PoliomyelitisPhase 4NCT00611559

Study of a New Formulation of DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children

A Phase 4 study testing Infanrix™ penta and Infanrix™ hexa in people with Poliomyelitis and Acellular Pertussis, run by GlaxoSmithKline at 3 sites in Russia.

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 new formulation administered as a 4th consecutive dose will be compared to the current formulation of the vaccine in this partially double blind study. The study will be double-blind with respect to the two DTPa-HBV-IPV/Hib groups. The study will be open with respect to the DTPa-HBV-IPV group. Read more about this study

Who is it for?: Ages 18 to 23 monthsHealthy volunteers can take part
Conditions the study is for: Poliomyelitis, Acellular Pertussis, Tetanus
What is being tested?: Infanrix™ penta and Infanrix™ hexa
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 283 participants
Where: 3 sitesRussia
Study dates: 14 Feb 2008to 25 Jun 2008
Phase: Phase 4
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 18 to 23 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
Subjects must have completed full three-dose primary vaccination course with DTPa-HBV-IPV/Hib or DTPa-HBV-IPV in the primary study DTPa-HBV-IPV-109 (study NCT00320463).
A male or female between, and including 18 and 23 months of age at the time of the booster vaccination.
Written informed consent obtained from the parent or guardian 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 vaccines within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the booster dose.
Participation in another clinical study, between the primary study NCT00320463 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis and hepatitis B since the conclusion visit of study NCT00320463.
Previous booster vaccination against Haemophilus influenzae diseases in the DTPa-HBV-IPV/Hib groups, since the conclusion visit of study NCT00320463.

Show all 19Show fewer

History of exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae disease since the conclusion visit of study NCT00320463.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Acute disease at the time of enrolment.
Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
Any of the following adverse events having occurred after previous administration of DTP vaccine:
Hypersensitivity reaction due to the vaccine.
Encephalopathy defined as an acute, severe central nervous system disorder of unknown etiology occurring within 7 days following previous vaccination and generally consisting of major alterations in consciousness, unresponsiveness, generalized or focal seizures that persist more than a few hours, with failure to recover within 24 hours.
Any of the following adverse events having occurred after previous administration of DTP vaccine:
Temperature of >= 40.0 °C (axillary temperature), within 48 hours of vaccination.
Collapse or shock-like state within 48 hours of vaccination.
Persistent, inconsolable crying lasting >= 3 hours, occurring within 48 hours of vaccination.
Convulsions with or without fever, occurring within 3 days of vaccination

Trial locations and contacts

3 sites in 1 country.

Russia3 sites

GSK Investigational Site
Murmansk, 183046
GSK Investigational Site
Perm, 614022
GSK Investigational Site
Syktyvkar, 167000

Other trials in Russia

About this study

Official title: Immunogenicity and Reactogenicity Study of a New Formulation of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children

The new formulation administered as a 4th consecutive dose will be compared to the current formulation of the vaccine in this partially double blind study.

The study will be double-blind with respect to the two DTPa-HBV-IPV/Hib groups. The study will be open with respect to the DTPa-HBV-IPV group.

Conditions: Poliomyelitis, Acellular Pertussis, Tetanus, Diphtheria, Hepatitis B
Being tested: Infanrix™ penta, Infanrix™ hexa
Keywords: Infanrix hexa, combined vaccine
Medical subject headings: Poliomyelitis, Tetanus, Diphtheria, Hepatitis B

What participants receive

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

Infanrix™ pentaBiological
Also called Pediarix
Subjects received a booster dose
Infanrix™ hexaBiological
Subjects received a booster dose

Study groups in NCT00611559
Study group	Role	What they receive
Infanrix hexa Preservative-Free Formulation Group	Experimental	Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa Receives: Biological: Infanrix™ hexa
Infanrix hexa Preservative-Containing Formulation Group	Active comparator	Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa Receives: Biological: Infanrix™ hexa
Infanrix penta Preservative-Free Formulation Group	Active comparator	Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta. Receives: Biological: Infanrix™ penta

