跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT03135834
NCT03135834已完成3 期

A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED STUDY TO ASSESS THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF BIVALENT RLP2086 WHEN ADMINISTERED AS A 2-DOSE REGIMEN AND A FIRST-IN-HUMAN STUDY TO DESCRIBE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A BIVALENT RLP2086-CONTAINING PENTAVALENT VACCINE (MENABCWY) IN HEALTHY SUBJECTS>=10 TO <26 YEARS OF AGE

Pfizer139 个研究点 分布在 2 个国家目标入组 1,610 人开始时间: 2017年4月24日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症

试验速览

阶段
3 期
状态
已完成
发起方
Pfizer
入组人数
1,610
试验地点
139
主要终点
Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a 0-,6- month schedule. This trial is also studying safety and immunogenicity of a meningococcal pentavalent vaccine.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 25 Years（Child, Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Male or female subject aged >=10 and <26 years at the time of enrollment.
  • •Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
  • •Negative urine pregnancy test for all female subjects.
  • •Subjects who have not received, or who have received no more than 1 prior dose within the past 4 years, of a vaccine containing 1 or more ACWY serogroup

排除标准

  • •Previous vaccination with any meningococcal serogroup B or purely polysaccharide (nonconjugate) meningococcal vaccine.
  • •Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
  • •A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study.
  • •Significant neurological disorder or history of seizure (excluding simple febrile seizure).
  • •Current chronic use of systemic antibiotics.
  • •Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.
  • •Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

结局指标

主要结局

Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)

时间窗: 30 days after Vaccination 1

A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Any Vaccination (Group 2 and 4 Combined)

时间窗: 30 days after any vaccination

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.

Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)

时间窗: 30 days after Vaccination 2

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Stage1: Percentage of Participants With at Least 1 Medically Attended AE Throughout the Stage 1 (Group 2 and 4 Combined)

时间窗: Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 (Group 2 and 4 Combined)

时间窗: 7 days after Vaccination 1

Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were graded as mild (\>2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and severe (\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).

Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 (Group 2 and 4 Combined)

时间窗: 7 days after Vaccination 2

Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were graded as mild (\>2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and severe (\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).

Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined)

时间窗: 7 days after Vaccination 1

Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site, and joint pain were recorded by using an e-diary. Fever was defined as \>=38.0 degree Celsius (C) and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \>40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\>=6 in 24 hours).

Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined)

时间窗: 7 days after Vaccination 2

Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site, and joint pain were recorded by using an e-diary. Fever was defined as \>=38.0 degree C and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \>40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\>=6 in 24 hours).

Stage1: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Vaccination 1 (Group 2 and 4 Combined)

时间窗: 7 days after Vaccination 1

Stage1: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Vaccination 2 (Group 2 and 4 Combined)

时间窗: 7 days after Vaccination 2

Stage1: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)

时间窗: 30 days after Vaccination 2

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.

Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)

时间窗: 30 days after Vaccination 1

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)

时间窗: 30 days after Vaccination 2

A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Stage1: Percentage of Participants With Fold Rise >=4 in hSBA for Each of the 4 Primary MenB Test Strains From Baseline to 1 Month After Vaccination 2 (Group 2 and 4 Combined)

时间窗: From Baseline (blood draw prior to Vaccination 1) to 1 month after Vaccination 2

The 4-fold increase: a) participants with baseline hSBA titer below limit of detection (LOD or an hSBA titer \<1:4), response was defined as hSBA titer \>=1:16 or LLOQ (whichever titer is higher); b) Participants with baseline hSBA titer \>= LOD and \< LLOQ, response was defined as hSBA titer \>= 4 times the LLOQ; c) participants with baseline hSBA titer \>= LLOQ, response was defined as hSBA titer \>=4 times baseline titer. Four primary MenB test strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Analysis for this outcome measure was planned for combined Group 2 and 4.

Stage1: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)

时间窗: 30 days after Vaccination 1

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.

Stage1: Percentage of Participants With at Least 1 SAE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)

时间窗: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.

Stage1: Percentage of Participants With at Least 1 SAE During the Stage 1 Follow-up Phase (Group 2 and 4 Combined)

时间窗: Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. There was one participant who did not meet criteria for Stage 1 follow-up safety population. The subject's SAE happened in the follow-up phase but was not included in the follow-up safety population for Stage 1 (but in the safety population for Stage 1). Therefore, the SAE was not included in the follow-up table but in the broadly defined throughout Stage 1 table.

Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Follow-up Phase (Group 2 and 4 Combined)

时间窗: Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Stage1: Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= Lower Limit of Quantitation (LLOQ) for All 4 Primary Test Strains Combined 1 Month After Vaccination 2 (Group 2 and 4 Combined)

时间窗: 1 month after Vaccination 2

Percentage of participants who achieved an hSBA titer \>= LLOQ for all 4 primary MenB test strains combined (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome. Analysis for this outcome measure was planned for combined Group 2 and 4.

Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination (Group 2 and 4 Combined)

时间窗: 30 days after any vaccination

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)

时间窗: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 2 (Group 2 and 4 Combined)

时间窗: 30 minutes after Vaccination 2

Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration.

Stage1: Percentage of Participants With at Least 1 SAE Throughout the Stage 1 (Group 2 and 4 Combined)

时间窗: Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. There was one participant who did not meet criteria for Stage 1 follow-up safety population. The subject's SAE happened in the follow-up phase but was not included in the follow-up safety population for Stage 1 (but in the safety population for Stage 1). Therefore, the SAE was not included in the follow-up table but in the broadly defined throughout Stage 1 table.

Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Any Vaccination (Group 2 and 4 Combined)

时间窗: 30 days after any Vaccination

A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) During the Stage 1 Follow-up Phase (Group 2 and 4 Combined)

时间窗: Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)

A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Throughout the Stage 1 (Group 2 and 4)

时间窗: Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)

A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Stage2: Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 1 Through Group 4

时间窗: 7 days after booster vaccination

Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were graded as mild (\>2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and severe (\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).

Stage2: Percentage of Participants With at Least 1 NDCMC During Booster Vaccination Phase: Group 1 Through Group 4

时间窗: Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination

A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Stage2: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Booster Vaccination: Group 1 Through Group 4

时间窗: 7 days after booster vaccination

Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)

时间窗: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)

时间窗: 30 days after Vaccination 1

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.

Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)

时间窗: 30 days after Vaccination 2

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.

Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Any Vaccination (Group 2 and 4 Combined)

时间窗: 30 days after any vaccination

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.

Stage1: Percentage of Participants With at Least 1 AE During Vaccination Phase (Group 2 and 4 Combined)

时间窗: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.

Stage2: Percentage of Participants With at Least 1 SAE During Booster Vaccination Phase: Group 1 Through Group 4

时间窗: Booster vaccination phase: From booster vaccination through 1 month after booster vaccination

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. SAE of "pregnancy" for one participant during the booster vaccination phase was recorded erroneously and hence it was included in results of Group 4.

Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 1 (Group 2 and 4 Combined)

时间窗: 30 minutes after Vaccination 1

Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration.

Stage1: Number of Participants Who Missed School/Work Due to AE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)

时间窗: Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)

Stage2: Percentage of Participants With at Least 1 NDCMC Throughout Booster Phase: Group 1 Through Group 4

时间窗: Throughout Booster Phase: From booster vaccination through 6 months after booster vaccination

A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4

时间窗: 7 days after booster vaccination

Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain and joint pain were recorded in an e-diary. Fever was defined as \>=38.0 degree Celsius (C) and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \>40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\>=6 in 24 hours).

Stage2: Percentage of Participants With at Least 1 Medically Attended AE During Booster Vaccination Phase: Group 1 Through Group 4

时间窗: Booster vaccination phase: From booster vaccination through 1 month after booster vaccination

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Stage2: Percentage of Participants With at Least 1 Medically Attended AE During the Booster Follow-up Phase: Group 1 Through Group 4

时间窗: Booster Follow-up Phase: From 1 month after booster vaccination through 6 months after booster vaccination (up to 5 months)

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Stage2: Percentage of Participants With at Least 1 SAE During the Booster Follow-up Phase: Group 1 Through Group 4

时间窗: Booster follow-up phase: From 1 month after booster vaccination through 6 months after booster vaccination (up to 5 months)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.

