TetanusPhase 3NCT00467519

Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine in Children 4 to 6 Years of Age

A Phase 3 study testing Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis) and DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed) in people with Tetanus and Diphtheria, run by Sanofi Pasteur, a Sanofi Company at 43 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Currently, there is no 5-component acellular pertussis vaccine licensed for the 5th dose in US children aged 4 to 6 years.This study is aimed at providing evidence of sero-protection, booster response and safety of this formulation as a 5th dose. Read more about this study

Who is it for?: Ages 4 to 6 yearsHealthy volunteers can take part
Conditions the study is for: Tetanus, Diphtheria, Pertussis
What is being tested?: Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis) and DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,045 participants
Where: 43 sitesin 2 countries
Study dates: Apr 2007to Dec 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 4 to 6 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy, as determined by medical history and physical examination.
Aged 4 to 6 (< 7) years at the time of study vaccination on Day 0.
Signed and dated informed consent form that has been approved by the Institutional Review Board (IRB) by the parent or legally authorized representative.
Signed and dated informed assent form from the subject if required by the IRB.
Able to attend scheduled visits at Visit 1 and Visit 2 and able to comply with all trial procedures. Subjects will be invited to participate in the long-term immunogenicity follow-up study but a commitment to participate in the long-term is not required as an inclusion criterion.
Documented vaccination history of 4 previous doses of DAPTACEL according to the recommended national immunization schedule for Diphtheria, tetanus and acellular pertussis (DTaP).

Who cannot join

Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
Planned participation in another clinical trial during the original trial period.
Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
Systemic hypersensitivity to any of the vaccine components or history of life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
Chronic illness at a stage that could interfere with trial conduct or completion.
Blood or blood-derived products received in the past 3 months.

Show all 9Show fewer

Receipt of any other vaccine within 30 days prior to study vaccination, or planning to receive another vaccine within 30 days before the Visit 2 blood draw (with the exception of the annual influenza vaccine).
History of diphtheria, tetanus or pertussis infection (confirmed either serologically or microbiologically).
Thrombocytopenia or bleeding disorder contraindicating intra muscular vaccination.

Trial locations and contacts

43 sites in 2 countries.

Country

City, postcode or hospital

43 sites in 2 countries

United States42 sites

Study site
Bardstown, Kentucky, 40004
Study site
Bellevue, Nebraska, 68123
Study site
Birmingham, Alabama, 35205
Study site
Birmingham, Alabama, 35244
Study site
Bossier City, Louisiana, 71111
Study site
Chesapeake, Virginia, 23321
Study site
Cleveland, Ohio, 44121
Study site
Crestview Hills, Kentucky, 41017
Study site
Erie, Pennsylvania, 16505
Study site
Fargo, North Dakota, 58103
Study site
Fayetteville, Arkansas, 72703
Study site
Fountain Valley, California, 92708
Study site
Frederick, Maryland, 21702
Study site
Gresham, Oregon, 97030
Study site
Huntington Beach, California, 92647
Study site
Jonesboro, Arkansas, 72401
Study site
Kingsport, Tennessee, 37660
Study site
La Crosse, Wisconsin, 54601
Study site
Layton, Utah, 84041
Study site
Little Rock, Arkansas, 72205
Study site
Louisville, Kentucky, 40291
Study site
Marietta, Georgia, 30062
Study site
Midlothian, Virginia, 23113
Study site
Norristown, Pennsylvania, 19401
Study site
Norwich, Connecticut, 06360
Study site
Oakland, California, 94611
Study site
Omaha, Nebraska, 68124
Study site
Omaha, Nebraska, 68131
Study site
Omaha, Nebraska, 68132
Study site
Pittsburgh, Pennsylvania, 15236
Study site
Pittsburgh, Pennsylvania, 15241
Study site
Rochester, New York, 14618
Study site
Roseville, California, 95661
Study site
Rydal, Pennsylvania, 19046
Study site
Sacramento, California, 95815
Study site
San Antonio, Texas, 78229
Study site
Spokane, Washington, 99202
Study site
Spokane, Washington, 99218
Study site
Springville, Utah, 84663
Study site
Tullahoma, Tennessee, 37388
Study site
Uniontown, Pennsylvania, 15401
Study site
Woodstock, Georgia, 30189

