A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.

NCT03135834 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: B19710572016-004421-17
• Study Type: interventional
• Target: 1,610
• Locations: 4 countries
• Sites: 75

Brief Summary

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.

Conditions

Meningococcal Vaccine

Outcome Measures

Primary Outcomes (48)

• 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)

  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.

  1 month after Vaccination 2

• 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)

  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.

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

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

  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).

  7 days after Vaccination 1

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

  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).

  7 days after Vaccination 2

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

  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).

  7 days after Vaccination 1

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

  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).

  7 days after Vaccination 2

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

  7 days after Vaccination 1

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

  7 days after Vaccination 2

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

  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.

  30 days after Vaccination 1

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

  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.

  30 days after Vaccination 2

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

  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.

  30 days after any vaccination

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

  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.

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

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

  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.

  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 SAE Throughout the Stage 1 (Group 2 and 4 Combined)

  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.

  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 Vaccination 1 (Group 2 and 4 Combined)

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

  30 days after Vaccination 1

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

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

  30 days after Vaccination 2

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

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

  30 days after any vaccination

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

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

  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 2 and 4 Combined)

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

  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 Throughout the Stage 1 (Group 2 and 4 Combined)

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

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

• 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)

  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.

  30 days after Vaccination 1

• 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)

  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.

  30 days after Vaccination 2

• 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)

  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.

  30 days after any 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)

  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.

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

• 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)

  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.

  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 Newly Diagnosed Chronic Medical Condition (NDCMC) Throughout the Stage 1 (Group 2 and 4)

  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.

  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 1 (Group 2 and 4 Combined)

  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.

  30 days after Vaccination 1

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

  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.

  30 days after Vaccination 2

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

  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.

  30 days after any vaccination

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

  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.

  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 2 and 4 Combined)

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

  30 minutes after Vaccination 1

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

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

  30 minutes after Vaccination 2

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

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

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

  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).

  7 days after booster vaccination

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

  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).

  7 days after booster vaccination

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

  7 days after booster vaccination

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

  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.

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

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

  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.

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

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

  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.

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

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

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

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

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

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

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

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

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

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

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

  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.

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

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

  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.

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

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

  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.

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

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

  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.

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

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

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

  30 minutes after booster vaccination

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

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

Secondary Outcomes (57)

• 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: 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 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 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)

Study Arms (4)

Group 1 (ACWY Naive subjects, MenABCWY/Saline)

EXPERIMENTAL

ACWY Naive subjects, MenABCWY/Saline

Biological: MenABCWY; Biological: Saline

Group 2 (ACWY Naive subjects, rLP2086/MenACWY-CRM)

EXPERIMENTAL

ACWY Naive subjects, rLP2086/MenACWY-CRM

Biological: rLP2086; Biological: MenACWY-CRM

Group 3 (ACWY Experienced subjects, MenABCWY/Saline)

EXPERIMENTAL

ACWY Experienced subjects, MenABCWY/Saline

Biological: MenABCWY; Biological: Saline

Group 4 (ACWY Experienced subjects, rLP2086/MenACWY-CRM)

EXPERIMENTAL

ACWY Experienced subjects, rLP2086/MenACWY-CRM

Biological: rLP2086; Biological: MenACWY-CRM

Interventions

MenABCWY BIOLOGICAL

N meningitidis group A, B, C, W, and Y vaccine

Group 1 (ACWY Naive subjects, MenABCWY/Saline); Group 3 (ACWY Experienced subjects, MenABCWY/Saline)

Saline BIOLOGICAL

Placebo

Group 1 (ACWY Naive subjects, MenABCWY/Saline); Group 3 (ACWY Experienced subjects, MenABCWY/Saline)

rLP2086 BIOLOGICAL

Bivalent recombinant lipoprotein 2086 vaccine

Group 2 (ACWY Naive subjects, rLP2086/MenACWY-CRM); Group 4 (ACWY Experienced subjects, rLP2086/MenACWY-CRM)

MenACWY-CRM BIOLOGICAL

meningococcal group A, C, W-135, and Y conjugate vaccine

Group 2 (ACWY Naive subjects, rLP2086/MenACWY-CRM); Group 4 (ACWY Experienced subjects, rLP2086/MenACWY-CRM)

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (75)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35205, United States

Location

Optimal Research, LLC

Huntsville, Alabama, 35802, United States

Location

Synexus Clinical Research US, Inc./Fountain Hills Family Practice, P.C.

Fountain Hills, Arizona, 85268, United States

Location

Clinical Research Consortium

Tempe, Arizona, 85283, United States

Location

Harrisburg Family Medical Center

Harrisburg, Arkansas, 72432, United States

Location

Paradigm Clinical Research Centers, Inc.

La Mesa, California, 91942, United States

Location

California Research Foundation

San Diego, California, 92123, United States

Location

Kaiser Permanente Santa Clara

Santa Clara, California, 95051, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

Health Awareness, Inc.

Jupiter, Florida, 33458, United States

Location

Optimal Research, LLC

Melbourne, Florida, 32934, United States

Location

Meridian Clinical Research LLC

Savannah, Georgia, 31406, United States

Location

Optimal Research

Peoria, Illinois, 61614, United States

Location

Meridian Clinical Research

Sioux City, Iowa, 51106, United States

Location

Alliance for Multispecialty Research, LLC

Newton, Kansas, 67114, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67205, United States

Location

Alliance For Multispecialty Research (AMR)

Wichita, Kansas, 67207, United States

Location

Alliance for Multispecialty Research, LLC

Wichita, Kansas, 67207, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

Kentucky Pediatric/Adult Research

Bardstown, Kentucky, 40004, United States

Location

Horizon Research Group of Opelousas, LLC

Eunice, Louisiana, 70535, United States

Location

ACC Pediatric Research

Haughton, Louisiana, 71037, United States

Location

Methodist Physicians Clinic/CCT Research

Fremont, Nebraska, 68025, United States

Location

Meridian Clinical Research, LLC

Norfolk, Nebraska, 68701, United States

Location

Meridian Clinical Research, LLC

Omaha, Nebraska, 68134, United States

Location

Meridian Clinical Research, LLC

Binghamton, New York, 13901, United States

Location

United Medical Associates

Binghamton, New York, 13901, United States

Location

Meridian Clinical Research, LLC

Binghamton, New York, 13905, United States

Location

United Medical Associates

Binghamton, New York, 13905, United States

Location

Regional Clinical Research, Inc

Endwell, New York, 13760, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

Meridian Clinical Research, LLC

Vestal, New York, 13850, United States

Location

Regional Clinical Research, Inc

Vestal, New York, 13850, United States

Location

Capitol Pediatrics & Adolescent Center PLLC

Raleigh, North Carolina, 27609, United States

Location

Meridian Clinical Research, LLC

Cincinnati, Ohio, 45246, United States

Location

Velocity Clinical Research, Inc.

Cleveland, Ohio, 44122, United States

Location

Aventiv Research Inc.

Columbus, Ohio, 43213, United States

Location

Ohio Pediatric Research Association, Inc.

Dayton, Ohio, 45414, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Liberty Family Practice

Erie, Pennsylvania, 16508, United States

Location

Charleston Pediatrics, PA

Charleston, South Carolina, 29403, United States

Location

PMG Research of Charleston, LLC

Mt. Pleasant, South Carolina, 29464, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405, United States

Location

Internal Medicine and Pediatric Associates of Bristol, PC

Bristol, Tennessee, 37620, United States

Location

PMG Research of Bristol, LLC

Bristol, Tennessee, 37620, United States

Location

Holston Medical Group

Kingsport, Tennessee, 37660, United States

Location

Clinical Research Associates, Inc.

