Acellular Pertussis, Diphtheria, Tetanus
Conditions
Brief summary
The purpose of this study was to investigate the following questions through post-marketing surveillance: * Unknown/Unexpected adverse events and the serious adverse events. * The circumstances in which the adverse events occurred under the practical application. * Factors considered to have influence on safety. * Factors considered to have influence on efficacy. * Miscellaneous - Facts about mechanism, efficacy and safety which were not clearly known due to the inherent problems of the drugs.
Interventions
BIOLOGICALGSK Biologicals' Infanrix™
Primary and booster vaccination according to vaccination schedule. Intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
All children receiving Infanrix™ were eligible for this survey.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Serious Adverse Events | 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. |
| Number of Subjects Reporting Solicited Symptoms | During the 4-week follow-up period after each 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. |
| Number of Subjects Reporting Unsolicited Adverse Events | 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. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 1,258 |
| Total | 1,258 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Other | 14 |
Baseline characteristics
| Characteristic | Infanrix Group |
|---|---|
| Age, Continuous | 5.0 months STANDARD_DEVIATION 8.44 |
| Sex: Female, Male Female | 615 Participants |
| Sex: Female, Male Male | 643 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1,258 |
| other Total, other adverse events | 90 / 877 |
| serious Total, serious adverse events | 3 / 1,258 |
Outcome results
Primary
Number of Subjects Reporting Serious Adverse Events
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.
Time frame: Since the beginning of the study and during the entire study period (up to 6 years)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infanrix Group | Number of Subjects Reporting Serious Adverse Events | 3 Subjects |
Primary
Number of Subjects Reporting Solicited Symptoms
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.
Time frame: During the 4-week follow-up period after each dose
Population: Analysis was performed on the subjects who received the considered dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Drowsiness after Booster at 15-18 Months (n=88) | 5 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Drowsiness after Booster at 4-6 Years (n=22) | 1 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Itching after Booster at 4-6 Years (n=22) | 4 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Pain after Dose 1 (n=798) | 29 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Induration after Dose 1 (n=798) | 51 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Induration after Dose 2 (n=843) | 72 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Induration after Dose 3 (n=877) | 86 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Induration after Booster at 15-18 Months (n=88) | 19 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Induration after Booster at 4-6 Years (n=22) | 5 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Itching after Dose 1 (n=798) | 5 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Itching after Dose 2 (n=843) | 8 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Itching after Dose 3 (n=877) | 2 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Itching after Booster at 15-18 Months (n=88) | 8 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Pain after Dose 2 (n=843) | 31 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Pain after Dose 3 (n=877) | 43 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Pain after Booster at 15-18 Months (n=88) | 13 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Pain after Booster at 4-6 Years (n=22) | 6 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Redness after Dose 1 (n=798) | 51 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Redness after Dose 2 (n=843) | 76 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Redness after Dose 3 (n=877) | 79 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Redness after Booster at 15-18 Months (n=88) | 22 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Redness after Booster at 4-6 Years (n=22) | 4 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Swelling after Dose 1 (n=798) | 26 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Swelling after Dose 2 (n=843) | 43 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Swelling after Dose 3 (n=877) | 51 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Swelling after Booster at 15-18 Months (n=88) | 20 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Swelling after Booster at 4-6 Years (n=22) | 5 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Anorexia after Dose 1 (n=798) | 41 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Anorexia after Dose 2 (n=843) | 40 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Anorexia after Dose 3 (n=877) | 31 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Anorexia after Booster at 15-18 Months (n=88) | 5 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Anorexia after Booster at 4-6 Years (n=22) | 0 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Convulsions after Dose 1 (n=798) | 1 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Convulsions after Dose 2 (n=843) | 1 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Convulsions after Dose 3 (n=877) | 2 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Convulsions after Booster at 15-18 Months (n=88) | 0 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Convulsions after Booster at 4-6 Years (n=22) | 0 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Cough after Dose 1 (n=798) | 21 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Cough after Dose 2 (n=843) | 18 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Cough after Dose 3 (n=877) | 20 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Cough after Booster at 15-18 Months (n=88) | 3 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Cough after Booster at 4-6 Years (n=22) | 0 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Diarrhea after Dose 1 (n=798) | 15 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Diarrhea after Dose 2 (n=843) | 15 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Diarrhea after Dose 3 (n=877) | 20 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Diarrhea after Booster at 15-18 Months (n=88) | 4 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Diarrhea after Booster at 4-6 Years (n=22) | 0 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Drowsiness after Dose 1 (n=798) | 47 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Drowsiness after Dose 2 (n=843) | 41 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Drowsiness after Dose 3 (n=877) | 38 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Eruption after Dose 1 (n=798) | 6 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Eruption after Dose 2 (n=843) | 7 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Eruption after Dose 3 (n=877) | 13 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Eruption after Booster at 15-18 Months (n=88) | 2 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Eruption after Booster at 4-6 Years (n=22) | 0 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Fever after Dose 1 (n=798) | 40 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Fever after Dose 2 (n=843) | 36 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Fever after Dose 3 (n=877) | 17 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Fever after Booster at 15-18 Months (n=88) | 6 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Fever after Booster at 4-6 Years (n=22) | 2 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Irritability after Dose 1 (n=798) | 90 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Irritability after Dose 2 (n=843) | 82 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Irritability after Dose 3 (n=877) | 74 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Irritability after Booster at 15-18 Months (n=88) | 9 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Irritability after Booster at 4-6 Years (n=22) | 1 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Vomiting after Dose 1 (n=798) | 20 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Vomiting after Dose 2 (n=843) | 13 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Vomiting after Dose 3 (n=877) | 13 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Vomiting after Booster at 15-18 Months (n=88) | 1 Subjects |
| Infanrix Group | Number of Subjects Reporting Solicited Symptoms | Vomiting after Booster at 4-6 Years (n=22) | 0 Subjects |
Primary
Number of Subjects Reporting Unsolicited Adverse Events
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.
Time frame: Within the 31-day (Day 0-30) following vaccination.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Infanrix Group | Number of Subjects Reporting Unsolicited Adverse Events | 144 Subjects |