PertussisPhase 3NCT00287092
Comparison of Safety and Immunogenicity of Pediacel™ and Infanrix™ IPV+Hib (Penta) Given in a 3 Dose Schedule in Infants
A Phase 3 study testing DT5aP-IPV-Hib 5-component Pertussis vaccine and Infanrix® -IPV+Hib in people with Pertussis and Diphtheria, run by Sanofi Pasteur, a Sanofi Company at 14 sites in 2 countries.
Trial summary
Pediacel™ is currently licensed in the UK for use as a 3 dose regimen for the active immunisation of infants against Diphtheria, Tetanus, Pertussis, Poliomyelitis and invasive infections caused by Haemophilus influenzae type b. Read more about this study
- Who is it for?
- Ages 80 to 120 daysHealthy volunteers can take part
- Conditions the study is for
- Pertussis, Diphtheria, Tetanus
- What is being tested?
- DT5aP-IPV-Hib 5-component Pertussis vaccine and Infanrix® -IPV+Hib
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 807 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Feb 2006to Sep 2008
- 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 80 to 120 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants aged 80 to 120 days inclusive on the day of inclusion.
- Born at full term of pregnancy (> 37 weeks)
- Informed consent form signed by the parent(s) or other legal representative according to local regulations
- Parent(s) or legal representative able to attend all scheduled visits and to understand and comply with the study procedures (able to read and write; access to a telephone).
Who cannot join
- Rectal temperature ≥ 38.0°C
- Moderate or severe acute illness with or without fever
- Participation in another clinical trial in the 4 weeks preceding the first trial vaccination
- Having received any DTaP, IPV, or Hib vaccines prior to study initiation or any vaccination in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Known history of diphtheria, tetanus, pertussis, H. influenzae type b infections, poliomyelitis
Show all 15Show fewer
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- Systemic hypersensitivity to any of the vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde)
- History of a life-threatening reaction (such as encephalopathy, Hypotonic Hyporesponsive Episode, severe fever, convulsions, etc.) to the trial vaccine or a vaccine containing the same substances
- Blood or blood-derived products (immunoglobulins) received in the past 4 weeks
- Vaccination planned in the 6 weeks following any trial vaccination
- Known HIV seropositivity
- Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- History of seizures or progressive, evolving or unstable neurological condition
- Clinically significant findings on review of systems that might interfere with correct vaccination or which, in the opinion of the Investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
Finland13 sites
Study site
Espoo, 02100
Study site
Helsinki, 00100
Study site
Helsinki, 00930
Study site
Jarvenpaa, 04400
Study site
Jyväskylä, 40100
Study site
Kotka, 48100
Study site
Lahti, 15140
Study site
Oulu, 90100
Study site
Pori, 28120
Study site
Tampere, 33520
Study site
Turku, 20520
Study site
Vantaa, 01300
Study site
Vantaa, 01600
About this study
Official title: A Randomised, Controlled, Double-Blind Study of the Immunogenicity and Safety of PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed) Compared To Infanrix®-IPV+Hib When Both Vaccines Are Given to Infants Using a Three Dose Immunisation Schedule ("Nordic Schedule" 3-5-12 Months)
Pediacel™ is currently licensed in the UK for use as a 3 dose regimen for the active immunisation of infants against Diphtheria, Tetanus, Pertussis, Poliomyelitis and invasive infections caused by Haemophilus influenzae type b. However there are currently no clinical data supporting the use of Pediacel™ using a 3, 5, and 12 months of age vaccination schedule. This study is designed to provide safety and immunogenicity data to support the use of Pediacel™ according to a 3, 5, and 12 months schedule.
- Conditions
- Pertussis, Diphtheria, Tetanus, Poliomyelitis, Haemophilus Influenzae Type b
- Being tested
- DT5aP-IPV-Hib 5-component Pertussis vaccine, Infanrix® -IPV+Hib
- Keywords
- Haemophilus influenzae type b;, Corynebacterium diphtheriae;, Clostridium tetani;, Bordetella pertussis;, poliovirus types 1, 2 and 3;, Vero cell;, Influenza;, Diphtheria
- Medical subject headings
- Whooping Cough, Diphtheria, Tetanus, Poliomyelitis, Haemophilus Infections, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DT5aP-IPV-Hib 5-component Pertussis vaccineBiological
Also called Pediacel™
0.5 mL, IM
Infanrix® -IPV+HibBiological
Also called Infanrix®
0.5 mL, IM
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Participants will receive PEDIACEL vaccine Receives: Biological: DT5aP-IPV-Hib 5-component Pertussis vaccine |
| Group 2 | Active comparator | Participants will receive Infanrix-IPV+Hib vaccines Receives: Biological: Infanrix® -IPV+Hib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide information concerning the immunogenicity of PEDIACEL® Vaccine.
