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Trial record 1 of 1 for:    16394299 [PUBMED-IDS]
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Rotavirus Efficacy and Safety Trial (REST)(V260-006)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00090233
Recruitment Status : Completed
First Posted : August 27, 2004
Results First Posted : May 5, 2011
Last Update Posted : October 5, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Rotavirus Infections
Interventions Biological: Rotateq™
Biological: Comparator: Placebo
Enrollment 69274
Recruitment Details 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).
Pre-assignment Details

Participants with: history of congenital abdominal disorders, intussusception, or abdominal surgery; history of

known prior rotavirus disease, chronic diarrhea, or failure to thrive were excluded from the trial before

assignment to groups.

Arm/Group Title RotaTeq™ Placebo
Hide Arm/Group Description Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season postvaccination. The rotavirus season for each site was prospectively determined using historical epidemiologic data. Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season postvaccination. The rotavirus season for each site was prospectively determined using historical epidemiologic data.
Period Title: Overall Study
Started 34644 [1] 34630 [2]
Vaccinated at Visit 1 34035 [3] 34003 [4]
Vaccinated at Visit 2 31052 31066
Vaccinated at Visit 3 29667 29598
Completed 29645 [5] 29565 [5]
Not Completed 4999 5065
Reason Not Completed
Randomized Not Vaccinated (Visit 1)             609             627
Adverse Event             214             198
Lost to Follow-up             68             95
Protocol Violation             960             1022
Withdrawal by Subject             182             211
Moved             203             189
Not Specified             1211             1160
Data not available at data cut-off point             1552             1563
[1]
Evaluated by data safety monitoring board (DSMB) when they recommended stopping enrollment
[2]
Evaluated by data safety monitoring board when they recommended stopping enrollment
[3]
Randomized Not vaccinated 609
[4]
Randomized Not vaccinated 627
[5]
Does not include participants who discontinued prior to the 42 day safety follow-up
Arm/Group Title RotaTeq™ Placebo Total
Hide Arm/Group Description Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart. Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart. Total of all reporting groups
Overall Number of Baseline Participants 34644 34630 69274
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34644 participants 34630 participants 69274 participants
5 Weeks of Age and Under 1 4 5
6 to 12 Weeks of Age 34551 34527 69078
Over 12 Weeks of Age 92 99 191
[1]
Measure Description: The eligibility for this study was to enroll infants 6-12 weeks of age; however infants that were 5 weeks and under, and infants who were 12 weeks and over were inadvertently enrolled outside these ranges. Those infants who received at least 1 dose of study vaccine, were followed for safety.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34644 participants 34630 participants 69274 participants
Female
17058
  49.2%
17101
  49.4%
34159
  49.3%
Male
17586
  50.8%
17529
  50.6%
35115
  50.7%
Race/Ethnicity  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 34644 participants 34630 participants 69274 participants
White 23772 23788 47560
Hispanic American 4963 4911 9874
Black 2908 2941 5849
Multi Racial 1815 1817 3632
Asian 536 552 1088
Native American 531 514 1045
Other 119 107 226
1.Primary Outcome
Title Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants in the study were followed for potential cases of intussusception.
Arm/Group Title RotaTeq™ Placebo
Hide Arm/Group Description:
Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
Overall Number of Participants Analyzed 34002 33969
Measure Type: Number
Unit of Measure: Participants
6 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RotaTeq™, Placebo
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Relative Risk ≤10.0 (non-inferiority margin).
Statistical Test of Hypothesis P-Value 0.006
Comments

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.

Method Exact binomial test
Comments Exact binomial test adjusted for group-sequential design.
Method of Estimation Estimation Parameter relative risk
Estimated Value 1.6
Confidence Interval 95%
0.4 to 6.4
Estimation Comments [Not Specified]
2.Primary Outcome
Title Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population Using Per-Protocol Case Definition
Arm/Group Title RotaTeq™ Placebo
Hide Arm/Group Description:
The number of participants randomized to treatment with RotaTeq™ is different from the number analyzed because some participants were excluded due to protocol violations and/or participants without follow-up and/or participants classified as unevaluable due to detection of wildtype rotavirus in the stool prior to 14 days Postdose 3; incomplete clinical and/or laboratory results; or stool samples collected out of day range.
The number of participants randomized to treatment with Placebo is different from the number analyzed because some participants were excluded due to protocol violations and/or participants without follow-up and/or participants classified as unevaluable due to detection of wildtype rotavirus in the stool prior to 14 days Postdose 3; incomplete clinical and/or laboratory results; or stool samples collected out of day range.
Overall Number of Participants Analyzed 2207 2305
Measure Type: Number
Unit of Measure: Participants
82 315
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RotaTeq™, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments

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.

Method Exact binomial test
Comments Exact binomial test.
Method of Estimation Estimation Parameter Efficacy=1-Relative Risk
Estimated Value 74.0
Confidence Interval 95%
66.8 to 79.9
Estimation Comments Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.
3.Secondary Outcome
Title G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population among participants in Finland using Per-Protocol Case Definition
Arm/Group Title RotaTeq™ Placebo
Hide Arm/Group Description:
Participants randomized to treatment with RotaTeq™ tested with data available for analysis excluding protocol violators, participants with invalid data based on laboratory determinations, participants with wildtype rotavirus detected in the stool, or with samples taken outside the range of 9 to 33 days postdose 3.
Participants randomized to treatment with Placebo tested with data available for analysis excluding protocol violators, participants with invalid data based on laboratory determinations, participants with wildtype rotavirus detected in the stool, or with samples taken outside the range of 9 to 33 days postdose 3.
Overall Number of Participants Analyzed 117 89
Measure Type: Number
Unit of Measure: Participants
95 8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RotaTeq™
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments 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.
Method Exact binomial test
Comments [Not Specified]
Method of Estimation Estimation Parameter Proportion
Estimated Value 81.2
Confidence Interval 95%
72.9 to 87.8
Estimation Comments [Not Specified]
4.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population Using Per-Protocol Case Definition
Arm/Group Title RotaTeq™ Placebo
Hide Arm/Group Description:
Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
Overall Number of Participants Analyzed 28646 28488
Measure Type: Number
Unit of Measure: Annual # of events per 1000 person-years
Hospital admissions 6 144
Emergency department visits 14 213
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RotaTeq™, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Rate Reduction>0%
Method Poisson regression
Comments

Poisson regression with generalized estimating equations.

Validated with Van Elteren’s extension of Wilcoxon Rank Sum test.

Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 94.5
Confidence Interval 95%
91.2 to 96.6
Estimation Comments Risk 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.
5.Secondary Outcome
Title 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.
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population Using Per-Protocol Case Definition
Arm/Group Title RotaTeq™ Placebo
Hide Arm/Group Description:
Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
Overall Number of Participants Analyzed 2201 2292
Measure Type: Number
Unit of Measure: Participants
First episode scores 48 262
Worst episode scores 49 265
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RotaTeq™, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments 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.
Method Exact binomial test
Comments [Not Specified]
Method of Estimation Estimation Parameter Efficacy=1-Relative Risk
Estimated Value 81.5
Confidence Interval 95%
74.9 to 86.7
Estimation Comments Estimated value is based on the worst episode scores.
6.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population Using Per-Protocol Case Definition
Arm/Group Title RotaTeq™ Placebo
Hide Arm/Group Description:
Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
Overall Number of Participants Analyzed 2198 2271
Measure Type: Number
Unit of Measure: Participants
First episode scores 1 51
Worst episode scores 1 51
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RotaTeq™, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments 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.
Method Exact binomial test
Comments [Not Specified]
Method of Estimation Estimation Parameter Efficacy=1-Relative Risk
Estimated Value 98.0
Confidence Interval 95%
88.3 to 100
Estimation Comments [Not Specified]
7.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population
Arm/Group Title RotaTeq™ Placebo
Hide Arm/Group Description:
Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
Overall Number of Participants Analyzed 558 592
Measure Type: Number
Unit of Measure: Participants
Hepatitis B (N=202, N=214) 197 203
Haemophilus influenzae type b (N=558, N=592) 417 426
Diphtheria (N=136, N=144) 136 142
Tetanus (N=132, N=140) 132 140
Polio type 1 (N=341, N=360) 328 349
Polio type 2 (N=341, N=359) 311 326
Polio type 3 (N=341, N=359) 324 343
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RotaTeq™, Placebo
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Difference (vaccine-placebo) in seroprotection rates was greater than -.10 (non-inferiority margin).
Statistical Test of Hypothesis P-Value <0.001
Comments 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.
Method Miettenen and Nurminen
Comments [Not Specified]
8.Secondary Outcome
Title Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population; excluding protocol violators and participants with invalid data based on laboratory determinations.
Arm/Group Title RotaTeq™ Placebo
Hide Arm/Group Description:
Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
Overall Number of Participants Analyzed 59 78
Geometric Mean (95% Confidence Interval)
Unit of Measure: ELISA units/mL
Pertussis PT
20.18
(17.10 to 23.81)
22.73
(19.59 to 26.37)
Pertussis FHA
55.69
(48.01 to 64.59)
64.33
(55.41 to 74.69)
Pertussis Pertactin
34.77
(26.46 to 45.70)
59.17
(46.21 to 75.76)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RotaTeq™, Placebo
Comments The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis PT was used for analysis.
Type of Statistical Test Non-Inferiority or Equivalence
Comments GMTR was greater than 0.5 (non-inferiority margin).
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments t-test on natural log of titers
Method of Estimation Estimation Parameter GMTR for Pertussis PT
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.7 to 1.1
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RotaTeq™, Placebo
Comments The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis FHA was used for analysis.
Type of Statistical Test Non-Inferiority or Equivalence
Comments GMTR was greater than 0.5 (non-inferiority margin).
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments t-test on natural log of titers
Method of Estimation Estimation Parameter GMTR for Pertussis FHA
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
0.7 to 1.1
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RotaTeq™, Placebo
Comments The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis Pertactin was used for analysis.
Type of Statistical Test Non-Inferiority or Equivalence
Comments GMTR was greater than 0.5 (non-inferiority margin).
Statistical Test of Hypothesis P-Value 0.193
Comments [Not Specified]
Method t-test, 1 sided
Comments t-test on natural log of titers
Method of Estimation Estimation Parameter GMTR for Pertussis Pertactin
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.4 to 0.8
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Per Protocol Population; excluding protocol violators and participants with invalid data based on laboratory determinations.
Arm/Group Title RotaTeq™ Placebo
Hide Arm/Group Description:
Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
Overall Number of Participants Analyzed 185 198
Geometric Mean (95% Confidence Interval)
Unit of Measure: micrograms/mL
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)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RotaTeq™, Placebo
Comments The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 4 was used for analysis.
Type of Statistical Test Non-Inferiority or Equivalence
Comments GMTR was greater than 0.5 (non-inferiority margin).
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments t-test on natural log of titers
Method of Estimation Estimation Parameter GMTR for pneumococcal serotype 4
Estimated Value 1.2
Confidence Interval 95%
1.0 to 1.4
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection RotaTeq™, Placebo
Comments The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 6B was used for analysis.
Type of Statistical Test Non-Inferiority or Equivalence
Comments GMTR was greater than 0.5 (non-inferiority margin).
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments t-test on natural log of titers
Method of Estimation Estimation Parameter GMTR for pneumococcal serotype 6B
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
1.0 to 1.9
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection RotaTeq™, Placebo
Comments The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 9V was used for analysis.
Type of Statistical Test Non-Inferiority or Equivalence
Comments GMTR was greater than 0.5 (non-inferiority margin).
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments t-test on natural log of titers
Method of Estimation Estimation Parameter GMTR for pneumococcal serotype 9V
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.9 to 1.3
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection RotaTeq™, Placebo
Comments The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 14 was used for analysis.
Type of Statistical Test Non-Inferiority or Equivalence
Comments GMTR was greater than 0.5 (non-inferiority margin).
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments t-test on natural log of titers
Method of Estimation Estimation Parameter GMTR for pneumococcal serotype 14
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.7 to 1.3
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection RotaTeq™, Placebo
Comments The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 18C was used for analysis.
Type of Statistical Test Non-Inferiority or Equivalence
Comments GMTR was greater than 0.5 (non-inferiority margin).
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments t-test on natural log of titers
Method of Estimation Estimation Parameter GMTR for pneumococcal serotype 18C
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
1.1 to 1.6
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection RotaTeq™, Placebo
Comments The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 19F was used for analysis.
Type of Statistical Test Non-Inferiority or Equivalence
Comments GMTR was greater than 0.5 (non-inferiority margin).
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments t-test on natural log of titers
Method of Estimation Estimation Parameter GMTR for pneumococcal serotype 19F
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.8 to 1.4
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection RotaTeq™, Placebo
Comments The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 23F was used for analysis.
Type of Statistical Test Non-Inferiority or Equivalence
Comments GMTR was greater than 0.5 (non-inferiority margin).
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 1 sided
Comments t-test on natural log of titers
Method of Estimation Estimation Parameter GMTR for pneumococcal serotype 23F
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.9 to 1.5
Estimation Comments [Not Specified]
Time Frame 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
Adverse Event Reporting Description Participants listed in SAE tables (34904–RotaTeq; 34862-Placebo) are those who received study treatment. Other AEs were reported for a pre-defined subset who received ≥1 dose (4808-RotaTeq; 4796–Placebo). Although a participant may have had ≥ 2 AEs they are counted only once in a category. The same participant may appear in different categories.
 
Arm/Group Title RotaTeq™ Placebo
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Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.

The Not Completed total includes participants discontinued at any time before the completion of the third study vaccination and/or the 42-day safety follow-up period post vaccination 3.

Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.

The Not Completed total includes participants discontinued at any time before the completion of the third study vaccination and/or the 42-day safety follow-up period post vaccination 3.

All-Cause Mortality
RotaTeq™ Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
RotaTeq™ Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   863/34904 (2.47%)   955/34862 (2.74%) 
Blood and lymphatic system disorders     
Anaemia  1  7/34904 (0.02%)  3/34862 (0.01%) 
Idiopathic thrombocytopenic purpura  1  1/34904 (0.00%)  0/34862 (0.00%) 
Lymphadenitis  1  2/34904 (0.01%)  4/34862 (0.01%) 
Lymphadenopathy  1  0/34904 (0.00%)  2/34862 (0.01%) 
Neutropenia  1  0/34904 (0.00%)  2/34862 (0.01%) 
Thrombocytopenia  1  1/34904 (0.00%)  0/34862 (0.00%) 
Cardiac disorders     
Bradycardia  1  1/34904 (0.00%)  0/34862 (0.00%) 
Cardiac failure congestive  1  2/34904 (0.01%)  1/34862 (0.00%) 
Cardio-respiratory arrest  1  1/34904 (0.00%)  0/34862 (0.00%) 
Cardiopulmonary failure  1  0/34904 (0.00%)  1/34862 (0.00%) 
Cyanosis  1  3/34904 (0.01%)  1/34862 (0.00%) 
Congenital, familial and genetic disorders     
Atrial septal defect  1  1/34904 (0.00%)  1/34862 (0.00%) 
Cerebral palsy  1  0/34904 (0.00%)  1/34862 (0.00%) 
Coarctation of the aorta  1  0/34904 (0.00%)  2/34862 (0.01%) 
Congenital cystic kidney disease  1  0/34904 (0.00%)  1/34862 (0.00%) 
Congenital intestinal malformation  1  1/34904 (0.00%)  1/34862 (0.00%) 
Cryptorchism  1  0/34904 (0.00%)  1/34862 (0.00%) 
Cystic fibrosis  1  1/34904 (0.00%)  1/34862 (0.00%) 
Developmental glaucoma  1  0/34904 (0.00%)  1/34862 (0.00%) 
Glycogen storage disease type ib  1  1/34904 (0.00%)  0/34862 (0.00%) 
Hip dysplasia  1  2/34904 (0.01%)  0/34862 (0.00%) 
Hydrocele  1  1/34904 (0.00%)  0/34862 (0.00%) 
Kidney malformation  1  1/34904 (0.00%)  0/34862 (0.00%) 
Polycystic liver disease  1  0/34904 (0.00%)  1/34862 (0.00%) 
Pulmonary artery stenosis congenital  1  1/34904 (0.00%)  0/34862 (0.00%) 
Pyloric stenosis  1  1/34904 (0.00%)  2/34862 (0.01%) 
Retinoblastoma  1  0/34904 (0.00%)  1/34862 (0.00%) 
Ventricular septal defect  1  1/34904 (0.00%)  2/34862 (0.01%) 
Eye disorders     
Chalazion  1  1/34904 (0.00%)  0/34862 (0.00%) 
Conjunctivitis  1  0/34904 (0.00%)  1/34862 (0.00%) 
Gastrointestinal disorders     
Abdominal distension  1  2/34904 (0.01%)  3/34862 (0.01%) 
Abdominal pain  1  5/34904 (0.01%)  3/34862 (0.01%) 
Anal fissure  1  3/34904 (0.01%)  1/34862 (0.00%) 
Anal fistula  1  0/34904 (0.00%)  2/34862 (0.01%) 
Anal haemorrhage  1  1/34904 (0.00%)  0/34862 (0.00%) 
Anal skin tags  1  1/34904 (0.00%)  0/34862 (0.00%) 
Aphthous stomatitis  1  0/34904 (0.00%)  1/34862 (0.00%) 
Cheilitis  1  1/34904 (0.00%)  0/34862 (0.00%) 
Colitis  1  1/34904 (0.00%)  0/34862 (0.00%) 
Constipation  1  7/34904 (0.02%)  6/34862 (0.02%) 
Diarrhoea  1  9/34904 (0.03%)  21/34862 (0.06%) 
Diarrhoea haemorrhagic  1  1/34904 (0.00%)  0/34862 (0.00%) 
Duodenitis  1  1/34904 (0.00%)  0/34862 (0.00%) 
Dysphagia  1  1/34904 (0.00%)  0/34862 (0.00%) 
Enteritis  1  2/34904 (0.01%)  4/34862 (0.01%) 
Faecaloma  1  1/34904 (0.00%)  0/34862 (0.00%) 
Flatulence  1  0/34904 (0.00%)  2/34862 (0.01%) 
Gastric ulcer  1  1/34904 (0.00%)  0/34862 (0.00%) 
Gastritis  1  0/34904 (0.00%)  1/34862 (0.00%) 
Gastrointestinal inflammation  1  0/34904 (0.00%)  1/34862 (0.00%) 
Gastrointestinal pain  1  0/34904 (0.00%)  1/34862 (0.00%) 
Gastrooesophageal reflux disease  1  29/34904 (0.08%)  17/34862 (0.05%) 
Haematemesis  1  3/34904 (0.01%)  0/34862 (0.00%) 
Haematochezia  1  1/34904 (0.00%)  3/34862 (0.01%) 
Infantile colic  1  2/34904 (0.01%)  2/34862 (0.01%) 
Inguinal hernia  1  11/34904 (0.03%)  8/34862 (0.02%) 
Inguinal hernia, obstructive  1  1/34904 (0.00%)  1/34862 (0.00%) 
Intussusception  1  13/34904 (0.04%)  22/34862 (0.06%) 
Nausea  1  0/34904 (0.00%)  1/34862 (0.00%) 
Oesophageal obstruction  1  1/34904 (0.00%)  0/34862 (0.00%) 
Oesophagitis  1  0/34904 (0.00%)  1/34862 (0.00%) 
Rectal prolapse  1  0/34904 (0.00%)  1/34862 (0.00%) 
Reflux oesophagitis  1  1/34904 (0.00%)  1/34862 (0.00%) 
Regurgitation of food  1  1/34904 (0.00%)  2/34862 (0.01%) 
Retching  1  0/34904 (0.00%)  1/34862 (0.00%) 
Stomatitis  1  0/34904 (0.00%)  2/34862 (0.01%) 
Umbilical hernia  1  1/34904 (0.00%)  0/34862 (0.00%) 
Varices oesophageal  1  1/34904 (0.00%)  0/34862 (0.00%) 
Volvulus of bowel  1  0/34904 (0.00%)  1/34862 (0.00%) 
Vomiting  1  23/34904 (0.07%)  20/34862 (0.06%) 
General disorders     
Brain death  1  0/34904 (0.00%)  1/34862 (0.00%) 
Chills  1  0/34904 (0.00%)  1/34862 (0.00%) 
Cyst  1  0/34904 (0.00%)  1/34862 (0.00%) 
Death  1  1/34904 (0.00%)  4/34862 (0.01%) 
Drowning  1  0/34904 (0.00%)  1/34862 (0.00%) 
Fever neonatal  1  2/34904 (0.01%)  1/34862 (0.00%) 
Hernia  1  1/34904 (0.00%)  0/34862 (0.00%) 
Injection site inflammation  1  1/34904 (0.00%)  0/34862 (0.00%) 
Irritability  1  9/34904 (0.03%)  4/34862 (0.01%) 
Near sudden infant death syndrome  1  1/34904 (0.00%)  1/34862 (0.00%) 
Oedema peripheral  1  2/34904 (0.01%)  0/34862 (0.00%) 
Pyrexia  1  43/34904 (0.12%)  49/34862 (0.14%) 
Sudden death  1  1/34904 (0.00%)  0/34862 (0.00%) 
Sudden infant death syndrome  1  7/34904 (0.02%)  9/34862 (0.03%) 
Hepatobiliary disorders     
Hepatic steatosis  1  1/34904 (0.00%)  0/34862 (0.00%) 
Hepatomegaly  1  1/34904 (0.00%)  0/34862 (0.00%) 
Immune system disorders     
Anaphylactic reaction  1  0/34904 (0.00%)  1/34862 (0.00%) 
Food allergy  1  1/34904 (0.00%)  0/34862 (0.00%) 
Hypersensitivity  1  1/34904 (0.00%)  1/34862 (0.00%) 
Milk allergy  1  4/34904 (0.01%)  1/34862 (0.00%) 
Infections and infestations     
Abscess  1  0/34904 (0.00%)  1/34862 (0.00%) 
Abscess neck  1  1/34904 (0.00%)  1/34862 (0.00%) 
Acute tonsillitis  1  0/34904 (0.00%)  1/34862 (0.00%) 
Adenovirus infection  1  1/34904 (0.00%)  0/34862 (0.00%) 
Amoebic dysentery  1  0/34904 (0.00%)  1/34862 (0.00%) 
Anal abscess  1  2/34904 (0.01%)  0/34862 (0.00%) 
Arthritis bacterial  1  0/34904 (0.00%)  1/34862 (0.00%) 
Bacteraemia  1  1/34904 (0.00%)  1/34862 (0.00%) 
Botulism  1  2/34904 (0.01%)  0/34862 (0.00%) 
Bronchiolitis  1  215/34904 (0.62%)  253/34862 (0.73%) 
Bronchitis  1  25/34904 (0.07%)  20/34862 (0.06%) 
Bronchitis acute  1  3/34904 (0.01%)  3/34862 (0.01%) 
Bronchitis acute viral  1  0/34904 (0.00%)  1/34862 (0.00%) 
Bronchitis chronic  1  1/34904 (0.00%)  2/34862 (0.01%) 
Bronchitis viral  1  1/34904 (0.00%)  1/34862 (0.00%) 
Bronchopneumonia  1  11/34904 (0.03%)  6/34862 (0.02%) 
Campylobacter intestinal infection  1  1/34904 (0.00%)  0/34862 (0.00%) 
Catheter site infection  1  0/34904 (0.00%)  1/34862 (0.00%) 
Cellulitis  1  1/34904 (0.00%)  6/34862 (0.02%) 
Cellulitis staphylococcal  1  1/34904 (0.00%)  0/34862 (0.00%) 
Chest wall abscess  1  1/34904 (0.00%)  0/34862 (0.00%) 
Clostridium colitis  1  0/34904 (0.00%)  1/34862 (0.00%) 
Coxsackie viral infection  1  0/34904 (0.00%)  1/34862 (0.00%) 
Croup infectious  1  8/34904 (0.02%)  5/34862 (0.01%) 
Cystitis  1  2/34904 (0.01%)  0/34862 (0.00%) 
Dysentery  1  1/34904 (0.00%)  0/34862 (0.00%) 
Ear infection  1  3/34904 (0.01%)  2/34862 (0.01%) 
Eczema infected  1  0/34904 (0.00%)  1/34862 (0.00%) 
Enterocolitis infectious  1  0/34904 (0.00%)  1/34862 (0.00%) 
Enterovirus infection  1  0/34904 (0.00%)  1/34862 (0.00%) 
Escherichia sepsis  1  0/34904 (0.00%)  1/34862 (0.00%) 
Escherichia urinary tract infection  1  0/34904 (0.00%)  2/34862 (0.01%) 
Exanthema subitum  1  3/34904 (0.01%)  2/34862 (0.01%) 
Febrile infection  1  2/34904 (0.01%)  3/34862 (0.01%) 
Gastroenteritis  1  73/34904 (0.21%)  127/34862 (0.36%) 
Gastroenteritis adenovirus  1  4/34904 (0.01%)  1/34862 (0.00%) 
Gastroenteritis rotavirus  1  3/34904 (0.01%)  18/34862 (0.05%) 
Gastroenteritis salmonella  1  2/34904 (0.01%)  4/34862 (0.01%) 
Gastroenteritis viral  1  8/34904 (0.02%)  6/34862 (0.02%) 
Gastrointestinal infection  1  0/34904 (0.00%)  1/34862 (0.00%) 
Groin abscess  1  0/34904 (0.00%)  1/34862 (0.00%) 
Haemophilus sepsis  1  0/34904 (0.00%)  1/34862 (0.00%) 
Herpes simplex  1  1/34904 (0.00%)  0/34862 (0.00%) 
Impetigo  1  1/34904 (0.00%)  0/34862 (0.00%) 
Influenza  1  5/34904 (0.01%)  6/34862 (0.02%) 
Kawasaki's disease  1  5/34904 (0.01%)  0/34862 (0.00%) 
Laryngitis  1  12/34904 (0.03%)  6/34862 (0.02%) 
Laryngotracheitis  1  2/34904 (0.01%)  0/34862 (0.00%) 
Laryngotracheo bronchitis  1  0/34904 (0.00%)  1/34862 (0.00%) 
Lobar pneumonia  1  7/34904 (0.02%)  4/34862 (0.01%) 
Lower respiratory tract infection  1  0/34904 (0.00%)  3/34862 (0.01%) 
Meningitis  1  4/34904 (0.01%)  2/34862 (0.01%) 
Meningitis aseptic  1  2/34904 (0.01%)  2/34862 (0.01%) 
Meningitis bacterial  1  1/34904 (0.00%)  1/34862 (0.00%) 
Meningitis enteroviral  1  0/34904 (0.00%)  1/34862 (0.00%) 
Meningitis haemophilus  1  0/34904 (0.00%)  1/34862 (0.00%) 
Meningitis streptococcal  1  2/34904 (0.01%)  0/34862 (0.00%) 
Meningitis viral  1  3/34904 (0.01%)  4/34862 (0.01%) 
Nasopharyngitis  1  0/34904 (0.00%)  1/34862 (0.00%) 
Oral candidiasis  1  4/34904 (0.01%)  1/34862 (0.00%) 
Otitis externa  1  2/34904 (0.01%)  0/34862 (0.00%) 
Otitis media  1  28/34904 (0.08%)  24/34862 (0.07%) 
Otitis media acute  1  3/34904 (0.01%)  2/34862 (0.01%) 
Parainfluenzae virus infection  1  2/34904 (0.01%)  0/34862 (0.00%) 
Parotitis  1  1/34904 (0.00%)  0/34862 (0.00%) 
Perianal abscess  1  2/34904 (0.01%)  0/34862 (0.00%) 
Perineal abscess  1  0/34904 (0.00%)  1/34862 (0.00%) 
Periorbital cellulitis  1  2/34904 (0.01%)  2/34862 (0.01%) 
Pertussis  1  6/34904 (0.02%)  7/34862 (0.02%) 
Pharyngitis  1  2/34904 (0.01%)  3/34862 (0.01%) 
Pneumococcal bacteraemia  1  1/34904 (0.00%)  0/34862 (0.00%) 
Pneumococcal infection  1  0/34904 (0.00%)  1/34862 (0.00%) 
Pneumococcal sepsis  1  0/34904 (0.00%)  1/34862 (0.00%) 
Pneumocystis jiroveci pneumonia  1  0/34904 (0.00%)  1/34862 (0.00%) 
Pneumonia  1  55/34904 (0.16%)  58/34862 (0.17%) 
Pneumonia bacterial  1  0/34904 (0.00%)  1/34862 (0.00%) 
Pneumonia primary atypical  1  1/34904 (0.00%)  1/34862 (0.00%) 
Pneumonia respiratory syncytial viral  1  5/34904 (0.01%)  2/34862 (0.01%) 
Pneumonia viral  1  1/34904 (0.00%)  3/34862 (0.01%) 
Pseudocroup  1  0/34904 (0.00%)  2/34862 (0.01%) 
Pyelocystitis  1  1/34904 (0.00%)  0/34862 (0.00%) 
Pyelonephritis  1  22/34904 (0.06%)  27/34862 (0.08%) 
Pyelonephritis acute  1  16/34904 (0.05%)  12/34862 (0.03%) 
Respiratory syncytial virus infection  1  10/34904 (0.03%)  6/34862 (0.02%) 
Respiratory tract infection  1  13/34904 (0.04%)  14/34862 (0.04%) 
Respiratory tract infection viral  1  3/34904 (0.01%)  2/34862 (0.01%) 
Rhinitis  1  1/34904 (0.00%)  1/34862 (0.00%) 
Roseola  1  2/34904 (0.01%)  1/34862 (0.00%) 
Salmonellosis  1  0/34904 (0.00%)  2/34862 (0.01%) 
Scrotal infection  1  0/34904 (0.00%)  1/34862 (0.00%) 
Sepsis  1  7/34904 (0.02%)  4/34862 (0.01%) 
Septic shock  1  1/34904 (0.00%)  2/34862 (0.01%) 
Sinusitis  1  1/34904 (0.00%)  0/34862 (0.00%) 
Skin infection  1  0/34904 (0.00%)  2/34862 (0.01%) 
Staphylococcal sepsis  1  1/34904 (0.00%)  0/34862 (0.00%) 
Subcutaneous abscess  1  1/34904 (0.00%)  0/34862 (0.00%) 
Tonsillitis  1  0/34904 (0.00%)  1/34862 (0.00%) 
Tonsillitis streptococcal  1  0/34904 (0.00%)  1/34862 (0.00%) 
Tuberculosis  1  2/34904 (0.01%)  0/34862 (0.00%) 
Tuberculosis of peripheral lymph nodes  1  1/34904 (0.00%)  0/34862 (0.00%) 
Upper respiratory tract infection  1  27/34904 (0.08%)  15/34862 (0.04%) 
Urinary tract infection  1  38/34904 (0.11%)  29/34862 (0.08%) 
Urosepsis  1  0/34904 (0.00%)  6/34862 (0.02%) 
Varicella  1  2/34904 (0.01%)  0/34862 (0.00%) 
Viral infection  1  14/34904 (0.04%)  17/34862 (0.05%) 
Viral pharyngitis  1  0/34904 (0.00%)  1/34862 (0.00%) 
Viral rash  1  1/34904 (0.00%)  0/34862 (0.00%) 
Viral upper respiratory tract infection  1  2/34904 (0.01%)  4/34862 (0.01%) 
Injury, poisoning and procedural complications     
Accidental overdose  1  1/34904 (0.00%)  0/34862 (0.00%) 
Burns second degree  1  1/34904 (0.00%)  1/34862 (0.00%) 
Concussion  1  3/34904 (0.01%)  6/34862 (0.02%) 
Contusion  1  2/34904 (0.01%)  1/34862 (0.00%) 
Extradural haematoma  1  0/34904 (0.00%)  1/34862 (0.00%) 
Fall  1  3/34904 (0.01%)  5/34862 (0.01%) 
Femur fracture  1  1/34904 (0.00%)  5/34862 (0.01%) 
Fractured skull depressed  1  1/34904 (0.00%)  1/34862 (0.00%) 
Head injury  1  3/34904 (0.01%)  2/34862 (0.01%) 
Heat exhaustion  1  0/34904 (0.00%)  1/34862 (0.00%) 
Humerus fracture  1  0/34904 (0.00%)  2/34862 (0.01%) 
Injury asphyxiation  1  2/34904 (0.01%)  0/34862 (0.00%) 
Limb injury  1  1/34904 (0.00%)  0/34862 (0.00%) 
Multiple fractures  1  2/34904 (0.01%)  0/34862 (0.00%) 
Overdose  1  3/34904 (0.01%)  2/34862 (0.01%) 
Post procedural haematoma  1  0/34904 (0.00%)  1/34862 (0.00%) 
Road traffic accident  1  4/34904 (0.01%)  2/34862 (0.01%) 
Skull fracture  1  7/34904 (0.02%)  7/34862 (0.02%) 
Subdural haematoma  1  0/34904 (0.00%)  1/34862 (0.00%) 
Subdural haemorrhage  1  1/34904 (0.00%)  0/34862 (0.00%) 
Thermal burn  1  1/34904 (0.00%)  4/34862 (0.01%) 
Tibia fracture  1  0/34904 (0.00%)  1/34862 (0.00%) 
Upper limb fracture  1  0/34904 (0.00%)  1/34862 (0.00%) 
Investigations     
Body temperature increased  1  1/34904 (0.00%)  0/34862 (0.00%) 
Occult blood positive  1  6/34904 (0.02%)  3/34862 (0.01%) 
Transaminases increased  1  1/34904 (0.00%)  0/34862 (0.00%) 
Weight decreased  1  0/34904 (0.00%)  2/34862 (0.01%) 
Metabolism and nutrition disorders     
Acidosis  1  1/34904 (0.00%)  1/34862 (0.00%) 
Anorexia  1  3/34904 (0.01%)  4/34862 (0.01%) 
Cow's milk intolerance  1  0/34904 (0.00%)  1/34862 (0.00%) 
Decreased appetite  1  3/34904 (0.01%)  1/34862 (0.00%) 
Dehydration  1  19/34904 (0.05%)  23/34862 (0.07%) 
Diet refusal  1  5/34904 (0.01%)  4/34862 (0.01%) 
Failure to thrive  1  2/34904 (0.01%)  4/34862 (0.01%) 
Feeding disorder  1  2/34904 (0.01%)  0/34862 (0.00%) 
Feeding disorder neonatal  1  0/34904 (0.00%)  1/34862 (0.00%) 
Food intolerance  1  0/34904 (0.00%)  2/34862 (0.01%) 
Hyperinsulinaemia  1  1/34904 (0.00%)  0/34862 (0.00%) 
Hypernatraemia  1  0/34904 (0.00%)  1/34862 (0.00%) 
Hyponatraemia  1  1/34904 (0.00%)  0/34862 (0.00%) 
Lactose intolerance  1  1/34904 (0.00%)  0/34862 (0.00%) 
Metabolic acidosis  1  0/34904 (0.00%)  2/34862 (0.01%) 
Weight gain poor  1  1/34904 (0.00%)  2/34862 (0.01%) 
Musculoskeletal and connective tissue disorders     
Chondromalacia  1  1/34904 (0.00%)  0/34862 (0.00%) 
Growth retardation  1  0/34904 (0.00%)  1/34862 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Brain neoplasm  1  1/34904 (0.00%)  1/34862 (0.00%) 
Haemangioma  1  4/34904 (0.01%)  2/34862 (0.01%) 
Neoplasm malignant  1  1/34904 (0.00%)  2/34862 (0.01%) 
Neuroblastoma  1  0/34904 (0.00%)  3/34862 (0.01%) 
Pineal parenchymal neoplasm malignant  1  1/34904 (0.00%)  0/34862 (0.00%) 
Nervous system disorders     
Anoxic encephalopathy  1  0/34904 (0.00%)  1/34862 (0.00%) 
Brain oedema  1  2/34904 (0.01%)  0/34862 (0.00%) 
Cerebral haemorrhage  1  1/34904 (0.00%)  0/34862 (0.00%) 
Convulsion  1  17/34904 (0.05%)  9/34862 (0.03%) 
Depressed level of consciousness  1  0/34904 (0.00%)  1/34862 (0.00%) 
Encephalopathy  1  1/34904 (0.00%)  0/34862 (0.00%) 
Epilepsy  1  4/34904 (0.01%)  2/34862 (0.01%) 
Febrile convulsion  1  6/34904 (0.02%)  4/34862 (0.01%) 
Hemiplegia  1  1/34904 (0.00%)  0/34862 (0.00%) 
Hydrocephalus  1  1/34904 (0.00%)  2/34862 (0.01%) 
Hypotonia  1  1/34904 (0.00%)  0/34862 (0.00%) 
Hypoxic encephalopathy  1  1/34904 (0.00%)  1/34862 (0.00%) 
Infantile spasms  1  1/34904 (0.00%)  3/34862 (0.01%) 
Intraneural cyst  1  1/34904 (0.00%)  0/34862 (0.00%) 
Lethargy  1  0/34904 (0.00%)  1/34862 (0.00%) 
Loss of consciousness  1  0/34904 (0.00%)  1/34862 (0.00%) 
Myoclonus  1  0/34904 (0.00%)  1/34862 (0.00%) 
Nystagmus  1  0/34904 (0.00%)  1/34862 (0.00%) 
Somnolence  1  0/34904 (0.00%)  3/34862 (0.01%) 
Spinal cord haemorrhage  1  1/34904 (0.00%)  0/34862 (0.00%) 
Status epilepticus  1  0/34904 (0.00%)  1/34862 (0.00%) 
Subarachnoid haemorrhage  1  1/34904 (0.00%)  1/34862 (0.00%) 
Syncope  1  1/34904 (0.00%)  0/34862 (0.00%) 
Syncope vasovagal  1  0/34904 (0.00%)  1/34862 (0.00%) 
Thalamus haemorrhage  1  1/34904 (0.00%)  0/34862 (0.00%) 
Tremor  1  0/34904 (0.00%)  1/34862 (0.00%) 
Vocal cord paralysis  1  1/34904 (0.00%)  0/34862 (0.00%) 
Psychiatric disorders     
Agitation  1  1/34904 (0.00%)  0/34862 (0.00%) 
Apathy  1  0/34904 (0.00%)  1/34862 (0.00%) 
Breath holding  1  2/34904 (0.01%)  0/34862 (0.00%) 
Crying  1  5/34904 (0.01%)  5/34862 (0.01%) 
Eating disorder  1  0/34904 (0.00%)  1/34862 (0.00%) 
Restlessness  1  0/34904 (0.00%)  1/34862 (0.00%) 
Sleep disorder  1  1/34904 (0.00%)  1/34862 (0.00%) 
Staring  1  0/34904 (0.00%)  1/34862 (0.00%) 
Renal and urinary disorders     
Hydronephrosis  1  1/34904 (0.00%)  1/34862 (0.00%) 
Vesicoureteric reflux  1  1/34904 (0.00%)  1/34862 (0.00%) 
Reproductive system and breast disorders     
Balanitis  1  1/34904 (0.00%)  1/34862 (0.00%) 
Epididymitis  1  1/34904 (0.00%)  1/34862 (0.00%) 
Phimosis  1  0/34904 (0.00%)  1/34862 (0.00%) 
Testicular torsion  1  1/34904 (0.00%)  0/34862 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  0/34904 (0.00%)  1/34862 (0.00%) 
Apnoea  1  7/34904 (0.02%)  5/34862 (0.01%) 
Apnoeic attack  1  2/34904 (0.01%)  3/34862 (0.01%) 
Aspiration  1  1/34904 (0.00%)  1/34862 (0.00%) 
Asthma  1  10/34904 (0.03%)  11/34862 (0.03%) 
Atelectasis  1  1/34904 (0.00%)  1/34862 (0.00%) 
Bronchial hyperactivity  1  7/34904 (0.02%)  5/34862 (0.01%) 
Bronchospasm  1  3/34904 (0.01%)  0/34862 (0.00%) 
Choking  1  1/34904 (0.00%)  2/34862 (0.01%) 
Chronic respiratory disease  1  0/34904 (0.00%)  1/34862 (0.00%) 
Cough  1  3/34904 (0.01%)  3/34862 (0.01%) 
Dyspnoea  1  1/34904 (0.00%)  2/34862 (0.01%) 
Hypoxia  1  5/34904 (0.01%)  5/34862 (0.01%) 
Interstitial lung disease  1  0/34904 (0.00%)  1/34862 (0.00%) 
Laryngospasm  1  2/34904 (0.01%)  0/34862 (0.00%) 
Nasal congestion  1  0/34904 (0.00%)  1/34862 (0.00%) 
Neonatal apnoeic attack  1  1/34904 (0.00%)  0/34862 (0.00%) 
Neonatal respiratory distress syndrome  1  1/34904 (0.00%)  0/34862 (0.00%) 
Obstructive airways disorder  1  0/34904 (0.00%)  2/34862 (0.01%) 
Pulmonary congestion  1  0/34904 (0.00%)  1/34862 (0.00%) 
Pulmonary haemorrhage  1  0/34904 (0.00%)  1/34862 (0.00%) 
Respiratory acidosis  1  1/34904 (0.00%)  0/34862 (0.00%) 
Respiratory disorder  1  1/34904 (0.00%)  1/34862 (0.00%) 
Respiratory distress  1  7/34904 (0.02%)  7/34862 (0.02%) 
Respiratory failure  1  1/34904 (0.00%)  2/34862 (0.01%) 
Rhinitis allergic  1  1/34904 (0.00%)  2/34862 (0.01%) 
Sleep apnoea syndrome  1  1/34904 (0.00%)  1/34862 (0.00%) 
Status asthmaticus  1  1/34904 (0.00%)  0/34862 (0.00%) 
Tachypnoea  1  1/34904 (0.00%)  1/34862 (0.00%) 
Tracheomalacia  1  1/34904 (0.00%)  0/34862 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis  1  2/34904 (0.01%)  0/34862 (0.00%) 
Dermatitis allergic  1  1/34904 (0.00%)  0/34862 (0.00%) 
Dermatitis atopic  1  4/34904 (0.01%)  5/34862 (0.01%) 
Eczema  1  1/34904 (0.00%)  0/34862 (0.00%) 
Eczema infantile  1  0/34904 (0.00%)  1/34862 (0.00%) 
Lichen sclerosus  1  0/34904 (0.00%)  1/34862 (0.00%) 
Psoriasis  1  0/34904 (0.00%)  1/34862 (0.00%) 
Purpura  1  0/34904 (0.00%)  1/34862 (0.00%) 
Rash  1  1/34904 (0.00%)  0/34862 (0.00%) 
Seborrhoea  1  1/34904 (0.00%)  0/34862 (0.00%) 
Urticaria  1  2/34904 (0.01%)  2/34862 (0.01%) 
Urticaria pigmentosa  1  0/34904 (0.00%)  1/34862 (0.00%) 
Social circumstances     
Child abuse  1  1/34904 (0.00%)  1/34862 (0.00%) 
Child neglect  1  0/34904 (0.00%)  1/34862 (0.00%) 
Overfeeding of infant  1  1/34904 (0.00%)  0/34862 (0.00%) 
Vascular disorders     
Circulatory collapse  1  1/34904 (0.00%)  0/34862 (0.00%) 
Haematoma  1  0/34904 (0.00%)  2/34862 (0.01%) 
Haemorrhage  1  0/34904 (0.00%)  1/34862 (0.00%) 
Pallor  1  0/34904 (0.00%)  1/34862 (0.00%) 
Vasculitis  1  0/34904 (0.00%)  1/34862 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
RotaTeq™ Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   4000/4800 (83.33%)   4047/4787 (84.54%) 
Eye disorders     
Conjunctivitis  1  315/4800 (6.56%)  339/4787 (7.08%) 
Gastrointestinal disorders     
Abdominal pain upper  1  53/4800 (1.10%)  40/4787 (0.84%) 
Constipation  1  188/4800 (3.92%)  214/4787 (4.47%) 
Diarrhoea  1  1047/4800 (21.81%)  1022/4787 (21.35%) 
Flatulence  1  273/4800 (5.69%)  282/4787 (5.89%) 
Gastrooesophageal reflux disease  1  62/4800 (1.29%)  59/4787 (1.23%) 
Infantile colic  1  70/4800 (1.46%)  65/4787 (1.36%) 
Regurgitation of food  1  175/4800 (3.65%)  183/4787 (3.82%) 
Teething  1  196/4800 (4.08%)  165/4787 (3.45%) 
Vomiting  1  613/4800 (12.77%)  644/4787 (13.45%) 
General disorders     
Injection site pain  1  216/4800 (4.50%)  228/4787 (4.76%) 
Irritability  1  881/4800 (18.35%)  862/4787 (18.01%) 
Pyrexia  1  1970/4800 (41.04%)  2056/4787 (42.95%) 
Infections and infestations     
Bronchiolitis  1  200/4800 (4.17%)  185/4787 (3.86%) 
Bronchitis  1  79/4800 (1.65%)  73/4787 (1.52%) 
Candida nappy rash  1  46/4800 (0.96%)  51/4787 (1.07%) 
Ear infection  1  94/4800 (1.96%)  107/4787 (2.24%) 
Gastroenteritis  1  447/4800 (9.31%)  454/4787 (9.48%) 
Influenza  1  89/4800 (1.85%)  72/4787 (1.50%) 
Nasopharyngitis  1  276/4800 (5.75%)  277/4787 (5.79%) 
Oral candidiasis  1  185/4800 (3.85%)  188/4787 (3.93%) 
Otitis media  1  624/4800 (13.00%)  602/4787 (12.58%) 
Pharyngitis  1  60/4800 (1.25%)  57/4787 (1.19%) 
Respiratory tract infection  1  97/4800 (2.02%)  83/4787 (1.73%) 
Rhinitis  1  348/4800 (7.25%)  337/4787 (7.04%) 
Upper respiratory tract infection  1  1230/4800 (25.62%)  1279/4787 (26.72%) 
Viral infection  1  105/4800 (2.19%)  121/4787 (2.53%) 
Metabolism and nutrition disorders     
Decreased appetite  1  68/4800 (1.42%)  67/4787 (1.40%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  45/4800 (0.94%)  46/4787 (0.96%) 
Psychiatric disorders     
Agitation  1  215/4800 (4.48%)  180/4787 (3.76%) 
Crying  1  160/4800 (3.33%)  190/4787 (3.97%) 
Restlessness  1  63/4800 (1.31%)  69/4787 (1.44%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  471/4800 (9.81%)  456/4787 (9.53%) 
Nasal congestion  1  293/4800 (6.10%)  294/4787 (6.14%) 
Rhinorrhoea  1  222/4800 (4.63%)  254/4787 (5.31%) 
Wheezing  1  52/4800 (1.08%)  51/4787 (1.07%) 
Skin and subcutaneous tissue disorders     
Dermatitis  1  47/4800 (0.98%)  25/4787 (0.52%) 
Dermatitis diaper  1  106/4800 (2.21%)  120/4787 (2.51%) 
Eczema  1  129/4800 (2.69%)  110/4787 (2.30%) 
Rash  1  167/4800 (3.48%)  153/4787 (3.20%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (8.1)
70,301 participants randomized, 69,274 evaluated, when DSMB first recommended ending enrollment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00090233     History of Changes
Other Study ID Numbers: V260-006
2004_012
First Submitted: August 25, 2004
First Posted: August 27, 2004
Results First Submitted: June 29, 2009
Results First Posted: May 5, 2011
Last Update Posted: October 5, 2015