Persistency Study After Hib-CRM (Cross-Reacting Material)197 or Hib-TT (Tetanus Toxoid) Vaccines in Chinese Children
NCT ID: NCT02139228
Last Updated: 2015-11-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
426 participants
INTERVENTIONAL
2014-11-30
2015-01-31
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
PARALLEL
PREVENTION
NONE
Study Groups
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Hib CRM197
Subjects treated with 3 doses of CRM 197 -conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37\_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37\_07E1 (NCT01226953).
No vaccine was administered during this trial
Hib-CRM197
No vaccine administered in V37\_07E2 study
Hib TT
Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37\_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37\_07E1 (NCT01226953).
No vaccine was administered during this trial
Hib-TT
No vaccine administered in V37\_07E2 study
Interventions
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Hib-CRM197
No vaccine administered in V37\_07E2 study
Hib-TT
No vaccine administered in V37\_07E2 study
Eligibility Criteria
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Inclusion Criteria
2. Children whose parent(s) or legal guardian(s) had given written consent after the nature of the study was explained according to local regulatory requirements.
Exclusion Criteria
2. Treatment with corticosteroids or other immunosuppressive/immunostimulant drugs as defined below:
i) 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 topical, inhaled and/or intranasal corticosteroids were allowed) ii) receipt of immunostimulants within 60 days prior to Visit 1
3. Administration of immunoglobulins 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.
5 Years
6 Years
ALL
Yes
Sponsors
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Novartis Vaccines
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Vaccines
Role: STUDY_CHAIR
Novartis Vaccines
Locations
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DingXing Center for Disease Control and Prevention
Dingxing, Hebei, China
Countries
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Other Identifiers
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V37_07E2
Identifier Type: -
Identifier Source: org_study_id
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