Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers

NCT ID: NCT01106092

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-13
• Study Completion Date: 2010-09-02

Brief Summary

The purpose of the study is to assess the immunogenicity and safety of three formulations of GSK Biologicals' GSK2036874A vaccine compared to Zilbrix™/Hib and Poliorix™ vaccines administered concomitantly, when administered as a single booster dose to healthy poliovirus-primed toddlers aged 12-24 months.

Detailed Description

The study will be conducted in a partially double-blinded manner. The study will be double-blinded with respect to the three GSK2036874A formulation groups and open-label with respect to the Control Group.

Conditions

Haemophilus Influenzae Type b; Tetanus; Hepatitis B; Whole Cell Pertussis; Diphtheria; Poliomyelitis Vaccines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

GSK2036874A GROUP 1

Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.

Group Type: EXPERIMENTAL

GSK2036874A vaccine

Intervention Type: BIOLOGICAL

Intramuscular, single dose

GSK2036874A GROUP 2

Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.

Group Type: EXPERIMENTAL

GSK2036874A vaccine

Intervention Type: BIOLOGICAL

Intramuscular, single dose

GSK2036874A GROUP 3

Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.

Group Type: EXPERIMENTAL

GSK2036874A vaccine

Intervention Type: BIOLOGICAL

Intramuscular, single dose

ZILBRIX/HIB/POLIORIX GROUP

Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.

Group Type: ACTIVE_COMPARATOR

Zilbrix™/Hib vaccine

Intervention Type: BIOLOGICAL

Intramuscular, single dose

Poliorix™

Intervention Type: BIOLOGICAL

Intramuscular, single dose

Interventions

GSK2036874A vaccine

Intramuscular, single dose

Intervention Type: BIOLOGICAL

Zilbrix™/Hib vaccine

Intramuscular, single dose

Intervention Type: BIOLOGICAL

Poliorix™

Intramuscular, single dose

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• A male or female subject, between and including 12 and 24 months of age at the time of booster vaccination.
• Subjects who have received three doses of polio vaccine as primary vaccination along with the routine vaccinations indicated during the first year of life.
• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (s) can and will comply with the requirements of the protocol.
• 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.

Exclusion Criteria

• Use of any investigational or non-registered product other than the study vaccine(s) 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.
• Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination, or planned administration during the active study period (up to Visit 2).
• 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.
• History of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenza type b diseases.
• Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or H. influenzae diseases.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• A family history of congenital or hereditary immunodeficiency.
• Major congenital defects or serious chronic illness.
• History of neurologic disorders or seizures.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
• Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
• Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
• Child in care.
• Occurrence of any of the following adverse events after a previous administration of a diphtheria-tetanus-pertussis vaccine:

• encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine,
• fever >= 40 °C within 48 hours of vaccination not due to another identifiable cause,
• collapse or shock-like state within 48 hours of vaccination,
• convulsions with or without fever, occurring within 3 days of vaccination.
• Acute disease and/or fever at the time of enrolment.

• Fever is defined as temperature >= 37.5°C on oral, axillary or tympanic setting, or >= 38.0°C on rectal setting.
• Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
• Other conditions which, in the opinion of the investigator, may potentially interfere with interpretation of study results.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

City of Muntinlupa, , Philippines

Countries

Philippines

References

Quiambao B, Van Der Meeren O, Kolhe D, Gatchalian S. A randomized, dose-ranging assessment of the immunogenicity and safety of a booster dose of a combined diphtheria-tetanus-whole cell pertussis-hepatitis B-inactivated poliovirus-Hemophilus influenzae type b (DTPw-HBV-IPV/Hib) vaccine vs. co-administration of DTPw-HBV/Hib and IPV vaccines in 12 to 24 months old Filipino toddlers. Hum Vaccin Immunother. 2012 Mar;8(3):347-54. doi: 10.4161/hv.18630. Epub 2012 Feb 14.

Reference Type: BACKGROUND

PMID: 22330958 (View on PubMed)

Quiambao B et al. The immunogenicity and safety of a new combined DTPw-HBV-IPV/HIB vaccine when administered as a booster dose in Filipino toddlers. Abstract presented at the 7th World Congress for World Society for Pediatric Infectious Diseases (WSPID), Melbourne, Australia, 16-19 November 2011.

Reference Type: BACKGROUND

Study Documents

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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Other Identifiers

2016-000645-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

113264

Identifier Type: -

Identifier Source: org_study_id