PoliomyelitisPhase 3NCT01353703

Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine

A Phase 3 study testing Infanrix hexa™ in people with Poliomyelitis and Tetanus, run by GlaxoSmithKline at 4 sites in India.

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

This study evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks or a 2-4-6 months schedule. Read more about this study

Who is it for?: Ages 6 to 10 weeksHealthy volunteers can take part
Conditions the study is for: Poliomyelitis, Tetanus, Acellular Pertussis
What is being tested?: Infanrix hexa™
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 224 participants
Where: 4 sitesIndia
Study dates: 16 Apr 2012to 25 Feb 2013
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 6 to 10 weeks
All sexes
Healthy volunteers accepted
Child

Who may be able to join

All subjects must satisfy ALL the following criteria at study entry:
A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination
Documented administration of a hepatitis B vaccine dose at birth
Subjects who the investigator believes that their parent(s)/legally acceptable representative(s) [LAR(s)] can and will comply with the requirements of the protocol
Written informed consent obtained from the parent(s)/LAR(s) of the subject
Healthy subjects as established by medical history and clinical examination before entering into the study
Born after a gestation period of at least 36 weeks

Who cannot join

The following criteria should be checked at the time of study entry. If ANYexclusion criterion applies, the subject must not be included in the study:
Child in care
Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose, or planned use during the study period
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose
Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral human rotavirus (HRV) vaccination which is allowed at any time during the study
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

Show all 13Show fewer

Evidence of previous diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b (Hib) vaccination or disease, with the exception of a birth dose of hepatitis B vaccine and oral poliovirus vaccine (OPV) as per local standard of care
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
Family history of congenital or hereditary immunodeficiency
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
Major congenital defects or serious chronic illness
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
Acute disease and/or fever at the time of enrolment

Trial locations and contacts

4 sites in 1 country.

India4 sites

GSK Investigational Site
Belgaun, 590010
GSK Investigational Site
Chennai
GSK Investigational Site
Pune, 411018
GSK Investigational Site
Pune

Other trials in India

About this study

Official title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa™ Vaccine in Healthy Infants in India

Conditions: Poliomyelitis, Tetanus, Acellular Pertussis, Haemophilus Influenzae Type b, Diphtheria, Hepatitis B
Being tested: Infanrix hexa™
Keywords: Infanrix hexa™, Primary vaccination, India, combination vaccine, infants
Medical subject headings: Poliomyelitis, Tetanus, Haemophilus Infections, Diphtheria, Hepatitis B

What participants receive

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

Infanrix hexa™Biological
Also called DTPa-HBV-IPV/Hib
Intramuscular, three doses

Study groups in NCT01353703
Study group	Role	What they receive
INFANRIX HEXA 6-10-14 GROUP	Experimental	Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh. Receives: Biological: Infanrix hexa™
INFANRIX HEXA 2-4-6 GROUP	Active comparator	Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh. Receives: Biological: Infanrix hexa™

What is being measured

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

Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Measured: One month post Dose 3 (Month 3 or Month 5)
Number of Seroprotected Subjects Against Hepatitis B (HBs)
A seroprotected subject was defined as a vaccinated subject with anti-HBS antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).
Measured: One month post Dose 3 (Month 3 or Month 5)
Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens
A seroprotected subject was defined as a subject with anti-Poliovirus 1,2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).
Measured: One month post Dose 3 (Month 3 or Month 5)
Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens
A seroprotected subject was defined as a subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Measured: One month post Dose 3 (Month 3 or Month 5)
Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
Vaccine response was defined as : For initially seronegative subjects (S-), antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at 1 month after the third dose; For initially seropositive subjects (S+): antibody concentration at 1 month after the third dose ≥ 1 fold increase in the pre-vaccination antibody concentration.
Measured: One month post Dose 3 (Month 3 or Month 5)

Secondary outcomes (16)

Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Measured: One month post Dose 3 (Month 3 or Month 5)
Anti-HBs Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Measured: One month post Dose 3 (Month 3 or Month 5)
Anti-Polio Types 1, 2, 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Measured: One month post Dose 3 (Month 3 or Month 5)
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
Measured: One month post Dose 3 (Month 3 or Month 5)
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Measured: One month post Dose 3 (Month 3 or Month 5)
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Measured: One month post Dose 3 (Month 3 or Month 5)
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens
A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).
Measured: At Month 0
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Measured: At Month 0
Number of Seroprotected Subjects Against Anti-HBs Antigens
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Measured: At Month 0
Anti-Polio Types 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Measured: At Month 0
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Measured: At Month 0
Anti-HBs Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Measured: At Month 0
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of any particular symptom regardless of intensity grade.
Measured: During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group)
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = incidence of any particular symptom regardless of intensity grade or relationship to study vaccination.
Measured: During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group)
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: Up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group)
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 up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group))

Timeline

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

16 Apr 201225 Feb 2013

First posted16 May 2011 (estimated)
Study start16 Apr 2012
Primary completion25 Feb 2013
Study completion25 Feb 2013

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 PoliomyelitisStudies 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: 224 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01353703
Sponsor's protocol ID: 111157
Other IDs: 2013-003427-10
Status last verified: Dec 2019
First submitted: 12 May 2011
Last updated: 2 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)

Publications

Lalwani SK, Agarkhedkar S, Sundaram B, Mahantashetti NS, Malshe N, Agarkhedkar S, Van Der Meeren O, Mehta S, Karkada N, Han HH, Mesaros N. Immunogenicity and safety of 3-dose primary vaccination with combined DTPa-HBV-IPV/Hib in Indian infants. Hum Vaccin Immunother. 2017 Jan 2;13(1):120-127. doi: 10.1080/21645515.2016.1225639. Epub 2016 Sep 15.
PubMed 27629913

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?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Infanrix Hexa™ Vaccine in Healthy Infants in India
ClinicalTrials.gov ID: NCT01353703
Acronym / sponsor ID: 111157
Conditions: Poliomyelitis, Tetanus, Acellular Pertussis, Haemophilus Influenzae Type b, Diphtheria, Hepatitis B
Keywords: Infanrix hexa™, Primary vaccination, India, combination vaccine, infants
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 224 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 16 Apr 2012 (actual)
Primary completion: 25 Feb 2013 (actual)
Study completion: 25 Feb 2013 (actual)
First posted: 16 May 2011 (estimated)
Results: Posted 25 Jan 2019

Clinical summary

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

Study design

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

Arm	Type	Receives
INFANRIX HEXA 6-10-14 GROUP	Experimental	Biological: Infanrix hexa™Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.
INFANRIX HEXA 2-4-6 GROUP	Active comparator	Biological: Infanrix hexa™Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.

Who may qualify

Ages: 6 to 10 weeks
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (7 listed)

A male or female between, and including, 6 and 10 weeks of age at the time of the first vaccination
Documented administration of a hepatitis B vaccine dose at birth
Subjects who the investigator believes that their parent(s)/legally acceptable representative(s) [LAR(s)] can and will comply with the requirements of the protocol
Written informed consent obtained from the parent(s)/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)

The following criteria should be checked at the time of study entry. If ANYexclusion criterion applies, the subject must not be included in the study:
Child in care
Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose, or planned use during the study period
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose
Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral human rotavirus (HRV) vaccination which is allowed at any time during the study

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 hexa™Also: DTPa-HBV-IPV/HibIntramuscular, three doses	Biological	INFANRIX HEXA 2-4-6 GROUP, INFANRIX HEXA 6-10-14 GROUP

Primary outcome

Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
Time frame: One month post Dose 3 (Month 3 or Month 5)
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Number of Seroprotected Subjects Against Hepatitis B (HBs)
Time frame: One month post Dose 3 (Month 3 or Month 5)
A seroprotected subject was defined as a vaccinated subject with anti-HBS antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).
Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens
Time frame: One month post Dose 3 (Month 3 or Month 5)
A seroprotected subject was defined as a subject with anti-Poliovirus 1,2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).
Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens
Time frame: One month post Dose 3 (Month 3 or Month 5)
A seroprotected subject was defined as a subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
Time frame: One month post Dose 3 (Month 3 or Month 5)
Vaccine response was defined as : For initially seronegative subjects (S-), antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at 1 month after the third dose; For initially seropositive subjects (S+): antibody concentration at 1 month after the third dose ≥ 1 fold increase in the pre-vaccination antibody concentration.

