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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 )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b
Interventions Biological: Hib-CRM197
Biological: Hib-TT
Enrollment 426
Recruitment Details One center in China
Pre-assignment Details All subjects enrolled into the parent V37_07E1 study were invited to participate in the trial.
Arm/Group Title Hib CRM197 Hib TT
Hide Arm/Group 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

Period Title: Overall Study
Started 215 211
Completed 215 211
Not Completed 0 0
Arm/Group Title Hib CRM197 Hib TT Total
Hide Arm/Group 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

Total of all reporting groups
Overall Number of Baseline Participants 215 211 426
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 215 participants 211 participants 426 participants
5  (0) 5  (0) 5  (0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 215 participants 211 participants 426 participants
Female
99
  46.0%
106
  50.2%
205
  48.1%
Male
116
  54.0%
105
  49.8%
221
  51.9%
1.Primary Outcome
Title Geometric Mean Anti-PRP (Polyribosyl Ribitol Phosphate) Concentrations at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1)
Hide Description 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.
Time Frame At Day 1 (4 years post booster dose administered in study V37_07E1)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was evaluated on the Per Protocol set (PPS)-All subjects in the All Enrolled Set with no reportable protocol deviations.
Arm/Group Title Hib CRM197 Hib TT
Hide Arm/Group 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

Overall Number of Participants Analyzed 215 211
Geometric Mean (95% Confidence Interval)
Unit of Measure: Concentration in μg/mL
2.66
(2 to 3.54)
5.05
(3.97 to 6.42)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hib CRM197, Hib TT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Group Ratios
Estimated Value 0.53
Confidence Interval (2-Sided) 95%
0.36 to 0.76
Estimation Comments [Not Specified]
2.Secondary Outcome
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)
Hide Description 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.
Time Frame At Day 1 (4 years post booster dose administered in study V37_07E1)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was evaluated on the Per Protocol set (PPS) (i.e. All subjects in the All Enrolled Set with no reportable protocol deviations).
Arm/Group Title Hib CRM197 Hib TT
Hide Arm/Group 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

Overall Number of Participants Analyzed 215 211
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of subjects
Anti-PRP Concentrations ≥ 1.0 μg/mL
77
(71 to 82)
88
(83 to 92)
Anti-PRP Concentrations ≥ 0.15 μg/mL
77
(71 to 82)
88
(83 to 92)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Hib CRM197, Hib TT
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Clopper-Pearson
Comments [Not Specified]
Method of Estimation Estimation Parameter Vaccine Group Differences
Estimated Value -11
Confidence Interval (2-Sided) 95%
-18.6 to -4.2
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Safety section not applicable for this study
 
Arm/Group Title Hib CRM197 Hib TT
Hide Arm/Group 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

All-Cause Mortality
Hib CRM197 Hib TT
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Hib CRM197 Hib TT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Hib CRM197 Hib TT
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Other disclosure agreement: The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics Srl
EMail: RegistryContactVaccinesUS@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT02139228    
Other Study ID Numbers: V37_07E2
First Submitted: May 13, 2014
First Posted: May 15, 2014
Results First Submitted: May 19, 2015
Results First Posted: November 9, 2015
Last Update Posted: November 9, 2015