Trial Outcomes & Findings for Primary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals' Meningococcal Vaccine 134612 (NCT NCT00465816)
NCT ID: NCT00465816
Last Updated: 2018-06-08
Results Overview
The rSBA titers were expressed as geometric mean titers (GMTs).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
611 participants
Primary outcome timeframe
At 1 month after vaccination with Nimenrix vaccine (Month 1)
Results posted on
2018-06-08
Participant Flow
During the screening the following was performed: informed consent was obtained and signed from parents or guardians of subjects, check for inclusion/exclusion criteria and contraindications/precautions was performed, and medical history of subjects was collected.
Participant milestones
| Measure |
Nimenrix + Twinrix Group
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Overall Study
STARTED
|
367
|
122
|
122
|
|
Overall Study
COMPLETED
|
367
|
122
|
120
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
Reasons for withdrawal
| Measure |
Nimenrix + Twinrix Group
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
Baseline Characteristics
Primary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals' Meningococcal Vaccine 134612
Baseline characteristics by cohort
| Measure |
Nimenrix + Twinrix Group
n=367 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=122 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
n=122 Participants
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Total
n=611 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
14.3 Years
STANDARD_DEVIATION 1.89 • n=5 Participants
|
14.3 Years
STANDARD_DEVIATION 1.84 • n=7 Participants
|
14.3 Years
STANDARD_DEVIATION 1.94 • n=5 Participants
|
14.3 Years
STANDARD_DEVIATION 1.89 • n=4 Participants
|
|
Sex: Female, Male
Female
|
195 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
324 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
172 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
287 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African heritage/African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - central/south Asian heritage
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - east Asian heritage
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - south east Asian heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/north African heritage
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian/European heritage
|
361 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
599 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not specified
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At 1 month after vaccination with Nimenrix vaccine (Month 1)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.
The rSBA titers were expressed as geometric mean titers (GMTs).
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=360 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=115 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
rSBA-MenA
|
5263.9 Titer
Interval 4818.0 to 5751.0
|
5211.7 Titer
Interval 4509.8 to 6022.8
|
—
|
|
Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
rSBA-MenC
|
4344.6 Titer
Interval 3800.3 to 4966.8
|
4926.9 Titer
Interval 3684.8 to 6587.7
|
—
|
|
Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
rSBA-MenW-135
|
8922.1 Titer
Interval 8278.4 to 9615.9
|
8987.7 Titer
Interval 7628.9 to 10588.6
|
—
|
|
Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers
rSBA-MenY
|
9291.5 Titer
Interval 8537.7 to 10111.9
|
9492.8 Titer
Interval 8172.4 to 11026.6
|
—
|
PRIMARY outcome
Timeframe: At 1 month after the third dose of Twinrix vaccine (Month 7)Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on initially seronegative subjects in those groups that received the Twinrix vaccine.
A seroconverted subject was defined as a subject with anti-Hepatitis A virus (HAV) antibody concentration greater than or equal to 15 milli-International Units per Milliliter (mIU/mL) in previously seronegative subjects.
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=321 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=95 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Number of Subjects Seroconverted for Hepatitis A
|
321 Participants
|
95 Participants
|
—
|
PRIMARY outcome
Timeframe: At 1 month after the third dose of Twinrix vaccine (Month 7)Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.
A seroprotected subject was defined as a subject with anti-Hepatitis B surface antigen (HBs) antibody concentration greater than or equal to 10 milli-International Units per Milliliter (mIU/mL).
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=330 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=97 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Number of Subjects Seroprotected for Hepatitis B
|
327 Participants
|
97 Participants
|
—
|
SECONDARY outcome
Timeframe: At 1 month after vaccination with Nimenrix vaccine (Month 1)Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.
Vaccine response is defined as an rSBA titer of at least 1:32 in subjects initially seronegative \[rSBA titer below1:8\] and as a 4-fold increase in titer in subjects initially seropositive \[rSBA titre greater than or equal to 1:8\].
