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Completed

NCT Number: NCT02139228

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

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.

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Key information

Conditions

Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b Bacterial Infections Bacterial Infections and Mycoses Epiglottitis Gram-Negative Bacterial Infections Haemophilus Infections Infections Lung Diseases Meningitis Nervous System Diseases Neuroinflammatory Diseases Pasteurellaceae Infections Pneumonia Respiratory Tract Diseases Respiratory Tract Infections Supraglottitis

Age range

5 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

DingXing Center for Disease Control and Prevention

Dingxing, Hebei, 050021, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hib-CRM197

Biological

No vaccine administered in V37_07E2 study

Hib-TT

Biological

No vaccine administered in V37_07E2 study

Primary outcomes

  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 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)

    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.

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
May 15, 2014
Registry last updated
Nov 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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