Gastroenteritis, Rotavirus
Conditions
Brief summary
To observe the safety, tolerability and immunogenicity of the administration of 3 doses of rotateq in healthy Indian infants between 6 weeks through exactly 12 weeks of age at entry.
Interventions
Pentavalent vaccine 9G1, G2, G3, G4 & P1) given 3 times. Dose 1 will be administered at study entry; Dose 2 will be administered 4 to 10 weeks (28 to 70 days) after Dose 1; and Dose 3 will be administered 4 to 10 weeks (28 to 70 days) after Dose 2.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Age 6 weeks through exactly 12 weeks * Healthy infants
Exclusion criteria
* Clinical evidence of active gastrointestinal illness * Fever, with a rectal temperature of greater than and equal to thirty eight degree celsius at the time of immunization * History of congenital abdominal disorders, intussusception, or abdominal surgery * History of known prior rotavirus disease * Known or suspected impairment of immunological function * Prior administration of any rotavirus vaccine * Known hypersensitivity to any component of the rotavirus vaccine, e.g. trypsin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA | Baseline and Approximately 6 Months |
| The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies (SNA) | Baseline and Approximately 6 Months |
| The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA) | Baseline and Approximately 6 Months |
| The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA) | Baseline and Approximately 6 Months |
| The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA) | Baseline and Approximately 6 Months |
| The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA) | Baseline and Approximately 6 Months |
| The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies(SNA) | Baseline and Approximately 6 Months |
| The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA | Baseline and Approximately 6 Months |
| The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1 | Baseline and Approximately 6 Months |
| The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2 | Baseline and Approximately 6 Months |
| The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3 | Baseline and Approximately 6 Months |
| The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4 | Baseline and Approximately 6 Months |
| The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1 | Baseline and Approximately 6 Months |
Participant flow
Recruitment details
Phase III First Patient In (FPI): 09-May-2008 Last Patient Out (LPO): 20-Nov-2008 Multi-center study 1. Department of Paediatrics, Kashyap Nursing Home, Mumbai. 2. Department of Paediatrics, KEM Hospital, Pune 3. Department of Paediatrics, J.K.Lon, SMS Hospital, Jaipur 4. Panchsheel Hospital, Delhi
Pre-assignment details
Open-label, single-arm study. Healthy infants between the ages of 6 weeks through exactly 12 weeks (≥42 to ≤84 days) at entry who did not have clinical evidence of active gastrointestinal illness; who did not have fever, with a rectal temperature of greater than and equal to 38 degrees Celsius at first vaccination were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| RotaTeq™ Vaccine (V260) Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart. | 110 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 7 |
Baseline characteristics
| Characteristic | RotaTeq™ Vaccine (V260) |
|---|---|
| Age, Continuous | 59.01 Days STANDARD_DEVIATION 13.52 |
| Height | 57.61 Centimeters STANDARD_DEVIATION 5.04 |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 63 Participants |
| Temperature | 98.58 Fahrenheit STANDARD_DEVIATION 0.7 |
| Weight | 4.73 Kilograms STANDARD_DEVIATION 0.71 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 47 / 104 |
| serious Total, serious adverse events | 1 / 104 |
Outcome results
Primary
The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA
Time frame: Baseline and Approximately 6 Months
Population: The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RotaTeq™ Vaccine (V260) | The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA | 82.35 Percentage of Participants |
Primary
The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA
Time frame: Baseline and Approximately 6 Months
Population: The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RotaTeq™ Vaccine (V260) | The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA | 82.83 Percentage of Participants |
Primary
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies (SNA)
Time frame: Baseline and Approximately 6 Months
Population: The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RotaTeq™ Vaccine (V260) | The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies (SNA) | 38.24 Percentage of Participants |
Primary
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies(SNA)
Time frame: Baseline and Approximately 6 Months
Population: The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RotaTeq™ Vaccine (V260) | The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies(SNA) | 37.37 Percentage of Participants |
Primary
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)
Time frame: Baseline and Approximately 6 Months
Population: The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RotaTeq™ Vaccine (V260) | The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA) | 14.71 Percentage of Participants |
Primary
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)
Time frame: Baseline and Approximately 6 Months
Population: The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RotaTeq™ Vaccine (V260) | The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA) | 14.14 Percentage of Participants |
Primary
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)
Time frame: Baseline and Approximately 6 Months
Population: The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RotaTeq™ Vaccine (V260) | The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA) | 30.39 Percentage of Participants |
Primary
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)
Time frame: Baseline and Approximately 6 Months
Population: The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RotaTeq™ Vaccine (V260) | The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA) | 29.29 Percentage of Participants |
Primary
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)
Time frame: Baseline and Approximately 6 Months
Population: The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RotaTeq™ Vaccine (V260) | The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA) | 35.35 Percentage of Participants |
Primary
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)
Time frame: Baseline and Approximately 6 Months
Population: The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RotaTeq™ Vaccine (V260) | The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA) | 37.25 Percentage of Participants |
Primary
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)
Time frame: Baseline and Approximately 6 Months
Population: The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RotaTeq™ Vaccine (V260) | The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA) | 30.39 Percentage of Participants |
Primary
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)
Time frame: Baseline and Approximately 6 Months
Population: The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RotaTeq™ Vaccine (V260) | The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA) | 29.29 Percentage of Participants |
Primary
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1
Time frame: Baseline and Approximately 6 Months
Population: The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RotaTeq™ Vaccine (V260) | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1 | G1 GMT at Baseline | 43.11 Titer |
| RotaTeq™ Vaccine (V260) | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1 | G1 GMT at 6 Months | 81.19 Titer |
Primary
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1
Time frame: Baseline and Approximately 6 Months
Population: The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RotaTeq™ Vaccine (V260) | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1 | G1 GMT at Baseline | 43.53 Titer |
| RotaTeq™ Vaccine (V260) | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1 | G1 GMT at 6 Months | 85.79 Titer |
Primary
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2
Time frame: Baseline and Approximately 6 Months
Population: The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RotaTeq™ Vaccine (V260) | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2 | G2 GMT at Baseline | 63.25 Titer |
| RotaTeq™ Vaccine (V260) | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2 | G2 GMT at 6 Months | 50.33 Titer |
Primary
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2
Time frame: Baseline and Approximately 6 Months
Population: The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RotaTeq™ Vaccine (V260) | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2 | G2 GMT at Baseline | 62.91 Titer |
| RotaTeq™ Vaccine (V260) | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2 | G2 GMT at 6 Months | 49.21 Titer |
Primary
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3
Time frame: Baseline and Approximately 6 Months
Population: The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RotaTeq™ Vaccine (V260) | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3 | G3 GMT at Baseline | 27.71 Titer |
| RotaTeq™ Vaccine (V260) | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3 | G3 GMT at 6 Months | 32.95 Titer |
Primary
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3
Time frame: Baseline and Approximately 6 Months
Population: The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RotaTeq™ Vaccine (V260) | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3 | G3 GMT at Baseline | 27.22 Titer |
| RotaTeq™ Vaccine (V260) | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3 | G3 GMT at 6 Months | 34.32 Titer |
Primary
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4
Time frame: Baseline and Approximately 6 Months
Population: The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RotaTeq™ Vaccine (V260) | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4 | G4 GMT at Baseline | 51.74 Titer |
| RotaTeq™ Vaccine (V260) | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4 | G4 GMT at 6 Months | 80.88 Titer |
Primary
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4
Time frame: Baseline and Approximately 6 Months
Population: The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RotaTeq™ Vaccine (V260) | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4 | G4 GMT at Baseline | 51.91 Titer |
| RotaTeq™ Vaccine (V260) | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4 | G4 GMT at 6 Months | 84.43 Titer |
Primary
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA
Time frame: Baseline and Approximately 6 Months
Population: The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RotaTeq™ Vaccine (V260) | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA | IgA GMT at Baseline | 3.81 Titer |
| RotaTeq™ Vaccine (V260) | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA | IgA GMT at 6 Months | 79.95 Titer |
Primary
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA
Time frame: Baseline and Approximately 6 Months
Population: The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RotaTeq™ Vaccine (V260) | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA | IgA GMT at Baseline | 3.68 Titer |
| RotaTeq™ Vaccine (V260) | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA | IgA GMT at 6 Months | 75.12 Titer |
Primary
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1
Time frame: Baseline and Approximately 6 Months
Population: The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RotaTeq™ Vaccine (V260) | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1 | P1 GMT at Baseline | 84.17 Titer |
| RotaTeq™ Vaccine (V260) | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1 | P1 GMT at 6 Months | 100.01 Titer |
Primary
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1
Time frame: Baseline and Approximately 6 Months
Population: The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RotaTeq™ Vaccine (V260) | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1 | P1 GMT at Baseline | 86.61 Titer |
| RotaTeq™ Vaccine (V260) | The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1 | P1 GMT at 6 Months | 104.56 Titer |