Rotavirus
Conditions
Brief summary
This is a Phase I clinical trial including 2 parts to evaluate the safety and immune response to RotaTeq™ /placebo in subjects of 65 to 80 years of age. In Part I, approximately 60 subjects in US will be randomly assigned to 1 of 2 treatment groups receiving 3 doses of RotaTeq™ or placebo. In Part II, approximately 200 subjects internationally will be randomly assigned to 1 of 3 treatment groups. Part II will start after Part I data analysis is reviewed and approved by the FDA/CBER, the Safety Evaluation Committee (SEC) and other regulatory agencies. Duration for the entire study will be approximately 4 years. Note: As the result of a business decision by the Sponsor, the study did not proceed with Part II. Therefore, this report includes the results for Part I only.
Interventions
BIOLOGICALComparator: RotaTeq
Three 2.0 mL oral doses of RotaTeq. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
BIOLOGICALComparator: Placebo
Three 2.0 mL oral doses of RotaTeq. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
BIOLOGICALComparator: RotaTeq + Placebo
One 2.0 mL oral dose of RotaTeq and two 2.0 mL oral doses of placebo over an approximately 3-5 month treatment period
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Is 65 to 80 years of age with controlled chronic illness * agrees to participate in the study by giving written informed consent and cognitively competent as assessed by Mini-Mental State Examination * for Part I: subject is living independently outside any long-term care facilities; for Part II: subject is expected to be a resident in a long term care facility (LTCF) including nursing homes with the exception of hospice care * can be adequately followed for safety via visit or phone * subject's routine safety lab results are within specified ranges * has negative test results for HIV, Hepatitis B, and Hepatitis C
Exclusion criteria
* abdominal cancer/surgery within the past 6 months * known or suspected immune diseases, e.g. diabetes * any chronic or relapsing infections * a fever at the time of immunization * active vomiting or diarrhea at the time of immunization * chronic diarrhea, irritable bowel syndrome, or inflammatory disease of intestinal or colon in the past 12 months * subjects' spouses/cohabitants are not healthy or are immunocompromised; roommates in LTCFs are not healthy and/or do not agree to participate in the study * cannot be adequately followed for safety via visit or phone * any other clinically significant conditions that, in the investigators' opinion, would interfere with subject's participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part I: Number of Participants With Nonserious and Serious Adverse Experiences (AEs) | Up to 42 days following any dose of RotaTeq™ or placebo | All randomized participants were contacted via telephone or in-center visit on Days 7, 14, 28, and 42 after each dose. Participants received a Vaccination Report Card (VRC) at each vaccination visit as well as instructions for recording AEs. Participants were also instructed to record potential acute gastroenteritis episodes (AGEs) that occurred within 42 days after any dose on the report card. |
| Part I: Number of Participants With Serious Adverse Experiences (SAEs) | Up to 180 days following the third dose of RotaTeq™ or placebo | All randomized participants were contacted via telephone or in-center visit on Days 7, 14, 28, and 42 after each dose. Participants received a Vaccination Report Card (VRC) at each vaccination visit as well as instructions for recording AEs. Participants were also instructed to record potential acute gastroenteritis episodes (AGEs) that occurred within 42 days after any dose on the report card. SAEs were followed by passive surveillance (in which either participants self reported or information was collected at participants' last visit) for 180 days following the final dose. |
| Part I: Geometric Mean Titers (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA) | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo | GMTs of serum anti-rotavirus IgA responses after 1, 2, or 3 doses of RotaTeq™ or placebo. |
| Part II: Number of Participants With Nonserious Adverse Experiences | Up to 42 days following any dose of RotaTeq™ and/or placebo | Part II was not conducted due to study termination; this report summarizes study results from Part I only. |
| Part II: Number of Participants With Serious Adverse Experiences | Up to 180 days following the third dose of RotaTeq™ and/or placebo | Part II was not conducted due to study termination; this report summarizes study results from Part I only. |
| Part II: Geometric Mean Titer (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA) | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 | Part II was not conducted due to study termination; this report summarizes study results from Part I only. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1 | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo | — |
| Part II: Percentage of Participants With a >=3-fold Rise From Baseline of Serum Anti-rotavirus IgA and SNA Responses to Rotavirus Serotypes G1, G2, G3, G4 and P1A | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 | Part II was not conducted due to study termination; this report summarizes study results from Part I only. |
| Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2 | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo | — |
| Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3 | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo | — |
| Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4 | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo | — |
| Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8] | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo | — |
| Part II: Geometric Mean Titers (GMTs) of Serum Neutralizing Antibody (SNA) Responses to G1, G2, G3, G4, and P1A | Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 | Part II was not conducted due to study termination; this report summarizes study results from Part I only. |
Participant flow
Recruitment details
Enrollment of participants occurred at 8 study sites in the United States.
Pre-assignment details
Part II was not conducted; no participants were recruited.
Participants by arm
| Arm | Count |
|---|---|
| RotaTeq™ Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2. | 44 |
| Placebo Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2. | 22 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | RotaTeq™ | Placebo | Total |
|---|---|---|---|
| Age, Customized | 44 participants | 22 participants | 66 participants |
| Region of Enrollment United States | 44 participants | 22 participants | 66 participants |
| Sex: Female, Male Female | 23 Participants | 13 Participants | 36 Participants |
| Sex: Female, Male Male | 21 Participants | 9 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 44 | 4 / 22 |
| serious Total, serious adverse events | 2 / 44 | 0 / 22 |
Outcome results
Primary
Part I: Geometric Mean Titers (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA)
GMTs of serum anti-rotavirus IgA responses after 1, 2, or 3 doses of RotaTeq™ or placebo.
Time frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo
Population: All endpoints exclude protocol violators \& participants with invalid data based on laboratory determinations.~Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window \& were not protocol violators.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RotaTeq™ | Part I: Geometric Mean Titers (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA) | Pre-Vaccination GMT (n=36 RotaTeq/ n=19 placebo) | 679.6 titers |
| RotaTeq™ | Part I: Geometric Mean Titers (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA) | Postdose 1 GMT (n=28 RotaTeq/ n=16 placebo) | 1026.8 titers |
| RotaTeq™ | Part I: Geometric Mean Titers (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA) | Postdose 2 GMT (n=37 RotaTeq/ n=20 placebo) | 1187.0 titers |
| RotaTeq™ | Part I: Geometric Mean Titers (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA) | Postdose 3 GMT (n=38 RotaTeq/ n=18 placebo) | 1179.9 titers |
| Placebo | Part I: Geometric Mean Titers (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA) | Postdose 3 GMT (n=38 RotaTeq/ n=18 placebo) | 578.5 titers |
| Placebo | Part I: Geometric Mean Titers (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA) | Pre-Vaccination GMT (n=36 RotaTeq/ n=19 placebo) | 578.4 titers |
| Placebo | Part I: Geometric Mean Titers (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA) | Postdose 2 GMT (n=37 RotaTeq/ n=20 placebo) | 657.7 titers |
| Placebo | Part I: Geometric Mean Titers (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA) | Postdose 1 GMT (n=28 RotaTeq/ n=16 placebo) | 552.8 titers |
Primary
Part II: Geometric Mean Titer (GMT) of Serum Anti-rotavirus Immunoglobulin A (IgA)
Part II was not conducted due to study termination; this report summarizes study results from Part I only.
Time frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3
Primary
Part II: Number of Participants With Nonserious Adverse Experiences
Part II was not conducted due to study termination; this report summarizes study results from Part I only.
Time frame: Up to 42 days following any dose of RotaTeq™ and/or placebo
Primary
Part II: Number of Participants With Serious Adverse Experiences
Part II was not conducted due to study termination; this report summarizes study results from Part I only.
Time frame: Up to 180 days following the third dose of RotaTeq™ and/or placebo
Primary
Part I: Number of Participants With Nonserious and Serious Adverse Experiences (AEs)
All randomized participants were contacted via telephone or in-center visit on Days 7, 14, 28, and 42 after each dose. Participants received a Vaccination Report Card (VRC) at each vaccination visit as well as instructions for recording AEs. Participants were also instructed to record potential acute gastroenteritis episodes (AGEs) that occurred within 42 days after any dose on the report card.
