DiphtheriaPhase 3NCT01177722

A Study of DTaP-IPV-Hep B-PRP-T Vaccine Given With Prevenar™ and Rotarix™ in Healthy Latin American Infants

A Phase 3 study testing DTaP-IPV-Hep B-PRP-T Vaccine and DTaP-Hep B-IPV vaccine in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 2 sites in 2 countries.

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

The purpose of this study is to generate immunogenicity and safety data of an investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine compared to a control vaccine, Infanrix hexa™ when given along with Prevenar™ and Rotarix™ vaccines. Read more about this study

Who is it for?: Ages 55 to 65 daysHealthy volunteers can take part
Conditions the study is for: Diphtheria, Tetanus, Whooping Cough
What is being tested?: DTaP-IPV-Hep B-PRP-T Vaccine and DTaP-Hep B-IPV vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,375 participants
Where: 2 sitesin 2 countries
Study dates: Aug 2010to Dec 2011
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 55 to 65 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Two month old infants (55 to 65 days old) on the day of inclusion.
Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg.
Informed consent form signed by one or both parents or by the legally acceptable representative as per local requirements.
Able to attend all scheduled visits and to comply with all trial procedures.
Received Hepatitis B and Bacille de Calmette-Guérin (BCG) vaccines between birth and one month of life in agreement with the national immunization calendar.

Who cannot join

Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
Planned participation in another clinical trial during the present trial period.
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy, or long-term systemic corticosteroid therapy.
Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
Blood or blood-derived products received since birth that might interfere with the assessment of the immune response.

Show all 14Show fewer

Any vaccination before trial vaccination (except Hepatitis B and Bacille de Calmette Guérin given at birth).
Any planned vaccination until 1 month after the last trial vaccination (except the study vaccines, rotavirus and pneumococcal conjugated vaccines).
Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or Hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically).
Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infections.
Known personal or maternal history of Human Immunodeficiency Virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C seropositivity.
Known coagulopathy, thrombocytopenia or a bleeding disorder preceding inclusion contraindicating intramuscular (IM) vaccination.
History of seizures or encephalopathy.
Febrile illness (temperature ≥ 38.0°C), or moderate or severe acute illness/infection on the day of inclusion, according to the Investigator judgment.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Colombia1 site

Study site
Cali

Other trials in Colombia

Costa Rica1 site

Study site
San José

Other trials in Costa Rica

About this study

Official title: Lot-to-Lot Consistency Study of DTaP-IPV-Hep B-PRP-T Vaccine Administered at 2-4-6 Months of Age in Healthy Latin American Infants Concomitantly With Prevenar™ and Rotarix™

Primary Objectives:

To demonstrate the equivalence of immunogenicity of 3 lots of DTaP-IPV-Hep B-PRP-T vaccine 1 month after a 3-dose primary series (2, 4 and 6 months) when given with Prevenar™ and Rotarix™, in terms of immunoresponses.
To demonstrate the non-inferiority of the hexavalent DTaP-IPV-Hep B-PRP-T vaccine to the licensed hexavalent Infanrix hexa vaccine when given with Prevenar™ and Rotarix™.

Secondary Objectives:

To describe in each group the immunogenicity parameters for all antigens for each vaccine
To assess the safety profile in terms of solicited and unsolicited adverse events and serious adverse events in each group for each vaccine.

Read the detailed description

Each participant will receive 3 doses of 1 of 3 lots of the investigational hexavalent vaccine or the control vaccine, Infanrix hexa™, administered with Prevenar™ at 2, 4, and 6 months of age and Rotarix™ at 2 and 4 months of age.

All participants will be monitored for safety for 6 months after the last injection of the primary vaccination series.

Conditions: Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Poliomyelitis
Being tested: DTaP-IPV-Hep B-PRP-T Vaccine, DTaP-Hep B-IPV vaccine
Keywords: Diphtheria, Tetanus, Whooping cough, Hepatitis B, Poliomyelitis, Diphtheria-Tetanus-acellular Pertussis Vaccines
Medical subject headings: Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Poliomyelitis

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 VaccineBiological
0.5 mL, Intramuscular
DTaP-IPV-Hep B-PRP-T VaccineBiological
0.5 mL, Intramuscular
DTaP-IPV-Hep B-PRP-T VaccineBiological
0.5 mL, Intramuscular
DTaP-Hep B-IPV vaccineBiological
Also called Infanrix hexa™
0.5 mL, Intramuscular

Study groups in NCT01177722
Study group	Role	What they receive
Group 1: DTaP-IPV-Hep B-PRP-T (Lot A)	Experimental	Not described Receives: Biological: DTaP-IPV-Hep B-PRP-T Vaccine
Group 2: DTaP-IPV-Hep B-PRP-T (Lot B)	Experimental	Not described Receives: Biological: DTaP-IPV-Hep B-PRP-T Vaccine
Group 3: DTaP-IPV-Hep B-PRP-T (Lot C)	Experimental	Not described Receives: Biological: DTaP-IPV-Hep B-PRP-T Vaccine
Group 4: Active Control	Active comparator	Not described Receives: Biological: DTaP-Hep B-IPV vaccine

