TetanusPhase 3NCT01086423

Immunogenicity and Safety Study of GSK Biologicals' Infanrix-IPV+Hib™ Vaccine

A Phase 3 study testing Infanrix-IPV/Hib™, Infanrix Hib™ and Poliorix™ in people with Tetanus and Poliomyelitis, run by GlaxoSmithKline at 2 sites in China.

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

The purpose of the study is to evaluate the immunogenicity and reactogenicity of Infanrix-IPV/Hib™ vaccine when administered to healthy Chinese infants at 2, 3 and 4 or 3, 4 and 5 months of age. Read more about this study

Who is it for?: Ages 60 to 90 daysHealthy volunteers can take part
Conditions the study is for: Tetanus, Poliomyelitis, Acellular Pertussis
What is being tested?: Infanrix-IPV/Hib™, Infanrix Hib™ and Poliorix™
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 985 participants
Where: 2 sitesChina
Study dates: 1 Mar 2010to 19 Nov 2010
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 60 to 90 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

A male or female infant between, and including, 60 and 90 days of age at the time of the first study visit.
Born after a gestation period of 36 to 42 weeks, inclusive.
Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
Written informed consent obtained from the parent(s) or LAR(s) of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Who cannot join

Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Child in care.
Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of hepatitis B vaccine.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.

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Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis and/or Haemophilus influenzae type b (Hib) disease or vaccination.
History of seizures or progressive neurological disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
Major congenital defects or serious chronic illness.
The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
Current febrile illness or axillary temperature > 37.0°C or other moderate to severe illness within 24 hours of study vaccine administration.

Trial locations and contacts

2 sites in 1 country.

China2 sites

GSK Investigational Site
Wuzhou, Guangxi, 543002
GSK Investigational Site
Wuzhou, Guangxi, 543100

Other trials in China

About this study

Official title: Immunogenicity and Safety of GlaxoSmithKline Biologicals' DTPa-IPV/Hib (Infanrix-IPV+Hib™) in Infants

The purpose of the study is to evaluate the immunogenicity and reactogenicity of Infanrix-IPV/Hib™ vaccine when administered to healthy Chinese infants at 2, 3 and 4 or 3, 4 and 5 months of age.

Conditions: Tetanus, Poliomyelitis, Acellular Pertussis, Diphtheria, Haemophilus Influenzae Type b
Being tested: Infanrix-IPV/Hib™, Infanrix Hib™, Poliorix™
Keywords: Infanrix-IPV+Hib
Medical subject headings: Tetanus, Poliomyelitis, Diphtheria, Haemophilus Infections

What participants receive

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

Infanrix-IPV/Hib™Biological
Intramuscular, three doses
Infanrix Hib™Biological
Intramuscular, three doses
Poliorix™Biological
Intramuscular, three doses

Study groups in NCT01086423
Study group	Role	What they receive
INFANRIX-IPV+HIB 1 GROUP	Experimental	Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh. Receives: Biological: Infanrix-IPV/Hib™
INFANRIX-IPV+HIB 2 GROUP	Experimental	Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh. Receives: Biological: Infanrix-IPV/Hib™
INFANRIX-HIB+POLIORIX GROUP	Active comparator	Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively. Receives: Biological: Infanrix Hib™; Biological: Poliorix™

What is being measured

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

Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Measured: One month after the third vaccine dose (Month 3 or Month 4)
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigen
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL).
Measured: One month after the third vaccine dose (Month 3 or Month 4)
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens
A seroprotected subject was defined as a subject with anti-poliovirus (anti-polio) types 1, 2 and 3 antibody titres ≥ the value of 8.
Measured: One month after the third vaccine dose (Month 3 or Month 4)
Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens
Vaccine response was defined as:
For PT and FHA response, antibody concentration ≥ 20 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at post-vaccination.
For PRN response: for initially seronegative subjects [antibody concentration lower than (<) 5 EL.U/mL], post-vaccination antibody concentration ≥ 20 EL.U/mL; for initially seropositive subjects (antibody concentration ≥ 5 EL.U/mL), at least a 4-fold increase in antibody concentration from pre to post-vaccination.
Measured: One month after the third vaccine dose (Month 3 or Month 4)

Secondary outcomes (8)

Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Measured: Before the first dose (Month 0) and one month after the third dose of vaccination (Month 3 or Month 4)
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
Measured: Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)
Anti-polio Types 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Measured: Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Measured: Before (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Measured: During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to study vaccination.
Measured: During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: During the 31-day (Days 0-30) post-vaccination period after any dose
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: During the entire study period (from Month 0 to Month 4/5)

Timeline

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

1 Mar 201019 Nov 2010

First posted15 Mar 2010 (estimated)
Study start1 Mar 2010
Primary completion19 Nov 2010
Study completion19 Nov 2010

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 TetanusStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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: 985 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01086423
Sponsor's protocol ID: 112584
Status last verified: Apr 2017
First submitted: 11 Mar 2010
Last updated: 6 Jun 2018
Results posted: Yes, on ClinicalTrials.gov

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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All Tetanus trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety of GlaxoSmithKline Biologicals' DTPa-IPV/Hib (Infanrix-IPV+Hib™) in Infants
ClinicalTrials.gov ID: NCT01086423
Acronym / sponsor ID: 112584
Conditions: Tetanus, Poliomyelitis, Acellular Pertussis, Diphtheria, Haemophilus Influenzae Type b
Keywords: Infanrix-IPV+Hib
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 985 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Mar 2010
Primary completion: 19 Nov 2010 (actual)
Study completion: 19 Nov 2010 (actual)
First posted: 15 Mar 2010 (estimated)
Results: Posted 10 Apr 2017

Clinical summary

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

The purpose of the study is to evaluate the immunogenicity and reactogenicity of Infanrix-IPV/Hib™ vaccine when administered to healthy Chinese infants at 2, 3 and 4 or 3, 4 and 5 months of age.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
INFANRIX-IPV+HIB 1 GROUP	Experimental	Biological: Infanrix-IPV/Hib™Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
INFANRIX-IPV+HIB 2 GROUP	Experimental	Biological: Infanrix-IPV/Hib™Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
INFANRIX-HIB+POLIORIX GROUP	Active comparator	Biological: Infanrix Hib™, Biological: Poliorix™Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.

Who may qualify

Ages: 60 to 90 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

A male or female infant between, and including, 60 and 90 days of age at the time of the first study visit.
Born after a gestation period of 36 to 42 weeks, inclusive.
Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
Written informed consent obtained from the parent(s) or LAR(s) of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Key exclusion criteria (13 listed)

Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Child in care.
Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of hepatitis B vaccine.

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
Infanrix-IPV/Hib™Intramuscular, three doses	Biological	INFANRIX-IPV+HIB 1 GROUP, INFANRIX-IPV+HIB 2 GROUP
Infanrix Hib™Intramuscular, three doses	Biological	INFANRIX-HIB+POLIORIX GROUP
Poliorix™Intramuscular, three doses	Biological	INFANRIX-HIB+POLIORIX GROUP

Primary outcome

Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens
Time frame: One month after the third vaccine dose (Month 3 or Month 4)
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigen
Time frame: One month after the third vaccine dose (Month 3 or Month 4)
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL).
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens
Time frame: One month after the third vaccine dose (Month 3 or Month 4)
A seroprotected subject was defined as a subject with anti-poliovirus (anti-polio) types 1, 2 and 3 antibody titres ≥ the value of 8.
Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens
Time frame: One month after the third vaccine dose (Month 3 or Month 4)
Vaccine response was defined as: For PT and FHA response, antibody concentration ≥ 20 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at post-vaccination. For PRN response: for initially seronegative subjects [antibody concentration lower than (<) 5 EL.U/mL], post-vaccination antibody concentration ≥ 20 EL.U/mL; for initially seropositive subjects (antibody concentration ≥ 5 EL.U/mL), at least a 4-fold increase in antibody concentration from pre to post-vaccination.

