Haemophilus Influenzae Type b (Hib) InfectionPhase 3NCT01125527
Immunogenicity and Safety of a Monovalent Glycoprotein-Conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children
A Phase 3 study testing Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib) and Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib) in people with Haemophilus Influenzae Type b (Hib) Infection, run by Novartis Vaccines at 1 site in China.
Trial summary
This study will evaluate the safety and immunogenicity of single dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 13-59 months of age. Read more about this study
- Who is it for?
- Ages 13 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Haemophilus Influenzae Type b (Hib) Infection
- What is being tested?
- Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib) and Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- Aug 2009to Apr 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 13 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants 13-59 months of age.
Who cannot join
- Prior Hib vaccine administration.
- History of serious reaction(s) following vaccination.
- Any vaccination within 7 days of study vaccination.
- Known or suspected immune impairment.
- Premature (before 37th week of gestation) or birth weight less than 2500g
- For additional entry criteria please refer to the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Observer-blind, Randomized, Controlled, Single-coordinating Center Study to Investigate Immunogenicity and Safety of a Monovalent Glycoprotein-conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children in China, According to the Recommended Regimen of 1 Dose
This study will evaluate the safety and immunogenicity of single dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 13-59 months of age.
- Being tested
- Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib), Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib)
- Keywords
- Haemophilus influenzae type b (Hib), Vaccine, Anti PRP antibody
- Medical subject headings
- Haemophilus Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib)Biological
a single dose was administered
Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib)Biological
a single dose was administered
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Biological: Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib) |
| Arm 2 | Active comparator | Not described Receives: Biological: Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-PRP antibody levels at day 31 post last vaccination
Measured: 30 days after last vaccination
Secondary outcomes (1)
Solicited local and systemic reactions, AEs, and SAEs
Measured: 30 days post last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startAug 2009
- Primary completionOct 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemophilus Influenzae Type b (Hib) InfectionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125527
- Sponsor's protocol ID
- V37_06
- Status last verified
- Dec 2011
- First submitted
- 14 May 2010
- Last updated
- 1 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Observer-blind, Randomized, Controlled, Single-coordinating Center Study to Investigate Immunogenicity and Safety of a Monovalent Glycoprotein-conjugated (Diptheria Toxin -CRM197) Hib Vaccine in 13-59 Months Old Healthy Children in China, According to the Recommended Regimen of 1 Dose
- ClinicalTrials.gov ID
- NCT01125527
- Acronym / sponsor ID
- V37_06
- Keywords
- Haemophilus influenzae type b (Hib), Vaccine, Anti PRP antibody
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 18 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety and immunogenicity of single dose of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 13-59 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Biological: Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib) |
| Arm 2 | Active comparator | Biological: Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib) |
Who may qualify
- Ages
- 13 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants 13-59 months of age.
Key exclusion criteria (6 listed)
- Prior Hib vaccine administration.
- History of serious reaction(s) following vaccination.
- Any vaccination within 7 days of study vaccination.
- Known or suspected immune impairment.
- Premature (before 37th week of gestation) or birth weight less than 2500g
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 |
|---|---|---|
| Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib)a single dose was administered | Biological | Arm 1 |
| Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib)a single dose was administered | Biological | Arm 2 |
Primary outcome
Anti-PRP antibody levels at day 31 post last vaccination
Time frame: 30 days after last vaccination
1 secondary outcome
Solicited local and systemic reactions, AEs, and SAEs
Time frame: 30 days post last vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib) and Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib) in people with Haemophilus Influenzae Type b (Hib) Infection, 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 1 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 1 Dec 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Anti-PRP antibody levels at day 31 post last vaccination (time frame: 30 days after last vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Dec 2016.