DiphtheriaPhase 3NCT00662870
Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine
A Phase 3 study testing DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine) and Pentacel: DTaP-IPV/Hib in people with Diphtheria and Tetanus, run by Sanofi at 26 sites in United States.
Trial summary
This study was designed to assess the lot comparability of DAPTACEL, as well as the safety and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines. Stage I Primary Objectives: 1. Read more about this study
- Who is it for?
- Ages 42 to 84 daysHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Whooping Cough
- What is being tested?
- DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine) and Pentacel: DTaP-IPV/Hib
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,941 participants
- Where
- 26 sitesUnited States
- Study dates
- May 2001to Jan 2004
- 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 42 to 84 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants 2 months of age.
- Infants with at least 37 weeks of gestation at delivery.
- Signed informed consent from parent or guardian.
- Able to attend the scheduled visits and to comply with the study procedure.
- Subjects must have received the first dose of hepatitis B vaccine from birth to 28 days prior to the first dose of DAPTACEL or Pentacel.
Who cannot join
- Clinically significant findings on review of systems or physical examination (determined by investigator or sub-investigator to be sufficient for exclusion).
- Known or suspected hypersensitivity to any component of the study vaccine to be administered.
- Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
- Known HIV-positive mother.
- Personal or immediate family history of congenital immune deficiency.
- Developmental delay or neurologic disorders.
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- Chronic medical, congenital, developmental or surgical disease.
- Participation in any other experimental vaccine trial.
- Any condition which, in the opinion of the investigator or sub-investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
- Prior history of having received more than one dose of hepatitis B vaccine, any diphtheria, tetanus and acellular pertussis combination vaccine (DTaP), diphtheria, tetanus and whole-cell pertussis combination vaccine (DTwP), Haemophilus influenzae type b (Hib)-conjugate vaccine, poliovirus vaccine or pneumococcal conjugate vaccine
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Study site
Austin, TX 78758, Texas, 78758
Study site
Bardstown, KY 40004, Kentucky, 40004
Study site
Bossier City, LA 71111, Louisiana, 71111
Study site
Bridgeton, MO 63044, Missouri, 63044
Study site
Chapel Hill, NC 27514, North Carolina, 27514
Study site
Chicago, IL 60614, Illinois, 60614
Study site
Englewood, CO 80112, Colorado, 80112
Study site
Fayetteville, AR 72703, Arkansas, 72703
Study site
Fort Worth, TX 76107, Texas, 76106
Study site
Fountain Valley, CA 92708, California, 92708
Study site
Jonesboro, AR 72401, Arkansas, 7240
Study site
Kingsport, TN 37664, Tennessee, 37664
Study site
LaCrosse, WI 54601, Wisconsin, 54601
Study site
Little Rock, AR 72211, Arkansas, 72211
Study site
Marietta, GA 30062, Georgia, 30062
Study site
Marshfield, WI 54449, Wisconsin, 54449
Study site
Norristown, PA 19401, Pennsylvania, 19401
Study site
Norwich, CT 06360, Connecticut, 06360
Study site
Orlando, FL 32856, Florida, 32856
Study site
Pittsburgh, PA 15213, Pennsylvania, 15213
Study site
Pittsburgh, PA 15241, Pennsylvania, 15241
Study site
Portland, OR 97201, Oregon, 97201
Study site
Provo, UT 84604, Utah, 84604
Study site
Rochester, NY 14620, New York, 14620
Study site
San Antonio, TX 78205, Texas, 78205
Study site
Spokane, WA 99220, Washington, 99220
About this study
Official title: Safety, Immunogenicity and Lot Comparability of DAPTACEL™ (Aventis Pasteur Classic Five-component Pertussis Vaccine in Combination With Tetanus and Diphtheria Toxoids Adsorbed) When Administered With Other Recommended Vaccines at 2, 4, 6, and 15 to 16 Months of Age.
This study was designed to assess the lot comparability of DAPTACEL, as well as the safety and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines.
Stage I Primary Objectives:
Read more
- To assess the lot-comparability of immunogenicity of DAPTACEL by when co-administered with other recommended vaccines.
- To compare the immune response to DTaP-IPV/Hib (Pentacel) with those of three lots of DAPTACEL when co-administered with other recommended vaccines.
- To compare the immune response of PRP-T antigen in Pentacel with that of ActHIB concurrently administered in a different injection site with DAPTACEL when these vaccines are co-administered with other recommended vaccines.
Stage II Primary Objectives:
- To compare the immune response of DAPTACEL when the 4th dose is co-administered with Hib or other infant vaccines.
- To compare the the immune response of Pentacel with those elicited by DAPTACEL when co-administered with ActHIB in toddlers.
Read the detailed description
This is a two-stage, randomized, multi-center study to assess the safety, immunogenicity and lot comparability of DAPTACEL
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Polio, Haemophilus Influenzae Type b
- Being tested
- DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine), Pentacel: DTaP-IPV/Hib
- Keywords
- DAPTACEL, Diphtheria, Tetanus, Whooping Cough, Polio, Haemophilus influenzae type b, Pertussis
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough, Poliomyelitis, Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)Biological
Also called DAPTACEL®
0.5 mL, Intramuscular
Pentacel: DTaP-IPV/HibBiological
Also called Pentacel
0.5 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| DAPTACEL Lot 1 | Experimental | Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 1 Receives: Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine) |
| DAPTACEL Lot 2 | Experimental | Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 2 Receives: Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine) |
| DAPTACEL Lot 3 | Experimental | Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 3 Receives: Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine) |
| Pentacel | Active comparator | Participants receiving Pentacel vaccine Receives: Biological: Pentacel: DTaP-IPV/Hib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity: To provide information concerning the immune response of DAPTACEL after vaccination.
