Trial Outcomes & Findings for Immunogenicity and Safety of GlaxoSmithKline Biologicals' MMRV Vaccine vs. ProQuad® in Children 12-14 Months of Age (NCT NCT00578175)
NCT ID: NCT00578175
Last Updated: 2018-10-09
Results Overview
Seroresponse for antibodies to VZV is defined as the appearance post-vaccination of anti-VZV antibodies \[concentration greater than or equal to the threshold of 75 milli-international units per milliliter (mIU/mL)\] in the serum of subjects below the assay cut-off value of 25 mIU/mL before vaccination.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
1851 participants
Primary outcome timeframe
At Day 42 after vaccination
Results posted on
2018-10-09
Participant Flow
While the total numbers of subjects enrolled in the study was of 1851, the total number of subjects that entered the study was 1783. The remaining 67 subjects received a subject number but no vaccine dose and were therefore excluded from the analysis and group assignment.
Participant milestones
| Measure |
Refrigerator-stored Priorix-Tetra Group
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Overall Study
STARTED
|
705
|
689
|
389
|
|
Overall Study
COMPLETED
|
635
|
646
|
365
|
|
Overall Study
NOT COMPLETED
|
70
|
43
|
24
|
Reasons for withdrawal
| Measure |
Refrigerator-stored Priorix-Tetra Group
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
|
Overall Study
Other reasons
|
70
|
42
|
23
|
Baseline Characteristics
Immunogenicity and Safety of GlaxoSmithKline Biologicals' MMRV Vaccine vs. ProQuad® in Children 12-14 Months of Age
Baseline characteristics by cohort
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=705 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=689 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=389 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
Total
n=1783 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
12.3 months
STANDARD_DEVIATION 0.58 • n=5 Participants
|
12.3 months
STANDARD_DEVIATION 0.59 • n=7 Participants
|
12.3 months
STANDARD_DEVIATION 0.61 • n=5 Participants
|
12.3 months
STANDARD_DEVIATION 0.59 • n=4 Participants
|
|
Sex: Female, Male
Female
|
356 Participants
n=5 Participants
|
346 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
888 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
349 Participants
n=5 Participants
|
343 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
895 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Day 42 after vaccinationPopulation: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Seroresponse for antibodies to VZV is defined as the appearance post-vaccination of anti-VZV antibodies \[concentration greater than or equal to the threshold of 75 milli-international units per milliliter (mIU/mL)\] in the serum of subjects below the assay cut-off value of 25 mIU/mL before vaccination.
Outcome measures
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=622 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=630 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=347 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Number of Subjects With Seroresponse for Antibodies to Varicella Virus (VZV)
|
355 subjects
|
440 subjects
|
301 subjects
|
PRIMARY outcome
Timeframe: At Day 42 after vaccinationPopulation: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Concentrations are given as Geometric Mean Concentrations (GMCs).
Outcome measures
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=629 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=636 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=352 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Concentration of Antibodies to Varicella Virus (VZV)
|
83.6 milli-international units per milliliter
Interval 77.0 to 90.8
|
109.9 milli-international units per milliliter
Interval 102.1 to 118.3
|
164.3 milli-international units per milliliter
Interval 152.3 to 177.3
|
PRIMARY outcome
Timeframe: At Day 42 after vaccinationPopulation: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Seroresponse for antibodies to mumps virus is defined as the appearance post-vaccination of anti-mumps virus antibodies \[titer greater than or equal to the threshold of 51 Effective Doses (ED50)\] in the serum of subjects below the assay cut-off value of 24 ED50 before vaccination.
Outcome measures
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=532 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=531 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=276 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Number of Subjects With Seroresponse for Antibodies to Mumps Virus
|
491 subjects
|
498 subjects
|
256 subjects
|
PRIMARY outcome
Timeframe: At Day 42 after vaccinationPopulation: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Seroresponse for antibodies to measles virus is defined as the appearance post-vaccination of anti-measles virus antibodies \[concentration greater than or equal to the threshold of 200 milli-international units per milliliter (mIU/mL)\] in the serum of subjects below the assay cut-off value of 150 mIU/mL before vaccination.
