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

Primary Purpose

Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Hib-CRM197

Hib-TT

About this trial

This is an interventional prevention trial for Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b focused on measuring Haemophilus influenzae type b, persistency, children, CRM197, anti-PRP antibody

Eligibility Criteria

5 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

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).
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
Administration of immunoglobulins and/or any blood products up to 3 months before enrollment.
Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the blood sampling.
Any condition, which, in the opinion of the investigator, might be a contraindication to the execution of the blood draw.

Sites / Locations

DingXing Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hib CRM197

Hib TT

Arm Description

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

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

Outcomes

Primary Outcome Measures

Geometric Mean Anti-PRP (Polyribosyl Ribitol Phosphate) Concentrations 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

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)

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.

Full Information

NCT ID

NCT02139228

First Posted

May 13, 2014

Last Updated

October 13, 2015

Sponsor

Novartis Vaccines

1. Study Identification

Unique Protocol Identification Number

NCT02139228

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Vaccines

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b

Keywords

Haemophilus influenzae type b, persistency, children, CRM197, anti-PRP antibody

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

426 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hib CRM197

Arm Type

Experimental

Arm Description

Arm Title

Hib TT

Arm Type

Active Comparator

Arm Description

Intervention Type

Biological

Intervention Name(s)

Hib-CRM197

Intervention Description

No vaccine administered in V37_07E2 study

Intervention Type

Biological

Intervention Name(s)

Hib-TT

Intervention Description

No vaccine administered in V37_07E2 study

Primary Outcome Measure Information:

Title

Geometric Mean Anti-PRP (Polyribosyl Ribitol Phosphate) Concentrations at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1)

Description

Time Frame

At Day 1 (4 years post booster dose administered in study V37_07E1)

Secondary Outcome Measure Information:

Title

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)

Description

Time Frame

At Day 1 (4 years post booster dose administered in study V37_07E1)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Children previously enrolled in V37_07E1 study and who received the appropriate vaccination. 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: 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). 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 Administration of immunoglobulins and/or any blood products up to 3 months before enrollment. Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the blood sampling. Any condition, which, in the opinion of the investigator, might be a contraindication to the execution of the blood draw.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Vaccines

Organizational Affiliation

Novartis Vaccines

Official's Role

Study Chair

Facility Information:

Facility Name

DingXing Center for Disease Control and Prevention

City

Dingxing

State/Province

Hebei

ZIP/Postal Code

050021

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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