Rotavirus Infections
Conditions
Brief summary
This study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine.
Interventions
Three oral doses (\ 8.81 X 10\^7 IU/Dose for Lot 1; \ 8.01 X 10\^7 IU/Dose for Lot 2; and \ 6.91 X 10\^7 IU/Dose for Lot 3) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination
BIOLOGICALPlacebo
Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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
* History of abdominal disorders from a birth defect, intussusception, or abdominal surgery * Known or suspected problems with the immune system * Fever at time of immunization * Prior administration of a rotavirus vaccine * History of known prior rotavirus disease, chronic diarrhea, or failure to thrive.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] | 42 days following the 3rd vaccination | Antibody response to 3 manufactured lots of RotaTeq™ and placebo groups, based on the SNA PostDose 3 geometric mean titers (GMTs) (expressed in dilution units) against rotavirus serotypes G1, G2, G3, G4 and P1A\[8\] |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Clinical Adverse Experiences (CAEs) | Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first | Subjects in this study were followed for all CAEs, including intussusception. A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product |
| Number of Subjects With Serious Clinical Adverse Experiences (SCAEs) | Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first | Subjects were followed for all SCAEs. SCAEs are any CAEs occurring at any dose that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose. |
| Number of Subjects With Vaccine-Related Clinical AEs (CAEs) | Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first | CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator, who is a qualified physician, as being related to the vaccine according to his/her best clinical judgment. |
| Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs) | Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first | Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose |
| Geometric Mean Antibody Titer(s) (GMT) to Serum Anti-rotavirus Immunoglobulin A (IgA). | 42 days following the 3rd vaccination | Post Dose 3 serum samples were assayed for serum anti-rotavirus IgA |
| Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs) | Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first | CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator who is a qualified physician as being related to the vaccine according to his/her best clinical judgment. |
| Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs) | Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first | SCAEs are any CAEs that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose. |
| Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs) | Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first | Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose. |
| Number of Subjects Discontinued Due to Clinical Adverse Experiences | Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first | A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product. |
Participant flow
Recruitment details
The study was conducted at 10 sites in the United States from 09-May-2003 (first patient in) to 02-Jul-2004 (last dose given). Last subject completed follow-up: 13-Aug-2004. All data corrections applied (Frozen File) date: 30-Sep-2004
Pre-assignment details
Subjects with prior rotavirus disease, chronic diarrhea, and fever at time of immunization were excluded from the trial.
Participants by arm
| Arm | Count |
|---|---|
| RotaTeq™ Lot 1 Three oral doses (\
8.81 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination. | 226 |
| RotaTeq™ Lot 2 Three oral doses ( \
8.01 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination. | 225 |
| RotaTeq™ Lot 3 Three oral doses ( \
6.91 X 10\^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination. | 229 |
| Placebo Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination. | 113 |
| Total | 793 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 1 |
| Overall Study | Lost to Follow-up | 2 | 2 | 1 | 2 |
| Overall Study | Moved | 1 | 1 | 0 | 1 |
| Overall Study | Other | 4 | 2 | 3 | 0 |
| Overall Study | Protocol Violation | 5 | 7 | 8 | 6 |
| Overall Study | Withdrawal by Subject | 13 | 5 | 16 | 6 |
Baseline characteristics
| Characteristic | RotaTeq™ Lot 1 | RotaTeq™ Lot 2 | RotaTeq™ Lot 3 | Placebo | Total |
|---|---|---|---|---|---|
| Age, Customized 6 to 12 Weeks | 225 participants | 224 participants | 228 participants | 113 participants | 790 participants |
| Age, Customized Over 12 Weeks | 1 participants | 1 participants | 1 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized Black | 13 participants | 11 participants | 6 participants | 5 participants | 35 participants |
| Race/Ethnicity, Customized Hispanic American | 57 participants | 49 participants | 52 participants | 28 participants | 186 participants |
| Race/Ethnicity, Customized Multi-Racial | 10 participants | 10 participants | 16 participants | 6 participants | 42 participants |
| Race/Ethnicity, Customized Other | 7 participants | 11 participants | 8 participants | 6 participants | 32 participants |
| Race/Ethnicity, Customized White | 139 participants | 144 participants | 147 participants | 68 participants | 498 participants |
| Sex: Female, Male Female | 118 Participants | 98 Participants | 108 Participants | 43 Participants | 367 Participants |
| Sex: Female, Male Male | 108 Participants | 127 Participants | 121 Participants | 70 Participants | 426 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 206 / 226 | 212 / 224 | 211 / 229 | 101 / 111 |
| serious Total, serious adverse events | 4 / 226 | 4 / 224 | 2 / 229 | 3 / 111 |
Outcome results
Primary
Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8]
Antibody response to 3 manufactured lots of RotaTeq™ and placebo groups, based on the SNA PostDose 3 geometric mean titers (GMTs) (expressed in dilution units) against rotavirus serotypes G1, G2, G3, G4 and P1A\[8\]
Time frame: 42 days following the 3rd vaccination
Population: Per Protocol Population; excluding protocol violators and subjects with invalid data based on laboratory determinations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RotaTeq™ Lot 1 | Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] | G4 SNA (dilution units) | 66.0 dilution units |
| RotaTeq™ Lot 1 | Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] | G2 SNA (dilution units) | 20.7 dilution units |
| RotaTeq™ Lot 1 | Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] | P1A[8] SNA (dilution units) | 71.1 dilution units |
| RotaTeq™ Lot 1 | Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] | G3 SNA (dilution units) | 18.0 dilution units |
| RotaTeq™ Lot 1 | Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] | G1 SNA (dilution units) | 167.9 dilution units |
| RotaTeq™ Lot 2 | Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] | G3 SNA (dilution units) | 18.5 dilution units |
| RotaTeq™ Lot 2 | Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] | G4 SNA (dilution units) | 74.3 dilution units |
| RotaTeq™ Lot 2 | Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] | P1A[8] SNA (dilution units) | 72.3 dilution units |
| RotaTeq™ Lot 2 | Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] | G2 SNA (dilution units) | 22.6 dilution units |
| RotaTeq™ Lot 2 | Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] | G1 SNA (dilution units) | 193.2 dilution units |
| RotaTeq™ Lot 3 | Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] | G3 SNA (dilution units) | 14.6 dilution units |
| RotaTeq™ Lot 3 | Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] | G1 SNA (dilution units) | 171.0 dilution units |
| RotaTeq™ Lot 3 | Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] | G2 SNA (dilution units) | 17.8 dilution units |
| RotaTeq™ Lot 3 | Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] | G4 SNA (dilution units) | 65.7 dilution units |
| RotaTeq™ Lot 3 | Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] | P1A[8] SNA (dilution units) | 65.6 dilution units |
| Placebo | Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] | G4 SNA (dilution units) | 7.8 dilution units |
| Placebo | Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] | G2 SNA (dilution units) | 5.9 dilution units |
| Placebo | Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] | G1 SNA (dilution units) | 9.3 dilution units |
| Placebo | Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] | G3 SNA (dilution units) | 9.6 dilution units |
| Placebo | Serum Neutralizing Antibodies (SNA) Response Against Rotavirus Serotypes G1, G2, G3, G4 and P1A[8] | P1A[8] SNA (dilution units) | 10.2 dilution units |
Comparison: A pairwise comparison of lots was made for each serotype, for each pair of lots.p-value: <0.001ANOVA
Comparison: A pairwise comparison of lots was made for each serotype, for each pair of lots.p-value: <0.001ANOVA
Comparison: A pairwise comparison of lots was made for each serotype, for each pair of lots.p-value: <0.001ANCOVA
Other Pre-specified
Geometric Mean Antibody Titer(s) (GMT) to Serum Anti-rotavirus Immunoglobulin A (IgA).
Post Dose 3 serum samples were assayed for serum anti-rotavirus IgA
Time frame: 42 days following the 3rd vaccination
Population: Per Protocol Population; excluding protocol violators and subjects with invalid data based on laboratory determinations.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RotaTeq™ Lot 1 | Geometric Mean Antibody Titer(s) (GMT) to Serum Anti-rotavirus Immunoglobulin A (IgA). | 292.7 units/mL |
| RotaTeq™ Lot 2 | Geometric Mean Antibody Titer(s) (GMT) to Serum Anti-rotavirus Immunoglobulin A (IgA). | 272.5 units/mL |
| RotaTeq™ Lot 3 | Geometric Mean Antibody Titer(s) (GMT) to Serum Anti-rotavirus Immunoglobulin A (IgA). | 266.2 units/mL |
| Placebo | Geometric Mean Antibody Titer(s) (GMT) to Serum Anti-rotavirus Immunoglobulin A (IgA). | 0.4 units/mL |
Other Pre-specified
Number of Subjects Discontinued Due to Clinical Adverse Experiences
A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product.
Time frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
Population: All subjects who were vaccinated and followed up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RotaTeq™ Lot 1 | Number of Subjects Discontinued Due to Clinical Adverse Experiences | Discontinued due to CAEs | 0 Participants |
| RotaTeq™ Lot 1 | Number of Subjects Discontinued Due to Clinical Adverse Experiences | Not discontinued due to CAEs | 226 Participants |
| RotaTeq™ Lot 2 | Number of Subjects Discontinued Due to Clinical Adverse Experiences | Not discontinued due to CAEs | 224 Participants |
| RotaTeq™ Lot 2 | Number of Subjects Discontinued Due to Clinical Adverse Experiences | Discontinued due to CAEs | 0 Participants |
| RotaTeq™ Lot 3 | Number of Subjects Discontinued Due to Clinical Adverse Experiences | Discontinued due to CAEs | 1 Participants |
| RotaTeq™ Lot 3 | Number of Subjects Discontinued Due to Clinical Adverse Experiences | Not discontinued due to CAEs | 228 Participants |
| Placebo | Number of Subjects Discontinued Due to Clinical Adverse Experiences | Discontinued due to CAEs | 1 Participants |
| Placebo | Number of Subjects Discontinued Due to Clinical Adverse Experiences | Not discontinued due to CAEs | 110 Participants |
Other Pre-specified
Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs)
SCAEs are any CAEs that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.
Time frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
Population: All subjects who were vaccinated and followed up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RotaTeq™ Lot 1 | Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs) | Discontinued due to serious CAEs | 0 Participants |
| RotaTeq™ Lot 1 | Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs) | Not discontinued due to serious CAEs | 226 Participants |
| RotaTeq™ Lot 2 | Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs) | Not discontinued due to serious CAEs | 224 Participants |
| RotaTeq™ Lot 2 | Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs) | Discontinued due to serious CAEs | 0 Participants |
| RotaTeq™ Lot 3 | Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs) | Discontinued due to serious CAEs | 1 Participants |
| RotaTeq™ Lot 3 | Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs) | Not discontinued due to serious CAEs | 228 Participants |
| Placebo | Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs) | Discontinued due to serious CAEs | 1 Participants |
| Placebo | Number of Subjects Discontinued Due to Serious Clinical Adverse Experiences (SCAEs) | Not discontinued due to serious CAEs | 110 Participants |
Other Pre-specified
Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs)
Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.
Time frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
Population: All subjects who were vaccinated and followed up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RotaTeq™ Lot 1 | Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs) | Discontinued due to serious vaccine-related CAEs | 0 Participants |
| RotaTeq™ Lot 1 | Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs) | NOTdiscontinued dueto serious vaccine-related CAEs | 226 Participants |
| RotaTeq™ Lot 2 | Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs) | NOTdiscontinued dueto serious vaccine-related CAEs | 224 Participants |
| RotaTeq™ Lot 2 | Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs) | Discontinued due to serious vaccine-related CAEs | 0 Participants |
| RotaTeq™ Lot 3 | Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs) | Discontinued due to serious vaccine-related CAEs | 0 Participants |
| RotaTeq™ Lot 3 | Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs) | NOTdiscontinued dueto serious vaccine-related CAEs | 229 Participants |
| Placebo | Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs) | Discontinued due to serious vaccine-related CAEs | 1 Participants |
| Placebo | Number of Subjects Discontinued Due to Serious Vaccine-related Clinical Adverse Experiences (CAEs) | NOTdiscontinued dueto serious vaccine-related CAEs | 110 Participants |
Other Pre-specified
Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs)
CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator who is a qualified physician as being related to the vaccine according to his/her best clinical judgment.
Time frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
Population: All subjects who were vaccinated and followed up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RotaTeq™ Lot 1 | Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs) | Discontinued due to vaccine-related CAEs | 0 Participants |
| RotaTeq™ Lot 1 | Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs) | Not discontinued due to vaccine-related CAEs | 226 Participants |
| RotaTeq™ Lot 2 | Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs) | Not discontinued due to vaccine-related CAEs | 224 Participants |
| RotaTeq™ Lot 2 | Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs) | Discontinued due to vaccine-related CAEs | 0 Participants |
| RotaTeq™ Lot 3 | Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs) | Discontinued due to vaccine-related CAEs | 0 Participants |
| RotaTeq™ Lot 3 | Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs) | Not discontinued due to vaccine-related CAEs | 229 Participants |
| Placebo | Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs) | Discontinued due to vaccine-related CAEs | 1 Participants |
| Placebo | Number of Subjects Discontinued Due to Vaccine-Related Clinical Adverse Experiences (CAEs) | Not discontinued due to vaccine-related CAEs | 110 Participants |
Other Pre-specified
Number of Subjects With Clinical Adverse Experiences (CAEs)
Subjects in this study were followed for all CAEs, including intussusception. A CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Time frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
Population: Safety Population: All subjects who were vaccinated and followed up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RotaTeq™ Lot 1 | Number of Subjects With Clinical Adverse Experiences (CAEs) | With CAEs | 207 Participants |
| RotaTeq™ Lot 1 | Number of Subjects With Clinical Adverse Experiences (CAEs) | Without CAEs | 19 Participants |
| RotaTeq™ Lot 2 | Number of Subjects With Clinical Adverse Experiences (CAEs) | Without CAEs | 11 Participants |
| RotaTeq™ Lot 2 | Number of Subjects With Clinical Adverse Experiences (CAEs) | With CAEs | 213 Participants |
| RotaTeq™ Lot 3 | Number of Subjects With Clinical Adverse Experiences (CAEs) | With CAEs | 212 Participants |
| RotaTeq™ Lot 3 | Number of Subjects With Clinical Adverse Experiences (CAEs) | Without CAEs | 17 Participants |
| Placebo | Number of Subjects With Clinical Adverse Experiences (CAEs) | With CAEs | 101 Participants |
| Placebo | Number of Subjects With Clinical Adverse Experiences (CAEs) | Without CAEs | 10 Participants |
Other Pre-specified
Number of Subjects With Serious Clinical Adverse Experiences (SCAEs)
Subjects were followed for all SCAEs. SCAEs are any CAEs occurring at any dose that: results in death; or is life threatening; or results in persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose.
