Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b
Conditions
Keywords
Haemophilus influenzae type b, persistency, children, CRM197, anti-PRP antibody
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.
Interventions
BIOLOGICALHib-CRM197
No vaccine administered in V37\_07E2 study
BIOLOGICALHib-TT
No vaccine administered in V37\_07E2 study
Sponsors
Novartis Vaccines
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 6 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Anti-PRP (Polyribosyl Ribitol Phosphate) Concentrations 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
Countries
China
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 215 |
| 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 | 211 |
| Total | 426 |
Baseline characteristics
| Characteristic | Hib CRM197 | Hib TT | Total |
|---|---|---|---|
| Age, Continuous Age | 5 years STANDARD_DEVIATION 0 | 5 years STANDARD_DEVIATION 0 | 5 years STANDARD_DEVIATION 0 |
| Sex: Female, Male Female | 99 Participants | 106 Participants | 205 Participants |
| Sex: Female, Male Male | 116 Participants | 105 Participants | 221 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
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.
Time frame: At Day 1 (4 years post booster dose administered in study V37_07E1)
Population: Analysis was evaluated on the Per Protocol set (PPS)-All subjects in the All Enrolled Set with no reportable protocol deviations.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Hib CRM197 | Geometric Mean Anti-PRP (Polyribosyl Ribitol Phosphate) Concentrations at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1) | 2.66 Concentration in μg/mL |
| Hib TT | Geometric Mean Anti-PRP (Polyribosyl Ribitol Phosphate) Concentrations at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1) | 5.05 Concentration in μg/mL |
95% CI: [0.36, 0.76]ANOVA
Secondary
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.
Time frame: At Day 1 (4 years post booster dose administered in study V37_07E1)
Population: Analysis was evaluated on the Per Protocol set (PPS) (i.e. All subjects in the All Enrolled Set with no reportable protocol deviations).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hib CRM197 | 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) | Anti-PRP Concentrations ≥ 1.0 μg/mL | 77 Percentage of subjects |
| Hib CRM197 | 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) | Anti-PRP Concentrations ≥ 0.15 μg/mL | 77 Percentage of subjects |
| Hib TT | 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) | Anti-PRP Concentrations ≥ 1.0 μg/mL | 88 Percentage of subjects |
| Hib TT | 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) | Anti-PRP Concentrations ≥ 0.15 μg/mL | 88 Percentage of subjects |
95% CI: [-18.6, -4.2]Clopper-Pearson