Pedro A. Piedra, MD W. Paul Glezen, MD Baylor College of Medicine, Houston, Texas

1. Wheezing Illness in Children with Asthma Aged 1.5 to 4 Years After Live Attenuated Influenza Vaccine (LAIV), Central Texas Field Trial, 1998-2002 Manjusha J. Gaglani, MBBS Mark Riggs, PhD Scott & White Memorial Hospital and Clinic TAMU Health Science Center, Temple, Texas Pedro A. Piedra, MD W. Paul Glezen, MD Baylor College of Medicine, Houston, Texas

2. Criteria for LAIV on enrollment in the TrialPiedra et al: Pediatrics 2005; 116:e397-e407 Healthy Children, 1.5 to 18 years of age, without immunocompromized household contact Children with mild intermittent asthma were included Definition: Mild intermittent asthma was defined as history of asthma or reactive airway disease (RAD) not requiring daily (or every other day) use of steroids (oral or inhaled) or bronchodilator therapy for asthma control, not hospitalized or seen in the emergency room for asthma in the prior 12 months (prior 6 months if they were < 2 years old). Children with exercise-induced asthma were included. Children with allergic rhinitis on daily nasal steroids were included. [Others were offered inactivated influenza vaccine if not allergic to eggs.]

3. Pre-School Children with a History of Asthma/Reactivate Airway Disease (RAD) Who Received the Live Attenuated Influenza Vaccine (LAIV) in the Central Texas Field Trial, Scott & White Clinic (SWC). 1998-2002 Year 1.5 - 4 years of age RAD* No RAD 1998-99 138 712 1999-00 192 783 2000-01 167 718 2001-02 109 607 *identified by parent history, medical record or both (about 1/3 in each group)

4. Relative Risk of Medically Attended Acute Respiratory Illness (MAARI) 1 - 14 Days after LAIV for Children 1.5 – 4 Years of Age with RAD, Central Texas Field Trial, 1998-2002. Year 1 – 14 days post-LAIV* Pre-LAIV & >14 Days RR Post-LAIV (reference)* 95% CI 1998-99 51.9 110.3 0.49 0.26, 0.92 1999-00 90.1 119.8 0.74 0.48, 1.12 2000-01 116.5 128.6 0.95 0.62, 1.44 2001-02 19.8 78.6 0.25 0.08, 0.81 *Rate per 10,000 child-days

5. Relative Risk of Lower Respiratory Illness (LRI) 1 – 14 Days after LAIV for Children 1.5 – 4 Years of Age with RAD, Central Texas Field Trial, 1998 – 2002. Year 1 – 14 days post-LAIV* Pre-LAIV & >14 Days RR Post-LAIV (reference)* 95% CI 1998-99 5.2 16.3 0.32 0.04, 2.34 1999-00 3.8 10.7 0.39 0.05, 2.90 2000-01 12.9 24.0 0.59 0.17, 1.97 2001-02 0.0 9.2 n/a *Rate per 10,000 child-days

6. Relative Risk of Asthma/RAD Events 1 – 14 Days after LAIV for Children 1.5 – 4 Years of Age with RAD Central Texas Field Trial, 1998 – 2002. Year 1 – 14 days post-LAIV* Pre-LAIV & >14 Days RR Post-LAIV (reference)* 95% CI 1998-99 10.4 18.7 0.60 0.14, 2.50 1999-00 15.0 18.4 0.80 0.28, 2.26 2000-01 8.6 12.0 0.70 0.16, 3.19 2001-02 0.0 3.1 n/a *Rate per 10,000 child-days

7. Relative Risk of Medically Attended Acute Respiratory Illness (MAARI) 1 – 42 Days after LAIV for Children 1.5 – 4 Years of Age with RAD Central Texas Field Trial, 1998 – 2002. Year 1 – 42 days post-LAIV* Pre-LAIV & >42 Days RR Post-LAIV (reference)* 95% CI 1998-99 78.3 123.4 0.64 0.46, 0.88 1999-00 111.8 108.0 0.94 0.73, 1.23 2000-01 126.2 114.9 1.12 0.82, 1.53 2001-02 49.3 101.2 0.55 0.32, 0.93 *Rate per 10,000 child-days

8. Relative Risk of Lower Respiratory Illness (LRI)1 – 42 Days after LAIV for Children 1.5 – 4 Years of Age with RAD Central Texas Field Trial, 1998 – 2002. Year 1 – 42 days post-LAIV* Pre-LAIV & >42 Days RR Post-LAIV (reference)* 95% CI 1998-99 17.4 17.7 0.92 0.45, 1.90 1999-00 6.3 11.3 0.58 0.21, 1.58 2000-01 23.2 17.1 1.31 0.61, 2.84 2001-02 2.2 12.5 0.13 0.01, 1.06 *Rate per 10,000 child-days

9. Relative Risk of Asthma/Reactive Airways Disease (RAD) 1–42 Days after LAIV for Children 1.5 – 4 Years of Age with RAD, Central Texas Field Trial, 1998 – 2002. Year 1 – 42 days post-LAIV* Pre-LAIV & >42 Days RR Post-LAIV (reference)* 95% CI 1998-99 7.0 17.7 0.41 0.14, 1.16 1999-00 21.4 12.3 1.71 0.89, 3.29 2000-01 10.2 12.2 0.74 0.26, 2.10 2001-02 0.0 12.5 n/a *Rate per 10,000 child-days