Rotavirus Efficacy and Safety Trial (REST)(V260-006)
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ClinicalTrials.gov Identifier: NCT00090233 |
Recruitment Status
:
Completed
First Posted
: August 27, 2004
Results First Posted
: May 5, 2011
Last Update Posted
: October 5, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rotavirus Infections | Biological: Rotateq™ Biological: Comparator: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 69274 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Safety and Efficacy of Pentavalent (G1, G2, G3, G4 , and P1) Human-Bovine Reassortant Rotavirus Vaccine in Healthy Infants |
Study Start Date : | January 2001 |
Actual Primary Completion Date : | October 2004 |
Actual Study Completion Date : | October 2004 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
RotaTeq
|
Biological: Rotateq™
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.
Other Name: V260
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Placebo Comparator: 2
Placebo
|
Biological: Comparator: 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.
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- Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo [ Time Frame: Within 42 days following any dose of RotaTeq™/placebo ]Number of participants with confirmed intussusception within 42 days after each vaccination with RotaTeq™/placebo.
- Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination [ Time Frame: At least 14 days following the 3rd vaccination through the first full rotavirus season ]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.
- G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus [ Time Frame: 14 days following the 3rd vaccination ]Number of participants with a 3-fold rise or greater in G1 Serum neutralizing antibody (SNA) responses against rotavirus from baseline to postdose 3.
- 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 [ Time Frame: At least 14 days following the 3rd vaccination ]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.
- 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. [ Time Frame: At least 14 days following the 3rd vaccination through the first rotavirus season ]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)].
- 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 [ Time Frame: At least 14 days following the 3rd vaccination through the first rotavirus season ]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)].
- 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 [ Time Frame: 42 days following third dose ]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.
- Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin [ Time Frame: 42 days following third dose ]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).
- Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F [ Time Frame: 42 days following third dose ]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.

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Ages Eligible for Study: | 6 Weeks to 12 Weeks (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy infants
Exclusion Criteria:
- None Specified

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00090233
Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT00090233 History of Changes |
Other Study ID Numbers: |
V260-006 2004_012 |
First Posted: | August 27, 2004 Key Record Dates |
Results First Posted: | May 5, 2011 |
Last Update Posted: | October 5, 2015 |
Last Verified: | September 2015 |
Additional relevant MeSH terms:
Rotavirus Infections Reoviridae Infections RNA Virus Infections Virus Diseases |