DiphtheriaPhase 2NCT00831311

Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants

A Phase 2 study testing DTaP-IPV-HB-PRP~T and DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company 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

Search all trials

Trial summary

Primary Objective: To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP~T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary series. Read more about this study

Who is it for?: Ages 50 to 70 daysHealthy volunteers can take part
Conditions the study is for: Diphtheria, Tetanus, Pertussis
What is being tested?: DTaP-IPV-HB-PRP~T and DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 624 participants
Where: 1 siteArgentina
Study dates: Oct 2004to Mar 2007
Phase: Phase 2
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 50 to 70 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Infant of either gender, aged 50 to 70 days inclusive
Mother is negative for HBsAg
Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg
Written informed consent form signed by at least one parent or by another legal representative and an independent witness
Parent/legal representative able to attend scheduled visits and to comply with the trial procedures during the entire duration of the trial.

Who cannot join

Axillary temperature ≥37.1°C on the day of inclusion
Current or planned enrolment in another clinical trial during the clinical trial period
Known mother's history of Human Immunodeficiency Virus (HIV) infection
Known immunodeficiency (congenital or acquired) or induced by immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth, or systemic corticosteroids in the last 4 weeks (≥0.5 mg per kilogram and per day equivalent prednisolone and lasting more than 7 days)
Receipt of blood-derived products since birth
Acute symptoms or severe chronic illness (e.g. cardiac, renal insufficiency, diabetes, auto immune disorders, congenital defect) that may interfere with conduct or completion of trial

Show all 12Show fewer

Occurrence of seizures since birth
Hypersensitivity to any of the vaccine components
Coagulopathy contraindicating intramuscular injection
History of (documented) clinical or serological/microbiological confirmed infection due to pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b (Hib) or hepatitis B (HB) diseases
History of vaccination against pertussis, tetanus, diphtheria, polio, Hib or HB infections
Vaccination within the last 4 weeks.

Trial locations and contacts

1 site in 1 country.

Argentina1 site

Study site
Córdoba

Other trials in Argentina

About this study

Official title: Phase-II Immunogenicity Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age in Healthy Argentinean Infants

Primary Objective:

To demonstrate that the immune response of the DTaP-IPV-Hep B-PRP~T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary series.

Secondary Objectives:

To describe in each group the immunogenicity parameters one month after the three-dose primary series.
To describe safety profile after each vaccination in both groups.

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

What participants receive

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

DTaP-IPV-HB-PRP~TBiological
0.5 mL, Intramuscular
DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccineBiological
Also called PENTAXIM™, ENGERIX B® PEDIATRICO
0.5 mL, Intramuscular (right and left thighs, respectively)

Study groups in NCT00831311
Study group	Role	What they receive
1	Experimental	DTaP IPV HB-PRP~T vaccine group Receives: Biological: DTaP-IPV-HB-PRP~T
2	Active comparator	PENTAXIM™ and ENGERIX B® vaccines group Receives: Biological: DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccine

What is being measured

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

Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Seroconversion was assessed by means of enzyme immunoassay (EIA) for anti-pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies. Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination.
Measured: 1 month post last vaccination
Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Immunogenicity was assessed by radioimmunoassay (RIA) for anti-hepatitis B (HBs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-tetanus, serum neutralization (SN) for anti-diphtheria, and microneutralization for anti-polio type 1, 2, and 3 antibodies.
Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hepatitis Bs, ≥ 0.15 μg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-tetanus and anti-diphtheria, and ≥ 8 1/dil for anti-polio types 1, 2, and 3 at 30 days after the third vaccination.
Measured: Day 150 (1 month post-vaccination 3)
Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Geometric mean titers to Tetanus antigen was assessed by means of enzyme immunoassay (EIA) before the first vaccination (at Day 0) and 1 month after the third vaccination (Day 150).
Measured: Day 150 (1 month post-vaccination 3)
Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Geometric mean titers to the Polio Antigens were assessed by means of microneutralization assay for anti-polio types 1, 2, and 3 before the first vaccination (at Day 0) and 1 month post-vaccination 3 (Day 150).
Measured: Day 150 (1 month post-vaccination 3)

Secondary outcomes (3)

Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP~T and PENTAXIM™ injection sites
Measured: Day 0 up to Day 7 post-vaccination
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Solicited injection site reactions - erythema, edema, induration, and pain were assessed in each participant at the DTaP-IPV-Hep B-PRP~T and ENGERIX B® injection sites.
Measured: Day 0 up to Day 7 post-vaccination
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Solicited systemic reactions: Pyrexia (temperature), Somnolence, Irritability, Anorexia, Vomiting not otherwise specified (NOS), Diarrhea NOS, and Crying were assessed in each participant following vaccination.
Grade 3 reactions defined as: Pyrexia (temperature), ≥ 39.1°C; Somnolence, sleeping most of the time; Irritability, continuously irritable for ≥ 3 hours; Anorexia, refused most or all feeds; Vomiting NOS, frequent vomiting and inability to have any oral intake; Diarrhea NOS, multiple liquid stools without any solid material; and Crying, persistent, inconsolable cry ≥ 3 hours and/or high-pitched cry.
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.

