Last updated: 01/22/2020 10:50:15
Immune response and safety comparison of 3 lots of GSK Biologicals' DTaP-IPV candidate vaccine to DTaP + IPV vaccines
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Safety, immunogenicity and consistency of 3 manufacturing lots of DTaP-IPV vaccine versus separate injections of GSK Biologicals' DTaP + Aventis Pasteur's IPV administered as booster doses to healthy children 4-6 years, each co-administered with Merck's MMR vaccine
Trial description: The aims of this trial are to demonstrate the consistency of three manufacturing lots of GSK Biologicals' DTaP-IPV candidate vaccine in terms of immunogenicity and to evaluate the non-inferiority of GSK Biologicals' DTaP-IPV vaccine with respect to immunogenicity and safety compared to the control vaccines (separate injections of GSK Biologicals' DTaP vaccine [Infanrix] and Aventis Pasteur's IPV vaccine [IPOL]) when administered as a 5th dose of DTaP and a 4th dose of inactivated poliovirus vaccine in subjects 4 to 6 years of age. Vaccines will be co-administered with the second dose of M-M-RII, which is recommended at this age. Concomitant administration of a US-licensed influenza vaccine will be allowed according to seasonal availability of vaccine and at the discretion of the investigator.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Geometric Mean Concentrations (GMCs) for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies in a subset of subjects
Timeframe: At Month 1 (i.e. one month after vaccination)
Geometric Mean Concentrations (GMCs) for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibodies in a subset of subjects
Timeframe: At Month 1 (i.e. one month after vaccination)
Geometric Mean Titers (GMTs) for anti-poliovirus types 1, 2 and 3 antibodies in a subset of subjects
Timeframe: At Month 1 (i.e. one month after vaccination)
Number of subjects with booster response against diphtheria toxoid (D) and tetanus toxoid (T) antigens in a subset of subjects
Timeframe: At Month 1 (i.e. one month after vaccination)
Number of subjects with booster response against pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN) antigens in a subset of subjects
Timeframe: At Month 1 (i.e. one month after vaccination)
Number of subjects with circumferential swelling at the injection site
Timeframe: Within 4 days (Day 0-3) after vaccination
Secondary outcomes:
Number of seroprotected subjects against diphteria (D) and tetanus (T) antigens in a subset of subjects
Timeframe: At Month 1 (i.e. one month after vaccination)
Number of seroprotected subjects against poliovirus types 1, 2 and 3 antigens in a subset of subjects
Timeframe: At Month 1 (i.e. one month after vaccination)
Number of seropositive subjects against pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN) antigens in a subset of subjects
Timeframe: At Month 1 (i.e. one month after vaccination)
Number of subjects with anti-D and anti-T antibody concentrations greater than or equal to (≥) 1 IU/mL
Timeframe: At Month 1 (i.e. one month after vaccination)
Number of subjects with booster response for poliovirus types 1, 2 and 3 antigens in a subset of subjects
Timeframe: At Month 1 (i.e. one month after vaccination)
Geometric mean titers (GMTs) for serum haemagglutination-inhibition (HI) anti-H1N1, anti-H3N2 and anti-B antibodies in a subset of subjects
Timeframe: At Day 0 (i.e. before vaccination) and at Month 1 (i.e. one month after vaccination)
Number of seroconverted subjects against influenza virus strains H1N1, H3N2, and B in a subset of subjects
Timeframe: At Month 1 (i.e. one month after vaccination)
Number of seroprotected subjects against influenza virus strains H1N1, H3N2, and B in a subset of subjects
Timeframe: At Day 0 (i.e. before vaccination) and at Month 1 (i.e. one month after vaccination)
Number of subjects with any and Grade 3 solicited local symptoms
Timeframe: During the 4-day (Day 0-3) post-vaccination period
Number of subjects with any and Grade 3 increase in the mid-upper arm circumference at the injection site
Timeframe: During the 4-day (Day 0-3) post-vaccination period
Number of subjects with any, Grade 3 and related solicited general symptoms
Timeframe: During the 4-day (Day 0-3) post-vaccination period
Number of subjects with any, Grade 3 and related solicited general symptoms specific to M-M-R II vaccination
Timeframe: During the 15-day (Day 0-14) post-vaccination period
Number of subjects with any unsolicited adverse events (AEs)
Timeframe: Within 31 days (Days 0-30) post-vaccination period
Number of subjects with serious adverse events (SAEs)
Timeframe: During the entire study period (from Day 0 through 6 months [minimum 182 days post-vaccination])
Number of subjects with onset of chronic illness(es) and AE(s) leading to emergency room (ER) or to physician office visits
Timeframe: During the extended safety follow-up phase (i.e. 5 months following the active phase [from Day 31 up to minimum 182 days post-vaccination])
Interventions:
Biological/vaccine: SB213503 lot 1
Biological/vaccine: SB213503 lot 2
Biological/vaccine: SB213503 lot 3
Biological/vaccine: Infanrix
Biological/vaccine: IPOL
Biological/vaccine: M-M-R II
Enrollment:
4209
Observational study model:
Not applicable
Primary completion date:
2006-01-11
Time perspective:
Not applicable
Clinical publications:
Black S et al. (2008) Diphtheria-Tetanus-Acellular Pertussis and Inactivated Poliovirus Vaccines Given Separately or Combined for Booster Dosing at 4-6 Years of Age. Pediatr Infect Dis J. 27(4):341-346.
