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

NCT01323647 | Completed Phase 3 Results

• 1 other identifier: 114306
• Study Type: interventional
• Target: 957
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Poliomyelitis

Keywords

IPV; PoliorixTM; China

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Before booster vaccination.

Secondary Outcomes (4)

• Number of Subjects With Any and Grade 3 Solicited Local Symptoms

  Within 4-days (Days 0-3) post Poliorix™ booster vaccination.

• Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.

  Within 4-days (Days 0-3) post Poliorix™ booster vaccination.

• Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)

  Within the 31-day (Days 0-30) follow-up period after the Poliorix™ booster vaccination.

• Number of Subjects With Serious Adverse Events (SAEs)

  During the entire study period (Day 0 to Month 1).

Study Arms (2)

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.

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.

Biological: Infanrix+Hib

Interventions

PoliorixTM BIOLOGICAL

Single dose, intramuscular administration

Group A

Infanrix+Hib BIOLOGICAL

Single dose, intramuscular injection. Part of the local standard of care. No outcome measures associated.

Group A; Group B

Eligibility Criteria

• Age: 18 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Wuzhou, Guangxi, China

Location

GSK Investigational Site

Mengshan Town, China

Location

Related Publications (1)

• 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.

  PMID: 26873055 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Poliomyelitis

Interventions

diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2011
• First Posted: March 25, 2011
• Study Start: April 25, 2011
• Primary Completion: September 19, 2011
• Study Completion: September 19, 2011
• Last Updated: February 11, 2019
• Results First Posted: December 7, 2016

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (2)