Oct 2004Mar 2007

First posted28 Jan 2009 (estimated)
Study startOct 2004
Primary completionNov 2005
Study completionMar 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 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 624 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00831311
Sponsor's protocol ID: A3L02
Status last verified: Nov 2013
First submitted: 27 Jan 2009
Last updated: 17 Dec 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Tregnaghi MW, Zambrano B, Santos-Lima E. Immunogenicity and safety of an investigational hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-hepatitis B-Haemophilus influenzae B conjugate combined vaccine in healthy 2-, 4-, and 6-month-old Argentinean infants. Pediatr Infect Dis J. 2011 Jun;30(6):e88-96. doi: 10.1097/INF.0b013e318212eb80.
PubMed 21372751

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 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase-II Immunogenicity Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 Months of Age in Healthy Argentinean Infants
ClinicalTrials.gov ID: NCT00831311
Acronym / sponsor ID: A3L02
Conditions: Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b, Poliomyelitis
Keywords: Diphtheria, Tetanus, Pertussis, Whooping cough, Hepatitis B, Poliomyelitis, Haemophilus influenzae type b
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 624 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2004
Primary completion: Nov 2005 (actual)
Study completion: Mar 2007 (actual)
First posted: 28 Jan 2009 (estimated)
Results: Posted 21 Nov 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 demonstrate that the immune response of the DTaP-IPV-Hep B-PRP~T is non-inferior for all valences to those of the association of PENTAXIM™ and ENGERIX B® PEDIATRICO one month after a three-dose primary series.

Secondary Objectives:

To describe in each group the immunogenicity parameters one month after the three-dose primary series.
To describe safety profile after each vaccination in both groups.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Biological: DTaP-IPV-HB-PRP~TDTaP IPV HB-PRP~T vaccine group
2	Active comparator	Biological: DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccinePENTAXIM™ and ENGERIX B® vaccines group

Who may qualify

Ages: 50 to 70 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Infant of either gender, aged 50 to 70 days inclusive
Mother is negative for HBsAg
Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg
Written informed consent form signed by at least one parent or by another legal representative and an independent witness
Parent/legal representative able to attend scheduled visits and to comply with the trial procedures during the entire duration of the trial.

Key exclusion criteria (12 listed)

Axillary temperature ≥37.1°C on the day of inclusion
Current or planned enrolment in another clinical trial during the clinical trial period
Known mother's history of Human Immunodeficiency Virus (HIV) infection
Known immunodeficiency (congenital or acquired) or induced by immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth, or systemic corticosteroids in the last 4 weeks (≥0.5 mg per kilogram and per day equivalent prednisolone and lasting more than 7 days)
Receipt of blood-derived products since birth

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-HB-PRP~T0.5 mL, Intramuscular	Biological	1
DTaP-IPV//PRP~T combined vaccine & Recombinant hep B vaccineAlso: PENTAXIM™, ENGERIX B® PEDIATRICO0.5 mL, Intramuscular (right and left thighs, respectively)	Biological	2

Primary outcome

Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Time frame: 1 month post last vaccination
Seroconversion was assessed by means of enzyme immunoassay (EIA) for anti-pertussis toxoid (PT) and anti-filamentous hemagglutinin (FHA) antibodies. Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination.
Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Time frame: Day 150 (1 month post-vaccination 3)
Immunogenicity was assessed by radioimmunoassay (RIA) for anti-hepatitis B (HBs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-tetanus, serum neutralization (SN) for anti-diphtheria, and microneutralization for anti-polio type 1, 2, and 3 antibodies. Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hepatitis Bs, ≥ 0.15 μg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-tetanus and anti-diphtheria, and ≥ 8 1/dil for anti-polio types 1, 2, and 3 at 30 days after the third vaccination.
Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Time frame: Day 150 (1 month post-vaccination 3)
Geometric mean titers to Tetanus antigen was assessed by means of enzyme immunoassay (EIA) before the first vaccination (at Day 0) and 1 month after the third vaccination (Day 150).
Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Time frame: Day 150 (1 month post-vaccination 3)
Geometric mean titers to the Polio Antigens were assessed by means of microneutralization assay for anti-polio types 1, 2, and 3 before the first vaccination (at Day 0) and 1 month post-vaccination 3 (Day 150).

3 secondary outcomes

Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™
Time frame: Day 0 up to Day 7 post-vaccination
Number of Participants Reporting At Least One Solicited Injection Site Reaction Following Each Vaccination With Either DTaP-IPV-Hep B-PRP~T or ENGERIX B®
Time frame: Day 0 up to Day 7 post-vaccination
Number of Participants Reporting At Least One Solicited Systemic Reaction Following Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®
Time frame: Day 0 up to Day 7 post-vaccination

Results and safety

Results posted to the registry on 21 Nov 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
Group 1: DTaP-IPV-Hep B-PRP~T	312	300
Group 2: PENTAXIM™ and ENGERIX B®	312	304

Primary outcome: Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®

Time frame: 1 month post last vaccination. Number. Unit: Percentage of Participants

Measure	Group 1: DTaP-IPV-Hep B-PRP~T n = 260	Group 2: PENTAXIM™ and ENGERIX B® n = 271
Anti-Pertussis toxoid (N = 233, 241)	92	93 (0 to 0)
Anti-Filamentous hemagglutinin (N = 250, 249)	93	90 (0 to 0)

Population analysed: Seroconversion for anti-pertussis toxoid and anti-filamentous hemagglutinin antibodies was assessed in the per-protocol population.

Primary outcome: Percentage of Participants With Seroprotection for Anti-Hepatitis B, Anti-Polyribosyl Ribitol Phosphate (PRP), Anti-Tetanus, Anti-Diphtheria, and Anti-Polio Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®

Time frame: Day 150 (1 month post-vaccination 3). Number. Unit: Percentage of Participants

Measure	Group 1: DTaP-IPV-Hep B-PRP~T n = 260	Group 2: PENTAXIM™ and ENGERIX B® n = 271
Anti-Hepatitis B (N = 258, 271)	99	100 (0 to 0)
Anti-PRP (N = 260, 270)	95	97 (0 to 0)
Anti-Tetanus (N = 260, 271)	100	100 (0 to 0)
Anti-Diphtheria (N = 260, 271)	100	100 (0 to 0)
Anti-Polio Type 1 (N = 259, 268)	100	100 (0 to 0)
Anti-Polio Type 2 (N = 257, 269)	100	100 (0 to 0)
Anti-Polio Type 3 (N = 257, 263)	100	100 (0 to 0)

Population analysed: Seroprotection to the vaccine antigens was assessed in the per-protocol population.

Primary outcome: Geometric Mean Titers of Anti-Tetanus Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®

Time frame: Day 150 (1 month post-vaccination 3). Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Group 1: DTaP-IPV-Hep B-PRP~T n = 260	Group 2: PENTAXIM™ and ENGERIX B® n = 271
Day 0 (N = 256, 267)	1.14 (0.960 to 1.36)	1.16 (0.989 to 1.37)
Day 150 (N = 260, 271)	2.29 (2.09 to 2.51)	1.79 (1.66 to 1.92)

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

Primary outcome: Geometric Mean Titers of Anti-Polio Types 1, 2, and 3 Antibodies Before and Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B®

Time frame: Day 150 (1 month post-vaccination 3). Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Group 1: DTaP-IPV-Hep B-PRP~T n = 260	Group 2: PENTAXIM™ and ENGERIX B® n = 271
Anti-Polio Type 1 Day 0 (N = 250, 258)	7.41 (6.34 to 8.65)	7.04 (6.08 to 8.15)
Anti-Polio Type 1 Day 150 (N = 259, 268)	4091 (3452 to 4848)	4198 (3595 to 4901)
Anti-Polio Type 2 Day 0 (N = 249, 261)	11.5 (9.72 to 13.7)	10.5 (9.02 to 12.1)
Anti-Polio Type 2 Day 150 (N = 257, 269)	3244 (2757 to 3817)	3223 (2753 to 3773)
Anti-Polio Type 3 Day 0 (N = 246, 254)	6.89 (6.09 to 7.81)	6.77 (6.04 to 7.60)
Anti-Polio Type 3 Day 150 (N = 257, 263)	3839 (3197 to 4610)	5502 (4608 to 6570)

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

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events data were collected from the day of vaccination (Day 0) up to Day 150 post-vaccination.. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: DTaP-IPV-Hep B-PRP~T	19 of 311 (6.1%)	305 of 311 (98.1%)	Not reported
Group 2: PENTAXIM™ and ENGERIX B®	22 of 312 (7.1%)	307 of 312 (98.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21372751Tregnaghi MW, Zambrano B, Santos-Lima E. Immunogenicity and safety of an investigational hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-hepatitis B-Haemophilus influenzae B conjugate combined vaccine in healthy 2-, 4-, and 6-month-old Argentinean infants. Pediatr Infect Dis J. 2011 Jun;30(6):e88-96. doi: 10.1097/INF.0b013e318212eb80.
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
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

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?

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 12 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 17 Dec 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 21 Nov 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?

Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T or PENTAXIM™ and ENGERIX B® (time frame: 1 month post last 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 NCT00831311, 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 17 Dec 2013.