Bacterial Infections; Virus Diseases
Conditions
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.
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
Interventions
BIOLOGICALAR51 (12, 10)
vaccine formulation containing 12 mcg of PRP-T and 10 mcg of HBsAg
BIOLOGICALPR51 (3, 10)
vaccine formulation containing 3 mcg of PRP-OMPC and 10 mcg of HBsAg
BIOLOGICALPR51 (6, 10)
vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of HBsAg
BIOLOGICALPR51 (6, 15)
vaccine formulation containing 6 mcg of PRP-OMPC and 15 mcg of HBsAg
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 9 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) |
| 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 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) |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| 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) |
Outcome results
None listed