DiphtheriaPhase 2NCT00362427
Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar®
A Phase 2 study testing Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC in people with Diphtheria and Pertussis, run by Sanofi Pasteur, a Sanofi Company at 8 sites in Canada.
Trial summary
PR5I, a hexavalent pediatric combination vaccine is being developed to reduce the number of injections during the first 2 years of life while providing a complete course of immunization against infection caused by H. Read more about this study
- Who is it for?
- Ages 42 to 89 daysHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Pertussis, Polio
- What is being tested?
- Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 8 sitesCanada
- Study dates
- Aug 2006to Mar 2009
- Phase
- Phase 2
- 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 42 to 89 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants aged 42 to 89 days inclusive on the day of inclusion.
- Born at full term of pregnancy (>37 weeks).
- Informed consent form signed by the parent(s) or legally authorized representative.
- Able to attend all scheduled visits and to comply with the study procedures.
- Parent or legally authorized representative has access to a telephone.
- Parent or legally authorized representative able to read and write in English or French.
Who cannot join
- Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Personal or immediate family history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy.
- Known or suspected systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine(s).
- Chronic illness that could interfere with trial conduct or completion.
- Received blood or blood-derived products since birth.
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- Any vaccination preceding the first trial vaccination or planned in the 4 weeks after any trial vaccination (flu vaccine may be given a minimum of 4 weeks prior to the first study vaccination).
- Previous vaccination with any acellular pertussis- (DTaP) or whole cell pertussis- (DTwP) based combination vaccines, Haemophilus influenzae type b (Hib)-conjugate, poliovirus, hepatitis B, or pneumococcal conjugate vaccines.
- Coagulation disorder contraindicating IM vaccination.
- Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion).
- Developmental delay or neurological disorder.
- Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
- Documented Hepatitis B surface Antigen (HBsAg) seropositivity in the child or his/her mother.
- History of Hib, hepatitis B, diphtheria, tetanus, pertussis or poliovirus disease.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Canada8 sites
Study site
Beauport, Quebec, G1E 7G9
Study site
Coquitlam, British Columbia, V3C 4J2
Study site
Halifax, Nova Scotia, B3K 6R8
Study site
Montreal, Quebec, H3H 1P3
Study site
Montreal, Quebec, H3T 1C5
Study site
Ottawa, Ontario, K1S 0G8
Study site
Surrey, British Columbia, V3R 8P8
Study site
Winnipeg, Manitoba, R3E 3P4
About this study
Official title: A Randomized Trial to Assess the Immunogenicity and Safety of PR5I With an Adjuvant Composition Enhancement to the Hepatitis B Component and When Given Concomitantly With Prevnar®
PR5I, a hexavalent pediatric combination vaccine is being developed to reduce the number of injections during the first 2 years of life while providing a complete course of immunization against infection caused by H. influenzae type b, hepatitis B virus, Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, and poliovirus types 1, 2, and 3.
Primary Objective: To evaluate immunogenicity of PR5I with the adjuvant composition enhancement to the hepatitis B component when administered concomitantly with Prevnar®
Secondary Objectives: To assess the safety and immunogenicity of PR5I when administered concomitantly, or one month apart with Prevnar® or separately with licensed vaccines used for routine infant vaccination in Canada.
- Conditions
- Diphtheria, Pertussis, Polio, Hepatitis B, Tetanus
- Being tested
- Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
- Keywords
- Hepatitis B, Pertussis, Diphtheria, Tetanus, H. influenzae type b, Polio
- Medical subject headings
- Diphtheria, Whooping Cough, Poliomyelitis, Hepatitis B, Tetanus, Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPCBiological
Also called PR5I
0.5 mL, 4 doses, IM
Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPCBiological
Also called PR5I
0.5 Ml, 4 doses, IM
Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPCBiological
Also called PR5I, PENTACEL™, NGERIX-B®
0.5 mL, 4 doses, IM with concommitant vaccines
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC |
| Group B | Experimental | Not described Receives: Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC |
| Group C | Active comparator | Not described Receives: Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide information concerning the immune response of subjects that received PR5I concomitantly with Prevnar
Measured: 14 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionFeb 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiphtheriaStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362427
- Sponsor's protocol ID
- PR504
- Status last verified
- Jan 2014
- First submitted
- 9 Aug 2006
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Halperin SA, Tapiero B, Dionne M, Meekison W, Diaz-Mitoma F, Zickler P, Rubin E, Embree J, Bhuyan P, Lee A, Li M, Tomovici A. Safety and immunogenicity of a toddler dose following an infant series of a hexavalent diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b, hepatitis B vaccine administered concurrently or at separate visits with a heptavalent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2014 Jan;33(1):73-80. doi: 10.1097/01.inf.0000437806.76221.20.
