Trial Outcomes & Findings for Post Market Surveillance for Infanrix™ (NCT NCT00908115)
NCT ID: NCT00908115
Last Updated: 2020-01-02
Results Overview
A serious adverse event is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Recruitment status
COMPLETED
Target enrollment
1258 participants
Primary outcome timeframe
Since the beginning of the study and during the entire study period (up to 6 years)
Results posted on
2020-01-02
Participant Flow
Participant milestones
| Measure |
Infanrix Group
Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
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|---|---|
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Overall Study
STARTED
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1258
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Overall Study
COMPLETED
|
1244
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Overall Study
NOT COMPLETED
|
14
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Reasons for withdrawal
| Measure |
Infanrix Group
Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
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Overall Study
Other
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14
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Baseline Characteristics
Post Market Surveillance for Infanrix™
Baseline characteristics by cohort
| Measure |
Infanrix Group
n=1258 Participants
Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
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|---|---|
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Age, Continuous
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5.0 months
STANDARD_DEVIATION 8.44 • n=5 Participants
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Sex: Female, Male
Female
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615 Participants
n=5 Participants
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Sex: Female, Male
Male
|
643 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Since the beginning of the study and during the entire study period (up to 6 years)A serious adverse event is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
Outcome measures
| Measure |
Infanrix Group
n=1258 Participants
Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
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|---|---|
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Number of Subjects Reporting Serious Adverse Events
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3 Subjects
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PRIMARY outcome
Timeframe: During the 4-week follow-up period after each dosePopulation: Analysis was performed on the subjects who received the considered dose.
Solicited local symptoms assessed include induration, itching, pain, redness, and swelling. Solicited general symptoms assessed include anorexia, convulsions, cough, diarrhea, drowsiness, eruption, fever, irritability, and vomiting.
Outcome measures
| Measure |
Infanrix Group
n=877 Participants
Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
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|---|---|
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Number of Subjects Reporting Solicited Symptoms
Convulsions after Booster at 4-6 Years (n=22)
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0 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Cough after Dose 1 (n=798)
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21 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Cough after Dose 2 (n=843)
|
18 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Cough after Dose 3 (n=877)
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20 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Cough after Booster at 15-18 Months (n=88)
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3 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Cough after Booster at 4-6 Years (n=22)
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0 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Diarrhea after Dose 1 (n=798)
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15 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Eruption after Booster at 4-6 Years (n=22)
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0 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Fever after Dose 1 (n=798)
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40 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Fever after Dose 2 (n=843)
|
36 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Fever after Dose 3 (n=877)
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17 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Fever after Booster at 15-18 Months (n=88)
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6 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Fever after Booster at 4-6 Years (n=22)
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2 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Irritability after Dose 1 (n=798)
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90 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Irritability after Dose 2 (n=843)
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82 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Irritability after Dose 3 (n=877)
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74 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Anorexia after Booster at 4-6 Years (n=22)
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0 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Convulsions after Dose 1 (n=798)
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1 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Convulsions after Dose 2 (n=843)
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1 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Convulsions after Dose 3 (n=877)
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2 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Convulsions after Booster at 15-18 Months (n=88)
|
0 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Induration after Dose 3 (n=877)
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86 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Induration after Booster at 15-18 Months (n=88)
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19 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Induration after Booster at 4-6 Years (n=22)
|
5 Subjects
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Number of Subjects Reporting Solicited Symptoms
Itching after Dose 1 (n=798)
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5 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Itching after Dose 2 (n=843)
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8 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Diarrhea after Dose 2 (n=843)
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15 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Diarrhea after Dose 3 (n=877)
|
20 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Diarrhea after Booster at 15-18 Months (n=88)
|
4 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Diarrhea after Booster at 4-6 Years (n=22)
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0 Subjects
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|
Number of Subjects Reporting Solicited Symptoms
Drowsiness after Dose 1 (n=798)
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47 Subjects
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|
Number of Subjects Reporting Solicited Symptoms
Drowsiness after Dose 2 (n=843)
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41 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Drowsiness after Dose 3 (n=877)
|
38 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Drowsiness after Booster at 15-18 Months (n=88)
|
5 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Drowsiness after Booster at 4-6 Years (n=22)
|
1 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Eruption after Dose 1 (n=798)
|
6 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Eruption after Dose 2 (n=843)
|
7 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Eruption after Dose 3 (n=877)
|
13 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Eruption after Booster at 15-18 Months (n=88)
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2 Subjects
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|
Number of Subjects Reporting Solicited Symptoms
Vomiting after Dose 1 (n=798)
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20 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Vomiting after Dose 2 (n=843)
|
13 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Vomiting after Dose 3 (n=877)
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13 Subjects
|
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Number of Subjects Reporting Solicited Symptoms
Vomiting after Booster at 15-18 Months (n=88)
|
1 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Vomiting after Booster at 4-6 Years (n=22)
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0 Subjects
