Evaluate Immunogenicity, Safety & Reactogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine Given as Catch-up Immunization in Children Older Than 7 mo of Age or as 3-dose Primary Immunization in Children Before 6 mo of Age
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 10
- 主要终点
- Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 Microgram Per Milliliter (µg/mL). (Primary/Full Vaccination)
研究概览
简要总结
The purpose of this phase IIIb study is to determine whether children who have not received a 3-dose primary vaccination with the pneumococcal conjugate vaccine before their 6 months of age, can receive the vaccine as part of a catch-up immunization schedule. The immunogenicity, safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine will be evaluated for four different age groups with different schedules:
< 6 months of age group: 3-dose primary vaccination + a booster dose. 7 to 11 months of age group: 2-dose primary vaccination + a booster dose. 12 to 23 months of age group: 2-dose vaccination; no booster dose. 24 months to 5 years of age group: 1-dose vaccination; no booster dose. Children below 6 months of age will receive concomitantly a DTPa-IPV/Hib vaccine.
详细描述
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 9 Weeks 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female between, and including
- •9-12 weeks of age at the time of first vaccination for the <6 Mo group.
- •7-11 months of age at the time of first vaccination for the 7-11 Mo group.
- •12-23 months of age at the time of first vaccination for the 12-23 Mo group.
- •24 months to 5 years at the time of first vaccination for the >= 24 Mo group.
- •Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
- •Written informed consent obtained from the parent or guardian of the subject.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- •Born after a gestation period between 36 and 42 weeks.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the entire study period for each age-group.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before and ending one month after each dose of vaccine(s).
- •Previous vaccination against S. pneumoniae.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- •History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or neurological disease.
- •Acute disease at the time of enrolment.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
- •A family history of congenital or hereditary immunodeficiency.
- •Major congenital defects or serious chronic illness.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the entire study period.
研究组 & 干预措施
Synflorix <6M Group
This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
干预措施: Infanrix IPV/Hib (Biological)
Synflorix >=24M Group
This group consisted of subjects aged between 24 months (inclusive) to 5 years (inclusive) at vaccination who received one dose of Synflorix™. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
干预措施: Synflorix (Biological)
Synflorix 12-23M Group
This group consisted of subjects 12 to 23 months inclusive at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose 2 months later. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
干预措施: Synflorix (Biological)
Synflorix 7-11M Group
This group consisted of subjects 7 to 11 months of age at first vaccination who received 2 doses of Synflorix™, one first dose at enrolment followed by a second dose one month later, and a booster dose at 12-15 months of age. The Synflorix™ vaccine was administrated intramuscularly in the right thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
干预措施: Synflorix (Biological)
Synflorix <6M Group
This group consisted of subjects up to 6 months of age at first vaccination who received 3 doses of Synflorix™ vaccine co-administered with Infanrix™ IPV/Hib at 3, 4 and 5 months of age and a booster dose of the same vaccines at 12-15 months of age. Vaccines were administrated intramuscularly in the right (Synflorix™) or the left (Infanrix™ IPV/Hib ) thigh or deltoid region (deltoid region only for children >12 months of age if muscle size was adequate).
干预措施: Synflorix (Biological)
结局指标
主要结局
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 Microgram Per Milliliter (µg/mL). (Primary/Full Vaccination)
时间窗: At one month after primary (Synflorix <6M & Synflorix 7-11M Groups) or after the full (Synflorix 12-23M & Synflorix >=24M Groups) vaccination course with Synflorix™, that is Month (M)3 for Synflorix <6M & 12-23M groups, M2 for Synflorix 7-11M Group, & M1
Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition Enzyme-Linked Immuno-Sorbent Assay (ELISA) method. The \>=0.20 microgram per milliliter (microg/mL) cut-off corresponded to the seroprotection cut-off as regards anti-pneumococcal serotypes antibody concentrations. Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations ≥ 0.05 microg/mL.
次要结局
- Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination)(At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.)
- Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations. (Booster Vaccination)(Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups)
- Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A. (Primary/Full Vaccination)(At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.)
- Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Primary/Full Vaccination)(At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.)
- Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A. (Booster Vaccination)(Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups)
- Number of Subjects With Solicited General Symptoms (Any and Grade 3). (Booster Vaccination)(Within 4 day (Days 0-3) following the booster vacination)
- Number of Subjects With Solicited General Symptoms (Primary Vaccination)(Within 4-day (Days 0-3) following the primary vaccination)
- Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-T) Antibody Concentrations.(Booster Vaccination)(Before (M9 = PRE-BST) and one month after the booster dose (M10 = POST-BST) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.)
- Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations. (Booster Vaccination)(Before (M9 = PRE-BST) and one month after the booster dose (M10 = POST-BST) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.)
- Anti-polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations. (Primary Vaccination)(At 1 month after the administration of the primary vaccination course (Month [M]3 = POST-PRY) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group)
- Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations. (Primary Vaccination)(At 1 month after the administration of the primary vaccination course(Month [M]3 = POST-PRY) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group)
- Anti-polio Type 1, 2 and 3 Titers. (Primary Vaccination)(At 1 month after the administration of the primary vaccination course (Month [M]3 = POST-PRY) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.)
- Booster Vaccine Response to PT, FHA and PRN(Before and one month after the booster dose with Synflorix™)
- Number of Subjects With Unsolicited Adverse Events (AEs). (Booster Vaccination)(Within 31 day (Days 0-30) following the booster vaccination)
- Number of Subjects With Serious Adverse Events (SAEs) (Primary Vaccination)(During the Primary vaccination course up until start of Booster vaccination course)
- Opsonophagocytic Activity Against Pneumococcal Cross-reactive Serotypes 6A and 19A. (Primary/Full Vaccination)(At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.)
- Antibody Concentrations Against Protein D (Anti-PD). (Primary/Full Vaccination)(At 1 month after the administration of the primary (< 6 months and 7-11 months groups) or the full (12-23 months and >= 24 months groups) vaccination course, with Synflorix™ vaccine.)
- Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations >= 0.20 µg/mL. (Booster Vaccination)(Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups)
- Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A.(Booster Vaccination)(Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups)
- Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. (Booster Vaccination)(Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups)
- Antibody Concentrations Against Protein D. (Booster Vaccination)(Before and one month after the booster dose with Synflorix™ for the < 6 months and 7-11 months groups)
- Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-T) Antibody Concentrations. (Primary Vaccination)(At 1 month after the administration of the primary vaccination course (Month [M]3 = POST-PRY) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.)
- Number of Subjects Solicited Local Symptoms (Any and Grade 3). (Primary Vaccination)(Within 4-day (Days 0-3) following the primary vaccination)
- Number of Subjects With Solicited Local Symptoms (Any and Grade 3). (Booster Vaccination)(Within 4-day (Days 0-3) following the booster vaccination)
- Number of Subjects With Unsolicited Adverse Events (AEs). (Primary Vaccination)(Within 31-day (Days 0-30) post primary vaccination)
- Number of Subjects With Serious Adverse Events (SAEs). (Booster Vaccination)(During the booster vaccination course)
- Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations. (Booster Vaccination)(Before (M9 = PRE-BST) and one month after the booster dose (M10 = POST-BST) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.)
- Titers of Antibodies Against Polio Type 1, 2 and 3 (Anti-polio 1, 2 and 3). (Booster Vaccination)(Before (M9 = PRE-BST) and one month after the booster dose (M10 = POST-BST) with Infanrix™ IPV/Hib vaccine when co-administered with Synflorix™, for the < 6 months Group.)