Measured: 1 Month post-dose 3
Secondary outcomes (1)
To provide information concerning the safety after administration of PEDIACEL® Vaccine
Measured: Entire study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2006 (estimated)
- Study startFeb 2006
- Primary completionMay 2007
- Study completionSep 2008
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 PertussisStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 807 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287092
- Sponsor's protocol ID
- A5I15
- Status last verified
- Jan 2015
- First submitted
- 3 Feb 2006
- Last updated
- 7 Jan 2015
- Results posted
- No
Publications
Vesikari T, Silfverdal SA, Boisnard F, Thomas S, Mwawasi G, Reynolds D. Randomized, controlled, multicenter study of the immunogenicity and safety of a fully liquid combination diphtheria-tetanus toxoid-five-component acellular pertussis (DTaP5), inactivated poliovirus (IPV), and haemophilus influenzae type b (Hib) vaccine compared with a DTaP3-IPV/Hib vaccine administered at 3, 5, and 12 months of age. Clin Vaccine Immunol. 2013 Oct;20(10):1647-53. doi: 10.1128/CVI.00414-13. Epub 2013 Aug 21.
PubMed 23966556
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled, Double-Blind Study of the Immunogenicity and Safety of PEDIACEL®, a Combined Diphtheria, Tetanus, Five Component Acellular Pertussis, Inactivated Poliomyelitis and Haemophilus Influenzae Type b Conjugate Vaccine (Adsorbed) Compared To Infanrix®-IPV+Hib When Both Vaccines Are Given to Infants Using a Three Dose Immunisation Schedule ("Nordic Schedule" 3-5-12 Months)
- ClinicalTrials.gov ID
- NCT00287092
- Acronym / sponsor ID
- A5I15
- Conditions
- Pertussis, Diphtheria, Tetanus, Poliomyelitis, Haemophilus Influenzae Type b
- Keywords
- Haemophilus influenzae type b;, Corynebacterium diphtheriae;, Clostridium tetani;, Bordetella pertussis;, poliovirus types 1, 2 and 3;, Vero cell;, Influenza;, Diphtheria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 807 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- May 2007 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 6 Feb 2006 (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.
Pediacel™ is currently licensed in the UK for use as a 3 dose regimen for the active immunisation of infants against Diphtheria, Tetanus, Pertussis, Poliomyelitis and invasive infections caused by Haemophilus influenzae type b. However there are currently no clinical data supporting the use of Pediacel™ using a 3, 5, and 12 months of age vaccination schedule. This study is designed to provide safety and immunogenicity data to support the use of Pediacel™ according to a 3, 5, and 12 months schedule.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: DT5aP-IPV-Hib 5-component Pertussis vaccineParticipants will receive PEDIACEL vaccine |
| Group 2 | Active comparator | Biological: Infanrix® -IPV+HibParticipants will receive Infanrix-IPV+Hib vaccines |
Who may qualify
- Ages
- 80 to 120 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants aged 80 to 120 days inclusive on the day of inclusion.
- Born at full term of pregnancy (> 37 weeks)
- Informed consent form signed by the parent(s) or other legal representative according to local regulations
- Parent(s) or legal representative able to attend all scheduled visits and to understand and comply with the study procedures (able to read and write; access to a telephone).
Key exclusion criteria (15 listed)
- Rectal temperature ≥ 38.0°C
- Moderate or severe acute illness with or without fever
- Participation in another clinical trial in the 4 weeks preceding the first trial vaccination
- Having received any DTaP, IPV, or Hib vaccines prior to study initiation or any vaccination in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
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 |
|---|---|---|
| DT5aP-IPV-Hib 5-component Pertussis vaccineAlso: Pediacel™0.5 mL, IM | Biological | Group 1 |
| Infanrix® -IPV+HibAlso: Infanrix®0.5 mL, IM | Biological | Group 2 |
Primary outcome
To provide information concerning the immunogenicity of PEDIACEL® Vaccine.
Time frame: 1 Month post-dose 3
1 secondary outcome
To provide information concerning the safety after administration of PEDIACEL® Vaccine
Time frame: Entire study period
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 7 Jan 2015.
- Derived from this study: PubMed 23966556Vesikari T, Silfverdal SA, Boisnard F, Thomas S, Mwawasi G, Reynolds D. Randomized, controlled, multicenter study of the immunogenicity and safety of a fully liquid combination diphtheria-tetanus toxoid-five-component acellular pertussis (DTaP5), inactivated poliovirus (IPV), and haemophilus influenzae type b (Hib) vaccine compared with a DTaP3-IPV/Hib vaccine administered at 3, 5, and 12 months of age. Clin Vaccine Immunol. 2013 Oct;20(10):1647-53. doi: 10.1128/CVI.00414-13. Epub 2013 Aug 21.
- Related InfoLink provided by the sponsor.
Related trials for Pertussis
RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingObservational study
Assessment of the Acceptability of, and Factors Associated With, Recommended Vaccinations During Pregnancy in Maternity Units in the Ile-de-France Region
Vaccination Coverage Among Pregnant Women
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
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.
Medical Director study director
Sanofi Pasteur Inc.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DT5aP-IPV-Hib 5-component Pertussis vaccine and Infanrix® -IPV+Hib in people with Pertussis and Diphtheria, run by Sanofi Pasteur, a Sanofi Company at 14 sites in 2 countries.
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 15 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 7 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Finland, Sweden. 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?
To provide information concerning the immunogenicity of PEDIACEL® Vaccine. (time frame: 1 Month post-dose 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00287092, 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 7 Jan 2015.