Trial Outcomes & Findings for V260 Study: Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants (V260-010) (NCT NCT00258154)
NCT ID: NCT00258154
Last Updated: 2015-10-06
Results Overview
Geometric Mean Titer (GMT)/antibody responses to RotaTeq™ and INFANRIX™ in relation to anti-hepatitis B surface antigen HBsAg at start of a 3-dose regimen
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
403 participants
Primary outcome timeframe
Day 1 of a 3-dose regimen
Results posted on
2015-10-06
Participant Flow
Enrollment occurred at 26 sites in Austria, Belgium, and Germany from 22Feb2006 (first subject in) to 13Nov2006 (last subject out). Cutoff date for all clinical and laboratory data from the Case Report Forms in-house was 08Jun2007. Access to the clinical database was granted on 15Jun2007.
Excluded from randomization were patients with history of congenital abdominal disorders, intussusception, or abdominal surgery; history of known prior rotavirus disease, chronic diarrhea, or failure to thrive, clinical evidence of active gastrointestinal illness and those with fever, a rectal temperature \>38.1°C (\>100.5°F) at time of immunization.
Participant milestones
| Measure |
RotaTeq™ + INFANRIX Hexa
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
201
|
202
|
|
Overall Study
Vaccinated at Visit 1
|
201
|
202
|
|
Overall Study
Vaccinated at Visit 2
|
198
|
198
|
|
Overall Study
Vaccinated at Visit 3
|
195
|
197
|
|
Overall Study
COMPLETED
|
192
|
195
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
| Measure |
RotaTeq™ + INFANRIX Hexa
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
4
|
|
Overall Study
Patient Moved
|
3
|
1
|
Baseline Characteristics
V260 Study: Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants (V260-010)
Baseline characteristics by cohort
| Measure |
RotaTeq™ + INFANRIX Hexa
n=201 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=202 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
Total
n=403 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
5 Weeks of Age and Under
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Age, Customized
6-12 Weeks of Age
|
199 participants
n=99 Participants
|
202 participants
n=107 Participants
|
401 participants
n=206 Participants
|
|
Age, Customized
Over 12 Weeks of Age
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
104 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
206 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=99 Participants
|
100 Participants
n=107 Participants
|
197 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multi-Racial
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
186 Participants
n=99 Participants
|
187 Participants
n=107 Participants
|
373 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1 of a 3-dose regimenPopulation: All per-protocol subjects were included in the analysis of primary endpoints for polyribosylribitol phosphate (PRP) and hepatitis B surface antigen (HBsAg). Subjects listed in the Protocol Violation Memo were excluded from the immunogenicity analysis; N analyzed = number of subjects contributing to per protocol analysis.
Geometric Mean Titer (GMT)/antibody responses to RotaTeq™ and INFANRIX™ in relation to anti-hepatitis B surface antigen HBsAg at start of a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=185 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=184 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg, Predose 1
|
12.7 mIU/mL
Interval 10.0 to 16.1
|
13.5 mIU/mL
Interval 10.5 to 17.4
|
PRIMARY outcome
Timeframe: 42 days after 3-dose regimenPopulation: All per-protocol subjects were included in the analysis of primary endpoints for polyribosylribitol phosphate (PRP) and hepatitis B surface antigen (HBsAg). Subjects listed in the Protocol Violation Memo were excluded from the immunogenicity analysis; N analyzed = number of subjects contributing to per protocol analysis.
GMT/antibody responses to RotaTeq™ and INFANRIX™ in relation to anti-hepatitis B surface antigen HBsAg at 42 days after 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=184 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=184 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg , at 42 Days After a 3-dose Regimen
|
227.8 mIU/mL
Interval 189.2 to 274.2
|
261.0 mIU/mL
Interval 219.3 to 310.7
|
PRIMARY outcome
Timeframe: Day 1 of 3-dose regimenPopulation: All per-protocol subjects were included in the analysis of primary endpoints for polyribosylribitol phosphate (PRP) and hepatitis B surface antigen (HBsAg). Subjects listed in the Protocol Violation Memo were excluded from the immunogenicity analysis; N analyzed = number of subjects contributing to per protocol analysis.
GMT/antibody responses to RotaTeq™ and INFANRIX™ hexa in relation to serum anti-polyribosylribitol phosphate PRP at start of 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=184 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=184 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP, Predose 1
|
204.3 ng/mL
Interval 181.6 to 229.8
|
189.7 ng/mL
Interval 170.0 to 211.8
|
PRIMARY outcome
Timeframe: 42 days after a 3-dose regimenPopulation: All per-protocol subjects were included in the analysis of primary endpoints for polyribosylribitol phosphate (PRP) and hepatitis B surface antigen (HBsAg). Subjects listed in the Protocol Violation Memo were excluded from the immunogenicity analysis; N analyzed = number of subjects contributing to per protocol analysis.
