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CompletedNCT00090233Updated Oct 5, 2015Results posted

Rotavirus Efficacy and Safety Trial (REST)(V260-006)

A Phase 3 interventional study of Rotateq™ and Comparator: Placebo in Rotavirus Infections, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 6 Weeks to 12 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-05.

Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
69,274
Allocation
Randomized
Ages
6 Weeks to 12 Weeks
Sex
All
01

Study summary

This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis.

02

Conditions studied

  • Rotavirus Infections

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03

In context

Rotavirus Infections

104 studies on the registry are indexed under Rotavirus Infections; 3 are open to participants now.

This study's enrollment of 69,274 is above the median of 403 across 69 interventional studies indexed under Rotavirus Infections.

Browse Rotavirus Infections studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.

Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.

Browse Merck Sharp & Dohme LLC studies →All Merck & Co., Inc studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Weeks to 12 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy infants

Exclusion criteria

Exclusion Criteria:

  • None Specified
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
69,274 participants (actual)

Study arms

  • Experimental
    1

    RotaTeq

    Biological: Rotateq™

  • Placebo comparator
    2

    Placebo

    Biological: Comparator: Placebo

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.

    Also known as: V260

  • 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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

07

Results

Posted May 5, 2011
Limitations and caveats
70,301 participants randomized, 69,274 evaluated, when DSMB first recommended ending enrollment.

Participant flow

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).

Participant flow — Overall Study
MilestoneRotaTeq™Placebo
Started3464434630
Vaccinated at visit 13403534003
Vaccinated at visit 23105231066
Vaccinated at visit 32966729598
Completed2964529565
Not completed49995065
Withdrew: Randomized not vaccinated (visit 1)609627
Withdrew: Adverse event214198
Withdrew: Lost to follow-up6895
Withdrew: Protocol violation9601022
Withdrew: Withdrawal by subject182211
Withdrew: Moved203189
Withdrew: Other12111160
Withdrew: Data not available at data cut-off point15521563

