Status:
COMPLETED
Safety and Immunogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b
Lead Sponsor:
Novartis Vaccines
Conditions:
Haemophilus Influenzae Type b
Eligibility:
All Genders
2-4 years
Phase:
PHASE3
Brief Summary
This study will investigate safety and immunogenicity of a monovalent conjugated vaccine against Haemophilus influenzae type b in healthy children aged 2 to 4 months in China.
Eligibility Criteria
Inclusion
- Infants of either sex, aged 2 - 4 months
- In good health as determined by:
- medical history
- physical examination
- clinical judgment of the investigator;
- Available for all visits scheduled in the study and able to comply with all study regulations
- For whom written informed consent has been obtained from at least one parent or legal guardian
Exclusion
- Parent or legal guardian is unwilling or unable to give written informed consent to participate in study
- Infants who have received any other Haemophilus influenzae type b immunization dose before
- Infants who presented a previous disease potentially related to Haemophilus influenzae type b
- Infants who had household contact and/or intimate exposure in the previous 30 days to an individual with ascertained Haemophilus influenzae type b disease
- Premature (before 37th 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 ≥ 38.0 °C (axillary body temperature) 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 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.
- 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 objective
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
916 Patients enrolled
Trial Details
Trial ID
NCT00808392
Start Date
November 1 2008
End Date
February 1 2009
Last Update
December 29 2011
Active Locations (2)
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1
the CDC of Dingxing county(site no 02)
Dingxing, Hebei, China, 072650
2
The CDC of Zhengding county(site no 01)
Zhengding, Hebei, China, 050800