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Primary objective:
Secondary objective:
Participants will be randomized into one of 2 groups to receive either a dose of the TdcP-IPV on Day 0 (visit 1) and Hepatitis B vaccine on subsequent visits 2, 3 and 4 (Group 1); or no vaccination on Day 0, concomitant administration of TdcP-IPV and Hepatitis B vaccine on Day 28 (Visit 2) and Hepatitis B vaccine on subsequent visits 3 and 4 (Group 2).
All participants will be followed up for immunogenicity and safety
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group 1 | Experimental | Participants randomized to receive Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) at month 0, Hepatitis B at months 1, 2 and 7. |
|
| Study Group 2 | Active Comparator | Participants randomized to receive Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP-IPV) + Hepatitis B at month 0, Hepatitis B at months 1 and 6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPV | Biological | 0.5 mL, Intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection against diphtheria and tetanus antigens after vaccination with either Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and Inactivated Poliomyelitis (Tdcp-IPV) or concurrent Tdcp-IPV and Hepatitis B vaccine | Seroprotection defined as: Diphtheria levels ≥ 0.01 IU/mL and ≥ 0.1 IU/mL; Tetanus levels ≥ 0.01 EU/mL and ≥ 0.1 EU/mL. | Day 0 (pre-vaccination) and 1 month, 3, 5 and 10 years post-vaccination |
| Geometric Mean Titers for Diphtheria and Tetanus after vaccination with either Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine & Inactivated Poliomyelitis Vaccine (Tdcp-IPV) or concurrent Tdcp IPV and Hepatitis B vaccine | Diphtheria antibodies assayed using enzyme-linked immunoassay; Tetanus antibodies were assessed using microneutralization assay | Day 0 (pre-vaccination) and 1 month, 3, 5 and 10 years post-vaccination |
| Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events occurring during trial | Solicited local injection site reactions: Redness, Swelling, and Tenderness. Solicited systemic reactions: Altered Appetite, Headache, General Malaise, Nausea, Vomiting and Muscle aches. | Day 0 up to day 30 following each vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers for Pertussis antibodies after vaccination with either Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and Inactivated Poliomyelitis Vaccine (TdcP IPV) or concurrent Tdcp IPV and Hepatitis B vaccine | Anti pertussis toxoid, anti filamentous hemagglutinin, anti fimbriae 2 + 3 and anti Pertactin antibodies were assayed by enzyme linked immunoassay; Polio types 1, 2, and 3 were assayed using neutralizing antibodies to poliovirus types1, 2 and 3. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winnipeg | Manitoba | R3E 3P4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25540274 | Result | Embree J, Law B, Voloshen T, Tomovici A. Immunogenicity, safety, and antibody persistence at 3, 5, and 10 years postvaccination in adolescents randomized to booster immunization with a combined tetanus, diphtheria, 5-component acellular pertussis, and inactivated poliomyelitis vaccine administered with a hepatitis B virus vaccine concurrently or 1 month apart. Clin Vaccine Immunol. 2015 Mar;22(3):282-90. doi: 10.1128/CVI.00682-14. Epub 2014 Dec 24. |
| Label | URL |
|---|---|
| Related Info | View source |
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|
| Hepatitis B vaccine | Biological | 0.5 ml, Intramuscular |
|
|
| Day 0 (pre-vaccination) and 1 month, 3, 5 and 10 years post-vaccination |
| ID | Term |
|---|---|
| D014917 | Whooping Cough |
| D013742 | Tetanus |
| D004165 | Diphtheria |
| D011051 | Poliomyelitis |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| 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 |
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| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| D011054 | Poliovirus Vaccine, Inactivated |
| D017325 | Hepatitis B Vaccines |
| C075655 | Recombivax HB |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D015164 | Vaccines, Inactivated |
| D023321 | Poliovirus Vaccines |
| D014765 | Viral Vaccines |
| D014761 | Viral Hepatitis Vaccines |
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