Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Poliorix™ Vaccine

NCT01021293 | Completed Phase 3 Results

• 2 other identifiers: 1126792011-003167-30
• Study Type: interventional
• Target: 1,101
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Poliomyelitis; Poliomyelitis Vaccines

Keywords

Poliorix; IPV

Outcome Measures

Primary Outcomes (1)

• 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).

  At Month 3, one month after the third vaccine dose

Secondary Outcomes (6)

• Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3

  At Day 0, prior to the first vaccine dose

• Anti-poliovirus Types 1, 2 and 3 Antibody Titers

  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

  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

  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)

  Within the 31-day (Days 0-30) post-vaccination period

Study Arms (2)

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.

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.

Biological: Oral Poliovirus vaccine

Interventions

Poliorix™ BIOLOGICAL

3 doses, intramuscular administration

Poliorix Group

Oral Poliovirus vaccine BIOLOGICAL

3 doses, oral administration

Control Group

Eligibility Criteria

• Age: 60 Days - 90 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Current febrile illness or axillary temperature \> 37.0 ºC or other moderate to severe illness within 24 hours of study vaccine administration.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Wuzhou, Guangxi, China

Location

Related Publications (2)

• 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.

  BACKGROUND

• 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 BACKGROUND

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

Poliovirus Vaccine, Oral

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

Intervention Hierarchy (Ancestors)

Poliovirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

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: November 25, 2009
• First Posted: November 26, 2009
• Study Start: November 28, 2009
• Primary Completion: July 5, 2010
• Study Completion: July 5, 2010
• Last Updated: January 21, 2020
• Results First Posted: April 25, 2017

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

CN (1)