Haemophilus Influenzae Type b (Hib) InfectionPhase 3NCT01025544
Study in Toddlers (12-18 Months) Comparing a Booster Dose of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b Infections in China
A Phase 3 study testing Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine) and Hiberix (Haemophilus influenzae type b (Hib) vaccine) 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 booster doses of the two vaccines used to prevent Haemophilus influenzae type b infections in children 12-18 months of age. Read more about this study
- Who is it for?
- Ages 12 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Haemophilus Influenzae Type b (Hib) Infection
- What is being tested?
- Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine) and Hiberix (Haemophilus influenzae type b (Hib) vaccine)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 846 participants
- Where
- 1 siteChina
- Study dates
- Sep 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 12 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Toddlers 12-18 months of age who have previously participated in study M37P2.
Who cannot join
- Prior Hib booster administration.
- History of serious reaction(s) following vaccination.
- Vaccination within 14 days of study vaccination.
- Known or suspected immune impairment.
- 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 Open Label, Multi-Center Pediatric Study in China Comparing Booster Doses of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b (Hib) Infection
This study will evaluate the safety and immunogenicity of booster doses of the two vaccines used to prevent Haemophilus influenzae type b infections in children 12-18 months of age.
- Being tested
- Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine), Hiberix (Haemophilus influenzae type b (Hib) vaccine)
- Keywords
- Haemophilus influenzae type b (Hib), Vaccine, Booster
- 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.
Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine)Biological
Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.
Hiberix (Haemophilus influenzae type b (Hib) vaccine)Biological
Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Biological: Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine) |
| Arm 2 | Active comparator | Not described Receives: Biological: Hiberix (Haemophilus influenzae type b (Hib) vaccine) |
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 booster
Measured: 31 days after vaccination
Secondary outcomes (1)
Solicited local and systemic reactions, AEs, and SAEs
Measured: 30 days post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionDec 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 846 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Basel, Study chair, 41 61 324 1111
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025544
- Sponsor's protocol ID
- M37P2E1
- Status last verified
- Dec 2011
- First submitted
- 2 Dec 2009
- Last updated
- 8 Dec 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Open Label, Multi-Center Pediatric Study in China Comparing Booster Doses of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b (Hib) Infection
- ClinicalTrials.gov ID
- NCT01025544
- Acronym / sponsor ID
- M37P2E1
- Keywords
- Haemophilus influenzae type b (Hib), Vaccine, Booster
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 846 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 3 Dec 2009 (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 booster doses of the two vaccines used to prevent Haemophilus influenzae type b infections in children 12-18 months of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Biological: Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine) |
| Arm 2 | Active comparator | Biological: Hiberix (Haemophilus influenzae type b (Hib) vaccine) |
Who may qualify
- Ages
- 12 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Toddlers 12-18 months of age who have previously participated in study M37P2.
Key exclusion criteria (5 listed)
- Prior Hib booster administration.
- History of serious reaction(s) following vaccination.
- Vaccination within 14 days of study vaccination.
- Known or suspected immune impairment.
- For additional entry criteria please refer to the protocol.
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 |
|---|---|---|
| Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine)Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines. | Biological | Arm 1 |
| Hiberix (Haemophilus influenzae type b (Hib) vaccine)Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines. | Biological | Arm 2 |
Primary outcome
Anti-PRP antibody levels at day 31 post booster
Time frame: 31 days after vaccination
1 secondary outcome
Solicited local and systemic reactions, AEs, and SAEs
Time frame: 30 days post 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 8 Dec 2011.
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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.
Novartis Basel study chair
41 61 324 1111
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 Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine) and Hiberix (Haemophilus influenzae type b (Hib) vaccine) 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 5 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 8 Dec 2011. 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 booster (time frame: 31 days after 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 8 Dec 2011.