Trial Outcomes & Findings for Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021) (NCT NCT00496054)

NCT ID: NCT00496054

Last Updated: 2017-04-13

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 110 participants
• Primary outcome timeframe: Baseline and Approximately 6 Months
• Results posted on: 2017-04-13

Participant Flow

Phase III First Patient In (FPI): 09-May-2008 Last Patient Out (LPO): 20-Nov-2008 Multi-center study 1. Department of Paediatrics, Kashyap Nursing Home, Mumbai. 2. Department of Paediatrics, KEM Hospital, Pune 3. Department of Paediatrics, J.K.Lon, SMS Hospital, Jaipur 4. Panchsheel Hospital, Delhi

Open-label, single-arm study. Healthy infants between the ages of 6 weeks through exactly 12 weeks (≥42 to ≤84 days) at entry who did not have clinical evidence of active gastrointestinal illness; who did not have fever, with a rectal temperature of greater than and equal to 38 degrees Celsius at first vaccination were enrolled in the study.

Participant milestones

Measure	RotaTeq™ Vaccine (V260) Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
Overall Study STARTED	110
Overall Study COMPLETED	102
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	RotaTeq™ Vaccine (V260) Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	7

Baseline Characteristics

Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India (V260-021)

Baseline characteristics by cohort

Measure	RotaTeq™ Vaccine (V260) n=110 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
Age, Continuous	59.01 Days STANDARD_DEVIATION 13.52 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	63 Participants n=5 Participants
Height	57.61 Centimeters STANDARD_DEVIATION 5.04 • n=5 Participants
Temperature	98.58 Fahrenheit STANDARD_DEVIATION 0.70 • n=5 Participants
Weight	4.73 Kilograms STANDARD_DEVIATION 0.71 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Approximately 6 Months

Population: The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data

Outcome measures

Measure	RotaTeq™ Vaccine (V260) n=102 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA	82.35 Percentage of Participants Interval 74.95 to 89.75

PRIMARY outcome

Timeframe: Baseline and Approximately 6 Months

Population: The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results.

Outcome measures

Measure	RotaTeq™ Vaccine (V260) n=99 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
The Percentage of Participants Who Exhibit a 3 Fold Rise or Greater From Baseline to Approximately 6 Months in Rotavirus Specific Serum in IgA	82.83 Percentage of Participants Interval 75.4 to 90.26

PRIMARY outcome

Timeframe: Baseline and Approximately 6 Months

Population: The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data

Outcome measures

Measure	RotaTeq™ Vaccine (V260) n=102 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies (SNA)	38.24 Percentage of Participants Interval 28.81 to 47.67

PRIMARY outcome

Timeframe: Baseline and Approximately 6 Months

Population: The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data

Outcome measures

Measure	RotaTeq™ Vaccine (V260) n=102 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)	14.71 Percentage of Participants Interval 7.84 to 21.58

PRIMARY outcome

Timeframe: Baseline and Approximately 6 Months

Population: The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data

Outcome measures

Measure	RotaTeq™ Vaccine (V260) n=102 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)	30.39 Percentage of Participants Interval 21.46 to 39.32

PRIMARY outcome

Timeframe: Baseline and Approximately 6 Months

Population: The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data

Outcome measures

Measure	RotaTeq™ Vaccine (V260) n=102 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)	37.25 Percentage of Participants Interval 27.87 to 46.63

PRIMARY outcome

Timeframe: Baseline and Approximately 6 Months

Population: The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data

Outcome measures

Measure	RotaTeq™ Vaccine (V260) n=102 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)	30.39 Percentage of Participants Interval 21.46 to 39.32

PRIMARY outcome

Timeframe: Baseline and Approximately 6 Months

Population: The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results

Outcome measures

Measure	RotaTeq™ Vaccine (V260) n=99 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G1 Serum Neutralizing Antibodies(SNA)	37.37 Percentage of Participants Interval 27.84 to 46.9