Stage2: Percentage of Participants With at Least 1 SAE Throughout Booster Phase: Group 1 Through Group 4

时间窗: Throughout Booster phase: From booster vaccination through 6 months after booster vaccination

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. SAE of "pregnancy" for one participant during the booster vaccination phase was recorded erroneously and hence it was reported in result of outcome measure 37 for Group 4. Subsequently correction was made by the trial site and not included in subsequent phase/results. Hence, that 1 participant is not included in results of Group 4 here.

Stage2: Percentage of Participants With at Least 1 Medically Attended AE Throughout Booster Phase: Group 1 Through Group 4

时间窗: Throughout Booster Phase: From booster vaccination through 6 months after booster vaccination

Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.

Stage2: Percentage of Participants With at Least 1 Immediate AE After Booster Vaccination: Group 1 Through Group 4

时间窗: 30 minutes after booster vaccination

Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration.

Stage2: Percentage of Participants With at Least 1 NDCMC During the Booster Follow-up Phase: Group 1 Through Group 4

时间窗: Booster Follow-up Phase: From 1 month after booster vaccination through 6 months after booster vaccination (up to 5 months)

A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.

Stage2: Percentage of Participants With at Least 1 AE During Booster Vaccination Phase: Group 1 Through Group 4

时间窗: Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.

Stage2: Number of Participants Who Missed School/Work Due to AE After Booster Vaccination: Group 1 Through Group 4

