DiphtheriaPhase 3NCT00343421
Study to Compare Pediacel® to Infanrix®-IPV+Hib When Both Are Co-Administered With Prevenar® in Infants and Toddlers
A Phase 3 study testing PEDIACEL® and Prevenar® and Infanrix®-IPV+Hib and Prevenar® in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 2 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate safety and immunogenicity of Pediacel® in infants and toddlers when given at 2,3,4 and 12-18 months of age. Primary Objectives: To compare the post-dose 3 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both are co-administered with Prevenar®. Read more about this study
- Who is it for?
- Ages 55 to 75 daysHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Pertussis
- What is being tested?
- PEDIACEL® and Prevenar® and Infanrix®-IPV+Hib and Prevenar®
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 588 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2006to Jun 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 55 to 75 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants 55 to 75 days old, inclusive on the day of first vaccination
- Born at full term of pregnancy (> 37 weeks)
- Informed consent form signed by the parent(s) or the legal guardian
- Parents or the legal guardian able to read and write in the local language
- Parent(s) or the legal guardian able to attend all scheduled visits and to comply with the study procedures.
Who cannot join
- Presence of fever (defined as rectal body temperature ≥ 38.0°C) reported within the last 72 hours
- Moderate or severe acute illness with or without fever
- Participation in another clinical trial in the 30 days preceding first study vaccination
- Planned participation in another clinical trial during the present study period
- Received diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b or a pneumococcal vaccine separately or in combination prior to study vaccination
- Received any vaccination in the 30 days preceding the first study vaccination and/or is planning any vaccination within 6 weeks following any of the study vaccinations
Show all 14Show fewer
- Congenital or acquired humoral/cellular immunodeficiency or immunosuppressive therapy such as long-term systemic corticosteroids therapy (≥ 2 mg/kg/day prednisone equivalent for ≥ 14 days) in the previous 30 days
- Systemic or local hypersensitivity to any of the study vaccine components (including neomycin, streptomycin, polymyxin B and formaldehyde)
- History of life-threatening reaction(s) (such as encephalopathy, Hypotonic-Hyporesponsive Episode, rectal body temperature ≥ 40.0°C, convulsions with or without fever) to any vaccine containing the same components as the study vaccines
- Blood or blood-derived products (immunoglobulins) received since birth
- Known Human immunodeficiency virus (HIV) seropositivity
- Known thrombocytopenia or other bleeding disorder contraindicating intramuscular vaccination
- History of encephalopathy, seizures or progressive, evolving or unstable neurological condition
- Clinically significant findings on review of systems that might interfere with study vaccination or which, in the opinion of the Investigator, would interfere with the evaluation of the study vaccine/objectives or pose a health risk to the subject.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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 Co-Administered With Prevenar® to Infants and Toddlers at 2, 3, 4 and 12-18 Months of Age
The purpose of this study is to evaluate safety and immunogenicity of Pediacel® in infants and toddlers when given at 2,3,4 and 12-18 months of age.
Primary Objectives:
- To compare the post-dose 3 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both are co-administered with Prevenar®.
- To describe the post-dose 3 pertussis antibody responses.
Secondary Objectives:
- To compare the post-dose 4 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both are co-administered with Prevenar®.
- To describe the safety after each vaccination following co-administration with Prevenar®.
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis, Haemophilus Influenzae Type b
- Being tested
- PEDIACEL® and Prevenar®, Infanrix®-IPV+Hib and Prevenar®
- Keywords
- Diphtheria, Tetanus, Pertussis, Poliomyelitis, Haemophilus influenzae type b, Pneumococcal infections
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough, Poliomyelitis, Haemophilus Infections, Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEDIACEL® and Prevenar®Biological
Also called PEDIACEL®: DT5aP-IPV-Hib 5-component Pertussis vaccine, Prevenar®: Pneumococcal saccharide conj. vaccine, adsorbed
0.5 mL each, IM (opposite thigh)
Infanrix®-IPV+Hib and Prevenar®Biological
Also called Infanrix®-IPV+Hib: DTap, IPV and adsorbed conjugated Hib, Prevenar®: Pneumococcal saccharide conj vaccine, adsorbed.