PubMed 24346596Tapiero B, Halperin SA, Dionne M, Meekison W, Diaz-Mitoma F, Zickler P, Rubin E, Embree J, Bhuyan P, Lee AW, Li M, Tomovici A. Safety and immunogenicity of a hexavalent vaccine administered at 2, 4 and 6 months of age with or without a heptavalent pneumococcal conjugate vaccine: a randomized, open-label study. Pediatr Infect Dis J. 2013 Jan;32(1):54-61. doi: 10.1097/INF.0b013e3182717edf.
PubMed 23241989
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Assess the Immunogenicity and Safety of PR5I With an Adjuvant Composition Enhancement to the Hepatitis B Component and When Given Concomitantly With Prevnar®
- ClinicalTrials.gov ID
- NCT00362427
- Acronym / sponsor ID
- PR504
- Conditions
- Diphtheria, Pertussis, Polio, Hepatitis B, Tetanus
- Keywords
- Hepatitis B, Pertussis, Diphtheria, Tetanus, H. influenzae type b, Polio
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Aug 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 10 Aug 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.
PR5I, a hexavalent pediatric combination vaccine is being developed to reduce the number of injections during the first 2 years of life while providing a complete course of immunization against infection caused by H. influenzae type b, hepatitis B virus, Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, and poliovirus types 1, 2, and 3.
Primary Objective: To evaluate immunogenicity of PR5I with the adjuvant composition enhancement to the hepatitis B component when administered concomitantly with Prevnar®
Secondary Objectives: To assess the safety and immunogenicity of PR5I when administered concomitantly, or one month apart with Prevnar® or separately with licensed vaccines used for routine infant vaccination in Canada.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC |
| Group B | Experimental | Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC |
| Group C | Active comparator | Biological: Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC |
Who may qualify
- Ages
- 42 to 89 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Infants aged 42 to 89 days inclusive on the day of inclusion.
- Born at full term of pregnancy (>37 weeks).
- Informed consent form signed by the parent(s) or legally authorized representative.
- Able to attend all scheduled visits and to comply with the study procedures.
- Parent or legally authorized representative has access to a telephone.
Key exclusion criteria (14 listed)
- Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Personal or immediate family history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy.
- Known or suspected systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine(s).
- Chronic illness that could interfere with trial conduct or completion.
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 |
|---|---|---|
| Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPCAlso: PR5I0.5 mL, 4 doses, IM | Biological | Group A |
| Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPCAlso: PR5I0.5 Ml, 4 doses, IM | Biological | Group B |
| Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPCAlso: PR5I, PENTACEL™, NGERIX-B®0.5 mL, 4 doses, IM with concommitant vaccines | Biological | Group C |
Primary outcome
To provide information concerning the immune response of subjects that received PR5I concomitantly with Prevnar
Time frame: 14 Months
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 14 Jan 2014.
- Derived from this study: PubMed 24346596Halperin SA, Tapiero B, Dionne M, Meekison W, Diaz-Mitoma F, Zickler P, Rubin E, Embree J, Bhuyan P, Lee A, Li M, Tomovici A. Safety and immunogenicity of a toddler dose following an infant series of a hexavalent diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b, hepatitis B vaccine administered concurrently or at separate visits with a heptavalent pneumococcal conjugate vaccine. Pediatr Infect Dis J. 2014 Jan;33(1):73-80. doi: 10.1097/01.inf.0000437806.76221.20.
- Derived from this study: PubMed 23241989Tapiero B, Halperin SA, Dionne M, Meekison W, Diaz-Mitoma F, Zickler P, Rubin E, Embree J, Bhuyan P, Lee AW, Li M, Tomovici A. Safety and immunogenicity of a hexavalent vaccine administered at 2, 4 and 6 months of age with or without a heptavalent pneumococcal conjugate vaccine: a randomized, open-label study. Pediatr Infect Dis J. 2013 Jan;32(1):54-61. doi: 10.1097/INF.0b013e3182717edf.
- Related InfoLink provided by the sponsor.
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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.
Medical Director study director
Sanofi Pasteur Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC in people with Diphtheria and Pertussis, run by Sanofi Pasteur, a Sanofi Company at 8 sites in Canada.
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 6 inclusion and 14 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 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 immune response of subjects that received PR5I concomitantly with Prevnar (time frame: 14 Months). 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 NCT00362427, which also lists 2 linked publications.
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 14 Jan 2014.