A Phase IIIb, Open, Randomized, Controlled, Multicenter Study of the Immunogenicity and Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine Administered on a 0-6 Mth Schedule Concomitantly With Wyeth Lederle's Pneumococcal Conjugate Vaccine in Healthy Children 15 Months of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 521
- 试验地点
- 19
- 主要终点
- Number of Seropositive Subjects for Anti-HAV Antibodies
研究概览
简要总结
This is a study to evaluate the immunogenicity and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a pneumococcal conjugate vaccine in children as young as 15 months of age.
详细描述
An open, controlled comparison of Havrix administered alone or with Prevnar. The three groups evaluated are: 1) Havrix alone, 2) Havrix plus Prevnar and 3) Prevnar followed by Havrix one month later.
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
- 12 Months 至 13 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female child 12 or 13 months of age at the time of entry into the Enrollment Phase,
- •Free of obvious health problems,
- •Subjects must have previously received three doses of Prevnar in his/her first year of life.
排除标准
- •Use of any investigational or non-registered drug or vaccine within 42 days preceding the first dose of study vaccine, or planned use during the study period,
- •Chronic administration of immuno-suppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period. (For corticosteroids, this will mean prednisone, or equivalent, less than 0.5 mg/kg/day. Inhaled, nasal and topical steroids are allowed.),
- •Administration of the ACIP-recommended fourth dose of Prevnar prior to entering the Enrollment Phase of the study,
- •Planned administration or administration of any vaccine not foreseen by the study protocol within the period of 42 days before and 30 days after each dose of study vaccine(s),
- •Previous vaccination against hepatitis A,
- •History of hepatitis A or known exposure to hepatitis A,
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection,
- •A family history of congenital, hereditary or infectious immunodeficiency or parental risk factors for HIV infection,
- •History of allergic disease/reactions or hypersensitivity likely to be exacerbated by any component of Havrix (e.g., neomycin, 2-phenoxyethanol) or Prevnar (e.g., diphtheria toxoid),
- •Major congenital defects or serious chronic illness,
- •History of any neurologic disorder (history of febrile seizures not associated with an underlying neurological disorder does not exclude the subject),
- •Acute disease, defined as the presence of a moderate or severe illness with or without fever, at the time of vaccination,
- •Administration of immunoglobulins and/or any blood products within three months prior to the first dose of study vaccine or planned administration at any time during the entire study period.
研究组 & 干预措施
Havrix Group
Healthy male or female subjects, 15 months of age, who received Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Day 0 and at Month 6-9.
干预措施: GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix) (Biological)
Havrix+Prevnar Group
Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
干预措施: GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix) (Biological)
Havrix+Prevnar Group
Healthy male or female subjects, 15 months of age, who received Havrix® and Prevnar™ vaccines co-administered intramuscularly in the right and left anterolateral thighs, respectively, at Day 0 and Havrix® vaccine administered intramuscularly in the right anterolateral thigh, at Month 6-9.
干预措施: Prevnar™ (Biological)
Prevnar Havrix Group
Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
干预措施: GSK Biologicals 2-dose inactivated hepatitis A vaccine (Havrix) (Biological)
Prevnar Havrix Group
Healthy male or female subjects, 15 months of age, who received Prevnar™ vaccine administered intramuscularly in the left anterolateral thigh, at Day 0 and Havrix® vaccine, administered intramuscularly in the right anterolateral thigh, at Day 30 and at Month 7-10.
干预措施: Prevnar™ (Biological)
结局指标
主要结局
Number of Seropositive Subjects for Anti-HAV Antibodies
时间窗: At one month after Dose 2 of Havrix® vaccine (Month 7-10)
Cut-off values assessed were greater than or equal to (≥) 15 milli-international units per milliliter (mIU/mL) in the sera of subjects seronegative before vaccination.
Concentrations for Anti-HAV Antibodies
时间窗: At one month after Dose 2 of Havrix® vaccine (Month 7-10)
Anti-HAV antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
次要结局
- Anti-4, Anti-6B, Anti-9V, Anti-14, Anti-19F and Anti-23F Antibody Concentrations(At one month after Prevnar™ vaccination (Day 30))
- Number of Subjects With an Immune Response to Anti-pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F(At one month after Prevnar™ vaccination (Day 30))
- Number of Seropositive Subjects for Anti-HAV Antibodies(At one month after Dose 2 of Havrix® vaccine (Month 8-11))
- Concentrations for Anti-HAV Antibodies(At one month after Dose 2 of Havrix® vaccine (Month 8-11))
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses)
- Number of Subjects With Vaccine Response to Anti-HAV Antibodies(One month after Dose 2 of Havrix® vaccine (Month 7-10/8-10))
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(During the 31-day (Day 0-30) follow-up period)
- Number of Subjects With Serious Adverse Events (SAEs), New Chronic Illnesses (NCIs) and Medically Significant Events (MSEs)(During the Active Phase (from Day 0 to Day 30 after final vaccine dose for each subject))
- Number of Subjects With SAEs, NCIs and MSEs(During the Extended Safety Follow-up (ESFU) Phase (from Day 30 to 6 months after final vaccine dose))