8 secondary outcomes

Anti-D and Anti-T Antibody Concentrations
Time frame: Before the first dose (Month 0) and one month after the third dose of vaccination (Month 3 or Month 4)
Anti-PRP Antibody Concentrations
Time frame: Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)
Anti-polio Types 1, 2 and 3 Antibody Titers
Time frame: Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Time frame: Before (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)
Number of Subjects With Any Solicited Local Symptoms
Time frame: During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses
Number of Subjects With Any Solicited General Symptoms
Time frame: During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: During the 31-day (Days 0-30) post-vaccination period after any dose
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period (from Month 0 to Month 4/5)

Results and safety

Results posted to the registry on 10 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Infanrix-IPV+Hib 1 Group	330	320
Infanrix-IPV+Hib 2 Group	324	321
Infanrix-Hib+Poliorix Group	330	321

Primary outcome: Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens

Time frame: One month after the third vaccine dose (Month 3 or Month 4). Count of participants. Unit: Participants

Measure	Infanrix-IPV+Hib 1 Group n = 147	Infanrix-IPV+Hib 2 Group n = 156	Infanrix-Hib+Poliorix Group n = 147
Anti-D	146	156	147
Anti-T	147	156	147

Infanrix-IPV+Hib 1 Group vs Infanrix-Hib+Poliorix Group: Difference in seroprotection rate: 0.68 (95% CI -1.88 to 3.76)
Infanrix-IPV+Hib 1 Group vs Infanrix-Hib+Poliorix Group: Difference in seroprotection rate: 0 (95% CI -2.56 to 2.56)

Population analysed: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.

Primary outcome: Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigen

Time frame: One month after the third vaccine dose (Month 3 or Month 4). Count of participants. Unit: Participants

Measure	Infanrix-IPV+Hib 1 Group n = 147	Infanrix-IPV+Hib 2 Group n = 157	Infanrix-Hib+Poliorix Group n = 150
Value	142	155	133

Infanrix-IPV+Hib 1 Group vs Infanrix-Hib+Poliorix Group: Difference in seroprotection rate: -7.93 (95% CI -14.44 to -2.13)

Population analysed: The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.

Primary outcome: Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens

Time frame: One month after the third vaccine dose (Month 3 or Month 4). Count of participants. Unit: Participants

Measure	Infanrix-IPV+Hib 1 Group n = 147	Infanrix-IPV+Hib 2 Group n = 157	Infanrix-Hib+Poliorix Group n = 150
Anti-polio 1	147	157	150
Anti-polio 2	147	157	150
Anti-polio 3	147	157	150

Infanrix-IPV+Hib 1 Group vs Infanrix-Hib+Poliorix Group: Difference in seroprotection rate: 0 (95% CI -2.51 to 2.56)
Infanrix-IPV+Hib 1 Group vs Infanrix-Hib+Poliorix Group: Difference in seroprotection rate: 0 (95% CI -2.51 to 2.56)
Infanrix-IPV+Hib 1 Group vs Infanrix-Hib+Poliorix Group: Difference in seroprotection rate: 0 (95% CI -2.51 to 2.56)

Primary outcome: Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens

Time frame: One month after the third vaccine dose (Month 3 or Month 4). Count of participants. Unit: Participants

Measure	Infanrix-IPV+Hib 1 Group n = 147	Infanrix-IPV+Hib 2 Group n = 156	Infanrix-Hib+Poliorix Group n = 148
Anti-PT	147	155	147
Anti-FHA	147	155	144
Anti-PRN	145	156	145

Infanrix-IPV+Hib 1 Group vs Infanrix-Hib+Poliorix Group: Difference in seroprotection rate: -0.68 (95% CI -3.74 to 1.89)
Infanrix-IPV+Hib 1 Group vs Infanrix-Hib+Poliorix Group: Difference in seroprotection rate: -2.7 (95% CI -6.75 to -0.11)
Infanrix-IPV+Hib 1 Group vs Infanrix-Hib+Poliorix Group: Difference in seroprotection rate: -0.67 (95% CI -4.6 to 3.04)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Infanrix-IPV+Hib 1 Group	6 of 330 (1.8%)	279 of 330 (84.5%)	1 of 330
Infanrix-IPV+Hib 2 Group	3 of 324 (0.9%)	277 of 324 (85.5%)	0 of 324
Infanrix-Hib+Poliorix Group	4 of 330 (1.2%)	272 of 330 (82.4%)	0 of 330

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

GSK Clinical Trials study director

GlaxoSmithKline

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Infanrix-IPV/Hib™, Infanrix Hib™ and Poliorix™ in people with Tetanus and Poliomyelitis, run by GlaxoSmithKline at 2 sites in China.

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 13 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 6 Jun 2018. 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 China. 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 10 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens (time frame: One month after the third vaccine dose (Month 3 or Month 4)). 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 NCT01086423.

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 6 Jun 2018.