DiphtheriaPhase 3NCT00797511

Immunogenicity and Safety of Adacel Polio Vaccine

A Phase 3 study testing TdcP-IPV vaccine in people with Diphtheria and Tetanus, run by Sanofi at 1 site in Taiwan.

Completed

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

Trial summary

The present study is designed to meet the requirements of the Taiwanese Health Authorities for registration of ADACEL POLIO in Taiwan. Subjects will receive one dose of the study vaccine at 6 to 8 years of age. Blood samples will be taken for antibody titration. Read more about this study

Who is it for?: Ages 6 to 8 yearsHealthy volunteers can take part
Conditions the study is for: Diphtheria, Tetanus, Pertussis
What is being tested?: TdcP-IPV vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 132 participants
Where: 1 siteTaiwan
Study dates: Nov 2008to Jul 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 6 to 8 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Aged 6 to 8 years on the day of inclusion
Informed consent form signed by the parent(s) or another legally acceptable representative
Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
Written documentation of complete primary series and fourth dose of diphtheria, tetanus, pertussis (DTP) and Polio vaccines
Parent(s)/legal representative present or fully completed pre-inclusion medical questionnaire.

Who cannot join

Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination
Planned participation in another clinical trial during the present trial period
Known or suspected 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
Known systemic hypersensitivity to any of the vaccine components (or residues carried over from manufacture, such as formaldehyde, glutaraldehyde, streptomycin, neomycin and polymyxin B ) or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances with specific focus on subjects who had, after previous administration of DTP vaccine, one of the pre-listed adverse events.
Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy

Show all 16Show fewer

Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response
Receipt of any vaccine in the 4 weeks preceding the trial vaccination
Planned receipt of any vaccine in the 4 weeks following the trial vaccination
Known Human Immunodeficiency Virus (HIV), Hepatitis B surface (HBs) antigen, or Hepatitis C seropositivity
History of diphtheria and/or tetanus and/or pertussis and/or poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
Previous fifth vaccination against diphtheria and/or tetanus and/or pertussis and/or poliomyelitis diseases with either the trial vaccine or another vaccine
Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular (IM) vaccination
Subject at high risk for diphtheria and/or tetanus and/or pertussis and/or poliomyelitis infection during the trial
Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw
Febrile illness (temperature ≥ 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Study site
Taipei, Taipei, 100

Other trials in Taiwan

About this study

Official title: Immunogenicity and Safety of ADACEL POLIO (TdcP-IPV Vaccine) Administered at 6 to 8 Years of Age as a Fifth Dose in Healthy Children in Taiwan

The present study is designed to meet the requirements of the Taiwanese Health Authorities for registration of ADACEL POLIO in Taiwan.

Subjects will receive one dose of the study vaccine at 6 to 8 years of age. Blood samples will be taken for antibody titration. The expected total duration of follow-up for each subject will be 28 days.

Conditions: Diphtheria, Tetanus, Pertussis, Poliomyelitis
Being tested: TdcP-IPV vaccine
Keywords: Diphtheria, Tetanus, Pertussis, Poliomyelitis
Medical subject headings: Diphtheria, Tetanus, Whooping Cough, Poliomyelitis

What participants receive

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

TdcP-IPV vaccineBiological
Also called ADACEL POLIO
0.5 mL, Intramuscular

Study groups in NCT00797511
Study group	Role	What they receive
Study Group	Experimental	Participants will receive one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0 Receives: Biological: TdcP-IPV vaccine

What is being measured

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

Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
Diphtheria concentrations determined by diphtheria toxin neutralization assay (Dip SN); Tetanus concentrations determined by enzyme-linked immunosorbent assay (ELISA).
Seroprotection titer levels were defined as: Anti-diphtheria antibody titers ≥0.1 international unit (IU) per milliliter (mL); Anti-tetanus antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL; Anti-Polio (≥ 8 1/dilution).
Measured: Day 28 post-vaccination
Number of Participants With Booster Response to Vaccine Pertussis Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
The anti-Pertussis concentration were determined by ELISA. The criteria for demonstrating booster response are: (i) Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) for each anti-pertussis antibody (PT, FHA, FIM, and PRN) but a post-vaccination levels ≥ 4 x LLOQ; or (ii) Pre-vaccination antibody concentrations ≥ LLOQ but < 4 x LLOQ with a 4-fold rise rate; or (iii) Pre-vaccination antibody concentrations ≥ 4 x LLOQ but with a 2-fold rise rate.
Measured: Day 28 post-vaccination
Geometric Mean Titers (GMTs) of Antibodies to ADACEL Polio Vaccine Antigens Following Vaccination
Diphtheria antibody concentrations determined by diphtheria toxin neutralization assay; Tetanus antibody concentrations determined by enzyme-linked immunosorbent assay (ELISA).
Measured: Day 28 post-vaccination
Geometric Mean Titers of Antibodies to Pertussis Antigens Following Vaccination With ADACEL Polio
Pre- and post-vaccination GMTs for the Pertussis toxoid (PT), Pertussis filamentous hemagglutinin (FHA), Pertussis pertactin (PRN), and Pertussis Fimbriae types 2 and 3 (FIM), all determined by enzyme-linked immunosorbent assay (ELISA).
Measured: Day 0 (pre-vaccination) and Day 28 post-vaccination

