A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Lot Consistency, Safety, Tolerability, And Immunogenicity Of A Meningococcal Serogroup B Bivalent Rlp2086 Vaccine In Healthy Subjects Aged >/=10 To <19 Years

NCT01830855 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Pfizer
Phase	Phase 3
Status	COMPLETED
Enrolment	3596
Start date	2013-04
Completion	2015-04

Conditions

• Meningococcal Vaccine

Interventions

• rLP2086
• rLP2086
• rLP2086
• Havrix (HAV)
• Saline

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 — One month after third bivalent rLP2086 vaccination
  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.
• hSBA Geometric Mean Titers (GMTs) for Each of the 2 Primary Test Strains Measured 1 Month After the Third Vaccination With Bivalent rLP2086 Vaccine — One month after third bivalent rLP2086 vaccination
• Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After First Vaccination — Within 7 Days after first vaccination
• Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Second Vaccination — Within 7 Days after second vaccination
• Percentage of Participants Reporting Local Reactions (LRs) Within 7 Days After Third Vaccination — Within 7 Days after third vaccination
• Percentage of Participants Reporting Systemic Events (SEs) and Antipyretic Use Within 7 Days After First Vaccination — Within 7 Days after first vaccination
  Here, N signifies participants with known values reporting specific characteristic.

Countries

United States, Canada, Czechia, Finland, Germany, Italy, Poland, United Kingdom