Bacterial Infections; Virus Diseases Clinical Trial
Official title:
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
| Verified date | October 2015 |
| Source | Merck Sharp & Dohme Corp. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Health Canada |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 708 |
| Est. completion date | March 2003 |
| Est. primary completion date | March 2003 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 6 Weeks to 9 Weeks |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme Corp. |
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-inacti — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | No | |
| Primary | 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) | No | |
| Primary | 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) | No | |
| Primary | 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) | No | |
| Primary | 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) | No | |
| Primary | 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) | No | |
| Secondary | 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) | Yes | |
| Secondary | 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) | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00551915 -
A Study of the Safety and Tolerability of V419 in Healthy Infants at 2,4, 6 and 12 to 14 Months of Age (V419-003)
|
Phase 2 |