reactogenicity and safety of Vaxem™Hib

• Conditions: Meningitis, epiglottitis, pneumonia, arthritis caused by Haemophilus influenzae type b.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-005203-24-Outside-EU/EEA
• Lead Sponsor: ovartis Vaccines and Diagnostics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-10
• Last Update Posted: 6 January 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

1.Male and female children, 2 months to 5 years of age, who are scheduled to receive vaccination to prevent Haemophilus influenzae type b

2.Individuals in good health as determined by the outcome of medical history, physical assessment and clinical judgment of the investigator

3.After the nature of the study has been explained according to local regulatory requirements, documented informed consent from parent(s) and/or legally authorized caretaker(s) of the child

4.Ability to comply with all study procedures and follow-up as scheduled in the study protocol

Are the trial subjects under 18? yes
Number of subjects for this age range: 750
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.The Investigator and research staff should review the Vaxem™Hib vaccine Korean Prescribing information to verify that no contraindications, special warnings and/or precautions are indicated for any subject prior to enrolment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and reactogenicity profile of Vaxem™Hib in Korean children;Secondary Objective: Not Applicable;Primary end point(s): 1. Occurrence of solicited local (tenderness, erythema, induration) and systemic reactions (change in eating habits, persistent crying, irritability, vomiting, diarrhea) for 7 days following each vaccine dose . ;Timepoint(s) of evaluation of this end point: Days 1 to 7 after each vaccination

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Occurrence of unsolicited AEs through 28 day Follow-Up after each vaccine dose<br>2. Occurrence of SAEs during the entire PMS period <br>;Timepoint(s) of evaluation of this end point: 1. Days 1 to 28 after each vaccination<br>2. Occurrence of SAEs throughout the entire study period