Trial Outcomes & Findings for RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016) (NCT NCT00443846)
NCT ID: NCT00443846
Last Updated: 2018-06-20
Results Overview
Antibody seroprotection to meningiococcal Group C serotype was measured by serum bactericidal antibody with rabbit complement (sRBA). The criterion for seroresponse was an sRBA titer \>=1:8.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
247 participants
Primary outcome timeframe
28 days after the second dose of MCC vaccine (approximately 20 weeks)
Results posted on
2018-06-20
Participant Flow
A total of 249 participants were screened and 247 were randomized.
Participant milestones
| Measure |
Group 1: Concomitant Administration
Participants received 2 concomitant doses of RotaTeq® and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age and a third dose of RotaTeq® at 24-25 weeks of age (and 28 to 42 days after the vaccine administration at 20-21 weeks of age)
|
Group 2: Sequential Administration
Participants received 3 doses of RotaTeq® at 6-7 weeks of age, 15-16 weeks of age, and 24-25 weeks of age (and 28 to 42 days after the MMC vaccine administered at 20-21 weeks of age), and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age.
|
|---|---|---|
|
Overall Study
STARTED
|
124
|
123
|
|
Overall Study
Vaccinated
|
116
|
123
|
|
Overall Study
COMPLETED
|
113
|
117
|
|
Overall Study
NOT COMPLETED
|
11
|
6
|
Reasons for withdrawal
| Measure |
Group 1: Concomitant Administration
Participants received 2 concomitant doses of RotaTeq® and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age and a third dose of RotaTeq® at 24-25 weeks of age (and 28 to 42 days after the vaccine administration at 20-21 weeks of age)
|
Group 2: Sequential Administration
Participants received 3 doses of RotaTeq® at 6-7 weeks of age, 15-16 weeks of age, and 24-25 weeks of age (and 28 to 42 days after the MMC vaccine administered at 20-21 weeks of age), and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age.
|
|---|---|---|
|
Overall Study
Withdrawn due to intercurrent disease
|
1
|
0
|
|
Overall Study
Not vaccinated, no blood sample drawn
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Personal reason
|
8
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)
Baseline characteristics by cohort
| Measure |
Group 1: Concomitant Administration
n=124 Participants
Participants received 2 concomitant doses of RotaTeq® and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age and a third dose of RotaTeq® at 24-25 weeks of age (and 28 to 42 days after the vaccine administration at 20-21 weeks of age)
|
Group 2: Sequential Administration
n=123 Participants
Participants received 3 doses of RotaTeq® at 6-7 weeks of age, 15-16 weeks of age, and 24-25 weeks of age (and 28 to 42 days after the MMC vaccine administered at 20-21 weeks of age), and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age.
|
Total
n=247 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.1 Weeks
STANDARD_DEVIATION 0.5 • n=5 Participants
|
7.2 Weeks
STANDARD_DEVIATION 0.6 • n=7 Participants
|
7.1 Weeks
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days after the second dose of MCC vaccine (approximately 20 weeks)Population: The population analyzed was randomized participants excluding those with protocol violations that may have interfered with the immunogenicity evaluation.
Antibody seroprotection to meningiococcal Group C serotype was measured by serum bactericidal antibody with rabbit complement (sRBA). The criterion for seroresponse was an sRBA titer \>=1:8.
Outcome measures
| Measure |
Group 1: Concomitant Administration
n=104 Participants
Participants received 2 concomitant doses of RotaTeq® and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age and a third dose of RotaTeq® at 24-25 weeks of age (and 28 to 42 days after the vaccine administration at 20-21 weeks of age)
|
Group 2: Sequential Administration
n=106 Participants
Participants received 3 doses of RotaTeq® at 6-7 weeks of age, 15-16 weeks of age, and 24-25 weeks of age (and 28 to 42 days after the MMC vaccine administered at 20-21 weeks of age), and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age.
|
|---|---|---|
|
Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype
|
100 Percentage of participants
Interval 96.5 to 100.0
|
100 Percentage of participants
Interval 96.6 to 100.0
|
Adverse Events
Group 1: Concomitant Administration
Serious events: 1 serious events
Other events: 98 other events
Deaths: 0 deaths
Group 2: Sequential Administration
Serious events: 1 serious events
Other events: 105 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Concomitant Administration
n=116 participants at risk
Participants received 2 concomitant doses of RotaTeq® and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age and a third dose of RotaTeq® at 24-25 weeks of age (and 28 to 42 days after the vaccine administration at 20-21 weeks of age)
|
Group 2: Sequential Administration
n=122 participants at risk
Participants received 3 doses of RotaTeq® at 6-7 weeks of age, 15-16 weeks of age, and 24-25 weeks of age (and 28 to 42 days after the MMC vaccine administered at 20-21 weeks of age), and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age.