Secondary outcomes (1)

Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
Solicited Injection Site Reactions: Pain, Erythema/redness, Swelling, and Extensive swelling of vaccinated limb. Solicited Systemic Reactions: Fever (temperature ≥ 37.5ºC), Headache, Malaise, and Myalgia.
Measured: Day 0 up to Day 7 post-vaccination

Timeline

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

Nov 2008Jul 2009

First posted25 Nov 2008 (estimated)
Study startNov 2008
Primary completionApr 2009
Study completionJul 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 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 132 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00797511
Sponsor's protocol ID: TD525
Status last verified: Oct 2012
First submitted: 24 Nov 2008
Last updated: 26 Nov 2012
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 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
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
Diphtheria-Tetanus-acellular Pertussis Vaccines

All Diphtheria trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety of ADACEL POLIO (TdcP-IPV Vaccine) Administered at 6 to 8 Years of Age as a Fifth Dose in Healthy Children in Taiwan
ClinicalTrials.gov ID: NCT00797511
Acronym / sponsor ID: TD525
Conditions: Diphtheria, Tetanus, Pertussis, Poliomyelitis
Keywords: Diphtheria, Tetanus, Pertussis, Poliomyelitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 132 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Apr 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 25 Nov 2008 (estimated)
Results: Posted 26 Nov 2012

Clinical summary

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

The present study is designed to meet the requirements of the Taiwanese Health Authorities for registration of ADACEL POLIO in Taiwan.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Study Group	Experimental	Biological: TdcP-IPV vaccineParticipants will receive one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0

Who may qualify

Ages: 6 to 8 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Aged 6 to 8 years on the day of inclusion
Informed consent form signed by the parent(s) or another legally acceptable representative
Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
Written documentation of complete primary series and fourth dose of diphtheria, tetanus, pertussis (DTP) and Polio vaccines
Parent(s)/legal representative present or fully completed pre-inclusion medical questionnaire.

Key exclusion criteria (16 listed)

Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination
Planned participation in another clinical trial during the present trial period
Known or suspected 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
Known systemic hypersensitivity to any of the vaccine components (or residues carried over from manufacture, such as formaldehyde, glutaraldehyde, streptomycin, neomycin and polymyxin B ) or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances with specific focus on subjects who had, after previous administration of DTP vaccine, one of the pre-listed adverse events.
Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator

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
TdcP-IPV vaccineAlso: ADACEL POLIO0.5 mL, Intramuscular	Biological	Study Group

Primary outcome

Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
Time frame: Day 28 post-vaccination
Diphtheria concentrations determined by diphtheria toxin neutralization assay (Dip SN); Tetanus concentrations determined by enzyme-linked immunosorbent assay (ELISA). Seroprotection titer levels were defined as: Anti-diphtheria antibody titers ≥0.1 international unit (IU) per milliliter (mL); Anti-tetanus antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL; Anti-Polio (≥ 8 1/dilution).
Number of Participants With Booster Response to Vaccine Pertussis Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.
Time frame: Day 28 post-vaccination
The anti-Pertussis concentration were determined by ELISA. The criteria for demonstrating booster response are: (i) Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) for each anti-pertussis antibody (PT, FHA, FIM, and PRN) but a post-vaccination levels ≥ 4 x LLOQ; or (ii) Pre-vaccination antibody concentrations ≥ LLOQ but < 4 x LLOQ with a 4-fold rise rate; or (iii) Pre-vaccination antibody concentrations ≥ 4 x LLOQ but with a 2-fold rise rate.
Geometric Mean Titers (GMTs) of Antibodies to ADACEL Polio Vaccine Antigens Following Vaccination
Time frame: Day 28 post-vaccination
Diphtheria antibody concentrations determined by diphtheria toxin neutralization assay; Tetanus antibody concentrations determined by enzyme-linked immunosorbent assay (ELISA).
Geometric Mean Titers of Antibodies to Pertussis Antigens Following Vaccination With ADACEL Polio
Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
Pre- and post-vaccination GMTs for the Pertussis toxoid (PT), Pertussis filamentous hemagglutinin (FHA), Pertussis pertactin (PRN), and Pertussis Fimbriae types 2 and 3 (FIM), all determined by enzyme-linked immunosorbent assay (ELISA).

