Comparison between a Booster Dose of Vaxem™ Hib to HIBERIX®

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

• Registration Number: EUCTR2014-005013-23-Outside-EU/EEA
• Lead Sponsor: ovartis Vaccines and Diagnostics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-25
• Last Update Posted: 1 December 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 916

Inclusion Criteria

Toddlers 12-18 months of age who have previously participated in study M37P2.
Children's parents or legal guardian have given written consent after the nature of the study has been
explained according to local regulatory requirements.
Toddlers in good health as determined by the outcome of medical history, physical examination and clinical
judgment of the investigator.
Availability for both visits scheduled in the study and able to comply with all study regulations.
Are the trial subjects under 18? yes
Number of subjects for this age range: 916
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

Parent(s) or legal guardian(s) are unwilling or unable to give written informed consent to participate in
study.
Subjects who have already received a Hib booster dose.
History of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or
hypersensitivity to any vaccine component.
Fever = 38.0°C (axillary) or/and significant acute or chronic infection requiring systemic antibiotic or
antiviral therapy within the past 7 days before enrollment.
Subjects with any serious chronic disease such as cardiac, neurological, metabolic, hematologic, or
neoplastic disease.
Known/suspected immunodeficiency or any immunologic disorder.
Subjects with any neurological disorder, e.g. epilepsy or history of seizure disorder.
Subjects with a genetic anomaly.
Treatment with corticosteroids or other immunosuppressive drugs.
Previous receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives.
Vaccination with any other vaccine 14 days before or after the booster dose with Vaxem™ Hib .
Participation in any other investigational trial simultaneously.
Planned surgery during the study period.
Any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study
objectives.

Study & Design

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