Other trials in United States

Canada1 site

Study site
Edmonton, Alberta, T6G 2C8

Other trials in Canada

About this study

Official title: Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine as Fifth Dose Booster in Children 4 to 6 Years of Age

Primary Objective:

To compare the immune responses of Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) Vaccine to Diphtheria, tetanus and acellular pertussis (DTaP) vaccine (all antigens) when each is administered as a 5th dose and given concurrently, to children aged 4 to 6 years.

Secondary/Observational Objectives:

To compare the immune responses for pertussis antigens of Tdap Vaccine to DTaP vaccine (for pertussis antigens) when each is administered as a 5th dose and given concurrently, to children aged 4 to 6 years.
To present the long-term immunogenicity at 1-, 3-, and 5-years post-vaccination after each long-term follow-up.
To describe the safety profile following vaccine administration.

Conditions: Tetanus, Diphtheria, Pertussis
Being tested: Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis), DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)
Keywords: Tetanus; Diphtheria; Pertussis; ADACEL; DAPTACEL
Medical subject headings: Tetanus, Diphtheria, Whooping Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)Biological
Also called Adacel
0.5 mL, IM
DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)Biological
Also called DAPTACEL in the US, TRIPACEL in Canada
0.5 mL, IM

Study groups in NCT00467519
Study group	Role	What they receive
Group 1	Experimental	DAPTACEL primed participants Receives: Biological: Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)
Group 2	Experimental	Pentacel primed participants Receives: Biological: DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level
Seroprotection rate at level ≥ 0.1 IU/mL was defined as antibody concentrations ≥ 0.1 IU/mL.
Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA).
Measured: Pre-dose and 30 days post-vaccination
Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL
Serothreshold rate at level ≥ 1.0 IU/mL was defined as antibody concentrations ≥ 1.0 IU/mL.
Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA).
Measured: Pre-dose and 30 days post-vaccination
Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis
Booster response was defined as post titer ≥ 0.4 IU/mL and pre-titer < 0.1 IU/mL, or Post/Pre titer ≥ 4 increase and pre titer ≥ 0.1 IU/mL but < 2 IU/mL, or Post/Pre titer ≥ 2 increase and pre-titer ≥ 2 IU/mL
Post-vaccination titers for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).
Measured: 30 Days post-vaccination
Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus
Booster response was defined as post titer ≥ 0.4 IU/mL and pre titer < 0.1 IU/mL, or Post/Pre titer ≥ 4 increase and pre-titer ≥ 0.1 IU/mL but < 2 IU/mL, or Post/Pre titer ≥ 2 increase and pre-titer ≥ 2 IU/mL.
Post-vaccination titers for Diphtheria was determined by neutralization assay; tetanus titers was determined by an enzyme-linked immunosorbent assay (ELISA).
Measured: 30 Days post-vaccination
Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis
Pre- and post-vaccination GMTs and their 95% confidence intervals for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).
Measured: Pre-dose and 30 Days Post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007Dec 2009

First posted30 Apr 2007 (estimated)
Study startApr 2007
Primary completionNov 2009
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for TetanusStudies 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: 1,045 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00467519
Sponsor's protocol ID: TD517
Status last verified: Jan 2014
First submitted: 27 Apr 2007
Last updated: 7 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Lm-LLO-TT and Gemcitabine in Unresectable Pancreatic Ductal Adenocarcinoma
Pancreas Cancer, Duct Cell Adenocarcinoma, Pancreatic Cancer
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 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

All Tetanus trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity of Tdap Vaccine Compared to DTaP Vaccine as Fifth Dose Booster in Children 4 to 6 Years of Age
ClinicalTrials.gov ID: NCT00467519
Acronym / sponsor ID: TD517
Conditions: Tetanus, Diphtheria, Pertussis
Keywords: Tetanus; Diphtheria; Pertussis; ADACEL; DAPTACEL
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,045 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Apr 2007
Primary completion: Nov 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 30 Apr 2007 (estimated)
Results: Posted 3 Dec 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary Objective:

To compare the immune responses of Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) Vaccine to Diphtheria, tetanus and acellular pertussis (DTaP) vaccine (all antigens) when each is administered as a 5th dose and given concurrently, to children aged 4 to 6 years.