Measured: 30 days post-vaccination 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startMay 2001
- Primary completionJan 2004
- Study completionJan 2004
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 SanofiThe 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
- 1,941 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Sanofi Pasteur, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662870
- Sponsor's protocol ID
- P3T06
- Status last verified
- Jan 2012
- First submitted
- 17 Apr 2008
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Guerra FA, Blatter MM, Greenberg DP, Pichichero M, Noriega FR; Pentacel Study Group. Safety and immunogenicity of a pentavalent vaccine compared with separate administration of licensed equivalent vaccines in US infants and toddlers and persistence of antibodies before a preschool booster dose: a randomized, clinical trial. Pediatrics. 2009 Jan;123(1):301-12. doi: 10.1542/peds.2007-3317.
PubMed 19117896
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Immunogenicity and Lot Comparability of DAPTACEL™ (Aventis Pasteur Classic Five-component Pertussis Vaccine in Combination With Tetanus and Diphtheria Toxoids Adsorbed) When Administered With Other Recommended Vaccines at 2, 4, 6, and 15 to 16 Months of Age.
- ClinicalTrials.gov ID
- NCT00662870
- Acronym / sponsor ID
- P3T06
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Polio, Haemophilus Influenzae Type b
- Keywords
- DAPTACEL, Diphtheria, Tetanus, Whooping Cough, Polio, Haemophilus influenzae type b, Pertussis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,941 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2001
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jan 2004 (actual)
- First posted
- 21 Apr 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.
This study was designed to assess the lot comparability of DAPTACEL, as well as the safety and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines.
Stage I Primary Objectives:
- To assess the lot-comparability of immunogenicity of DAPTACEL by when co-administered with other recommended vaccines.
- To compare the immune response to DTaP-IPV/Hib (Pentacel) with those of three lots of DAPTACEL when co-administered with other recommended vaccines.
- To compare the immune response of PRP-T antigen in Pentacel with that of ActHIB concurrently administered in a different injection site with DAPTACEL when these vaccines are co-administered with other recommended vaccines.
Stage II Primary Objectives:
- To compare the immune response of DAPTACEL when the 4th dose is co-administered with Hib or other infant vaccines.
- To compare the the immune response of Pentacel with those elicited by DAPTACEL when co-administered with ActHIB in toddlers.
Detailed description
This is a two-stage, randomized, multi-center study to assess the safety, immunogenicity and lot comparability of DAPTACEL
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DAPTACEL Lot 1 | Experimental | Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 1 |
| DAPTACEL Lot 2 | Experimental | Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 2 |
| DAPTACEL Lot 3 | Experimental | Biological: DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)Participants receiving Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine (DAPTACEL) Lot 3 |
| Pentacel | Active comparator | Biological: Pentacel: DTaP-IPV/HibParticipants receiving Pentacel vaccine |
Who may qualify
- Ages
- 42 to 84 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy infants 2 months of age.
- Infants with at least 37 weeks of gestation at delivery.
- Signed informed consent from parent or guardian.
- Able to attend the scheduled visits and to comply with the study procedure.
- Subjects must have received the first dose of hepatitis B vaccine from birth to 28 days prior to the first dose of DAPTACEL or Pentacel.
Key exclusion criteria (10 listed)
- Clinically significant findings on review of systems or physical examination (determined by investigator or sub-investigator to be sufficient for exclusion).
- Known or suspected hypersensitivity to any component of the study vaccine to be administered.
- Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
- Known HIV-positive mother.
- Personal or immediate family history of congenital immune deficiency.
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 |
|---|---|---|
| DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine)Also: DAPTACEL®0.5 mL, Intramuscular | Biological | DAPTACEL Lot 1, DAPTACEL Lot 2, DAPTACEL Lot 3 |
| Pentacel: DTaP-IPV/HibAlso: Pentacel0.5 mL, Intramuscular | Biological | Pentacel |
Primary outcome
Immunogenicity: To provide information concerning the immune response of DAPTACEL after vaccination.
Time frame: 30 days post-vaccination 3
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 31 Jan 2012.
- Results publication: PubMed 19117896Guerra FA, Blatter MM, Greenberg DP, Pichichero M, Noriega FR; Pentacel Study Group. Safety and immunogenicity of a pentavalent vaccine compared with separate administration of licensed equivalent vaccines in US infants and toddlers and persistence of antibodies before a preschool booster dose: a randomized, clinical trial. Pediatrics. 2009 Jan;123(1):301-12. doi: 10.1542/peds.2007-3317.
- 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 Monitor study director
Sanofi Pasteur, Inc.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DAPTACEL® (Diphtheria and Tetanus Toxoids and Acellular Pertussis vaccine) and Pentacel: DTaP-IPV/Hib in people with Diphtheria and Tetanus, run by Sanofi at 26 sites 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 5 inclusion and 10 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 31 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites 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.
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?
Immunogenicity: To provide information concerning the immune response of DAPTACEL after vaccination. (time frame: 30 days post-vaccination 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 NCT00662870, 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 31 Jan 2012.