Rotavirus Disease
Conditions
Brief summary
The study is being conducted to demonstrate that the vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with INFANRIX(tm)hexa without impairing the safety and immunogenicity of either vaccine.
Interventions
3 doses of rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2
BIOLOGICALComparator: placebo
3 doses of placebo to rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2
BIOLOGICALComparator: Infanrix(tm) Hexa
3 doses of oral Infanrix(tm) Hexa on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Healthy infant per investigator, 6 through 12 weeks of age
Exclusion criteria
* History of congenital abdominal disorders, intussusception, or abdominal surgery * Known or suspected impairment of immunological function * Known hypersensitivity to any component of the rotavirus vaccine * Prior administration of any rotavirus vaccine * Known hypersensitivity or contraindication to any component of INFANRIX(tm) hexa * Any infant born from a known HBsAg-positive mother * Prior administration of any oral polio vaccine * Receipt of one or more doses of inactivated poliovirus vaccine, diptheria, tetanus and acellular pertussis vaccine, diptheria, tetanus and pertussis vaccine, Haemophilus influenzae type b vaccine, or any hepatitis B vaccine prior to the first vaccination, or receipt of any vaccines with these antigens at any time during the course of the study * Fever, with a rectal temperature greater than or equal to 38.1 degree C (greater than or equal to 100.5 degree F) at the time of immunization * History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive * Clinical evidence of active gastrointestinal illness * Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 2 weeks prior to vaccination * Infants residing in a household with an immunocompromised person * Prior receipt of a blood transfusion or blood products * Participation in another clinical study within 42 days before the beginning or anytime during the duration of the current clinical study * Any infant who cannot be adequately followed for safety by a contact visit * History of seizure disorders or prior history followed for safety by a contact visit * Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg, Predose 1 | Day 1 of a 3-dose regimen | 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 |
| Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg , at 42 Days After a 3-dose Regimen | 42 days after 3-dose regimen | GMT/antibody responses to RotaTeq™ and INFANRIX™ in relation to anti-hepatitis B surface antigen HBsAg at 42 days after 3-dose regimen |
| Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP, Predose 1 | Day 1 of 3-dose regimen | GMT/antibody responses to RotaTeq™ and INFANRIX™ hexa in relation to serum anti-polyribosylribitol phosphate PRP at start of 3-dose regimen |
| Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP at 42 Days After a 3-dose Regimen | 42 days after a 3-dose regimen | GMT/antibody responses to RotaTeq™ and INFANRIX™ hexa in relation to serum anti-polyribosylribitol phosphate PRP at 42 days after a 3-dose regimen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 3 When Administered Concomitantly With RotaTeq™, Predose 1 | Predose (Day 1 of a 3-dose regimen) | 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 |
| 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 | 42 days after a 3-dose regimen | 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 |
| Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Diphtheria Toxoid When Administered Concomitantly With RotaTeq™, Predose 1 | Predose (Day 1 of a 3-dose regimen) | 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 |
| 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 | 42 days after a 3-dose regimen | 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 |
| Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Tetanus Toxoid When Administered Concomitantly With RotaTeq™, Predose 1 | Predose (Day 1 of a 3-dose regimen) | 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 |
| 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 | 42 days after a 3-dose regimen | 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 |
| Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis FHA When Administered Concomitantly With RotaTeq™, Predose 1 | Predose (Day 1 of a 3-dose regimen) | 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 |
| 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 | 42 days after a 3-dose regimen | GMT of pertussis FHA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen |
| Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Pertactin When Administered Concomitantly With RotaTeq™, Predose 1 | Predose (Day 1 of a 3-dose regimen) | 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 |
| 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 | 42 days after a 3-dose regimen | GMT of pertussis Pertactin in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen |
| Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Toxoid When Administered Concomitantly With RotaTeq™, Predose 1 | Predose (Day 1 of a 3-dose regimen) | 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 |
| 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 | 42 days after a 3-dose regimen | GMT of pertussis toxoid in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen |
| Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeq™, Predose 1 | Predose (Day 1 of a 3-dose regimen) | 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 |
| Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, 42 Days After a 3-dose Regimen | 42 days after a 3-dose regimen | GMT of serotype G1 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen |
| Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, Predose 1 | Predose (Day 1 of a 3-dose regimen) | 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 |
| Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen | 42 days after a 3-dose regimen | GMT of serotype G2 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen |
| Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1 | Predose (Day 1 of a 3-dose regimen) | GMT of serotype G3 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1 |
| Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen | 42 days after a 3-dose regimen | GMT of serotype G3 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen |
| Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1 | Predose (Day 1 of a 3-dose regimen) | GMT of serotype G4 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1 |
| Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen | 42 days after a 3-dose regimen | GMT of serotype G4 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen |
| Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1 | Predose (Day 1 of a 3-dose regimen) | GMT of serotype P1A in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1 |
| Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen | 42 days after a 3-dose regimen | GMT of serotype P1A in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen |
| Serum Neutralizing Antibody (SNA) Response to Serum Anti-rotavirus IgA in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1 | Predose (Day 1 of a 3-dose regimen) | GMT of serum anti-rotavirus IgA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1 |
| 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 | 42 days after a 3-dose regimen | 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 |
| Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, Predose 1 | Predose (Day 1 of a 3-dose regimen) | 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 |
| 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 | 42 days after a 3-dose regimen | 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 |
| Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 2 When Administered Concomitantly With RotaTeq™, Predose 1 | Pre-dose (Day 1 of a 3-dose regimen) | 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 |
| 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 | 42 days after in a 3-dose regimen | 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 |
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| RotaTeq™ + INFANRIX Hexa Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart. | 201 |
| 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. | 202 |
| Total | 403 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Patient Moved | 3 | 1 |
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | RotaTeq™ + INFANRIX Hexa | Placebo + INFANRIX Hexa | Total |
|---|---|---|---|
| Age, Customized 5 Weeks of Age and Under | 1 participants | 0 participants | 1 participants |
| Age, Customized 6-12 Weeks of Age | 199 participants | 202 participants | 401 participants |
| Age, Customized Over 12 Weeks of Age | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 4 Participants | 2 Participants | 6 Participants |
| Race/Ethnicity, Customized Black | 10 Participants | 11 Participants | 21 Participants |
| Race/Ethnicity, Customized Multi-Racial | 1 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 186 Participants | 187 Participants | 373 Participants |
| Sex: Female, Male Female | 104 Participants | 102 Participants | 206 Participants |
| Sex: Female, Male Male | 97 Participants | 100 Participants | 197 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 166 / 201 | 167 / 202 |
| serious Total, serious adverse events | 3 / 201 | 6 / 202 |
Outcome results
Primary
Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg , at 42 Days After a 3-dose Regimen
GMT/antibody responses to RotaTeq™ and INFANRIX™ in relation to anti-hepatitis B surface antigen HBsAg at 42 days after 3-dose regimen
Time frame: 42 days after 3-dose regimen
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | 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 |
| Placebo + INFANRIX Hexa | Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg , at 42 Days After a 3-dose Regimen | 261.0 mIU/mL |
p-value: <0.00195% CI: [-3.7, 3.6]Miettinen and Nurminen's
Primary
Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg, Predose 1
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
Time frame: Day 1 of a 3-dose regimen
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg, Predose 1 | 12.7 mIU/mL |
| Placebo + INFANRIX Hexa | Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg, Predose 1 | 13.5 mIU/mL |
Primary
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP at 42 Days After a 3-dose Regimen
GMT/antibody responses to RotaTeq™ and INFANRIX™ hexa in relation to serum anti-polyribosylribitol phosphate PRP at 42 days after a 3-dose regimen
Time frame: 42 days after a 3-dose regimen
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP at 42 Days After a 3-dose Regimen | 1316 ng/mL |
| Placebo + INFANRIX Hexa | Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP at 42 Days After a 3-dose Regimen | 1400 ng/mL |
p-value: 0.01595% CI: [-9.3, 1.3]Miettinen and Nurminen's
Primary
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP, Predose 1
GMT/antibody responses to RotaTeq™ and INFANRIX™ hexa in relation to serum anti-polyribosylribitol phosphate PRP at start of 3-dose regimen
Time frame: Day 1 of 3-dose regimen
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP, Predose 1 | 204.3 ng/mL |
| Placebo + INFANRIX Hexa | Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP, Predose 1 | 189.7 ng/mL |
Secondary
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
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
Time frame: 42 days after a 3-dose regimen
Population: Per Protocol Analysis on Subset B (subjects with odd allocation number)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | 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 |
| Placebo + INFANRIX Hexa | 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 |
Secondary
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Diphtheria Toxoid When Administered Concomitantly With RotaTeq™, Predose 1
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
Time frame: Predose (Day 1 of a 3-dose regimen)
Population: Per Protocol Analysis on Subset B (subjects with odd allocation number)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Diphtheria Toxoid When Administered Concomitantly With RotaTeq™, Predose 1 | 0.0 IU/mL |
| Placebo + INFANRIX Hexa | Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Diphtheria Toxoid When Administered Concomitantly With RotaTeq™, Predose 1 | 0.0 IU/mL |
Secondary
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
GMT of pertussis FHA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen
Time frame: 42 days after a 3-dose regimen
Population: Per Protocol Analysis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | 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 |
| Placebo + INFANRIX Hexa | 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 | 78.8 EU/mL |
Secondary
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis FHA When Administered Concomitantly With RotaTeq™, Predose 1
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
Time frame: Predose (Day 1 of a 3-dose regimen)
Population: Per Protocol Analysis
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis FHA When Administered Concomitantly With RotaTeq™, Predose 1 | 4.3 EU/mL |
| Placebo + INFANRIX Hexa | Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis FHA When Administered Concomitantly With RotaTeq™, Predose 1 | 3.7 EU/mL |
Secondary
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
GMT of pertussis Pertactin in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen
Time frame: 42 days after a 3-dose regimen
Population: Per Protocol Analysis
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | 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 |
| Placebo + INFANRIX Hexa | 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 | 108.2 EU/mL |
Secondary
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Pertactin When Administered Concomitantly With RotaTeq™, Predose 1
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
Time frame: Predose (Day 1 of a 3-dose regimen)
Population: Per Protocol Analysis
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Pertactin When Administered Concomitantly With RotaTeq™, Predose 1 | 1.0 EU/mL |
| Placebo + INFANRIX Hexa | Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Pertactin When Administered Concomitantly With RotaTeq™, Predose 1 | 1.0 EU/mL |
Secondary
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
GMT of pertussis toxoid in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen
Time frame: 42 days after a 3-dose regimen
Population: Per Protocol Analysis
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | 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 |
| Placebo + INFANRIX Hexa | 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 | 28.3 EU/mL |
Secondary
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Toxoid When Administered Concomitantly With RotaTeq™, Predose 1
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
Time frame: Predose (Day 1 of a 3-dose regimen)
Population: Per Protocol Analysis
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Toxoid When Administered Concomitantly With RotaTeq™, Predose 1 | 0.2 EU/mL |
| Placebo + INFANRIX Hexa | Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Pertussis Toxoid When Administered Concomitantly With RotaTeq™, Predose 1 | 0.2 EU/mL |
Secondary
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
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
Time frame: 42 days after a 3-dose regimen
Population: Per Protocol Analysis on Subset A (subjects with even allocation numbers)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | 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 |
| Placebo + INFANRIX Hexa | 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 | 160.2 Dilution Unit |
Secondary
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeq™, Predose 1
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
Time frame: Predose (Day 1 of a 3-dose regimen)
Population: Per Protocol Analysis on Subset A (subjects with even allocation numbers)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | 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 |
| Placebo + INFANRIX Hexa | Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeq™, Predose 1 | 18.3 Dilution Unit |
Secondary
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
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
Time frame: 42 days after in a 3-dose regimen
Population: Per Protocol Analysis on Subset A (subjects with even allocation numbers)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | 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 |
| Placebo + INFANRIX Hexa | 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 | 69.4 Dilution Unit |
Secondary
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 2 When Administered Concomitantly With RotaTeq™, Predose 1
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
Time frame: Pre-dose (Day 1 of a 3-dose regimen)
Population: Per Protocol Analysis on Subset A (subjects with even allocation numbers)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | 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 |
| Placebo + INFANRIX Hexa | Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 2 When Administered Concomitantly With RotaTeq™, Predose 1 | 12.7 Dilution Unit |
Secondary
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
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
Time frame: 42 days after a 3-dose regimen
Population: Per Protocol Analysis on Subset A (subjects with even allocation numbers)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | 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 |
| Placebo + INFANRIX Hexa | 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 | 263.9 Dilution Unit |
Secondary
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 3 When Administered Concomitantly With RotaTeq™, Predose 1
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
Time frame: Predose (Day 1 of a 3-dose regimen)
Population: Per Protocol Analysis on Subset A (subjects with even allocation numbers)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | 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 |
| Placebo + INFANRIX Hexa | Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 3 When Administered Concomitantly With RotaTeq™, Predose 1 | 7.8 Dilution Unit |
Secondary
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
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
Time frame: 42 days after a 3-dose regimen
Population: Per Protocol Analysis on Subset B (subjects with odd allocation numbers
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | 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 |
| Placebo + INFANRIX Hexa | 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 | 1.5 Dilution Unit |
