PoliomyelitisPhase 3NCT01021293

Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Poliorix™ Vaccine

A Phase 3 study testing Poliorix™ and Oral Poliovirus vaccine in people with Poliomyelitis and Poliomyelitis Vaccines, run by GlaxoSmithKline at 1 site in China.

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 the study is to evaluate the immunogenicity and safety of Poliorix™ when administered to healthy Chinese infants at 2, 3 and 4 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: Poliomyelitis, Poliomyelitis Vaccines
What is being tested?: Poliorix™ and Oral Poliovirus vaccine
Type of treatment: Vaccines, Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,101 participants
Where: 1 siteChina
Study dates: 28 Nov 2009to 5 Jul 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 vaccination.
Born after a gestation period of 36 to 42 weeks inclusive.
Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (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.

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.
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 exception of DTP, Hib and/or hepatitis B vaccine(s).
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.
Evidence of previous or intercurrent poliomyelitis disease or vaccination.

Show all 13Show fewer

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.
Child in care.
The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved and if no other exclusion criteria are met:
Current febrile illness or axillary temperature > 37.0 ºC or other moderate to severe illness within 24 hours of study vaccine administration.

Trial locations and contacts

1 site in 1 country.

China1 site

GSK Investigational Site
Wuzhou, Guangxi

Other trials in China

About this study

Official title: Immunogenicity and Safety of GSK Biologicals' IPV (Poliorix™) in Infants

The purpose of the study is to evaluate the immunogenicity and safety of Poliorix™ when administered to healthy Chinese infants at 2, 3 and 4 months of age.

Conditions: Poliomyelitis, Poliomyelitis Vaccines
Being tested: Poliorix™, Oral Poliovirus vaccine
Keywords: Poliorix, IPV
Medical subject headings: Poliomyelitis

What participants receive

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

Poliorix™Biological
3 doses, intramuscular administration
Oral Poliovirus vaccineBiological
3 doses, oral administration

Study groups in NCT01021293
Study group	Role	What they receive
Poliorix Group	Experimental	Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh. Receives: Biological: Poliorix™
Control Group	Active comparator	Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China. Receives: Biological: Oral Poliovirus vaccine

What is being measured

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

Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
A seroprotected subject was defined as a vaccinated subject with anti-polio types 1, 2 and 3 titers greater than or equal to (≥) 8 effective dose 50 (ED50).
Measured: At Month 3, one month after the third vaccine dose

Secondary outcomes (6)

Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
A seroprotected subject was defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 titers ≥ 8 ED50.
Measured: At Day 0, prior to the first vaccine dose
Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Measured: Prior to the first vaccine dose (Day 0) and one month after the third vaccine dose (Month 3)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. This outcome measure concerns subjects from the Poliorix Group only.
Measured: During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, gastrointestinal symptoms, irritability/fussiness, loss of appetite and fever [defined as axillary temperature higher than (>) 37.0°C degrees Celsius]. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = subject did not eat at all. Grade 3 gastrointestinal symptoms = gastrointestinal symptoms that prevented normal activity. Grade 3 fever= temperature > 39°C. Related = symptom assessed by the investigator as causally related to the vaccination.
Measured: During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across doses
Number of Subjects With Any 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: Within the 31-day (Days 0-30) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity.
Measured: During the entire study period (from Day 0 to Month 3)

Timeline

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

28 Nov 20095 Jul 2010

First posted26 Nov 2009 (estimated)
Study start28 Nov 2009
Primary completion5 Jul 2010
Study completion5 Jul 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.
Publications (2)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: 1,101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01021293
Sponsor's protocol ID: 112679
Other IDs: 2011-003167-30
Status last verified: Jan 2020
First submitted: 25 Nov 2009
Last updated: 21 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

Li R et al. Immunogenicity and safety of an inactivated poliovirus vaccine in Chinese infants. Abstract presented at the 7th World Congress for World Society for Pediatric Infectious Diseases (WSPID). The Melbourne, The Australia, 16-19 November 2011.
Li R, Li CG, Li Y, Liu Y, Zhao H, Chen X, Kuriyakose S, Van Der Meeren O, Hardt K, Hezareh M, Roy-Ghanta S. Primary and booster vaccination with an inactivated poliovirus vaccine (IPV) is immunogenic and well-tolerated in infants and toddlers in China. Vaccine. 2016 Mar 14;34(12):1436-43. doi: 10.1016/j.vaccine.2016.02.010. Epub 2016 Feb 9.
PubMed 26873055