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=355 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=114 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135
rSBA-MenA
|
246 Participants
|
76 Participants
|
—
|
|
Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135
rSBA-MenC
|
333 Participants
|
101 Participants
|
—
|
|
Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135
rSBA-MenW-135
|
346 Participants
|
112 Participants
|
—
|
|
Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135
rSBA-MenY
|
335 Participants
|
105 Participants
|
—
|
SECONDARY outcome
Timeframe: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.
The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128.
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=360 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=115 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
rSBA-MenA ≥ 1:8 [Month 0]
|
105 Participants
|
33 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
rSBA-MenA ≥ 1:8 [Month 1]
|
352 Participants
|
113 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
rSBA-MenC ≥ 1:8 [Month 0]
|
187 Participants
|
67 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
rSBA-MenC ≥ 1:8 [Month 1]
|
359 Participants
|
114 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
rSBA-MenW-135 ≥ 1:8 [Month 0]
|
277 Participants
|
96 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
rSBA-MenW-135 ≥ 1:8 [Month 1]
|
360 Participants
|
115 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
rSBA-MenY ≥ 1:8 [Month 0]
|
275 Participants
|
95 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
rSBA-MenY ≥ 1:8 [Month 1]
|
359 Participants
|
115 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
rSBA-MenA ≥ 1:128 [Month 0]
|
91 Participants
|
30 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
rSBA-MenA ≥ 1:128 [Month 1]
|
352 Participants
|
113 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
rSBA-MenC ≥ 1:128 [Month 0]
|
122 Participants
|
44 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
rSBA-MenC ≥ 1:128 [Month 1]
|
358 Participants
|
113 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
rSBA-MenW-135 ≥ 1:128 [Month 0]
|
180 Participants
|
64 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
rSBA-MenW-135 ≥ 1:128 [Month 1]
|
359 Participants
|
115 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
rSBA-MenY ≥ 1:128 [Month 0]
|
218 Participants
|
80 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values
rSBA-MenY ≥ 1:128 [Month 1]
|
359 Participants
|
115 Participants
|
—
|
SECONDARY outcome
Timeframe: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)Population: The analysis was performed on the ATP cohort for immunogenicity post Dose 1, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested by Enzyme-linked Immunosorbent assay (ELISA) for anti-PSA and anti-PSC antibodies while the other half were tested for anti PSW-135 and anti-PSY antibodies.
Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=180 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=58 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations
Anti-PSA [Month 0]
|
0.25 micrograms per milliliter (µg/mL)
Interval 0.21 to 0.3
|
0.24 micrograms per milliliter (µg/mL)
Interval 0.19 to 0.31
|
—
|
|
Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations
Anti-PSA [Month 1]
|
27.23 micrograms per milliliter (µg/mL)
Interval 22.91 to 32.38
|
18.47 micrograms per milliliter (µg/mL)
Interval 12.02 to 28.38
|
—
|
|
Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations
Anti-PSC [Month 0]
|
0.22 micrograms per milliliter (µg/mL)
Interval 0.19 to 0.26
|
0.26 micrograms per milliliter (µg/mL)
Interval 0.19 to 0.35
|
—
|
|
Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations
Anti-PSC [Month 1]
|
18.58 micrograms per milliliter (µg/mL)
Interval 15.44 to 22.37
|
21.15 micrograms per milliliter (µg/mL)
Interval 14.87 to 30.09
|
—
|
|
Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations
Anti-PSW-135 [Month 0]
|
0.19 micrograms per milliliter (µg/mL)
Interval 0.17 to 0.21
|
0.16 micrograms per milliliter (µg/mL)
Interval 0.15 to 0.17
|
—
|
|
Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations
Anti-PSW-135 [Month 1]
|
6.78 micrograms per milliliter (µg/mL)
Interval 5.52 to 8.32
|
6.72 micrograms per milliliter (µg/mL)
Interval 4.62 to 9.76
|
—
|
|
Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations
Anti-PSY [Month 0]
|
0.22 micrograms per milliliter (µg/mL)
Interval 0.18 to 0.25
|
0.17 micrograms per milliliter (µg/mL)
Interval 0.14 to 0.21
|
—
|
|
Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations
Anti-PSY [Month 1]
|
14.04 micrograms per milliliter (µg/mL)
Interval 11.52 to 17.1
|
12.50 micrograms per milliliter (µg/mL)
Interval 8.49 to 18.41
|
—
|
SECONDARY outcome
Timeframe: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)Population: The analysis was performed on the ATP cohort for immunogenicity post Dose 1, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested by Enzyme-linked Immunosorbent assay (ELISA) for anti-PSA and anti-PSC antibodies while the other half were tested for anti PSW-135 and anti-PSY antibodies.
The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL.
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=180 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=58 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
Anti-PSA ≥ 0.3 µg/mL [Month 0]
|
45 Participants
|
13 Participants
|
—
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
Anti-PSA ≥ 0.3 µg/mL [Month 1]
|
179 Participants
|
54 Participants
|
—
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
Anti-PSC ≥ 0.3 µg/mL [Month 0]
|
32 Participants
|
13 Participants
|
—
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
Anti-PSC ≥ 0.3 µg/mL [Month 1]
|
179 Participants
|
54 Participants
|
—
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
Anti-PSW-135 ≥ 0.3 µg/mL [Month 0]
|
19 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
Anti-PSW-135 ≥ 0.3 µg/mL [Month 1]
|
176 Participants
|
56 Participants
|
—
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
Anti-PSY ≥ 0.3 µg/mL [Month 0]
|
24 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
Anti-PSY ≥ 0.3 µg/mL [Month 1]
|
178 Participants
|
54 Participants
|
—
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
Anti-PSA ≥ 2.0 µg/mL [Month 0]
|
14 Participants
|
3 Participants
|
—
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
Anti-PSA ≥ 2.0 µg/mL [Month 1]
|
178 Participants
|
52 Participants
|
—
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
Anti-PSC ≥ 2.0 µg/mL [Month 0]
|
10 Participants
|
6 Participants
|
—
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
Anti-PSC ≥ 2.0 µg/mL [Month 1]
|
176 Participants
|
53 Participants
|
—
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
Anti-PSW-135 ≥ 2.0 µg/mL [Month 0]
|
3 Participants
|
0 Participants
|
—
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
Anti-PSW-135 ≥ 2.0 µg/mL [Month 1]
|
146 Participants
|
48 Participants
|
—
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
Anti-PSY ≥ 2.0 µg/mL [Month 0]
|
10 Participants
|
2 Participants
|
—
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values
Anti-PSY ≥ 2.0 µg/mL [Month 1]
|
172 Participants
|
51 Participants
|
—
|
SECONDARY outcome
Timeframe: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.
Concentrations were provided as Geometric Mean Concentrations expressed as International Units per milliliter (IU/mL).
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=355 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=114 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Anti-Tetanus Toxoid (TT) Antibody Concentrations
Month 0
|
0.800 International Units per milliliter
Interval 0.692 to 0.926
|
1.020 International Units per milliliter
Interval 0.795 to 1.308
|
—
|
|
Anti-Tetanus Toxoid (TT) Antibody Concentrations
Month 1
|
16.794 International Units per milliliter
Interval 15.318 to 18.411
|
17.252 International Units per milliliter
Interval 14.603 to 20.381
|
—
|
SECONDARY outcome
Timeframe: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1)Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 1 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.
The cut-off value assessed was greater than or equal to 0.1 International Units per milliliter (IU/mL).
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=355 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=114 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Number of Subjects With Anti-tetanus Toxoid Antibody Concentrations Above the Pre-defines Cut-off Value
Month 0
|
293 Participants
|
111 Participants
|
—
|
|
Number of Subjects With Anti-tetanus Toxoid Antibody Concentrations Above the Pre-defines Cut-off Value
Month 1
|
354 Participants
|
112 Participants
|
—
|
SECONDARY outcome
Timeframe: At 7 months after vaccination with Nimenrix (At Month 7)Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.
The rSBA titers were expressed as geometric mean titers.
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=334 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=112 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7
rSBA-MenA
|
2121.6 Titer
Interval 1913.5 to 2352.2
|
2298.3 Titer
Interval 1909.0 to 2767.0
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7
rSBA-MenC
|
952.4 Titer
Interval 826.2 to 1097.8
|
1053.9 Titer
Interval 803.1 to 1382.9
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7
rSBA-MenW-135
|
3283.4 Titer
Interval 2998.4 to 3595.4
|
3497.7 Titer
Interval 3008.0 to 4067.2
|
—
|
|
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7
rSBA-MenY
|
4432.7 Titer
Interval 4027.4 to 4878.8
|
4455.6 Titer
Interval 3821.4 to 5195.1
|
—
|
SECONDARY outcome
Timeframe: At 7 months after vaccination with Nimenrix (At Month 7)Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Nimenrix vaccine.
The cut-off values assessed were greater than or equal to (≥) 1:8 and ≥ 1:128.
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=334 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=112 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7
rSBA-MenA ≥ 1:8
|
330 Participants
|
107 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7
rSBA-MenC ≥ 1:8
|
332 Participants
|
110 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7
rSBA-MenW-135 ≥ 1:8
|
334 Participants
|
112 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7
rSBA-MenY ≥ 1:8
|
333 Participants
|
112 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7
rSBA-MenA ≥ 1:128
|
329 Participants
|
107 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7
rSBA-MenC ≥ 1:128
|
318 Participants
|
108 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7
rSBA-MenW-135 ≥ 1:128
|
333 Participants
|
112 Participants
|
—
|
|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7
rSBA-MenY ≥ 1:128
|
332 Participants
|
112 Participants
|
—
|
SECONDARY outcome
Timeframe: At 7 months after vaccination with Nimenrix (At Month 7)Population: The analysis was performed on the ATP cohort for immunogenicity post Dose 2 and 3, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested by ELISA for anti-PSA and anti-PSC antibodies while the other half were tested for anti PSW-135 and anti-PSY antibodies.
Concentrations were provided as Geometric Mean Concentrations expressed as micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=167 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=56 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7
Anti-PSA
|
4.14 micrograms per milliliter (µg/mL)
Interval 3.34 to 5.15
|
3.88 micrograms per milliliter (µg/mL)
Interval 2.44 to 6.16
|
—
|
|
Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7
Anti-PSC
|
3.28 micrograms per milliliter (µg/mL)
Interval 2.6 to 4.14
|
4.15 micrograms per milliliter (µg/mL)
Interval 2.59 to 6.67
|
—
|
|
Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7
Anti-PSW-135
|
2.46 micrograms per milliliter (µg/mL)
Interval 1.99 to 3.05
|
3.08 micrograms per milliliter (µg/mL)
Interval 2.11 to 4.5
|
—
|
|
Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7
Anti-PSY
|
3.76 micrograms per milliliter (µg/mL)
Interval 2.95 to 4.78
|
4.28 micrograms per milliliter (µg/mL)
Interval 2.9 to 6.31
|
—
|
SECONDARY outcome
Timeframe: At 7 months after vaccination with Nimenrix (At Month 7)Population: The analysis was performed on the ATP cohort for immunogenicity post Dose 2 and 3, only on those groups of subjects that received Nimenrix. A randomized subset of half of the subjects had sera tested by ELISA for anti-PSA and anti-PSC antibodies while the other half were tested for anti PSW-135 and anti-PSY antibodies.
The cut-off values assessed include greater than or equal to (≥) 0.3 micrograms per milliliter (µg/mL) and ≥ 2.0 µg/mL.
