Trial Outcomes & Findings for Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age (NCT NCT00345579)
NCT ID: NCT00345579
Last Updated: 2016-12-16
Results Overview
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4432 participants
Primary outcome timeframe
From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)
Results posted on
2016-12-16
Participant Flow
This summary presents results for the primary vaccination phase up to the end of the extended safety follow-up (until, but excluding, the booster dose at 12-15 months of age). For results about the booster/fourth dose phase, see study NCT00345683.
Of the 4432 subjects enrolled, 4391 were vaccinated and 4162 completed the primary vaccination phase of the study (3114 in the MenHibrix Group and 1048 in the ActHIB Group).
Participant milestones
| Measure |
MenHibrix Group
Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
|
ActHIB Group
Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
|
|---|---|---|
|
Overall Study
STARTED
|
3278
|
1113
|
|
Overall Study
COMPLETED
|
3114
|
1048
|
|
Overall Study
NOT COMPLETED
|
164
|
65
|
Reasons for withdrawal
| Measure |
MenHibrix Group
Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
|
ActHIB Group
Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
6
|
|
Overall Study
Protocol Violation
|
14
|
5
|
|
Overall Study
Withdrawal by Subject
|
50
|
17
|
|
Overall Study
Lost to Follow-up
|
82
|
36
|
|
Overall Study
Other
|
9
|
1
|
Baseline Characteristics
Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age
Baseline characteristics by cohort
| Measure |
MenHibrix Group
n=3278 Participants
Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
|
ActHIB Group
n=1113 Participants
Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
|
Total
n=4391 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.6 Days
STANDARD_DEVIATION 10.45 • n=5 Participants
|
59.0 Days
STANDARD_DEVIATION 10.39 • n=7 Participants
|
58.8 Days
STANDARD_DEVIATION 10.42 • n=5 Participants
|
|
Gender
Female
|
1576 Participants
n=5 Participants
|
557 Participants
n=7 Participants
|
2133 Participants
n=5 Participants
|
|
Gender
Male
|
1702 Participants
n=5 Participants
|
556 Participants
n=7 Participants
|
2258 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)Population: The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Outcome measures
| Measure |
MenHibrix Group
n=3278 Participants
Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
|
ActHIB Group
n=1113 Participants
Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs)
|
109 Subjects
|
33 Subjects
|
PRIMARY outcome
Timeframe: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)Population: The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Outcome measures
| Measure |
MenHibrix Group
n=3278 Participants
Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
|
ActHIB Group
n=1113 Participants
Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
|
|---|---|---|
|
Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)
|
50 Subjects
|
18 Subjects
|
PRIMARY outcome
Timeframe: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)Population: The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.
Outcome measures
| Measure |
MenHibrix Group
n=3278 Participants
Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
|
ActHIB Group
n=1113 Participants
Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
|
|---|---|---|
|
Number of Subjects Reporting Rash
|
243 Subjects
|
81 Subjects
|
PRIMARY outcome
Timeframe: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)Population: The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.
Outcome measures
| Measure |
MenHibrix Group
n=3278 Participants
Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
|
ActHIB Group
n=1113 Participants
Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
|
|---|---|---|
|
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER)
|
114 Subjects
|
44 Subjects
|
PRIMARY outcome
Timeframe: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)Population: The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Outcome measures
| Measure |
MenHibrix Group
n=3278 Participants
Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
|
ActHIB Group
n=1113 Participants
Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
157 Subjects
|
48 Subjects
|
PRIMARY outcome
Timeframe: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)Population: The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Outcome measures
| Measure |
MenHibrix Group
n=3278 Participants
Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
|
ActHIB Group
n=1113 Participants
Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
|
|---|---|---|
|
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
|
66 Subjects
|
25 Subjects
|
PRIMARY outcome
Timeframe: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)Population: The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae
Outcome measures
| Measure |
MenHibrix Group
n=3278 Participants
Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
|
ActHIB Group
n=1113 Participants
Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
|
|---|---|---|
|
Number of Subjects With Rash
|
386 Subjects
|
134 Subjects
|
PRIMARY outcome
Timeframe: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)Population: The Primary Total Vaccinated cohort included all subjects with at least one primary vaccine dose of study vaccine administered.
Outcome measures
| Measure |
MenHibrix Group
n=3278 Participants
Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
|
ActHIB Group
n=1113 Participants
Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
|
|---|---|---|
|
Number of Subjects With Adverse Events Resulting in Emergency Room (ER)
|
198 Subjects
|
69 Subjects
|
Adverse Events
MenHibrix Group
Serious events: 157 serious events
Other events: 0 other events
Deaths: 0 deaths
ActHIB Group
Serious events: 48 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MenHibrix Group
n=3278 participants at risk
Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
|
ActHIB Group
n=1113 participants at risk
Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
|
|---|---|---|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
General disorders
Oedema peripheral
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.09%
1/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Septic shock
|
0.00%
0/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.09%
1/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.06%
2/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Varicella
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Gastroenteritis
|
0.98%
32/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.99%
11/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Bronchiolitis
|
1.2%
39/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.54%
6/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Bronchopneumonia
|
0.52%
17/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.81%
9/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Nervous system disorders
Febrile convulsion
|
0.15%
5/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.09%
1/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Injury, poisoning and procedural complications
Fractured skull depressed
|
0.00%
0/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.09%
1/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Vascular disorders
Haematoma
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Renal and urinary disorders
Haematuria
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Vascular disorders
Haemorrhagic infarction
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Gastrointestinal disorders
Ileus
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.15%
5/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.45%
5/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Pneumonia
|
0.27%
9/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.18%
2/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.31%
10/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.09%
1/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Viral infection
|
0.00%
0/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.18%
2/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.06%
2/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.09%
1/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Otitis media
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Urinary tract infection
|
0.12%
4/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.27%
9/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.18%
2/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
General disorders
Pyrexia
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.18%
2/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.09%
3/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.09%
1/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Croup infectious
|
0.06%
2/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.09%
1/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
General disorders
Sudden infant death syndrome
|
0.09%
3/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.18%
2/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.09%
1/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Pyelonephritis
|
0.09%
3/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.09%
1/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Cellulitis
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Nervous system disorders
Convulsion
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Pharyngitis
|
0.06%
2/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.18%
2/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.06%
2/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.09%
1/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.09%
1/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.09%
1/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.09%
3/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Tracheitis
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.18%
2/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.09%
1/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Vascular disorders
Hypovolaemic shock
|
0.06%
2/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Influenza
|
0.00%
0/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.09%
1/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Lobar pneumonia
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Nasopharyngitis
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Nervous system disorders
Nystagmus
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.09%
1/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Subcutaneous abscess
|
0.06%
2/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.09%
1/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.00%
0/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.09%
1/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Psychiatric disorders
Breath holding
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Bronchitis
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.09%
1/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Social circumstances
Child abuse
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.09%
1/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.09%
1/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Nervous system disorders
Epilepsy
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.09%
1/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.03%
1/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.00%
0/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/3278 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
0.09%
1/1113 • Serious Adverse Events: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Solicited symptoms and unsolicited AEs were not collected during the study. Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
|
Other adverse events
Adverse event data not reported
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