Persistency study after Hib-CRM197 or Hib-TT vaccines in Chinese Childre

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

• Registration Number: EUCTR2015-001453-32-Outside-EU/EEA
• Lead Sponsor: ovartis Vaccines and Diagnostics Srl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-29
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 670

Inclusion Criteria

1. children previously enrolled in V37_07E1 study and who received the appropriate vaccination;
2. children whose parent(s) or legal guardian(s) have given written consent after the nature of the study has been explained according to local regulatory requirements
Are the trial subjects under 18? yes
Number of subjects for this age range: 670
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. any confirmed or suspected current immunosuppressive or immunodeficient condition since the end of V37_07E1 study, based on medical history and physical examination (no laboratory testing required);
2. treatment with corticosteroids or other immunosuppressive/immunostimulant drugs as defined below:
-chronic use of oral and parenteral immunosuppressants (>/= 15 days of use) or other immune-modifying drugs within 60 days prior to the blood sampling (short term usage of topic, inhaled and/or intranasal corticosteroids is allowed)
-receipt of immunostimulants within 60 days prior to Visit 1
3. administration of immunoglobulines and/or any blood products up to 3 months before enrollment;
4. use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the blood sampling.
5. any condition, which, in the opinion of the investigator, might be a contraindication to the execution of the blood draw.

Study & Design

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