Trial Outcomes & Findings for Lot Consistency, Immuno, Safety of Meningococcal Vaccine GSK134612 Given With Fluarix™ to 18-55 Year-Old Adults (NCT NCT00453986)
NCT ID: NCT00453986
Last Updated: 2018-09-25
Results Overview
Titers were expressed as geometric mean antibody titers and were calculated on all subjects from both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1352 participants
Primary outcome timeframe
One month after vaccination (at Month 1)
Results posted on
2018-09-25
Participant Flow
All subjects were included in 1 of the 2 cohorts: Flu vaccine cohort: in the 5 groups, subjects received Nimenrix vaccine (lots A, B or C) or Mencevax ACWY vaccine or Nimenrix lot A and Fluarix vaccines. Non-Flu vaccine cohort: in the 4 groups, subjects received Nimenrix vaccine (lots A, B or C) or Mencevax ACWY vaccine.
Participant milestones
| Measure |
Nimenrix A Group
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
|
Nimenrix+Fluarix Group
subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
311
|
311
|
313
|
312
|
105
|
|
Overall Study
COMPLETED
|
305
|
306
|
307
|
310
|
105
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
6
|
2
|
0
|
Reasons for withdrawal
| Measure |
Nimenrix A Group
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
|
Nimenrix+Fluarix Group
subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
5
|
6
|
2
|
0
|
Baseline Characteristics
Lot Consistency, Immuno, Safety of Meningococcal Vaccine GSK134612 Given With Fluarix™ to 18-55 Year-Old Adults
Baseline characteristics by cohort
| Measure |
Nimenrix A Group
n=311 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=311 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
n=313 Participants
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
n=312 Participants
subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
|
Nimenrix+Fluarix Group
n=105 Participants
subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
|
Total
n=1352 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
35.2 Years
STANDARD_DEVIATION 10.48 • n=5 Participants
|
35.1 Years
STANDARD_DEVIATION 10.50 • n=7 Participants
|
35.7 Years
STANDARD_DEVIATION 10.75 • n=5 Participants
|
34.9 Years
STANDARD_DEVIATION 10.73 • n=4 Participants
|
35.9 Years
STANDARD_DEVIATION 10.40 • n=21 Participants
|
35.4 Years
STANDARD_DEVIATION 10.57 • n=8 Participants
|
|
Sex: Female, Male
Female
|
135 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
151 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
598 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
176 Participants
n=5 Participants
|
172 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
754 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian - South east Asian heritage
|
223 Participants
n=5 Participants
|
223 Participants
n=7 Participants
|
224 Participants
n=5 Participants
|
224 Participants
n=4 Participants
|
105 Participants
n=21 Participants
|
999 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White - Arabic / North African heritage
|
88 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
351 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian / European heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: One month after vaccination (at Month 1)Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
Titers were expressed as geometric mean antibody titers and were calculated on all subjects from both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.
Outcome measures
| Measure |
Nimenrix A Group
n=297 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=292 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
n=296 Participants
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups.
rSBA-MenY
|
7872.7 Titers
Interval 6849.0 to 9049.3
|
7235.7 Titers
Interval 6257.6 to 8366.8
|
8041.4 Titers
Interval 6952.1 to 9301.3
|
|
Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups.
rSBA-MenA
|
3913.1 Titers
Interval 3468.9 to 4414.1
|
3503.5 Titers
Interval 3083.0 to 3981.4
|
3470.8 Titers
Interval 3051.7 to 3947.3
|
|
Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups.
rSBA-MenC
|
9467.0 Titers
Interval 7980.2 to 11230.7
|
8118.7 Titers
Interval 6818.9 to 9666.3
|
9051.0 Titers
Interval 7538.6 to 10866.8
|
|
Serum Bactericidal Assay (Performed Using Baby Rabbit Complement) for Neisseria Meningitidis Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) Antibody Titers, in Each of the 3 Lot Groups.
rSBA-MenW-135
|
5263.2 Titers
Interval 4527.0 to 6119.1
|
4890.6 Titers
Interval 4145.5 to 5769.6
|
5260.1 Titers
Interval 4536.8 to 6098.7
|
PRIMARY outcome
Timeframe: One month after vaccination (at Month 1)Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
Vaccine response was defined as a rSBA titer of at least 1:32 in initially seronegative subjects (\<1:8) and as 4-fold increase in titer in initially seropositive subjects (≥1:8). A seronegative subject had antibody titer below 1:8 prior to vaccination and a seropositive subject had antibody titer equal to or above 1:8 prior to vaccination. Vaccine response was assessed for subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Outcome measures
| Measure |
Nimenrix A Group
n=288 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=862 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenA seronegative
|
25 Participants
|
107 Participants
|
—
|
|
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenA seropositive
|
151 Participants
|
488 Participants
|
—
|
|
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenC seronegative
|
64 Participants
|
198 Participants
|
—
|
|
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenC seropositive
|
201 Participants
|
579 Participants
|
—
|
|
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenW-135 seronegative
|
53 Participants
|
151 Participants
|
—
|
|
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenW-135 seropositive
|
189 Participants
|
625 Participants
|
—
|
|
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenY seronegative
|
32 Participants
|
68 Participants
|
—
|
|
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenY seropositive
|
195 Participants
|
682 Participants
|
—
|
|
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenA total
|
176 Participants
|
595 Participants
|
—
|
|
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenC total
|
265 Participants
|
777 Participants
|
—
|
|
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenW-135 total
|
242 Participants
|
776 Participants
|
—
|
|
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenY total
|
227 Participants
|
750 Participants
|
—
|
PRIMARY outcome
Timeframe: One month after vaccination (at Month 1)Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine and on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort).
Outcome measures
| Measure |
Nimenrix A Group
n=105 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=308 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix Lot A + Fluarix Vaccines or the Nimenrix Vaccine (Pooled Lots in the Flu Vaccine Cohort)
rSBA-MenA
|
2831.1 Titers
Interval 2282.4 to 3511.7
|
3784.2 Titers
Interval 3326.3 to 4305.1
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix Lot A + Fluarix Vaccines or the Nimenrix Vaccine (Pooled Lots in the Flu Vaccine Cohort)
rSBA-MenC
|
6579.5 Titers
Interval 4861.5 to 8904.6
|
10130.8 Titers
Interval 8672.3 to 11834.5
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix Lot A + Fluarix Vaccines or the Nimenrix Vaccine (Pooled Lots in the Flu Vaccine Cohort)
rSBA-MenW-135
|
4394.8 Titers
Interval 3316.3 to 5824.0
|
6016.8 Titers
Interval 5201.4 to 6960.2
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix Lot A + Fluarix Vaccines or the Nimenrix Vaccine (Pooled Lots in the Flu Vaccine Cohort)
rSBA-MenY
|
5650.9 Titers
Interval 4530.9 to
|
7464.1 Titers
Interval 6500.3 to 8570.8
|
—
|
PRIMARY outcome
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.
Outcome measures
| Measure |
Nimenrix A Group
n=105 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Anti-A/H1N1 [Month 0]
|
54.1 Titers
Interval 43.0 to 68.1
|
—
|
—
|
|
Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Anti-A/H1N1 [Month 1]
|
537.2 Titers
Interval 446.9 to 645.8
|
—
|
—
|
|
Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Anti-A/H3N2 [Month 0]
|
31.5 Titers
Interval 25.1 to 39.6
|
—
|
—
|
|
Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Anti-A/H3N2 [Month 1]
|
177.8 Titers
Interval 150.0 to 210.7
|
—
|
—
|
|
Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Anti-B [Month 0]
|
20.9 Titers
Interval 17.0 to 25.7
|
—
|
—
|
|
Serum Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Anti-B [Month 1]
|
192.7 Titers
Interval 156.4 to 237.6
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after vaccination (at Month 1)Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
Seroconversion was defined as the percentage of subjects with either a pre-vaccination HI titer \<1:10 and a post-vaccination titer \>1:40, or a pre-vaccination titer \>1:10 and a minimum 4-fold increase at post-vaccination titer, for each vaccine strain. Seroconversion was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.
Outcome measures
| Measure |
Nimenrix A Group
n=105 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Seroconverted Subjects for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Anti-A/H1N1
|
75 Participants
|
—
|
—
|
|
Number of Seroconverted Subjects for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Anti-A/H3N2
|
65 Participants
|
—
|
—
|
|
Number of Seroconverted Subjects for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Anti-B
|
78 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after vaccination (at Month 1)Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
Conversion factor defined as the fold increase in serum HI Geometric Mean Titers 1 month after vaccination compared to pre-vaccination, for each vaccine strain. Conversion factor was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.
Outcome measures
| Measure |
Nimenrix A Group
n=105 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Seroconversion Factor for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Anti-A/H1N1
|
9.9 Fold increase in serum HI GMTs
Interval 7.5 to 13.1
|
—
|
—
|
|
Seroconversion Factor for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Anti-A/H3N2
|
5.6 Fold increase in serum HI GMTs
Interval 4.4 to 7.2
|
—
|
—
|
|
Seroconversion Factor for HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Anti-B
|
9.1 Fold increase in serum HI GMTs
Interval 7.1 to 11.6
|
—
|
—
|
PRIMARY outcome
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1)Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40 after vaccination (for each vaccine strain) that usually is accepted as indicating protection. Seroprotection was calculated on all subjects receiving 1 dose of Fluarix vaccine in the Flu vaccine cohort. The 3 influenza virus strains represented in the vaccine were A/H1N1, A/H3N2, and B.
Outcome measures
| Measure |
Nimenrix A Group
n=105 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Seroprotected Subjects HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Anti-A/H1N1 [Month 0]
|
68 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Anti-A/H1N1 [Month 1]
|
104 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Anti-A/H3N2 [Month 0]
|
57 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Anti-A/H3N2 [Month 1]
|
102 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Anti-B [Month 0]
|
44 Participants
|
—
|
—
|
|
Number of Seroprotected Subjects HI Antibody Titers for Each of the 3 Influenza Virus Strains, in Subjects Receiving the Fluarix Vaccine.
Anti-B [Month 1]
|
100 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects of both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.
Outcome measures
| Measure |
Nimenrix A Group
n=297 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=292 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
n=296 Participants
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups.
rSBA-MenA >= 1:8 [Month 0]
|
226 Participants
|
207 Participants
|
212 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups.
rSBA-MenA >= 1:8 [Month 1]
|
292 Participants
|
287 Participants
|
289 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups.
rSBA-MenC >= 1:8 [Month 0]
|
220 Participants
|
213 Participants
|
217 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups.
rSBA-MenC >= 1:8 [Month 1]
|
296 Participants
|
289 Participants
|
295 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups.
rSBA-MenW-135 >= 1:8 [Month 0]
|
238 Participants
|
231 Participants
|
238 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups.
rSBA-MenW-135 >= 1:8 [Month 1]
|
297 Participants
|
290 Participants
|
296 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups.
rSBA-MenY >= 1:8 [Month 0]
|
266 Participants
|
264 Participants
|
263 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups.
rSBA-MenY >= 1:8 [Month 1]
|
297 Participants
|
291 Participants
|
294 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups.