PRIMARY outcome

Timeframe: Baseline and Approximately 6 Months

Population: The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results

Outcome measures

Measure	RotaTeq™ Vaccine (V260) n=99 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G2 Serum Neutralizing Antibodies(SNA)	14.14 Percentage of Participants Interval 7.28 to 21.0

PRIMARY outcome

Timeframe: Baseline and Approximately 6 Months

Population: The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results

Outcome measures

Measure	RotaTeq™ Vaccine (V260) n=99 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G3 Serum Neutralizing Antibodies(SNA)	29.29 Percentage of Participants Interval 20.33 to 38.25

PRIMARY outcome

Timeframe: Baseline and Approximately 6 Months

Population: The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results

Outcome measures

Measure	RotaTeq™ Vaccine (V260) n=99 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in G4 Serum Neutralizing Antibodies(SNA)	35.35 Percentage of Participants Interval 25.93 to 44.77

PRIMARY outcome

Timeframe: Baseline and Approximately 6 Months

Population: The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results

Outcome measures

Measure	RotaTeq™ Vaccine (V260) n=99 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
The Percentage of Participants Who Exihibit 3 Fold Rise Responses or Greater From Baseline to Approximately 6 Months in P1 Serum Neutralizing Antibodies(SNA)	29.29 Percentage of Participants Interval 20.33 to 38.25

PRIMARY outcome

Timeframe: Baseline and Approximately 6 Months

Population: The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data

Outcome measures

Measure	RotaTeq™ Vaccine (V260) n=102 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA IgA GMT at Baseline	3.81 Titer Interval 2.74 to 5.29
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA IgA GMT at 6 Months	79.95 Titer Interval 55.23 to 115.73

PRIMARY outcome

Timeframe: Baseline and Approximately 6 Months

Population: The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results

Outcome measures

Measure	RotaTeq™ Vaccine (V260) n=99 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA IgA GMT at Baseline	3.68 Titer Interval 2.66 to 5.09
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for IgA IgA GMT at 6 Months	75.12 Titer Interval 51.67 to 109.22

PRIMARY outcome

Timeframe: Baseline and Approximately 6 Months

Population: The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data

Outcome measures

Measure	RotaTeq™ Vaccine (V260) n=102 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1 G1 GMT at Baseline	43.53 Titer Interval 35.59 to 53.24
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1 G1 GMT at 6 Months	85.79 Titer Interval 68.65 to 107.2

PRIMARY outcome

Timeframe: Baseline and Approximately 6 Months

Population: The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data

Outcome measures

Measure	RotaTeq™ Vaccine (V260) n=102 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2 G2 GMT at Baseline	63.25 Titer Interval 53.46 to 74.83
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2 G2 GMT at 6 Months	50.33 Titer Interval 41.66 to 60.81

PRIMARY outcome

Timeframe: Baseline and Approximately 6 Months

Population: The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data

Outcome measures

Measure	RotaTeq™ Vaccine (V260) n=102 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3 G3 GMT at Baseline	27.22 Titer Interval 21.23 to 34.9
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3 G3 GMT at 6 Months	34.32 Titer Interval 26.71 to 44.09

PRIMARY outcome

Timeframe: Baseline and Approximately 6 Months

Population: The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data

Outcome measures

Measure	RotaTeq™ Vaccine (V260) n=102 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4 G4 GMT at Baseline	51.91 Titer Interval 43.29 to 62.23
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4 G4 GMT at 6 Months	84.43 Titer Interval 69.36 to 102.79

PRIMARY outcome

Timeframe: Baseline and Approximately 6 Months

Population: The number of subjects contributing to the Full analysis set (FAS) analysis includes all subjects who had immunogenicity data

Outcome measures

Measure	RotaTeq™ Vaccine (V260) n=102 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1 P1 GMT at Baseline	86.61 Titer Interval 69.48 to 107.95
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1 P1 GMT at 6 Months	104.56 Titer Interval 82.86 to 131.94

PRIMARY outcome

Timeframe: Baseline and Approximately 6 Months

Population: The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results

Outcome measures

Measure	RotaTeq™ Vaccine (V260) n=99 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1 G1 GMT at Baseline	43.11 Titer Interval 35.07 to 52.98
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G1 G1 GMT at 6 Months	81.19 Titer Interval 65.15 to 101.19

PRIMARY outcome

Timeframe: Baseline and Approximately 6 Months

Population: The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results

Outcome measures

Measure	RotaTeq™ Vaccine (V260) n=99 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2 G2 GMT at Baseline	62.91 Titer Interval 52.91 to 74.79
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G2 G2 GMT at 6 Months	49.21 Titer Interval 40.62 to 59.61

PRIMARY outcome

Timeframe: Baseline and Approximately 6 Months

Population: The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results

Outcome measures

Measure	RotaTeq™ Vaccine (V260) n=99 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3 G3 GMT at Baseline	27.71 Titer Interval 21.48 to 35.73
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G3 G3 GMT at 6 Months	32.95 Titer Interval 25.6 to 42.42

PRIMARY outcome

Timeframe: Baseline and Approximately 6 Months

Population: The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results

Outcome measures

Measure	RotaTeq™ Vaccine (V260) n=99 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4 G4 GMT at Baseline	51.74 Titer Interval 42.94 to 62.35
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for G4 G4 GMT at 6 Months	80.88 Titer Interval 65.52 to 98.34

PRIMARY outcome

Timeframe: Baseline and Approximately 6 Months

Population: The number of subjects contributing to the per protocol analysis includes all subjects who are not general protocol violators, received all 3 vaccinations at 3 separate visits scheduled at least 4 weeks (28 days) apart and had valid serology results

Outcome measures

Measure	RotaTeq™ Vaccine (V260) n=99 Participants Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1 P1 GMT at Baseline	84.17 Titer Interval 67.27 to 105.31
The Summary of Geometric Mean Titer (GMT) at Baseline & Approximately 6 Months for P1 P1 GMT at 6 Months	100.01 Titer Interval 79.28 to 126.15

Adverse Events

RotaTeq™ Vaccine (V260)

Serious events: 1 serious events

Other events: 47 other events

Deaths: 0 deaths

Serious adverse events

Measure

RotaTeq™ Vaccine (V260) n=104 participants at risk Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.

Infections and infestations Meningitis

0.96% 1/104 • 1. Any SAE/NSAE reported day 1 through day 14 of vaccination 2. Any serious vaccine related AE that occurred throughout the study 3. Any death 4. Any event of clinical interest (intussusception) that occurred throughout the study Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) from Day 1 through Day 14 after each dose of RotaTeq™ Temperatures and any episodes of vomiting and diarrhea were recorded on the card daily from Day 1 through Day 7 after each dose 6 subjects did not report after dose 1 and were considered lost to follow-up

