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This is a study to show that vaccination with three doses of Quinvaxem presented in Uniject is not inferior to vaccination with three doses of Quinvaxem presented in single dose vials, with respect to protection against all antibodies (anti-hepatitis B surface antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and anti-Bordetella pertussis) one (1) month after completion of the 6-10-14 week vaccination course.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quinvaxem in Uniject | Experimental | A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen One dose of Quinvaxem given intramuscularly at Weeks 6, 10 and 14 by injection into the anterolateral region of the thigh using the Uniject pre-filled injection device |
|
| Quinvaxem in single dose vials | Active Comparator | A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen One dose of Quinvaxem given intramuscularly at Weeks 6, 10 and 14 by injection into the anterolateral region of the thigh using a needle and syringe from single dose vials |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quinvaxem in Uniject | Biological |
| ||
| Quinvaxem in single dose vials |
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection Rate: Anti-PRP Antibodies | 1 month after the third vaccination | |
| Seroprotection Rate: Anti-hepatitis B Surface Antibodies | 1 month after the third vaccination | |
| Anti-diphtheria Toxoid Antibodies | 1 month after the third vaccination | |
| Seroprotection Rate: Anti-tetanus Toxoid Antibodies | 1 month after the third vaccination | |
| Seroprotection Rate: Anti-B. Pertussis Antibodies | 1 month after the third vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria RZ Capeding, MD | Research Institute for Tropical Medicine (RITM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute for Tropical Medicine | City of Muntinlupa | Philippines |
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| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D014917 | Whooping Cough |
| D013742 | Tetanus |
| D006509 | Hepatitis B |
| D006192 | Haemophilus Infections |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| Biological |
|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D003015 | Clostridium Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D016871 | Pasteurellaceae Infections |