Study in Infants (6-12 Months) Comparing Two Doses of a Monovalent Glycoprotein-Conjugated (non-toxic mutant of Diptheria Toxin -CRM197) Vaccine Versus a Tetanus Toxoid-Conjugated Vaccine Available for the Prevention of Haemophilus Influenzae Type b Infections in China

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

• Registration Number: EUCTR2014-005136-33-Outside-EU/EEA
• Lead Sponsor: ovartis Vaccines and Diagnostics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-28
• Last Update Posted: 1 December 2014

Recruitment & Eligibility

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

Inclusion Criteria

- Healthy infants 180-364 days of age inclusive.
- Written informed consent obtained from parent/legal guardian after the nature of the study has been explained according to local regulatory requirements.
- Infants in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
- Infants who will be available for all scheduled visits (i.e. not planning to leave the area before the end of the study period).
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

- Parent or legal guardian is unwilling or unable to give written informed consent to participate in study.
- Subjects who will be unavailable for the duration of the study period.
- Infants who have received any other Haemophilus influenzae type b immunization dose prior to study start.
- Infants who presented a previous disease potentially related to Haemophilus influenzae type b.
- Children who had household contact and/or intimate exposure in the previous 30 days to an individual with ascertained Haemophilus irifluenzae type b disease.
- Premature (before 37 week of gestation) or birth weight less than 2500 g.
- History of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component.
- Fever >38 °C (axillary) and/or significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the previous 7 days before enrollment.
- Subjects with any serious chronic disease such as cardiac, neurological, metabolic, hematologic, or neoplastic disease.
- Known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder.
- Subjects with any neurological disorder, e.g. epilepsy or history of seizure disorder.
- Subjects with a clinically significant genetic anomaly.
- Treatment with corticosteroids or other immunosuppressive drugs.
- Any previous treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives.
- Any vaccination administered within one week (7 days) before enrollment and/ or any planned administration of any vaccine outside the Chinese routine vaccination program.
- Simultaneous participation in any other investigational trial.
- Planned surgery during the study period.
- 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