Secondary/Observational Objectives:

To compare the immune responses for pertussis antigens of Tdap Vaccine to DTaP vaccine (for pertussis antigens) when each is administered as a 5th dose and given concurrently, to children aged 4 to 6 years.
To present the long-term immunogenicity at 1-, 3-, and 5-years post-vaccination after each long-term follow-up.
To describe the safety profile following vaccine administration.

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: Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)DAPTACEL primed participants
Group 2	Experimental	Biological: DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)Pentacel primed participants

Who may qualify

Ages: 4 to 6 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

Healthy, as determined by medical history and physical examination.
Aged 4 to 6 (< 7) years at the time of study vaccination on Day 0.
Signed and dated informed consent form that has been approved by the Institutional Review Board (IRB) by the parent or legally authorized representative.
Signed and dated informed assent form from the subject if required by the IRB.
Able to attend scheduled visits at Visit 1 and Visit 2 and able to comply with all trial procedures. Subjects will be invited to participate in the long-term immunogenicity follow-up study but a commitment to participate in the long-term is not required as an inclusion criterion.

Key exclusion criteria (9 listed)

Participation in another clinical trial in the 4 weeks preceding the trial vaccination.
Planned participation in another clinical trial during the original trial period.
Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
Systemic hypersensitivity to any of the vaccine components or history of life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
Chronic illness at a stage 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
Tdap (Tetanus Toxoid Reduced Diphtheria Toxoid/Acellular Pertussis)Also: Adacel0.5 mL, IM	Biological	Group 1
DTaP (Diphtheria & Tetanus Toxoids & Acellular Pertussis Adsorbed)Also: DAPTACEL in the US, TRIPACEL in Canada0.5 mL, IM	Biological	Group 2

Primary outcome

Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level
Time frame: Pre-dose and 30 days post-vaccination
Seroprotection rate at level ≥ 0.1 IU/mL was defined as antibody concentrations ≥ 0.1 IU/mL. Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA).
Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL
Time frame: Pre-dose and 30 days post-vaccination
Serothreshold rate at level ≥ 1.0 IU/mL was defined as antibody concentrations ≥ 1.0 IU/mL. Diphtheria titers were determined by toxin neutralization assay; tetanus titers were determined by enzyme-linked immunosorbent assay (ELISA).
Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis
Time frame: 30 Days post-vaccination
Booster response was defined as post titer ≥ 0.4 IU/mL and pre-titer < 0.1 IU/mL, or Post/Pre titer ≥ 4 increase and pre titer ≥ 0.1 IU/mL but < 2 IU/mL, or Post/Pre titer ≥ 2 increase and pre-titer ≥ 2 IU/mL Post-vaccination titers for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).
Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus
Time frame: 30 Days post-vaccination
Booster response was defined as post titer ≥ 0.4 IU/mL and pre titer < 0.1 IU/mL, or Post/Pre titer ≥ 4 increase and pre-titer ≥ 0.1 IU/mL but < 2 IU/mL, or Post/Pre titer ≥ 2 increase and pre-titer ≥ 2 IU/mL. Post-vaccination titers for Diphtheria was determined by neutralization assay; tetanus titers was determined by an enzyme-linked immunosorbent assay (ELISA).
Geometric Mean Titers (GMTs) at Baseline and 30 Days Post Vaccination for Pertussis
Time frame: Pre-dose and 30 Days Post-vaccination
Pre- and post-vaccination GMTs and their 95% confidence intervals for pertussis toxoid (PT), pertussis filamentous hemagglutinin (FHA), pertussis pertactin (PRN), and pertussis Fimbriae types 2 and 3 (FIM), were determined by enzyme-linked immunosorbent assay (ELISA).

