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

NCT02139228 | Completed Phase 3 Results

• 1 other identifier: V37_07E2
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (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)

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

Study Arms (2)

Hib CRM197

EXPERIMENTAL

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

Hib TT

ACTIVE COMPARATOR

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

Interventions

Hib-CRM197 BIOLOGICAL

No vaccine administered in V37\_07E2 study

Hib CRM197

Hib-TT BIOLOGICAL

No vaccine administered in V37\_07E2 study

Hib TT

Eligibility Criteria

• Age: 5 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (1)

DingXing Center for Disease Control and Prevention

Dingxing, Hebei, 050021, China

Location

MeSH Terms

Conditions

Meningitis; Epiglottitis; Pneumonia; Haemophilus Infections

Interventions

HibTITER protein, Haemophilus influenzae; Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Supraglottitis; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pasteurellaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics Srl

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 15, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: November 9, 2015
• Results First Posted: November 9, 2015

Record last verified: 2015-10

Locations

CN (1)