Immunogenicity and Safety Study of Kinrix® Co-administered With Varivax®
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 478
- 试验地点
- 12
- 主要终点
- Number of Subjects With Booster Responses to Diphteria and Tetanus
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
- •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
- •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
- •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.
研究组 & 干预措施
Kinrix + M-M-R II + Varivax
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.
干预措施: GSK Biologicals'Kinrix® (Biological)
Kinrix + M-M-R II + Varivax
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.
干预措施: Merck and Company's MMRII (Biological)
Kinrix + M-M-R II + Varivax
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.
干预措施: Merck and Company's Varivax (Biological)
Kinrix + M-M-R II -> Varivax
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.
干预措施: GSK Biologicals'Kinrix® (Biological)
Kinrix + M-M-R II -> Varivax
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.
干预措施: Merck and Company's MMRII (Biological)
Kinrix + M-M-R II -> Varivax
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.
干预措施: Merck and Company's Varivax (Biological)
结局指标
主要结局
Number of Subjects With Booster Responses to Diphteria and Tetanus
时间窗: One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.
Anti-diphteria (anti-D) and anti-tetanus (anti-T) booster response was defined as: * initially seronegative subjects (sero-) (pre-booster antibody concentration below cut-off of \< 0.1 international units per milliliter (IU/mL)) with an increase of at least four times the cut-off one month after vaccination (post-booster antibody concentration ≥0.4 IU/mL) * initially seropositive subjects (sero+) (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
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (FHA) and Anti-pertactin (Anti-PRN) Booster Responses, Measured in Enzyme-Linked Immunosorbent Assay Units Per Milliliter (EL.U/mL)
时间窗: One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.
anti-PT, anti-FHA and anti-PRN booster response : * initially sero- (pre-booster antibody concentration below cut-off \< 5.0 EL.U/mL) with increase of at least four times cut-off one month after vaccination (concentration post-booster ≥20.0 EL.U/mL) * initially sero+ with pre-booster antibody concentration ≥5.0 EL.U/mL and \< 20.0 EL.U/mL with increase of at least four times pre-booster concentration one month post-booster * initially sero+ with pre-booster antibody concentration ≥20.0 EL.U/mL with an increase of at least two times the pre-booster antibody concentration one month post-booster
Geometric Mean Titers (GMTs) for Antibodies to Poliovirus Types 1, 2 and 3
时间窗: One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.
Titers are expressed as GMTs.
次要结局
- GMCs for Anti-PT, Anti-FHA, Anti-PRN Antibodies(One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.)
- Number of Subjects With an Anti-polio 1, 2, 3 Booster Response(One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.)
- Number of Subjects Seropositive for Anti-PT, Anti-FHA and Anti-PRN Antibodies(One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.)
- Number of Subjects With Any Solicited General Symptoms(Within 4 days (Day 0 to 3) after booster immunization * for Kinrix + M-M-R II -> Varivax Group before vaccination with Varivax)
- Number of Subjects With Unsolicited Adverse Events(Up to 31 days (Day 0 through Day 30) after booster vaccination * for Kinrix + M-M-R II -> Varivax Group before vaccination with Varivax)
- Number of Subjects With Anti-D and Anti-T Antibody Concentrations Above Cut-off Value(One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.)
- Geometric Mean Concentrations (GMCs) for Anti-D and Anti-T Antibodies(One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.)
- Number of Subjects Seroprotected Against Diphteria and Tetanus(One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.)
- Number of Subjects Protected Against Poliovirus 1, 2 and 3(One month after Kinrix vaccination (Month 1), prior to Varivax vaccination for Kinrix + M-M-R II -> Varivax Group.)
- Number of Subjects With Any Solicited Local Symptoms(Within 4 days (Day 0 to 3) after booster immunization * for Kinrix + M-M-R II -> Varivax Group before vaccination with Varivax)
- Number of Subjects With Serious Adverse Events (SAEs)(During the entire study period (from Day 0 to 6 months post-vaccination))