Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Childre

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

• Registration Number: EUCTR2014-005246-22-Outside-EU/EEA
• Lead Sponsor: ovartis Vaccines and Diagnostics, S.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-02
• Last Update Posted: 8 December 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 729

Inclusion Criteria

1. 13-59 months-old children;
2. in good health as determined by:
a. medical history
b. physical examination
c. clinical judgment of the investigator;
3. available for all visits scheduled in the study and able to comply with all study regulations;
4. written informed consent obtained, from at least one parent or legal guardian.
Are the trial subjects under 18? yes
Number of subjects for this age range: 729
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

Subjects presenting any of the following will not be included in the study:
1. parent or legal guardian is unwilling or unable to give written informed consent to participate in study;
2. children who have received any other Haemophilus influenzae type b immunization dose before;
3. children who presented a previous disease potentially related to Haemophilus influenzae type b;
4. children who had household contact and/or intimate exposure in the previous 30days to an individual with ascertained invasive Haemophilus influenzae type b disease;
5. premature (before 37th week of gestation) or birth weight less than 2500 g;
6. history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;
7. fever >=38.0 °C (axillary) and/or significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment;
8. subjects with any serious chronic disease such as cardiac, neurological, metabolic, hematologic, or neoplastic disease;
9. known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder;
10. subjects with any neurological disorder, e.g. epilepsy or history of seizure disorder;
11. subjects with a clinically significant genetic anomaly;
12. treatment with corticosteroids or other immunosuppressive drugs;
13. any previous treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives;
14. any vaccination administered within one week (7 days) before enrollment and/ or any planned administration of any vaccine outside the Chinese routine vaccination program;
15. participation in any other investigational trial simultaneously;
16. planned surgery during the study period;
17. any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objective.

Study & Design

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