Results and safety

Results posted to the registry on 3 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tdap Vaccine Group	531	517
DTaP Vaccine Group	511	488

Primary outcome: Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level

Time frame: Pre-dose and 30 days post-vaccination. Number. Unit: Percentage of Participants

Measure	Tdap Vaccine Group n = 442	DTaP Vaccine Group n = 426
Diphtheria (IU/mL), Pre-dose [n = 442, 425]	65	69
Diphtheria (IU/mL), Post-dose [n = 442, 426]	100	100
Tetanus (IU/mL), Pre-dose [n = 442, 426]	81	85
Tetanus (IU/mL), Post-dose [n = 442, 426]	100	100

Population analysed: Diphtheria and tetanus antibody analysis was in all enrolled and vaccinated participants in the per-protocol population.

Primary outcome: Percentage of Participants Who Achieved Serothreshold at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at Level ≥ 1.0 IU/mL

Time frame: Pre-dose and 30 days post-vaccination. Number. Unit: Percentage of Participants

Measure	Tdap Vaccine Group n = 442	DTaP Vaccine Group n = 426
Diphtheria (IU/mL), Pre-dose	4	7
Diphtheria (IU/mL), Post-dose	99	100
Tetanus (IU/mL), Pre-dose	11	12
Tetanus (IU/mL), Post-dose	97	98

Population analysed: Diphtheria and tetanus antibody analysis was in all enrolled and vaccinated participants in the per-protocol population.

Primary outcome: Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Pertussis

Time frame: 30 Days post-vaccination. Number. Unit: Percentage of Participants

Measure	Tdap Vaccine Group n = 441	DTaP Vaccine Group n = 423
Pertussis Toxoid (EU/mL) [n = 401, 387]	88	94
Filamentous Haemagglutinin (EU/mL) [n = 432, 407]	92	89
Pertactin (EU/mL) [n = 441, 423]	92	95
Fimbriae types 2 and 3 (EU/mL) [n = 432, 418]	95	94

Population analysed: Pertussis antibody booster response analysis was in all enrolled and vaccinated participants in the per-protocol population.

Primary outcome: Percentage of Participants Who Demonstrated Booster Response at 30 Days Post-Vaccination for Diphtheria and Tetanus

Time frame: 30 Days post-vaccination. Number. Unit: Percentage of Participants

Measure	Tdap Vaccine Group n = 442	DTaP Vaccine Group n = 426
Diphtheria (IU/mL) [n = 442, 425]	99	99
Tetanus (IU/mL) [n = 442, 426]	98	97

Population analysed: Diphtheria and tetanus antibody booster response were analysed in all enrolled and vaccinated participants, per-protocol population.

Adverse events

Time frame: Adverse event data were collected from the day of vaccination to 6 months post-vaccination.. Other adverse events reported at 5.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tdap Vaccine Group	4 of 531 (0.8%)	318 of 531 (59.9%)	Not reported
DTaP Vaccine Group	5 of 511 (1%)	353 of 511 (69.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Tetanus

RecruitingPhase 1
Lm-LLO-TT and Gemcitabine in Unresectable Pancreatic Ductal Adenocarcinoma
Pancreas Cancer, Duct Cell Adenocarcinoma, Pancreatic Cancer
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 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

43 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 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 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States, 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 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?

Yes. Results are posted in the registry (first posted 3 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Who Achieved Seroprotection at Baseline and 30 Days Post-vaccination for Diphtheria and Tetanus at ≥ 0.1 IU/mL Level (time frame: Pre-dose and 30 days post-vaccination). The study lists 5 primary outcomes in all. 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 NCT00467519.

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 Feb 2014.