rSBA-MenA >= 1:128 [Month 0]
|
199 Participants
|
175 Participants
|
184 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups.
rSBA-MenW-135 >= 1:128 [Month 1]
|
294 Participants
|
289 Participants
|
295 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups.
rSBA-MenA >= 1:128 [Month 1]
|
291 Participants
|
286 Participants
|
288 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups.
rSBA-MenC >= 1:128 [Month 0]
|
143 Participants
|
132 Participants
|
140 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups.
rSBA-MenC >= 1:128 [Month 1]
|
293 Participants
|
286 Participants
|
293 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups.
rSBA-MenW-135 >= 1:128 [Month 0]
|
165 Participants
|
178 Participants
|
171 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups.
rSBA-MenY >= 1:128 [Month 0]
|
232 Participants
|
219 Participants
|
231 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Each of the 3 Lot Groups.
rSBA-MenY >= 1:128 [Month 1]
|
295 Participants
|
291 Participants
|
293 Participants
|
SECONDARY outcome
Timeframe: Prior to vaccination (at Month 0).Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
Titers were expressed as geometric mean antibody titers and were calculated on all subjects of both cohorts receiving 1 dose of Nimenrix vaccine lot A, B or C.
Outcome measures
| Measure |
Nimenrix A Group
n=294 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=286 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
n=291 Participants
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups.
rSBA-MenA [Month 0]
|
215.1 Titers
Interval 174.2 to 265.6
|
172.6 Titers
Interval 135.9 to 219.2
|
157.5 Titers
Interval 125.3 to 198.0
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups.
rSBA-MenC [Month 0]
|
87.6 Titers
Interval 69.2 to 110.9
|
83.2 Titers
Interval 65.3 to 106.1
|
75.1 Titers
Interval 59.5 to 94.7
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups.
rSBA-MenW-135 [Month 0]
|
111.7 Titers
Interval 90.3 to 138.2
|
124.6 Titers
Interval 98.8 to 157.2
|
115.1 Titers
Interval 92.4 to 143.5
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Each of the 3 Lot Groups.
rSBA-MenY [Month 0]
|
275.8 Titers
Interval 224.8 to 338.4
|
270.3 Titers
Interval 223.6 to 326.7
|
315.6 Titers
Interval 260.6 to 382.1
|
SECONDARY outcome
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort) and on subjects receiving 1 dose of Mencevax ACWY vaccine (in the Flu vaccine cohort).
Outcome measures
| Measure |
Nimenrix A Group
n=105 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=308 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
n=104 Participants
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
rSBA-MenA >=1:8 [Month 0]
|
81 Participants
|
219 Participants
|
82 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
rSBA-MenA >=1:8 [Month 1]
|
102 Participants
|
305 Participants
|
104 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
rSBA-MenC >=1:8 [Month 0]
|
84 Participants
|
225 Participants
|
84 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
rSBA-MenC >=1:8 [Month 1]
|
104 Participants
|
306 Participants
|
103 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
rSBA-MenW-135 >=1:8 [Month 0]
|
85 Participants
|
259 Participants
|
84 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
rSBA-MenW-135 >=1:8 [Month 1]
|
105 Participants
|
308 Participants
|
103 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
rSBA-MenY >=1:8 [Month 0]
|
96 Participants
|
277 Participants
|
88 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
rSBA-MenY >=1:8 [Month 1]
|
105 Participants
|
306 Participants
|
104 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
rSBA-MenA >=1:128 [Month 0]
|
64 Participants
|
180 Participants
|
69 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
rSBA-MenA >=1:128 [Month 1]
|
101 Participants
|
305 Participants
|
103 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
rSBA-MenC >=1:128 [Month 0]
|
58 Participants
|
154 Participants
|
54 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
rSBA-MenC >=1:128 [Month 1]
|
103 Participants
|
304 Participants
|
103 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
rSBA-MenW-135 >=1:128 [Month 0]
|
62 Participants
|
192 Participants
|
54 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
rSBA-MenW-135 >=1:128 [Month 1]
|
102 Participants
|
306 Participants
|
102 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
rSBA-MenY >=1:128 [Month 0]
|
82 Participants
|
228 Participants
|
79 Participants
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
rSBA-MenY >=1:128 [Month 1]
|
104 Participants
|
305 Participants
|
103 Participants
|
SECONDARY outcome
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
Titers were expressed as geometric mean antibody titers and were calculated on all subjects receiving 1 dose of Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving 1 dose of Nimenrix vaccine among all the manufactured lots (pooled groups from the Flu vaccine cohort) and on subjects receiving 1 dose of Mencevax ACWY vaccine (in the Flu vaccine cohort).
Outcome measures
| Measure |
Nimenrix A Group
n=105 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=308 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
n=104 Participants
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort
rSBA-MenA [Month 0]
|
200.5 Titers
Interval 145.3 to 276.8
|
154.8 Titers
Interval 122.2 to 196.1
|
250.8 Titers
Interval 182.0 to 345.6
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort
rSBA-MenA [Month 1]
|
2831.1 Titers
Interval 2282.4 to 3511.7
|
3784.2 Titers
Interval 3326.3 to 4305.1
|
1826.9 Titers
Interval 1492.3 to 2236.6
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort
rSBA-MenC [Month 0]
|
139.1 Titers
Interval 94.2 to 205.2
|
100.8 Titers
Interval 78.4 to 129.6
|
120.0 Titers
Interval 78.7 to 182.8
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort
rSBA-MenC [Month 1]
|
6579.5 Titers
Interval 4861.5 to 8904.6
|
10130.8 Titers
Interval 8672.3 to 11834.5
|
8784.9 Titers
Interval 6759.4 to 11417.3
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort
rSBA-MenW-135 [Month 0]
|
121.0 Titers
Interval 84.3 to 173.7
|
146.2 Titers
Interval 119.5 to 178.8
|
86.2 Titers
Interval 60.9 to 121.9
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort
rSBA-MenW-135 [Month 1]
|
4394.8 Titers
Interval 3316.3 to 5824.0
|
6016.8 Titers
Interval 5201.4 to 6960.2
|
2361.1 Titers
Interval 1757.7 to 3171.6
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort
rSBA-MenY [Month 0]
|
309.6 Titers
Interval 229.9 to 417.0
|
287.4 Titers
Interval 236.2 to 349.6
|
209.9 Titers
Interval 147.4 to 299.0
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, for Subjects in the Flu Vaccine Cohort
rSBA-MenY [Month 1]
|
5650.9 Titers
Interval 4530.9 to 7047.7
|
7464.1 Titers
Interval 6500.3 to 8570.8
|
3363.5 Titers
Interval 2630.9 to 4300.1
|
SECONDARY outcome
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
Assay cut-off values assessed were ≥1:8 and ≥1:128. Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Outcome measures
| Measure |
Nimenrix A Group
n=885 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=294 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenA >=1:8 [Month 0]
|
645 Participants
|
229 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenA >=1:8 [Month 1]
|
868 Participants
|
291 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenC >=1:8 [Month 0]
|
650 Participants
|
223 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenC >=1:8 [Month 1]
|
880 Participants
|
291 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenW-135 >=1:8 [Month 0]
|
707 Participants
|
227 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenW-135 >=1:8 [Month 1]
|
883 Participants
|
292 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenY >=1:8 [Month 0]
|
793 Participants
|
256 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenY >=1:8 [Month 1]
|
882 Participants
|
294 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenA >=1:128 [Month 0]
|
558 Participants
|
200 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenA >=1:128 [Month 1]
|
865 Participants
|
290 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenC >=1:128 [Month 0]
|
415 Participants
|
152 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenC >=1:128 [Month 1]
|
872 Participants
|
289 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenW-135 >=1:128 [Month 0]
|
514 Participants
|
155 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenW-135 >=1:128 [Month 1]
|
878 Participants
|
288 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenY >=1:128 [Month 0]
|
682 Participants
|
224 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Titers Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenY >=1:128 [Month 1]
|
879 Participants
|
293 Participants
|
—
|
SECONDARY outcome
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
Titers were expressed as geometric mean antibody titers and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Outcome measures
| Measure |
Nimenrix A Group
n=885 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=294 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenA [Month 0]
|
180.4 Titers
Interval 158.4 to 205.6
|
216.3 Titers
Interval 177.4 to 263.7
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenA [Month 1]
|
3624.7 Titers
Interval 3371.7 to 3896.8
|
2127.2 Titers
Interval 1909.2 to 2370.1
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenC [Month 0]
|
81.7 Titers
Interval 71.3 to 93.7
|
91.2 Titers
Interval 71.5 to 116.4
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenC [Month 1]
|
8865.9 Titers
Interval 8011.0 to 9812.0
|
7371.2 Titers
Interval 6297.4 to 8628.2
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenW-135 [Month 0]
|
117.0 Titers
Interval 103.0 to 132.9
|
94.0 Titers
Interval 75.2 to 117.4
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenW-135 [Month 1]
|
5136.2 Titers
Interval 4698.8 to 5614.3
|
2461.3 Titers
Interval 2081.0 to 2911.0
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenY [Month 0]
|
286.5 Titers
Interval 256.0 to 320.6
|
262.2 Titers
Interval 211.8 to 324.5
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY Antibody Titers, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
rSBA-MenY [Month 1]
|
7710.7 Titers
Interval 7100.1 to 8373.8
|
4314.3 Titers
Interval 3782.1 to 4921.5
|
—
|
SECONDARY outcome
Timeframe: One month after vaccination (at Month 1)Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
Vaccine response was defined as a rSBA titer of at least 1:32 in initially seronegative subjects (\<1:8) and as 4-fold increase in titer in initially seropositive subjects (≥ 1:8). A seronegative subject had antibody titer \>1:8 and a seropositive subject had antibody titer ≥1:8 prior to vaccination. Vaccine response was assessed for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Outcome measures
| Measure |
Nimenrix A Group
n=102 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=300 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
n=102 Participants
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort
rSBA-MenA seronegative
|
5 Participants
|
44 Participants
|
6 Participants
|
|
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort
rSBA-MenA seropositive
|
60 Participants
|
168 Participants
|
50 Participants
|
|
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort
rSBA-MenC seronegative
|
13 Participants
|
68 Participants
|
16 Participants
|
|
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort
rSBA-MenC seropositive
|
73 Participants
|
193 Participants
|
72 Participants
|
|
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort
rSBA-MenW-135 seronegative
|
15 Participants
|
40 Participants
|
17 Participants
|
|
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort
rSBA-MenW-135 seropositive
|
74 Participants
|
235 Participants
|
72 Participants
|
|
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort
rSBA-MenY seronegative
|
6 Participants
|