Time frame: Up to 42 days following any dose of RotaTeq™ or placebo
Population: All randomized participants who received at least one dose of RotaTeq™ or placebo are included in the summaries.~Number of participants with one or more adverse experience.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RotaTeq™ | Part I: Number of Participants With Nonserious and Serious Adverse Experiences (AEs) | 26 participants |
| Placebo | Part I: Number of Participants With Nonserious and Serious Adverse Experiences (AEs) | 9 participants |
Primary
Part I: Number of Participants With Serious Adverse Experiences (SAEs)
All randomized participants were contacted via telephone or in-center visit on Days 7, 14, 28, and 42 after each dose. Participants received a Vaccination Report Card (VRC) at each vaccination visit as well as instructions for recording AEs. Participants were also instructed to record potential acute gastroenteritis episodes (AGEs) that occurred within 42 days after any dose on the report card. SAEs were followed by passive surveillance (in which either participants self reported or information was collected at participants' last visit) for 180 days following the final dose.
Time frame: Up to 180 days following the third dose of RotaTeq™ or placebo
Population: All randomized participants who received at least one dose of RotaTeq™ or placebo are included in the summaries.~Number of participants with one or more adverse experience.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RotaTeq™ | Part I: Number of Participants With Serious Adverse Experiences (SAEs) | 1 participants |
| Placebo | Part I: Number of Participants With Serious Adverse Experiences (SAEs) | 0 participants |
Secondary
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1
Time frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo
Population: All endpoints exclude protocol violators \& participants with invalid data based on laboratory determinations.~Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window \& were not protocol violators.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RotaTeq™ | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1 | Pre-Vaccination GMT (n=36 RotaTeq/ n=19 Placebo) | 314.5 titers |
| RotaTeq™ | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1 | Postdose 1 GMT (n=28 RotaTeq/ n=16 Placebo) | 506.2 titers |
| RotaTeq™ | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1 | Postdose 2 GMT (n=37 RotaTeq/ n=20 Placebo) | 556.1 titers |
| RotaTeq™ | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1 | Postdose 3 GMT (n=38 RotaTeq/ n=18 Placebo) | 535.9 titers |
| Placebo | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1 | Postdose 3 GMT (n=38 RotaTeq/ n=18 Placebo) | 231.6 titers |
| Placebo | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1 | Pre-Vaccination GMT (n=36 RotaTeq/ n=19 Placebo) | 281.4 titers |
| Placebo | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1 | Postdose 2 GMT (n=37 RotaTeq/ n=20 Placebo) | 226.7 titers |
| Placebo | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G1 | Postdose 1 GMT (n=28 RotaTeq/ n=16 Placebo) | 228.7 titers |
Secondary
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2
Time frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo
Population: All endpoints exclude protocol violators \& participants with invalid data based on laboratory determinations.~Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window \& were not protocol violators.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RotaTeq™ | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2 | Pre-Vaccination GMT (n= 36 RotaTeq/ n=19 placebo) | 62.8 titers |
| RotaTeq™ | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2 | Postdose 1 GMT (n= 28 RotaTeq/ n=16 placebo) | 123.4 titers |
| RotaTeq™ | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2 | Postdose 2 GMT (n= 37 RotaTeq/ n=20 placebo) | 111.2 titers |
| RotaTeq™ | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2 | Postdose 3 GMT (n= 38 RotaTeq/ n=18 placebo) | 127.0 titers |
| Placebo | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2 | Postdose 3 GMT (n= 38 RotaTeq/ n=18 placebo) | 71.3 titers |
| Placebo | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2 | Pre-Vaccination GMT (n= 36 RotaTeq/ n=19 placebo) | 68.2 titers |
| Placebo | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2 | Postdose 2 GMT (n= 37 RotaTeq/ n=20 placebo) | 74.3 titers |
| Placebo | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G2 | Postdose 1 GMT (n= 28 RotaTeq/ n=16 placebo) | 56.3 titers |
Secondary
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3
Time frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo
Population: All endpoints exclude protocol violators \& participants with invalid data based on laboratory determinations.~Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window \& were not protocol violators.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RotaTeq™ | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3 | Pre-Vaccination GMT (n= 36 RotaTeq/ n=19 placebo) | 141.8 titers |
| RotaTeq™ | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3 | Postdose 1 GMT (n= 28 RotaTeq/ n=16 placebo) | 404.6 titers |
| RotaTeq™ | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3 | Postdose 2 GMT (n= 37 RotaTeq/ n=20 placebo) | 330.7 titers |
| RotaTeq™ | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3 | Postdose 3 GMT (n= 38 RotaTeq/ n=18 placebo) | 388.0 titers |
| Placebo | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3 | Postdose 3 GMT (n= 38 RotaTeq/ n=18 placebo) | 102.1 titers |
| Placebo | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3 | Pre-Vaccination GMT (n= 36 RotaTeq/ n=19 placebo) | 90.9 titers |
| Placebo | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3 | Postdose 2 GMT (n= 37 RotaTeq/ n=20 placebo) | 119.8 titers |
| Placebo | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G3 | Postdose 1 GMT (n= 28 RotaTeq/ n=16 placebo) | 94.5 titers |
Secondary
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4
Time frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo
Population: All endpoints exclude protocol violators \& participants with invalid data based on laboratory determinations.~Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window \& were not protocol violators.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RotaTeq™ | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4 | Pre-Vaccination GMT (n= 36 RotaTeq/ n=19 placebo) | 91.6 titers |
| RotaTeq™ | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4 | Postdose 1 GMT (n= 28 RotaTeq/ n=16 placebo) | 199.2 titers |
| RotaTeq™ | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4 | Postdose 2 GMT (n= 37 RotaTeq/ n=20 placebo) | 223.9 titers |
| RotaTeq™ | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4 | Postdose 3 GMT (n= 3 RotaTeq/ n=18 placebo) | 221.7 titers |
| Placebo | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4 | Postdose 3 GMT (n= 3 RotaTeq/ n=18 placebo) | 106.9 titers |
| Placebo | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4 | Pre-Vaccination GMT (n= 36 RotaTeq/ n=19 placebo) | 102.7 titers |
| Placebo | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4 | Postdose 2 GMT (n= 37 RotaTeq/ n=20 placebo) | 110.1 titers |
| Placebo | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype G4 | Postdose 1 GMT (n= 28 RotaTeq/ n=16 placebo) | 93.1 titers |
Secondary
Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8]
Time frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3 of RotaTeq™ or placebo
Population: All endpoints exclude protocol violators \& participants with invalid data based on laboratory determinations.~Analyses of endpoints based on a Per-protocol (PP) population: participants who received at least one dose study designed material and had at least one valid assay result within study specified time window \& were not protocol violators.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RotaTeq™ | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8] | Pre-Vaccination GMT (n= 36 RotaTeq/ n=19 placebo) | 230.8 titers |
| RotaTeq™ | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8] | Postdose 1 GMT (n= 28 RotaTeq/ n=16 placebo) | 306.4 titers |
| RotaTeq™ | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8] | Postdose 2 GMT (n= 37 RotaTeq/ n=20 placebo) | 375.6 titers |
| RotaTeq™ | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8] | Postdose 3 GMT (n= 38 RotaTeq/ n=18 placebo) | 327.6 titers |
| Placebo | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8] | Postdose 3 GMT (n= 38 RotaTeq/ n=18 placebo) | 160.7 titers |
| Placebo | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8] | Pre-Vaccination GMT (n= 36 RotaTeq/ n=19 placebo) | 143.4 titers |
| Placebo | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8] | Postdose 2 GMT (n= 37 RotaTeq/ n=20 placebo) | 154.0 titers |
| Placebo | Part I: Geometric Mean Titer (GMT) of Serum Neutralizing Antibody (SNA) Response to Human Rotavirus Serotype P1A[8] | Postdose 1 GMT (n= 28 RotaTeq/ n=16 placebo) | 126.1 titers |
Secondary
Part II: Geometric Mean Titers (GMTs) of Serum Neutralizing Antibody (SNA) Responses to G1, G2, G3, G4, and P1A
Part II was not conducted due to study termination; this report summarizes study results from Part I only.
Time frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3
Secondary
Part II: Percentage of Participants With a >=3-fold Rise From Baseline of Serum Anti-rotavirus IgA and SNA Responses to Rotavirus Serotypes G1, G2, G3, G4 and P1A
Part II was not conducted due to study termination; this report summarizes study results from Part I only.
Time frame: Prior to Dose 1 and 28 to 42 days Postdose 1, 2, and 3