Trial Outcomes & Findings for Control of Epidemic Influenza Through a School-based Influenza Vaccination Program (NCT NCT00138294)

Last Updated: 2017-05-19

Results Overview

The rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). This data was obtained from the SWHP database.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

29255 participants

Primary outcome timeframe

12/16/2007 to 3/29/2008 (15 weeks)

Results posted on

2017-05-19

Participant Flow

The participants in the intervention cities were enrolled to the study and signed informed consent. The participants in the comparison cities were not enrolled to the study and the relevant data for these participants were obtained from the Scott and White Clinic database.

Participant milestones

Participant milestones
Measure	Intervention Cities Eligible children 4 years of age and older whose parents provided consent (assent for children\>7 years) in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) were offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program.
Overall Study STARTED	29255
Overall Study COMPLETED	29255
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Control of Epidemic Influenza Through a School-based Influenza Vaccination Program

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Cities n=29255 Participants Eligible children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland with be offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program.
Age, Categorical <=18 years	29255 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	8 years n=5 Participants
Sex: Female, Male Female	15106 Participants n=5 Participants
Sex: Female, Male Male	14149 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9163 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20092 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	203 Participants n=5 Participants
Race (NIH/OMB) Asian	519 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2335 Participants n=5 Participants
Race (NIH/OMB) White	24699 Participants n=5 Participants
Race (NIH/OMB) More than one race	1499 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	29255 participants n=5 Participants

PRIMARY outcome

Timeframe: 12/16/2007 to 3/29/2008 (15 weeks)

Population: Overall rate of MAARI (MAARIs/1000 persons-week) were compared between the intervention and comparison cities during the epidemic period (irrespective of the vaccination status). Total number of participants reflect the number of SWHP participants in the intervention and comparison cities respectively.

Outcome measures

Outcome measures
Measure	Intervention Cities n=759975 Person Weeks Eligible children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland were offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.	Comparison Cities n=1005540 Person Weeks Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites received their influenza vaccines by the local healthcare providers. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
MAARI Rate During the Epidemic Period (2007-2008)	12503 Number of MAARI	18998 Number of MAARI

PRIMARY outcome

Timeframe: 1/4/2009 to 3/21/2009 (11 weeks)

Outcome measures

Outcome measures
Measure	Intervention Cities n=556567 Person Weeks Eligible children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland were offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.	Comparison Cities n=714659 Person Weeks Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites received their influenza vaccines by the local healthcare providers. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
MAARI Rate During the Epidemic Period (2008-2009)	6630 Number of MAARI	12429 Number of MAARI

PRIMARY outcome

Timeframe: 8/25/09 to 4/3/10 (32 weeks)

Outcome measures

Outcome measures
Measure	Intervention Cities n=1427521 Person Weeks Eligible children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland were offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.	Comparison Cities n=1793665 Person Weeks Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites received their influenza vaccines by the local healthcare providers. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
MAARI Rate During the Epidemic and Pandemic Period (2009-2010)	15155 Number of MAARI	25984 Number of MAARI

SECONDARY outcome

Timeframe: pre-, post- influenza vaccination

Population: This analyses was limited to the children enrolled in the intervention cities. 29255 doses of LAIV were administered to children 4-18 years of age. 21555 doses were seasonal LAIV and 7700 doses were pandemic LAIV.

Serious adverse events (SAEs) within 42 days post-LAIV vaccination will be captured in seasonal and pandemic vaccinated study subjects.

Outcome measures

Outcome measures
Measure	Intervention Cities n=29255 Participants Eligible children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland were offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.	Comparison Cities Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites received their influenza vaccines by the local healthcare providers. Age-specific rates for medically attended acute respiratory illness (MAARI) in the influenza outbreak periods.
Proportion of SAEs Detected in LAIV Recipients Incidence of SAEs among seasonal LAIV recipients	0.00005 proportion of events	—
Proportion of SAEs Detected in LAIV Recipients Incidence of SAEs among pandemic LAIV recipients	0.00012 proportion of events	—

Adverse Events

All Enrolled Study Participants

Serious events: 57 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Enrolled Study Participants n=29255 participants at risk Children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) with be offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites will received their influenza vaccines (live attenuated or inactivated influenza vaccines) by the local healthcare providers
Psychiatric disorders Psychiatric Disorder	0.01% 3/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
Musculoskeletal and connective tissue disorders Trauma/Skeletal Pain	0.01% 2/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
Nervous system disorders Migraine/Headache	0.00% 1/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
Nervous system disorders Seizure	0.01% 2/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
Investigations Elective Surgery	0.02% 5/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
Musculoskeletal and connective tissue disorders Soft tissue and/or bone infection	0.01% 2/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
Renal and urinary disorders Urinary Tract Infection	0.00% 1/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
General disorders Sepsis	0.00% 1/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
Nervous system disorders Meningitis	0.01% 2/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
Gastrointestinal disorders Pharyngitis/Group A Strep/Abscess	0.00% 1/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
Respiratory, thoracic and mediastinal disorders Lower Respiratory Tract Infection (LRTI)	0.02% 7/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
Respiratory, thoracic and mediastinal disorders 2009 H1N1 Pneumonia/LRTI	0.02% 6/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
Respiratory, thoracic and mediastinal disorders Acute Asthma Attack	0.01% 2/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
Blood and lymphatic system disorders Sickle Cell Crisis	0.00% 1/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
Gastrointestinal disorders Gastroenteritis/Mesentric Adenitis	0.00% 1/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
Gastrointestinal disorders Emesis and Weight Loss	0.00% 1/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
Gastrointestinal disorders Appendicitis	0.03% 10/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
Gastrointestinal disorders Acute abdominal pain	0.00% 1/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
Gastrointestinal disorders Intussususception	0.00% 1/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
Blood and lymphatic system disorders Henoch-Schonlein Purpura	0.00% 1/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
Eye disorders Optic neuritis	0.00% 1/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
Nervous system disorders Guillain Barre Syndrom	0.00% 1/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
Musculoskeletal and connective tissue disorders Oilgoarticular post-infectious arthritis	0.00% 1/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
General disorders Death	0.00% 1/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).
General disorders Carbon Monoxide Poisoning	0.01% 2/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).

Other adverse events

Other adverse events
Measure	All Enrolled Study Participants n=29255 participants at risk Children 4 years of age and older in the intervention cites (Temple, Belton, Academy, Troy, Salado, Rogers, and Holland) with be offered live attenuated or inactivated influenza vaccines through a school-based research vaccination program. Children living in the comparison cities (Waco, Bryan and College Station) which are within 90 miles of the intervention cites will received their influenza vaccines (live attenuated or inactivated influenza vaccines) by the local healthcare providers
Pregnancy, puerperium and perinatal conditions Pregnancy	0.00% 1/29255 Non-serious adverse events were not captured during the course of this study except for pregnancy(ies).

Additional Information

Pedro A Piedra, MD

Baylor College of Medicine

Phone: 713-798-5240

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place