Outcome measures
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=626 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=636 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=350 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Number of Subjects With Seroresponse for Antibodies to Measles Virus
|
616 subjects
|
633 subjects
|
342 subjects
|
PRIMARY outcome
Timeframe: At Day 42 after vaccinationPopulation: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Seroresponse for antibodies to rubella virus is defined as the appearance post-vaccination of anti-rubella virus antibodies \[concentration greater than or equal to the threshold of 10 international units per milliliter (IU/mL)\] in the serum of subjects below the assay cut-off value of 4 IU/mL before vaccination.
Outcome measures
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=628 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=636 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=351 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Number of Subjects With Seroresponse for Antibodies to Rubella Virus
|
616 subjects
|
622 subjects
|
349 subjects
|
PRIMARY outcome
Timeframe: At Day 42 after vaccinationPopulation: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Concentrations are given as Geometric Mean Concentrations (GMCs).
Outcome measures
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=404 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=409 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=227 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Concentration of Antibodies to Hepatitis A Virus (HAV)
|
40.5 milli-international units per milliliter
Interval 37.1 to 44.2
|
40.3 milli-international units per milliliter
Interval 37.0 to 44.0
|
40.0 milli-international units per milliliter
Interval 35.7 to 44.9
|
PRIMARY outcome
Timeframe: At Day 42 after vaccinationPopulation: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Concentrations are given as Geometric Mean Concentrations (GMCs).
Outcome measures
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=461 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=468 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=266 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F
S.Pneu.4 (n= 461, 463, 266)
|
3.35 micrograms per milliliter (µg/mL)
Interval 3.1 to 3.63
|
3.31 micrograms per milliliter (µg/mL)
Interval 3.04 to 3.59
|
3.02 micrograms per milliliter (µg/mL)
Interval 2.72 to 3.34
|
|
Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F
S.Pneu.6B (n= 460, 464, 265)
|
5.65 micrograms per milliliter (µg/mL)
Interval 5.16 to 6.19
|
5.91 micrograms per milliliter (µg/mL)
Interval 5.4 to 6.45
|
5.43 micrograms per milliliter (µg/mL)
Interval 4.9 to 6.02
|
|
Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F
S.Pneu.9V (n=461, 468, 266)
|
5.81 micrograms per milliliter (µg/mL)
Interval 5.37 to 6.29
|
5.66 micrograms per milliliter (µg/mL)
Interval 5.23 to 6.13
|
5.54 micrograms per milliliter (µg/mL)
Interval 5.02 to 6.12
|
|
Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F
S.Pneu.14 (n= 460, 465, 266)
|
9.71 micrograms per milliliter (µg/mL)
Interval 8.99 to 10.5
|
9.54 micrograms per milliliter (µg/mL)
Interval 8.81 to 10.34
|
8.96 micrograms per milliliter (µg/mL)
Interval 8.07 to 9.95
|
|
Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F
S.Pneu.18C (n= 458, 465, 263)
|
5.50 micrograms per milliliter (µg/mL)
Interval 5.04 to 6.01
|
5.80 micrograms per milliliter (µg/mL)
Interval 5.3 to 6.34
|
5.51 micrograms per milliliter (µg/mL)
Interval 4.95 to 6.12
|
|
Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F
S.Pneu.19F (n= 454, 460, 261)
|
2.52 micrograms per milliliter (µg/mL)
Interval 2.32 to 2.74
|
2.52 micrograms per milliliter (µg/mL)
Interval 2.32 to 2.73
|
2.31 micrograms per milliliter (µg/mL)
Interval 2.06 to 2.59
|
|
Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F
S.Pneu.23F (n= 459, 464, 266)
|
10.10 micrograms per milliliter (µg/mL)
Interval 9.22 to 11.06
|
10.85 micrograms per milliliter (µg/mL)
Interval 9.87 to 11.91
|
9.79 micrograms per milliliter (µg/mL)
Interval 8.65 to 11.07
|
SECONDARY outcome
Timeframe: At Day 42 after vaccinationPopulation: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.
Outcome measures
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=591 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=601 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=327 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Antibody Titers to Mumps Virus
|
222.4 titer
Interval 202.5 to 244.3
|
224.6 titer
Interval 206.9 to 243.9
|
253.1 titer
Interval 222.7 to 287.7
|
SECONDARY outcome
Timeframe: At Day 42 after vaccinationPopulation: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Concentrations are given as Geometric Mean Concentrations (GMCs).