What is being measured

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

Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™
Antibodies against Hepatitis B (Hep B) were measured by chemiluminescence detection.
Measured: Day 0 (pre-vaccination) Dose 1 and 30 days post-vaccination
Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine
Seroprotection was defined as titers ≥ 0.01 IU/mL for Diphtheria (D) and Tetanus (T); ≥ 10 IU/mL for Hep B; ≥ 0.15 µg/mL for PRP, and ≥ 8 (1/dil) for Poliovirus. Vaccine response for PT and FHA were defined as a titer ≥ lower limit of quantitation (LLOQ) in initially seronegative participants, or at least persistence (post-vaccination titer ≥ pre-vaccination titer) in initially seropositive subjects (titer ≥ LLOQ).
Measured: 30 Days post-dose 3

Secondary outcomes (3)

Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine
Antibodies were measured by toxin neutralization test for Diphtheria (D); enzyme-linked immunosorbent assay (ELISA) for Tetanus (T), Pertussis toxoid (PT), and Filamentous hemagglutinin (FHA); neutralization assay for Poliovirus types 1, 2, and 3; chemiluminescence detection for Hepatitis B (Hep B), and Farr type radioimmunoassay for Haemophilus influenza type b (PRP).
Measured: Day 0 (pre-vaccination) and 30 days post-dose 3
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine
Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia,and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, (Temperature) ≥ 39.6°C; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.
Measured: Day 0 up to 7 after each dose
Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine
Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of the limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia (Temperature), ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of time or difficult to wake up; Anorexia, refuses ≥ 3 feed/meals or refuses most feeds/meals; and Irritability, inconsolable.
Measured: Day 0 up to 7 post each vaccination

Timeline

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

Aug 2010Dec 2011

First posted9 Aug 2010 (estimated)
Study startAug 2010
Primary completionOct 2011
Study completionDec 2011

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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,375 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01177722
Sponsor's protocol ID: A3L24
Other IDs: UTN: U1111-1111-5801
Status last verified: Apr 2014
First submitted: 6 Aug 2010
Last updated: 5 May 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Lot-to-Lot Consistency Study of DTaP-IPV-Hep B-PRP-T Vaccine Administered at 2-4-6 Months of Age in Healthy Latin American Infants Concomitantly With Prevenar™ and Rotarix™
ClinicalTrials.gov ID: NCT01177722
Acronym / sponsor ID: A3L24
Conditions: Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Poliomyelitis
Keywords: Diphtheria, Tetanus, Whooping cough, Hepatitis B, Poliomyelitis, Diphtheria-Tetanus-acellular Pertussis Vaccines
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,375 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Oct 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 9 Aug 2010 (estimated)
Results: Posted 5 May 2014

Clinical summary

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

Primary Objectives:

To demonstrate the equivalence of immunogenicity of 3 lots of DTaP-IPV-Hep B-PRP-T vaccine 1 month after a 3-dose primary series (2, 4 and 6 months) when given with Prevenar™ and Rotarix™, in terms of immunoresponses.
To demonstrate the non-inferiority of the hexavalent DTaP-IPV-Hep B-PRP-T vaccine to the licensed hexavalent Infanrix hexa vaccine when given with Prevenar™ and Rotarix™.

Secondary Objectives:

To describe in each group the immunogenicity parameters for all antigens for each vaccine
To assess the safety profile in terms of solicited and unsolicited adverse events and serious adverse events in each group for each vaccine.

Detailed description

All participants will be monitored for safety for 6 months after the last injection of the primary vaccination series.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Group 1: DTaP-IPV-Hep B-PRP-T (Lot A)	Experimental	Biological: DTaP-IPV-Hep B-PRP-T Vaccine
Group 2: DTaP-IPV-Hep B-PRP-T (Lot B)	Experimental	Biological: DTaP-IPV-Hep B-PRP-T Vaccine
Group 3: DTaP-IPV-Hep B-PRP-T (Lot C)	Experimental	Biological: DTaP-IPV-Hep B-PRP-T Vaccine
Group 4: Active Control	Active comparator	Biological: DTaP-Hep B-IPV vaccine

Who may qualify

Ages: 55 to 65 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Two month old infants (55 to 65 days old) on the day of inclusion.
Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg.
Informed consent form signed by one or both parents or by the legally acceptable representative as per local requirements.
Able to attend all scheduled visits and to comply with all trial procedures.
Received Hepatitis B and Bacille de Calmette-Guérin (BCG) vaccines between birth and one month of life in agreement with the national immunization calendar.