Time frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
Population: All subjects who were vaccinated and followed up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RotaTeq™ Lot 1 | Number of Subjects With Serious Clinical Adverse Experiences (SCAEs) | With Serious CAEs | 4 Participants |
| RotaTeq™ Lot 1 | Number of Subjects With Serious Clinical Adverse Experiences (SCAEs) | Without Serious CAEs | 222 Participants |
| RotaTeq™ Lot 2 | Number of Subjects With Serious Clinical Adverse Experiences (SCAEs) | Without Serious CAEs | 220 Participants |
| RotaTeq™ Lot 2 | Number of Subjects With Serious Clinical Adverse Experiences (SCAEs) | With Serious CAEs | 4 Participants |
| RotaTeq™ Lot 3 | Number of Subjects With Serious Clinical Adverse Experiences (SCAEs) | With Serious CAEs | 2 Participants |
| RotaTeq™ Lot 3 | Number of Subjects With Serious Clinical Adverse Experiences (SCAEs) | Without Serious CAEs | 227 Participants |
| Placebo | Number of Subjects With Serious Clinical Adverse Experiences (SCAEs) | With Serious CAEs | 3 Participants |
| Placebo | Number of Subjects With Serious Clinical Adverse Experiences (SCAEs) | Without Serious CAEs | 108 Participants |
Other Pre-specified
Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs)
Serious vaccine-related CAEs are CAEs assessed by an investigator as being related to the vaccine that; results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is cancer; or is an overdose
Time frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
Population: All subjects who were vaccinated and followed up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RotaTeq™ Lot 1 | Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs) | With serious vaccine-related CAEs | 0 Participants |
| RotaTeq™ Lot 1 | Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs) | Without serious vaccine-related CAEs | 226 Participants |
| RotaTeq™ Lot 2 | Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs) | Without serious vaccine-related CAEs | 224 Participants |
| RotaTeq™ Lot 2 | Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs) | With serious vaccine-related CAEs | 0 Participants |
| RotaTeq™ Lot 3 | Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs) | With serious vaccine-related CAEs | 0 Participants |
| RotaTeq™ Lot 3 | Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs) | Without serious vaccine-related CAEs | 229 Participants |
| Placebo | Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs) | With serious vaccine-related CAEs | 1 Participants |
| Placebo | Number of Subjects With Serious Vaccine-Related Clinical AEs (CAEs) | Without serious vaccine-related CAEs | 110 Participants |
Other Pre-specified
Number of Subjects With Vaccine-Related Clinical AEs (CAEs)
CAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product. Vaccine-related CAEs are CAEs that are assessed by an investigator, who is a qualified physician, as being related to the vaccine according to his/her best clinical judgment.
Time frame: Up to 42 days following each study vaccination, or until the time of the subsequent study vaccination(s), whichever occurred first
Population: All subjects who were vaccinated and followed up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RotaTeq™ Lot 1 | Number of Subjects With Vaccine-Related Clinical AEs (CAEs) | With vaccine-related CAEs | 167 Participants |
| RotaTeq™ Lot 1 | Number of Subjects With Vaccine-Related Clinical AEs (CAEs) | Without vaccine-related CAEs | 59 Participants |
| RotaTeq™ Lot 2 | Number of Subjects With Vaccine-Related Clinical AEs (CAEs) | Without vaccine-related CAEs | 51 Participants |
| RotaTeq™ Lot 2 | Number of Subjects With Vaccine-Related Clinical AEs (CAEs) | With vaccine-related CAEs | 173 Participants |
| RotaTeq™ Lot 3 | Number of Subjects With Vaccine-Related Clinical AEs (CAEs) | Without vaccine-related CAEs | 64 Participants |
| RotaTeq™ Lot 3 | Number of Subjects With Vaccine-Related Clinical AEs (CAEs) | With vaccine-related CAEs | 165 Participants |
| Placebo | Number of Subjects With Vaccine-Related Clinical AEs (CAEs) | Without vaccine-related CAEs | 33 Participants |
| Placebo | Number of Subjects With Vaccine-Related Clinical AEs (CAEs) | With vaccine-related CAEs | 78 Participants |