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=167 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=56 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7
Anti-PSA ≥ 0.3 µg/mL
|
160 Participants
|
52 Participants
|
—
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7
Anti-PSC ≥ 0.3 µg/mL
|
157 Participants
|
52 Participants
|
—
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7
Anti-PSW-135 ≥ 0.3 µg/mL
|
157 Participants
|
51 Participants
|
—
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7
Anti-PSY ≥ 0.3 µg/mL
|
154 Participants
|
53 Participants
|
—
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7
Anti-PSA ≥ 2.0 µg/mL
|
110 Participants
|
34 Participants
|
—
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7
Anti-PSC ≥ 2.0 µg/mL
|
94 Participants
|
35 Participants
|
—
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7
Anti-PSW-135 ≥ 2.0 µg/mL
|
93 Participants
|
41 Participants
|
—
|
|
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7
Anti-PSY ≥ 2.0 µg/mL
|
104 Participants
|
37 Participants
|
—
|
SECONDARY outcome
Timeframe: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.
Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=333 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=99 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations
Month 0
|
7.9 milli-Internatinal Units per Milliliter
Interval 7.6 to 8.1
|
7.6 milli-Internatinal Units per Milliliter
Interval 7.4 to 7.9
|
—
|
|
Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations
Month 7
|
5876.7 milli-Internatinal Units per Milliliter
Interval 5362.9 to 6439.8
|
6739.0 milli-Internatinal Units per Milliliter
Interval 5757.4 to 7887.9
|
—
|
SECONDARY outcome
Timeframe: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity post Dose 2 and 3 including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.
The cut-off value assessed was greater than or equal to 15 milli-Internatinal Units per Milliliter (mIU/mL).
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=333 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=99 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Number of Subjects With IgG Anti-HAV Antibody Concentrations Above the Pre-defined Cut-off Value
Month 0
|
10 Participants
|
2 Participants
|
—
|
|
Number of Subjects With IgG Anti-HAV Antibody Concentrations Above the Pre-defined Cut-off Value
Month 7
|
331 Participants
|
97 Participants
|
—
|
SECONDARY outcome
Timeframe: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.
Concentrations are given as Geomatric Mean Concentrations expressed as milli-Internatinal Units per Milliliter (mIU/mL).
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=333 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=100 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
IgG Anti-HBs Antibody Concentrations
Month 0
|
1.7 milli-Internatinal Units per Milliliter
Interval 1.6 to 1.7
|
1.7 milli-Internatinal Units per Milliliter
Interval 1.6 to 1.8
|
—
|
|
IgG Anti-HBs Antibody Concentrations
Month 7
|
6088.2 milli-Internatinal Units per Milliliter
Interval 4977.5 to 7446.7
|
7654.7 milli-Internatinal Units per Milliliter
Interval 5518.8 to 10617.3
|
—
|
SECONDARY outcome
Timeframe: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7)Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity including all evaluable subjects for whom immunogenicity data were available for the considered time point(s), only on those groups of subjects that received the Twinrix vaccine.
The cut-off value assessed was greater than or equal to 10 milli-Internatinal Units per Milliliter (mIU/mL).
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=333 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=100 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Number of Subjects With IgG Anti-HB Antibody Concentrations Above the Pre-defined Cut-off Value
Month 0
|
1 Participants
|
0 Participants
|
—
|
|
Number of Subjects With IgG Anti-HB Antibody Concentrations Above the Pre-defined Cut-off Value
Month 7
|
327 Participants
|
97 Participants
|
—
|
SECONDARY outcome
Timeframe: During a 4-day period (Days 0-3) after Nimenrix vaccinationPopulation: The analysis was done on the Total Vaccinated Cohort including all subjects with study vaccine administered and with a completed symptom sheet. Only subjects from the groups receiving Nimenrix were assessed.