Secondary
Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Tetanus Toxoid When Administered Concomitantly With RotaTeq™, Predose 1
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
Time frame: Predose (Day 1 of a 3-dose regimen)
Population: Per Protocol Analysis on Subset B (subjects with odd allocation numbers)
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Tetanus Toxoid When Administered Concomitantly With RotaTeq™, Predose 1 | 0.2 IU/mL |
| Placebo + INFANRIX Hexa | Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Tetanus Toxoid When Administered Concomitantly With RotaTeq™, Predose 1 | 0.3 IU/mL |
Secondary
Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, 42 Days After a 3-dose Regimen
GMT of serotype G1 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen
Time frame: 42 days after a 3-dose regimen
Population: Per Protocol Analysis
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | 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 |
| Placebo + INFANRIX Hexa | Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, 42 Days After a 3-dose Regimen | 8.2 GMT |
Secondary
Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, Predose 1
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
Time frame: Predose (Day 1 of a 3-dose regimen)
Population: Per Protocol Analysis
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, Predose 1 | 23.3 GMT |
| Placebo + INFANRIX Hexa | Serum Neutralizing Antibody (SNA) Response to Serotype G1 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, Predose 1 | 24 GMT |
Secondary
Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen
GMT of serotype G2 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen
Time frame: 42 days after a 3-dose regimen
Population: Per Protocol Analysis
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | 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 |
| Placebo + INFANRIX Hexa | Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen | 6.1 GMT |
Secondary
Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, Predose 1
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
Time frame: Predose (Day 1 of a 3-dose regimen)
Population: Per Protocol Analysis
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, Predose 1 | 11.7 GMT |
| Placebo + INFANRIX Hexa | Serum Neutralizing Antibody (SNA) Response to Serotype G2 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa, Predose 1 | 12.2 GMT |
Secondary
Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen
GMT of serotype G3 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen
Time frame: 42 days after a 3-dose regimen
Population: Per Protocol Analysis
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | 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 |
| Placebo + INFANRIX Hexa | Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen | 5.8 GMT |
Secondary
Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1
GMT of serotype G3 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1
Time frame: Predose (Day 1 of a 3-dose regimen)
Population: Per Protocol Analysis
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1 | 11.5 GMT |
| Placebo + INFANRIX Hexa | Serum Neutralizing Antibody (SNA) Response to Serotype G3 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1 | 9.8 GMT |
Secondary
Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen
GMT of serotype G4 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen
Time frame: 42 days after a 3-dose regimen
Population: Per Protocol Analysis
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | 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 |
| Placebo + INFANRIX Hexa | Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen | 7.1 GMT |
Secondary
Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1
GMT of serotype G4 in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1
Time frame: Predose (Day 1 of a 3-dose regimen)
Population: Per Protocol Analysis
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1 | 15.5 GMT |
| Placebo + INFANRIX Hexa | Serum Neutralizing Antibody (SNA) Response to Serotype G4 in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1 | 17.9 GMT |
Secondary
Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen
GMT of serotype P1A in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa 42 days after a 3-dose regimen
Time frame: 42 days after a 3-dose regimen
Population: Per Protocol Analysis
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | 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 |
| Placebo + INFANRIX Hexa | Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa 42 Days After a 3-dose Regimen | 10.7 GMT |
Secondary
Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1
GMT of serotype P1A in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1
Time frame: Predose (Day 1 of a 3-dose regimen)
Population: Per Protocol Analysis
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1 | 36.8 GMT |
| Placebo + INFANRIX Hexa | Serum Neutralizing Antibody (SNA) Response to Serotype P1A in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1 | 33.2 GMT |
Secondary
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
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
Time frame: 42 days after a 3-dose regimen
Population: Per Protocol Analysis
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | 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 |
| Placebo + INFANRIX Hexa | 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 | 0.2 GMT |
Secondary
Serum Neutralizing Antibody (SNA) Response to Serum Anti-rotavirus IgA in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1
GMT of serum anti-rotavirus IgA in subjects receiving RotaTeq™ + INFANRIX™ hexa compared to those receiving placebo + INFANRIX™ hexa Predose 1
Time frame: Predose (Day 1 of a 3-dose regimen)
Population: Per Protocol Analysis
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ + INFANRIX Hexa | Serum Neutralizing Antibody (SNA) Response to Serum Anti-rotavirus IgA in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1 | 0.1 GMT |
| Placebo + INFANRIX Hexa | Serum Neutralizing Antibody (SNA) Response to Serum Anti-rotavirus IgA in Patients Receiving RotaTeq™ Concomitantly With INFANRIX™ Hexa Predose 1 | 0.1 GMT |