DiphtheriaPhase 3NCT00303316

Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months in Healthy Argentinean Infants

A Phase 3 study testing DTaP-IPV//PRP~T combined vaccine in people with Diphtheria and Tetanus, run by Sanofi at 1 site in Argentina.

Completed

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

Official record

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Trial summary

This study will assess both the antibody persistence of the investigational vaccine and the immune response and safety of a booster dose of PENTAXIM™ vaccine in 18 months-old toddlers who participated in an earlier study in order to determine if they are still protected before they receive a booster dose of D, T, IPV… Read more about this study

Who is it for?: Ages 510 to 578 daysHealthy volunteers can take part
Conditions the study is for: Diphtheria, Tetanus, Pertussis
What is being tested?: DTaP-IPV//PRP~T combined vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 458 participants
Where: 1 siteArgentina
Study dates: Feb 2006to Sep 2007
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 510 to 578 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Toddler at 18 months of age (range: 510 days to 578 days of age inclusive)
Participated in study A3L02 (NCT00831311) and has completed the three-dose primary series with either diphtheria, tetanus, pertussis (2-component acellular), recombinant Hepatitis B Hansenula and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T) or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 months of age
Written informed consent form signed by at least one parent or by a legal representative and an independent witness
Able to attend all scheduled visits and to comply with all trial procedures.

Who cannot join

Participation in another clinical trial in the four weeks preceding the trial vaccination
Planned participation in another clinical trial during the present 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 a life-threatening reaction to 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 last six months

Show all 17Show fewer

Any vaccination in the four weeks preceding the trial
Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, polio, or hepatitis B antigen, since the end of the primary series
History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b, polio, or hepatitis B infection(s) (confirmed either clinically, serologically, or microbiologically)
Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
History of seizures
Fever (axillary temperature ≥37.4°C or equivalent rectal temperature ≥38.0°C) or acute illness on the day of inclusion
Known contraindication to further vaccination with a pertussis vaccine such as:
Encephalopathy; Inconsolable crying for >3 hours within 48 hours following vaccine injection
Hypotonic hyporesponsive episode within 48 hours following vaccine injection
Seizures with or without fever within three days following vaccine injection
Axillary temperature >39.4°C or equivalent rectal temperature > 40.0°C within 48 hours following vaccine injection.

Trial locations and contacts

1 site in 1 country.

Argentina1 site

Study site
Córdoba, Córdoba Province, 5000

Other trials in Argentina

About this study

Official title: Immunogenicity Study of the Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months of Age Following a Primary Series of DTaP-IPV-HB-PRP~T Combined Vaccine or of PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age in Healthy Argentinean Infants

Primary Objective:

To describe the antibody persistence at 18 months of age and the booster effect of a dose of PENTAXIM™ on immunogenicity.

Secondary objective:

To describe the safety profile of the booster dose PENTAXIM™ in each vaccine group defined by the vaccines received during the primary series.

Conditions: Diphtheria, Tetanus, Pertussis, Poliomyelitis, Hepatitis B
Being tested: DTaP-IPV//PRP~T combined vaccine
Keywords: Diphtheria, Tetanus, Pertussis, whooping cough, Haemophilus influenzae type b, Hepatitis B, Poliomyelitis
Medical subject headings: Diphtheria, Tetanus, Whooping Cough, Poliomyelitis, Hepatitis B, Haemophilus Infections

What participants receive

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

DTaP-IPV//PRP~T combined vaccineBiological
Also called PENTAXIM™
0.5 mL, Intramuscular
DTaP-IPV//PRP~T combined vaccineBiological
Also called PENTAXIM™
0.5 mL, Intramuscular

Study groups in NCT00303316
Study group	Role	What they receive
DTacP IPV HepB PRP-T Combined Vaccine Group	Experimental	Participant will receive a booster dose of PENTAXIM™ having received DTacP-IPV-HepB-PRP-T (primary series) in Study A3L02. Receives: Biological: DTaP-IPV//PRP~T combined vaccine
PENTAXIM™ and ENGERIX B® Vaccine Group	Active comparator	Participant will receive a booster dose of PENTAXIM™ having received ENGERIX B® and PEDIATRICO in Study A3L02 (Primary series) Receives: Biological: DTaP-IPV//PRP~T combined vaccine

What is being measured

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

Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Antibody persistence (pre-booster) were defined as titers ≥ 10 mIU/mL for hepatitis B (Hep B;); ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.01 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for polio types 1, 2, and 3; and ≥ 4 EU/mL for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA).
Measured: Day 0 (Before booster vaccination)
Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Booster response were defined as titers ≥ 1.0 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.1 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for Polio types 1, 2, and 3; and for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) ≥ 4 EU/mL and a ≥ 4 fold increase from pre-booster to post-booster value.
Measured: Day 30 Post-booster Vaccination
Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Antibody titers determination:
Hepatitis B (Hep B) by enhanced chemiluminescence assay; Haemophilus influenzae type b (PRP), Tetanus, Pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA); Diphtheria by neutralization test; Poliovirus types 1,2, and 3 by microneutralization assay.
Measured: Day 0 (pre-booster) and Day 30 post-booster

