A Phase 3, Randomized, Placebo-controlled, Observer-blinded, Trial To Assess The Safety, Tolerability, And Immunogenicity Of Bivalent Rlp2086 Vaccine When Administered As A 3-dose Regimen In Healthy Young Adults Aged >=18 To <26 Years
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Pfizer
- Enrollment
- 3301
- Locations
- 54
- Primary Endpoint
- Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This study is looking at a new vaccine that might prevent meningococcal disease, and will study the immune response elicited by this vaccine when given to healthy young adults. The study will also look at the safety of the new vaccine as well as how it is tolerated.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subject aged \>=18 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.
Exclusion Criteria
- •Previous vaccination with any meningococcal serogroup B vaccine.
- •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.
- •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.
Outcomes
Primary Outcomes
Percentage of Participants With at Least 1 Adverse Event (AE) During the Vaccination Phase
Time Frame: From the first vaccination up to 1 month after the third vaccination
Percentage of Participants With Greater Than or Equal to(>=)4 Fold Rise in Serum Bactericidal Assay Using Human Complement(hSBA) for 4 Primary Strains and Composite Response (hSBA>=Lower Limit of Quantification for All 4 Primary Strains Combined):Group 1
Time Frame: One month after third bivalent rLP2086 vaccination
Here, N signifies participants with valid and determinate hSBA titers for given strain at specified time point. This outcome measure was planned to be analyzed for Group 1 only.
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Second Vaccination
Time Frame: Within 7 days after second vaccination
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination
Time Frame: Within 7 days after first vaccination
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Second Vaccination
Time Frame: Within 7 days after second vaccination
Percentage of Participants With at Least 1 Adverse Event (AE) Within 30 Days After Any Vaccination
Time Frame: Within 30 days after any 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 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 Medically Attended AE 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: Within 30 days after second 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 the third vaccination
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After Third Vaccination
Time Frame: Within 7 days after third 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) 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 Within 30 Days After Second Vaccination
Time Frame: Within 30 days after second 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 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 Medically Attended AE 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) 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) 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 Third Vaccination
Time Frame: Within 30 days after third 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 Reporting at Least 1 Medically Attended Adverse Event Throughout the Study Period
Time Frame: From the first vaccination up to 6 month after the third vaccination
Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After First Vaccination
Time Frame: Within 30 minutes after first vaccination
Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Second Vaccination
Time Frame: Within 30 minutes after second vaccination
Number of Days Participants 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
Percentage of Participants Reporting Pre-specified Local Reactions (LRs) Within 7 Days After First Vaccination
Time Frame: Within 7 days after first vaccination
Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After Third Vaccination
Time Frame: Within 7 days after third 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 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 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 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 Follow-Up Phase
Time Frame: From 1 month after third vaccination up to 6 months after the third vaccination
Percentage of Participants Reporting at Least 1 Immediate Adverse Event (AE) After Third Vaccination
Time Frame: Within 30 minutes after third vaccination
Secondary Outcomes
- Percentage of Participants With hSBA Titers >= Lower Limit of Quantification for 10 Secondary Strains Before First Vaccination and 1 Month After Third Bivalent rLP2086 Vaccination: Group 1(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: Group 1(Before vaccination 1, 1 Month after Vaccination 2)
- Percentage of Participants With hSBA Titers >=1:4,>=1:8,>=1:16,>=1:32,>=1:64,>=1:128 for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1(Before Vaccination (Vac) 1, 1 Month after Vac 2, 3)
- Percentage of Participants With hSBA Titers >=LLOQ for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1(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 Before First Vaccination to 1 Month After Third Bivalent rLP2086 Vaccination(One month after third bivalent rLP2086 vaccination)
- hSBA Geometric Mean Titers (GMTs) for 4 Primary Test Strains Before First Vaccination, 1 Month After Second and Third Bivalent rLP2086 Vaccination: Group 1(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 Each of the 10 Secondary Strains Before First Vaccination and 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1(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: Group 1(Before first vaccination, 1 month after third vaccination)
- 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: Group 1(One month after second Bivalent rLP2086 vaccination)
- Percentage of Participants Achieving at Least a 2-Fold Increase in hSBA Titer for 4 Primary Test Strains Before First Vaccination to 1 Month After the Third Bivalent rLP2086 Vaccination: Group 1(One month after third bivalent rLP2086 vaccination)