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Persistency Study After Hib-CRM (Cross-Reacting Material)197 or Hib-TT (Tetanus Toxoid) Vaccines in Chinese Children

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ClinicalTrials.gov Identifier: NCT02139228
Recruitment Status : Completed
First Posted : May 15, 2014
Results First Posted : November 9, 2015
Last Update Posted : November 9, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Tracking Information
First Submitted Date  ICMJE May 13, 2014
First Posted Date  ICMJE May 15, 2014
Results First Submitted Date  ICMJE May 19, 2015
Results First Posted Date  ICMJE November 9, 2015
Last Update Posted Date November 9, 2015
Study Start Date  ICMJE November 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 13, 2015)
Geometric Mean Anti-PRP (Polyribosyl Ribitol Phosphate) Concentrations at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1) [ Time Frame: At Day 1 (4 years post booster dose administered in study V37_07E1) ]
Immunogenicity was measured as geometric mean of Anti- PRP Concentrations, approximately 4 years after booster vaccination with either Hib-CRM197 or Hib-TT in children participating in previous V37_07E1 trial.
Original Primary Outcome Measures  ICMJE
 (submitted: May 13, 2014)
Ratio of anti-PRP antibody geometric mean concentrations (GMCs), approximately four years after booster vaccination by vaccine group. [ Time Frame: day 1 (four years after booster vaccination received in V37_07E1 study) ]
To assess anti- PRP antibodies persistency in children participating in previous V37_07E1 trial, approximately 4 years after booster vaccination with either Hib-CRM197 or Hib-TT.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2015)
Percentages of Subjects With Anti-PRP Concentrations ≥1.0 μg/mL and ≥0.15 μg/mL at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1) [ Time Frame: At Day 1 (4 years post booster dose administered in study V37_07E1) ]
Immunogenicity was measured as the percentages of subjects with Anti-PRP Concentrations ≥1.0 μg/mL and ≥0.15 μg/mL approximately 4 years after booster vaccination with either Hib-CRM197 or Hib-TT in V37_07E1 trial.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Persistency Study After Hib-CRM (Cross-Reacting Material)197 or Hib-TT (Tetanus Toxoid) Vaccines in Chinese Children
Official Title  ICMJE A Phase IIIb, Controlled, Open Label, Single-Center, Persistency, Extension Study in Chinese Children After a 2+1 Dose Series of Either CRM197-Conjugate Haemophilus Influenzae Type b Vaccine or Tetanus Toxoid-Conjugate Haemophilus Influenzae Type b Vaccine
Brief Summary Evaluate the persistency of immune response against Haemophilus influenzae type b by assessing anti-PRP antibody levels in children vaccinated with either Hib-CRM197 or Hib-TT booster vaccine approximately 4 years before.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b
Intervention  ICMJE
  • Biological: Hib-CRM197
    No vaccine administered in V37_07E2 study
  • Biological: Hib-TT
    No vaccine administered in V37_07E2 study
Study Arms  ICMJE
  • Experimental: 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

    Intervention: Biological: Hib-CRM197
  • Active Comparator: 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

    Intervention: Biological: Hib-TT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2014)
426
Original Estimated Enrollment  ICMJE
 (submitted: May 13, 2014)
660
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Children previously enrolled in V37_07E1 study and who received the appropriate vaccination.
  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:

  1. Any confirmed or suspected current immunosuppressive or immunodeficient condition since the end of V37_07E1 study, based on medical history and physical examination (no laboratory testing required).
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02139228
Other Study ID Numbers  ICMJE V37_07E2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Vaccines )
Study Sponsor  ICMJE Novartis Vaccines
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Novartis Vaccines Novartis Vaccines
PRS Account Novartis
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP