Haemophilus Influenzae Type bPhase 4NCT00197782
The Immediate and Longterm Immune Responses of UK Infants and Young Children to a Booster Dose of Hib Vaccine
A Phase 4 study testing Hib conjugate vaccine in people with Haemophilus Influenzae Type b, run by Public Health England.
Trial summary
To measure the magnitude and persistence of the antibody response to a booster dose of Hib conjugate vaccine given between 9 months and 4 years of age to UK children who had completed primary immunisation with 3 doses of Hib vaccine given at 2/3/4 months of age either as a combined D/T/wholecellpertussis/Hib or… Read more about this study
- Who is it for?
- Ages 9 months to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Haemophilus Influenzae Type b
- What is being tested?
- Hib conjugate vaccine
- Type of treatment
- Vaccines
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Apr 2003to Dec 2005
- Phase
- Phase 4
- 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 9 months to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Written informed consent from parent or legal guardian of the infant or child
- Age >= 9 months and <4 years at recruitment
- Eligible to receive a single dose of Hib vaccine as per the UK schedule
- Receipt of three doses of Hib vaccine in infancy
Who cannot join
- History of Hib infection
- History of severe local reaction that can be confidently related to a prior Hib immunisation
- Deferral of vaccination if acute illness and/or temperature >38C on day of vaccination
About this study
To measure the magnitude and persistence of the antibody response to a booster dose of Hib conjugate vaccine given between 9 months and 4 years of age to UK children who had completed primary immunisation with 3 doses of Hib vaccine given at 2/3/4 months of age either as a combined D/T/wholecellpertussis/Hib or D/T/acellularpertussis/Hib vaccine.
- Conditions
- Haemophilus Influenzae Type b
- Being tested
- Hib conjugate vaccine
- Medical subject headings
- Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hib conjugate vaccineBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startApr 2003
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Public Health England
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Elizabeth Miller, Public Health England
- Investigators
- Elizabeth Miller, MBBS FRCPath, Principal investigator, Public Health England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00197782
- Sponsor's protocol ID
- Hibboost
- Status last verified
- Aug 2018
- First submitted
- 12 Sep 2005
- Last updated
- 24 Aug 2018
- Results posted
- No
Publications
Southern J, McVernon J, Gelb D, Andrews N, Morris R, Crowley-Luke A, Goldblatt D, Miller E. Immunogenicity of a fourth dose of Haemophilus influenzae type b (Hib) conjugate vaccine and antibody persistence in young children from the United Kingdom who were primed with acellular or whole-cell pertussis component-containing Hib combinations in infancy. Clin Vaccine Immunol. 2007 Oct;14(10):1328-33. doi: 10.1128/CVI.00191-07. Epub 2007 Aug 15.
PubMed 17699835
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate and Longterm Immune Responses of UK Infants and Young Children to a Booster Dose of Hib Vaccine
- ClinicalTrials.gov ID
- NCT00197782
- Acronym / sponsor ID
- Hibboost
- Conditions
- Haemophilus Influenzae Type b
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Public Health EnglandOther government
- Study start
- Apr 2003
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 20 Sep 2005 (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.
To measure the magnitude and persistence of the antibody response to a booster dose of Hib conjugate vaccine given between 9 months and 4 years of age to UK children who had completed primary immunisation with 3 doses of Hib vaccine given at 2/3/4 months of age either as a combined D/T/wholecellpertussis/Hib or D/T/acellularpertussis/Hib vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 9 months to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Written informed consent from parent or legal guardian of the infant or child
- Age >= 9 months and <4 years at recruitment
- Eligible to receive a single dose of Hib vaccine as per the UK schedule
- Receipt of three doses of Hib vaccine in infancy
Key exclusion criteria (3 listed)
- History of Hib infection
- History of severe local reaction that can be confidently related to a prior Hib immunisation
- Deferral of vaccination if acute illness and/or temperature >38C on day of vaccination
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 conjugate vaccine | Biological | – |
Primary outcome
Not reported in the source record.
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 24 Aug 2018.
- Results publication: PubMed 17699835Southern J, McVernon J, Gelb D, Andrews N, Morris R, Crowley-Luke A, Goldblatt D, Miller E. Immunogenicity of a fourth dose of Haemophilus influenzae type b (Hib) conjugate vaccine and antibody persistence in young children from the United Kingdom who were primed with acellular or whole-cell pertussis component-containing Hib combinations in infancy. Clin Vaccine Immunol. 2007 Oct;14(10):1328-33. doi: 10.1128/CVI.00191-07. Epub 2007 Aug 15.
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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.
Elizabeth Miller, MBBS FRCPath principal investigator
Public Health England
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hib conjugate vaccine in people with Haemophilus Influenzae Type b, run by Public Health England.
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 4 inclusion and 3 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 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00197782, which also lists 1 linked publication.
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 24 Aug 2018.