Safety of Haemophilus Influenza Type b Vaccine When Administered to Korean Children

Novartis

Status and phase: Completed; Phase 4

Conditions: Haemophilus Influenzae Type B Infection

Treatments: Biological: Haemophilus influenza type b conjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01404962

V37_11

Details and patient eligibility

About

This is a multicenter, post marketing surveillance study which aims to evaluate the safety profile of haemophilus influenza type b vaccine when administered to Korean children according to the product insert.

Enrollment: 764 patients

Sex: All

Ages: 2 months to 5 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and female children 2 months to 5 years of age scheduled to receive vaccination

Exclusion criteria

• Contraindications to Vaxem™Hib Korean Prescribing information

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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764 participants in 1 patient group

Group 1

Other group

Treatment:

Biological: Haemophilus influenza type b conjugate vaccine