Rotavirus Infections
Conditions
Brief summary
This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis.
Interventions
BIOLOGICALRotateq™
3 doses of 2.0 mL RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2.
BIOLOGICALComparator: Placebo
3 doses of 2.0 mL Placebo to RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Healthy infants
Exclusion criteria
* None Specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo | Within 42 days following any dose of RotaTeq™/placebo | Number of participants with confirmed intussusception within 42 days after each vaccination with RotaTeq™/placebo. |
| Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination | At least 14 days following the 3rd vaccination through the first full rotavirus season | Rotavirus gastroenteritis cases consist of all participants with one or more episodes classified as positive. Multiple positive episodes for one participant are counted as a single case. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of a 3-dose Regimen of RotaTeq™ Against Moderate-to-severe Rotavirus Disease (Clinical Score >8) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose. | At least 14 days following the 3rd vaccination through the first rotavirus season | Number of participants with rotavirus gastroenteritis whose clinical score was \>8 for the first episode and for the worst episode. Scores evaluated the intensity and duration of diarrhea, vomiting, fever, and behavioral symptoms. The total score for an episode is equal to the sum of the scores for each of the symptoms \[range: total score 0 (best) to 24 (worst)\]. |
| Efficacy of a 3-dose Regimen of RotaTeq™ Against Severe Rotavirus Disease (Clinical Score > 16) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose | At least 14 days following the 3rd vaccination through the first rotavirus season | Number of participants with rotavirus gastroenteritis whose clinical score was \>16 for the first episode and for the worst episode. Scores evaluated the intensity and duration of diarrhea, vomiting, fever, and behavioral symptoms. The total score for an episode is equal to the sum of the scores for each of the symptoms \[range: total score 0 (best) to 24 (worst)\]. |
| G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus | 14 days following the 3rd vaccination | Number of participants with a 3-fold rise or greater in G1 Serum neutralizing antibody (SNA) responses against rotavirus from baseline to postdose 3. |
| Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin | 42 days following third dose | Measurement of immune response in the group that received RotaTeq™ and the group that received placebo was performed by determining geometric mean antibody titers to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin. Antibody titers were measured with an indirect, non-competitive, enzyme immunoassay (EIA). |
| Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F | 42 days following third dose | Measurement of immune response in the group that received RotaTeq™ and the group that received placebo was performed by determining geometric mean antibody titers to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. Serum antibody titers to type-specific pneumococcal polysaccharides were determined by an EIA. |
| Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo | 42 days following third dose | The number of participants who achieved seroprotection/seroconversion to hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, & polio types 1, 2, & 3, per established criteria. |
| Occurrence of Hospital Admissions and Visits to Emergency Departments (or the Equivalent at International Sites) for Rotavirus Disease Associated With Serotypes G1, G2, G3, or G4 | At least 14 days following the 3rd vaccination | Health Outcomes Substudy - Occurrence of hospital admissions and emergency department visits for episode(s) of rotavirus gastroenteritis associated with serotypes G1, G2, G3, or G4 by treatment group. Occurrence was expressed as the annual number of events per 1000 person-years. |
Participant flow
Recruitment details
Participants were recruited at 356 sites in Belgium, Costa Rica, Finland, Germany, Guatemala, Italy, Jamaica, Mexico, Puerto Rico, Sweden, Taiwan, and the United States from 12 Jan 2001 first patient in (FPI) to 06 Oct 2004 last patient in (LPI).
Pre-assignment details
Participants with: history of congenital abdominal disorders, intussusception, or abdominal surgery; history of known prior rotavirus disease, chronic diarrhea, or failure to thrive were excluded from the trial before assignment to groups.