What is being measured

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

Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off One Month After the Booster Dose
Anti-HB antibodies cut-off value assessed was ≥ 10 milli-international units per milliliter (mIU/mL)
Measured: One month after the booster dose
Number of Subjects With Anti-polyribosyl-ribitol-phosphate (PRP) Antibodies Concentrations Above the Cut-off One Month After the Booster Dose
Anti-PRP antibodies cut-off value assessed was ≥ 0.15 microgram per milliliter (µg/mL)
Measured: One month after the booster dose
Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off One Month After the Booster Dose
Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was ≥ 0.1 international units per milliliter (IU/mL)
Measured: One month after the booster dose
Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose
Anti-poliovirus antibodies cut-off value assessed was ≥ 8 effective dose 50 (ED50)
Measured: One month after the booster dose
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose
Concentration of anti-PT, ant-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per millilitre (EL.U/mL)
Measured: One month after the booster dose

Secondary outcomes (13)

Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose
Anti-HB antibodies cut-off value assessed were ≥ 10 mIU/mL and ≥ 100 mIU/mL
Number of subjects with cut-off ≥ 10 mIU/mL one month after the booster dose was already presented in the primary outcomes
Measured: Before (Pre) and one month after (Post) the booster dose
Anti-HB Antibodies Concentration
Concentration of anti-HB antibodies given as GMC in mIU/mL
Measured: Before (Pre) and one month after (Post) the booster dose
Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose
Anti-PRP antibodies cut-off value assessed were ≥ 0.15 µg/mL and ≥ 1.0 µg/mL
Number of subjects with cut-off ≥ 0.15 µg/mL one month after the booster dose was already presented in the primary outcomes
Measured: Before (Pre) and one month after (Post) the booster dose
Anti-PRP Antibodies Concentration
Concentration of anti-PRP antibodies given as GMC in µg/mL
Measured: Before (Pre) and one month after (Post) the booster dose
Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off Before the Booster Dose
Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was ≥ 0.1 IU/mL
Measured: Before the booster dose administration (at baseline)
Anti-diphtheria and Anti-tetanus Antibodies Concentration
Concentration of anti-diphtheria and anti-tetanus antibodies given as GMC in IU/mL
Measured: Before (Pre) and one month after (Post) the booster dose
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose
Anti-PT, anti-FHA and anti-PRN antibodies cut-off value assessed were ≥ 5 EL.U/mL
Measured: Before (Pre) and one month after (Post) the booster dose
Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose
Concentration of anti-PT, anti-FHA and anti-PRN antibodies given as GMC in EL.U/mL
Measured: Before the booster dose administration (at baseline)
Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose
Anti-poliovirus antibodies cut-off value assessed was ≥ 8 ED50
Measured: Before the booster dose
Anti-poliovirus Antibodies Titer
Concentration of anti-poliovirus antibodies given as geometric mean titers (GMT)
Measured: Before (Pre) and one month after (Post) the booster dose
Number of Subjects Reporting Solicited Symptoms
Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite
Measured: Within the 4-day (Day 0-3) post-vaccination period
Number of Subjects Reporting Unsolicited Adverse Events (AE)
An AE is 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.
Measured: Within the 31-day (Day 0-30) post-vaccination period
Number of Subjects Reporting Serious Adverse Events (SAE)
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above
Measured: Up to one month after the booster dose administration

Timeline

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

14 Feb 200825 Jun 2008

First posted11 Feb 2008 (estimated)
Study start14 Feb 2008
Primary completion25 Jun 2008
Study completion25 Jun 2008

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 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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 283 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00611559
Sponsor's protocol ID: 110478
Status last verified: May 2017
First submitted: 29 Jan 2008
Last updated: 6 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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

Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
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
RecruitingPhase 1
Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults
Polio Immunity
Active, not recruiting
Effects of Virtual Walking on Chronic Pain and Psychological Distress for Individuals With Severe Mobility Impairment
Severe Mobility Impairment, Spinal Cord Injuries (SCI)

All Poliomyelitis 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 Reactogenicity Study of a New Formulation of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Administered as a Booster Dose to 18-23 Months Old Children
ClinicalTrials.gov ID: NCT00611559
Acronym / sponsor ID: 110478
Conditions: Poliomyelitis, Acellular Pertussis, Tetanus, Diphtheria, Hepatitis B
Keywords: Infanrix hexa, combined vaccine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 283 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 14 Feb 2008
Primary completion: 25 Jun 2008 (actual)
Study completion: 25 Jun 2008 (actual)
First posted: 11 Feb 2008 (estimated)
Results: Posted 10 Aug 2009

Clinical summary

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

The new formulation administered as a 4th consecutive dose will be compared to the current formulation of the vaccine in this partially double blind study.

