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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 )

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.

Condition or disease Intervention/treatment Phase
Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b Biological: Hib-CRM197 Biological: Hib-TT Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 426 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : November 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2015


Arm Intervention/treatment
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

Biological: Hib-CRM197
No vaccine administered in V37_07E2 study

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

Biological: Hib-TT
No vaccine administered in V37_07E2 study




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   5 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139228


Locations
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China, Hebei
DingXing Center for Disease Control and Prevention
Dingxing, Hebei, China, 050021
Sponsors and Collaborators
Novartis Vaccines
Investigators
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Study Chair: Novartis Vaccines Novartis Vaccines
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Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT02139228    
Other Study ID Numbers: V37_07E2
First Posted: May 15, 2014    Key Record Dates
Results First Posted: November 9, 2015
Last Update Posted: November 9, 2015
Last Verified: October 2015
Keywords provided by Novartis ( Novartis Vaccines ):
Haemophilus influenzae type b
persistency
children
CRM197
anti-PRP antibody
Additional relevant MeSH terms:
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Tetanus
Influenza, Human
Pneumonia
Epiglottitis
Meningitis
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Central Nervous System Diseases
Nervous System Diseases
Bacterial Infections
Clostridium Infections
Gram-Positive Bacterial Infections
Supraglottitis