Trial Outcomes & Findings for Persistency Study After Hib-CRM (Cross-Reacting Material)197 or Hib-TT (Tetanus Toxoid) Vaccines in Chinese Children (NCT NCT02139228)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

426 participants

Primary outcome timeframe

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

Results posted on

2015-11-09

Participant Flow

One center in China

All subjects enrolled into the parent V37\_07E1 study were invited to participate in the trial.

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	215	211
Overall Study COMPLETED	215	211
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hib CRM197 n=215 Participants 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	Hib TT n=211 Participants 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 n=426 Participants Total of all reporting groups
Age, Continuous Age	5 years STANDARD_DEVIATION 0 • n=5 Participants	5 years STANDARD_DEVIATION 0 • n=7 Participants	5 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	99 Participants n=5 Participants	106 Participants n=7 Participants	205 Participants n=5 Participants
Sex: Female, Male Male	116 Participants n=5 Participants	105 Participants n=7 Participants	221 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Hib CRM197 n=215 Participants 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	Hib TT n=211 Participants 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
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 Interval 2.0 to 3.54	5.05 Concentration in μg/mL Interval 3.97 to 6.42

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Hib CRM197 n=215 Participants 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	Hib TT n=211 Participants 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
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 Interval 71.0 to 82.0	88 Percentage of subjects Interval 83.0 to 92.0
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 Interval 71.0 to 82.0	88 Percentage of subjects Interval 83.0 to 92.0

Adverse Events

Hib CRM197

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hib TT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Posting Director

Novartis Vaccines and Diagnostics Srl

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER