# Presentation: 552816

## Wheezing Illness in Children with Asthma Aged 1.5 to 4 Years After Live Attenuated Influenza Vaccine (LAIV), Central Texas Field Trial, 1998-2002

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

**Manjusha J. Gaglani, MBBS**
**Mark Riggs, PhD**
**Scott & White Memorial Hospital and Clinic**
**TAMU Health Science Center, Temple, Texas**

## Criteria for LAIV on enrollment in the TrialPiedra 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.]**

## 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

**	****	****RAD*****	****No RAD**

**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**

- *identified by parent history, medical record or both (about 1/3 in each group)

**1998-99****	****	****138****	****712**
**1999-00****	****	****192****	****783**
**2000-01****	****	****167****	****718**
**2001-02****	****	****109****	****607**

**Notes:**
Role of Virus in Clinical Course and Recovery of AOM (cont)
Similar results from a larger prospective study of 271 children with persistent OM indicated that more patients with combined viral and bacterial infection had persistent OM than did patients with only bacterial or viral infection.
According to the authors, the data from the study suggest that the clinical course of bacterial AOM can be worsened significantly when viruses and bacteria interact. The presence of a virus in middle ear fluid may contribute to the initiation and outcome of bacterial AOM.

	Chonmaitree T, Owen MJ, Patel JA, et al. Pediatrics. 1992;120:856-862.

## 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**

## 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**

## 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**

## 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**

## 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**

## 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**