0.5 mL each, IM (opposite thigh)
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | PEDIACEL co-administered with Prevenar Receives: Biological: PEDIACEL® and Prevenar® |
| Group 2 | Active comparator | Infanrix-IPV+Hib co-administered with Prevenar Receives: Biological: Infanrix®-IPV+Hib and Prevenar® |
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® and Infanrix®-IPV+Hib
Measured: 1 month post-vaccination
Secondary outcomes (1)
To provide information concerning the safety after administration of PEDIACEL® and Infanrix®-IPV+Hib
Measured: Entire study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2006 (estimated)
- Study startJul 2006
- Primary completionJun 2008
- Study completionJun 2009
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 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 588 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
- NCT00343421
- Sponsor's protocol ID
- A5I16
- Status last verified
- Jun 2016
- First submitted
- 21 Jun 2006
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Grimprel E, Wysocki J, Boisnard F, Thomas S, Mwawasi G, Reynolds D. Immunogenicity and safety of fully liquid DTaP(5)-IPV-Hib compared with DTaP(3)-IPV/Hib when both coadministered with a heptavalent pneumococcal conjugate vaccine (PCV7) at 2, 3, 4, and 12 to 18 months of age: a phase III, single-blind, randomised, controlled, multicentre study. Vaccine. 2011 Oct 6;29(43):7370-8. doi: 10.1016/j.vaccine.2011.07.078. Epub 2011 Jul 30.
PubMed 21807056
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 Co-Administered With Prevenar® to Infants and Toddlers at 2, 3, 4 and 12-18 Months of Age
- ClinicalTrials.gov ID
- NCT00343421
- Acronym / sponsor ID
- A5I16
- Conditions
- Diphtheria, Tetanus, Pertussis, Poliomyelitis, Haemophilus Influenzae Type b
- Keywords
- Diphtheria, Tetanus, Pertussis, Poliomyelitis, Haemophilus influenzae type b, Pneumococcal infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 588 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 23 Jun 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.
The purpose of this study is to evaluate safety and immunogenicity of Pediacel® in infants and toddlers when given at 2,3,4 and 12-18 months of age.
Primary Objectives:
- To compare the post-dose 3 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both are co-administered with Prevenar®.
- To describe the post-dose 3 pertussis antibody responses.
Secondary Objectives:
- To compare the post-dose 4 immunogenicity of Pediacel® to Infanrix®-IPV+Hib when both are co-administered with Prevenar®.
- To describe the safety after each vaccination following co-administration with Prevenar®.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: PEDIACEL® and Prevenar®PEDIACEL co-administered with Prevenar |
| Group 2 | Active comparator | Biological: Infanrix®-IPV+Hib and Prevenar®Infanrix-IPV+Hib co-administered with Prevenar |
Who may qualify
- Ages
- 55 to 75 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infants 55 to 75 days old, inclusive on the day of first vaccination
- Born at full term of pregnancy (> 37 weeks)
- Informed consent form signed by the parent(s) or the legal guardian
- Parents or the legal guardian able to read and write in the local language
- Parent(s) or the legal guardian able to attend all scheduled visits and to comply with the study procedures.
Key exclusion criteria (14 listed)
- Presence of fever (defined as rectal body temperature ≥ 38.0°C) reported within the last 72 hours
- Moderate or severe acute illness with or without fever
- Participation in another clinical trial in the 30 days preceding first study vaccination
- Planned participation in another clinical trial during the present study period
- Received diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b or a pneumococcal vaccine separately or in combination prior to study 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 |
|---|---|---|
| PEDIACEL® and Prevenar®Also: PEDIACEL®: DT5aP-IPV-Hib 5-component Pertussis vaccine, Prevenar®: Pneumococcal saccharide conj. vaccine, adsorbed0.5 mL each, IM (opposite thigh) | Biological | Group 1 |
| Infanrix®-IPV+Hib and Prevenar®Also: Infanrix®-IPV+Hib: DTap, IPV and adsorbed conjugated Hib, Prevenar®: Pneumococcal saccharide conj vaccine, adsorbed.0.5 mL each, IM (opposite thigh) | Biological | Group 2 |
Primary outcome
To provide information concerning the immunogenicity of PEDIACEL® and Infanrix®-IPV+Hib
Time frame: 1 month post-vaccination
1 secondary outcome
To provide information concerning the safety after administration of PEDIACEL® and Infanrix®-IPV+Hib
Time frame: Entire study
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 3 Jun 2016.
- Results publication: PubMed 21807056Grimprel E, Wysocki J, Boisnard F, Thomas S, Mwawasi G, Reynolds D. Immunogenicity and safety of fully liquid DTaP(5)-IPV-Hib compared with DTaP(3)-IPV/Hib when both coadministered with a heptavalent pneumococcal conjugate vaccine (PCV7) at 2, 3, 4, and 12 to 18 months of age: a phase III, single-blind, randomised, controlled, multicentre study. Vaccine. 2011 Oct 6;29(43):7370-8. doi: 10.1016/j.vaccine.2011.07.078. Epub 2011 Jul 30.
- 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.
2 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 PEDIACEL® and Prevenar® and Infanrix®-IPV+Hib and Prevenar® in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 2 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 5 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 3 Jun 2016. 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, Poland. 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® and Infanrix®-IPV+Hib (time frame: 1 month post-vaccination). 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 NCT00343421, 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 3 Jun 2016.