Drug updated on 12/11/2024
| Dosage Form | Injection (intramuscular; 0.5 mL) |
| Drug Class | Vaccines |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for active immunization against diphtheria, tetanus, and pertussis as a 5-dose series in infants and children aged 6 weeks through 6 years (prior to the seventh birthday).
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Summary
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- In adults with obstructive airway diseases (OAD) who received the Tdap vaccine, 89.0% achieved seroprotective anti-diphtheria antibody concentrations, and 97.2% achieved seroprotective anti-tetanus antibody concentrations at one month post-vaccination; 78.3%-96.1% showed booster responses across the three pertussis antigens, consistent with responses in the general adult population from six Tdap trials.
- No significant differences in Tdap vaccine effectiveness among various population types or subgroups were observed. Comparative effectiveness data with other vaccines or drugs were not provided.
- The most frequently reported solicited local adverse event for Tdap in adults with obstructive airway diseases was injection site pain (47.7%), while fatigue was the most frequently reported systemic adverse event (19.3%). Both events had low rates of grade 3 intensity (0.9% for injection site pain and 2.8% for fatigue), with no significant safety concerns identified from unsolicited and serious adverse events within one month post-vaccination.
- In pregnant women, Tdap showed no increased risk for key adverse events, including stillbirth, supported by moderate strength of evidence (SoE).
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Infanrix (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) Prescribing Information. | 2023 | GlaxoSmithKline, Philadelphia, PA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Immunogenicity and safety of reduced-antigen tetanus, diphtheria and acellular pertussis vaccination in adults treated for obstructive airway diseases | 2023 | Human Vaccines & Immunotherapeutics |
| Safety of vaccines used for routine immunization in the United States: An updated systematic review and meta-analysis | 2021 | Vaccine |