16 secondary outcomes

Anti-D and Anti-T Antibody Concentrations
Time frame: One month post Dose 3 (Month 3 or Month 5)
Anti-HBs Antibody Concentrations
Time frame: One month post Dose 3 (Month 3 or Month 5)
Anti-Polio Types 1, 2, 3 Antibody Titers
Time frame: One month post Dose 3 (Month 3 or Month 5)
Anti-PRP Antibody Concentrations
Time frame: One month post Dose 3 (Month 3 or Month 5)
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Time frame: One month post Dose 3 (Month 3 or Month 5)
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
Time frame: One month post Dose 3 (Month 3 or Month 5)
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens
Time frame: At Month 0
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
Time frame: At Month 0
Number of Seroprotected Subjects Against Anti-HBs Antigens
Time frame: At Month 0
Anti-Polio Types 1, 2 and 3 Antibody Titers
Time frame: At Month 0
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Time frame: At Month 0
Anti-HBs Antibody Concentrations
Time frame: At Month 0
Number of Subjects With Any Solicited Local Symptoms
Time frame: During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group)
Number of Subjects With Solicited General Symptoms
Time frame: During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group)
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: During the 31-day (Days 0-30) post-vaccination period: Up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group)
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period (from Month 0 up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group))

Results and safety

Results posted to the registry on 25 Jan 2019, 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 Hexa 6-10-14 Group	112	111
Infanrix Hexa 2-4-6 Group	112	112

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

Time frame: One month post Dose 3 (Month 3 or Month 5). Count of participants. Unit: Participants

Measure	Infanrix Hexa 6-10-14 Group n = 105	Infanrix Hexa 2-4-6 Group n = 106
Anti-D	105	106
Anti-T	105	106

Population analysed: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.

Primary outcome: Number of Seroprotected Subjects Against Hepatitis B (HBs)

Time frame: One month post Dose 3 (Month 3 or Month 5). Count of participants. Unit: Participants

Measure	Infanrix Hexa 6-10-14 Group n = 101	Infanrix Hexa 2-4-6 Group n = 105
Value	101	104

Primary outcome: Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens

Time frame: One month post Dose 3 (Month 3 or Month 5). Count of participants. Unit: Participants

Measure	Infanrix Hexa 6-10-14 Group n = 99	Infanrix Hexa 2-4-6 Group n = 99
Anti-Polio 1	99	99
Anti-Polio 2	77	88
Anti-Polio 3	73	79

Primary outcome: Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens

Time frame: One month post Dose 3 (Month 3 or Month 5). Count of participants. Unit: Participants

Measure	Infanrix Hexa 6-10-14 Group n = 105	Infanrix Hexa 2-4-6 Group n = 106
Value	104	105

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited 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 to Month 3 or Month 5).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Infanrix Hexa 6-10-14 Group	2 of 112 (1.8%)	45 of 112 (40.2%)	0 of 112
Infanrix Hexa 2-4-6 Group	3 of 112 (2.7%)	36 of 112 (32.1%)	0 of 112

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27629913Lalwani SK, Agarkhedkar S, Sundaram B, Mahantashetti NS, Malshe N, Agarkhedkar S, Van Der Meeren O, Mehta S, Karkada N, Han HH, Mesaros N. Immunogenicity and safety of 3-dose primary vaccination with combined DTPa-HBV-IPV/Hib in Indian infants. Hum Vaccin Immunother. 2017 Jan 2;13(1):120-127. doi: 10.1080/21645515.2016.1225639. Epub 2016 Sep 15.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. IPD is available via the Clinical Study Data Request site (click on the link provided below)

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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

4 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 hexa™ in people with Poliomyelitis and Tetanus, run by GlaxoSmithKline at 4 sites in India.

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 7 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 2 Jan 2020. 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 India. 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 25 Jan 2019). 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 Diphteria (D) and Tetanus (T) Antigens (time frame: One month post Dose 3 (Month 3 or Month 5)). The study lists 5 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 NCT01353703, 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 2 Jan 2020.