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|
Number of Subjects Reporting Solicited Symptoms
Induration after Dose 1 (n=798)
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51 Subjects
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Number of Subjects Reporting Solicited Symptoms
Induration after Dose 2 (n=843)
|
72 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Itching after Dose 3 (n=877)
|
2 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Itching after Booster at 15-18 Months (n=88)
|
8 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Itching after Booster at 4-6 Years (n=22)
|
4 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Pain after Dose 1 (n=798)
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29 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Pain after Dose 2 (n=843)
|
31 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Pain after Dose 3 (n=877)
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43 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Pain after Booster at 15-18 Months (n=88)
|
13 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Pain after Booster at 4-6 Years (n=22)
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6 Subjects
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Number of Subjects Reporting Solicited Symptoms
Redness after Dose 1 (n=798)
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51 Subjects
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Number of Subjects Reporting Solicited Symptoms
Redness after Dose 2 (n=843)
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76 Subjects
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Number of Subjects Reporting Solicited Symptoms
Redness after Dose 3 (n=877)
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79 Subjects
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Number of Subjects Reporting Solicited Symptoms
Redness after Booster at 15-18 Months (n=88)
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22 Subjects
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Number of Subjects Reporting Solicited Symptoms
Redness after Booster at 4-6 Years (n=22)
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4 Subjects
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Number of Subjects Reporting Solicited Symptoms
Swelling after Dose 1 (n=798)
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26 Subjects
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Number of Subjects Reporting Solicited Symptoms
Swelling after Dose 2 (n=843)
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43 Subjects
|
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Number of Subjects Reporting Solicited Symptoms
Swelling after Dose 3 (n=877)
|
51 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Swelling after Booster at 15-18 Months (n=88)
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20 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Swelling after Booster at 4-6 Years (n=22)
|
5 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Anorexia after Dose 1 (n=798)
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41 Subjects
|
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Number of Subjects Reporting Solicited Symptoms
Anorexia after Dose 2 (n=843)
|
40 Subjects
|
|
Number of Subjects Reporting Solicited Symptoms
Anorexia after Dose 3 (n=877)
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31 Subjects
|
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Number of Subjects Reporting Solicited Symptoms
Anorexia after Booster at 15-18 Months (n=88)
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5 Subjects
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Number of Subjects Reporting Solicited Symptoms
Irritability after Booster at 15-18 Months (n=88)
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9 Subjects
|
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Number of Subjects Reporting Solicited Symptoms
Irritability after Booster at 4-6 Years (n=22)
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1 Subjects
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PRIMARY outcome
Timeframe: Within the 31-day (Day 0-30) following vaccination.An adverse event is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Outcome measures
| Measure |
Infanrix Group
n=1258 Participants
Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
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|---|---|
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Number of Subjects Reporting Unsolicited Adverse Events
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144 Subjects
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Adverse Events
Infanrix Group
Serious events: 3 serious events
Other events: 90 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Infanrix Group
n=877 participants at risk；n=1258 participants at risk
Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
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|---|---|
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Infections and infestations
Croup infectious
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0.08%
1/1258 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
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Infections and infestations
Gastroenteritis
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0.08%
1/1258 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
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Infections and infestations
Urinary tract infection
|
0.08%
1/1258 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
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Other adverse events
| Measure |
Infanrix Group
n=877 participants at risk；n=1258 participants at risk
Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
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|---|---|
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General disorders
Induration PRI D1
|
6.4%
51/798 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
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|
General disorders
Induration PRI D2
|
8.5%
72/843 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Induration PRI D3
|
9.8%
86/877 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Redness PRI D1
|
6.4%
51/798 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Redness PRI D2
|
9.0%
76/843 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Redness PRI D3
|
9.0%
79/877 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Swelling PRI D2
|
5.1%
43/843 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Drowsiness PRI D1
|
5.9%
47/798 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Irritability PRI D1
|
11.3%
90/798 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Irritability PRI D2
|
9.7%
82/843 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Irritability PRI D3
|
8.4%
74/877 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Swelling PRI D3
|
5.8%
51/877 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Induration BST 15-18M
|
21.6%
19/88 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Itching BST 15-18M
|
9.1%
8/88 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Pain BST 15-18M
|
14.8%
13/88 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Redness BST 15-18M
|
25.0%
22/88 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Swelling BST 15-18M
|
22.7%
20/88 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Induration BST 4-6Y
|
22.7%
5/22 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Itching BST 4-6Y
|
18.2%
4/22 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Pain BST 4-6Y
|
27.3%
6/22 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Redness BST 4-6Y
|
18.2%
4/22 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Swelling BST 4-6Y
|
22.7%
5/22 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Anorexia PRI D1
|
5.1%
41/798 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Fever PRI D1
|
5.0%
40/798 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Anorexia BST 15-18M
|
5.7%
5/88 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Drowsiness BST 15-18M
|
5.7%
5/88 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Fever BST 15-18M
|
6.8%
6/88 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Irritability BST 15-18M
|
10.2%
9/88 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
|
General disorders
Fever BST 4-6Y
|
9.1%
2/22 • SAES were collected during the entire study period (Day 0 up to 6 years), Unsolicited AEs: within Day 0-30 and Solicited AEs during 4 weeks post vaccination periods. No unsolicited AEs with a frequency >5% were reported. Therefore the total number of participants at risk in Other AE section is the highest number of participants at risk analysed for solicited AEs (i.e. after Dose 3). PRI = primary; D1 = Dose 1; D2 = Dose 2; D3= Dose 3; BST = Booster ;15-18 Months = 15-18M; 4-6 Years = 4-6Y.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
|
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