Participants by arm
| Arm | Count |
|---|---|
| RotaTeq™ Three oral doses (\
6.5x10\^7 to \
1.2x10\^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart. | 34,644 |
| Placebo Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart. | 34,630 |
| Total | 69,274 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 214 | 198 |
| Overall Study | Data not available at data cut-off point | 1,552 | 1,563 |
| Overall Study | Lost to Follow-up | 68 | 95 |
| Overall Study | Moved | 203 | 189 |
| Overall Study | Other | 1,211 | 1,160 |
| Overall Study | Protocol Violation | 960 | 1,022 |
| Overall Study | Randomized Not Vaccinated (Visit 1) | 609 | 627 |
| Overall Study | Withdrawal by Subject | 182 | 211 |
Baseline characteristics
| Characteristic | RotaTeq™ | Placebo | Total |
|---|---|---|---|
| Age, Customized 5 Weeks of Age and Under | 1 Participants | 4 Participants | 5 Participants |
| Age, Customized 6 to 12 Weeks of Age | 34551 Participants | 34527 Participants | 69078 Participants |
| Age, Customized Over 12 Weeks of Age | 92 Participants | 99 Participants | 191 Participants |
| Race/Ethnicity Asian | 536 participants | 552 participants | 1088 participants |
| Race/Ethnicity Black | 2908 participants | 2941 participants | 5849 participants |
| Race/Ethnicity Hispanic American | 4963 participants | 4911 participants | 9874 participants |
| Race/Ethnicity Multi Racial | 1815 participants | 1817 participants | 3632 participants |
| Race/Ethnicity Native American | 531 participants | 514 participants | 1045 participants |
| Race/Ethnicity Other | 119 participants | 107 participants | 226 participants |
| Race/Ethnicity White | 23772 participants | 23788 participants | 47560 participants |
| Sex: Female, Male Female | 17058 Participants | 17101 Participants | 34159 Participants |
| Sex: Female, Male Male | 17586 Participants | 17529 Participants | 35115 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4,000 / 4,800 | 4,047 / 4,787 |
| serious Total, serious adverse events | 863 / 34,904 | 955 / 34,862 |
Outcome results
Primary
Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo
Number of participants with confirmed intussusception within 42 days after each vaccination with RotaTeq™/placebo.
Time frame: Within 42 days following any dose of RotaTeq™/placebo
Population: All participants in the study were followed for potential cases of intussusception.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RotaTeq™ | Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo | 6 Participants |
| Placebo | Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo | 5 Participants |
p-value: 0.00695% CI: [0.4, 6.4]Exact binomial test
Primary
Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination
Rotavirus gastroenteritis cases consist of all participants with one or more episodes classified as positive. Multiple positive episodes for one participant are counted as a single case.
Time frame: At least 14 days following the 3rd vaccination through the first full rotavirus season
Population: Per Protocol Population Using Per-Protocol Case Definition
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RotaTeq™ | Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination | 82 Participants |
| Placebo | Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination | 315 Participants |
p-value: <0.00195% CI: [66.8, 79.9]Exact binomial test
Secondary
Efficacy of a 3-dose Regimen of RotaTeq™ Against Moderate-to-severe Rotavirus Disease (Clinical Score >8) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose.
Number of participants with rotavirus gastroenteritis whose clinical score was \>8 for the first episode and for the worst episode. Scores evaluated the intensity and duration of diarrhea, vomiting, fever, and behavioral symptoms. The total score for an episode is equal to the sum of the scores for each of the symptoms \[range: total score 0 (best) to 24 (worst)\].
Time frame: At least 14 days following the 3rd vaccination through the first rotavirus season
Population: Per Protocol Population Using Per-Protocol Case Definition
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RotaTeq™ | Efficacy of a 3-dose Regimen of RotaTeq™ Against Moderate-to-severe Rotavirus Disease (Clinical Score >8) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose. | First episode scores | 48 Participants |
| RotaTeq™ | Efficacy of a 3-dose Regimen of RotaTeq™ Against Moderate-to-severe Rotavirus Disease (Clinical Score >8) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose. | Worst episode scores | 49 Participants |
| Placebo | Efficacy of a 3-dose Regimen of RotaTeq™ Against Moderate-to-severe Rotavirus Disease (Clinical Score >8) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose. | First episode scores | 262 Participants |
| Placebo | Efficacy of a 3-dose Regimen of RotaTeq™ Against Moderate-to-severe Rotavirus Disease (Clinical Score >8) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose. | Worst episode scores | 265 Participants |
p-value: <0.00195% CI: [74.9, 86.7]Exact binomial test
Secondary
Efficacy of a 3-dose Regimen of RotaTeq™ Against Severe Rotavirus Disease (Clinical Score > 16) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose
Number of participants with rotavirus gastroenteritis whose clinical score was \>16 for the first episode and for the worst episode. Scores evaluated the intensity and duration of diarrhea, vomiting, fever, and behavioral symptoms. The total score for an episode is equal to the sum of the scores for each of the symptoms \[range: total score 0 (best) to 24 (worst)\].
