 to 14 months of age. |
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| 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. |
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| 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. |
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| 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. |
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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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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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 |
|---|---|---|---|
| 19124057 | Result | 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. |
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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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| 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 |
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| PR51 (6, 15) | Biological | vaccine formulation containing 6 mcg of PRP-OMPC and 15 mcg of HBsAg |
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