Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules
Study Details
Study Description
Brief Summary
Rotavirus, sometimes called the "stomach flu," is the most common cause of severe diarrhea in children. Vaccines can prevent many types of infections and work by causing the body to make proteins called antibodies that fight infection. For some vaccines, more than one vaccination is needed so that the body will make enough antibodies to fight infection. The vaccines (RotaTeq® or Rotarix® oral vaccines) given in this study are recommended for infants by the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP). These vaccines require either 2 or 3 vaccinations to be effective. Healthy infants between 6 weeks and 14 weeks, 6 days of age at Visit 1 will participate for about 10-12 months. Study procedures include reaction assessment and blood sample.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Rotavirus is the most common cause of severe gastroenteritis among children. The purpose of the proposed study is to determine the non-inferiority and safety of the 2 licensed rotavirus vaccines when both are administered to the same child during sequential vaccinations. Both Rotarix® and RotaTeq® vaccines have been evaluated for safety and efficacy in placebo-controlled trials with more than 70,000 infants each and it is likely that both vaccines delivered in various combinations will be safe and effective. Since RotaTeq® was licensed in the United States (US) in 2006, approximately 6 million doses have been administered in the US. In addition, Rotarix® has been licensed in over 100 nations worldwide and has been delivered to many children in Latin America where it has been recommended for universal vaccination for over 2 years. Now both RotaTeq® and Rotarix® are licensed in the US, and it is expected that health care providers will administer both vaccines. A 3-dose regimen is recommended for RotaTeq® and a 2-dose regimen for Rotarix®. From previous experience, it is likely that one of the vaccines may become unavailable for some period or pediatric offices may switch from one vaccine to the other. Thus, it is probable that mixed schedules will be administered to infants. The primary objective is to determine if the proportion of seroresponders in the sequential mixed rotavirus vaccine groups (RotaTeq® and Rotarix®) is non-inferior to the proportion of seroresponders in the recommended schedule of the single vaccine alone group. Secondary Objectives are: to determine the neutralizing rotavirus antibody responses to the most common rotavirus serotypes (G1-G4 and G9) at 3-6 weeks after the last vaccination for both the sequential, mixed rotavirus vaccine schedule and the single rotavirus vaccine recommended schedule; and to determine if sequential mixed rotavirus vaccine schedules are safe with no statistically significant increase in fever, diarrhea, vomiting, or intussusception in the mixed schedule groups when compared with the recommended schedule of the single vaccine alone group. Normal healthy full-term infants who are scheduled to receive their routine infant immunizations and who are at least 6 weeks of age and no more than 14 weeks, 6 days of age at Visit 1 will be recruited from their primary care clinic. Infants will be randomized (open label) to one of 5 different rotavirus vaccine study groups. Two study groups will be administered the standard RotaTeq® or Rotarix® vaccines as 3 and 2 doses, respectively, and 3 study groups will be administered mixed sequences of RotaTeq® and Rotarix® given as 3 doses. All rotavirus vaccines will be administered concurrently with the other routinely administered childhood vaccines. Parents/legal guardians will be given a memory aid and a thermometer, and asked to record any suspected fever (with measured temperature documented) or adverse events for Days 1-8 after vaccination. At approximately 1 week after vaccination, study personnel will contact the parents/legal guardians, review the completed memory aid, and record the findings on the case report form. Blood for immunogenicity testing will be obtained 3-6 weeks after the last dose of vaccine. For the four 3-dose rotavirus vaccine study groups, blood will be obtained at approximately 7 months of age (3-6 weeks after the last rotavirus vaccine dose). For the single Rotarix® vaccine study group, blood will be obtained at approximately 5 months of age (3-6 weeks after the last dose of Rotarix® vaccine). The primary analysis will be based on rates of induction of anti-rotavirus serum immunoglobulin (Ig) A in the 5 study groups 3-6 weeks
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group 1, RotaTeq® x 3 2, 4 and 6 months of age: RotaTeq® |
Biological: RotaTeq®
2-mL ready-to-use oral solution of live reassortant rotaviruses, containing G1, G2, G3, G4, and P1A, which contains a minimum of 2.0 to 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IU per aggregate dose. The buffered stabilizer solution contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum. RotaTeq® contains no preservatives. RotaTeq® is a pale yellow clear liquid that may have a pink tint.
|
| Experimental: Group 5, Rotarix®, RotaTeq® x2 2 months of age: Rotarix®; 4 and 6 months of age: RotaTeq® |
Biological: Rotarix®
Each 1-mL dose of Rotarix® contains a suspension of at least 10^6 median Cell Culture Infective Dose (CCID50) of live, attenuated human G1P rotavirus after reconstitution. The lyophilized vaccine contains amino acids, dextran, Dulbecco's Modified Eagle Medium (DMEM), sorbitol, and sucrose. The liquid diluent contains calcium carbonate, sterile water, and xanthan. The diluent includes an antacid component (calcium carbonate) to protect the vaccine during passage through the acid environment of the stomach. Rotarix® contains no preservatives. Once reconstituted, the vaccine will appear white and turbid.
Biological: RotaTeq®
2-mL ready-to-use oral solution of live reassortant rotaviruses, containing G1, G2, G3, G4, and P1A, which contains a minimum of 2.0 to 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IU per aggregate dose. The buffered stabilizer solution contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum. RotaTeq® contains no preservatives. RotaTeq® is a pale yellow clear liquid that may have a pink tint.
|
| Active Comparator: Group 4, Rotarix® x 2 2 and 4 months of age: Rotarix® |
Biological: Rotarix®
Each 1-mL dose of Rotarix® contains a suspension of at least 10^6 median Cell Culture Infective Dose (CCID50) of live, attenuated human G1P rotavirus after reconstitution. The lyophilized vaccine contains amino acids, dextran, Dulbecco's Modified Eagle Medium (DMEM), sorbitol, and sucrose. The liquid diluent contains calcium carbonate, sterile water, and xanthan. The diluent includes an antacid component (calcium carbonate) to protect the vaccine during passage through the acid environment of the stomach. Rotarix® contains no preservatives. Once reconstituted, the vaccine will appear white and turbid.
|
| Experimental: Group 2, RotaTeq®, Rotarix® x 2 2 months of age: RotaTeq®; 4 and 6 months of age: Rotarix® |
Biological: Rotarix®
Each 1-mL dose of Rotarix® contains a suspension of at least 10^6 median Cell Culture Infective Dose (CCID50) of live, attenuated human G1P rotavirus after reconstitution. The lyophilized vaccine contains amino acids, dextran, Dulbecco's Modified Eagle Medium (DMEM), sorbitol, and sucrose. The liquid diluent contains calcium carbonate, sterile water, and xanthan. The diluent includes an antacid component (calcium carbonate) to protect the vaccine during passage through the acid environment of the stomach. Rotarix® contains no preservatives. Once reconstituted, the vaccine will appear white and turbid.
Biological: RotaTeq®
2-mL ready-to-use oral solution of live reassortant rotaviruses, containing G1, G2, G3, G4, and P1A, which contains a minimum of 2.0 to 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IU per aggregate dose. The buffered stabilizer solution contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum. RotaTeq® contains no preservatives. RotaTeq® is a pale yellow clear liquid that may have a pink tint.
|
| Experimental: Group 3, RotaTeq® x 2, Rotarix® 2 and 4 months of age: RotaTeq®; 6 months of age: Rotarix® |
Biological: Rotarix®
Each 1-mL dose of Rotarix® contains a suspension of at least 10^6 median Cell Culture Infective Dose (CCID50) of live, attenuated human G1P rotavirus after reconstitution. The lyophilized vaccine contains amino acids, dextran, Dulbecco's Modified Eagle Medium (DMEM), sorbitol, and sucrose. The liquid diluent contains calcium carbonate, sterile water, and xanthan. The diluent includes an antacid component (calcium carbonate) to protect the vaccine during passage through the acid environment of the stomach. Rotarix® contains no preservatives. Once reconstituted, the vaccine will appear white and turbid.
Biological: RotaTeq®
2-mL ready-to-use oral solution of live reassortant rotaviruses, containing G1, G2, G3, G4, and P1A, which contains a minimum of 2.0 to 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IU per aggregate dose. The buffered stabilizer solution contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum. RotaTeq® contains no preservatives. RotaTeq® is a pale yellow clear liquid that may have a pink tint.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay [3-6 weeks after the last vaccination]
Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the anti-rotavirus IgA antibody titer. A participant met the threshold of a positive response if the post vaccination anti-rotavirus IgA antibody titer was 20 or greater.
- Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the 89-12 IgA Assay [3-6 weeks after the last vaccination]
Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA 89-12 assay to determine the anti-rotavirus IgA antibody titer. A participant met the threshold of a positive response if the post vaccination anti-rotavirus IgA antibody titier was 20 or greater.
- Geometric Mean Serum Anti-rotavirus IgA Titer [3-6 weeks after the last dose of vaccine]
Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the anti-rotavirus IgA antibody titers. The geometric mean titers (GMT) for each group were calculated along with the 95% confidence intervals.
Secondary Outcome Measures
- GMT of Neutralizing Rotavirus Antibody to the Most Common Rotavirus Serotypes (G1-G4 and G9) [3-6 weeks after the last dose of vaccine.]
Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the neutralizing antibody assay against the most common rotavirus serotypes, G1-G4 and G9. Antigen-specific geometric mean titers (GMT) for each group were calculated along with the 95% confidence intervals.
- Number of Participants Experiencing Solicited Systemic Reactions in the 8 Days After Vaccination [Days 1-8 after each vaccination]
The participants' parent/guardian was given a memory aid to record for 8 days the presence of solicited reactions of fever, diarrhea and vomiting. Fever was considered experienced if the participant was assessed with an axillary temperature of 100.4F or greater on any day in the 8-day period after any vaccination. Diarrhea was considered experienced if the participant had 3 or more looser than normal stools in a day. Vomiting was considered experienced if the participant vomited 2 or more times in a day.
- Number of Participants Experiencing Hematochezia at Any Time During the Study [Day 1 through 6 months after the last vaccination]
Hematochezia was defined as any stools that are black and tarry; maroon in color; or frank red blood. At each visit, signs of hematochezia were assessed and the participant's parent/guardian was instructed to contact the clinical site at any time if the participant had evidence of hematochezia.
- Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotypes G1, G2, G4P6 and G9 [3-6 weeks after the last dose of vaccine.]
Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the antibody titers to rotavirus serotypes G1, G2, G4P6 and G9. A participant met the threshold of a positive response if the post vaccination antigen-specific antibody titer was 10 or greater.
- Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotype G3 [3-6 weeks after the last dose of vaccine.]
Blood was collected from all participants prior to vaccination and at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the antibody titers to rotavirus serotype G3. A participant met the threshold of a positive response if the post vaccination antibody titer was 10 or greater.
- Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotypes G4P8 [3-6 weeks after the last dose of vaccine.]
Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the antibody titers to rotavirus serotype G4P8. A participant met the threshold of a positive response if the post vaccination antibody titer was 10 or greater.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female infants who are at least 6 weeks of age and no more than 14 weeks, 6 days of age at Visit 1.
-
Parent(s)/legal guardian(s) have signed informed consent documents.
-
Children who will be available for the entire study period and whose parents/legal guardians can be reached by telephone.
-
Healthy infants as determined by medical history and by a baseline physical examination with no clinically significant abnormal findings within 14 days before the first dose.
-
Parents/legal guardians able to complete all relevant study procedures during study participation.
