Immunogenicity and safety study of GSK Biologicals Kinrix when co-administered with GSK Biologicals Varivax.

• Conditions: Booster immunization of healthy children 4-6 years of age against diphtheria, tetanus, pertussis and polio diseases.; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-002946-11-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-22
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 478

Inclusion Criteria

Subjects for whom the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female child between 4 and 6 years of age, inclusive.
Written informed consent obtained from the parent or guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Having received 4 doses of DTaP using Pediarix and/or Infanrix, and 3 doses of poliovirus vaccine using Pediarix and/or IPOL in the first 2 years of life
Previously received 1 dose of M-M-RII and Varivax in the second year of life.

Are the trial subjects under 18? yes
Number of subjects for this age range: 478
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.
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 non-investigational product or device.
History of previous or intercurrent diphtheria, tetanus, pertussis, polio, measles, mumps, rubella or varicella dis-ease, 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 planned administration of immu-nosuppressants 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 prod-ucts at any time prior to study vaccination or planned ad-ministration during the study period ending at Day 30.
Any confirmed or suspected immunosuppressive or im-munodeficient condition, including human immunodeficiency virus infection
History of seizures or progressive neurological disorder, including infantile spasms, uncontrolled epilepsy or pro-gressive encephalopathy.
Major congenital defects or serious chronic illness.
Acute disease at the time of enrolment.
History of allergic disease or reactions likely to be exacer-bated by any component of the vaccines, including allergic reactions to formaldehyde, neomycin, polymyxin B, streptomycin, gelatin, and/or latex.
History of anaphylactic reaction to egg proteins or previous doses of the vaccines.
Encephalopathy within 7 days of administration of previous dose of Infanrix or Pediarix.
Fever >= 40.5°C or 104.9°F within 48 hours of previous dose of Infanrix or Pediarix not due to another identifiable cause.
Collapse or shock-like state within 48 hours of previous dose of DTaP or DTaP-containing vaccine.
Persistent, severe, inconsolable screaming or crying lasting >= 3 hours occurring within 48 hours of administration of previous dose of DTaP or DTaP-containing vaccine.
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, 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 has been demonstrated.
Residence in the same household as the following per-sons:
-New-born infants.
-Pregnant mother/women without documented posi-tive history of chickenpox disease or laboratory evidence of prior varicella vaccination.
-Pregnant women at or beyond 28 weeks gestation regardless of varicella vaccination status or varicella dis-ease history.
-Persons with known immunodeficiency.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified