Trial Outcomes & Findings for Safety Study of GSK Biologicals' DTPa-IPV/Hib (Infanrix™-IPV/Hib) (NCT NCT00964028)
NCT ID: NCT00964028
Last Updated: 2018-06-06
Results Overview
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
50 participants
Primary outcome timeframe
During the 4-day (Days 0-3) follow-up period after each dose and across doses
Results posted on
2018-06-06
Participant Flow
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participant milestones
| Measure |
Infanrix-IPV/Hib M2-M3-M4 Group
Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
|
Infanrix-IPV/Hib M3-M4-M5 Group
Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Infanrix-IPV/Hib M2-M3-M4 Group
Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
|
Infanrix-IPV/Hib M3-M4-M5 Group
Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Safety Study of GSK Biologicals' DTPa-IPV/Hib (Infanrix™-IPV/Hib)
Baseline characteristics by cohort
| Measure |
Infanrix-IPV/Hib M2-M3-M4 Group
n=25 Participants
Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
|
Infanrix-IPV/Hib M3-M4-M5 Group
n=25 Participants
Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.1 Weeks
STANDARD_DEVIATION 1.36 • n=99 Participants
|
14.2 Weeks
STANDARD_DEVIATION 1.18 • n=107 Participants
|
12.15 Weeks
STANDARD_DEVIATION 2.42 • n=206 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian-East Asian heritage
|
24 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian-Japanese heritage
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: During the 4-day (Days 0-3) follow-up period after each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Outcome measures
| Measure |
Infanrix-IPV/Hib M2-M3-M4 Group
n=25 Participants
Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
|
Infanrix-IPV/Hib M3-M4-M5 Group
n=25 Participants
Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
|
|---|---|---|
|
Number of Subjects With Any Solicited Local Symptoms
Any Pain, Across doses
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms
Any Pain, Dose 1
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms
Any Redness, Dose 1
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms
Any Swelling, Dose 1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms
Any Pain, Dose 2
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms
Any Redness, Dose 2
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms
Any Swelling, Dose 2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms
Any Pain, Dose 3
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms
Any Redness, Dose 3
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms
Any Swelling, Dose 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms
Any Redness, Across doses
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms
Any Swelling, Across doses
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the 4-day (Days 0-3) follow-up period after each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above 37.0 degrees Celsius (°C)\]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination.
Outcome measures
| Measure |
Infanrix-IPV/Hib M2-M3-M4 Group
n=25 Participants
Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
|
Infanrix-IPV/Hib M3-M4-M5 Group
n=25 Participants
Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
|
|---|---|---|
|
Number of Subjects With Any Solicited General Symptoms
Any Drowsiness, Dose 1
|
9 Participants
|
1 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Irritability, Dose 1
|
9 Participants
|
5 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Loss of appetite, Dose 1
|
7 Participants
|
1 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Fever, Dose 1
|
8 Participants
|
8 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Drowsiness, Dose 2
|
3 Participants
|
5 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Irritability, Dose 2
|
6 Participants
|
3 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Loss of appetite, Dose 2
|
3 Participants
|
3 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Fever, Dose 2
|
5 Participants
|
5 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Drowsiness, Dose 3
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Irritability, Dose 3
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Loss of appetite, Dose 3
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Fever, Dose 3
|
7 Participants
|
3 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Drowsiness, Across doses
|
12 Participants
|
5 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Irritability, Across doses
|
15 Participants
|
8 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Loss of appetite, Across doses
|
9 Participants
|
4 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Fever, Across doses
|
13 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: During the 31-day (Days 0-30) follow-up period after each vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Infanrix-IPV/Hib M2-M3-M4 Group
n=25 Participants
Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
|
Infanrix-IPV/Hib M3-M4-M5 Group
n=25 Participants
Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
|
|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
|
16 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: During the whole study period (from Day 0 until Month 3 or Month 4)Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Infanrix-IPV/Hib M2-M3-M4 Group
n=25 Participants
Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
|
Infanrix-IPV/Hib M3-M4-M5 Group
n=25 Participants
Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
Adverse Events
Infanrix-IPV/Hib M2-M3-M4 Group
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Infanrix-IPV/Hib M3-M4-M5 Group
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Infanrix-IPV/Hib M2-M3-M4 Group
n=25 participants at risk
Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
|
Infanrix-IPV/Hib M3-M4-M5 Group
n=25 participants at risk
Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
|
|---|---|---|
|
General disorders
Pyrexia
|
20.0%
5/25 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 until Month 3/4).
|
0.00%
0/25 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 until Month 3/4).
|
|
General disorders
Pain
|
16.0%
4/25 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 until Month 3/4).
|
12.0%
3/25 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 until Month 3/4).
|
|
General disorders
Redness
|
16.0%
4/25 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 until Month 3/4).
|
0.00%
0/25 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 until Month 3/4).
|
|
General disorders
Swelling
|
8.0%
2/25 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 until Month 3/4).
|
0.00%
0/25 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 until Month 3/4).
|
|
General disorders
Drowsiness
|
48.0%
12/25 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 until Month 3/4).
|
20.0%
5/25 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 until Month 3/4).
|
|
General disorders
Irritability
|
60.0%
15/25 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 until Month 3/4).
|
32.0%
8/25 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 until Month 3/4).
|
|
General disorders
Loss of appetite
|
36.0%
9/25 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 until Month 3/4).
|
16.0%
4/25 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 until Month 3/4).
|
|
General disorders
Fever
|
52.0%
13/25 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 until Month 3/4).
|
48.0%
12/25 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 until Month 3/4).
|
|
Gastrointestinal disorders
Diarrhoea
|
16.0%
4/25 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 until Month 3/4).
|
0.00%
0/25 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 until Month 3/4).
|
|
Infections and infestations
Upper respiratory tract infection
|
40.0%
10/25 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 until Month 3/4).
|
4.0%
1/25 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 until Month 3/4).
|
|
Infections and infestations
Nasopharyngitis
|
16.0%
4/25 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 until Month 3/4).
|
0.00%
0/25 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Day 0 until Month 3/4).
|
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