Key exclusion criteria (14 listed)

Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
Planned participation in another clinical trial during the present trial period.
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy, or long-term systemic corticosteroid therapy.
Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
Chronic illness at a stage that could interfere with trial conduct or completion, 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
DTaP-IPV-Hep B-PRP-T Vaccine0.5 mL, Intramuscular	Biological	Group 1: DTaP-IPV-Hep B-PRP-T (Lot A)
DTaP-IPV-Hep B-PRP-T Vaccine0.5 mL, Intramuscular	Biological	Group 2: DTaP-IPV-Hep B-PRP-T (Lot B)
DTaP-IPV-Hep B-PRP-T Vaccine0.5 mL, Intramuscular	Biological	Group 3: DTaP-IPV-Hep B-PRP-T (Lot C)
DTaP-Hep B-IPV vaccineAlso: Infanrix hexa™0.5 mL, Intramuscular	Biological	Group 4: Active Control

Primary outcome

Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™
Time frame: Day 0 (pre-vaccination) Dose 1 and 30 days post-vaccination
Antibodies against Hepatitis B (Hep B) were measured by chemiluminescence detection.
Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine
Time frame: 30 Days post-dose 3
Seroprotection was defined as titers ≥ 0.01 IU/mL for Diphtheria (D) and Tetanus (T); ≥ 10 IU/mL for Hep B; ≥ 0.15 µg/mL for PRP, and ≥ 8 (1/dil) for Poliovirus. Vaccine response for PT and FHA were defined as a titer ≥ lower limit of quantitation (LLOQ) in initially seronegative participants, or at least persistence (post-vaccination titer ≥ pre-vaccination titer) in initially seropositive subjects (titer ≥ LLOQ).

3 secondary outcomes

Geometric Mean Titers (GMTs) of Antibodies After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine
Time frame: Day 0 (pre-vaccination) and 30 days post-dose 3
Number of Participants Reporting at Least One Solicited Injection Site (Study Vaccine) or Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine
Time frame: Day 0 up to 7 after each dose
Number of Participants Reporting at Least One Solicited Injection Site Reaction at the Prevenar Injection Site After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine
Time frame: Day 0 up to 7 post each vaccination

Results and safety

Results posted to the registry on 5 May 2014, 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 A	344	331
DTaP-IPV-Hep B-PRP~T Batch B	344	334
DTaP-IPV-Hep B-PRP~T Batch C	342	333
Infanrix Hexa	345	338

Primary outcome: Geometric Mean Titers (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™

Time frame: Day 0 (pre-vaccination) Dose 1 and 30 days post-vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	DTap-IPV-Hep B-PRP~T Batch A n = 312	DTaP-IPV-Hep B-PRP~T Batch B n = 310	DTaP-IPV-Hep B-PRP~T Batch C n = 313	Infanrix Hexa n = 316
Anti-Hep B Pre-dose 1	4.02 (3.50 to 4.61)	4.07 (3.58 to 4.62)	4.93 (4.20 to 5.79)	4.30 (3.68 to 5.03)
Anti-Hep B Post-dose 3	3048 (2672 to 3476)	2801 (2467 to 3181)	3202 (2794 to 3668)	2766 (2466 to 3102)

Population analysed: GMTs were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per-Protocol Population).

Primary outcome: Number of Participants With Seroprotection or Vaccine Response After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccine

Time frame: 30 Days post-dose 3. Number. Unit: Participants

Measure	DTap-IPV-Hep B-PRP~T Batch A n = 312	DTaP-IPV-Hep B-PRP~T Batch B n = 310	DTaP-IPV-Hep B-PRP~T Batch C n = 313	Infanrix Hexa n = 316
Anti-Diphtheria (N = 310, 310, 312, 315)	310	310	312	315
Anti-Tetanus (N = 311, 310, 311, 314)	311	310	311	314
Anti-PT (N = 308, 309, 308, 312)	304	299	299	307
Anti-FHA (N = 306, 306, 304, 311)	306	305	303	309
Anti-Polio 1 (N = 310, 309, 308, 311)	310	309	308	311
Anti-Polio 2 (N = 309, 309, 307, 312)	309	309	307	312
Anti-Polio 3 (N = 310, 309, 307, 312)	310	309	307	311
Anti-Hep B (N = 312, 310, 312, 316)	311	310	310	316

Population analysed: Seroprotection and vaccine response were assessed in all subjects who did not have any protocol violation that might interfere with primary criteria evaluation (Per Protocol Population).

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose.. 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 A	10 of 345 (2.9%)	208 of 345 (60.3%)	Not reported
DTaP-IPV-Hep B-PRP~T Batch B	14 of 343 (4.1%)	206 of 343 (60.1%)	Not reported
DTaP-IPV-Hep B-PRP~T Batch C	16 of 342 (4.7%)	216 of 342 (63.2%)	Not reported
Infanrix Hexa	10 of 345 (2.9%)	193 of 345 (55.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Diphtheria

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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.

Medical Director study director

Sanofi Pasteur Inc.

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DTaP-IPV-Hep B-PRP-T Vaccine and DTaP-Hep B-IPV vaccine in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 2 sites in 2 countries.

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 14 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 5 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Colombia, Costa Rica. 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 5 May 2014). 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 (GMTs) of Anti-Hepatitis B Before and After 3 Dose Primary Vaccination With Either DTaP-IPV-Hep B-PRP~T Batch A, B, or C, or Infanrix Hexa™ (time frame: Day 0 (pre-vaccination) Dose 1 and 30 days post-vaccination). The study lists 2 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 NCT01177722.

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 5 May 2014.