时间窗: Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination

次要结局

  • Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)(1 month after Vaccination 2 (Vacc 2))
  • Stage1: hSBA GMTs for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4 and 1 Month After Vaccination 2 in Groups 1 and 3(For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2)
  • Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)(1 month after Vaccination 2)
  • Stage1: hSBA GMTs for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4(Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1])
  • Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)(1 month after Vaccination 2 (Vacc 2))
  • Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)(1 month after Vaccination 2 (Vacc 2))
  • Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=LLOQ for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4(1 month after Vaccination 1)
  • Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)(1 month after Vaccination 2)
  • Stage1: Percentage of Participants With Antipyretic Medication Use 30 Days After Vaccination 1: Group 1 and Group 3(30 days after Vaccination 1)
  • Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)(1 month after Vaccination 2)
  • Stage1: hSBA Geometric Mean Titers (GMTs) for All 4 Primary MenB Test Strains Combined 1 Month After Vaccination 2 (Group 2 and 4 Combined)(1 month after Vaccination 2 (Vacc 2))
  • Stage1: Percentage of Participants With >=4 Fold Rise in hSBA for 4 Primary MenB Strains and Composite Response (hSBA >=LLOQ for All 4 Primary MenB Strains Combined) From Baseline-1 Month After Vaccination 2 (Group 1 and 3 Combined;Group 2 and 4 Combined)(Baseline to 1 month after Vaccination 2)
  • Stage1: Percentage of Participants With at Least 1 SAE Throughout the Stage 1: Group 1 and Group 3(Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months))
  • Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination: Group 1 and Group 3(30 days after any vaccination)
  • Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4(1 month after Vaccination 1)
  • Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ, Whichever is Higher) for ACWY Test Strains 1 Month After the Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3(For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2)
  • Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3(For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2)
  • Stage1: hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)(1 month after Vaccination 2 (Vacc 2))
  • Stage1: hSBA Geometric Mean Titers (GMTs) for ACWY Test Strains 1 Month After Vaccination 1: Groups 1, 2, 3 and 4(1 month after Vaccination 1)
  • Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4(Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1])
  • Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: Group 1 and Group 3(7 days after Vaccination 1 (Vacc 1))
  • Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)(1 month after Vaccination 2 (Vacc 2))
  • Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW and hSBA-MenY Titers >=1:8 (or LLOQ) for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4(Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1])
  • Stage1: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)(Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1])
  • Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains During Persistence Phase (Group 1 and 3 Combined; Group 2 and 4 Combined)(12, 24, 36 and 48 months after Vaccination 2 (Vacc 2))
  • Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains 1 Month After Booster Vaccination (Group 1 and 3 Combined; Group 2 and 4 Combined)(1 month after booster vaccination)
  • Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: Group 1 and Group 3(7 days after Vaccination 2 (Vacc 2))
  • Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)(Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1])
  • Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or >=LLOQ if Higher) for ACWY Test Strains 1 Month After Booster Vaccination: Groups 1 and 3 (Separately)(1 month after booster vaccination)
  • Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3(7 days after Vaccination 1 (Vacc 1))
  • Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Vaccination 2: Group 1 and Group 3(30 days after Vaccination 2)
  • Stage1: Percentage of Participants With at Least 1 NDCMC Within 30 Days After Any Vaccination: Group 1 and Group 3(30 days after any vaccination)
  • Stage1: Percentage of Participants With at Least 1 NDCMC During the Stage 1 Follow-up Phase: Group 1 and Group 3(Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months))
  • Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)(Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1])
  • Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ if Higher) for ACWY Test Strains During Persistence Phase: Groups 1, 2, 3 and 4(12, 24, 36 and 48 months after Vaccination 2 (Vacc 2))
  • Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3(7 days after Vaccination 2 (Vacc 2))
  • Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Vaccination 1: Group 1 and Group 3(30 days after Vaccination 1)
  • Stage1: Percentage of Participants With at Least 1 SAE During the Vaccination Phase: Group 1 and Group 3(Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months))
  • Stage1: Percentage of Participants With at Least 1 Medically Attended AE Throughout the Stage 1: Group 1 and Group 3(Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months))
  • Stage1: Percentage of Participants With at Least 1 NDCMC Within 30 Days After Vaccination 1: Group 1 and Group 3(30 days after vaccination 1)
  • Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 1: Group 1 and Group 3(30 days after vaccination 1)
  • Stage1: Percentage of Participants With Antipyretic Medication Use 30 Days After Vaccination 2: Group 1 and Group 3(30 days after Vaccination 2)
  • Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Any Vaccination: Group 1 and Group 3(30 days after any vaccination)
  • Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 1: Group 1 and Group 3(30 days after vaccination 1)
  • Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination Any Vaccination: Group 1 and Group 3(30 days after any vaccination)
  • Stage1: Percentage of Participants With at Least 1 AE During the Stage 1 Vaccination Phase: Group 1 and Group 3(Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months))
  • Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 2: Group 1 and Group 3(30 minutes after Vaccination 2)
  • Stage1: Percentage of Participants With at Least 1 SAE During the Stage 1 Follow-up Phase: Group 1 and Group 3(Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months))
  • Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 2: Group 1 and Group 3(30 days after vaccination 2)
  • Stage1: Percentage of Participants With at Least 1 NDCMC Within 30 Days After Vaccination 2: Group 1 and Group 3(30 days after vaccination 2)
  • Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Vaccination Phase: Group 1 and Group 3(Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months))
  • Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Follow-up Phase: Group 1 and Group 3(Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months))
  • Stage1: Percentage of Participants With at Least 1 NDCMC During the Stage 1 Vaccination Phase: Group 1 and Group 3(Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months))
  • Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 1: Group 1 and Group 3(30 minutes after Vaccination 1)
  • Stage1: Number of Participants Who Missed School/Work Due to AE During the Stage 1 Vaccination Phase: Group 1 and Group 3(Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months))
  • Stage1: Percentage of Participants With at Least 1 NDCMC Throughout the Stage 1: Group 1 and Group 3(Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months))
  • Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 2: Group 1 and Group 3(30 days after vaccination 2)

研究者

发起方
Pfizer
申办方类型
Industry
责任方
Sponsor

研究点 (139)

Loading locations...

相似试验

撤回
2 期
Safety and Immunogenicity of SCB-2019 in Children <18 Years of AgeCOVID-19
NCT05193279Clover Biopharmaceuticals AUS Pty Ltd
已完成
2 期
Safety and Immunogenicity of Two Adjuvanted and One Non-adjuvanted H5N1 Influenza Vaccine in AdultsInfluenza
NCT00382187Novartis Vaccines40
已完成
2 期
Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two(Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines in Non-Elderly Adult and Elderly SubjectsPandemic Influenza Disease
NCT00311480Novartis520
已完成
3 期
Safety, Tolerability, and Immunogenicity of a 3-dose Regimen of V114 in Healthy Infants (PNEU-PED-EU-2/V114-026)Pneumococcal Infections
NCT04016714Merck Sharp & Dohme LLC1,191
已完成
3 期
Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Co-administered With an Hepatitis A Virus VaccineHealthy Volunteers
NCT03525119Takeda900