Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B
NCT ID: NCT01362517
Last Updated: 2013-09-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
131 participants
INTERVENTIONAL
2010-04-30
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Quinvaxem
Quinvaxem
A single dose (0.5 mL) of Quinvaxem contains:
diphtheria antitoxin (\>= 30 IU), tetanus antitoxin (\>= 60 IU), whole-cell inactive pertussis bacteria (\>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen
One dose of Quinvaxem given at 2, 3 and 4 months of age
Interventions
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Quinvaxem
A single dose (0.5 mL) of Quinvaxem contains:
diphtheria antitoxin (\>= 30 IU), tetanus antitoxin (\>= 60 IU), whole-cell inactive pertussis bacteria (\>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen
One dose of Quinvaxem given at 2, 3 and 4 months of age
Eligibility Criteria
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Inclusion Criteria
* Have a normal gestational age (≥ 37 weeks); birth weight \> 2.5 kg
* There is no congenital disease detected through interview and clinical examination
* Already had or not yet received Hepatitis B vaccination at birth
* Do not have dermatological diseases such as eczema, allergies
* Parent or legal guardian voluntarily provides consent for their child for participation in the study by signing the informed consent and agrees to comply with all study procedures
Exclusion Criteria
* Have an acute infection at the time of study vaccination
* Contraindications to Quinvaxem
* Receiving treatment with systemic corticosteroids
* Currently participating in another clinical trial
* In receipt of a parenteral immunoglobulin preparation and/or blood/blood products since birth
* Parents intend to move to another location during the study (the next 12 months)
60 Days
120 Days
ALL
Yes
Sponsors
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Crucell Holland BV
INDUSTRY
Responsible Party
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Principal Investigators
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Tran Ngoc Huu, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Pasteur Institute of Ho Chi Minh City
Locations
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Pasteur Institute
Ho Chi Minh City, , Vietnam
Countries
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Other Identifiers
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QVX-V-C001
Identifier Type: -
Identifier Source: org_study_id
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