2개월령 건강한 영아에서 21가 폐렴구균 접합백신의 로트 간 일관성 연구
건강한 영유아에서 21가 폐렴구균 접합 백신 4회 투여 요법의 안전성과 면역원성을 조사하기 위한 3상, 무작위, 수정 이중 맹검, 능동 대조군, 평행군, 로트 간 일관성, 4개 군 연구
This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) in a similar way (ie, same immune response) when they are given to infants aged from approximately 2 months (42 to 89 days) and are safe compared to a licensed 20-valent pneumococcal vaccine (20vPCV) (Prevnar 20™).
The study duration per participant will be up to approximately 17 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 months of age. Cohort A will include randomization to three PCV21 formulation groups or one 20vPCV comparator group (Group 1-4, approximately 896 total participants), whereas Cohort B will include randomization to three PCV21 formulation groups only (Groups 1-3, approximately 1299 total participants). Routine pediatric vaccines will be given as per local recommendations.
There will be 6 study visits: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age, V06 separated from V05 by 30 days
연구 개요
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Trial Transparency email recommended (Toll free for US & Canada)
- 전화번호: option 6 800-633-1610
- 이메일: Contact-US@sanofi.com
연구 장소
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Arkansas
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Fayetteville, Arkansas, 미국, 72703
- 모병
- Northwest Arkansas Pediatric Clinic- Site Number : 8400039
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California
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Huntington Park, California, 미국, 90255
- 모병
- Matrix Clinical Research - Huntington Park- Site Number : 8400029
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Los Angeles, California, 미국, 90008
- 모병
- Community Clinical Research- Site Number : 8400030
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Los Angeles, California, 미국, 90057
- 모병
- Matrix Clinical Research - Los Angeles- Site Number : 8400028
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Florida
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Tampa, Florida, 미국, 33613
- 모병
- PAS Research - Tampa- Site Number : 8400034
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Kentucky
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Bardstown, Kentucky, 미국, 40004
- 모병
- Kentucky Pediatric Research- Site Number : 8400036
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Michigan
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Allen Park, Michigan, 미국, 48101
- 모병
- Michigan Institute of Research- Site Number : 8400004
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New York
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Syracuse, New York, 미국, 13210
- 모병
- Nappi Wellness Institute\t- Site Number : 8400037
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South Carolina
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Charleston, South Carolina, 미국, 29407
- 모병
- Tribe Clinical Research At Neighbors Pediatrics- Site Number : 8400008
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Simpsonville, South Carolina, 미국, 29681
- 모병
- Parkside Pediatrics - Simpsonville- Site Number : 8400005
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Spartanburg, South Carolina, 미국, 29301
- 모병
- Tribe Clinical Research - Spartanburg- Site Number : 8400026
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Texas
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Edinburg, Texas, 미국, 78539
- 모병
- PAS Research - Children's Care Clinic- Site Number : 8400035
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Richmond, Texas, 미국, 77469
- 모병
- Pediatric Center - Richmond- Site Number : 8400038
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Utah
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Ogden, Utah, 미국, 84404
- 모병
- Rio Clinical Trials - Canyon View- Site Number : 8400031
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San Pedro Sula, 온두라스, 21104
- 모병
- Investigational Site Number : 3400001
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Tegucigalpa, 온두라스, 11101
- 모병
- Investigational Site Number : 3400003
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Tegucigalpa, 온두라스, 11101
- 모병
- Investigational Site Number : 3400002
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Bangkok, 태국, 10400
- 모병
- Investigational Site Number : 7640002
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Chiang Mai, 태국, 50180
- 모병
- Investigational Site Number : 7640004
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Hat Yai, 태국, 90110
- 모병
- Investigational Site Number : 7640003
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Khon Kaen, 태국, 40002
- 모병
- Investigational Site Number : 7640001
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Pathum Wan, 태국, 10330
- 모병
- Investigational Site Number : 7640005
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Guayama, 푸에르토 리코, 00786
- 모병
- Investigational Site Number : 6300005
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San Juan, 푸에르토 리코, 00918
- 모병
- Investigational Site Number : 6300006
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Trujillo Alto, 푸에르토 리코, 00976
- 모병
- Investigational Site Number : 6300007
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Aged 42 to 89 days on the day of inclusion
- Participants who are healthy as determined by medical evaluation including medical history and physical examination
- Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period above 28 (> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 kg, and in both cases medically stable
Exclusion Criteria:
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy
- History of microbiologically confirmed Streptococcus pneumoniae infection or disease
- Any contraindication to the routine pediatric vaccine being administered in the study
- History of seizure or significant stable or progressive neurologic disorders such as infantile spasms, inflammatory nervous system diseases, encephalopathy, cerebral palsy
- Known systemic hypersensitivity to any of the study interventions components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances3
- Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legally acceptable representative (LAR(s)), contraindicating intramuscular (IM) injection.
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection.
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration.
- Receipt of any BCG vaccine within 4 weeks preceding the first study intervention administration or planned receipt any BCG vaccine within the study period
- Previous vaccination against Streptococcus pneumoniae
- Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, H. influenzae type b, poliovirus
- Receipt of more than 1 dose of hepatitis B vaccine
- Receipt of immune globulins, blood or blood-derived products since birth
- Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Group 1: PCV21
Participants will be administered via intramuscular injection (IM) PCV21 vaccine lot 1 for Doses 1, 2 and 3; PCV21 lot 1, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines. |
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
다른 이름들:
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실험적: Group 2: PCV21
Participants will be administered via IM injection PCV21 vaccine lot 2 for Doses 1, 2 and 3; PCV21 lot 2, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines. |
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
다른 이름들:
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실험적: Group 3: PCV21
Participants will be administered via IM injection PCV21 vaccine lot 3 for Doses 1, 2 and 3; PCV21 lot 3, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines. |
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
다른 이름들:
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활성 비교기: Group 4: 20vPCV (Cohort A only)
Participants will be administered via IM injection 20vPCV at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines. |
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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For all participants: Serotype specific Immunoglobulin g (IgG) Geometric Mean Concentration (GMC)
기간: 30 days after the third dose of PCV21 vaccine
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Serotype specific IgG concentrations for all serotypes included in PCV21 vaccine as measured by electrochemiluminescence assay (ECL) |
30 days after the third dose of PCV21 vaccine
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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For all participants: Serotype specific IgG concentration ≥ 0.35 µg/mL
기간: 30 days after the third dose of PCV21 vaccine
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Serotype specific IgG concentration ≥ 0.35 μg/mL (seroresponse) for all serotypes included in PCV21 as measured by ECL |
30 days after the third dose of PCV21 vaccine
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For all participants: Presence of any immediate adverse events (AEs)
기간: Within 30 minutes after each vaccine injection
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Number of participants experiencing immediate AEs |
Within 30 minutes after each vaccine injection
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For participants in Cohort A (reactogenicity subset): Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection
기간: Through 7 days after each vaccine injection
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Number of participants experiencing solicited injection site and systemic reactions |
Through 7 days after each vaccine injection
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For all participants: Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs
기간: Through 30 days after each vaccine injection
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Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs |
Through 30 days after each vaccine injection
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For all participants: Presence of serious adverse events (SAEs) and adverse events of special interest (AESIs) throughout the study
기간: Throughout the study (through 6 months post-last vaccine injection)
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Number of participants experiencing SAEs and AESIs |
Throughout the study (through 6 months post-last vaccine injection)
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
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
- PSK00029
- PSK00029 (기타 식별자: Sanofi Identifier)
- U1111-1308-6832 (기타 식별자: WHO ICTRP)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .