A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years

Pfizer3,596 enrolled

Overview

This study is looking at a new vaccine that might prevent meningococcal disease, and will study whether healthy adolescent subjects receiving different lots of vaccine respond in a similar way. The study will also look at the safety of the new vaccine as well as how it is tolerated.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

3,596

Conditions

Meningococcal Vaccine

Interventions

rLP2086BIOLOGICAL

0.5 mL dose, given at 0, 2 and 6 months (lot 1)

rLP2086BIOLOGICAL

0.5 mL dose, given at 0, 2 and 6 months (lot 2)

rLP2086BIOLOGICAL

0.5 mL dose, given at 0, 2 and 6 months (lot 3)

Havrix (HAV)

Eligibility

Sex: ALLMin age: 10 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female subject aged \>=10 and \<19 years at the time of enrollment. 2. Healthy subject as determined by medical history, physical examination, and judgment of the investigator. 3. Negative urine pregnancy test for all female subjects. Exclusion Criteria: 1. Previous vaccination with any meningococcal serogroup B vaccine. 2. Subjects who have received prior HAV vaccination. 3. Subjects who are scheduled to receive 1 or more doses of an HPV vaccine as part of a 3-dose series during the period between Visit 1 and 28 days after the second vaccination. 4. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses. 5. 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. 6. Significant neurological disorder or history of seizure (excluding simple febrile seizure). 7. Current chronic use of systemic antibiotics. 8. Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination. 9. Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

Locations (99)

Outcomes

Primary Outcomes

Percentage of Participants With >=4 Fold Rise in Serum Bactericidal Assay Using Human Complement (hSBA) for 4 Primary Strains and Composite Response (hSBA >=Lower Limit of Quantification [LLOQ] for All 4 Primary Strains Combined) for Group 1

Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1,2,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA. Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point.

Time frame: One month after third bivalent rLP2086 vaccination

hSBA Geometric Mean Titers (GMTs) for Each of the 2 Primary Test Strains Measured 1 Month After the Third Vaccination With Bivalent rLP2086 Vaccine

Time frame: One month after third bivalent rLP2086 vaccination

Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination

Time frame: Within 7 Days after first vaccination

Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination

Time frame: Within 7 Days after second vaccination

Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination

Time frame: Within 7 Days after third vaccination

Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination

Here, N signifies participants with known values reporting specific characteristic.

Time frame: Within 7 Days after first vaccination

Data from ClinicalTrials.gov

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0.5 mL dose or 1.0 mL dose dependent on age given at month 0 and 6.

SalineBIOLOGICAL

0.5 mL dose of sterile normal saline for injection.

Birmingham Pediatric Associates, PC

Birmingham, Alabama, United States

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, United States

Southeastern Pediatrics

Dothan, Alabama, United States

Harrisburg Family Medical Center

Harrisburg, Arkansas, United States

The Children's Clinic of Jonesboro, P.A.

Jonesboro, Arkansas, United States

Arkansas Pediatric Clinic

Little Rock, Arkansas, United States

California Research Foundation

San Diego, California, United States

Colorado Springs Health Partners/Clinical Research Advantage, Inc.

Colorado Springs, Colorado, United States

Aga Clinical Trials

Hialeah, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

...and 89 more locations

Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination

Here, N signifies participants with known values reporting specific characteristic.

Time frame: Within 7 Days after second vaccination

Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination

Here, N signifies participants with known values reporting specific characteristic.

Time frame: Within 7 Days after third vaccination

Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After First Vaccination

Time frame: Within 30 days after first vaccination

Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Second Vaccination

Time frame: Within 30 days after second vaccination

Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Third Vaccination

Time frame: Within 30 days after third vaccination

Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Any Vaccination

Time frame: Within 30 days after any vaccination

Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Vaccination Phase

Time frame: From the first vaccination up to 1 month after the third vaccination

Percentage of Participants With at Least 1 Serious Adverse Event (SAE) During the Follow-Up Phase

Time frame: From 1 month after third vaccination up to 6 months after the third vaccination

Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Throughout the Study Period

Time frame: From the first vaccination up to 6 month after the third vaccination

Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After First Vaccination

Time frame: Within 30 days after first vaccination

Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Second Vaccination

Time frame: Within 30 days after second vaccination

Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Third Vaccination

Time frame: Within 30 days after third vaccination

Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination

Time frame: Within 30 days after any vaccination

Percentage of Participants With at Least 1 Medically Attended AE During the Vaccination Phase

Time frame: From the first vaccination up to 1 month after the third vaccination

Percentage of Participants With at Least 1 Medically Attended AE During the Follow-Up Phase

