Primary and Booster Vaccination Study With a Pneumococcal Vaccine in HIV Infected, HIV Exposed Uninfected and HIV Uninfected Children 6 to 10 Weeks of Age.
2018년 7월 11일 업데이트: GlaxoSmithKline
Primary and Booster Vaccination Course in Human Immunodeficiency Virus (HIV) Infected Infants, HIV Exposed Uninfected Infants and Unexposed Uninfected Infants Receiving the Pneumococcal Vaccine GSK 1024850A.
The purposes of this study:
- To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A in HIV infected infants, HIV exposed uninfected infants and HIV unexposed uninfected infants following a 3-dose primary vaccination at 6, 10 and 14 weeks of age and following booster vaccination at 9-10 months of age.
- To evaluate the immunogenicity, safety and reactogenicity of pneumococcal vaccine GSK1024850A in HIV unexposed uninfected infants receiving either a 3-dose primary vaccination according to the EPI vaccination schedule at 6, 10 and 14 weeks of age with or without booster vaccination at 9-10 months of age or a 2-dose primary vaccination at 6 and 14 weeks of age followed by booster vaccination at 9-10 months of age.
- This study also aims to assess the impact of the pneumococcal vaccine GSK1024850A on nasopharyngeal carriage of S. pneumoniae and H. influenzae up to 24 months of age in all study participants.
연구 개요
상태
완전한
정황
상세 설명
This protocol posting has been updated according to Protocol amendment 1, December 08
연구 유형
중재적
등록 (실제)
489
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Gauteng
-
Soweto, Gauteng, 남아프리카, 2013
- GSK Investigational Site
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
1개월 (어린이)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
- Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
- Written informed consent obtained from the parent(s)/guardian(s) of the child/ward.
- Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study).
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
- A family history of hereditary immunodeficiency other than HIV infection.
- Major congenital defects or serious chronic illness other than HIV infection.
- For HIV infected infants: Moderately and severely symptomatic: stages III and IV according to latest version of WHO classification.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b, and/or Streptococcus pneumoniae.
- History of, or intercurrent, diphtheria, tetanus, pertussis, and Haemophilus influenzae type b disease.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- History of any neurological disorders or seizures.
- Acute disease at the time of enrolment.
- Babies for which weight for age is < 3rd percentile at Visit 1, using standard growth charts, with the exception of HIV infected infants for which the decision of enrolment was left to the investigator's discretion.
- Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal (GI) tract, intussusception (IS) or other medical condition determined to be serious by the investigator.
- Gastroenteritis within 7 days preceding the study vaccine administration (warrants deferral of vaccination).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: HIV+/+ Group
Infants born from a HIV positive mother and confirmed as HIV infected.
Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8).
Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14).
Measles vaccine was not considered as a study vaccine.
The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination.
Rotarix™ was given orally.
|
경구, 2회
다른 이름들:
근육 주사, 4회분
다른 이름들:
Intramuscular injection, administered as 3 or 4 doses
Intramuscular injection, 2 doses
Oral 4 doses.
Given at any time during the study, routinely given concurrently with DTPw-HBV/Hib vaccine
다른 이름들:
|
|
실험적: HIV+/- Group
Infants born from a HIV positive mother and confirmed as HIV exposed uninfected.
Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8).
Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14).
Measles vaccine was not considered as a study vaccine.
The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination.
Rotarix™ was given orally.
|
경구, 2회
다른 이름들:
근육 주사, 4회분
다른 이름들:
Intramuscular injection, administered as 3 or 4 doses
Intramuscular injection, 2 doses
Oral 4 doses.
Given at any time during the study, routinely given concurrently with DTPw-HBV/Hib vaccine
다른 이름들:
|
|
실험적: HIV- (3+1) Group
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.
Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8).
Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14).
Measles vaccine was not considered as a study vaccine.
The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination.
Rotarix™ was given orally.
|
경구, 2회
다른 이름들:
근육 주사, 4회분
다른 이름들:
Intramuscular injection, administered as 3 or 4 doses
Intramuscular injection, 2 doses
Oral 4 doses.
Given at any time during the study, routinely given concurrently with DTPw-HBV/Hib vaccine
다른 이름들:
|
|
실험적: HIV- (EPI) Group
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2).
Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14).
Measles vaccine was not considered as a study vaccine.
The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination.
Rotarix™ was given orally.
|
경구, 2회
다른 이름들:
근육 주사, 4회분
다른 이름들:
Intramuscular injection, administered as 3 or 4 doses
Intramuscular injection, 2 doses
Oral 4 doses.
Given at any time during the study, routinely given concurrently with DTPw-HBV/Hib vaccine
다른 이름들:
|
|
실험적: HIV- (2+1) Group
Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8).
Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14).
Measles vaccine was not considered as a study vaccine.
The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination.
Rotarix™ was given orally.
|
경구, 2회
다른 이름들:
근육 주사, 4회분
다른 이름들:
Intramuscular injection, administered as 3 or 4 doses
Intramuscular injection, 2 doses
Oral 4 doses.
Given at any time during the study, routinely given concurrently with DTPw-HBV/Hib vaccine
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Subjects With Anti-pneumococcal Vaccine Serotype Antibody Concentrations Equal to or Above 0.20 Microgram Per Millilitre (µg/mL).
기간: 1 month following primary immunization (post-Dose 3 at Month 3 for the HIV+/+ Group, HIV+/- Group, HIV- (3+1) Group, HIV- (3+0) Group and post-Dose 2 at Month 3 for the HIV- (2+1) Group)
|
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
|
1 month following primary immunization (post-Dose 3 at Month 3 for the HIV+/+ Group, HIV+/- Group, HIV- (3+1) Group, HIV- (3+0) Group and post-Dose 2 at Month 3 for the HIV- (2+1) Group)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
기간: At Month 3 and Month 9
|
Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations.
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups, post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group.
The cut-off of the assay is 0.05 µg/mL.
|
At Month 3 and Month 9
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
기간: up to study end at Month 23 (24-27 months of age)
|
Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations.
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups.
The cut-off of the assay is 0.05 µg/mL.
|
up to study end at Month 23 (24-27 months of age)
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
기간: At Month 3 and at Month 9
|
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group.
Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line.
The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.
The cut-off of the assay is an opsonic titer of 8.
|
At Month 3 and at Month 9
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes.
기간: up to study end at Month 23 (24-27 months of age)
|
Pneumococcal vaccine serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups.
Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line.
The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.
The cut-off of the assay is an opsonic titer of 8.
|
up to study end at Month 23 (24-27 months of age)
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
기간: At Month 3 and Month 9
|
Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations.
Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A.
Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group.
The cut-off of the assay is 0.05 µg/mL.
|
At Month 3 and Month 9
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
기간: up to study end at Month 23 (24-27 months of age)
|
Concentrations were given in microgram per millilitre (µg/mL) and were expressed in geometric mean antibody concentrations.
Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A.
Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups.
The cut-off of the assay is 0.05 µg/mL.
|
up to study end at Month 23 (24-27 months of age)
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
기간: At Month 3 and at Month 9
|
Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A.
Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group.
Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line.
The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.
The cut-off of the assay is an opsonic titer of 8.
|
At Month 3 and at Month 9
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
기간: up to study end at Month 23 (24-27 months of age)
|
Cross-reactive pneumococcal vaccine serotypes assessed were 6A and 19A.
Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups.
Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line.
The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.
The cut-off of the assay is an opsonic titer of 8.
|
up to study end at Month 23 (24-27 months of age)
|
|
Concentrations of Antibodies Against Protein D (PD) by ELISA
기간: At Month 3 and at Month 9
|
Concentrations of antibodies are presented as GMCs expressed as ELISA units per milliliter (EL.U/mL).
The cut-off of the assay was 100 EL.U/mL.
Data were collected post-Dose 3 at Month 3 and post-Dose 4 at Month 9 for the HIV+/+, HIV+/- and HIV- (3+1) groups,post-Dose 3 at Month 3 and at Month 9 for HIV- (3+0) group, and post-Dose 2 at Month 3 and post-Dose 3 at Month 9 for the HIV- (2+1) Group.
|
At Month 3 and at Month 9
|
|
Concentrations of Antibodies Against Protein D (PD) by ELISA.
기간: up to study end at Month 23 (24-27 months of age)
|
Concentrations of antibodies are presented as GMCs expressed as ELISA units per milliliter (EL.U/mL).
The cut-off of the assay was 100 EL.U/mL.
Data were collected post-Dose 4 at Month 23 for the HIV+/+, HIV+/- and HIV- (3+1) groups and post-Dose 3 at Month 23 for HIV- (3+0) and HIV- (2+1) groups.
|
up to study end at Month 23 (24-27 months of age)
|
|
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT).
기간: 1 month following primary immunization (at Month 3)
|
Concentrations of antibodies are presented as GMCs expressed as International units per millilitre (IU/mL) The cut-off of the assay is 0.1IU/mL.
|
1 month following primary immunization (at Month 3)
|
|
Concentrations of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT).
기간: 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)
|
Concentrations of antibodies are presented as GMCs expressed as International units per millilitre (IU/mL).
The cut-off of the assay is 0.1IU/mL.
|
1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)
|
|
Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA.
기간: 1 month following primary immunization (at Month 3)
|
Concentrations of antibodies are presented as GMCs expressed as ELISA units per millilitre (EL.U/mL).
The cut-off of the assay is 15 EL.U/mL.
|
1 month following primary immunization (at Month 3)
|
|
Concentrations of Antibodies Against Bordetella Pertussis (BPT) by ELISA .
기간: 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)
|
Concentrations of antibodies are presented as GMCs expressed as ELISA units per millilitre (EL.U/mL).
The cut-off of the assay is 15 EL.U/mL.
|
1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)
|
|
Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP)
기간: 1 month following primary immunization (at Month 3)
|
Concentrations of antibodies are presented as GMCs expressed as microgram per millilitre (µg/mL).
The cut-off of the assay is 0.15 µg/mL.
|
1 month following primary immunization (at Month 3)
|
|
Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP)
기간: 1 month after the booster vaccination (at Month 15)
|
Concentrations of antibodies are presented as GMCs expressed as microgram per millilitre (µg/mL).
The cut-off of the assay is 0.15 µg/mL.
|
1 month after the booster vaccination (at Month 15)
|
|
Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA
기간: 1 month following primary immunization (at Month 3)
|
Concentrations of antibodies are presented as GMCs expressed as milli-International units per milliliter (mIU/mL). The cut-off of the assay is 10 mIU/mL. As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table showed results following partial or complete retesting/reanalysis |
1 month following primary immunization (at Month 3)
|
|
Concentrations of Antibodies Against Hepatitis B Surface Antigen (HBs) by ELISA.
기간: 1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)
|
Concentrations of antibodies were presented as GMCs expressed as milli-International units per milliliter (mIU/mL). The cut-off of the assay was 10 mIU/mL. As a decrease in the specificity of the anti-HBs ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL), the table showed results following partial or complete retesting/reanalysis |
1 month after the booster dose of DTPw-HBV/Hib vaccine (at Month 15)
|
|
Concentrations of Antibodies Against Rotavirus Immunoglobulin A (Rotavirus IgA), by Rotarix Vaccination Status.
기간: 1 month after the administration of the second vaccine dose (at Month 3)
|
Concentrations of antibodies are presented as GMCs expressed as units per millilitre (U/mL).
The cut-off of the assay is 20 U/mL.
Data were collected for subjects who received 1, 2 doses or no Rotarix dose during the study.
|
1 month after the administration of the second vaccine dose (at Month 3)
|
|
Concentrations of Antibodies Against Measles
기간: 1 month following administration of the 1st and 2nd vaccine dose (at Months 9 and 15)
|
Concentrations of antibodies are presented as GMCs expressed as milli-International units per milliliter (mIU/mL).The cut-off of the assay is 150 mIU/mL.
|
1 month following administration of the 1st and 2nd vaccine dose (at Months 9 and 15)
|
|
Anti-LytC IgA and Anti-PhtD IgA Antibodies Concentrations in Salivary Samples
기간: up to study end at Month 23 (24-27 months of age)
|
Salivary antibodies against selected common bacterial protein antigens.
Salivary samples (1.0 mL) were collected by using an Oracol™ device consisting of a sponge (2 cm3) placed on a stick that was used to brush the teeth and gums to absorb the saliva.
Salivary samples were sent to RMPRU (or GSK Biologicals' designated validated laboratory) where the sponge was centrifuged to extract the saliva and that was immediately stored at -70°C.
The cut-off of the assay was 2.3 U/mL for anti-LytC IgA and 2.2 U/mL for anti PhtD IgA.
|
up to study end at Month 23 (24-27 months of age)
|
|
Number of Swabs With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae (Vaccine Serotypes, Cross-reactive or Other Serotypes) and Other Bacterial Pathogens in the Nasopharynx.
기간: up to study end at Month 23 (24-27 months of age)
|
Positive cultures of H. influenza* (HI) and S. pneumonia(SP) and other bacterial pathogens such as Moraxella catarrhalis(MC), Group A streptococci and Staphylococcus aureus (SA), identified in the nasopharynx at each swab time point: Month (Mth) 0 (Pre-vaccination time point at 6-12 weeks of age), Mth 3 (18 weeks of age), Mth 8 (9-10 Months of age), Mth 9 (10-11 Months of age), Mth 11 (12-13 Months of age), Mth 14 (15-18 Months of age), Mth 15 (16-19 Months of age) and Mth 23 (24-27 Months of age).
*Data presented included only results from samples confirmed as positive for Hi/Non Typeable Hi after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay
|
up to study end at Month 23 (24-27 months of age)
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs
기간: up to study end at Month 23 (24-27 months of age)
|
Acquisition of new H. influenza* (HI) and S. pneumonia(SP) strains, identified in the nasopharynx at each swab time point: Month (Mth) 3 (18 weeks of age), Mth 8 (9-10 Months of age), Mth 9 (10-11 Months of age), Mth 11 (12-13 Months of age), Mth 14 (15-18 Months of age), Mth 15 (16-19 Months of age) and Mth 23 (24-27 Months of age).
*Data presented included only results from samples confirmed as positive for Hi/Non Typeable Hi after differentiation from H. haemolyticus by PCR assay
|
up to study end at Month 23 (24-27 months of age)
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
기간: During the 4-day (Days 0-3) post-primary vaccination period across doses
|
Solicited local AEs assessed were pain, redness and swelling.
Any = incidence of any local symptom regardless of intensity grade.
Grade 3 pain = cried when limb was moved/spontaneously painful.
Grade 3 redness/swelling = redness/swelling above 30 millimetre.
|
During the 4-day (Days 0-3) post-primary vaccination period across doses
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
기간: During the 4-day (Days 0-3) post-primary vaccination period across doses
|
General AEs = diarrhoea, drowsiness, irritability, loss of appetite, vomiting and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. diarrhoea: ≥ 6 looser than normal stools/day. vomiting: ≥ 3 episodes of vomiting/day. Fever = > 39.5°C Related = symptom assessed by the investigator as related to the vaccination. |
During the 4-day (Days 0-3) post-primary vaccination period across doses
|
|
Number of Subjects With Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
기간: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
|
Solicited local AEs assessed were pain, redness and swelling.
Any = incidence of any local symptom regardless of intensity grade.
Grade 3 pain = cried when limb was moved/spontaneously painful.
Grade 3 redness/swelling = redness/swelling above 30 millimetre.
|
During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
|
|
Number of Subjects With Any, Severe (Grade 3) and Related Solicited General Adverse Events (AEs).
기간: During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
|
Solicited general AEs = drowsiness, irritability, loss of appetite and fever (axillary ≥ 37.5 degrees Celsius). Any= Incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3: drowsiness = prevented normal activity. irritability = crying that could not be comforted/ prevented normal activity. loss of appetite = not eating at all. Fever = temperature > 39.5°C Related = symptom assessed by the investigator as related to the vaccination. |
During the 4-day (Days 0-3) period following booster vaccination with Synflorix vaccine
|
|
Number of Subjects With Unsolicited AEs.
기간: Within the 31-day (Days 0-30) post-primary vaccination period
|
An unsolicited adverse event is any adverse event (i.e.
any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
|
Within the 31-day (Days 0-30) post-primary vaccination period
|
|
Number of Subjects With Unsolicited AEs.