Secondary outcomes (1)

Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.
Grade 3 was defined as: Pain, cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hour or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥ 3 feeds/meals or refuses most feeds/meals; and Irritability, inconsolable.
Measured: Day 0 up to Day 30 post-booster vaccination

Timeline

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

Feb 2006Sep 2007

First posted16 Mar 2006 (estimated)
Study startFeb 2006
Primary completionApr 2007
Study completionSep 2007

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.
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: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 458 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00303316
Sponsor's protocol ID: A3L16
Status last verified: Jan 2013
First submitted: 13 Mar 2006
Last updated: 22 Feb 2013
Results posted: Yes, on ClinicalTrials.gov

Publications

Tregnaghi M, Zambrano B, Santos-Lima E. Antibody persistence after a primary series of a new DTaP-IPV-Hep B-PRP-T combined vaccine or separate DTaP-IPV//PRP-T and hepatitis B vaccines at 2, 4, and 6 months of age and the effect of a subsequent DTaP-IPV//PRP-T booster vaccination at 18 months of age in healthy Argentinean infants. Pediatr Infect Dis J. 2012 Jan;31(1):e24-30. doi: 10.1097/INF.0b013e318242460a.
PubMed 22157567

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 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity Study of the Antibody Persistence and Booster Effect of PENTAXIM™ at 18 Months of Age Following a Primary Series of DTaP-IPV-HB-PRP~T Combined Vaccine or of PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age in Healthy Argentinean Infants
ClinicalTrials.gov ID: NCT00303316
Acronym / sponsor ID: A3L16
Conditions: Diphtheria, Tetanus, Pertussis, Poliomyelitis, Hepatitis B
Keywords: Diphtheria, Tetanus, Pertussis, whooping cough, Haemophilus influenzae type b, Hepatitis B, Poliomyelitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 458 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: Feb 2006
Primary completion: Apr 2007 (actual)
Study completion: Sep 2007 (actual)
First posted: 16 Mar 2006 (estimated)
Results: Posted 22 Feb 2013

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 describe the antibody persistence at 18 months of age and the booster effect of a dose of PENTAXIM™ on immunogenicity.

Secondary objective:

To describe the safety profile of the booster dose PENTAXIM™ in each vaccine group defined by the vaccines received during the primary series.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
DTacP IPV HepB PRP-T Combined Vaccine Group	Experimental	Biological: DTaP-IPV//PRP~T combined vaccineParticipant will receive a booster dose of PENTAXIM™ having received DTacP-IPV-HepB-PRP-T (primary series) in Study A3L02.
PENTAXIM™ and ENGERIX B® Vaccine Group	Active comparator	Biological: DTaP-IPV//PRP~T combined vaccineParticipant will receive a booster dose of PENTAXIM™ having received ENGERIX B® and PEDIATRICO in Study A3L02 (Primary series)

Who may qualify

Ages: 510 to 578 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Toddler at 18 months of age (range: 510 days to 578 days of age inclusive)
Participated in study A3L02 (NCT00831311) and has completed the three-dose primary series with either diphtheria, tetanus, pertussis (2-component acellular), recombinant Hepatitis B Hansenula and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T) or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 months of age
Written informed consent form signed by at least one parent or by a legal representative and an independent witness
Able to attend all scheduled visits and to comply with all trial procedures.

Key exclusion criteria (17 listed)

Participation in another clinical trial in the four weeks preceding the trial vaccination
Planned participation in another clinical trial during the present 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 a life-threatening reaction to 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
DTaP-IPV//PRP~T combined vaccineAlso: PENTAXIM™0.5 mL, Intramuscular	Biological	DTacP IPV HepB PRP-T Combined Vaccine Group
DTaP-IPV//PRP~T combined vaccineAlso: PENTAXIM™0.5 mL, Intramuscular	Biological	PENTAXIM™ and ENGERIX B® Vaccine Group

Primary outcome

Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Time frame: Day 0 (Before booster vaccination)
Antibody persistence (pre-booster) were defined as titers ≥ 10 mIU/mL for hepatitis B (Hep B;); ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.01 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for polio types 1, 2, and 3; and ≥ 4 EU/mL for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA).
Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Time frame: Day 30 Post-booster Vaccination
Booster response were defined as titers ≥ 1.0 µg/mL for Haemophilus influenzae type b (PRP); ≥ 0.1 IU/mL for Diphtheria and Tetanus; ≥ 8 (1/dil) for Polio types 1, 2, and 3; and for Pertussis Toxoid (PT) and Filamentous Hemagglutinin (FHA) ≥ 4 EU/mL and a ≥ 4 fold increase from pre-booster to post-booster value.
Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.
Time frame: Day 0 (pre-booster) and Day 30 post-booster
Antibody titers determination: Hepatitis B (Hep B) by enhanced chemiluminescence assay; Haemophilus influenzae type b (PRP), Tetanus, Pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA); Diphtheria by neutralization test; Poliovirus types 1,2, and 3 by microneutralization assay.