The study will be double-blind with respect to the two DTPa-HBV-IPV/Hib groups. The study will be open with respect to the DTPa-HBV-IPV group.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Infanrix hexa Preservative-Free Formulation Group	Experimental	Biological: Infanrix™ hexaSubjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
Infanrix hexa Preservative-Containing Formulation Group	Active comparator	Biological: Infanrix™ hexaSubjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
Infanrix penta Preservative-Free Formulation Group	Active comparator	Biological: Infanrix™ pentaSubjects received a booster dose of the preservative-free formulation of Infanrix™ penta.

Who may qualify

Ages: 18 to 23 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
Subjects must have completed full three-dose primary vaccination course with DTPa-HBV-IPV/Hib or DTPa-HBV-IPV in the primary study DTPa-HBV-IPV-109 (study NCT00320463).
A male or female between, and including 18 and 23 months of age at the time of the booster vaccination.
Written informed consent obtained from the parent or guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Key exclusion criteria (19 listed)

Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the booster dose.
Participation in another clinical study, between the primary study NCT00320463 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis and hepatitis B since the conclusion visit of study NCT00320463.

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™ pentaAlso: PediarixSubjects received a booster dose	Biological	Infanrix penta Preservative-Free Formulation Group
Infanrix™ hexaSubjects received a booster dose	Biological	Infanrix hexa Preservative-Containing Formulation Group, Infanrix hexa Preservative-Free Formulation Group

Primary outcome

Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off One Month After the Booster Dose
Time frame: One month after the booster dose
Anti-HB antibodies cut-off value assessed was ≥ 10 milli-international units per milliliter (mIU/mL)
Number of Subjects With Anti-polyribosyl-ribitol-phosphate (PRP) Antibodies Concentrations Above the Cut-off One Month After the Booster Dose
Time frame: One month after the booster dose
Anti-PRP antibodies cut-off value assessed was ≥ 0.15 microgram per milliliter (µg/mL)
Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off One Month After the Booster Dose
Time frame: One month after the booster dose
Anti-diphtheria and anti-tetanus antibodies cut-off value assessed was ≥ 0.1 international units per milliliter (IU/mL)
Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose
Time frame: One month after the booster dose
Anti-poliovirus antibodies cut-off value assessed was ≥ 8 effective dose 50 (ED50)
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibodies Concentration One Month After the Booster Dose
Time frame: One month after the booster dose
Concentration of anti-PT, ant-FHA and anti-PRN antibodies given as geometric mean concentration (GMC) in Enzyme-Linked Immuno Sorbent Assay (ELISA) unit per millilitre (EL.U/mL)

13 secondary outcomes

Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off Before and One Month After the Booster Dose
Time frame: Before (Pre) and one month after (Post) the booster dose
Anti-HB Antibodies Concentration
Time frame: Before (Pre) and one month after (Post) the booster dose
Number of Subjects With Anti-PRP Antibodies Concentrations Above the Cut-off Before and One Month After the Booster Dose
Time frame: Before (Pre) and one month after (Post) the booster dose
Anti-PRP Antibodies Concentration
Time frame: Before (Pre) and one month after (Post) the booster dose
Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off Before the Booster Dose
Time frame: Before the booster dose administration (at baseline)
Anti-diphtheria and Anti-tetanus Antibodies Concentration
Time frame: Before (Pre) and one month after (Post) the booster dose
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibodies Concentration Above the Cut-off Before and One Month After the Booster Dose
Time frame: Before (Pre) and one month after (Post) the booster dose
Anti-PT, Anti-FHA, and Anti-PRN Antibodies Concentration Before the Booster Dose
Time frame: Before the booster dose administration (at baseline)
Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off Before the Booster Dose
Time frame: Before the booster dose
Anti-poliovirus Antibodies Titer
Time frame: Before (Pre) and one month after (Post) the booster dose
Number of Subjects Reporting Solicited Symptoms
Time frame: Within the 4-day (Day 0-3) post-vaccination period
Number of Subjects Reporting Unsolicited Adverse Events (AE)
Time frame: Within the 31-day (Day 0-30) post-vaccination period
Number of Subjects Reporting Serious Adverse Events (SAE)
Time frame: Up to one month after the booster dose administration

