Direct and Indirect Benefits of Influenza Vaccination in Schools and Households

The University of Hong Kong (HKU)

Status and phase: Completed; Phase 4

Conditions: Acute Respiratory Infection; Influenza-like Illness; Influenza Virus Infection

Treatments: Biological: Monovalent live attenuated pandemic influenza vaccine; Biological: Trivalent live attenuated seasonal influenza vaccine; Biological: Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT00981513

BJC004.6

Details and patient eligibility

About

The purpose of this study is to determine the degree of indirect benefits to family members and classmates resulting from administration of influenza vaccine to children.

Enrollment: 6,300 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Hong Kong residents aged between 7 and 11 and their family members.

Exclusion criteria

• Children with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin, or arginine or with life-threatening reactions to previous influenza vaccinations.
• Children receiving aspirin therapy or aspirin-containing therapy.
• Children with asthma or active wheezing.
• Children or family members with underlying immunocompromised condition or receiving immunosuppressive agents.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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6,300 participants in 2 patient groups, including a placebo group

Influenza vaccination

Active Comparator group

Description:

Live attenuated influenza vaccine (seasonal and pandemic strains) by nasal spray

Treatment:

Biological: Trivalent live attenuated seasonal influenza vaccine

Biological: Monovalent live attenuated pandemic influenza vaccine

Saline placebo

Placebo Comparator group

Description:

Saline nasal spray

Treatment:

Biological: Saline