Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type bPhase 3NCT02139228

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

A Phase 3 study testing Hib-CRM197 and Hib-TT in people with Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b, run by Novartis Vaccines at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 5 to 6 yearsHealthy volunteers can take part
Conditions the study is for: Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b
What is being tested?: Hib-CRM197 and Hib-TT
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 426 participants
Where: 1 siteChina
Study dates: Nov 2014to Jan 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 6 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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:
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.

Trial locations and contacts

1 site in 1 country.

China1 site

DingXing Center for Disease Control and Prevention
Dingxing, Hebei, 050021

Other trials in China

About this study

Official 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

Conditions: Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b
Being tested: Hib-CRM197, Hib-TT
Keywords: Haemophilus influenzae type b, persistency, children, CRM197, anti-PRP antibody
Medical subject headings: Meningitis, Epiglottitis, Pneumonia, Haemophilus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hib-CRM197Biological
No vaccine administered in V37_07E2 study
Hib-TTBiological
No vaccine administered in V37_07E2 study

Study groups in NCT02139228
Study group	Role	What they receive
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 Receives: 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 Receives: Biological: Hib-TT

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Jan 2015

First posted15 May 2014 (estimated)
Study startNov 2014
Primary completionDec 2014
Study completionJan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type bStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 426 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02139228
Sponsor's protocol ID: V37_07E2
Status last verified: Oct 2015
First submitted: 13 May 2014
Last updated: 9 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 9 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT02139228
Acronym / sponsor ID: V37_07E2
Conditions: Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b
Keywords: Haemophilus influenzae type b, persistency, children, CRM197, anti-PRP antibody
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 426 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Nov 2014
Primary completion: Dec 2014 (actual)
Study completion: Jan 2015 (actual)
First posted: 15 May 2014 (estimated)
Results: Posted 9 Nov 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Hib CRM197	Experimental	Biological: Hib-CRM197Subjects 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	Active comparator	Biological: Hib-TTSubjects 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

Who may qualify

Ages: 5 to 6 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (6 listed)

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:
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hib-CRM197No vaccine administered in V37_07E2 study	Biological	Hib CRM197
Hib-TTNo vaccine administered in V37_07E2 study	Biological	Hib TT

Primary outcome

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.

1 secondary outcome

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)

Results and safety

Results posted to the registry on 9 Nov 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hib CRM197	215	215
Hib TT	211	211

Primary outcome: 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). Geometric mean (95% Confidence Interval). Unit: Concentration in μg/mL

Measure	Hib CRM197 n = 215	Hib TT n = 211
Value	2.66 (2 to 3.54)	5.05 (3.97 to 6.42)

Hib CRM197 vs Hib TT: Vaccine Group Ratios: 0.53 (95% CI 0.36 to 0.76), ANOVA

Population analysed: Analysis was evaluated on the Per Protocol set (PPS)-All subjects in the All Enrolled Set with no reportable protocol deviations.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hib CRM197	0 of 0	0 of 0	Not reported
Hib TT	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Vaccines study chair

Novartis Vaccines

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hib-CRM197 and Hib-TT in people with Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b, run by Novartis Vaccines at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02139228.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2015.