Trial Outcomes & Findings for Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years (NCT NCT01235975)

Results Overview

Vaccine response for serum bactericidal assay using rabbit complement (rSBA) antibodies against Neisseria meningitides serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) was defined as: for initially seronegative subjects \[rSBA titer below (\<) 1:8\], post-vaccination rSBA titer greater than or equal to (≥) 1: 32; for initially seropositive subjects with rSBA titer between 1:8 and 1:128, at least four-fold increase in rSBA titer from pre to post vaccination; and for initially seropositive subjects with rSBA titer ≥1:128, at least two-fold increase in rSBA titer from pre to post vaccination.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

400 participants

Primary outcome timeframe

One month after vaccination (Month 1)

Results posted on

2018-08-20

Participant Flow

Out of the total number of subjects originally enrolled, only 369 subjects were eventually found to be eligible to be included in the Total Vaccinated Cohort.

Participant milestones

Participant milestones
Measure	Nimenrix Group Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.	Mencevax Group Healthy male or female subjects aged 56 years or older received a single dose of Mencevax vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
Overall Study STARTED	274	95
Overall Study COMPLETED	257	88
Overall Study NOT COMPLETED	17	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Nimenrix Group Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.	Mencevax Group Healthy male or female subjects aged 56 years or older received a single dose of Mencevax vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
Overall Study Serious Adverse Event	0	1
Overall Study Withdrawal by Subject	8	2
Overall Study Migrated/moved from study area	2	1
Overall Study Lost to Follow-up	7	3

Baseline Characteristics

Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mencevax Group n=95 Participants Healthy male or female subjects aged 56 years or older received a single dose of Mencevax vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.	Total n=369 Participants Total of all reporting groups	Nimenrix Group n=274 Participants Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
Age, Continuous	64.3 Years STANDARD_DEVIATION 7.39 • n=7 Participants	64.15 Years STANDARD_DEVIATION 7.25 • n=5 Participants	64.1 Years STANDARD_DEVIATION 7.22 • n=5 Participants
Sex: Female, Male Female	70 Participants n=7 Participants	252 Participants n=5 Participants	182 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=7 Participants	117 Participants n=5 Participants	92 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic / North African Heritage	95 Participants n=7 Participants	369 Participants n=5 Participants	274 Participants n=5 Participants

PRIMARY outcome

Timeframe: One month after vaccination (Month 1)

Population: The primary analysis was performed on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who met all eligibility criteria, who complied with the protocol requirements and for whom immunogenicity measures were available.

Vaccine response for serum bactericidal assay using rabbit complement (rSBA) antibodies against Neisseria meningitides serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) was defined as: for initially seronegative subjects \[rSBA titer below (\<) 1:8\], post-vaccination rSBA titer greater than or equal to (≥) 1: 32; for initially seropositive subjects with rSBA titer between 1:8 and 1:128, at least four-fold increase in rSBA titer from pre to post vaccination; and for initially seropositive subjects with rSBA titer ≥1:128, at least two-fold increase in rSBA titer from pre to post vaccination.