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

Haemophilus Influenzae Type B Infection Clinical Trial

Official title:

A Post Marketing Surveillance Study to Monitor the Reactogenicity and Safety of Vaxem™Hib When Administered According to the Prescribing Information in Korea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404962
• Other study ID #: V37_11
• Status: Completed
• Phase: Phase 4
• First received: July 25, 2011
• Last updated: November 30, 2016
• Start date: August 2011
• Est. completion date: July 2012

Study information

• Verified date: September 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 764
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Months to 5 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Haemophilus Influenzae Type B Infection
• Influenza, Human

Intervention

Biological:
• Haemophilus influenza type b conjugate vaccine
Primary series is 3 doses given to infants beginning at 2 months of age with an interval of 2 months apart (i.e. 2, 4 and 6 months of age). Booster vaccination consists of 1 dose and is given to toddlers 16 to 20 months of age. In this study, subjects will receive vaccination from routine primary care.

Locations

Country	Name	City	State
Korea, Republic of	Moon's Pediatrics Clinic	Gyeonggi-do
Korea, Republic of	Wooriai Pediatrics clinic	Incheon
Korea, Republic of	Hanil General Hospital	Seoul
Korea, Republic of	KyungHee University Hospital	Seoul
Korea, Republic of	Yonsei Pediatrics Clinic	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Adverse Events 28 days following vaccination		29 days to 5 months	No

External Links

•   Results for V37_11 from the Novartis Clinical Trials website