Outcome measures
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=626 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=636 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=350 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Concentration of Antibodies to Measles Virus
|
4723.1 milli-international units per milliliter
Interval 4436.4 to 5028.4
|
4650.3 milli-international units per milliliter
Interval 4430.9 to 4880.5
|
4207.1 milli-international units per milliliter
Interval 3823.3 to 4629.3
|
SECONDARY outcome
Timeframe: At Day 42 after vaccinationPopulation: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Concentrations are given as Geometric Mean Concentrations (GMCs).
Outcome measures
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=629 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=636 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=352 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Concentration of Antibodies to Rubella Virus
|
59.9 International units per milliliter
Interval 55.9 to 64.1
|
57.9 International units per milliliter
Interval 54.4 to 61.7
|
71.4 International units per milliliter
Interval 65.5 to 77.8
|
SECONDARY outcome
Timeframe: At Day 42 after vaccinationPopulation: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Vaccine response to Havrix is defined as the appearance post-vaccination of anti-hepatitis A virus (anti-HAV) antibodies \[concentration greater than or equal to 15 milli-international units per milliliter (mIU/mL)\] in the serum of subjects seronegative before vaccination (concentration below the assay cut-off value of 15 mIU/mL) or having a 2-fold increase above the pre-vaccination concentration in subjects who were seropositive before vaccination.
Outcome measures
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=404 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=409 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=227 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Number of Subjects With Vaccine Response to Havrix
|
344 subjects
|
345 subjects
|
195 subjects
|
SECONDARY outcome
Timeframe: At Day 42 after vaccinationPopulation: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Cut-off value assessed include 0.05 micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=461 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=468 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=266 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-9V (n= 461, 468, 266)
|
461 subjects
|
468 subjects
|
266 subjects
|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-14 (n= 460, 465, 266)
|
460 subjects
|
465 subjects
|
266 subjects
|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-6B (n= 460, 464, 265)
|
459 subjects
|
463 subjects
|
265 subjects
|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-4 (n= 461, 463, 266)
|
461 subjects
|
463 subjects
|
266 subjects
|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-18C (n= 458, 465, 263)
|
458 subjects
|
465 subjects
|
263 subjects
|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-19F (n= 454, 460, 261)
|
454 subjects
|
460 subjects
|
261 subjects
|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-23F (n= 459, 464, 266)
|
459 subjects
|
464 subjects
|
266 subjects
|
SECONDARY outcome
Timeframe: At Day 42 after vaccinationPopulation: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Cut-off value assessed include 0.2 micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=461 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=468 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=266 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-4 (n= 461, 463, 266)
|
461 subjects
|
463 subjects
|
266 subjects
|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-6B (n= 460, 464, 265)
|
458 subjects
|
460 subjects
|
265 subjects
|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-9V (n= 461, 468, 266)
|
461 subjects
|
468 subjects
|
266 subjects
|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-14 (n= 460, 465, 266)
|
460 subjects
|
465 subjects
|
266 subjects
|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-18C (n= 458, 465, 263)
|
458 subjects
|
464 subjects
|
263 subjects
|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-19F (n= 454, 460, 261)
|
451 subjects
|
459 subjects
|
259 subjects
|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-23F (n= 459, 464, 266)
|
459 subjects
|
464 subjects
|
266 subjects
|
SECONDARY outcome
Timeframe: At Day 42 after vaccinationPopulation: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Cut-off value assessed include 0.5 micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=461 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=468 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=266 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-4 (n= 461, 463, 266)
|
456 subjects
|
459 subjects
|
265 subjects
|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-6B (n= 460, 464, 265)
|
453 subjects
|
459 subjects
|
264 subjects
|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-9V (n= 461, 468, 266)
|
459 subjects
|
466 subjects
|
266 subjects
|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-14 (n= 460, 465, 266)
|
459 subjects
|
464 subjects
|
266 subjects
|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-18C (n= 458, 465, 263)
|
458 subjects
|
463 subjects
|
263 subjects
|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-19F (n= 454, 460, 261)
|
431 subjects
|
448 subjects
|
249 subjects
|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-23F (n= 459, 464, 266)
|
458 subjects
|
462 subjects
|
266 subjects
|
SECONDARY outcome
Timeframe: At Day 42 after vaccinationPopulation: Analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, on subjects with available results.