Outcome measures

PrimaryIntussusception 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
Reported as:
Number · Participants
Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo
ParticipantsRotaTeq™Placebo
Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo65
Statistical analysis
  • RotaTeq™ vs Placebo · Exact binomial test · p = 0.006 (p≤ 10/11, where p is proportion of participants with intussusception in vaccine group relative to total number of participants with intussusception. Based on conditional binomial approach. Adjusted for group-sequential design.) · Relative risk: 1.6 · 95% CI 0.4 to 6.4Exact binomial test adjusted for group-sequential design.
SecondaryG1 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
Reported as:
Number · Participants
G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus
ParticipantsRotaTeq™Placebo
G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus958
Statistical analysis
  • RotaTeq™ · Exact binomial test · p = <0.001 (p≥42%, where p is proportion of participants with ≥3-fold rise in antibody titer from Predose 1 to Postdose 3 in vaccine group. Based on binomial approach.) · Proportion: 81.2 · 95% CI 72.9 to 87.8
PrimaryOccurrence 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
Reported as:
Number · Participants
Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination
ParticipantsRotaTeq™Placebo
Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination82315
Statistical analysis
  • RotaTeq™ vs Placebo · Exact binomial test · p = <0.001 (Efficacy≥35%. Based on p≤.65/(.65+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, k is ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.) · Efficacy=1-relative risk: 74.0 · 95% CI 66.8 to 79.9Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.
SecondaryOccurrence 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
Reported as:
Number · Annual # of events per 1000 person-years
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
Annual # of events per 1000 person-yearsRotaTeq™Placebo
Hospital admissions6144
Emergency department visits14213
Statistical analysis
  • RotaTeq™ vs Placebo · Poisson regression · p = <0.001 (Rate Reduction\>0%) · Risk ratio (rr): 94.5 · 95% CI 91.2 to 96.6Risk ratio of rate of hospitalizations and emergency department visits between treatment groups. Reported here are results after 12 additional emergency department visits were identified among placebo recipients and data were re-analyzed.
SecondaryEfficacy 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
Reported as:
Number · Participants
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.
ParticipantsRotaTeq™Placebo
First episode scores48262
Worst episode scores49265
Statistical analysis
  • RotaTeq™ vs Placebo · Exact binomial test · p = <0.001 (Efficacy\>0%. Based on p\< 1/(1+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, and k is ratio of follow-up time; placebo / vaccine. Based on conditional binomial approach.) · Efficacy=1-relative risk: 81.5 · 95% CI 74.9 to 86.7Estimated value is based on the worst episode scores.
SecondaryEfficacy 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
Reported as:
Number · Participants
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
ParticipantsRotaTeq™Placebo
First episode scores151
Worst episode scores151
Statistical analysis
  • RotaTeq™ vs Placebo · Exact binomial test · p = <0.001 (Efficacy\>0%. Based on p\< 1/(1+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, and k is ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.) · Efficacy=1-relative risk: 98.0 · 95% CI 88.3 to 100
SecondarySeroprotection/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
Reported as:
Number · Participants
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
ParticipantsRotaTeq™Placebo
Hepatitis B (N=202, N=214)197203
Haemophilus influenzae type b (N=558, N=592)417426
Diphtheria (N=136, N=144)136142
Tetanus (N=132, N=140)132140
Polio type 1 (N=341, N=360)328349
Polio type 2 (N=341, N=359)311326
Polio type 3 (N=341, N=359)324343
Statistical analysis
  • RotaTeq™ vs Placebo · Miettenen and Nurminen · p = <0.001 (p\<0.001 was obtained for all comparisons. pv - pp ≥-.10, where p is proportion of participants who achieved seroprotection in the vaccine and placebo groups, respectively.)
SecondaryGeometric 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
Reported as:
Geometric mean · ELISA units/mL
Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin
ELISA units/mLRotaTeq™Placebo
Pertussis PT20.18 (17.10 to 23.81)22.73 (19.59 to 26.37)
Pertussis FHA55.69 (48.01 to 64.59)64.33 (55.41 to 74.69)
Pertussis Pertactin34.77 (26.46 to 45.70)59.17 (46.21 to 75.76)
Statistical analysis
  • RotaTeq™ vs Placebo · t-test, 1 sided · p = <0.001 · Gmtr for pertussis pt: 0.9 · 95% CI 0.7 to 1.1t-test on natural log of titers
  • RotaTeq™ vs Placebo · t-test, 1 sided · p = <0.001 · Gmtr for pertussis fha: 0.9 · 95% CI 0.7 to 1.1t-test on natural log of titers
  • RotaTeq™ vs Placebo · t-test, 1 sided · p = 0.193 · Gmtr for pertussis pertactin: 0.6 · 95% CI 0.4 to 0.8t-test on natural log of titers
SecondaryGeometric 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
Reported as:
Geometric mean · micrograms/mL
Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F
micrograms/mLRotaTeq™Placebo
Pneumococcal serotype 4 (N=181, N=196)1.13 (0.99 to 1.29)0.96 (0.84 to 1.09)
Pneumococcal serotype 6B (N=185, N=198)2.39 (1.93 to 2.95)1.72 (1.38 to 2.13)
Pneumococcal serotype 9V (N=166, N=181)1.90 (1.66 to 2.19)1.78 (1.55 to 2.04)
Pneumococcal serotype 14 (N=178, N=198)4.24 (3.39 to 5.29)4.33 (3.55 to 5.28)
Pneumococcal serotype 18C (N=166, N=180)2.60 (2.30 to 2.94)2.02 (1.76 to 2.32)
Pneumococcal serotype 19F (N=180, N=196)1.97 (1.61 to 2.42)1.84 (1.55 to 2.20)
Pneumococcal serotype 23F (N=185, N=198)1.71 (1.41 to 2.07)1.50 (1.24 to 1.80)
Statistical analysis
  • RotaTeq™ vs Placebo · t-test, 1 sided · p = <0.001 · Gmtr for pneumococcal serotype 4: 1.2 · 95% CI 1.0 to 1.4t-test on natural log of titers
  • RotaTeq™ vs Placebo · t-test, 1 sided · p = <0.001 · Gmtr for pneumococcal serotype 6b: 1.4 · 95% CI 1.0 to 1.9t-test on natural log of titers
  • RotaTeq™ vs Placebo · t-test, 1 sided · p = <0.001 · Gmtr for pneumococcal serotype 9v: 1.1 · 95% CI 0.9 to 1.3t-test on natural log of titers
  • RotaTeq™ vs Placebo · t-test, 1 sided · p = <0.001 · Gmtr for pneumococcal serotype 14: 1.0 · 95% CI 0.7 to 1.3t-test on natural log of titers
  • RotaTeq™ vs Placebo · t-test, 1 sided · p = <0.001 · Gmtr for pneumococcal serotype 18c: 1.3 · 95% CI 1.1 to 1.6t-test on natural log of titers
  • RotaTeq™ vs Placebo · t-test, 1 sided · p = <0.001 · Gmtr for pneumococcal serotype 19f: 1.1 · 95% CI 0.8 to 1.4t-test on natural log of titers
  • RotaTeq™ vs Placebo · t-test, 1 sided · p = <0.001 · Gmtr for pneumococcal serotype 23f: 1.1 · 95% CI 0.9 to 1.5t-test on natural log of titers

Adverse events

Collected over Participants in this study were followed for all serious adverse events (SAEs) and other adverse events (AEs), for up to 42 days following each study vaccination. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
RotaTeq™—863/34,904 (2.5%)4,000/4,800 (83.3%)
Placebo—955/34,862 (2.7%)4,047/4,787 (84.5%)
Most frequent serious events
Showing 10 of 339
Most frequent serious events
EventRotaTeq™Placebo
BronchiolitisInfections and infestations215/34904253/34862
GastroenteritisInfections and infestations73/34904127/34862
PneumoniaInfections and infestations55/3490458/34862
PyrexiaGeneral disorders43/3490449/34862
Urinary tract infectionInfections and infestations38/3490429/34862
Gastrooesophageal reflux diseaseGastrointestinal disorders29/3490417/34862
Otitis mediaInfections and infestations28/3490424/34862
PyelonephritisInfections and infestations22/3490427/34862
Upper respiratory tract infectionInfections and infestations27/3490415/34862
BronchitisInfections and infestations25/3490420/34862
Most frequent other events
Showing 10 of 40
Most frequent other events
EventRotaTeq™Placebo
PyrexiaGeneral disorders1970/48002056/4787
Upper respiratory tract infectionInfections and infestations1230/48001279/4787
DiarrhoeaGastrointestinal disorders1047/48001022/4787
IrritabilityGeneral disorders881/4800862/4787
VomitingGastrointestinal disorders613/4800644/4787
Otitis mediaInfections and infestations624/4800602/4787
CoughRespiratory, thoracic and mediastinal disorders471/4800456/4787
GastroenteritisInfections and infestations447/4800454/4787
RhinitisInfections and infestations348/4800337/4787
ConjunctivitisEye disorders315/4800339/4787

Baseline characteristics

Age, Customized
Age, Customized(Participants)RotaTeq™PlaceboTotal
5 Weeks of Age and Under145
6 to 12 Weeks of Age345513452769078
Over 12 Weeks of Age9299191
Sex: Female, Male
Sex: Female, Male(Participants)RotaTeq™PlaceboTotal
Female170581710134159
Male175861752935115
Race/Ethnicity
Race/Ethnicity(participants)RotaTeq™PlaceboTotal
White237722378847560
Hispanic American496349119874
Black290829415849
Multi Racial181518173632
Asian5365521088
Native American5315141045
Other119107226
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Vesikari T, Matson DO, Dennehy P, Van Damme P, Santosham M, Rodriguez Z, Dallas MJ, Heyse JF, Goveia MG, Black SB, Shinefield HR, Christie CD, Ylitalo S, Itzler RF, Coia ML, Onorato MT, Adeyi BA, Marshall GS, Gothefors L, Campens D, Karvonen A, Watt JP, O'Brien KL, DiNubile MJ, Clark HF, Boslego JW, Offit PA, Heaton PM; Rotavirus Efficacy and Safety Trial (REST) Study Team. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med. 2006 Jan 5;354(1):23-33. doi: 10.1056/NEJMoa052664. PubMed 16394299 ↗
  • Itzler R, Koch G, Matson DO, Gothefors L, Van Damme P, Dinubile MJ, Heaton PM. Robustness of the healthcare utilization results from the Rotavirus Efficacy and Safety Trial (REST) evaluating the human-bovine (WC3) reassortant pentavalent rotavirus vaccine (RV5). BMC Pediatr. 2010 Jun 11;10:42. doi: 10.1186/1471-2431-10-42. PubMed 20540778 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00090233
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Aug 27, 2004
Start date
Jan 2001
Primary completion
Oct 2004
Completion
Oct 2004
Results posted
May 5, 2011
Last update
Oct 5, 2015

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC
View the source record on ClinicalTrials.gov ↗

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