A Post Marking Study to Evaluate the Safety of FluMist in Children

MedImmune

Status: Completed

Conditions: Healthy

Treatments: Biological: FLuMist; Other: Unvaccinated Control; Biological: TIV (Injection)

Study type: Observational

Funder types: Industry

Identifiers

NCT00569894

MI-MA162

Details and patient eligibility

About

To assess the safety of FluMist vaccination

Full description

• To assess the safety of FluMist vaccination Rates of medically attended events in FluMist recipients, including serious adverse events (SAEs), anaphylaxis , urticaria, asthma, wheezing, pre-specified grouped diagnoses, and rare events potentially related to wild-type influenza, will be compared to rates in multiple non-randomized control groups.
• To assess the safety of annual FluMist re-vaccination [Rates of MAEs in the subset of children who receive FluMist in ≥2 consecutive years will be compared to rates in first-time vaccinees during the same season.]
• To assess the safety of FluMist vaccination in children previously vaccinated with trivalent inactivated influenza vaccine (TIV) [Rates of MAEs in the subset of children who received one or more prior TIV vaccinations will be compared to rates in children who did not receive prior TIV.]

Enrollment: 29,296 patients

Sex: All

Ages: 24 to 59 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy
• Age: born within the same calendar quarter as the reference FluMist vaccinee.

Exclusion criteria

• Children who have evidence of medical conditions that put them at high risk for complications of influenza (e.g., chronic cardiovascular and pulmonary disease) will be excluded from this control group.

Trial design

29,296 participants in 3 patient groups

2

Description:

TIV

Treatment:

Biological: TIV (Injection)

1

Description:

FluMist

Treatment:

Biological: FLuMist

3

Description:

Unvaccinated

Treatment:

Other: Unvaccinated Control