Time frame: At least 14 days following the 3rd vaccination through the first rotavirus season
Population: Per Protocol Population Using Per-Protocol Case Definition
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RotaTeq™ | Efficacy of a 3-dose Regimen of RotaTeq™ Against Severe Rotavirus Disease (Clinical Score > 16) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose | First episode scores | 1 Participants |
| RotaTeq™ | Efficacy of a 3-dose Regimen of RotaTeq™ Against Severe Rotavirus Disease (Clinical Score > 16) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose | Worst episode scores | 1 Participants |
| Placebo | Efficacy of a 3-dose Regimen of RotaTeq™ Against Severe Rotavirus Disease (Clinical Score > 16) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose | First episode scores | 51 Participants |
| Placebo | Efficacy of a 3-dose Regimen of RotaTeq™ Against Severe Rotavirus Disease (Clinical Score > 16) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose | Worst episode scores | 51 Participants |
p-value: <0.00195% CI: [88.3, 100]Exact binomial test
Secondary
G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus
Number of participants with a 3-fold rise or greater in G1 Serum neutralizing antibody (SNA) responses against rotavirus from baseline to postdose 3.
Time frame: 14 days following the 3rd vaccination
Population: Per Protocol Population among participants in Finland using Per-Protocol Case Definition
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RotaTeq™ | G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus | 95 Participants |
| Placebo | G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus | 8 Participants |
p-value: <0.00195% CI: [72.9, 87.8]Exact binomial test
Secondary
Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin
Measurement of immune response in the group that received RotaTeq™ and the group that received placebo was performed by determining geometric mean antibody titers to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin. Antibody titers were measured with an indirect, non-competitive, enzyme immunoassay (EIA).
Time frame: 42 days following third dose
Population: Per Protocol Population; excluding protocol violators and participants with invalid data based on laboratory determinations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RotaTeq™ | Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin | Pertussis FHA | 55.69 ELISA units/mL |
| RotaTeq™ | Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin | Pertussis Pertactin | 34.77 ELISA units/mL |
| RotaTeq™ | Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin | Pertussis PT | 20.18 ELISA units/mL |
| Placebo | Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin | Pertussis PT | 22.73 ELISA units/mL |
| Placebo | Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin | Pertussis FHA | 64.33 ELISA units/mL |
| Placebo | Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin | Pertussis Pertactin | 59.17 ELISA units/mL |
Comparison: The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis PT was used for analysis.p-value: <0.00195% CI: [0.7, 1.1]t-test, 1 sided
Comparison: The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis FHA was used for analysis.p-value: <0.00195% CI: [0.7, 1.1]t-test, 1 sided
Comparison: The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis Pertactin was used for analysis.p-value: 0.19395% CI: [0.4, 0.8]t-test, 1 sided
Secondary
Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F
Measurement of immune response in the group that received RotaTeq™ and the group that received placebo was performed by determining geometric mean antibody titers to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. Serum antibody titers to type-specific pneumococcal polysaccharides were determined by an EIA.
Time frame: 42 days following third dose
Population: Per Protocol Population; excluding protocol violators and participants with invalid data based on laboratory determinations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RotaTeq™ | Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F | Pneumococcal serotype 23F (N=185, N=198) | 1.71 micrograms/mL |
| RotaTeq™ | Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F | Pneumococcal serotype 4 (N=181, N=196) | 1.13 micrograms/mL |
| RotaTeq™ | Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F | Pneumococcal serotype 6B (N=185, N=198) | 2.39 micrograms/mL |
| RotaTeq™ | Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F | Pneumococcal serotype 9V (N=166, N=181) | 1.90 micrograms/mL |
| RotaTeq™ | Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F | Pneumococcal serotype 14 (N=178, N=198) | 4.24 micrograms/mL |
| RotaTeq™ | Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F | Pneumococcal serotype 18C (N=166, N=180) | 2.60 micrograms/mL |
| RotaTeq™ | Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F | Pneumococcal serotype 19F (N=180, N=196) | 1.97 micrograms/mL |
| Placebo | Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F | Pneumococcal serotype 23F (N=185, N=198) | 1.50 micrograms/mL |
| Placebo | Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F | Pneumococcal serotype 14 (N=178, N=198) | 4.33 micrograms/mL |
| Placebo | Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F | Pneumococcal serotype 4 (N=181, N=196) | 0.96 micrograms/mL |
