DiphtheriaPhase 3NCT00654901

Study of the DTaP-IPV-Hep B-PRP~T Combined Vaccine Following a Primary Series of DTacP IPV-HepB-PRP-T or Infanrix Hexa™

A Phase 3 study testing DTaP-IPV-Hep B-PRP~T vaccine (Batch 1), DTaP-IPV-Hep B-PRP~T vaccine (Batch 2) and DTaP-IPV-Hep B-PRP~T vaccine (Batch 3) in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 4 sites in Mexico.

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 is a follow-up of Study A3L11 (NCT00404651). Immunogenicity To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-Hep B-PRP~T or Infanrix hexa™. To describe the immunogenicity of a booster dose of DTaP-IPV-HepB-PRP~T in a subset of subjects. Read more about this study

Who is it for?: Ages 15 to 18 monthsHealthy volunteers can take part
Conditions the study is for: Diphtheria, Tetanus, Pertussis
What is being tested?: DTaP-IPV-Hep B-PRP~T vaccine (Batch 1), DTaP-IPV-Hep B-PRP~T vaccine (Batch 2) and DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 881 participants
Where: 4 sitesMexico
Study dates: Mar 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 15 to 18 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Toddlers previously included in Study A3L11 (NCT00404651) who completed the three-dose primary series vaccination of either DTaP-IPV-HepB-PRP-T or Infanrix hexa™ at 2, 4 and 6 months of age
Toddlers of 15 to 18 months (456 to 578 days) of age, inclusive
Informed Consent Form signed by at least one parent or legal representative and two mandatory witnesses
Able to attend all scheduled visits and to comply with all trial procedures.

Who cannot join

Participation in another clinical trial in the 4 weeks preceding the booster vaccination.
Planned participation in another clinical trial during the present trial period.
Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid 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 3 months.

Show all 16Show fewer

Any vaccination in the 4 weeks preceding the booster vaccination.
Any vaccination planned until the next visit.
History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B (HB) infection(s) (confirmed either clinically, serologically or microbiologically).
Administration of a vaccine against pertussis, tetanus, diphtheria, polio, Hib, and/or hepatitis B infection(s) since the end of participation in Study A3L11.
Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination.
Known maternal history of human immunodeficiency virus (HIV), Hepatitis B surface antigen (HbsAg) or Hepatitis C seropositivity.
Subjects with any related serious adverse event that occurred following the three-dose primary series administration of the investigational vaccine or of the reference vaccine in Study A3L11.
History of seizures.
Febrile (temperature ≥38.0°C) or acute illness on the day of inclusion
Known contraindication to further vaccination with a pertussis vaccine, i.e.: Encephalopathy; Temperature >40.0°C within 48 hours following a vaccine injection, not due to another identifiable cause during the primary series; Inconsolable crying that occurred for >3 hours within 48 hours following vaccine injection during the primary series; Hypotonic hyporesponsive episode within 48 hours following vaccine injection during the primary series; Seizures with or without fever within 3 days following vaccine injection.

Trial locations and contacts

4 sites in 1 country.

Mexico4 sites

Study site
Estado de México
Study site
Insurgentes Cuicuilco
Study site
Monterrey
Study site
Puebla City

Other trials in Mexico

About this study

Official title: Immunogenicity Study of the Antibody Persistence and Booster Effect of the DTaP-IPV-Hep B-PRP~T Combined Vaccine at 15 to 18 Months of Age Following a Primary Series of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Administered at 2, 4, and 6 Months of Age in Healthy Mexican Infants

This is a follow-up of Study A3L11 (NCT00404651).

Immunogenicity

To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-Hep B-PRP~T or Infanrix hexa™.
To describe the immunogenicity of a booster dose of DTaP-IPV-HepB-PRP~T in a subset of subjects.

Safety

To describe the safety profile after a booster dose of DTacP-IPV-HepB-PRP~T.