Other adverse events

Measure	RotaTeq™ Vaccine (V260) n=104 participants at risk Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
Ear and labyrinth disorders Ear Pain	0.96% 1/104 • Number of events 1 • 1. Any SAE/NSAE reported day 1 through day 14 of vaccination 2. Any serious vaccine related AE that occurred throughout the study 3. Any death 4. Any event of clinical interest (intussusception) that occurred throughout the study Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) from Day 1 through Day 14 after each dose of RotaTeq™ Temperatures and any episodes of vomiting and diarrhea were recorded on the card daily from Day 1 through Day 7 after each dose 6 subjects did not report after dose 1 and were considered lost to follow-up
Gastrointestinal disorders Abdominal pain	1.9% 2/104 • Number of events 2 • 1. Any SAE/NSAE reported day 1 through day 14 of vaccination 2. Any serious vaccine related AE that occurred throughout the study 3. Any death 4. Any event of clinical interest (intussusception) that occurred throughout the study Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) from Day 1 through Day 14 after each dose of RotaTeq™ Temperatures and any episodes of vomiting and diarrhea were recorded on the card daily from Day 1 through Day 7 after each dose 6 subjects did not report after dose 1 and were considered lost to follow-up
Gastrointestinal disorders Diarrhoea	21.2% 22/104 • Number of events 30 • 1. Any SAE/NSAE reported day 1 through day 14 of vaccination 2. Any serious vaccine related AE that occurred throughout the study 3. Any death 4. Any event of clinical interest (intussusception) that occurred throughout the study Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) from Day 1 through Day 14 after each dose of RotaTeq™ Temperatures and any episodes of vomiting and diarrhea were recorded on the card daily from Day 1 through Day 7 after each dose 6 subjects did not report after dose 1 and were considered lost to follow-up
Gastrointestinal disorders Vomiting	18.3% 19/104 • Number of events 29 • 1. Any SAE/NSAE reported day 1 through day 14 of vaccination 2. Any serious vaccine related AE that occurred throughout the study 3. Any death 4. Any event of clinical interest (intussusception) that occurred throughout the study Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) from Day 1 through Day 14 after each dose of RotaTeq™ Temperatures and any episodes of vomiting and diarrhea were recorded on the card daily from Day 1 through Day 7 after each dose 6 subjects did not report after dose 1 and were considered lost to follow-up
General disorders Irritability	0.96% 1/104 • Number of events 2 • 1. Any SAE/NSAE reported day 1 through day 14 of vaccination 2. Any serious vaccine related AE that occurred throughout the study 3. Any death 4. Any event of clinical interest (intussusception) that occurred throughout the study Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) from Day 1 through Day 14 after each dose of RotaTeq™ Temperatures and any episodes of vomiting and diarrhea were recorded on the card daily from Day 1 through Day 7 after each dose 6 subjects did not report after dose 1 and were considered lost to follow-up
General disorders Pyrexia	13.5% 14/104 • Number of events 19 • 1. Any SAE/NSAE reported day 1 through day 14 of vaccination 2. Any serious vaccine related AE that occurred throughout the study 3. Any death 4. Any event of clinical interest (intussusception) that occurred throughout the study Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) from Day 1 through Day 14 after each dose of RotaTeq™ Temperatures and any episodes of vomiting and diarrhea were recorded on the card daily from Day 1 through Day 7 after each dose 6 subjects did not report after dose 1 and were considered lost to follow-up
Infections and infestations Meningitis	0.96% 1/104 • Number of events 1 • 1. Any SAE/NSAE reported day 1 through day 14 of vaccination 2. Any serious vaccine related AE that occurred throughout the study 3. Any death 4. Any event of clinical interest (intussusception) that occurred throughout the study Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) from Day 1 through Day 14 after each dose of RotaTeq™ Temperatures and any episodes of vomiting and diarrhea were recorded on the card daily from Day 1 through Day 7 after each dose 6 subjects did not report after dose 1 and were considered lost to follow-up
Infections and infestations Nasopharyngitis	7.7% 8/104 • Number of events 8 • 1. Any SAE/NSAE reported day 1 through day 14 of vaccination 2. Any serious vaccine related AE that occurred throughout the study 3. Any death 4. Any event of clinical interest (intussusception) that occurred throughout the study Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) from Day 1 through Day 14 after each dose of RotaTeq™ Temperatures and any episodes of vomiting and diarrhea were recorded on the card daily from Day 1 through Day 7 after each dose 6 subjects did not report after dose 1 and were considered lost to follow-up
Respiratory, thoracic and mediastinal disorders Cough	3.8% 4/104 • Number of events 4 • 1. Any SAE/NSAE reported day 1 through day 14 of vaccination 2. Any serious vaccine related AE that occurred throughout the study 3. Any death 4. Any event of clinical interest (intussusception) that occurred throughout the study Parents/guardians were asked to record AEs on a standardized Vaccine Report Card (VRC) from Day 1 through Day 14 after each dose of RotaTeq™ Temperatures and any episodes of vomiting and diarrhea were recorded on the card daily from Day 1 through Day 7 after each dose 6 subjects did not report after dose 1 and were considered lost to follow-up

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

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