1 secondary outcome

Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Post-booster Vaccination With PENTAXIM™
Time frame: Day 0 up to Day 30 post-booster vaccination

Results and safety

Results posted to the registry on 22 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DTacP-IPV-Hep B-PRP~T Group	232	230
PENTAXIM™ and ENGERIX B® Group	226	223

Primary outcome: Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.

Time frame: Day 0 (Before booster vaccination). Number. Unit: Participants

Measure	DTacP-IPV-Hep B-PRP~T Group n = 232	PENTAXIM™ and ENGERIX B® Group n = 226
Anti-Hepatitis B (N = 228, 222)	195	221
Anti-PRP (N = 224, 217)	171	164
Anti-Diphtheria (N = 228, 221)	169	165
Anti-Tetanus (N = 229, 216)	229	216
Anti-Polio 1 (N = 214, 205)	213	205
Anti-Polio 2 (N = 217, 204)	215	203
Anti-Polio 3 (N = 214, 203)	205	199
Anti-Pertussis Toxoid (N= 216, 212)	190	190

Population analysed: Antibody Persistence was assessed in all enrolled participants with pre-booster vaccination data (Intent-to-Treat population).

Primary outcome: Summary of Booster Response in Participants at 18 Months of Age Following Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.

Time frame: Day 30 Post-booster Vaccination. Number. Unit: Participants

Measure	DTacP-IPV-Hep B-PRP~T Group n = 232	PENTAXIM™ and ENGERIX B® Group n = 226
Anti-PRP (N = 223, 216)	220	215
Anti-Diphtheria (N = 225, 221)	216	214
Anti-Tetanus (N = 222, 219)	222	219
Anti-Polio 1 (N = 211, 209)	211	209
Anti-Polio 2 (N = 208, 210)	208	210
Anti-Polio 3 (N = 205, 205)	205	205
Anti-Pertussis Toxoid (N = 226, 220)	226	220
Anti-Pertussis Toxoid (4-Fold Rise: N = 211, 208)	202	199

Population analysed: Booster responses were assessed in all vaccinated participants with endpoint data following the booster vaccination (Intent-to-Treat population).

Primary outcome: Geometric Mean Titers (GMTs) of Antibodies Before and After Booster Vaccination With PENTAXIM™ Following a Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age.

Time frame: Day 0 (pre-booster) and Day 30 post-booster. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	DTacP-IPV-Hep B-PRP~T Group n = 232	PENTAXIM™ and ENGERIX B® Group n = 226
Anti-Hepatitis B Pre-booster (N = 228, 222)	87.6 (69.2 to 111)	197 (168 to 230)
Anti-PRP Pre-booster (N = 224, 217)	0.399 (0.327 to 0.487)	0.326 (0.270 to 0.394)
Anti-PRP Post-booster (N = 223, 216)	27.4 (23.0 to 32.7)	41.4 (35.0 to 48.8)
Anti-Diphtheria Pre-booster (N = 228, 221)	0.022 (0.018 to 0.027)	0.018 (0.015 to 0.022)
Anti-Diphtheria Post-booster (N = 225, 221)	1.92 (1.58 to 2.32)	2.11 (1.74 to 2.56)
Anti-Tetanus Pre-booster (N = 229, 216)	0.287 (0.255 to 0.325)	0.171 (0.153 to 0.192)
Anti-Tetanus Post-booster (N = 222, 219)	4.81 (4.37 to 5.31)	4.54 (4.07 to 5.08)
Anti-Polio 1 Pre-booster (N= 214, 205)	303 (251 to 365)	232 (193 to 279)

Population analysed: Geometric mean titers were assessed in all participants with endpoint data who received the booster vaccine (Intent-to-Treat Analysis Set for immunogenicity).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events data were collected from Day 0 (before booster vaccination) up to Day 30 post-booster vaccination in the Safety Analysis Set population.. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DTacP-IPV-Hep B-PRP~T Group	3 of 231 (1.3%)	134 of 231 (58%)	Not reported
PENTAXIM™ and ENGERIX B® Group	1 of 223 (0.4%)	137 of 223 (61.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22157567Tregnaghi M, Zambrano B, Santos-Lima E. Antibody persistence after a primary series of a new DTaP-IPV-Hep B-PRP-T combined vaccine or separate DTaP-IPV//PRP-T and hepatitis B vaccines at 2, 4, and 6 months of age and the effect of a subsequent DTaP-IPV//PRP-T booster vaccination at 18 months of age in healthy Argentinean infants. Pediatr Infect Dis J. 2012 Jan;31(1):e24-30. doi: 10.1097/INF.0b013e318242460a.
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.

Clinical Trials study director

Sanofi Pasteur, a Sanofi Company

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 DTaP-IPV//PRP~T combined vaccine in people with Diphtheria and Tetanus, run by Sanofi at 1 site in Argentina.

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 4 inclusion and 17 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 22 Feb 2013. 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 Argentina. 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 22 Feb 2013). 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?

Summary of Antibody Persistence at 18 Months of Age in Participants That Received Primary Series Vaccination of Either DTaP-IPV-HepB-PRP~T or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age. (time frame: Day 0 (Before booster vaccination)). The study lists 3 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 NCT00303316, 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 22 Feb 2013.