Solicited local symptoms assessed include pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=365 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=119 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination
Pain
|
181 Participants
|
58 Participants
|
—
|
|
Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination
Redness
|
75 Participants
|
19 Participants
|
—
|
|
Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination
Swelling
|
71 Participants
|
18 Participants
|
—
|
SECONDARY outcome
Timeframe: During a 4-day period (Days 0-3) after each Twinrix vaccination, and across dosesPopulation: The analysis was done on the Total Vaccinated Cohort including all subjects with study vaccine administered and with a completed symptom sheet. Only subjects from the groups receiving Twinrix were assessed.
Solicited local symptoms assessed include pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=366 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=122 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination
Any Pain, Dose 3
|
143 Participants
|
41 Participants
|
—
|
|
Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination
Any Pain, Dose 1
|
143 Participants
|
52 Participants
|
—
|
|
Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination
Any Redness, Dose 1
|
36 Participants
|
9 Participants
|
—
|
|
Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination
Any Swelling, Dose 1
|
18 Participants
|
4 Participants
|
—
|
|
Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination
Any Pain, Dose 2
|
99 Participants
|
34 Participants
|
—
|
|
Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination
Any Redness, Dose 2
|
27 Participants
|
6 Participants
|
—
|
|
Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination
Any Swelling, Dose 2
|
12 Participants
|
5 Participants
|
—
|
|
Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination
Any Redness, Dose 3
|
30 Participants
|
14 Participants
|
—
|
|
Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination
Any Swelling, Dose 3
|
29 Participants
|
15 Participants
|
—
|
|
Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination
Any Pain, Across doses
|
228 Participants
|
73 Participants
|
—
|
|
Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination
Any Redness, Across doses
|
63 Participants
|
19 Participants
|
—
|
|
Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination
Any Swelling, Across doses
|
49 Participants
|
19 Participants
|
—
|
SECONDARY outcome
Timeframe: During a 4-day period (Days 0-3) after each vaccine dose and across dosesPopulation: The analysis was done on the Total Vaccinated Cohort including all subjects with study vaccine administered and with a completed symptom sheet.
Solicited general symptoms assessed include fatigue, fever (axillary temperature greater than or equal to 37.5 degrees Celcius), gastrointestinal symptoms and headache. Any = occurrence of the symptom regardless of intensity grade. Dose 1 = post-Nimenrix and post-Twinrix for the Nimenrix + Twinrix Group, post-Twinrix for the Twinrix Group and post-Nimenrix for the Nimenrix Group, Dose 2, 3 and Across doses = post-Twinrix for the Nimenrix + Twinrix Group and for the Twinrix Group.
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=366 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=119 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
n=122 Participants
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Fatigue, Dose 1
|
101 Participants
|
30 Participants
|
33 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Temperature (Axillary), Dose 1
|
9 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Gastrointestinal symptoms, Dose 1
|
44 Participants
|
10 Participants
|
15 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Headache, Dose 1
|
88 Participants
|
26 Participants
|
32 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Fatigue, Dose 2
|
47 Participants
|
—
|
15 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Temperature (Axillary), Dose 2
|
4 Participants
|
—
|
1 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Gastrointestinal symptoms, Dose 2
|
28 Participants
|
—
|
8 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Headache, Dose 2
|
49 Participants
|
—
|
13 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Fatigue, Dose 3
|
63 Participants
|
—
|
21 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Temperature (Axillary), Dose 3
|
6 Participants
|
—
|
3 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Gastrointestinal symptoms, Dose 3
|
21 Participants
|
—
|
7 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Headache, Dose 3
|
53 Participants
|
—
|
23 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Fatigue, Across doses
|
149 Participants
|
—
|
48 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Temperature (Axillary), Across doses
|
17 Participants
|
—
|
4 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Gastrointestinal symptoms, Across doses
|
72 Participants
|
—
|
23 Participants
|
|
Number of Subjects Reporting Any Solicited General Symptoms
Any Headache, Across doses
|
126 Participants
|
—
|
48 Participants
|
SECONDARY outcome
Timeframe: Up to 1 month after each vaccine dosePopulation: The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.
Unsolicited AE covers any AE 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.
