PoliomyelitisPhase 3NCT01323647

Immunogenicity and Safety of Booster Dose of PoliorixTM Vaccine in Previously Vaccinated Toddlers

A Phase 3 study testing PoliorixTM and Infanrix+Hib in people with 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

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Trial summary

Who is it for?: Ages 18 to 24 monthsHealthy volunteers can take part
Conditions the study is for: Poliomyelitis
What is being tested?: PoliorixTM and Infanrix+Hib
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 957 participants
Where: 2 sitesChina
Study dates: 25 Apr 2011to 19 Sep 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 24 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
Subjects who received the complete three-dose primary vaccination course in study NCT01021293.
Healthy male or female toddlers 18 to 24 months of age at the time of Visit 1 (Day 0).
Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Who cannot join

Child in care.
Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine(s), or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to Visit 1 (Day 0).
Administration of immunoglobulins and/or any blood products within the 3 months preceding Visit 1 (Day 0) or planned administration during the study period.
Administration of a vaccine not foreseen by the study protocol within 30 days of Visit 1 (Day 0) or planned administration during the study period.
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 12Show fewer

Evidence of previous booster vaccination against poliomyelitis or the disease since the conclusion visit of Study NCT01021293.
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.
Major congenital defects or serious chronic illness.
Acute disease and/or fever at the time of enrolment.

Trial locations and contacts

2 sites in 1 country.

China2 sites

GSK Investigational Site
Mengshan Town
GSK Investigational Site
Wuzhou, Guangxi

Other trials in China

About this study

Official title: Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (PoliorixTM) in Healthy Chinese Toddlers

This study aims to evaluate the persistence of anti-poliovirus antibodies in toddlers aged 18 months who were primed with oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in the primary study. The study will also assess the immunogenicity and reactogenicity of a booster dose of IPV in subjects primed with three doses of IPV.

Read the detailed description

All subjects will also receive a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) at Day 0. This vaccine will be provided as part of the local standard of care and will not be associated with any study endpoint.

Conditions: Poliomyelitis
Being tested: PoliorixTM, Infanrix+Hib
Keywords: IPV, PoliorixTM, China
Medical subject headings: Poliomyelitis

What participants receive

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

PoliorixTMBiological
Single dose, intramuscular administration
Infanrix+HibBiological
Single dose, intramuscular injection. Part of the local standard of care. No outcome measures associated.

Study groups in NCT01323647
Study group	Role	What they receive
Group A	Experimental	Subjects in this group will receive the GSK Biologicals' IPV vaccine at 18 months of age. Subjects will also receive a dose of DTPa/Hib (Infanrix+Hib) as part of the local standard of care. Receives: Biological: PoliorixTM; Biological: Infanrix+Hib
Group B	Active comparator	Subjects in this group will receive only a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) as part of the local standard of care and will not be associated with any study endpoint. Receives: Biological: Infanrix+Hib

What is being measured

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

Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value
A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 Effective Dose 50 (ED50). This outcome measure concerns subjects in the Poliorix Group only.
Measured: One month after Poliorix™ booster vaccination.
Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value
A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 ED50.
Measured: Before booster vaccination.
Antibody Titers Against Poliovirus Type 1, 2 and 3
Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals (CIs). This outcome measure concerns subjects in the Poliorix Group only.
Measured: One month after Poliorix™ booster vaccination.
Antibody Titers Against Poliovirus Type 1, 2 and 3.
Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs.
Measured: Before booster vaccination.

Secondary outcomes (4)

Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Cry 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 in the Poliorix Group only.
Measured: Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Solicited general symptoms assessed include drowsiness, irritability, loss of appetite and fever [defined as axillary temperature ≥ 37.1 degrees Celsius (°C)]. Any = occurence of any general symptom regardless of their intensity grade or relationship to study vaccine. Grade 3 drowsiness = drowsiness that prevented normal activities. Grade 3 fever = fever (axillary temperature) >39.0°C. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as causally related to the vaccination. This outcome measure concerns subjects in the Poliorix Group only.
Measured: Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
Number of Subjects Reporting 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. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. This outcome measure concerns subjects in the Poliorix Group only.
Measured: Within the 31-day (Days 0-30) follow-up period after the Poliorix™ booster vaccination.
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
Measured: During the entire study period (Day 0 to Month 1).

Timeline

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

25 Apr 201119 Sep 2011

First posted25 Mar 2011 (estimated)
Study start25 Apr 2011
Primary completion19 Sep 2011
Study completion19 Sep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 957 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01323647
Sponsor's protocol ID: 114306
Status last verified: May 2017
First submitted: 24 Mar 2011
Last updated: 11 Feb 2019
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.

Publications

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 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (PoliorixTM) in Healthy Chinese Toddlers
ClinicalTrials.gov ID: NCT01323647
Acronym / sponsor ID: 114306
Conditions: Poliomyelitis
Keywords: IPV, PoliorixTM, China
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 957 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 25 Apr 2011
Primary completion: 19 Sep 2011 (actual)
Study completion: 19 Sep 2011 (actual)
First posted: 25 Mar 2011 (estimated)
Results: Posted 7 Dec 2016

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
Group A	Experimental	Biological: PoliorixTM, Biological: Infanrix+HibSubjects in this group will receive the GSK Biologicals' IPV vaccine at 18 months of age. Subjects will also receive a dose of DTPa/Hib (Infanrix+Hib) as part of the local standard of care.
Group B	Active comparator	Biological: Infanrix+HibSubjects in this group will receive only a booster dose of GSK Biologicals' DTPa/Hib vaccine (Infanrix+Hib) as part of the local standard of care and will not be associated with any study endpoint.