GMT/antibody responses to RotaTeq™ and INFANRIX™ hexa in relation to serum anti-polyribosylribitol phosphate PRP at 42 days after a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=185 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=184 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP at 42 Days After a 3-dose Regimen
|
1316 ng/mL
Interval 1081.0 to 1603.0
|
1400 ng/mL
Interval 1172.0 to 1672.0
|
SECONDARY outcome
Timeframe: Predose (Day 1 of a 3-dose regimen)Population: Per Protocol Analysis on Subset A (subjects with even allocation numbers)
GMT of Poliovirus Type 1 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=97 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=67 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeq™, Predose 1
|
15.1 Dilution Unit
Interval 11.3 to 20.2
|
18.3 Dilution Unit
Interval 12.9 to 26.0
|
SECONDARY outcome
Timeframe: 42 days after a 3-dose regimenPopulation: Per Protocol Analysis on Subset A (subjects with even allocation numbers)
GMT of Poliovirus Type 1 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa , 42 days after a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=95 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=68 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen
|
94.9 Dilution Unit
Interval 68.9 to 130.6
|
160.2 Dilution Unit
Interval 113.6 to 225.8
|
SECONDARY outcome
Timeframe: Pre-dose (Day 1 of a 3-dose regimen)Population: Per Protocol Analysis on Subset A (subjects with even allocation numbers)
GMT of Poliovirus Type 2 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=97 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=67 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 2 When Administered Concomitantly With RotaTeq™, Predose 1
|
12.8 Dilution Unit
Interval 9.8 to 16.8
|
12.7 Dilution Unit
Interval 9.2 to 17.6
|
SECONDARY outcome
Timeframe: 42 days after in a 3-dose regimenPopulation: Per Protocol Analysis on Subset A (subjects with even allocation numbers)
GMT of Poliovirus Type 2 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=95 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=68 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 2 When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen
|
63.1 Dilution Unit
Interval 45.8 to 86.8
|
69.4 Dilution Unit
Interval 48.6 to 99.2
|
SECONDARY outcome
Timeframe: Predose (Day 1 of a 3-dose regimen)Population: Per Protocol Analysis on Subset A (subjects with even allocation numbers)
GMT of Poliovirus Type 3 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=97 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=67 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 3 When Administered Concomitantly With RotaTeq™, Predose 1
|
9.0 Dilution Unit
Interval 6.8 to 12.1
|
7.8 Dilution Unit
Interval 5.7 to 10.7
|
SECONDARY outcome
Timeframe: 42 days after a 3-dose regimenPopulation: Per Protocol Analysis on Subset A (subjects with even allocation numbers)
GMT of Poliovirus Type 3 in subjects with even allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=95 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=68 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 3 When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen
|
222.9 Dilution Unit
Interval 153.9 to 322.8
|
263.9 Dilution Unit
Interval 173.5 to 401.5
|
SECONDARY outcome
Timeframe: Predose (Day 1 of a 3-dose regimen)Population: Per Protocol Analysis on Subset B (subjects with odd allocation number)
GMT of diphtheria toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=78 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=104 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Diphtheria Toxoid When Administered Concomitantly With RotaTeq™, Predose 1
|
0.0 IU/mL
Interval 0.0 to 0.0
|
0.0 IU/mL
Interval 0.0 to 0.1
|
SECONDARY outcome
Timeframe: 42 days after a 3-dose regimenPopulation: Per Protocol Analysis on Subset B (subjects with odd allocation number)
GMT of diphtheria toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=73 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=100 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Diphtheria Toxoid When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen
|
0.1 IU/mL
Interval 0.1 to 0.1
|
0.1 IU/mL
Interval 0.1 to 0.1
|
SECONDARY outcome
Timeframe: Predose (Day 1 of a 3-dose regimen)Population: Per Protocol Analysis on Subset B (subjects with odd allocation numbers)
GMT of tetanus toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=76 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=104 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Tetanus Toxoid When Administered Concomitantly With RotaTeq™, Predose 1
|
0.2 IU/mL
Interval 0.2 to 0.4
|
0.3 IU/mL
Interval 0.2 to 0.5
|
SECONDARY outcome
Timeframe: 42 days after a 3-dose regimenPopulation: Per Protocol Analysis on Subset B (subjects with odd allocation numbers
GMT of tetanus toxoid in subjects with odd allocation numbers, receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=72 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=101 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Tetanus Toxoid When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen
|
1.4 Dilution Unit
Interval 1.1 to 1.7
|
1.5 Dilution Unit
Interval 1.2 to 1.8
|
SECONDARY outcome
Timeframe: Predose (Day 1 of a 3-dose regimen)Population: Per Protocol Analysis
GMT of pertussis FHA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=180 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=177 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis FHA When Administered Concomitantly With RotaTeq™, Predose 1
|
4.3 EU/mL
Interval 3.2 to 5.9
|
3.7 EU/mL
Interval 2.7 to 5.1
|
SECONDARY outcome
Timeframe: 42 days after a 3-dose regimenPopulation: Per Protocol Analysis
GMT of pertussis FHA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=177 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=176 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis FHA When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen
|
74 EU/mL
Interval 67.2 to 81.4
|
78.8 EU/mL
Interval 71.6 to 86.7
|
SECONDARY outcome
Timeframe: Predose (Day 1 of a 3-dose regimen)Population: Per Protocol Analysis
GMT of pertussis Pertactin in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=180 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=177 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Pertactin When Administered Concomitantly With RotaTeq™, Predose 1
|
1.0 EU/mL
Interval 0.7 to 1.4
|
1.0 EU/mL
Interval 0.7 to 1.4
|
SECONDARY outcome
Timeframe: 42 days after a 3-dose regimenPopulation: Per Protocol Analysis
GMT of pertussis Pertactin in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=177 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=177 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Pertactin When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen
|
109.6 EU/mL
Interval 96.7 to 124.1
|
108.2 EU/mL
Interval 93.5 to 125.1
|
SECONDARY outcome
Timeframe: Predose (Day 1 of a 3-dose regimen)Population: Per Protocol Analysis
GMT of pertussis toxoid in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=180 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=177 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Toxoid When Administered Concomitantly With RotaTeq™, Predose 1
|
0.2 EU/mL
Interval 0.2 to 0.2
|
0.2 EU/mL
Interval 0.2 to 0.3
|
SECONDARY outcome
Timeframe: 42 days after a 3-dose regimenPopulation: Per Protocol Analysis
GMT of pertussis toxoid in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=177 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=176 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Toxoid When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen
|
28.0 EU/mL
Interval 24.8 to 31.7
|
28.3 EU/mL
Interval 25.2 to 31.8
|
SECONDARY outcome
Timeframe: Predose (Day 1 of a 3-dose regimen)Population: Per Protocol Analysis
GMT of serotype G1 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=184 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=182 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, Predose 1
|
23.3 GMT
Interval 19.6 to 27.7
|
24 GMT
Interval 20.3 to 28.4
|
SECONDARY outcome
Timeframe: 42 days after a 3-dose regimenPopulation: Per Protocol Analysis
GMT of serotype G1 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=184 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=183 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, 42 Days After a 3-dose Regimen
|
115.7 GMT
Interval 94.2 to 142.1
|
8.2 GMT
Interval 7.2 to 9.3
|
SECONDARY outcome
Timeframe: Predose (Day 1 of a 3-dose regimen)Population: Per Protocol Analysis
GMT of serotype G2 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa at the start of a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=184 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=181 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, Predose 1
|
11.7 GMT
Interval 10.2 to 13.4
|
12.2 GMT
Interval 10.6 to 14.1
|
SECONDARY outcome
Timeframe: 42 days after a 3-dose regimenPopulation: Per Protocol Analysis
GMT of serotype G2 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=184 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=183 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen
|
16.6 GMT
Interval 14.0 to 19.7
|
6.1 GMT
Interval 5.6 to 6.6
|
SECONDARY outcome
Timeframe: Predose (Day 1 of a 3-dose regimen)Population: Per Protocol Analysis
GMT of serotype G3 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=184 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=182 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1
|
11.5 GMT
Interval 9.7 to 13.6
|
9.8 GMT
Interval 8.5 to 11.3
|
SECONDARY outcome
Timeframe: 42 days after a 3-dose regimenPopulation: Per Protocol Analysis
GMT of serotype G3 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=184 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=183 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen
|
28.0 GMT
Interval 23.4 to 33.5
|
5.8 GMT
Interval 5.5 to 6.3
|
SECONDARY outcome
Timeframe: Predose (Day 1 of a 3-dose regimen)Population: Per Protocol Analysis
GMT of serotype G4 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=184 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=182 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1
|
15.5 GMT
Interval 12.9 to 18.6
|
17.9 GMT
Interval 15.0 to 21.3
|
SECONDARY outcome
Timeframe: 42 days after a 3-dose regimenPopulation: Per Protocol Analysis
GMT of serotype G4 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=184 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=183 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen
|
33.6 GMT
Interval 28.6 to 39.6
|
7.1 GMT
Interval 6.5 to 7.7
|
SECONDARY outcome
Timeframe: Predose (Day 1 of a 3-dose regimen)Population: Per Protocol Analysis
GMT of serotype P1A in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=184 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=181 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1
|
36.8 GMT
Interval 30.9 to 44.0
|
33.2 GMT
Interval 28.1 to 39.3
|
SECONDARY outcome
Timeframe: 42 days after a 3-dose regimenPopulation: Per Protocol Analysis
GMT of serotype P1A in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=184 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=183 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen
|
74.5 GMT
Interval 60.7 to 91.3
|
10.7 GMT
Interval 9.2 to 12.4
|
SECONDARY outcome
Timeframe: Predose (Day 1 of a 3-dose regimen)Population: Per Protocol Analysis
GMT of serum anti-rotavirus IgA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=184 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=181 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Serum Neutralizing Antibody (SNA) Response to Serum Anti-rotavirus IgA in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1
