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
Not provided
The objective for this study is to characterize the safety profile of PENTACEL® vaccine for identification of potential vaccine-related adverse events not currently associated with PENTACEL® vaccine administration.
The study will be conducted at Kaiser Permanente Northern California and will commence with first use of licensed PENTACEL® vaccine within that organization.
Vaccination databases will be reviewed to identify Diphtheria and tetanus toxoid with acellular pertussis (DTaP) vaccinations of accrued subjects. Medical encounter, emergency room, hospitalization, laboratory, state death reporting, and related databases will be reviewed to identify medical care events.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pentacel Group | Infants initiated on PENTACEL® vaccine |
| |
| Other DTap vaccines Group | Infants initiated on other DTaP vaccines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTaP-IPV/Hib | Biological | 0.5 mL, Intramuscular |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| A summary of all non-elective hospitalization and emergency room visits as well as outcome of interest from chart review. | Outcome of interest identified from Kaiser Permanente Medical Care Program (KPMCP) computerized records via International Classification of Diseases, 9th edition (ICD-9) codes, defined as:
| Up to 6 months post -dose 4 DTap Vaccination |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Receipt of DTaP vaccine during the study period by a previously unvaccinated subjects
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oakland | California | 94612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27373595 | Derived | Hansen J, Timbol J, Lewis N, Pool V, Decker MD, Greenberg DP, Klein NP. Safety of DTaP-IPV/Hib vaccine administered routinely to infants and toddlers. Vaccine. 2016 Jul 29;34(35):4172-4179. doi: 10.1016/j.vaccine.2016.06.062. Epub 2016 Jun 30. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C541234 | diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine |
| C512971 | pentacel |
| D022681 | Diphtheria-Tetanus-acellular Pertussis Vaccines |
| C472675 | PEDIARIX |
| ID | Term |
|---|---|
| D010567 | Pertussis Vaccine |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other DTap Vaccines | Biological | 0.5 mL, Intramuscular |
|
|
| 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 |
| D016871 | Pasteurellaceae Infections |
| D045424 |
| Complex Mixtures |
| D004168 | Diphtheria Toxoid |
| D014121 | Toxoids |
| D013745 | Tetanus Toxoid |
| D017778 | Vaccines, Combined |
| D022282 | Vaccines, Acellular |
| D022223 | Vaccines, Subunit |