Who may qualify

Ages: 18 to 24 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
Subjects who received the complete three-dose primary vaccination course in study NCT01021293.
Healthy male or female toddlers 18 to 24 months of age at the time of Visit 1 (Day 0).
Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Key exclusion criteria (12 listed)

Child in care.
Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine(s), or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to Visit 1 (Day 0).
Administration of immunoglobulins and/or any blood products within the 3 months preceding Visit 1 (Day 0) or planned administration during the study period.
Administration of a vaccine not foreseen by the study protocol within 30 days of Visit 1 (Day 0) or planned administration during the study period.

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
PoliorixTMSingle dose, intramuscular administration	Biological	Group A
Infanrix+HibSingle dose, intramuscular injection. Part of the local standard of care. No outcome measures associated.	Biological	Group A, Group B

Primary outcome

Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value
Time frame: One month after Poliorix™ booster vaccination.
A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 Effective Dose 50 (ED50). This outcome measure concerns subjects in the Poliorix Group only.
Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value
Time frame: Before booster vaccination.
A seroprotected subject was defined as a vaccinated subject whose antibody titer is greater than or equal to (≥) 8 ED50.
Antibody Titers Against Poliovirus Type 1, 2 and 3
Time frame: One month after Poliorix™ booster vaccination.
Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals (CIs). This outcome measure concerns subjects in the Poliorix Group only.
Antibody Titers Against Poliovirus Type 1, 2 and 3.
Time frame: Before booster vaccination.
Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs.

4 secondary outcomes

Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Time frame: Within 4-days (Days 0-3) post Poliorix™ booster vaccination.
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Time frame: Within the 31-day (Days 0-30) follow-up period after the Poliorix™ booster vaccination.
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period (Day 0 to Month 1).

Results and safety

Results posted to the registry on 7 Dec 2016, 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	470	461
Control Group	487	487

Primary outcome: Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value

Time frame: One month after Poliorix™ booster vaccination.. Count of participants. Unit: Participants

Measure	Poliorix Group n = 456
Anti-poliovirus 1	456
Anti-poliovirus 2	456
Anti-poliovirus 3	456

Population analysed: The According-to-Protocol (ATP) cohort for immunogenicity included all evaluable subjects who did not receive a product or present a medical condition leading to exclusion from an ATP analysis as listed in protocol and for whom data concerning immunogenicity outcome variables were available.

Primary outcome: Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value

Time frame: Before booster vaccination.. Count of participants. Unit: Participants

Measure	Poliorix Group n = 470	Control Group n = 484
Anti-poliovirus 1	462	479
Anti-poliovirus 2	445	482
Anti-poliovirus 3	446	465

Population analysed: The ATP cohort for antibody persistence included all subjects who completed the full 3-dose primary vaccination course in the primary study and have not received an additional dose of Poliorix vaccine since the primary study.Those who had no history of poliovirus infection,and for whom serological results were available at the persistence timepoint

Primary outcome: Antibody Titers Against Poliovirus Type 1, 2 and 3

Time frame: One month after Poliorix™ booster vaccination.. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Poliorix Group n = 456
Anti-poliovirus 1	3420.8 (3153.8 to 3710.5)
Anti-poliovirus 2	1886.8 (1732.7 to 2054.5)
Anti-poliovirus 3	5097 (4706.8 to 5519.6)

Population analysed: The ATP cohort for immunogenicity included all evaluable subjects who did not receive a product or present a medical condition leading to exclusion from an ATP analysis as listed in protocol and for whom data concerning immunogenicity outcome variables were available.

Primary outcome: Antibody Titers Against Poliovirus Type 1, 2 and 3.

Time frame: Before booster vaccination.. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Poliorix Group n = 470	Control Group n = 484
Anti-poliovirus 1	97.6 (87.3 to 109.2)	533.0 (468.0 to 607.0)
Anti-poliovirus 2	87.8 (75.4 to 102.2)	205.5 (185.6 to 227.5)
Anti-poliovirus 3	109.7 (94.2 to 127.8)	85.0 (76.1 to 95.0)

4 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-Poliorix™ booster vaccination period; Unsolicited symptoms: during the 31-day (Days 0-30) post-Poliorix™ booster vaccination period. Serious Adverse Events (SAEs): during the entire study period (Day 0 to Month 1).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Poliorix Group	0 of 470 (0%)	202 of 470 (43%)	0 of 470
Control Group	1 of 487 (0.2%)	0 of 0	0 of 487

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: 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. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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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 PoliorixTM and Infanrix+Hib in people with 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 12 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 11 Feb 2019. 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 7 Dec 2016). 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 Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value (time frame: One month after Poliorix™ booster vaccination.). 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 NCT01323647, 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 11 Feb 2019.