Trial Outcomes & Findings for Dose Confirmation Efficacy Study (V260-007) (NCT NCT00092443)
NCT ID: NCT00092443
Last Updated: 2015-09-14
Results Overview
G1, G2, G3, and G4 Serotype Rotavirus Gastroenteritis Cases Occurring at Least 14 Days Postdose 3 Through the First Rotavirus Season Postvaccination in the Per-Protocol Population Using Per-Protocol Case Definition
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1312 participants
Primary outcome timeframe
At least 14 days following the 3rd vaccination
Results posted on
2015-09-14
Participant Flow
The study was conducted at 30 sites - 27 in the United States, and 3 in Finland from 24-Sep-2002 (first patient in) to 11-Feb-2004 (last dose given). Last subject completed follow-up: 08-Jun-2004. All data corrections applied (Frozen File): 07-Sep-2004
Excluded from the trial before assignment to groups were patients with: history of congenital abdominal disorders, intussusception, or abdominal surgery; history of known prior rotavirus disease, chronic diarrhea, or failure to thrive.
Participant milestones
| Measure |
RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)
Three 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, and followup for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
|
Placebo Matching RotaTeq™
Placebo matching RotaTeq™ administered 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 post vaccination.
|
|---|---|---|
|
Overall Study
STARTED
|
651
|
661
|
|
Overall Study
Vaccinated at Visit 1
|
650
|
660
|
|
Overall Study
Vaccinated at Visit 2
|
618
|
627
|
|
Overall Study
Vaccinated at Visit 3
|
593
|
608
|
|
Overall Study
COMPLETED
|
593
|
607
|
|
Overall Study
NOT COMPLETED
|
58
|
54
|
Reasons for withdrawal
| Measure |
RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)
Three 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, and followup for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
|
Placebo Matching RotaTeq™
Placebo matching RotaTeq™ administered 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 post vaccination.
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
13
|
|
Overall Study
Lost to Follow-up
|
7
|
3
|
|
Overall Study
Protocol Violation
|
11
|
9
|
|
Overall Study
Withdrawal by Subject
|
9
|
11
|
|
Overall Study
Moved
|
5
|
5
|
|
Overall Study
Other
|
17
|
13
|
Baseline Characteristics
Dose Confirmation Efficacy Study (V260-007)
Baseline characteristics by cohort
| Measure |
RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)
n=651 Participants
Three 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, and followup for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
|
Placebo Matching RotaTeq™
n=661 Participants
Placebo matching RotaTeq™ administered 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 post vaccination.
|
Total
n=1312 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
6 to 12 Weeks
|
648 participants
n=5 Participants
|
658 participants
n=7 Participants
|
1306 participants
n=5 Participants
|
|
Age, Customized
Over 12 Weeks
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
304 Participants
n=5 Participants
|
323 Participants
n=7 Participants
|
627 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
347 Participants
n=5 Participants
|
338 Participants
n=7 Participants
|
685 Participants
n=5 Participants
|
|
Race/Ethnicity
White
|
525 participants
n=5 Participants
|
540 participants
n=7 Participants
|
1065 participants
n=5 Participants
|
|
Race/Ethnicity
Hispanic American
|
79 participants
n=5 Participants
|
77 participants
n=7 Participants
|
156 participants
n=5 Participants
|
|
Race/Ethnicity
Black
|
21 participants
n=5 Participants
|
23 participants
n=7 Participants
|
44 participants
n=5 Participants
|
|
Race/Ethnicity
Multi-Racial
|
17 participants
n=5 Participants
|
15 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Race/Ethnicity
Other
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At least 14 days following the 3rd vaccinationPopulation: Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., unevaluable due to wild-type rotavirus-positive stool antigen Enzyme immunoassay (EIA) prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range.
G1, G2, G3, and G4 Serotype Rotavirus Gastroenteritis Cases Occurring at Least 14 Days Postdose 3 Through the First Rotavirus Season Postvaccination in the Per-Protocol Population Using Per-Protocol Case Definition
Outcome measures
| Measure |
RotaTeq™ at Expiry Potency (≈1.1 x 107 IU/Dose)
n=551 Participants
Three 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, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
|
Placebo Matching RotaTeq™
n=564 Participants
Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for AGEs through the first rotavirus season post vaccination.
|
RotaTeq™ at Expiry Potency (SNA - G3)
Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
|
RotaTeq™ at Expiry Potency (SNA - G4)
Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
|
RotaTeq™ at Expiry Potency (SNA - P1A)
Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
|
Placebo Matching RotaTeq™ (SNA - G1)
Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
|
Placebo Matching RotaTeq™ (SNA - G2)
Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
|
Placebo Matching RotaTeq™ (SNA - G3)
Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
|
Placebo Matching RotaTeq™ (SNA - G4)
Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
|
Placebo Matching RotaTeq™ (SNA - P1A)
Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose.
|
15 Participants
|
54 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 14 days following the 3rd vaccinationPopulation: Per Protocol Population; number randomized is different from number analyzed due to some data excluded from the analysis (e.g., unevaluable due to wild-type rotavirus-positive stool antigen EIA prior to 14 days Postdose 3, incomplete clinical and/or laboratory results, or stool samples collected out of day range.
Induction of postdose 3 rotavirus Serum neutralizing antibody (SNA) response (Number of subjects with ≥3 fold rise in antibody titer)
Outcome measures
| Measure |
RotaTeq™ at Expiry Potency (≈1.1 x 107 IU/Dose)
n=67 Participants
Three 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, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
|
Placebo Matching RotaTeq™
n=62 Participants
Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for AGEs through the first rotavirus season post vaccination.
|
RotaTeq™ at Expiry Potency (SNA - G3)
n=67 Participants
Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
|
RotaTeq™ at Expiry Potency (SNA - G4)
n=63 Participants
Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
|
RotaTeq™ at Expiry Potency (SNA - P1A)
n=61 Participants
Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
|
Placebo Matching RotaTeq™ (SNA - G1)
n=73 Participants
Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
|
Placebo Matching RotaTeq™ (SNA - G2)
n=70 Participants
Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
|
Placebo Matching RotaTeq™ (SNA - G3)
n=75 Participants
Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
|
Placebo Matching RotaTeq™ (SNA - G4)
n=70 Participants
Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
|
Placebo Matching RotaTeq™ (SNA - P1A)
n=69 Participants
Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Subjects With ≥3 Fold Rise in Antibody Titer
|
38 Participants
|
9 Participants
|
6 Participants
|
25 Participants
|
15 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
Adverse Events
RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)
Serious events: 21 serious events
Other events: 558 other events
Deaths: 0 deaths
Placebo Matching RotaTeq™
Serious events: 28 serious events
Other events: 565 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)
n=649 participants at risk
Three 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, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
|
Placebo Matching RotaTeq™
n=658 participants at risk
Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for AGEs through the first rotavirus season post vaccination.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/649
|
0.15%
1/658 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/649
|
0.15%
1/658 • Number of events 1
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/649
|
0.15%
1/658 • Number of events 1
|
|
Gastrointestinal disorders
Perirectal abscess
|
0.15%
1/649 • Number of events 1
|
0.00%
0/658
|
|
General disorders
Pyrexia
|
0.31%
2/649 • Number of events 2
|
0.00%
0/658
|
|
General disorders
Sudden infant death syndrome
|
0.15%
1/649 • Number of events 1
|
0.00%
0/658
|
|
Immune system disorders
Milk allergy
|
0.00%
0/649
|
0.15%
1/658 • Number of events 1
|
|
Infections and infestations
Bronchiolitis
|
1.1%
7/649 • Number of events 7
|
1.1%
7/658 • Number of events 7
|
|
Infections and infestations
Bronchitis
|
0.00%
0/649
|
0.15%
1/658 • Number of events 1
|
|
Infections and infestations
Croup infectious
|
0.00%
0/649
|
0.15%