|
0.1 GMT
Interval 0.1 to 0.2
|
0.1 GMT
Interval 0.1 to 0.2
|
SECONDARY outcome
Timeframe: 42 days after a 3-dose regimenPopulation: Per Protocol Analysis
GMT of serum anti-rotavirus IgA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen
Outcome measures
| Measure |
RotaTeq™ + INFANRIX Hexa
n=184 Participants
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=183 Participants
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Serum Neutralizing Antibody (SNA) Response to Serum Anti-rotavirus IgA in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen
|
160.0 GMT
Interval 119.0 to 215.3
|
0.2 GMT
Interval 0.1 to 0.2
|
Adverse Events
RotaTeq™ + INFANRIX Hexa
Serious events: 3 serious events
Other events: 166 other events
Deaths: 0 deaths
Placebo + INFANRIX Hexa
Serious events: 6 serious events
Other events: 167 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RotaTeq™ + INFANRIX Hexa
n=201 participants at risk
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=202 participants at risk
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal symptom
|
0.00%
0/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.50%
1/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.50%
1/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.50%
1/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
General disorders
Pyrexia
|
0.00%
0/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.99%
2/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.50%
1/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.50%
1/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.50%
1/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.50%
1/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.50%
1/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.50%
1/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.50%
1/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.00%
0/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.50%
1/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Psychiatric disorders
Crying
|
0.00%
0/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.50%
1/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.50%
1/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
Other adverse events
| Measure |
RotaTeq™ + INFANRIX Hexa
n=201 participants at risk
Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
|
Placebo + INFANRIX Hexa
n=202 participants at risk
For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
|
|---|---|---|
|
Eye disorders
Conjunctivitis
|
4.0%
8/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.5%
3/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
8/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
4.0%
8/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Gastrointestinal disorders
Diarrhoea
|
28.4%
57/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
32.2%
65/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Gastrointestinal disorders
Enteritis
|
13.4%
27/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
13.9%
28/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Gastrointestinal disorders
Flatulence
|
4.5%
9/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
2.5%
5/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Gastrointestinal disorders
Vomiting
|
30.8%
62/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
23.8%
48/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
General disorders
Irritability
|
3.5%
7/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
2.0%
4/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
General disorders
Pain
|
2.0%
4/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.99%
2/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
General disorders
Pyrexia
|
52.7%
106/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
56.4%
114/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
8/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
3.0%
6/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Oral candidiasis
|
1.5%
3/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
2.5%
5/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Respiratory tract infection
|
2.0%
4/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
1.5%
3/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Rhinitis
|
5.5%
11/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
8.4%
17/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.00%
2/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
2.5%
5/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Infections and infestations
Viral infection
|
2.5%
5/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.99%
2/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Nervous system disorders
Somnolence
|
3.5%
7/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
2.0%
4/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Psychiatric disorders
Crying
|
3.0%
6/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
3.5%
7/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Psychiatric disorders
Restlessness
|
5.5%
11/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
7.9%
16/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
8/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
5.4%
11/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
4/201 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
0.50%
1/202 • Patients in this study were followed for all adverse experiences, for 14 days following each study vaccination.
The number of patients listed in the Adverse Event tables is the number of patients who received study treatment. Although a patient may have had two or more clinical adverse experiences the patient is counted only once in a category. The same patient may appear in different categories.
|
Additional Information
Executive Vice President, Clinical and Quantitative Sciences
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck 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