Booster immunization of healthy children 4-6 years of age against diphtheria, tetanus, pertussis and polio diseases.
Conditions
Interventions
Trade Name: M-M-R-II
Product Name: MMR-II
Product Code: MMR
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: -
Other descriptive name: MEASLES VIRUS ENDERS' ED
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the non-inferiority of Kinrix co-administered with Varivax and M-M-RII compared to Kinrix co-administered with M-M-RII only in terms of diphtheria (D), tetanus (T), pertussis (PT), filamentous hemagglutinin (FHA), and pertactin (PRN) booster response and poliovirus geaometric mean titres (GMTs), one month after vaccination with Kinrix.;Secondary Objective: To evaluate Kinrix co-administered with Varivax and M-M-RII compared to Kinrix co-administered with M-M-RII only in terms of D, T, PT, FHA, PRN geometric mean concentrations (GMCs) and poliovirus booster responses, one month after vaccination with Kinrix. To assess the safety and reactogenicity of the study vaccines administered in both treatment groups. ;Primary end point(s): Booster responses for D, T, PT, FHA, and PRN. For anti-D and anti-T: initially seronegative subjects (pre-booster antibody concentration below cut-off of <0.1 IU/mL) with an in-crease of at least four times the cut-off one month after vaccination (post-booster antibody concentration = 0.4 IU/mL). initially seropositive subjects (pre-booster antibody concentration = 0.1 IU/mL) with an increase of at least four times the pre-booster antibody concentration one month after vaccination. For anti-PT, anti-FHA and anti-PRN: initially seronegative subjects (pre-booster antibody concentration below cut-off of <5 EL.U/mL) with an in-crease of at least four times the cut-off one month after vaccination (post-booster antibody concentration =20 EL.U/mL). initially seropositive subjects with pre-booster anti-body concentration = 5 EL.U/mL and <20 EL.U/mL with an increase of at least four times the pre-booster antibody concentration one month after vaccination. initially seropositive subjects with pre-booster anti-body concentration = 20 EL.U/mL with an increase of at least two times the pre-booster antibody concentration one month after vaccination. Post-vaccination GMTs for antibodies to poliovirus types 1, 2, and 3.;Timep | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity with respect to: Anti-D antibody concentration more than or equal to 1.0 IU/mL. Anti-T antibody concentration more than or equal to 1.0 IU/mL. Post-vaccination antibody GMCs for anti-D, anti-T, anti-PT, anti-FHA, anti-PRN. Anti-poliovirus type 1 booster response. Anti-poliovirus type 2 booster response. Anti-poliovirus type 3 booster response. Booster responses for anti-poliovirus 1, anti-poliovirus 2, and anti-poliovirus 3: are defined as follows: initially seronegative subjects (pre-booster antibody titer below cut-off of 8 ED50) with an antibody titer ?32 ED50 one month after vaccination. initially seropositive subjects (pre-booster antibody titers ?8 ED50) with an increase at least four times the pre-booster antibody titer one month after vaccination. Seroprotection status defined as: anti-D antibody concentration =0.1 IU/mL. anti-T antibody concentration =0.1 IU/mL. anti-poliovirus type 1 antibody titer =8 ED50 (Neutraliza-tion). anti-poliovirus type 2 antibody titer =8 ED50 (Neutraliza-tion). anti-poliovirus type 3 antibody titer =8 ED50 (Neutraliza-tion). Seropositivity rates defined as: anti-PT antibody concentrations =5 EL.U/mL. anti-FHA antibody concentrations =5 EL.U/mL. anti-PRN antibody concentrations =5 EL.U/mL. Incidence of solicited local (pain, redness, and swelling) and general (fever, drowsiness, and loss of appetite) symptoms. Incidence of unsolicited symptoms. Occurrence of SAEs. ;Timepoint(s) of evaluation of this end point: For immunogenecity endpoints : One month after vaccination (Days 31-48). For incidence of solicited local and general symptoms: Within 4 days (Day 0 to Day 3) after vaccination. For incidence of unsolicited symptoms: Within 31 days (Day 0 to Day 30) after vaccination. For occurence of SAEs: During the entire study period (from Visit 1 through 6 months [minimum 182 days] post-vaccination). | — |
Countries
United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed