Haemophilus Influenzae Type bPhase 3NCT00808392
Safety and Immunogenicity of a Monovalent Conjugated Vaccine Against Haemophilus Influenzae Type b
A Phase 3 study testing Haemophilus influenzae type b vaccine and Commercial Haemophilus influenzae type b vaccine in people with Haemophilus Influenzae Type b, run by Novartis Vaccines at 2 sites in China.
Trial summary
This study will investigate safety and immunogenicity of a monovalent conjugated vaccine against Haemophilus influenzae type b in healthy children aged 2 to 4 months in China. Read more about this study
- Who is it for?
- Ages 2 to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Haemophilus Influenzae Type b
- What is being tested?
- Haemophilus influenzae type b vaccine and Commercial Haemophilus influenzae type b vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 916 participants
- Where
- 2 sitesChina
- Study dates
- Nov 2008to Feb 2009
- 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 2 to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants of either sex, aged 2 - 4 months
- In good health as determined by:
- medical history
- physical examination
- clinical judgment of the investigator;
- Available for all visits scheduled in the study and able to comply with all study regulations
- For whom written informed consent has been obtained from at least one parent or legal guardian
Who cannot join
- Parent or legal guardian is unwilling or unable to give written informed consent to participate in study
- Infants who have received any other Haemophilus influenzae type b immunization dose before
- Infants who presented a previous disease potentially related to Haemophilus influenzae type b
- Infants who had household contact and/or intimate exposure in the previous 30 days to an individual with ascertained Haemophilus influenzae type b disease
- Premature (before 37th week of gestation) or birth weight less than 2500 g
- History of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or hypersensitivity to any vaccine component
Show all 17Show fewer
- Fever ≥ 38.0 °C (axillary body temperature) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrollment
- Subjects with any serious chronic disease such as cardiac, neurological, metabolic, hematologic, or neoplastic disease
- Known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder
- Subjects with any neurological disorder, e.g., epilepsy or history of seizure disorder
- Subjects with a clinically significant genetic anomaly
- Treatment with corticosteroids or other immunosuppressive drugs
- Any previous treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives
- Any vaccination administered within one week (7 days) before enrollment and/ or any planned administration of any vaccine outside the Chinese routine vaccination program.
- Participation in any other investigational trial simultaneously
- Planned surgery during the study period
- Any condition, which, in the opinion of the investigator, might interfere with the evaluation of the study objective
Trial locations and contacts
2 sites in 1 country.
China2 sites
the CDC of Dingxing county(site no 02)
Dingxing, Hebei, 072650
The CDC of Zhengding county(site no 01)
Zhengding, Hebei, 050800
About this study
Official title: A Phase III, Observer-blind, Randomized, Controlled, Multicenter Study to Investigate Immunogenicity and Safety of Haemophilus Influenzae Type b Vaccine in 2 - 4 Months Old Healthy Infants in China, According to the Recommended Regimen of 3 Intramuscular Doses Given One Month Apart
This study will investigate safety and immunogenicity of a monovalent conjugated vaccine against Haemophilus influenzae type b in healthy children aged 2 to 4 months in China.
- Conditions
- Haemophilus Influenzae Type b
- Being tested
- Haemophilus influenzae type b vaccine, Commercial Haemophilus influenzae type b vaccine
- Keywords
- vaccine, prevention, haemophilus influenzae type b, children
- Medical subject headings
- Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haemophilus influenzae type b vaccineBiological
3 doses one month apart of Monovalent conjugated vaccine against Haemophilus influenzae type b vaccine
Commercial Haemophilus influenzae type b vaccineBiological
3 doses one month apart of Haemophilus influenzae type b vaccine.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Biological: Haemophilus influenzae type b vaccine |
| 2 | Active comparator | Not described Receives: Biological: Commercial Haemophilus influenzae type b vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenic response measured by detection of anti-PRP antibodies by IgG enzyme linked immunosorbent assay (ELISA).
Measured: 90 days
Secondary outcomes (1)
Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after each single vaccination dose will be evaluated.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 916 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
- NCT00808392
- Sponsor's protocol ID
- M37P2
- Status last verified
- Dec 2011
- First submitted
- 12 Dec 2008
- Last updated
- 29 Dec 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Observer-blind, Randomized, Controlled, Multicenter Study to Investigate Immunogenicity and Safety of Haemophilus Influenzae Type b Vaccine in 2 - 4 Months Old Healthy Infants in China, According to the Recommended Regimen of 3 Intramuscular Doses Given One Month Apart
- ClinicalTrials.gov ID
- NCT00808392
- Acronym / sponsor ID
- M37P2
- Conditions
- Haemophilus Influenzae Type b
- Keywords
- vaccine, prevention, haemophilus influenzae type b, children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 916 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 15 Dec 2008 (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 investigate safety and immunogenicity of a monovalent conjugated vaccine against Haemophilus influenzae type b in healthy children aged 2 to 4 months in China.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Haemophilus influenzae type b vaccine |
| 2 | Active comparator | Biological: Commercial Haemophilus influenzae type b vaccine |
Who may qualify
- Ages
- 2 to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Infants of either sex, aged 2 - 4 months
- In good health as determined by:
- Available for all visits scheduled in the study and able to comply with all study regulations
- For whom written informed consent has been obtained from at least one parent or legal guardian
Key exclusion criteria (17 listed)
- Parent or legal guardian is unwilling or unable to give written informed consent to participate in study
- Infants who have received any other Haemophilus influenzae type b immunization dose before
- Infants who presented a previous disease potentially related to Haemophilus influenzae type b
- Infants who had household contact and/or intimate exposure in the previous 30 days to an individual with ascertained Haemophilus influenzae type b disease
- Premature (before 37th week of gestation) or birth weight less than 2500 g
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 |
|---|---|---|
| Haemophilus influenzae type b vaccine3 doses one month apart of Monovalent conjugated vaccine against Haemophilus influenzae type b vaccine | Biological | 1 |
| Commercial Haemophilus influenzae type b vaccine3 doses one month apart of Haemophilus influenzae type b vaccine. | Biological | 2 |
Primary outcome
Immunogenic response measured by detection of anti-PRP antibodies by IgG enzyme linked immunosorbent assay (ELISA).
Time frame: 90 days
1 secondary outcome
Rates of local and systemic reactions, adverse events (AEs), and serious adverse events (SAEs) after each single vaccination dose will be evaluated.
Time frame: 90 days
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 29 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Haemophilus influenzae type b vaccine and Commercial Haemophilus influenzae type b vaccine in people with Haemophilus Influenzae Type b, run by Novartis Vaccines at 2 sites 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 7 inclusion and 17 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 29 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 2 sites 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?
Immunogenic response measured by detection of anti-PRP antibodies by IgG enzyme linked immunosorbent assay (ELISA). (time frame: 90 days). 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 29 Dec 2011.