23 Participants
|
12 Participants
|
|
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort
rSBA-MenY seropositive
|
77 Participants
|
236 Participants
|
61 Participants
|
|
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort
rSBA-MenA total
|
65 Participants
|
212 Participants
|
56 Participants
|
|
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort
rSBA-MenC total
|
86 Participants
|
261 Participants
|
88 Participants
|
|
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort
rSBA-MenW-135 total
|
89 Participants
|
275 Participants
|
89 Participants
|
|
Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody, for Subjects in the Flu Vaccine Cohort
rSBA-MenY total
|
83 Participants
|
259 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Outcome measures
| Measure |
Nimenrix A Group
n=885 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=293 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-tetanus [Month 0]
|
454 Participants
|
153 Participants
|
—
|
|
Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-tetanus [Month 1]
|
703 Participants
|
156 Participants
|
—
|
SECONDARY outcome
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
Concentrations were expressed in geometric mean concentrations in International unit per milliliter (IU/mL) and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Outcome measures
| Measure |
Nimenrix A Group
n=885 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=293 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Anti-tetanus Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-tetanus [Month 0]
|
0.245 IU/mL
Interval 0.217 to 0.277
|
0.265 IU/mL
Interval 0.214 to 0.329
|
—
|
|
Anti-tetanus Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-tetanus [Month 1]
|
3.488 IU/mL
Interval 2.949 to 4.126
|
0.279 IU/mL
Interval 0.224 to 0.347
|
—
|
SECONDARY outcome
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
Blood samples were taken on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Outcome measures
| Measure |
Nimenrix A Group
n=105 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=308 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
n=104 Participants
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), for Subjects in the Flu Vaccine Cohort
Anti-tetanus [Month 0]
|
61 Participants
|
193 Participants
|
54 Participants
|
|
Number of Subjects With Anti-tetanus Antibody Concentrations Equal to or Above the Cut-off Value of 0.1 International Unit Per Milliliter (IU/mL), for Subjects in the Flu Vaccine Cohort
Anti-tetanus [Month 1]
|
84 Participants
|
254 Participants
|
53 Participants
|
SECONDARY outcome
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
Concentrations were expressed in geometric mean concentrations in International unit per milliliter (IU/mL) and were calculated on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Outcome measures
| Measure |
Nimenrix A Group
n=105 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=308 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
n=104 Participants
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Anti-tetanus Antibody Concentrations for Subjects in the Flu Vaccine Cohort
Anti-tetanus [Month 0]
|
0.295 IU/mL
Interval 0.206 to 0.421
|
0.418 IU/mL
Interval 0.334 to 0.523
|
0.287 IU/mL
Interval 0.197 to 0.419
|
|
Anti-tetanus Antibody Concentrations for Subjects in the Flu Vaccine Cohort
Anti-tetanus [Month 1]
|
3.073 IU/mL
Interval 1.937 to 4.874
|
4.655 IU/mL
Interval 3.557 to 6.092
|
0.276 IU/mL
Interval 0.19 to 0.402
|
SECONDARY outcome
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
Meningococcal polysaccharide serogroups, A, C, W-135 and Y = PSA, PSC, PSW-135 \& PSY. Assay cut-off values assessed were ≥ 0.3 microgram per milliliter (µg/mL) and ≥ 2.0 µg/mL. Blood samples were taken on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Outcome measures
| Measure |
Nimenrix A Group
n=449 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=148 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-PSA >=0.3 µg/mL [Month 0]
|
354 Participants
|
125 Participants
|
—
|
|
Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-PSA >=0.3 µg/mL [Month 1]
|
432 Participants
|
144 Participants
|
—
|
|
Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-PSC >=0.3 µg/mL [Month 0]
|
130 Participants
|
61 Participants
|
—
|
|
Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-PSC >=0.3 µg/mL [Month 1]
|
422 Participants
|
141 Participants
|
—
|
|
Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-PSW-135 >=0.3 µg/mL [Month 0]
|
135 Participants
|
38 Participants
|
—
|
|
Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-PSW-135 >=0.3 µg/mL [Month 1]
|
439 Participants
|
144 Participants
|
—
|
|
Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-PSY >=0.3 µg/mL [Month 0]
|
156 Participants
|
52 Participants
|
—
|
|
Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-PSY >=0.3 µg/mL [Month 1]
|
442 Participants
|
145 Participants
|
—
|
|
Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-PSA >=2.0 µg/mL [Month 0]
|
227 Participants
|
87 Participants
|
—
|
|
Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-PSA >=2.0 µg/mL [Month 1]
|
428 Participants
|
144 Participants
|
—
|
|
Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-PSC >=2.0 µg/mL [Month 0]
|
51 Participants
|
17 Participants
|
—
|
|
Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-PSC >=2.0 µg/mL [Month 1]
|
398 Participants
|
141 Participants
|
—
|
|
Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-PSW-135 >=2.0 µg/mL [Month 0]
|
41 Participants
|
11 Participants
|
—
|
|
Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-PSW-135 >=2.0 µg/mL [Month 1]
|
408 Participants
|
136 Participants
|
—
|
|
Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-PSY >=2.0 µg/mL [Month 0]
|
59 Participants
|
21 Participants
|
—
|
|
Number of Subjects With Anti-meningococcal Polysaccharide Serogroups, A, C, W-135 and Y Antibody Concentrations Equal to or Above the Cut-off Values, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-PSY >=2.0 µg/mL [Month 1]
|
420 Participants
|
142 Participants
|
—
|
SECONDARY outcome
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
Concentrations were expressed in geometric mean concentrations in microgram per milliliter (µg/mL) and were calculated on all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Outcome measures
| Measure |
Nimenrix A Group
n=449 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=148 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-PSA [Month 0]
|
2.14 µg/mL
Interval 1.82 to 2.52
|
2.65 µg/mL
Interval 2.05 to 3.43
|
—
|
|
Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-PSA [Month 1]
|
101.79 µg/mL
Interval 88.95 to 116.49
|
56.89 µg/mL
Interval 46.73 to 69.26
|
—
|
|
Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-PSC [Month 0]
|
0.33 µg/mL
Interval 0.29 to 0.37
|
0.38 µg/mL
Interval 0.3 to 0.49
|
—
|
|
Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-PSC [Month 1]
|
20.96 µg/mL
Interval 18.26 to 24.05
|
45.85 µg/mL
Interval 37.97 to 55.35
|
—
|
|
Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-PSW-135 [Month 0]
|
0.31 µg/mL
Interval 0.27 to 0.35
|
0.26 µg/mL
Interval 0.22 to 0.3
|
—
|
|
Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-PSW-135 [Month 1]
|
24.71 µg/mL
Interval 20.75 to 29.42
|
21.90 µg/mL
Interval 16.86 to 28.44
|
—
|
|
Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-PSY [Month 0]
|
0.36 µg/mL
Interval 0.32 to 0.41
|
0.35 µg/mL
Interval 0.28 to 0.44
|
—
|
|
Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Anti-PSY [Month 1]
|
36.94 µg/mL
Interval 31.1 to 43.87
|
30.41 µg/mL
Interval 22.94 to 40.3
|
—
|
SECONDARY outcome
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
Assay cut-off values assessed were ≥ 0.3 microgram per milliliter (µg/mL) and ≥ 2.0 µg/mL. Blood samples were taken on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Outcome measures
| Measure |
Nimenrix A Group
n=54 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=157 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
n=52 Participants
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
Anti-PSA >=0.3 µg/mL [Month 0]
|
46 Participants
|
136 Participants
|
51 Participants
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
Anti-PSA >=0.3 µg/mL [Month 1]
|
49 Participants
|
151 Participants
|
52 Participants
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
Anti-PSC >=0.3 µg/mL [Month 0]
|
16 Participants
|
50 Participants
|
24 Participants
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
Anti-PSC >=0.3 µg/mL [Month 1]
|
48 Participants
|
145 Participants
|
51 Participants
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
Anti-PSW-135 >=0.3 µg/mL [Month 0]
|
12 Participants
|
53 Participants
|
11 Participants
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
Anti-PSW-135 >=0.3 µg/mL [Month 1]
|
51 Participants
|
153 Participants
|
49 Participants
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
Anti-PSY >=0.3 µg/mL [Month 0]
|
13 Participants
|
61 Participants
|
17 Participants
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
Anti-PSY >=0.3 µg/mL [Month 1]
|
53 Participants
|
156 Participants
|
51 Participants
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
Anti-PSA >=2.0 µg/mL [Month 0]
|
30 Participants
|
100 Participants
|
37 Participants
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
Anti-PSA >=2.0 µg/mL [Month 1]
|
49 Participants
|
149 Participants
|
52 Participants
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
Anti-PSC >=2.0 µg/mL [Month 0]
|
5 Participants
|
24 Participants
|
8 Participants
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
Anti-PSC >=2.0 µg/mL [Month 1]
|
42 Participants
|
133 Participants
|
51 Participants
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
Anti-PSW-135 >=2.0 µg/mL [Month 0]
|
1 Participants
|
13 Participants
|
4 Participants
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
Anti-PSW-135 >=2.0 µg/mL [Month 1]
|
46 Participants
|
142 Participants
|
48 Participants
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
Anti-PSY >=2.0 µg/mL [Month 0]
|
6 Participants
|
25 Participants
|
6 Participants
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations Equal to or Above the Cut-off Values, for Subjects in the Flu Vaccine Cohort
Anti-PSY >=2.0 µg/mL [Month 1]
|
51 Participants
|
147 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: Prior to and one month after vaccination (at Month 0 and Month 1).Population: The According-To-Protocol cohort for immunogenicity included all evaluable subjects from whom assay results were available for antibodies against at least one study vaccine antigen component for the blood sample taken one month after the vaccination.
Concentrations were expressed in geometric mean concentrations in microgram per milliliter (µg/mL) and were calculated on subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Outcome measures
| Measure |
Nimenrix A Group
n=54 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=157 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
n=52 Participants
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort
Anti-PSY [Month 1]
|
25.39 µg/mL
Interval 15.71 to 41.01
|
40.46 µg/mL
Interval 30.0 to 54.57
|
24.67 µg/mL
Interval 15.03 to 40.51
|
|
Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort
Anti-PSA [Month 0]
|
2.40 µg/mL
Interval 1.61 to 3.58
|
4.08 µg/mL
Interval 3.16 to 5.26
|
3.83 µg/mL
Interval 2.64 to 5.56
|
|
Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort
Anti-PSA [Month 1]
|
56.47 µg/mL
Interval 35.76 to 89.19
|
142.33 µg/mL
Interval 113.63 to 178.28
|
56.43 µg/mL
Interval 40.72 to 78.18
|
|
Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort
Anti-PSC [Month 0]
|
0.30 µg/mL
Interval 0.22 to 0.41
|
0.41 µg/mL
Interval 0.31 to 0.53
|
0.48 µg/mL
Interval 0.3 to 0.76
|
|
Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort
Anti-PSC [Month 1]
|
9.05 µg/mL
Interval 5.7 to 14.36
|
19.26 µg/mL
Interval 15.22 to 24.37
|
46.30 µg/mL
Interval 32.29 to 66.39
|
|
Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort
Anti-PSW-135 [Month 0]
|
0.21 µg/mL
Interval 0.18 to 0.26
|
0.33 µg/mL
Interval 0.27 to 0.4
|
0.25 µg/mL
Interval 0.18 to 0.35
|
|
Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort
Anti-PSW-135 [Month 1]
|
20.06 µg/mL
Interval 12.27 to 32.81
|
26.44 µg/mL
Interval 19.66 to 35.55
|
26.27 µg/mL
Interval 17.54 to 39.35
|
|
Anti-PSA, Anti-PSC, Anti-PSW-135 & Anti-PSY Antibody Concentrations, for Subjects in the Flu Vaccine Cohort
Anti-PSY [Month 0]
|
0.29 µg/mL
Interval 0.2 to 0.43
|
0.41 µg/mL
Interval 0.32 to 0.52
|
0.32 µg/mL
Interval 0.22 to 0.46
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) follow-up period after vaccinationPopulation: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Outcome measures
| Measure |
Nimenrix A Group
n=927 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=310 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Any pain
|
180 Participants
|
42 Participants
|
—
|
|
Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Grade 3 pain
|
4 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Any redness
|
82 Participants
|
14 Participants
|
—
|
|
Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Redness > 50 mm
|
12 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Any swelling
|
73 Participants
|
6 Participants
|
—
|
|
Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Swelling > 50 mm
|
10 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) follow-up period after meningococcal vaccinationPopulation: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Outcome measures
| Measure |
Nimenrix A Group
n=105 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=311 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
n=104 Participants
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines.