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=367 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=122 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
n=122 Participants
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Post Dose 1
|
62 Participants
|
13 Participants
|
18 Participants
|
|
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Post Dose 2
|
26 Participants
|
NA Participants
Subjects in the Nimenrix Group only received 1 dose of vaccine. Hence, no results are available for Post Dose 2.
|
7 Participants
|
|
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Post Dose 3
|
52 Participants
|
NA Participants
Subjects in the Nimenrix Group only received 1 dose of vaccine. Hence, no results are available for Post Dose 3.
|
16 Participants
|
SECONDARY outcome
Timeframe: During the entire study (up to Month 7)Population: The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.
Specific AEs of new onset of chronic illnesses include e.g. autoimmune disorders, asthma, type I diabetes and allergies.
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=367 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=122 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
n=122 Participants
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Number of Subjects Reporting Any Specific AEs of New Onset of Chronic Illnesses
|
5 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: During the entire study (up to Month 7)Population: The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.
Rashes include e.g. hives, idiopathic thrombocytopenic purpura, petechiae.
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=367 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=122 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
n=122 Participants
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Number of Subjects Reporting Any Rash
|
5 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During the entire study (up to Month 7)Population: The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=367 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=122 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
n=122 Participants
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the entire study (up to Month 7)Population: The analysis was performed on the Total Vaccinated Cohort including all subjects with study vaccine administered.
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Outcome measures
| Measure |
Nimenrix + Twinrix Group
n=367 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=122 Participants
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
n=122 Participants
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
|
4 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Nimenrix + Twinrix Group
Serious events: 4 serious events
Other events: 312 other events
Deaths: 0 deaths
Nimenrix Group
Serious events: 0 serious events
Other events: 82 other events
Deaths: 0 deaths
Twinrix Group
Serious events: 1 serious events
Other events: 100 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nimenrix + Twinrix Group
n=367 participants at risk
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=122 participants at risk
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
n=122 participants at risk
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/367 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
0.00%
0/122 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
0.82%
1/122 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.27%
1/367 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
0.00%
0/122 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
0.00%
0/122 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.27%
1/367 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
0.00%
0/122 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
0.00%
0/122 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
|
Nervous system disorders
Hydrocephalus
|
0.27%
1/367 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
0.00%
0/122 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
0.00%
0/122 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
|
Nervous system disorders
Syncope
|
0.27%
1/367 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
0.00%
0/122 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
0.00%
0/122 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
|
Psychiatric disorders
Depression
|
0.27%
1/367 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
0.00%
0/122 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
0.00%
0/122 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
Other adverse events
| Measure |
Nimenrix + Twinrix Group
n=367 participants at risk
Subjects received 1 dose of Nimenrix vaccine at Month 0 and 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
Nimenrix Group
n=122 participants at risk
Subjects received 1 dose of Nimenrix vaccine at Month 0.
|
Twinrix Group
n=122 participants at risk
Subjects received 1 dose of Twinrix vaccine at Months 0, 1 and 6.
|
|---|---|---|---|
|
General disorders
Pain at the injection site
|
62.1%
228/367 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
0.00%
0/122 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
59.8%
73/122 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
|
General disorders
Swelling at the injection site
|
13.4%
49/367 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
0.00%
0/122 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
15.6%
19/122 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
|
General disorders
Redness at the injection site
|
17.2%
63/367 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
0.00%
0/122 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
15.6%
19/122 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
|
General disorders
Fatigue
|
40.6%
149/367 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
24.6%
30/122 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
39.3%
48/122 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
|
General disorders
Gastrointestinal symptoms
|
19.6%
72/367 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
8.2%
10/122 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
18.9%
23/122 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
|
General disorders
Headache
|
34.3%
126/367 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
21.3%
26/122 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
39.3%
48/122 • Serious Adverse Events were reported throughout the entire study period (up to Month 7). Unsolicited Adverse Events were reported up to one month after each vaccine dose. Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.
|
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