Case Study: Intussusception risk after rotavirus vaccination in US infants Flashcards Preview

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Flashcards in Case Study: Intussusception risk after rotavirus vaccination in US infants Deck (6):
1

Background

-RotaShield, first vaccine for prevention of rotavirus infection in infants
-post-licensure studies in other countries suggested increased risk of intussusception, so FDA requested study to quantify risk among US infants

2

Study Population

613,000 infant years (5-36.9 weeks of age) using medical claims data (healthcare, humana, aetna)

3

Exposure and Outcome

-Vaccination with RotaTeq and RotaRix initially identified by CPT code (validated with EMR)
-cases identified by ICD-9

4

Study design

SCRI (Self controlled risk interval)
-use vaccinated cases with intussusception in pre-specified risk or control window
-two intervals: 7 days and 21 days
-Ho: risk of outcome on average day in risk interval = risk of outcome on average day in control interval

5

Time varying confounder by age

-incorporate offset term into model

6

Conclusion

-RV5 associated with 1.5 excess cases of intussusception per 100,000 recipients of the first dose