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 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety of GSK Biologicals' IPV (Poliorix™) in Infants
ClinicalTrials.gov ID: NCT01021293
Acronym / sponsor ID: 112679
Conditions: Poliomyelitis, Poliomyelitis Vaccines
Keywords: Poliorix, IPV
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,101 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 28 Nov 2009 (actual)
Primary completion: 5 Jul 2010 (actual)
Study completion: 5 Jul 2010 (actual)
First posted: 26 Nov 2009 (estimated)
Results: Posted 25 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 safety of Poliorix™ when administered to healthy Chinese infants at 2, 3 and 4 months of age.

Study design

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

Arm	Type	Receives
Poliorix Group	Experimental	Biological: Poliorix™Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
Control Group	Active comparator	Biological: Oral Poliovirus vaccineHealthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.

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 vaccination.
Born after a gestation period of 36 to 42 weeks inclusive.
Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (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)

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.
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 exception of DTP, Hib and/or hepatitis B vaccine(s).
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.

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
Poliorix™3 doses, intramuscular administration	Biological	Poliorix Group
Oral Poliovirus vaccine3 doses, oral administration	Biological	Control Group

Primary outcome

Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Time frame: At Month 3, one month after the third vaccine dose
A seroprotected subject was defined as a vaccinated subject with anti-polio types 1, 2 and 3 titers greater than or equal to (≥) 8 effective dose 50 (ED50).

6 secondary outcomes

Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Time frame: At Day 0, prior to the first vaccine dose
Anti-poliovirus Types 1, 2 and 3 Antibody Titers
Time frame: Prior to the first vaccine dose (Day 0) and one month after the third vaccine dose (Month 3)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 4-day (Days 0-3) post-vaccination period following each vaccine dose and across doses
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: Within the 31-day (Days 0-30) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period (from Day 0 to Month 3)

Results and safety

Results posted to the registry on 25 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
Poliorix Group	550	538
Control Group	550	526

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

Time frame: At Month 3, one month after the third vaccine dose. Count of participants. Unit: Participants

Measure	Poliorix Group n = 306	Control Group n = 296
Anti-poliovirus 1	306	296
Anti-poliovirus 2	306	296
Anti-poliovirus 3	306	291

Poliorix Group vs Control Group: Difference in seroprotection rate: 0 (95% CI -1.28 to 1.24)
Poliorix Group vs Control Group: Difference in seroprotection rate: 0 (95% CI -1.28 to 1.24)
Poliorix Group vs Control Group: Difference in seroprotection rate: -1.69 (95% CI -3.9 to -0.44)

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

6 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: within the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Month 3).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Poliorix Group	3 of 550 (0.5%)	391 of 550 (71.1%)	0 of 550
Control Group	6 of 550 (1.1%)	366 of 550 (66.5%)	0 of 550

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundLi R et al. Immunogenicity and safety of an inactivated poliovirus vaccine in Chinese infants. Abstract presented at the 7th World Congress for World Society for Pediatric Infectious Diseases (WSPID). The Melbourne, The Australia, 16-19 November 2011.
Background: PubMed 26873055Li R, Li CG, Li Y, Liu Y, Zhao H, Chen X, Kuriyakose S, Van Der Meeren O, Hardt K, Hezareh M, Roy-Ghanta S. Primary and booster vaccination with an inactivated poliovirus vaccine (IPV) is immunogenic and well-tolerated in infants and toddlers in China. Vaccine. 2016 Mar 14;34(12):1436-43. doi: 10.1016/j.vaccine.2016.02.010. Epub 2016 Feb 9.
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

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Poliorix™ and Oral Poliovirus vaccine in people with Poliomyelitis and Poliomyelitis Vaccines, run by GlaxoSmithKline at 1 site 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 21 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 1 site 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 25 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 Poliovirus Types 1, 2 and 3 (time frame: At Month 3, one month after the third vaccine dose). 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 NCT01021293, which also lists 2 linked publications.

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 21 Jan 2020.