Weston WM et al. (2008) Kinrix: A new combination DTaP-IPV vaccine for children aged 4-6 years. Expert Rev Vaccines. 7( 9):1309-1320.
Medical condition
Tetanus, acellular pertussis, Diphtheria
Product
SB213503
Collaborators
Not applicable
Study date(s)
January 2005 to December 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
4 - 6 Years
Accepts healthy volunteers
Yes
- Male or female child between and including 4 and 6 years of age at the time of vaccination.
- Free of obvious health problems as established by medical history and brief medical evaluation before entering into the study.
- Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period.
- History of previous or intercurrent diphtheria, tetanus, pertussis, polio, measles, mumps, or rubella disease, or of vaccination against these diseases given after the second year of life.
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female child between and including 4 and 6 years of age at the time of vaccination.
- Free of obvious health problems as established by medical history and brief medical evaluation before entering into the study.
- Received 4 doses of Infanrix and 3 doses of IPOL during the first 2 years of life.
- Vaccination against measles, mumps, and rubella in the second year of life.
- Subjects whom the investigator believed would comply with the requirements of the protocol.
- Written informed consent obtained before study entry from the parent(s) or guardian(s) of the subject.
Exclusion criteria:
- Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period.
- History of previous or intercurrent diphtheria, tetanus, pertussis, polio, measles, mumps, or rubella disease, or of vaccination against these diseases given after the second year of life.
- Known exposure to diphtheria, tetanus, pertussis, or polio, prior to vaccination.
- Poliovirus vaccination with one or more doses of OPV vaccine.
- Administration or planned administration of a vaccine not foreseen by the study protocol within 30 days of study vaccination and ending at Day 30.
- Chronic administration or administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period ending at Day 30.
- Administration of immunoglobulins and/or any blood products within three months prior to study vaccination or planned administration during the study period ending at Day 30.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
- History of seizures or progressive neurological disorder, including infantile spasms, uncontrolled epilepsy or progressive encephalopathy.
- Major congenital defects or serious chronic illness.
- Acute disease at the time of enrollment.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including allergic reactions to 2-phenoxyethanol, formaldehyde, neomycin, polymyxin B, streptomycin, gelatin, and/or latex.
- History of anaphylactic reaction to egg proteins or previous doses of the vaccine(s).
- Encephalopathy within 7 days of administration of previous dose of Infanrix.
- Fever ≥ 40.5°C or 104.9°F (rectal temperature) (39.5°C or 103.1°F, oral/axillary) within 48 hours of previous dose of Infanrix not due to another identifiable cause.
- Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours of previous dose of Infanrix.
- Persistent, severe, inconsolable screaming or crying lasting ≥ 3 hours which occurred within 48 hours of administration of previous dose of Infanrix.
- Thrombocytopenia following a previous dose of M-M-RII or its component vaccines.
- Inability to contact a parent/guardian of the subject by telephone.
- Blood dyscrasias (including current thrombocytopenia), leukemia, lymphomas or other malignant neoplasms affecting the bone marrow or lymphatic systems.
- Family history of congenital or hereditary immunodeficiency, unless the immune competence of the subject was demonstrated.
Trial location(s)
Location
GSK Investigational Site
San Ramon, California, United States, 94583
Status
Study Complete
Location
GSK Investigational Site
Fairfield, California, United States, 94533
Status
Study Complete
Location
GSK Investigational Site
North Pleasanton, California, United States, 94588
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93726
Status
Study Complete
Location
GSK Investigational Site
Fremont, California, United States, 94538
Status
Study Complete
Location
GSK Investigational Site
Santa Clara, California, United States, 95051
Status
Study Complete
Location
GSK Investigational Site
Hayward, California, United States, 94545
Status
Study Complete
Location
GSK Investigational Site
San Jose, California, United States, 95119
Status
Study Complete
Location
GSK Investigational Site
Mechanicsville, Virginia, United States, 23111
Status
Study Complete
Location
GSK Investigational Site
Roseville, California, United States, 95661
Status
Study Complete
Location
GSK Investigational Site
Vallejo, California, United States, 94589
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95823
Status
Study Complete
Location
GSK Investigational Site
San Francisco, California, United States, 94115
Status
Study Complete
Location
GSK Investigational Site
Antioch, California, United States, 94509
Status
Study Complete
Location
GSK Investigational Site
Redwood City, California, United States, 94063
Status
Study Complete
Location
GSK Investigational Site
Walnut Creek, California, United States, 94596
Status
Study Complete
Location
GSK Investigational Site
Daly City, California, United States, 94015
Status
Study Complete
Location
GSK Investigational Site
Oakland, California, United States, 94611
Status
Study Complete
Location
GSK Investigational Site
Richmond, California, United States, 94801
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95825
Status
Study Complete
Location
GSK Investigational Site
Vacaville, California, United States, 95688
Status
Study Complete
Location
GSK Investigational Site
Santa Rosa, California, United States, 95403
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2006-01-11
Actual study completion date
2006-04-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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