Conditions: Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Haemophilus Influenzae Type B Infection
Being tested: DTaP-IPV-Hep B-PRP~T vaccine (Batch 1), DTaP-IPV-Hep B-PRP~T vaccine (Batch 2), DTaP-IPV-Hep B-PRP~T vaccine (Batch 3), Infanrix Hexa™
Keywords: Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Invasive Haemophilus influenzae type b., Haemophilus Influenzae Type B Infection
Medical subject headings: Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Poliomyelitis, Haemophilus Infections

What participants receive

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

DTaP-IPV-Hep B-PRP~T vaccine (Batch 1)Biological
0.5 mL, Intramuscular
DTaP-IPV-Hep B-PRP~T vaccine (Batch 2)Biological
0.5 mL, Intramuscular
DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)Biological
0.5 mL, Intramuscular
Infanrix Hexa™Biological
0.5 mL, Intramuscular

Study groups in NCT00654901
Study group	Role	What they receive
DTaP-IPV-Hep B-PRP~T Batch 1	Experimental	Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 (NCT00404651); and will receive a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. Receives: Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 1)
DTaP-IPV-Hep B-PRP~T Batch 2	Experimental	Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 (NCT00404651) and will receive a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. Receives: Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 2)
DTaP-IPV-Hep B-PRP~T Batch 3	Experimental	Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 (NCT00404651) and will receive a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. Receives: Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)
Infanrix Hexa™	Active comparator	Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), (Infanrix Hexa™) plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 (NCT00404651) and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study. Receives: Biological: Infanrix Hexa™

What is being measured

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

Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay (ELISA). Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by ELISA.
Measured: Day 0 (pre-booster) and Day 30 (one month post-booster)
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Antibody persistence and immunogenicity response:
Level 1: ≥ 10 mIU/mL for hepatitis B (Hep B), ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP), and ≥ 0.01 IU/mL for diphtheria (D) and tetanus (T). Level 2: ≥ 100 mIU/mL (Hep B), ≥ 1.0 µg/mL (PRP), and ≥ 0.1 IU/mL (D and T) Level 3, ≥ 1.0 IU/mL (D and T). Anti-polio titers were defined as ≥ 8 (1.dil), and pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by a 4 fold increase from Day 0.
Measured: Day 0 (pre-booster) and Day 30 (one month post-booster)
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Solicited Injection Site Reactions: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability.
Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb reduced; Erythema and swelling, ≥ 5cm; Extensive swelling of limb; Pyrexia, ≥ 39.6ºC; Vomiting ≥ 6 episodes/24 hours or requiring parenteral hydration; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ feeds or most feeds; Irritability, inconsolable.
Measured: Days 0 up to 7 after any injection

Timeline

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

Mar 2008Jul 2009

First posted9 Apr 2008 (estimated)
Study startMar 2008
Primary completionMay 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 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: None (open label)
Enrolment: 881 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00654901
Sponsor's protocol ID: A3L21
Status last verified: Apr 2016
First submitted: 3 Apr 2008
Last updated: 13 May 2016
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

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Pertussis (Whooping Cough), Diphtheria
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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 13 May 2016. 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 the DTaP-IPV-Hep B-PRP~T Combined Vaccine at 15 to 18 Months of Age Following a Primary Series of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Administered at 2, 4, and 6 Months of Age in Healthy Mexican Infants
ClinicalTrials.gov ID: NCT00654901
Acronym / sponsor ID: A3L21
Conditions: Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Haemophilus Influenzae Type B Infection
Keywords: Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Invasive Haemophilus influenzae type b., Haemophilus Influenzae Type B Infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 881 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: May 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 9 Apr 2008 (estimated)
Results: Posted 26 Jun 2013

Clinical summary

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

This is a follow-up of Study A3L11 (NCT00404651).

Immunogenicity

To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-Hep B-PRP~T or Infanrix hexa™.
To describe the immunogenicity of a booster dose of DTaP-IPV-HepB-PRP~T in a subset of subjects.

Safety

To describe the safety profile after a booster dose of DTacP-IPV-HepB-PRP~T.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
DTaP-IPV-Hep B-PRP~T Batch 1	Experimental	Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 1)Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 (NCT00404651); and will receive a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
DTaP-IPV-Hep B-PRP~T Batch 2	Experimental	Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 2)Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 (NCT00404651) and will receive a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
DTaP-IPV-Hep B-PRP~T Batch 3	Experimental	Biological: DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)Participants had received 3 primary doses of Batch 1 of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) in Study A3L11 (NCT00404651) and will receive a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.
Infanrix Hexa™	Active comparator	Biological: Infanrix Hexa™Participants had received 3 primary doses of Diphtheria (D), Tetanus (T), Pertussis (acellular, component [aP]), Hepatitis B (Hep B, [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), (Infanrix Hexa™) plus Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed in Study A3L11 (NCT00404651) and received a booster dose of (DTaP-IPV-Hep B-PRP~T) at Day 0 in the present study.