Cut-off value assessed include 1.0 micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=461 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=468 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=266 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-9V (n= 461, 468, 266)
|
450 subjects
|
459 subjects
|
265 subjects
|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-4 (n= 461, 463, 266)
|
437 subjects
|
423 subjects
|
249 subjects
|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-6B (n= 460, 464, 265)
|
442 subjects
|
453 subjects
|
259 subjects
|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-14 (n= 460, 465, 266)
|
458 subjects
|
463 subjects
|
266 subjects
|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-18C (n= 458, 465, 263)
|
446 subjects
|
455 subjects
|
259 subjects
|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-19F (n= 454, 460, 261)
|
390 subjects
|
390 subjects
|
214 subjects
|
|
Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value
Anti-S.Pneu-23F (n= 459, 464, 266)
|
446 subjects
|
458 subjects
|
265 subjects
|
SECONDARY outcome
Timeframe: During the 4 day follow up period following vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.
Solicited local symptoms assessed include pain, redness and swelling.
Outcome measures
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=673 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=666 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=378 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Number of Subjects Reporting Solicited Local Symptoms
Pain
|
136 subjects
|
114 subjects
|
65 subjects
|
|
Number of Subjects Reporting Solicited Local Symptoms
Redness
|
111 subjects
|
120 subjects
|
54 subjects
|
|
Number of Subjects Reporting Solicited Local Symptoms
Swelling
|
50 subjects
|
49 subjects
|
21 subjects
|
SECONDARY outcome
Timeframe: During the 15-day follow-up period following vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.
Fever was measured rectally.
Outcome measures
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=676 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=668 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=379 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 15-day Follow up Period After Vaccination
≥ 38.0°C/100.4°F
|
248 subjects
|
241 subjects
|
120 subjects
|
|
Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 15-day Follow up Period After Vaccination
> 39.5°C/103.1°F
|
33 subjects
|
48 subjects
|
14 subjects
|
SECONDARY outcome
Timeframe: During the 43-day follow-up period following vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.
Fever was measured rectally.
Outcome measures
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=676 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=668 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=379 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 43-day Follow-up Period After Vaccination
≥ 38.0°C/100.4°F
|
312 subjects
|
301 subjects
|
162 subjects
|
|
Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 43-day Follow-up Period After Vaccination
> 39.5°C/103.1°F
|
52 subjects
|
71 subjects
|
24 subjects
|
SECONDARY outcome
Timeframe: During the 43-day follow-up period after vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.
Outcome measures
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=676 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=668 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=379 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash
|
37 subjects
|
25 subjects
|
15 subjects
|
SECONDARY outcome
Timeframe: During the 43-day follow-up period after vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.
Outcome measures
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=676 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=668 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=379 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Number of Subjects Reporting Investigator-confirmed Varicella-like Rash
|
10 subjects
|
9 subjects
|
6 subjects
|
SECONDARY outcome
Timeframe: During the 43-day follow-up period after vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort, on subjects with available results.
Outcome measures
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=676 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=668 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=379 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling
|
14 subjects
|
7 subjects
|
5 subjects
|
SECONDARY outcome
Timeframe: During the 43-day follow-up period after vaccinationPopulation: Analysis was performed on the Total Vaccinated Cohort.
Unsolicited adverse event covers any adverse event 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. Medically-attended adverse event covers any adverse event which received medical attention. Medical attention is defined as hospitalization, an emergency room visit or a visit to or from medical personnel.
Outcome measures
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=705 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=689 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=389 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Number of Subjects Reporting Unsolicited Adverse Events and Medically-attended Adverse Events (Excluding Rash and Parotid/Salivary Gland Swelling)
Unsolicited adverse events
|
338 subjects
|
332 subjects
|
191 subjects
|
|
Number of Subjects Reporting Unsolicited Adverse Events and Medically-attended Adverse Events (Excluding Rash and Parotid/Salivary Gland Swelling)
Medically-attended adverse events
|
217 subjects
|
213 subjects
|
124 subjects
|
SECONDARY outcome
Timeframe: For approximately 6 months (Day 0-180)Population: Analysis was performed on the Total Vaccinated Cohort.
New onset chronic illnesses include autoimmune disorders, asthma, type I diabetes and allergies.
