Immunogenicity and Safety of Kinrix + (Measles Mumps Rubella) MMR Vaccine With and Without Varicella Vaccine in Healthy Children 4-6 Years

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status and phase

Completed
Phase 3

Conditions

Diphtheria
Tetanus
Acellular Pertussis

Treatments

Biological: Merck and Company's MMRII
Biological: GSK Biologicals'Kinrix®
Biological: Merck and Company's Varivax

Study type

Interventional

Funder types

Industry

Identifiers

NCT00871117
111852

Details and patient eligibility

About

The purpose of the study is to evaluate the immunogenicity and safety of Kinrix when co-administered with varicella (Varivax® \[varicella virus vaccine live\], Merck and Company) and (measles mumps rubella) MMR vaccines, compared to Kinrix co-administered with MMR vaccine alone. Both Kinrix and the second dose of Varivax are indicated in children 4-6 years of age, and there is great potential for the vaccines to be given concurrently. The aim of this trial is to demonstrate that co-administered Varivax does not negatively affect the immunogenicity or reactogenicity of Kinrix.

Full description

Subjects 4-6 years of age will be randomized into two groups to receive either Kinrix, Varivax and M-M-RII on day 0 (Group 1) or Kinrix and M-M-RII on day 0 and Varivax at month 1(Group 2). All subjects in both groups to provide blood samples prior to vaccination on day 0 and at month 1 (for Group 2, blood sampling is prior to vaccination with Varivax). Duration of the study will be approximately 6 months for each subject with a safety telephone contact 6 months after vaccinations.

Enrollment

478 patients

Sex

All

Ages

4 to 6 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Subjects for whom the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol.
  • 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 (Diphtheria, Tetanus Acellular Pertussis) DTaP vaccine using Pediarix and/or Infanrix, and 3 doses of poliovirus vaccine using Pediarix and/or (inactivated poliovirus vaccine, Aventis Pasteur) IPOL in the first 2 years of life.
  • Previously received 1 dose of M-M-RII and Varivax (separate or combined) in the second year of life.

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 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 (oral polio virus) 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 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 at any time 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 (HIV) 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 enrolment.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
  • 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 or Pediarix.
  • 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 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 ³3 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 persons:
  • New-born infants (0-4 weeks of age).
  • Pregnant mother/women without documented positive 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 disease history.
  • Persons with known immunodeficiency.
  • Active untreated tuberculosis.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

478 participants in 2 patient groups

Kinrix + M-M-R II + Varivax
Experimental group
Description:
Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
Treatment:
Biological: Merck and Company's Varivax
Biological: GSK Biologicals'Kinrix®
Biological: Merck and Company's MMRII
Kinrix + M-M-R II -> Varivax
Active Comparator group
Description:
Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
Treatment:
Biological: Merck and Company's Varivax
Biological: GSK Biologicals'Kinrix®
Biological: Merck and Company's MMRII

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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