Immunogenicity and Safety of GSK Biologicals' Boostrix Polio Vaccine in 3 and 4-year-old Children

Tetanus Clinical Trial

Official title:

Immunogenicity and Safety of GSK Biologicals' dTpa-IPV Vaccine (Boostrix Polio) as a Booster Dose in 3 and 4-year-old Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01245049
• Other study ID #: 111763
• Status: Completed
• Phase: Phase 3
• Start date: April 1, 2011
• Est. completion date: April 2, 2012

Study information

• Verified date: June 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM Polio to that of Sanofi Pasteur MSD's RepevaxTM, when co-administered with a second dose of PriorixTM, in healthy 3 and 4-year-old children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 387
• Est. completion date: April 2, 2012
• Est. primary completion date: March 27, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 4 Years

Eligibility

Inclusion Criteria:

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol should be enrolled in the study.

• A male or female child of 3 or 4 years of age at the time of booster vaccination (up to, but excluding 5 years of age).

• Subjects who have received a complete three-dose primary vaccination with diphtheria-tetanus-acellular pertussis (DTPa) vaccine and inactivated poliovirus (IPV) vaccine in the first six months of life, in line with recommendations in the United Kingdom (UK).

• Subjects who received a first dose of a live attenuated measles-mumps-rubella vaccine within the second year of life, in line with recommendations in the UK.

• Written informed consent obtained from the parent(s)/LAR(s) of the subject at the time of enrolment.

• Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

• 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, or planned use during the study period.

• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.

• Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of inactivated influenza vaccine.

• 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.

• Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis since primary vaccination in the first year of life.

• Previous measles, mumps and/or rubella second dose vaccination.

• Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, measles, mumps and/or rubella disease.

• Known exposure to measles, mumps and/or rubella within 30 days prior to study start.

• Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.

• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.

• Administration of immunoglobulin 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.

• Occurrence of any of the following adverse events after a previous administration of a DTP vaccine:

• Hypersensitivity reaction to any component of the vaccine;

• Encephalopathy of unknown aetiology occurring within 7 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 or within 24 hours of study vaccine administration.

Related Conditions & MeSH terms

• Acellular Pertussis
• Diphtheria
• Poliomyelitis
• Tetanus

Intervention

Biological:
• Boostrix PolioTM
Single dose, intramuscular administration.
• RepevaxTM
Single dose, intramuscular administration.
• PriorixTM
Single dose, intramuscular or subcutaneous administration.

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Atherstone	Warwickshire
United Kingdom	GSK Investigational Site	Axbridge	Somerset
United Kingdom	GSK Investigational Site	Bangor
United Kingdom	GSK Investigational Site	Bolton, Nr Manchester
United Kingdom	GSK Investigational Site	Bristol
United Kingdom	GSK Investigational Site	Crumpsall, Manchester
United Kingdom	GSK Investigational Site	Exeter
United Kingdom	GSK Investigational Site	Lancashire
United Kingdom	GSK Investigational Site	Oxford
United Kingdom	GSK Investigational Site	Randalstown
United Kingdom	GSK Investigational Site	Southampton	Hampshire
United Kingdom	GSK Investigational Site	St Austell	Cornwall
United Kingdom	GSK Investigational Site	Taunton	Somerset

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With a Booster Response to Diphtheria (D) and Tetanus (T) Antigens	Booster response was defined as: For initially seronegative subjects [i.e. pre-vaccination concentration below (<) cut-off value of 0.1 international units per milliliter (IU/mL)] antibody concentrations at least four times the assay cut-off [post vaccination concentration greater than or equal to (=) 0.4 IU/ml]. For initially seropositive subjects (pre-vaccination concentration = 0.1 IU/ml), an increase in antibody concentrations of at least four times the Pre booster vaccination concentration.	At Month 1, one month after the booster vaccination
Primary	Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).	At Month 1, one month after the booster vaccination
Primary	Anti-Polio Virus Type 1, 2 and 3 Antibody Titers	Antibody titers were presented as geometric mean titers (GMTs).	At Month 1, one month after the booster vaccination
Secondary	Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)	A seroprotected subject was defined a subject with anti-D and anti-T antibody concentrations = 0.1 international units per millilitre (IU/mL).	Before (Month 0) and one month after (Month 1) the booster vaccination
Secondary	Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN	A seropositive subject for anti-PT, anti-FHA and anti-PRN was a subject whose antibody concentration was = 5 EL.U/mL.	Before (Month 0) and one month after (Month 1) the booster vaccination
Secondary	Number of Seroprotected Subjects Against Polio Type 1, 2 and 3	A seroprotected subject was defined as a subject with anti-polio type 1, 2 and 3 antibody titres = the value of 8.	Before (Month 0) and one month after (Month 1) the booster vaccination
Secondary	Number of Seropositive Subjects for Anti-measles Antibody	A seropositive subject was defined as a subject with anti-measles antibody titers = 150 mIU/mL.	Before (Month 0) and one month after (Month 1) the booster vaccination
Secondary	Number of Seropositive Subjects for Anti-mumps Antibody	A seropositive subject was defined as a subject with anti-mumps antibody titers = 231 U/mL.	Before (Month 0) and one month after (Month 1) the booster vaccination
Secondary	Number of Seropositive Subjects for Anti-rubella Antibody	A seropositive subject was defined as a subject with anti-rubella antibody titers = 4 IU/mL.	Before (Month 0) and one month after (Month 1) the booster vaccination
Secondary	Anti-D and Anti-T Antibody Concentrations	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.	Before (Month 0) and one month after (Month 1) the booster vaccination
Secondary	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.	At Month 0, before the booster vaccination
Secondary	Anti-mumps Antibody Concentrations	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in U/mL.	Before (Month 0) and one month after (Month 1) the booster vaccination
Secondary	Anti-measles Antibody Concentrations	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.	Before (Month 0) and one month after (Month 1) the booster vaccination
Secondary	Anti-rubella Antibody Concentrations	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.	Before (Month 0) and one month after (Month 1) the booster vaccination
Secondary	Anti-Polio Type 1, 2 and 3 Antibody Titers	Antibody titers were presented as geometric mean titers (GMTs).	At Month 0, before the booster vaccination
Secondary	Number of Subjects With a Booster Response to PT, FHA and PRN Antigens	Booster response was defined as: For initially seronegative subjects (pre-vaccination concentration < 5 EL.U/mL), antibody concentrations at least four times the assay cut-off (post vaccination concentration = 20 EL.U/mL). For initially seropositive subjects (with pre-vaccination concentration = 5 EL.U/mL and < 20 EL.U/mL), an increase in antibody concentrations of at least four times the Pre booster vaccination concentration. For initially seropositive subjects (with pre-vaccination concentration = 20 EL.U/mL), an increase in antibody concentrations of at least two times the Pre booster vaccination concentration.	At Month 1, one month after the booster vaccination
Secondary	Number of Subjects With Booster Response for Polio Type 1, 2 and 3 Antigens	Booster response defined as: For initially seronegative subjects, antibody titers at least four times the cut-off (post-vaccination titer = 32); For initially seropositive subjects, an increase in antibody titers of at least four times the Pre booster vaccination titer.	At Month 1, one month after the booster vaccination
Secondary	Number of Seroconverted Subjects for Anti-measles	Seroconversion for anti-measles was defined as the appearance of antibodies after vaccination in subjects who were initially seronegative [with antibody concentrations = 150 milli-international units per millilitre (mIU/mL)].	Before (Month 0) and one month after (Month 1) the booster vaccination
Secondary	Number of Seroconverted Subjects for Anti-mumps	Seroconversion for anti-mumps was defined as the appearance of antibodies after vaccination in subjects who were initially seronegative [with antibody concentrations = 231 units per millilitre (U/mL)].	Before (Month 0) and one month after (Month 1) the booster vaccination
Secondary	Number of Subjects With Any Solicited Local Symptoms	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.	During the 4-day (Days 0-3) follow-up period after booster vaccination
Secondary	Number of Subjects With Any Solicited General Symptoms	Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.	During the 4-day (Days 0-3) follow-up period after booster vaccination
Secondary	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.	During the 31-day (Days 0-30) follow-up period after booster vaccination
Secondary	Number of Subjects With Serious Adverse Events (SAEs)	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	During the entire study period (From Day 0 to Month 1)

External Links

•   IPD for this study will be made available via the Clinical Study Data Request site.