DiphtheriaNCT00804284
Database Surveillance Safety Study of PENTACEL® Vaccine
An observational study of Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 1 site in United States.
Trial summary
The objective for this study is to characterize the safety profile of PENTACEL® vaccine for identification of potential vaccine-related adverse events not currently associated with PENTACEL® vaccine administration. Read more about this study
- Who is it for?
- Ages 6 weeks to 24 months, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Pertussis
- What is being tested?
- DTaP-IPV/Hib and Other DTap Vaccines
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 62,538 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jan 2015
- Phase
- Observational
- 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 6 weeks to 24 months
- Men only
- Healthy volunteers accepted
- Child
Study population: Receipt of DTaP vaccine during the study period by a previously unvaccinated subjects
Who may be able to join
- Receipt of DTaP vaccine during the study period by a previously unvaccinated child
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Licensure Safety Surveillance Study of Routine Use of PENTACEL® Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
The objective for this study is to characterize the safety profile of PENTACEL® vaccine for identification of potential vaccine-related adverse events not currently associated with PENTACEL® vaccine administration.
Read the detailed description
The study will be conducted at Kaiser Permanente Northern California and will commence with first use of licensed PENTACEL® vaccine within that organization.
Vaccination databases will be reviewed to identify Diphtheria and tetanus toxoid with acellular pertussis (DTaP) vaccinations of accrued subjects. Medical encounter, emergency room, hospitalization, laboratory, state death reporting, and related databases will be reviewed to identify medical care events.
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae
- Being tested
- DTaP-IPV/Hib, Other DTap Vaccines
- Keywords
- DAPTACEL®, PENTACEL®, Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough, Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTaP-IPV/HibBiological
Also called PENTACEL®
0.5 mL, Intramuscular
Other DTap VaccinesBiological
Also called DAPTACEL®, INFANRIX®, PEDIARIX®, TRIPEDIA®
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Pentacel Group | Infants initiated on PENTACEL® vaccine Receives: Biological: DTaP-IPV/Hib | |
| Other DTap vaccines Group | Infants initiated on other DTaP vaccines Receives: Biological: Other DTap Vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
A summary of all non-elective hospitalization and emergency room visits as well as outcome of interest from chart review.
Outcome of interest identified from Kaiser Permanente Medical Care Program (KPMCP) computerized records via International Classification of Diseases, 9th edition (ICD-9) codes, defined as:
- Death,
- Outpatient clinic visit for:
- seizure occurring within 72 hours of vaccination, Guillain-Barré Syndrome, encephalopathy, encephalitis, alteration of consciousness (other than secondary to another diagnosis), or meningitis
- hypersensitivity reactions (e.g. urticaria, angioedema, or anaphylaxis) occurring within 72 hours of vaccination,
- new-onset autoimmune disease (including idiopathic thrombocytopenic purpura, hemolytic anemia).
Measured: Up to 6 months post -dose 4 DTap Vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2014
- Study completionJan 2015
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
- Observational
- Observational model
- Cohort
- Enrolment
- 62,538 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
- NCT00804284
- Sponsor's protocol ID
- M5A11
- Status last verified
- Aug 2015
- First submitted
- 5 Dec 2008
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hansen J, Timbol J, Lewis N, Pool V, Decker MD, Greenberg DP, Klein NP. Safety of DTaP-IPV/Hib vaccine administered routinely to infants and toddlers. Vaccine. 2016 Jul 29;34(35):4172-4179. doi: 10.1016/j.vaccine.2016.06.062. Epub 2016 Jun 30.
PubMed 27373595
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Licensure Safety Surveillance Study of Routine Use of PENTACEL® Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine
- ClinicalTrials.gov ID
- NCT00804284
- Acronym / sponsor ID
- M5A11
- Conditions
- Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae
- Keywords
- DAPTACEL®, PENTACEL®, Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62,538 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Aug 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 8 Dec 2008 (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 objective for this study is to characterize the safety profile of PENTACEL® vaccine for identification of potential vaccine-related adverse events not currently associated with PENTACEL® vaccine administration.
Detailed description
The study will be conducted at Kaiser Permanente Northern California and will commence with first use of licensed PENTACEL® vaccine within that organization.
Vaccination databases will be reviewed to identify Diphtheria and tetanus toxoid with acellular pertussis (DTaP) vaccinations of accrued subjects. Medical encounter, emergency room, hospitalization, laboratory, state death reporting, and related databases will be reviewed to identify medical care events.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pentacel Group | – | Biological: DTaP-IPV/HibInfants initiated on PENTACEL® vaccine |
| Other DTap vaccines Group | – | Biological: Other DTap VaccinesInfants initiated on other DTaP vaccines |
Who may qualify
- Ages
- 6 weeks to 24 months
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Receipt of DTaP vaccine during the study period by a previously unvaccinated subjects
Key inclusion criteria (1 listed)
- Receipt of DTaP vaccine during the study period by a previously unvaccinated child
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| DTaP-IPV/HibAlso: PENTACEL®0.5 mL, Intramuscular | Biological | Pentacel Group |
| Other DTap VaccinesAlso: DAPTACEL®, INFANRIX®, PEDIARIX®, TRIPEDIA®0.5 mL, Intramuscular | Biological | Other DTap vaccines Group |
Primary outcome
A summary of all non-elective hospitalization and emergency room visits as well as outcome of interest from chart review.
Time frame: Up to 6 months post -dose 4 DTap Vaccination
Outcome of interest identified from Kaiser Permanente Medical Care Program (KPMCP) computerized records via International Classification of Diseases, 9th edition (ICD-9) codes, defined as: * Death, * Outpatient clinic visit for: * seizure occurring within 72 hours of vaccination, Guillain-Barré Syndrome, encephalopathy, encephalitis, alteration of consciousness (other than secondary to another diagnosis), or meningitis * hypersensitivity reactions (e.g. urticaria, angioedema, or anaphylaxis) occurring within 72 hours of vaccination, * new-onset autoimmune disease (including idiopathic thrombocytopenic purpura, hemolytic anemia).
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 19 Aug 2015.
- Derived from this study: PubMed 27373595Hansen J, Timbol J, Lewis N, Pool V, Decker MD, Greenberg DP, Klein NP. Safety of DTaP-IPV/Hib vaccine administered routinely to infants and toddlers. Vaccine. 2016 Jul 29;34(35):4172-4179. doi: 10.1016/j.vaccine.2016.06.062. Epub 2016 Jun 30.
- Related InfoLink provided by the sponsor.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 1 site in United States.
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 1 inclusion and 1 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 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
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?
A summary of all non-elective hospitalization and emergency room visits as well as outcome of interest from chart review. (time frame: Up to 6 months post -dose 4 DTap 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 NCT00804284, 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 19 Aug 2015.