Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate safety and immunogenicity of Pediacel® in infants and toddlers when given at 2,3,4 and 12-18 months of age.
Primary Objectives:
Secondary Objectives:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | PEDIACEL co-administered with Prevenar |
|
| Group 2 | Active Comparator | Infanrix-IPV+Hib co-administered with Prevenar |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEDIACEL® and Prevenar® | Biological | 0.5 mL each, IM (opposite thigh) |
|
| Measure | Description | Time Frame |
|---|---|---|
| To provide information concerning the immunogenicity of PEDIACEL® and Infanrix®-IPV+Hib | 1 month post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| To provide information concerning the safety after administration of PEDIACEL® and Infanrix®-IPV+Hib | Entire study |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paris | France | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21807056 | Result | Grimprel E, Wysocki J, Boisnard F, Thomas S, Mwawasi G, Reynolds D. Immunogenicity and safety of fully liquid DTaP(5)-IPV-Hib compared with DTaP(3)-IPV/Hib when both coadministered with a heptavalent pneumococcal conjugate vaccine (PCV7) at 2, 3, 4, and 12 to 18 months of age: a phase III, single-blind, randomised, controlled, multicentre study. Vaccine. 2011 Oct 6;29(43):7370-8. doi: 10.1016/j.vaccine.2011.07.078. Epub 2011 Jul 30. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Infanrix®-IPV+Hib and Prevenar® | Biological | 0.5 mL each, IM (opposite thigh) |
|
|
| Poznan |
| Poland |
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| D011051 | Poliomyelitis |
| D006192 | Haemophilus Infections |
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| 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 |
| D016871 | Pasteurellaceae Infections |
| D013290 | Streptococcal Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C541234 | diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine |
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| D011054 | Poliovirus Vaccine, Inactivated |
| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D017778 | Vaccines, Combined |
| D015164 | Vaccines, Inactivated |
| D023321 | Poliovirus Vaccines |
| D014765 | Viral Vaccines |
Not provided
Not provided