Time frame: From 1 month after third vaccination up to 6 months after the third vaccination

Percentage of Participants With at Least 1 Medically Attended AE Throughout the Study Period

Time frame: From the first vaccination up to 6 month after the third vaccination

Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After First Vaccination

Time frame: Within 30 days after first vaccination

Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Second Vaccination

Time frame: 30 days after second vaccination

Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Third Vaccination

Time frame: Within 30 days after third vaccination

Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Within 30 Days After Any Vaccination

Time frame: Within 30 Days After any Vaccination

Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Vaccination Phase

Time frame: From the first vaccination up to 1 month after the third vaccination

Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition During the Follow-Up Phase

Time frame: From 1 month after third vaccination up to 6 months after the third vaccination

Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition Throughout the Study Period

Time frame: From the first vaccination up to 6 month after the third vaccination

Percentage of Participants With at Least 1 Adverse Event (AE) WIthin 30 Days After First Vaccination

Time frame: Within 30 days after first vaccination

Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Second Vaccination

Time frame: Within 30 days after second vaccination

Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Third Vaccination

Time frame: Within 30 days after third vaccination

Percentage of Participants With at Least 1 Adverse Event Within 30 Days After Any Vaccination

Time frame: Within 30 Days after any vaccination

Percentage of Participants With at Least 1 Adverse Event During the Vaccination Phase

Time frame: From the first vaccination up to 1 month after the third vaccination

Percentage of Participants Reporting at Least 1 Immediate AE After First Vaccination

Time frame: Within 30 minutes after first vaccination

Percentage of Participants Reporting at Least 1 Immediate AE After Second Vaccination

Time frame: Within 30 minutes after second vaccination

Percentage of Participants Reporting at Least 1 Immediate AE After Third Vaccination

Time frame: Within 30 minutes after third vaccination

Number of Days Participant's Missed School or Work Due to AE During the Vaccination Phase

Time frame: From the first vaccination up to 1 month after the third vaccination

Secondary Outcomes

Percentage of Participants With hSBA Titers >=LLOQ for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination for Group 1

Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.

Time frame: Before first vaccination, 1 month after third vaccination

Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, >=1:128 for Each of the 10 Secondary Strains, Before Vaccination 1 and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1

Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.

Time frame: Before first vaccination, 1 month after third vaccination (Vac)

hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination for Group 1

Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.

Time frame: Before first vaccination, 1 month after third vaccination

Percentage of Participants Achieving Composite hSBA Titer >=Lower Limit of Quantitation for All 4 Primary Strains Before First Vaccination and 1 Month After Second Bivalent rLP2086 Vaccination for Group 1

Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2 ,3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.

Time frame: Before vaccination 1, 1 Month after Vaccination 2

Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for Each of the 4 Primary Strains Before First Vaccination to 1 Month After the Second Bivalent rLP2086 Vaccination for Group 1

Groups 2 and 3 were included for the Lot consistency analysis for primary strains only (hSBA geometric mean titer). The immunogenicity of two MnB strains in lots 1, 2, 3 were required to test for lot consistency. These data are presented separately in the other endpoints. The data for all the strains in Lot 1 (Group 1) is sufficient to describe the immunogenicity expected with the vaccine. The analytical plan was included in the protocol and agreement was reach with EMA and FDA.

Time frame: One month after second Bivalent rLP2086 vaccination

Percentage of Participants Achieving at Least a 4-Fold Increase in hSBA Titer for 2 Primary Strains Before First Vaccination to 1 Month After the Second and Third Bivalent rLP2086 Vaccination

Time frame: One month after second, third vaccination

hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains and for 2 Primary Test Strains and Before First Vaccination and 1 Month After the Second Bivalent rLP2086 Vaccination

Time frame: Before vaccination (Vac) 1, 1 Month after Vac 2

Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination

Time frame: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3

Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination

Results for PMB80\[A22\] 1:16, PMB2001\[A56\] 1:8, PMB2948\[B24\] 1:8 and PMB2707\[B44\] 1:8 are reported under secondary outcome measure 'Percentage of Participants With hSBA Titers \>=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination.

Time frame: Before Vaccination (Vac) 1, 1 Month after Vac 2, 3

Percentage of Participants Achieving at Least a 3-Fold Increase in hSBA Titer for 4 Primary Test Strains and for Primary Test Starins Before First Vaccination to 1 Month After Third Bivalent rLP2086 Vaccination

Time frame: One month after third bivalent rLP2086 vaccination

Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains and for 2 Primary Test Starins Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination

Time frame: One month after third bivalent rLP2086 vaccination (Vac)