Hib Immunisation in Very Preterm-born InfantsPhase 4VacciPremaNCT02179996
Diphtheria, Tetanus, Poliomyelitis -Pertussis-Hib Immunisation in Preterm-born Neonates
A Phase 4 study testing Three vaccine injections DTP-pertussis-Hib and Two vaccine injections DTP-pertussis-Hib in people with Hib Immunisation in Very Preterm-born Infants and Pertussis Immunisation in Very Preterm-born Infants, run by Central Hospital, Nancy, France at 2 sites in France.
Trial summary
Preterm neonates are fragile to infections. Their immune system is immature, yet in France, primary vaccines are injected at two months of age, as in term infants. Recommendations for vaccinations in infants have changed in France in 2013, suppressing the second injection at three months after birth. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Hib Immunisation in Very Preterm-born Infants, Pertussis Immunisation in Very Preterm-born Infants
- What is being tested?
- Three vaccine injections DTP-pertussis-Hib and Two vaccine injections DTP-pertussis-Hib
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2014to Sep 2015
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infants born < 33 weeks gestation in Nancy and Thionville Maternity Wards
- signed parental consent
Who cannot join
- immunodeficiency
- vaccine contra-indication
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Regional et Universitaire, Maternite Regionale
Nancy, 54000
Centre Hospitalier de Thionville
Thionville, 57100
About this study
Official title: Comparison of Two Vaccinal Schemes for DTP-Pertussis-Hib Primo-immunisation in Very Preterm-born Neonates: a Randomised Bicentric Controlled Study
Preterm neonates are fragile to infections. Their immune system is immature, yet in France, primary vaccines are injected at two months of age, as in term infants.
Recommendations for vaccinations in infants have changed in France in 2013, suppressing the second injection at three months after birth. Preterm and full-term born infants are now vaccinated at two and four months of age, but no data regarding efficacy in very preterm infants have been registered.
The investigators hypothesize that two vaccine injections (at two and four months) would be less efficient than three injections (two, three and four months) in very preterm-born infants.
- Conditions
- Hib Immunisation in Very Preterm-born Infants, Pertussis Immunisation in Very Preterm-born Infants
- Being tested
- Three vaccine injections DTP-pertussis-Hib, Two vaccine injections DTP-pertussis-Hib
- Keywords
- Vaccination, Very preterm-born infants, Hib immunisation, Pertussis immunisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three vaccine injections DTP-pertussis-HibBiological
DTP-pertussis-Hib injections at two, three, four months after birth
Two vaccine injections DTP-pertussis-HibBiological
DTP-pertussis-Hib injections are administered at two and four months after birth
| Study group | Role | What they receive |
|---|---|---|
| Three vaccine injections | Active comparator | Infants in this study arm will receive three vaccine injections at two, three and four months after birth (vaccine: DTP-pertussis-Hib). Receives: Biological: Three vaccine injections DTP-pertussis-Hib |
| Two vaccine injections | Experimental | Infants in this study arm will receive two vaccine injections at two and four months after birth (vaccine: DTP-pertussis-Hib). Receives: Biological: Two vaccine injections DTP-pertussis-Hib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hib antibody dosage in blood sample
Measured: 5 months after birth
Secondary outcomes (1)
Pertussis antibody dosage in blood sample
Measured: 5 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2015
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hib Immunisation in Very Preterm-born InfantsStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr Rachel VIEUX, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02179996
- Sponsor's protocol ID
- 2013-A01377-28
- Acronym
- VacciPrema
- Status last verified
- Jul 2015
- First submitted
- 1 Jul 2014
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Vaccinal Schemes for DTP-Pertussis-Hib Primo-immunisation in Very Preterm-born Neonates: a Randomised Bicentric Controlled Study
- ClinicalTrials.gov ID
- NCT02179996
- Acronym / sponsor ID
- VacciPrema / 2013-A01377-28
- Conditions
- Hib Immunisation in Very Preterm-born Infants, Pertussis Immunisation in Very Preterm-born Infants
- Keywords
- Vaccination, Very preterm-born infants, Hib immunisation, Pertussis immunisation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (estimated)
- First posted
- 2 Jul 2014 (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.
Preterm neonates are fragile to infections. Their immune system is immature, yet in France, primary vaccines are injected at two months of age, as in term infants.
Recommendations for vaccinations in infants have changed in France in 2013, suppressing the second injection at three months after birth. Preterm and full-term born infants are now vaccinated at two and four months of age, but no data regarding efficacy in very preterm infants have been registered.
The investigators hypothesize that two vaccine injections (at two and four months) would be less efficient than three injections (two, three and four months) in very preterm-born infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three vaccine injections | Active comparator | Biological: Three vaccine injections DTP-pertussis-HibInfants in this study arm will receive three vaccine injections at two, three and four months after birth (vaccine: DTP-pertussis-Hib). |
| Two vaccine injections | Experimental | Biological: Two vaccine injections DTP-pertussis-HibInfants in this study arm will receive two vaccine injections at two and four months after birth (vaccine: DTP-pertussis-Hib). |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- infants born < 33 weeks gestation in Nancy and Thionville Maternity Wards
- signed parental consent
Key exclusion criteria (2 listed)
- immunodeficiency
- vaccine contra-indication
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 |
|---|---|---|
| Three vaccine injections DTP-pertussis-HibDTP-pertussis-Hib injections at two, three, four months after birth | Biological | Three vaccine injections |
| Two vaccine injections DTP-pertussis-HibDTP-pertussis-Hib injections are administered at two and four months after birth | Biological | Two vaccine injections |
Primary outcome
Hib antibody dosage in blood sample
Time frame: 5 months after birth
1 secondary outcome
Pertussis antibody dosage in blood sample
Time frame: 5 months after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
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 4 study testing Three vaccine injections DTP-pertussis-Hib and Two vaccine injections DTP-pertussis-Hib in people with Hib Immunisation in Very Preterm-born Infants and Pertussis Immunisation in Very Preterm-born Infants, run by Central Hospital, Nancy, France at 2 sites in France.
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 2 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: status not confirmed, as of the sponsor's last update on 28 Jul 2015. 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 France. 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 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?
Results are not available in the source record.
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?
Hib antibody dosage in blood sample (time frame: 5 months after birth). 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 28 Jul 2015.