| Placebo | Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F | Pneumococcal serotype 19F (N=180, N=196) | 1.84 micrograms/mL |
| Placebo | Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F | Pneumococcal serotype 6B (N=185, N=198) | 1.72 micrograms/mL |
| Placebo | Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F | Pneumococcal serotype 18C (N=166, N=180) | 2.02 micrograms/mL |
| Placebo | Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F | Pneumococcal serotype 9V (N=166, N=181) | 1.78 micrograms/mL |
Comparison: The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 4 was used for analysis.p-value: <0.00195% CI: [1, 1.4]t-test, 1 sided
Comparison: The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 6B was used for analysis.p-value: <0.00195% CI: [1, 1.9]t-test, 1 sided
Comparison: The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 9V was used for analysis.p-value: <0.00195% CI: [0.9, 1.3]t-test, 1 sided
Comparison: The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 14 was used for analysis.p-value: <0.00195% CI: [0.7, 1.3]t-test, 1 sided
Comparison: The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 18C was used for analysis.p-value: <0.00195% CI: [1.1, 1.6]t-test, 1 sided
Comparison: The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 19F was used for analysis.p-value: <0.00195% CI: [0.8, 1.4]t-test, 1 sided
Comparison: The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 23F was used for analysis.p-value: <0.00195% CI: [0.9, 1.5]t-test, 1 sided
Secondary
Occurrence of Hospital Admissions and Visits to Emergency Departments (or the Equivalent at International Sites) for Rotavirus Disease Associated With Serotypes G1, G2, G3, or G4
Health Outcomes Substudy - Occurrence of hospital admissions and emergency department visits for episode(s) of rotavirus gastroenteritis associated with serotypes G1, G2, G3, or G4 by treatment group. Occurrence was expressed as the annual number of events per 1000 person-years.
Time frame: At least 14 days following the 3rd vaccination
Population: Per Protocol Population Using Per-Protocol Case Definition
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RotaTeq™ | Occurrence of Hospital Admissions and Visits to Emergency Departments (or the Equivalent at International Sites) for Rotavirus Disease Associated With Serotypes G1, G2, G3, or G4 | Hospital admissions | 6 Annual # of events per 1000 person-years |
| RotaTeq™ | Occurrence of Hospital Admissions and Visits to Emergency Departments (or the Equivalent at International Sites) for Rotavirus Disease Associated With Serotypes G1, G2, G3, or G4 | Emergency department visits | 14 Annual # of events per 1000 person-years |
| Placebo | Occurrence of Hospital Admissions and Visits to Emergency Departments (or the Equivalent at International Sites) for Rotavirus Disease Associated With Serotypes G1, G2, G3, or G4 | Hospital admissions | 144 Annual # of events per 1000 person-years |
| Placebo | Occurrence of Hospital Admissions and Visits to Emergency Departments (or the Equivalent at International Sites) for Rotavirus Disease Associated With Serotypes G1, G2, G3, or G4 | Emergency department visits | 213 Annual # of events per 1000 person-years |
p-value: <0.00195% CI: [91.2, 96.6]Poisson regression
Secondary
Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo
The number of participants who achieved seroprotection/seroconversion to hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, & polio types 1, 2, & 3, per established criteria.
Time frame: 42 days following third dose
Population: Per Protocol Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RotaTeq™ | Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo | Diphtheria (N=136, N=144) | 136 Participants |
| RotaTeq™ | Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo | Polio type 1 (N=341, N=360) | 328 Participants |
| RotaTeq™ | Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo | Haemophilus influenzae type b (N=558, N=592) | 417 Participants |
| RotaTeq™ | Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo | Polio type 2 (N=341, N=359) | 311 Participants |
| RotaTeq™ | Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo | Tetanus (N=132, N=140) | 132 Participants |
| RotaTeq™ | Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo | Polio type 3 (N=341, N=359) | 324 Participants |
| RotaTeq™ | Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo | Hepatitis B (N=202, N=214) | 197 Participants |
| Placebo | Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo | Polio type 3 (N=341, N=359) | 343 Participants |
| Placebo | Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo | Hepatitis B (N=202, N=214) | 203 Participants |
| Placebo | Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo | Haemophilus influenzae type b (N=558, N=592) | 426 Participants |
| Placebo | Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo | Diphtheria (N=136, N=144) | 142 Participants |
| Placebo | Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo | Tetanus (N=132, N=140) | 140 Participants |
| Placebo | Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo | Polio type 1 (N=341, N=360) | 349 Participants |
| Placebo | Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo | Polio type 2 (N=341, N=359) | 326 Participants |
p-value: <0.001Miettenen and Nurminen