Nashville, Tennessee, 37203, United States

Location

Benchmark Research

Austin, Texas, 78705, United States

Location

Texas Health Care, PLLC

Fort Worth, Texas, 76104, United States

Location

Ventavia Research Group, LLC

Fort Worth, Texas, 76104, United States

Location

Benchmark Research

Fort Worth, Texas, 76135, United States

Location

Acrc Trials

Plano, Texas, 75024, United States

Location

North Texas Family Medicine

Plano, Texas, 75093, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

J. Lewis Research Inc. / Foothill Family Clinic Draper

Draper, Utah, 84020, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic

Salt Lake City, Utah, 84109, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

J. Lewis Research, Inc. / Jordan River Family Medicine

South Jordan, Utah, 84095, United States

Location

PI-Coor Clinical Research, LLC

Burke, Virginia, 22015, United States

Location

Pediatric Research of Charlottesville, LLC

Charlottesville, Virginia, 22902, United States

Location

Ordinace praktickeho lekare pro deti a dorost

Jindřichův Hradec, 377 01, Czechia

Location

MEDICENTRUM 6 s.r.o. - Ordinace praktickeho lekare pro deti a dorost

Prague, 160 00, Czechia

Location

Espoo Vaccine Research Clinic

Espoo, 02230, Finland

Location

Helsinki South Vaccine Research Clinic

Helsinki, 00100, Finland

Location

Helsinki East Vaccine Research Clinic

Helsinki, 00930, Finland

Location

Jarvenpaa Vaccine Research Clinic

Jarvenpaa, 04400, Finland

Location

Kokkola Vaccine Research Clinic

Kokkola, 67100, Finland

Location

Oulu Vaccine Research Clinic

Oulu, 90220, Finland

Location

Pori Vaccine Research Clinic

Pori, 28100, Finland

Location

Seinajoki Vaccine Research Clinic

Seinäjoki, 60100, Finland

Location

Tampere Vaccine Research Clinic

Tampere, 33100, Finland

Location

Turku Vaccine Research Clinic

Turku, 20520, Finland

Location

Jerzy Brzostek Prywatny Gabinet Lekarski

Dębica, 39-200, Poland

Location

Hanna Czajka Indywidualna Specjalistyczna Praktyka Lekarska

Krakow, 30-348, Poland

Location

Oddzial Pediatrii i Neurologii Dzieciecej, Krakowski Szpital Specjalistyczny im. Jana Pawla II

Krakow, 31-202, Poland

Location

Related Publications (2)

• Peterson J, Drazan D, Moughan B, Maguire JD, Zolotas L, Maansson R, O'Neill R, Peyrani P, Jodar L, Gruber WC, Anderson AS, Beeslaar J. Randomized trial showing persistence of hSBA titers elicited by a pentavalent meningococcal MenABCWY vaccine for up to 4 years following a primary series and safety and immunogenicity of a booster dose. Vaccine. 2025 Jan 1;43(Pt 1):126469. doi: 10.1016/j.vaccine.2024.126469. Epub 2024 Nov 8.

  PMID: 39520893 DERIVED

• Peterson J, Drazan D, Czajka H, Maguire J, Pregaldien JL, Seppa I, Maansson R, O'Neill R, Balmer P, Jodar L, Jansen KU, Anderson AS, Perez JL, Beeslaar J. Immunogenicity and safety of a pentavalent meningococcal ABCWY vaccine in adolescents and young adults: an observer-blind, active-controlled, randomised trial. Lancet Infect Dis. 2023 Dec;23(12):1370-1382. doi: 10.1016/S1473-3099(23)00191-3. Epub 2023 Aug 11.

  PMID: 37579773 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Sodium Chloride; factor H-binding protein, Neisseria meningitidis; MenACWY-CRM vaccine

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

SAE of "pregnancy" for 1 participant during booster vaccination phase (Stage 2) was recorded erroneously and was reported in result of outcome measure 37. One participant had an SAE which was recorded after 8 months of vaccination 2 and one participant had an SAE after 15 months of Vaccination 2. This time period did not present Stage 1 or Stage 2. Hence, it was not included in related outcome measure summary. However, these participants were included in adverse events module for Stage 1.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 1, 2017
• Study Start: April 24, 2017
• Primary Completion: October 25, 2022
• Study Completion: October 25, 2022
• Last Updated: August 8, 2023
• Results First Posted: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share

Locations

US (60); FI (10); PL (3); CZ (2)