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Sponsors and Collaborators: |
Novartis Novartis Vaccines |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00808392 |
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.
Condition | Intervention | Phase |
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Haemophilus Influenzae Type B |
Biological: Haemophilus influenzae type b vaccine Biological: Commercial Haemophilus influenzae type b vaccine |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III, Observer-Blind, Randomized, Controlled, Multicenter Study to Investigate Immunogenicity and Safety of Haemophilus Influenzae Type b Vaccine in 2 - 4 Months Old Healthy Infants in China, According to the Recommended Regimen of 3 Intramuscular Doses Given One Month Apart |
Estimated Enrollment: | 900 |
Study Start Date: | November 2008 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Biological: Haemophilus influenzae type b vaccine
3 doses one month apart of Monovalent conjugated vaccine against Haemophilus influenzae type b vaccine
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2: Active Comparator |
Biological: Commercial Haemophilus influenzae type b vaccine
3 doses one month apart of Haemophilus influenzae type b vaccine.
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Ages Eligible for Study: | 2 Months to 4 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
In good health as determined by:
Exclusion Criteria:
China, Hebei | |
The CDC of Zhengding county(site no 01) | Recruiting |
Zhengding, Hebei, China, 050800 | |
Contact: Novartis Vaccines +1 800 244 7668 | |
Principal Investigator: Novartis Vaccines | |
the CDC of Dingxing county(site no 02) | Recruiting |
Dingxing, Hebei, China, 072650 | |
Contact: Novartis Vaccines +1 800 244 7668 | |
Principal Investigator: Novartis Vaccines |
Responsible Party: | Novartis Vaccines ( Novartis ) |
Study ID Numbers: | M37P2 |
Study First Received: | December 12, 2008 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00808392 |
Health Authority: | China: State Food and Drug Administration |
vaccine prevention haemophilus influenzae type b children |
Virus Diseases Haemophilus influenzae Respiratory Tract Diseases Respiratory Tract Infections |
Influenza, Human Healthy Orthomyxoviridae Infections |
RNA Virus Infections |