Results and safety

Results posted to the registry on 10 Aug 2009, 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 Preservative-free Formulation Group	111	110
Infanrix Hexa Preservative-containing Formulation Group	115	114
Infanrix Penta Preservative-free Formulation Group	57	56

Primary outcome: Number of Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off One Month After the Booster Dose

Time frame: One month after the booster dose. Number. Unit: subjects

Measure	Infanrix Hexa Preservative-free Formulation Group n = 91	Infanrix Hexa Preservative-containing Formulation Group n = 92	Infanrix Penta Preservative-free Formulation Group n = 48
Value	88	92	48

Population analysed: Analysis was performed on the According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available results

Primary outcome: Number of Subjects With Anti-polyribosyl-ribitol-phosphate (PRP) Antibodies Concentrations Above the Cut-off One Month After the Booster Dose

Time frame: One month after the booster dose. Number. Unit: subjects

Measure	Infanrix Hexa Preservative-free Formulation Group n = 76	Infanrix Hexa Preservative-containing Formulation Group n = 79	Infanrix Penta Preservative-free Formulation Group n = 42
Value	74	78	27

Population analysed: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Primary outcome: Number of Subjects With Anti-diphtheria and Anti-tetanus Antibodies Concentration Above the Cut-off One Month After the Booster Dose

Time frame: One month after the booster dose. Number. Unit: subjects

Measure	Infanrix Hexa Preservative-free Formulation Group n = 77	Infanrix Hexa Preservative-containing Formulation Group n = 79	Infanrix Penta Preservative-free Formulation Group n = 42
Anti-diphtheria	76	76	40
Anti-tetanus	76	78	42

Population analysed: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

Primary outcome: Number of Subjects With Anti-poliovirus Antibodies Concentration Above the Cut-off One Month After the Booster Dose

Time frame: One month after the booster dose. Number. Unit: subjects

Measure	Infanrix Hexa Preservative-free Formulation Group n = 55	Infanrix Hexa Preservative-containing Formulation Group n = 52	Infanrix Penta Preservative-free Formulation Group n = 31
Anti-poliovirus type 1	55	51	31
Anti-poliovirus type 2	55	51	30
Anti-poliovirus type 3	55	52	29

Population analysed: Analysis was performed on the ATP cohort for analysis of immunogenicity, on subjects with available results

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Infanrix Hexa Preservative-free Formulation Group	0 of 111 (0%)	59 of 111 (53.2%)	0 of 111
Infanrix Hexa Preservative-containing Formulation Group	0 of 115 (0%)	62 of 115 (53.9%)	0 of 115
Infanrix Penta Preservative-free Formulation Group	0 of 57 (0%)	26 of 57 (45.6%)	0 of 57

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.
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. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Related trials for Poliomyelitis

Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
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
RecruitingPhase 1
Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults
Polio Immunity
Active, not recruiting
Effects of Virtual Walking on Chronic Pain and Psychological Distress for Individuals With Severe Mobility Impairment
Severe Mobility Impairment, Spinal Cord Injuries (SCI)

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

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Infanrix™ penta and Infanrix™ hexa in people with Poliomyelitis and Acellular Pertussis, run by GlaxoSmithKline at 3 sites in Russia.

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 19 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 3 sites in Russia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 Aug 2009). 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 Subjects With Anti-hepatitis B (HB) Antibody Concentrations Above the Cut-off One Month After the Booster Dose (time frame: One month after the booster dose). 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 NCT00611559.

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.