Trial Outcomes & Findings for Evaluation of the Immunogenicity, Safety and Reactogenicity of the Combined DTPa-IPV Vaccine in Healthy Infants (NCT NCT00290342)
NCT ID: NCT00290342
Last Updated: 2018-10-29
Results Overview
A seroprotected subject was defined as a vaccinated subject with anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) the cut-off value of 0.1 international units/milliliter (IU//mL).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
458 participants
Primary outcome timeframe
One month (Month 5) post-primary vaccination course
Results posted on
2018-10-29
Participant Flow
Of the 458 subjects enrolled in the study, 6 subjects (5 from Infanrix-IPV Group and 1 from Infanrix + IMOVAX Polio Group) were not administered the study vaccine due to consent withdrawal from parents/guardians and received an elimination code.
Participant milestones
| Measure |
Infanrix-IPV Group
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
|
Infanrix + IMOVAX Polio Group
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.
|
|---|---|---|
|
Overall Study
STARTED
|
224
|
228
|
|
Overall Study
COMPLETED
|
217
|
223
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
Reasons for withdrawal
| Measure |
Infanrix-IPV Group
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
|
Infanrix + IMOVAX Polio Group
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.
|
|---|---|---|
|
Overall Study
Other
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Evaluation of the Immunogenicity, Safety and Reactogenicity of the Combined DTPa-IPV Vaccine in Healthy Infants
Baseline characteristics by cohort
| Measure |
Infanrix-IPV Group
n=224 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
|
Infanrix + IMOVAX Polio Group
n=228 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.
|
Total
n=452 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.8 Weeks
STANDARD_DEVIATION 0.9 • n=93 Participants
|
8.8 Weeks
STANDARD_DEVIATION 0.91 • n=4 Participants
|
8.8 Weeks
STANDARD_DEVIATION 0.63 • n=27 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=93 Participants
|
110 Participants
n=4 Participants
|
222 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=93 Participants
|
118 Participants
n=4 Participants
|
230 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: One month (Month 5) post-primary vaccination coursePopulation: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
A seroprotected subject was defined as a vaccinated subject with anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) the cut-off value of 0.1 international units/milliliter (IU//mL).
Outcome measures
| Measure |
Infanrix-IPV Group
n=204 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
|
Infanrix + IMOVAX Polio Group
n=211 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.
|
|---|---|---|
|
Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T)
Anti-D
|
204 Subjects
|
211 Subjects
|
|
Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T)
Anti-T
|
204 Subjects
|
211 Subjects
|
PRIMARY outcome
Timeframe: One month (Month 5) post-primary vaccination coursePopulation: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
A seroprotected subject was defined as a vaccinated subject with anti-poliovirus types 1, 2 and 3 (Anti-Polio 1, 2 and 3) antibody titers greater than or equal to (≥) the cut-off value of 8.
Outcome measures
| Measure |
Infanrix-IPV Group
n=204 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
|
Infanrix + IMOVAX Polio Group
n=207 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.
|
|---|---|---|
|
Number of Seroprotected Subjects Against Poliovirus (Anti-polio) Types 1, 2 and 3
Anti-polio 1 (N=204; 207)
|
204 Subjects
|
207 Subjects
|
|
Number of Seroprotected Subjects Against Poliovirus (Anti-polio) Types 1, 2 and 3
Anti-polio 2 (N=204; 205)
|
204 Subjects
|
204 Subjects
|
|
Number of Seroprotected Subjects Against Poliovirus (Anti-polio) Types 1, 2 and 3
Anti-polio 3 (N=204; 207)
|
203 Subjects
|
206 Subjects
|
PRIMARY outcome
Timeframe: One month (Month 5) post-primary vaccination coursePopulation: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Vaccine response was defined as: - for initially seronegative subjects, antibody concentrations ≥ 5 EL.U/mL one month after third vaccine dose; - for initially seropositive subjects, at least maintenance of pre-vaccination antibody concentrations one month after third vaccine dose.
Outcome measures
| Measure |
Infanrix-IPV Group
n=202 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
|
Infanrix + IMOVAX Polio Group
n=211 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.
|
|---|---|---|
|
Number of Subjects With a Vaccine Response for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA)
Anti-PT
|
200 Subjects
|
206 Subjects
|
|
Number of Subjects With a Vaccine Response for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA)
Anti-FHA
|
201 Subjects
|
209 Subjects
|
|
Number of Subjects With a Vaccine Response for Anti-pertussis Toxoid (Anti-PT), Anti-pertactin (Anti-PRN) and Anti-filamentous Haemagglutinin (Anti-FHA)
Anti-PRN
|
202 Subjects
|
210 Subjects
|
PRIMARY outcome
Timeframe: One month (Month 5) post-primary vaccination coursePopulation: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Vaccine response to pertussis toxoid (PT), pertactin (PRN) and filamentous haemagglutinin (FHA) was defined as the appearance of antibodies in subjects who were initially (i.e. before vaccination) seronegative (i.e. with concentrations \< 5 EL.U/mL), or at least as the maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ 5 EL.U/mL value).
Outcome measures
| Measure |
Infanrix-IPV Group
n=202 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
|
Infanrix + IMOVAX Polio Group
n=211 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.
|
|---|---|---|
|
Number of Subjects With Vaccine Response to Pertussis Toxoid (PT), Pertactin (PRN) and Filamentous Haemagglutinin (FHA) Antigens
Anti-PT (N=200; 209)
|
200 Subjects
|
206 Subjects
|
|
Number of Subjects With Vaccine Response to Pertussis Toxoid (PT), Pertactin (PRN) and Filamentous Haemagglutinin (FHA) Antigens
Anti-FHA (N=202; 211)
|
201 Subjects
|
209 Subjects
|
|
Number of Subjects With Vaccine Response to Pertussis Toxoid (PT), Pertactin (PRN) and Filamentous Haemagglutinin (FHA) Antigens
Anti-PRN (N=202; 211)
|
202 Subjects
|
210 Subjects
|
SECONDARY outcome
Timeframe: Before (Pre) and one month after (Post) the primary vaccination coursePopulation: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
A seroprotected subject was defined as a vaccinated subject with anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations greater than or equal to (≥) the cut-off value of 1 international units/milliliter (IU//mL).
Outcome measures
| Measure |
Infanrix-IPV Group
n=204 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
|
Infanrix + IMOVAX Polio Group
n=212 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.
|
|---|---|---|
|
Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T)
Anti-D, PRE (N=202; 212)
|
0 Subjects
|
0 Subjects
|
|
Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T)
Anti-D, POST (N=204; 211)
|
194 Subjects
|
187 Subjects
|
|
Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T)
Anti-T, PRE (N=202; 212)
|
1 Subjects
|
1 Subjects
|
|
Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T)
Anti-T, POST (N=204; 211)
|
204 Subjects
|
208 Subjects
|
SECONDARY outcome
Timeframe: Before (Pre) and one month after (Post) the primary vaccination coursePopulation: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per millilitre (mIU/mL).
Outcome measures
| Measure |
Infanrix-IPV Group
n=204 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
|
Infanrix + IMOVAX Polio Group
n=212 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.
|
|---|---|---|
|
Concentration of Antibodies Against Diphteria (Anti-D) and Tetanus (Anti-T)
Anti-D, PRE (N=202; 212)
|
0.052 IU/mL
Interval 0.051 to 0.054
|
0.053 IU/mL
Interval 0.05 to 0.055
|
|
Concentration of Antibodies Against Diphteria (Anti-D) and Tetanus (Anti-T)
Anti-D, POST (N=204; 211)
|
4.333 IU/mL
Interval 3.902 to 4.813
|
2.63 IU/mL
Interval 2.36 to 2.932
|
|
Concentration of Antibodies Against Diphteria (Anti-D) and Tetanus (Anti-T)
Anti-T, PRE (N=202; 212)
|
0.059 IU/mL
Interval 0.055 to 0.064
|
0.06 IU/mL
Interval 0.056 to 0.065
|
|
Concentration of Antibodies Against Diphteria (Anti-D) and Tetanus (Anti-T)
Anti-T, POST (N=204; 211)
|
10.306 IU/mL
Interval 9.5 to 11.18
|
7.139 IU/mL
Interval 6.512 to 7.826
|
SECONDARY outcome
Timeframe: Before (Pre) and one month after (Post) the primary vaccination coursePopulation: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Titers for anti-polio 1, 2 and 3 are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was greater than or equal to (≥) 8.
Outcome measures
| Measure |
Infanrix-IPV Group
n=204 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
|
Infanrix + IMOVAX Polio Group
n=212 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.