1/658 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.15%
1/649 • Number of events 1
|
0.15%
1/658 • Number of events 1
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/649
|
0.15%
1/658 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.15%
1/649 • Number of events 1
|
0.30%
2/658 • Number of events 2
|
|
Infections and infestations
Lobar pneumonia
|
0.15%
1/649 • Number of events 1
|
0.00%
0/658
|
|
Infections and infestations
Meningitis
|
0.15%
1/649 • Number of events 1
|
0.00%
0/658
|
|
Infections and infestations
Pertussis
|
0.00%
0/649
|
0.46%
3/658 • Number of events 3
|
|
Infections and infestations
Pneumonia
|
0.31%
2/649 • Number of events 2
|
0.00%
0/658
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/649
|
0.15%
1/658 • Number of events 1
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/649
|
0.30%
2/658 • Number of events 2
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.15%
1/649 • Number of events 1
|
0.15%
1/658 • Number of events 1
|
|
Infections and infestations
Tuberculosis
|
0.15%
1/649 • Number of events 1
|
0.00%
0/658
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/649
|
0.15%
1/658 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
0.15%
1/649 • Number of events 1
|
0.00%
0/658
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.15%
1/649 • Number of events 1
|
0.15%
1/658 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.15%
1/649 • Number of events 1
|
0.61%
4/658 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal cord neoplasm
|
0.00%
0/649
|
0.15%
1/658 • Number of events 1
|
|
Nervous system disorders
Cerebral cyst
|
0.00%
0/649
|
0.15%
1/658 • Number of events 1
|
|
Nervous system disorders
Partial seizures
|
0.15%
1/649 • Number of events 1
|
0.00%
0/658
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/649
|
0.15%
1/658 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.15%
1/649 • Number of events 1
|
0.00%
0/658
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/649
|
0.15%
1/658 • Number of events 1
|
Other adverse events
| Measure |
RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)
n=649 participants at risk
Three 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, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
|
Placebo Matching RotaTeq™
n=658 participants at risk
Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for AGEs through the first rotavirus season post vaccination.
|
|---|---|---|
|
Eye disorders
Conjunctivitis
|
7.7%
50/649 • Number of events 56
|
7.0%
46/658 • Number of events 53
|
|
Gastrointestinal disorders
Constipation
|
5.4%
35/649 • Number of events 39
|
5.2%
34/658 • Number of events 38
|
|
Gastrointestinal disorders
Diarrhoea
|
15.9%
103/649 • Number of events 160
|
16.7%
110/658 • Number of events 177
|
|
Gastrointestinal disorders
Flatulence
|
8.0%
52/649 • Number of events 72
|
7.4%
49/658 • Number of events 78
|
|
Gastrointestinal disorders
Regurgitation of food
|
6.8%
44/649 • Number of events 54
|
6.2%
41/658 • Number of events 55
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
81/649 • Number of events 112
|
11.7%
77/658 • Number of events 116
|
|
General disorders
Injection site pain
|
9.4%
61/649 • Number of events 82
|
9.4%
62/658 • Number of events 81
|
|
General disorders
Pyrexia
|
43.6%
283/649 • Number of events 450
|
40.3%
265/658 • Number of events 438
|
|
Infections and infestations
Gastroenteritis
|
14.0%
91/649 • Number of events 103
|
16.1%
106/658 • Number of events 132
|
|
Infections and infestations
Otitis media
|
18.3%
119/649 • Number of events 143
|
16.9%
111/658 • Number of events 144
|
|
Infections and infestations
Respiratory tract infection
|
6.3%
41/649 • Number of events 46
|
4.3%
28/658 • Number of events 32
|
|
Infections and infestations
Rhinitis
|
10.6%
69/649 • Number of events 84
|
12.3%
81/658 • Number of events 110
|
|
Infections and infestations
Upper respiratory tract infection
|
23.1%
150/649 • Number of events 192
|
21.7%
143/658 • Number of events 172
|
|
Psychiatric disorders
Agitation
|
15.7%
102/649 • Number of events 145
|
15.0%
99/658 • Number of events 145
|
|
Psychiatric disorders
Crying
|
8.2%
53/649 • Number of events 82
|
7.9%
52/658 • Number of events 79
|
|
Psychiatric disorders
Irritability
|
23.9%
155/649 • Number of events 248
|
26.1%
172/658 • Number of events 299
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.6%
95/649 • Number of events 111
|
13.7%
90/658 • Number of events 106
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.0%
39/649 • Number of events 47
|
8.1%
53/658 • Number of events 68
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.1%
59/649 • Number of events 73
|
6.4%
42/658 • Number of events 50
|
Additional Information
Vice President, Late Stage Development Group Leader
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER