- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00814710
Primary Vaccination Study With a Pneumococcal Conjugate Vaccine in Healthy Children 6 to 10 Weeks of Age
Primary Vaccination Course in Healthy Children Receiving the Pneumococcal Vaccine GSK 1024850A Co-administered With Tritanrix™-HepB/Hib at 6, 10 and 14 Weeks of Age
연구 개요
상태
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Kolkata, 인도, 700073
- GSK Investigational Site
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Ludhiana, 인도, 141 008
- GSK Investigational Site
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Pune, 인도
- GSK Investigational Site
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Vellore, 인도, 632004
- GSK Investigational Site
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
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 or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
- 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.
- 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 a non-investigational product (pharmaceutical product or device).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- A family history of congenital or hereditary immunodeficiency.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis B immunoglobulins at birth).
- Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of hepatitis B vaccination at birth or at least 30 days before the subject's first study visit).
- History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, Streptococcus 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.
- Major congenital defects or serious chronic illness.
- Acute disease at the time of enrolment.
- Babies for which birth weight is < 2 kilogram.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Synflorix & Tritanrix-HebB/Hib Group
Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
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근육 주사, 3회분
Intramuscular injection, 3 doses
다른 이름들:
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활성 비교기: Hiberix group & Tritanrix-HebB Group
Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
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Intramuscular injection, 3 doses
다른 이름들:
Intramuscular injection, 3 doses
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes
기간: One month after primary immunization (month 3)
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Concentrations were expressed as Geometric Mean Concentrations (GMCs) in microgram per milliliter (µg/mL). Pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. |
One month after primary immunization (month 3)
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Concentration of Antibody Against Protein D (PD)
기간: One month after primary immunization (month 3)
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Concentrations were expressed as GMCs GSK's 22F-inhibition in enzyme-linked-immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
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One month after primary immunization (month 3)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Subjects With Opsonophagocytic Activity Against Pneumococcal Serotypes
기간: One month after primary immunization (month 3)
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Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A. Opsonophagocytic activity was defined 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 was an opsonic titer equal to or greater than 8. |
One month after primary immunization (month 3)
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Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes Equal to or Above Cut-off Value
기간: One month after primary immunization
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Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A. The cut-off was defined as 0.20 microgram per milliliter (µg/mL). |
One month after primary immunization
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Concentrations of Antibodies Against Pneumococcal Cross-reactive Serotypes
기간: One month after primary immunization (month 3)
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Concentrations were expressed as GMCs in µg/mL.
Pneumococcal cross-reactive serotypes included 6A and 19A.
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One month after primary immunization (month 3)
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Number of Subjects Seropositive for Pneumococcal Serotypes
기간: One month after primary immunization (month 3)
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Vaccine pneumococcal serotypes included 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Cross-reactive pneumococcal serotypes included 6A and 19A. Seropositivity was defined as a titer equal to or greater than 0.05 µg/mL |
One month after primary immunization (month 3)
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Number of Subjects Seropositive for Protein D (PD)
기간: One month after primary immunization (month 3)
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Seropositivity for PD was defined greater than or equal to 100 EL.U/mL.
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One month after primary immunization (month 3)
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Concentration of Antibody Against Polyribosyl-ribitol Phosphate (PRP)
기간: One month after primary immunization (month 3)
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Concentration is expressed as GMC in µg/mL.
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One month after primary immunization (month 3)
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Concentration of Antibodies Against Diphteria (Anti-DT) and Tetanus (Anti-TT)
기간: One month after primary immunization (month 3)
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Concentrations were expressed as GMCs in international units per milliliter (IU/mL).
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One month after primary immunization (month 3)
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Concentration of Antibody Against Bordetella Pertussis (B. Pertussis)
기간: One month after primary immunization (month 3)
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Concentration was expressed as GMC in EL.U/mL.
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One month after primary immunization (month 3)
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Concentration of Antibody Against Hepatitis B (Anti-HBs) by Enzyme-Linked ImmunoSorbent Assay (ELISA).
기간: One month after primary immunization (month 3)
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Concentration was expressed as GMC in milli international units per milliliter (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 shows results following partial or complete retesting/reanalysis.
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One month after primary immunization (month 3)
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Number of Subjects Seropostive for B. Pertussis
기간: One month after primary immunization (month 3)
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Seropositivity was defined as and antibody concentration equal to or greater than 15 EL.U/mL.
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One month after primary immunization (month 3)
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Number of Seroprotected Subjects (Anti-DT, Anti-TT, Anti-PRP, Anti-HBs)
기간: One month after primary immunization (month 3)
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Seroprotection was defined as: Anti-DT antibody concentration equal to or greater than 0.1 IU/mL. Anti-TT antibody concentration equal to or greater than 0.1 IU/mL. Anti-PRP antibody concentration equal to or greater than 0.15 µg/mL Anti-HBs antibody concentration greater than or equal to 10 mIU/mL. |
One month after primary immunization (month 3)
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Number of Seroprotected Subjects (Anti-PRP Above the Cut-off of 1.0 µg/mL)
기간: One month after primary immunization (month 3)
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Anti-PRP antibody concentration equal to or greater than 1.0 µg/mL.
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One month after primary immunization (month 3)
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Number of Subjects With Solicited Local and General Symptoms
기간: Within 4 days (day 0-3) after vaccination
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Solicited local symptoms included pain, redness and swelling.
Solicited general symptoms included drowsiness, fever (equal to or above 38 degrees Celsius and above 39 degrees Celsius), irritability and loss of appetite.
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Within 4 days (day 0-3) after vaccination
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Number of Subjects With Unsolicited Adverse Events (AEs)
기간: Within 31 days (day 0-30) after vaccination
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An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Unsolicited AE covers any AE 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 31 days (day 0-30) after vaccination
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Number of Subjects With Serious Adverse Events (SAEs)
기간: Following first vaccination (Month 0) throughout the entire study period (month 3)
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SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
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Following first vaccination (Month 0) throughout the entire study period (month 3)
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
일반 간행물
- Lalwani S, Chatterjee S, Chhatwal J, Simon A, Ravula S, Francois N, Mehta S, Strezova A, Borys D. Randomized, open-label study of the impact of age on booster responses to the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in children in India. Clin Vaccine Immunol. 2014 Sep;21(9):1292-300. doi: 10.1128/CVI.00068-14. Epub 2014 Jul 9.
- Lalwani S, Chatterjee S, Chhatwal J, Verghese VP, Mehta S, Shafi F, Borys D, Moreira M, Schuerman L. Immunogenicity, safety, and reactogenicity of the 10-valent pneumococcal non-typeable Hemophilus influenzae protein D conjugate vaccine (PHiD-CV) when co-administered with the DTPw-HBV/Hib vaccine in Indian infants: a single-blind, randomized, controlled study. Hum Vaccin Immunother. 2012 May;8(5):612-22. doi: 10.4161/hv.19287. Epub 2012 May 1.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 111188
- 2011-004644-22 (EudraCT 번호)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 기간
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
연구 데이터/문서
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연구 프로토콜
정보 식별자: 111188정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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개별 참가자 데이터 세트
정보 식별자: 111188정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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주석이 달린 사례 보고서 양식
정보 식별자: 111188정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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임상 연구 보고서
정보 식별자: 111188정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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정보에 입각한 동의서
정보 식별자: 111188정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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데이터 세트 사양
정보 식별자: 111188정보 댓글: For additional information about this study please refer to the GSK Clinical Study Register
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통계 분석 계획
정보 식별자: 111188정보 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. .
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