Trial Outcomes & Findings for Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age. (NCT NCT00345683)
NCT ID: NCT00345683
Last Updated: 2016-11-29
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
4021 participants
Primary outcome timeframe
From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
Results posted on
2016-11-29
Participant Flow
This summary presents results for the booster/fourth dose vaccination phase up to the end of the 6-month safety follow-up. Subjects received 3-vaccine doses in the study NCT00345579 and were followed up to, but excluding, the fourth dose vaccination. This study begins 10 months after the first vaccination in the primary phase.
Of the 4021 subjects enrolled, 4020 received a booster vaccination and 3986 completed the booster phase (2985 in the Menhibrix Group and 1001 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 in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). 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 in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). 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
|
3010
|
1010
|
|
Overall Study
COMPLETED
|
2985
|
1001
|
|
Overall Study
NOT COMPLETED
|
25
|
9
|
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 in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). 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 in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). 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
Lost to Follow-up
|
19
|
7
|
|
Overall Study
Other
|
6
|
2
|
Baseline Characteristics
Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age.
Baseline characteristics by cohort
| Measure |
Menhibrix Group
n=3010 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 in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). 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=1010 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 in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). 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=4020 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.1 Days
STANDARD_DEVIATION 0.34 • n=5 Participants
|
12.1 Days
STANDARD_DEVIATION 0.33 • n=7 Participants
|
12.1 Days
STANDARD_DEVIATION 0.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1450 Participants
n=5 Participants
|
505 Participants
n=7 Participants
|
1955 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1560 Participants
n=5 Participants
|
505 Participants
n=7 Participants
|
2065 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)Population: The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.
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=3010 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 in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). 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=1010 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 in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). 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)
|
12 Subjects
|
1 Subjects
|
PRIMARY outcome
Timeframe: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)Population: The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Outcome measures
| Measure |
Menhibrix Group
n=3010 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 in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). 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=1010 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 in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). 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)
|
12 Subjects
|
6 Subjects
|
PRIMARY outcome
Timeframe: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)Population: The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae
Outcome measures
| Measure |
Menhibrix Group
n=3010 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 in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). 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=1010 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 in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). 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
|
123 Subjects
|
41 Subjects
|
PRIMARY outcome
Timeframe: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)Population: The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.
Outcome measures
| Measure |
Menhibrix Group
n=3010 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 in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). 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=1010 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 in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). 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) Visits
|
29 Subjects
|
16 Subjects
|
PRIMARY outcome
Timeframe: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)Population: The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.
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=3010 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 in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). 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=1010 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 in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). 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)
|
72 Subjects
|
18 Subjects
|
PRIMARY outcome
Timeframe: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)Population: The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Outcome measures
| Measure |
Menhibrix Group
n=3010 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 in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). 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=1010 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 in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). 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)
|
50 Subjects
|
18 Subjects
|
PRIMARY outcome
Timeframe: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)Population: The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae
Outcome measures
| Measure |
Menhibrix Group
n=3010 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 in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). 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=1010 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 in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). 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
|
227 Subjects
|
82 Subjects
|
PRIMARY outcome
Timeframe: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)Population: The Fourth dose Total Vaccinated cohort included all subjects who received the fourth study dose.
Outcome measures
| Measure |
Menhibrix Group
n=3010 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 in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). 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=1010 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 in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). 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) Visits
|
129 Subjects
|
48 Subjects
|
Adverse Events
Menhibrix Group
Serious events: 72 serious events
Other events: 0 other events
Deaths: 0 deaths
ActHIB Group
Serious events: 18 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Menhibrix Group
n=3010 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 in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). 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=1010 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 in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). 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.
|
|---|---|---|
|
Infections and infestations
Gastroenteritis
|
0.93%
28/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.69%
7/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.20%
6/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Infections and infestations
Bronchiolitis
|
0.27%
8/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.30%
3/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Infections and infestations
Staphylococcal infection
|
0.07%
2/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Infections and infestations
Abscess
|
0.03%
1/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.10%
3/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Nervous system disorders
Febrile convulsion
|
0.20%
6/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.20%
2/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.03%
1/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.03%
1/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.10%
1/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.03%
1/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Infections and infestations
Otitis media
|
0.03%
1/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.10%
1/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
General disorders
Pyrexia
|
0.03%
1/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.07%
2/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.07%
2/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.07%
2/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.10%
1/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Infections and infestations
Pneumonia
|
0.10%
3/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.20%
2/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Infections and infestations
Croup infectious
|
0.00%
0/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.10%
1/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.07%
2/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Nervous system disorders
Ataxia
|
0.03%
1/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.10%
1/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Infections and infestations
Bronchopneumonia
|
0.07%
2/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.07%
2/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Infections and infestations
Influenza
|
0.07%
2/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.03%
1/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Infections and infestations
Pneumonia bacterial
|
0.03%
1/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.03%
1/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.03%
1/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.03%
1/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.03%
1/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.10%
1/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Infections and infestations
Erysipelas
|
0.03%
1/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Infections and infestations
Folliculitis
|
0.03%
1/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Skin and subcutaneous tissue disorders
Henoch-schonlein purpura
|
0.03%
1/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.03%
1/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.03%
1/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangioma
|
0.03%
1/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.03%
1/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.00%
0/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.10%
1/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/3010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
0.10%
1/1010 • Serious Adverse Events: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study. Data for unsolicited AEs and solicited symptoms were not collected.
|
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