Clinical Trial: A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Safety And Tolerability Of A Meningococcal Serogroup B Bivalent Recombinant Lipoprotein (rlp2086) Vaccine Given In Health

Brief Summary:

A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2.

All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome:

• Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study [ Time Frame: Vaccination 1 up to 6 months after Vaccination 3 ]
  An adverse event (AE) was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly.
• Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1 [ Time Frame: Within 30 days after Vaccination 1 ]
  A medically attended AE was defined as a non-serious AE that required medical attention.
• Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2 [ Time Frame: Within 30 days after Vaccination 2 ]
  A medically attended AE was defined as a non-serious AE that required medical attention.
• Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3 [ Time Frame: Within 30 days after Vaccination 3 ]
  A medically attended AE was defined as a non-serious AE that required medical attention.

Original Primary Outcome: The primary endpoints will be the safety related variables, as measured by adverse events (AEs), and serious adverse events (SAEs). [ Time Frame: 12 months ]

Current Secondary Outcome:

• Percentage of Participants With at Least One Serious Adverse Event (SAE) During Pre-specified Time Periods [ Time Frame: Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3) ]
  An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
• Percentage of Participants With at Least One Medically Attended Adverse Event During Pre-specified Time Periods [ Time Frame: Within 30 days after any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3); follow-up phase (1 month up to 6 months after Vaccination 3); throughout study (Vaccination 1 up to 6 months after Vaccination 3) ]
  A medically attended AE was defined as a non-serious AE that required medical attention.
• Percentage of Participants With at Least One Newly Diagnosed Chronic Medical Condition During Pre-specified Time Periods [ Time Frame: Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase(Vaccination 1 up to 1 month after Vaccination 3); follow-up phase(1 month up to 6 months after Vaccination 3); throughout study(Vaccination 1 up to 6 months after Vaccination 3) ]
  A newly diagnosed chronic medical condition was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Newly diagnosed chronic medical condition did not include illnesses considered to be temporary conditions. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
• Percentage of Participants With at Least One Adverse Event (AE) During Pre-specified Time Periods [ Time Frame: Within 30 days after Vaccination 1, 2, 3, any vaccination; vaccination phase (Vaccination 1 up to 1 month after Vaccination 3) ]
  An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
• Percentage of Participants With at Least One Immediate Adverse Event (AE) After Each Study Vaccination [ Time Frame: Within 30 minutes after Vaccination 1, 2, 3 ]
  An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. Any AE that occurred within the first 30 minutes after the administration of study vaccine (bivalent rLP2086, HAV vaccine or saline) was classified as an immediate AE. Here, 'N' signifies those participants who were evaluable for this measure during specified time period.
• Number of Days Participant Missed School or Work Due to Adverse Events (AEs) [ Time Frame: Vaccination 1 up to 1 month after Vaccination 3 ]

Original Secondary Outcome:

• hSBA titers, as measured by GMTs, for each of the 2 primary strains at each blood draw visit [ Time Frame: month 0, 3, 7 ]
• Proportion of subjects with an rLP2086 specific hSBA titer ≥1:4 for each of the 2 primary strains. [ Time Frame: month 0, 3, 7 ]
• Proportion of subjects with an rLP2086 specific hSBA titer ≥1:4, ≥1:8, ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for each of the 2 primary strains [ Time Frame: month 0, 3, 7 ]
• Proportion of subjects achieving ≥4 fold rise on rLP2086 specific hSBA titer for each of the 2 primary strains [ Time Frame: month 0, 3, 7 ]

Dates:
Date Received: May 11, 2011
Date Started: November 2012
Date Completion:
Last Updated: February 25, 2015
Last Verified: February 2015