Rotavirus
Conditions
Keywords
Gastrointestinal Rotavirus
Brief summary
Immunogenicity and Safety of V260 in Healthy Infants in Korea
Interventions
3 doses of rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2
BIOLOGICALComparator: Placebo
3 doses of placebo to rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2
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
* At first study vaccination, age 6 weeks through exactly 12 weeks
Exclusion criteria
* History of congenital abdominal disorders, intussusception, or abdominal surgery * History of known prior rotavirus disease * Ongoing chronic diarrhea or failure to thrive * Clinical evidence of active gastrointestinal illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Anti-Rotavirus IgA Response | Baseline and 14 days Postdose 3 | Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in Serum IgA 14 days Postdose 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A | Baseline and 14 days Postdose 3 | Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in SNA response to G1, G2, G3, G4 and P1A 14 days Postdose 3 |
Participant flow
Recruitment details
The study was conducted at 8 sites.in Korea from 02-Aug-2005 (first patient in) to 25-May-2006 (last dose given). Last subject completed follow-up: 05-Jul-2006. All data corrections applied (Frozen File) on 18- Aug-2006
Pre-assignment details
Subjects with history of congenital abdominal disorders, intussusception, or abdominal surgery; history of known prior rotavirus disease; ongoing chronic diarrhea or failure to thrive and those with clinical evidence of active gastrointestinal illness were excluded.
Participants by arm
| Arm | Count |
|---|---|
| RotaTeq™ Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination. | 115 |
| Placebo Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination. | 63 |
| Total | 178 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Protocol Violation | 4 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | RotaTeq™ | Placebo | Total |
|---|---|---|---|
| Age, Customized 6-12 Weeks of Age | 114 participants | 63 participants | 177 participants |
| Age, Customized Over 12 Weeks of Age | 1 participants | 0 participants | 1 participants |
| Sex: Female, Male Female | 46 Participants | 30 Participants | 76 Participants |
| Sex: Female, Male Male | 69 Participants | 33 Participants | 102 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 110 / 114 | 63 / 63 |
| serious Total, serious adverse events | 6 / 114 | 7 / 63 |
Outcome results
Primary
Serum Anti-Rotavirus IgA Response
Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in Serum IgA 14 days Postdose 3
Time frame: Baseline and 14 days Postdose 3
Population: Per Protocol Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RotaTeq™ | Serum Anti-Rotavirus IgA Response | 89 Participants |
| Placebo | Serum Anti-Rotavirus IgA Response | 7 Participants |
p-value: 0.003Exact test of proportion
Secondary
Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A
Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in SNA response to G1, G2, G3, G4 and P1A 14 days Postdose 3
Time frame: Baseline and 14 days Postdose 3
Population: Per Protocol Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| RotaTeq™ | Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A | Number of subjects with ≥ 3-fold rise in SNA to G3 | 42 Participants |
| RotaTeq™ | Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A | Number of subjects with ≥ 3-fold rise in SNA to G2 | 34 Participants |
| RotaTeq™ | Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A | Number of subjects with ≥ 3-fold rise in SNA to G4 | 62 Participants |
| RotaTeq™ | Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A | Number of subjects with ≥3-fold rise in SNA to P1A | 65 Participants |
| RotaTeq™ | Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A | Number of subjects with ≥ 3-fold rise in SNA to G1 | 67 Participants |
| Placebo | Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A | Number of subjects with ≥3-fold rise in SNA to P1A | 3 Participants |
| Placebo | Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A | Number of subjects with ≥ 3-fold rise in SNA to G1 | 2 Participants |
| Placebo | Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A | Number of subjects with ≥ 3-fold rise in SNA to G2 | 1 Participants |
| Placebo | Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A | Number of subjects with ≥ 3-fold rise in SNA to G3 | 1 Participants |
| Placebo | Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A | Number of subjects with ≥ 3-fold rise in SNA to G4 | 4 Participants |