Who may qualify

Ages: 15 to 18 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Toddlers previously included in Study A3L11 (NCT00404651) who completed the three-dose primary series vaccination of either DTaP-IPV-HepB-PRP-T or Infanrix hexa™ at 2, 4 and 6 months of age
Toddlers of 15 to 18 months (456 to 578 days) of age, inclusive
Informed Consent Form signed by at least one parent or legal representative and two mandatory witnesses
Able to attend all scheduled visits and to comply with all trial procedures.

Key exclusion criteria (16 listed)

Participation in another clinical trial in the 4 weeks preceding the booster vaccination.
Planned participation in another clinical trial during the present trial period.
Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid 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-Hep B-PRP~T vaccine (Batch 1)0.5 mL, Intramuscular	Biological	DTaP-IPV-Hep B-PRP~T Batch 1
DTaP-IPV-Hep B-PRP~T vaccine (Batch 2)0.5 mL, Intramuscular	Biological	DTaP-IPV-Hep B-PRP~T Batch 2
DTaP-IPV-Hep B-PRP~T vaccine (Batch 3)0.5 mL, Intramuscular	Biological	DTaP-IPV-Hep B-PRP~T Batch 3
Infanrix Hexa™0.5 mL, Intramuscular	Biological	Infanrix Hexa™

Primary outcome

Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T
Time frame: Day 0 (pre-booster) and Day 30 (one month post-booster)
Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay (ELISA). Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by ELISA.
Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Time frame: Day 0 (pre-booster) and Day 30 (one month post-booster)
Antibody persistence and immunogenicity response: Level 1: ≥ 10 mIU/mL for hepatitis B (Hep B), ≥ 0.15 µg/mL for Haemophilus influenzae type b (PRP), and ≥ 0.01 IU/mL for diphtheria (D) and tetanus (T). Level 2: ≥ 100 mIU/mL (Hep B), ≥ 1.0 µg/mL (PRP), and ≥ 0.1 IU/mL (D and T) Level 3, ≥ 1.0 IU/mL (D and T). Anti-polio titers were defined as ≥ 8 (1.dil), and pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by a 4 fold increase from Day 0.
Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine
Time frame: Days 0 up to 7 after any injection
Solicited Injection Site Reactions: Pain, Erythema, Swelling, Extensive Swelling of Vaccinated Limb. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb reduced; Erythema and swelling, ≥ 5cm; Extensive swelling of limb; Pyrexia, ≥ 39.6ºC; Vomiting ≥ 6 episodes/24 hours or requiring parenteral hydration; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ feeds or most feeds; Irritability, inconsolable.

Results and safety

Results posted to the registry on 26 Jun 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
DTaP-IPV-Hep B-PRP~T Batch 1	254	250
DTaP-IPV-Hep B-PRP~T Batch 2	262	262
DTaP-IPV-Hep B-PRP~T Batch 3	252	250
Infanrix Hexa™	113	113

Primary outcome: Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T

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

Measure	DTaP-IPV-Hep B-PRP~T Batch 1 n = 58	DTaP-IPV-Hep B-PRP~T Batch 2 n = 61	DTaP-IPV-Hep B-PRP~T Batch 3 n = 58	Infanrix Hexa™ n = 65
Anti Hep B Pre-booster (N = 58, 60, 58, 65)	91.1 (56.8 to 146)	127 (83.9 to 193)	69.2 (42.3 to 113)	127 (86.2 to 186)
Anti Hep B Post-booster (N = 58, 61, 58, 65)	2167 (1314 to 3573)	3998 (2510 to 6368)	1877 (1152 to 3058)	4757 (3124 to 7243)
Anti PRP Pre-booster (N = 58, 60, 57, 65)	1.09 (0.644 to 1.86)	1.32 (0.937 to 1.87)	0.880 (0.510 to 1.52)	1.33 (0.839 to 2.10)
Anti PRP Post-booster (N = 58, 61, 58, 65)	64.0 (47.4 to 86.6)	94.8 (71.6 to 125)	49.7 (30.6 to 80.6)	102 (72.8 to 144)
Anti Diphtheria Pre-booster (N = 58, 60, 57, 64)	0.116 (0.072 to 0.187)	0.190 (0.126 to 0.287)	0.101 (0.062 to 0.164)	0.081 (0.055 to 0.119)
Anti Diphtheria Post-booster (N = 58, 61, 58, 65)	7.78 (4.88 to 12.4)	15.2 (10.1 to 23.1)	9.31 (5.80 to 14.9)	6.01 (3.99 to 9.06)
Anti Tetanus Pre-booster (N = 58, 60, 57, 65)	0.330 (0.236 to 0.462)	0.331 (0.256 to 0.427)	0.231 (0.167 to 0.318)	0.297 (0.229 to 0.385)
Anti Tetanus Post-booster (N = 58, 61, 58, 65)	5.26 (3.97 to 6.96)	8.49 (6.50 to 11.1)	5.55 (4.20 to 7.33)	6.98 (5.26 to 9.26)