기간: Within the 31-day (Days 0-30) post Synflorix booster vaccination period
|
An unsolicited adverse event is any adverse event (i.e.
any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
|
Within the 31-day (Days 0-30) post Synflorix booster vaccination period
|
|
Number of Subjects With Serious Adverse Events (SAEs).
기간: From study start at Month 0 (6 weeks of age and above) up to study end at Month 23 (24-27 months of age)
|
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
|
From study start at Month 0 (6 weeks of age and above) up to study end at Month 23 (24-27 months of age)
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Nunes MC, Moreira M, Koen A, van Niekerk N, Jose L, Cutland CL, Francois N, Schoonbroodt S, Ruiz-Guinazu J, Yarzabal JP, Borys D, Schuerman L, Madhi SA. Bacterial nasopharyngeal carriage following infant immunization with pneumococcal conjugate vaccines according to a 2+1 schedule in children in South Africa: an exploratory analysis of two clinical trials. Expert Rev Vaccines. 2020 Dec;19(12):1177-1189. doi: 10.1080/14760584.2020.1853533. Epub 2020 Dec 21.
- Madhi SA, Moreira M, Koen A, van Niekerk N, de Gouveia L, Jose L, Cutland CL, Francois N, Schoonbroodt S, Ruiz-Guinazu J, Yarzabal JP, Borys D, Schuerman L. Impact of HIV status and vaccination schedule on bacterial nasopharyngeal carriage following infant immunisation with the pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine in South Africa. Vaccine. 2020 Feb 28;38(10):2350-2360. doi: 10.1016/j.vaccine.2020.01.062. Epub 2020 Feb 5.
- Madhi SA, Koen A, Jose L, Moreira M, van Niekerk N, Cutland C, Francois N, Ruiz-Guinazu J, Yarzabal JP, Borys D, Schuerman L. Immunization with 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) according to different schedules in infants in South Africa: a phase III trial. Expert Rev Vaccines. 2017 Jun;16(6):641-656. doi: 10.1080/14760584.2017.1321990.
- Madhi SA, Koen A, Jose L, van Niekerk N, Adrian PV, Cutland C, Francois N, Ruiz-Guinazu J, Yarzabal JP, Moreira M, Borys D, Schuerman L. Vaccination with 10-valent pneumococcal conjugate vaccine in infants according to HIV status. Medicine (Baltimore). 2017 Jan;96(2):e5881. doi: 10.1097/MD.0000000000005881.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2009년 2월 17일
기본 완료 (실제)
2011년 6월 13일
연구 완료 (실제)
2012년 6월 27일
연구 등록 날짜
최초 제출
2009년 1월 22일
QC 기준을 충족하는 최초 제출
2009년 1월 22일
처음 게시됨 (추정)
2009년 1월 26일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 8월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 7월 11일
마지막으로 확인됨
2017년 10월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 111634
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
연구 데이터/문서
-
주석이 달린 사례 보고서 양식
정보 식별자: 111634정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
임상 연구 보고서
정보 식별자: 111634정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
연구 프로토콜
정보 식별자: 111634정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
데이터 세트 사양
정보 식별자: 111634정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
통계 분석 계획
정보 식별자: 111634정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
개별 참가자 데이터 세트
정보 식별자: 111634정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
-
정보에 입각한 동의서
정보 식별자: 111634정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
로타릭스에 대한 임상 시험
-
GlaxoSmithKline완전한
-
Children's Hospital Medical Center, CincinnatiCenters for Disease Control and Prevention완전한
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Wellcome Trust; Amsterdam Institute for Global Health and Development; Centre for Infectious... 그리고 다른 협력자들완전한마이크로바이옴 | 로타바이러스 위장염 | 유아 설사 | 로타바이러스 백신 | 항생 물질 | 항균 저항성(AMR)가나, 잠비아
-
GlaxoSmithKline완전한
-
Sanofi Pasteur, a Sanofi Company모집하지 않고 적극적으로건강한 자원봉사자 | 수막구균 예방접종덴마크, 핀란드, 스페인, 온두라스, 브라질, 체코, 독일, 폴란드, 영국