Outcome measures
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=705 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=689 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=389 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Number of Subjects Reporting New Onset Chronic Illnesses and Conditions Prompting Emergency Room Visits
New onsets of chronic diseases
|
11 subjects
|
11 subjects
|
7 subjects
|
|
Number of Subjects Reporting New Onset Chronic Illnesses and Conditions Prompting Emergency Room Visits
Emergency room visits
|
63 subjects
|
63 subjects
|
44 subjects
|
SECONDARY outcome
Timeframe: For approximately 6 months (Day 0-180)Population: Analysis was performed on the Total Vaccinated Cohort.
Serious adverse events assessed include medical occurrences that result in death, is 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 |
Refrigerator-stored Priorix-Tetra Group
n=705 Participants
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=689 Participants
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=389 Participants
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events
|
14 subjects
|
20 subjects
|
7 subjects
|
Adverse Events
Refrigerator-stored Priorix-Tetra Group
Serious events: 14 serious events
Other events: 547 other events
Deaths: 0 deaths
Freezer-stored Priorix-Tetra Group
Serious events: 20 serious events
Other events: 541 other events
Deaths: 0 deaths
Proquad Group
Serious events: 7 serious events
Other events: 297 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=705 participants at risk
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=689 participants at risk
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=389 participants at risk
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.14%
1/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.29%
2/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.14%
1/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.15%
1/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.29%
2/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Infections and infestations
Cellulitis
|
0.28%
2/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.29%
2/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.29%
2/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.51%
2/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Infections and infestations
Staphylococcal infection
|
0.14%
1/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.15%
1/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Infections and infestations
Abscess
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.15%
1/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Injury, poisoning and procedural complications
Accidental drug intake by child
|
0.14%
1/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Injury, poisoning and procedural complications
Accidental exposure
|
0.14%
1/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.26%
1/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.15%
1/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.14%
1/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Psychiatric disorders
Autism spectrum disorder
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.15%
1/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.26%
1/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.15%
1/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Nervous system disorders
Convulsion
|
0.14%
1/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.15%
1/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.15%
1/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Gastrointestinal disorders
Dysphagia
|
0.14%
1/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Infections and infestations
Ear infection
|
0.14%
1/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Injury, poisoning and procedural complications
Foreign body trauma
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.26%
1/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.26%
1/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.14%
1/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Metabolism and nutrition disorders
Hpoglycaemia
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.15%
1/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.15%
1/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Infections and infestations
Otitis media
|
0.14%
1/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.15%
1/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.26%
1/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.26%
1/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.15%
1/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Primitive neuroectodermal tumour
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.15%
1/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
General disorders
Pyrexia
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.15%
1/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.15%
1/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.14%
1/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.14%
1/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Infections and infestations
Subcutaneous abscess
|
0.14%
1/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.15%
1/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.15%
1/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.15%
1/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Infections and infestations
Viral infection
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.15%
1/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.15%
1/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
0.00%
0/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
Other adverse events
| Measure |
Refrigerator-stored Priorix-Tetra Group
n=705 participants at risk
Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Freezer-stored Priorix-Tetra Group
n=689 participants at risk
Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
|
Proquad Group
n=389 participants at risk
Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
|
|---|---|---|---|
|
General disorders
Pain
|
20.2%
136/673 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
17.1%
114/666 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
17.2%
65/378 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
General disorders
Redness
|
16.5%
111/673 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
18.0%
120/666 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
14.3%
54/378 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
General disorders
Swelling
|
7.4%
50/673 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
7.4%
49/666 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
5.6%
21/378 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
General disorders
Fever
|
46.2%
312/676 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
45.2%
302/668 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
43.0%
163/379 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
General disorders
Rash
|
32.7%
221/676 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
32.8%
219/668 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
33.8%
128/379 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Infections and infestations
Otitis media
|
10.1%
71/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
9.0%
62/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
8.7%
34/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Infections and infestations
Uper respiratory tract infection
|
7.0%
49/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
8.4%
58/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
10.8%
42/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Gastrointestinal disorders
Teething
|
6.0%
42/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
7.7%
53/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
7.2%
28/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.2%
37/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
6.7%
46/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
7.5%
29/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
General disorders
Irritability
|
3.5%
25/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
5.1%
35/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
5.1%
20/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.1%
29/705 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
3.0%
21/689 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
6.2%
24/389 • Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort.
|
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