Population analysed: Geometric mean titers were assessed in a subset of participants with endpoint data who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).

Primary outcome: Number of Participants With Antibody Persistence Before and Immunogenicity Response After Booster Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine

Time frame: Day 0 (pre-booster) and Day 30 (one month post-booster). Number. Unit: Participants

Measure	DTaP-IPV-Hep B-PRP~T Batch 1 n = 58	DTaP-IPV-Hep B-PRP~T Batch 2 n = 61	DTaP-IPV-Hep B-PRP~T Batch 3 n = 58	Infanrix Hexa™ n = 65
Anti-Hep B Level 1 Pre-booster (N=58, 60, 58, 65)	51	56	51	62
Anti-Hep B Level 2 Pre-booster (N=58, 60, 58, 65)	29	39	25	38
Anti-Hep B Level 1 Post-booster (N=58, 61, 58, 65)	58	61	57	65
Anti-Hep B Level 2 Post-booster (N=58, 61, 58, 65)	52	58	55	63
Anti-PRP Level 1 Pre-booster (N=58, 60, 57, 65)	51	54	47	60
Anti-PRP Level 2 Pre-booster (N=58, 60, 57, 65)	27	36	25	32
Anti-PRP Level 1 Post-booster (N=58, 61, 58, 65)	58	61	58	65
Anti-PRP Level 2 Post booster (N=58, 61, 58, 65)	58	61	55	64

Population analysed: Antibody persistence and immunogenicity response were assessed in all participants with endpoint data who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per Protocol Population).

Primary outcome: Number of Participants With Solicited Injection Site or Systemic Reactions After Vaccination With DTaP-IPV-Hep B-PRP~T Vaccine

Time frame: Days 0 up to 7 after any injection. Number. Unit: Participants

Measure	DTaP-IPV-Hep B-PRP~T Batch 1 n = 254	DTaP-IPV-Hep B-PRP~T Batch 2 n = 262	DTaP-IPV-Hep B-PRP~T Batch 3 n = 252	Infanrix Hexa™ n = 113
Injection site Pain	174	193	177	80
Grade 3 injection site Pain	8	11	14	6
Injection site Erythema	135	127	135	63
Grade 3 injection site Erythema	3	4	5	1
Injection site Swelling	51	69	58	35
Grade 3 injection site Swelling	2	3	3	1
Extensive Swelling of Vaccinated Limb	0	1	0	0
Grade 3 Extensive Swelling of Vaccinated Limb	0	1	0	0

Population analysed: Solicited reactions were assessed in all subjects who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population).

Adverse events

Time frame: Adverse events data were collected from Day 0 after the booster injection to up to 6 months post-booster injection.. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DTaP-IPV-Hep B-PRP~T Batch 1	1 of 254 (0.4%)	188 of 254 (74%)	Not reported
DTaP-IPV-Hep B-PRP~T Batch 2	1 of 262 (0.4%)	207 of 262 (79%)	Not reported
DTaP-IPV-Hep B-PRP~T Batch 3	1 of 252 (0.4%)	197 of 252 (78.2%)	Not reported
Infanrix Hexa™	0 of 113 (0%)	92 of 113 (81.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

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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 Director study director

Sanofi Pasteur, a Sanofi Company

4 sites 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 4 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 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Mexico. 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 Jun 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?

Geometric Mean Titers of Antibodies Before and After Booster Vaccination With DTaP-IPV-Hep B-PRP~T (time frame: Day 0 (pre-booster) and Day 30 (one month post-booster)). 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 NCT00654901.

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 13 May 2016.