1 secondary outcome

Number of Participants Reporting at Least 1 Solicited Injection Site or Systemic Reaction Post-vaccination With ADACEL Polio Vaccine
Time frame: Day 0 up to Day 7 post-vaccination

Results and safety

Results posted to the registry on 26 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ADACEL POLIO Vaccine Study Group	132	131

Primary outcome: Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.

Time frame: Day 28 post-vaccination. Number. Unit: Participants

Measure	ADACEL POLIO Vaccine Study Group n = 131
Anti-Diphtheria (Post-vaccination)	131
Anti-Tetanus (Post-vaccination)	131
Anti-Polio 1 (Post-vaccination)	131
Anti-Polio 2 (Post-vaccination)	131
Anti-Polio 3 (Post-vaccination)	131

Population analysed: Anti-tetanus and anti-diphtheria concentrations were assessed in the per-protocol population.

Primary outcome: Number of Participants With Booster Response to Vaccine Pertussis Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine.

Time frame: Day 28 post-vaccination. Number. Unit: Participants

Measure	ADACEL POLIO Vaccine Study Group n = 131
Anti-Pertussis (N = 114)	88
Anti-Filamentous Hemagglutinin (N = 130)	126
Anti-Fimbriae types 2 and 3 (N = 130)	116
Anti-Pertactin (N = 131)	130

Population analysed: Anti-Pertussis concentrations were assessed in the per-protocol population.

Primary outcome: Geometric Mean Titers (GMTs) of Antibodies to ADACEL Polio Vaccine Antigens Following Vaccination

Time frame: Day 28 post-vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	ADACEL POLIO Vaccine Study Group n = 131
Anti-Diphtheria (Post-vaccination)	3.81 (3.25 to 4.46)
Anti-Tetanus (Post-vaccination)	17.2 (14.8 to 20.0)
Anti-Polio 1 (Post-vaccination)	9627 (7960 to 11642)
Anti-Polio 2 (Post-vaccination)	7083 (6057 to 8282)
Anti-Polio 3 (Post-vaccination)	9860 (8244 to 11793)

Population analysed: Geometric mean titers were assessed in the per-protocol population.

Primary outcome: Geometric Mean Titers of Antibodies to Pertussis Antigens Following Vaccination With ADACEL Polio

Time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	ADACEL POLIO Vaccine Study Group n = 131
Anti-Pertussis Toxoid (Pre-vaccination)	4.53 (3.81 to 5.39)
Anti-Pertussis Toxoid (Post-vaccination)	42.7 (36.1 to 50.3)
Anti-Filamentous hemagglutinin (Pre-vaccination)	19.7 (16.4 to 23.7)
Anti-Filamentous hemagglutinin (Post-vaccination)	164 (145 to 185)
Anti-Fimbriae types 2 and 3 (Pre-vaccination)	17.5 (12.8 to 24.0)
Anti-Fimbriae types 2 and 3 (Post-vaccination)	423 (291 to 614)
Anti-Pertactin (Pre-vaccination)	11.9 (9.92 to 14.3)
Anti-Pertactin (Post-vaccination)	314 (263 to 376)

Population analysed: Geometric mean titers to the vaccine Pertussis antigens were assessed in the per-protocol population.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events data were collected from following vaccination (Day 0) for up to 1 month post-vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ADACEL POLIO Vaccine Study Group	2 of 132 (1.5%)	102 of 132 (77.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Diphtheria

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
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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)
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Active, not recruitingPhase 3
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
Diphtheria-Tetanus-acellular Pertussis Vaccines

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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TdcP-IPV vaccine in people with Diphtheria and Tetanus, run by Sanofi at 1 site in Taiwan.

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 16 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 26 Nov 2012. 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 Taiwan. 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 26 Nov 2012). 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?

Number of Participants With Seroprotection to Vaccine Antigens Following Vaccination With ADACEL Polio (TdcP-IPV) Vaccine. (time frame: Day 28 post-vaccination). The study lists 4 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 NCT00797511.

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 26 Nov 2012.