|
|---|---|---|
|
Titers for Poliovirus Type 1, 2 and 3 Antibodies
Anti-polio 1, PRE (N=199; 212)
|
6.3 Titers
Interval 5.5 to 7.1
|
6.1 Titers
Interval 5.4 to 6.9
|
|
Titers for Poliovirus Type 1, 2 and 3 Antibodies
Anti-polio 1, POST (N=204; 207)
|
755.7 Titers
Interval 643.5 to 887.4
|
263 Titers
Interval 232.1 to 298.0
|
|
Titers for Poliovirus Type 1, 2 and 3 Antibodies
Anti-polio 2, PRE (N=202; 211)
|
5.8 Titers
Interval 5.2 to 6.5
|
6.5 Titers
Interval 5.8 to 7.3
|
|
Titers for Poliovirus Type 1, 2 and 3 Antibodies
Anti-polio 2, POST (N=204; 205)
|
704.7 Titers
Interval 599.5 to 828.4
|
267.6 Titers
Interval 233.4 to 306.8
|
|
Titers for Poliovirus Type 1, 2 and 3 Antibodies
Anti-polio 3, PRE (N=202; 212)
|
5 Titers
Interval 4.5 to 5.4
|
4.9 Titers
Interval 4.5 to 5.3
|
|
Titers for Poliovirus Type 1, 2 and 3 Antibodies
Anti-polio 3, POST (N=204; 207)
|
1209.5 Titers
Interval 1040.1 to 1406.5
|
438.3 Titers
Interval 383.1 to 501.3
|
SECONDARY outcome
Timeframe: Before (Pre) and one month after (Post) the primary vaccination coursePopulation: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per millilitre (EL.U/mL).
Outcome measures
| Measure |
Infanrix-IPV Group
n=204 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
|
Infanrix + IMOVAX Polio Group
n=212 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.
|
|---|---|---|
|
Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA)
Anti-PT, PRE (N=200; 210)
|
3 EL.U/mL
Interval 2.8 to 3.2
|
3.2 EL.U/mL
Interval 3.0 to 3.5
|
|
Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA)
Anti-PT, POST (N=204; 211)
|
63.3 EL.U/mL
Interval 58.7 to 68.2
|
55.6 EL.U/mL
Interval 50.9 to 60.7
|
|
Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA)
Anti-FHA, PRE (N=202; 212)
|
7.4 EL.U/mL
Interval 6.5 to 8.4
|
8.5 EL.U/mL
Interval 7.4 to 9.7
|
|
Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA)
Anti-FHA, POST (N=204; 211)
|
294.3 EL.U/mL
Interval 269.5 to 321.4
|
259.6 EL.U/mL
Interval 235.1 to 286.6
|
|
Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA)
Anti-PRN, PRE (N=202; 212)
|
2.7 EL.U/mL
Interval 2.5 to 2.8
|
2.7 EL.U/mL
Interval 2.6 to 2.9
|
|
Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Pertactin (Anti-PRN) and Filamentous Haemagglutinin (Anti-FHA)
Anti-PRN, POST (N=204; 211)
|
205 EL.U/mL
Interval 187.7 to 223.9
|
155.6 EL.U/mL
Interval 140.7 to 172.1
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination period, across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had the symptom sheet filled-in.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = crying when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Outcome measures
| Measure |
Infanrix-IPV Group
n=220 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
|
Infanrix + IMOVAX Polio Group
n=226 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.
|
|---|---|---|
|
Number of Subjects Reporting Solicited Local Symptoms
Any Pain
|
92 Subjects
|
96 Subjects
|
|
Number of Subjects Reporting Solicited Local Symptoms
Grade 3 Pain
|
5 Subjects
|
8 Subjects
|
|
Number of Subjects Reporting Solicited Local Symptoms
Any Redness
|
115 Subjects
|
116 Subjects
|
|
Number of Subjects Reporting Solicited Local Symptoms
Grade 3 Redness
|
22 Subjects
|
26 Subjects
|
|
Number of Subjects Reporting Solicited Local Symptoms
Any Swelling
|
74 Subjects
|
79 Subjects
|
|
Number of Subjects Reporting Solicited Local Symptoms
Grade 3 Swelling
|
17 Subjects
|
20 Subjects
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination period, across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available and who had the symptom sheet filled-in.
Assessed solicited general symptoms were drowsiness, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 Loss of appetite = not eating at all. Related = symptom symptoms considered by the investigator to have a causal relationship to vaccination.
Outcome measures
| Measure |
Infanrix-IPV Group
n=221 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
|
Infanrix + IMOVAX Polio Group
n=226 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.
|
|---|---|---|
|
Number of Subjects Reporting Solicited General Symptoms
Any Drowsiness
|
95 Subjects
|
99 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Grade 3 Drowsiness
|
4 Subjects
|
2 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Related Drowsiness
|
54 Subjects
|
53 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Any Fever (axillary)
|
63 Subjects
|
38 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Grade 3 Fever (axillary)
|
4 Subjects
|
1 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Related Fever (axillary)
|
45 Subjects
|
22 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Any Irritability
|
140 Subjects
|
139 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Grade Irritability
|
14 Subjects
|
10 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Related Irritability
|
85 Subjects
|
91 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Any Loss of appetite
|
84 Subjects
|
78 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Grade 3 Loss of appetite
|
1 Subjects
|
0 Subjects
|
|
Number of Subjects Reporting Solicited General Symptoms
Related Loss of appetite
|
50 Subjects
|
46 Subjects
|
SECONDARY outcome
Timeframe: During the 31-day (Days 0-30) post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
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 Group
n=224 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
|
Infanrix + IMOVAX Polio Group
n=228 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.
|
|---|---|---|
|
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
|
135 Subjects
|
138 Subjects
|
SECONDARY outcome
Timeframe: During the entire study period (from Month 0 up to Month 5)Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available.
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 Group
n=224 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
|
Infanrix + IMOVAX Polio Group
n=228 Participants
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.
|
|---|---|---|
|
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
|
15 Subjects
|
17 Subjects
|
Adverse Events
Infanrix-IPV Group
Serious events: 15 serious events
Other events: 200 other events
Deaths: 0 deaths
Infanrix + IMOVAX Polio Group
Serious events: 17 serious events
Other events: 196 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Infanrix-IPV Group
n=224 participants at risk
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
|
Infanrix + IMOVAX Polio Group
n=228 participants at risk
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.
|
|---|---|---|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
0.00%
0/224 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
0.44%
1/228 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
|
Nervous system disorders
Febrile convulsion
|
0.45%
1/224 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
0.00%
0/228 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
|
General disorders
Pyrexia
|
0.89%
2/224 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
0.44%
1/228 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/224 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
0.88%
2/228 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.45%
1/224 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
0.00%
0/228 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
|
Infections and infestations
Bronchiolitis
|
3.1%
7/224 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
1.3%
3/228 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
|
Infections and infestations
Pneumonia
|
1.8%
4/224 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
2.2%
5/228 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
|
Infections and infestations
Urinary tract infection
|
1.3%
3/224 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
2.2%
5/228 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
|
Infections and infestations
Gastroenteritis
|
0.89%
2/224 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
0.88%
2/228 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
|
Infections and infestations
Kawasaki's disease
|
0.00%
0/224 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
0.44%
1/228 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
|
Infections and infestations
Otitis media acute
|
0.45%
1/224 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
0.00%
0/228 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
|
Infections and infestations
Pyelonephritis acute
|
0.45%
1/224 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
0.00%
0/228 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
|
Infections and infestations
Sepsis
|
0.45%
1/224 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
0.00%
0/228 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
Other adverse events
| Measure |
Infanrix-IPV Group
n=224 participants at risk
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' combined Infanrix™-IPV (DTPa-IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral thigh.
|
Infanrix + IMOVAX Polio Group
n=228 participants at risk
Healthy male or female subjects between and including 8 to 12 weeks (56-90 days) of age at the time of the first vaccination, who were born after a gestation period of 36 to 42 weeks, received 3 doses of the GSK Biologicals' Infanrix™ (DTPa) vaccine co-administered with Sanofi-Pasteur's IMOVAX Polio® (IPV) vaccine at 2, 4 and 6 months of age, intramuscularly into the antero-lateral sides of opposite thighs.
|
|---|---|---|
|
Infections and infestations
Bronchiolitis
|
6.2%
14/224 • Number of events 14 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
3.1%
7/228 • Number of events 11 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
|
Infections and infestations
Bronchitis
|
3.1%
7/224 • Number of events 8 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
5.3%
12/228 • Number of events 12 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
37.5%
84/224 • Number of events 130 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
34.2%
78/228 • Number of events 115 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
7.1%
16/224 • Number of events 18 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
7.5%
17/228 • Number of events 20 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
|
Gastrointestinal disorders
Diarrhoea
|
5.4%
12/224 • Number of events 16 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
3.5%
8/228 • Number of events 8 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
51.3%
115/224 • Number of events 212 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
50.9%
116/228 • Number of events 209 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
|
Infections and infestations
Gastroenteritis
|
4.5%
10/224 • Number of events 11 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
5.7%
13/228 • Number of events 14 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
|
Psychiatric disorders
Irritability
|
62.5%
140/224 • Number of events 238 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
61.0%
139/228 • Number of events 241 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
|
General disorders
Pain
|
41.1%
92/224 • Number of events 164 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
42.1%
96/228 • Number of events 161 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
|
General disorders
Pyrexia
|
33.0%
74/224 • Number of events 91 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
17.5%
40/228 • Number of events 48 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
|
Nervous system disorders
Somnolence
|
42.4%
95/224 • Number of events 152 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
43.4%
99/228 • Number of events 161 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
|
General disorders
Swelling
|
33.0%
74/224 • Number of events 114 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
34.6%
79/228 • Number of events 129 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
|
Infections and infestations
Upper respiratory tract infection
|
32.1%
72/224 • Number of events 98 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
26.8%
61/228 • Number of events 88 • 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 and SAEs during the entire study period (from Month 0 up to Month 5)
|
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