|
|---|---|---|
|
Infections and infestations
Viral infection
|
0.00%
0/116 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
0.82%
1/122 • Number of events 1 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
|
Nervous system disorders
Epilepsy
|
0.86%
1/116 • Number of events 1 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
0.00%
0/122 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
Other adverse events
| Measure |
Group 1: Concomitant Administration
n=116 participants at risk
Participants received 2 concomitant doses of RotaTeq® and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age and a third dose of RotaTeq® at 24-25 weeks of age (and 28 to 42 days after the vaccine administration at 20-21 weeks of age)
|
Group 2: Sequential Administration
n=122 participants at risk
Participants received 3 doses of RotaTeq® at 6-7 weeks of age, 15-16 weeks of age, and 24-25 weeks of age (and 28 to 42 days after the MMC vaccine administered at 20-21 weeks of age), and MCC vaccine at 10-11 weeks of age and 20-21 weeks of age.
|
|---|---|---|
|
Eye disorders
Conjunctivitis
|
3.4%
4/116 • Number of events 5 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
5.7%
7/122 • Number of events 7 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.3%
5/116 • Number of events 8 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
13.1%
16/122 • Number of events 21 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
|
Gastrointestinal disorders
Diarrhoea
|
32.8%
38/116 • Number of events 52 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
39.3%
48/122 • Number of events 73 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
|
Gastrointestinal disorders
Flatulence
|
7.8%
9/116 • Number of events 11 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
17.2%
21/122 • Number of events 26 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
|
Gastrointestinal disorders
Regurgitation of food
|
5.2%
6/116 • Number of events 7 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
10.7%
13/122 • Number of events 15 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
|
Gastrointestinal disorders
Teething
|
6.0%
7/116 • Number of events 8 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
1.6%
2/122 • Number of events 2 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
|
Gastrointestinal disorders
Vomiting
|
25.9%
30/116 • Number of events 36 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
22.1%
27/122 • Number of events 40 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
|
General disorders
Injection-site erythema
|
22.4%
26/116 • Number of events 30 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
18.9%
23/122 • Number of events 24 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
|
General disorders
Injection-site induration
|
3.4%
4/116 • Number of events 5 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
5.7%
7/122 • Number of events 8 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
|
General disorders
Injection-site pain
|
8.6%
10/116 • Number of events 11 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
4.9%
6/122 • Number of events 6 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
|
General disorders
Injection-site swelling
|
5.2%
6/116 • Number of events 7 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
8.2%
10/122 • Number of events 11 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
|
General disorders
Irritability
|
50.9%
59/116 • Number of events 76 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
41.8%
51/122 • Number of events 79 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
|
General disorders
Pyrexia
|
27.6%
32/116 • Number of events 38 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
27.9%
34/122 • Number of events 36 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
|
Infections and infestations
Rhinitis
|
11.2%
13/116 • Number of events 14 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
17.2%
21/122 • Number of events 26 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.4%
4/116 • Number of events 5 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
8.2%
10/122 • Number of events 11 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
|
Nervous system disorders
Somnolence
|
6.9%
8/116 • Number of events 10 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
7.4%
9/122 • Number of events 10 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
|
Psychiatric disorders
Crying
|
10.3%
12/116 • Number of events 16 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
20.5%
25/122 • Number of events 31 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.2%
6/116 • Number of events 6 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
5.7%
7/122 • Number of events 8 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.3%
5/116 • Number of events 5 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
6.6%
8/122 • Number of events 10 • Serious and other adverse events: up to 13 days after any vaccination visit; solicited diarrhea, vomiting, and temperature: up to 6 days after any vaccination visit; deaths and vaccine- or procedure-related serious adverse events: up to 27 weeks.
The population at risk was all vaccinated participants. One participant in Group 2 was excluded because they were lost to follow-up after receiving only the first dose of RotaTeq®.
|
Additional Information
Senior Vice President, Global Clinical Development
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