Any pain
|
23 Participants
|
84 Participants
|
16 Participants
|
|
Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines.
Grade 3 pain
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines.
Any redness
|
6 Participants
|
38 Participants
|
5 Participants
|
|
Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines.
Redness > 50 mm
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines.
Any swelling
|
4 Participants
|
32 Participants
|
1 Participants
|
|
Number of Subjects With Any and Severe Solicited Local Symptoms, for Subjects in the Flu Vaccine Cohort Receiving the Nimenrix or the Mencevax ACWY Vaccines.
Swelling > 50 mm
|
0 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) follow-up period after Fluarix vaccine administrationPopulation: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom irrespective of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimeter (mm). Solicited local symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine after the Fluarix vaccine administration.
Outcome measures
| Measure |
Nimenrix A Group
n=105 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Fluarix Vaccine
Any pain
|
29 Participants
|
—
|
—
|
|
Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Fluarix Vaccine
Grade 3 pain
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Fluarix Vaccine
Any redness
|
7 Participants
|
—
|
—
|
|
Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Fluarix Vaccine
Redness > 50 mm
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Fluarix Vaccine
Any swelling
|
7 Participants
|
—
|
—
|
|
Number of Subjects With Any and Severe Solicited Local Symptoms, in Subjects Receiving the Fluarix Vaccine
Swelling > 50 mm
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) follow-up period after vaccinationPopulation: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and fever (= axillary temperature ≥ 37.5 degrees Celsius). Any = occurrence of any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activities. Grade 3 fever = axillary temperature \> 39.5°C. Symptoms were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Outcome measures
| Measure |
Nimenrix A Group
n=927 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=310 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Any fatigue
|
114 Participants
|
30 Participants
|
—
|
|
Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Grade 3 fatigue
|
8 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Fever >= 37.5°C
|
37 Participants
|
14 Participants
|
—
|
|
Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Fever > 39.5°C
|
2 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Any gastrointestinal symptoms
|
43 Participants
|
10 Participants
|
—
|
|
Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Grade 3 gastrointestinal symptoms
|
2 Participants
|
1 Participants
|
—
|
|
Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Any headache
|
151 Participants
|
44 Participants
|
—
|
|
Number of Subjects With Any and Severe Solicited General Symptoms, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
Grade 3 headache
|
14 Participants
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) follow-up period after vaccinationPopulation: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
Solicited general symptoms = fatigue, gastrointestinal symptoms, headache and fever (= axillary temperature ≥ 37.5°C). Any = occurrence of any solicited general symptom irrespective of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activities. Grade 3 fever = \> 39.5°C. Symptoms were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Outcome measures
| Measure |
Nimenrix A Group
n=105 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=311 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
n=104 Participants
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort
Any fatigue
|
10 Participants
|
33 Participants
|
12 Participants
|
|
Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort
Grade 3 fatigue
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort
Fever >= 37.5°C
|
3 Participants
|
10 Participants
|
3 Participants
|
|
Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort
Fever > 39.5°C
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort
Any gastrointestinal symptoms
|
2 Participants
|
15 Participants
|
2 Participants
|
|
Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort
Grade 3 gastrointestinal symptoms
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort
Any headache
|
14 Participants
|
47 Participants
|
12 Participants
|
|
Number of Subjects With Any and Severe Solicited General Symptoms, for Subjects in the Flu Vaccine Cohort
Grade 3 headache
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Dose 1 (at Month 0) up to study end (at Month 6)Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
Rash assessed were hives, idiopathic thrombocytopenic purpura and petechiae and were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Outcome measures
| Measure |
Nimenrix A Group
n=935 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=312 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects Reporting Rash, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
|
10 Participants
|
3 Participants
|
—
|
SECONDARY outcome
Timeframe: From Dose 1 (at Month 0) up to study end (at Month 6)Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
NOCIs assessed were autoimmune disorders, asthma, type I diabetes and allergies and were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Outcome measures
| Measure |
Nimenrix A Group
n=935 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=312 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: From Dose 1 (at Month 0) up to study end (at Month 6)Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
AEs resulting in ER visits were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Outcome measures
| Measure |
Nimenrix A Group
n=935 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=312 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects Reporting Adverse Events (AEs) Resulting in Emergency Room (ER) Visits, in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
|
13 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: From Dose 1 (at Month 0) up to study end (at Month 6)Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
Rash assessed were hives, idiopathic thrombocytopenic purpura and petechiae and were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Outcome measures
| Measure |
Nimenrix A Group
n=105 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=311 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
n=104 Participants
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects Reporting Rash, for Subjects in the Flu Vaccine Cohort
|
0 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Dose 1 (at Month 0) up to study end (at Month 6)Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
NOCIs assessed were autoimmune disorders, asthma, type I diabetes and allergies and were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Outcome measures
| Measure |
Nimenrix A Group
n=105 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=311 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
n=104 Participants
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects Reporting New Onset of Chronic Illness(es) (NOCIs), for Subjects in the Flu Vaccine Cohort
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Dose 1 (at Month 0) up to study end (at Month 6)Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
AEs resulting in ER visits were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Outcome measures
| Measure |
Nimenrix A Group
n=105 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=311 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
n=104 Participants
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects Reporting Adverse Events (AEs) Resulting in Emergency Room (ER) Visits, for Subjects in the Flu Vaccine Cohort
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Dose 1 (at Month 0) up to 1 month after vaccination (at Month 1)Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Unsolicited AEs were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, B and C) or the Mencevax ACWY vaccine.
Outcome measures
| Measure |
Nimenrix A Group
n=935 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=312 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
|
135 Participants
|
47 Participants
|
—
|
SECONDARY outcome
Timeframe: From Dose 1 (at Month 0) up to study end (at Month 6)Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. SAEs were collected for all subjects of both cohorts receiving the Nimenrix vaccine (lot A without co-administration of Fluarix vaccine, lot B and lot C) or the Mencevax ACWY vaccine.
Outcome measures
| Measure |
Nimenrix A Group
n=935 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=312 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs), in Subjects Receiving the Nimenrix (From the 3 Manufactured Lots Pooled) or the Mencevax ACWY Vaccines.
|
7 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: From Dose 1 (at Month 0) up to 1 month after vaccination (at Month 1)Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
An unsolicited AE = any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. AEs were collected for subjects receiving Nimenrix vaccine lot A+Fluarix vaccine, Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and Mencevax ACWY vaccine (in the Flu vaccine cohort).
Outcome measures
| Measure |
Nimenrix A Group
n=105 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=311 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
n=104 Participants
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events (AEs), for Subjects in the Flu Vaccine Cohort
|
13 Participants
|
50 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: From Dose 1 (at Month 0) up to study end (at Month 6)Population: The Total Vaccinated Cohort included all vaccinated subjects for whom data were available.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. SAEs were collected for subjects receiving Nimenrix vaccine lot A co-administered with Fluarix vaccine, on subjects receiving Nimenrix vaccine (pooled groups from the Flu vaccine cohort) and on subjects receiving Mencevax ACWY vaccine (in the Flu vaccine cohort).
Outcome measures
| Measure |
Nimenrix A Group
n=105 Participants
subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix B Group
n=311 Participants
subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Nimenrix C Group
n=104 Participants
subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
|---|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs), for Subjects in the Flu Vaccine Cohort
|
0 Participants
|
4 Participants
|
0 Participants
|
Adverse Events
Nimenrix Group
Serious events: 7 serious events
Other events: 330 other events
Deaths: 0 deaths
Mencevax ACWY Group
Serious events: 1 serious events
Other events: 89 other events
Deaths: 0 deaths
Nimenrix+Fluarix Group
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nimenrix Group
n=935 participants at risk
subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
n=312 participants at risk
subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
|
Nimenrix+Fluarix Group
n=105 participants at risk
subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.21%
2/935 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
0.00%
0/312 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
0.00%
0/105 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.11%
1/935 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
0.00%
0/312 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
0.00%
0/105 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.11%
1/935 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
0.00%
0/312 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
0.00%
0/105 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.11%
1/935 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
0.00%
0/312 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
0.00%
0/105 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/935 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
0.32%
1/312 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
0.00%
0/105 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
|
Infections and infestations
Bronchitis
|
0.11%
1/935 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
0.00%
0/312 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
0.00%
0/105 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.11%
1/935 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
0.00%
0/312 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
0.00%
0/105 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
|
Infections and infestations
Orchitis
|
0.11%
1/935 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
0.00%
0/312 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
0.00%
0/105 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.11%
1/935 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
0.00%
0/312 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
0.00%
0/105 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
|
Infections and infestations
Pneumonia
|
0.11%
1/935 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
0.00%
0/312 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
0.00%
0/105 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
Other adverse events
| Measure |
Nimenrix Group
n=935 participants at risk
subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
|
Mencevax ACWY Group
n=312 participants at risk
subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
|
Nimenrix+Fluarix Group
n=105 participants at risk
subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
|
|---|---|---|---|
|
General disorders
Redness
|
8.8%
82/935 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
4.5%
14/312 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
10.5%
11/105 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
|
General disorders
Swelling
|
7.8%
73/935 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
1.9%
6/312 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
9.5%
10/105 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
|
General disorders
Fatigue
|
12.2%
114/935 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
9.6%
30/312 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
9.5%
10/105 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
|
General disorders
Pain
|
19.3%
180/935 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
13.5%
42/312 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
35.2%
37/105 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
|
General disorders
Headache
|
16.1%
151/935 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
14.1%
44/312 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
13.3%
14/105 • SAEs: from Dose 1 at Month 0 up to study end at Month 6. Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period after vaccination.
The number of subjects reporting solicited local symptoms in the Nimenrix+Fluarix Group was tabulated for any vaccination. Among the 105 subjects of the group, 23, 6 and 4 subjects reported pain, redness and swelling post-meningococcal vaccination and 29, 7 and 7 subjects reported pain, redness and swelling post-Fluarix vaccination.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER