Immune Response and Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccines

Completed · Phase 3

Conditions studied: Tetanus, Acellular Pertussis, Diphtheria

In brief

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.

Key facts

Study ID

NCT00148941

Run by

GlaxoSmithKline

People needed

4209

Starts

2005-01-06

Expected to finish

2006-12-04

Last updated by the study team

2020-02-05

Who can join

Age: 4 and older, up to 6. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Little Rock, Arkansas, United States
• GSK Investigational Site — Antioch, California, United States
• GSK Investigational Site — Daly City, California, United States
• GSK Investigational Site — Fairfield, California, United States
• GSK Investigational Site — Fremont, California, United States
• GSK Investigational Site — Fresno, California, United States
• GSK Investigational Site — Hayward, California, United States
• GSK Investigational Site — Oakland, California, United States
• GSK Investigational Site — Pleasanton, California, United States
• GSK Investigational Site — Redwood City, California, United States
• GSK Investigational Site — Richmond, California, United States
• GSK Investigational Site — Roseville, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — Sacramento, California, United States
• GSK Investigational Site — San Francisco, California, United States
• GSK Investigational Site — San Jose, California, United States
• GSK Investigational Site — San Ramon, California, United States
• GSK Investigational Site — Santa Clara, California, United States
• GSK Investigational Site — Santa Rosa, California, United States
• GSK Investigational Site — Vacaville, California, United States
• GSK Investigational Site — Vallejo, California, United States
• GSK Investigational Site — Walnut Creek, California, United States
• GSK Investigational Site — Columbus, Ohio, United States
• GSK Investigational Site — Mechanicsville, Virginia, United States

Full record on ClinicalTrials.gov

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