Exclusion Criteria:
-
Any clinically significant history of gastrointestinal disease including abdominal surgery or liver disease or other serious medical conditions as determined by the site investigator.
-
Any history of immunodeficiency in the infant (e.g., the infant is known to be human immunodeficiency virus (HIV) positive, to have hypogammaglobulinemia, or to have an underlying malignancy), or any infant with any unvaccinated household contact who is immunocompromised such as:
-
Any malignancies or are otherwise immunocompromised;
-
Primary immunodeficiency; or
-
Receiving immunosuppressive therapy.
-
Known sensitivity to any vaccine components, such as latex in the Rotarix® applicator.
-
Previous receipt of a rotavirus vaccine.
-
Acute illness at the time of vaccine administration, such as any of the following within the past 48 hours:
-
Axillary temperature of 100.4 degrees Fahrenheit or higher, or
-
More than 3 grossly watery stools, or
-
Any episodes of vomiting (forceful expulsion of partially digested milk/food). Infants with previous diagnoses of gastroesophageal reflux whose regurgitation episodes have not changed in the 48-hour period prior to the first vaccination may be enrolled.
If these symptoms clear within 48 hours and the subject meets the other inclusion/exclusion criteria, then the subject may be enrolled.
-
The subject is currently participating in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication) or has received an experimental agent within 1 month prior to enrollment in this study, or expects to receive another experimental agent during participation in this study.
-
Less than 37 weeks gestation at birth.
-
Receipt of blood and/or blood products (including immunoglobulin) within 4 weeks before vaccine administration.
-
Receipt of live vaccine within the past 30 days or a nonreplicating, inactivated, or subunit vaccine within the last 14 days, although planned licensed trivalent inactivated influenza vaccine that may be administered to children over 6 months of age during a routine clinic visit is permitted and would not be exclusionary.
-
The subject has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kaiser Permanente Vaccine Study Center | Oakland | California | United States | 94612-3610 |
| 2 | Children's Hospital & Research Center Oakland - Primary Care Clinic | Oakland | California | United States | 94618-1033 |
| 3 | Emory Children's Center - Pediatric Infectious Diseases | Atlanta | Georgia | United States | 30322-1014 |
| 4 | University of Iowa - Vaccine Research & Education Unit | Iowa City | Iowa | United States | 52242-2600 |
| 5 | University of Maryland School of Medicine - Center for Vaccine Development - Baltimore | Baltimore | Maryland | United States | 21201-1509 |
| 6 | Children's Mercy Hospital and Clinics - Infectious Diseases | Kansas City | Missouri | United States | 64108-4619 |
| 7 | Duke Translational Medicine Institute - Clinical Vaccine Unit | Durham | North Carolina | United States | 27704-2120 |
| 8 | Primary Physicians Research Inc. - Pittsburgh | Pittsburgh | Pennsylvania | United States | 15241-3100 |
| 9 | Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center | Nashville | Tennessee | United States | 37232-2573 |
| 10 | The University of Texas Medical Branch - Sealy Center for Vaccine Development (SCVD) | Galveston | Texas | United States | 77555-1121 |
| 11 | Baylor College of Medicine - Molecular Virology and Microbiology | Houston | Texas | United States | 77030-3411 |
| 12 | Group Health Research Institute - Seattle | Seattle | Washington | United States | 98101-1466 |
| 13 | Seattle Children's Hospital - Infectious Diseases | Seattle | Washington | United States | 98105-3901 |
Sponsors and Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 08-0017
- N01AI80006C
Study Results
Participant Flow
| Recruitment Details | Participants were healthy males and females age 6-14 weeks, recruited from the communities at large around the clinical sites. Participants were enrolled and vaccinated between 24MAR2011 and 08APR2013. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Group 1: RotaTeq, RotaTeq, RotaTeq | Group 2: RotaTeq, Rotarix, Rotarix | Group 3: RotaTeq, RotaTeq, Rotarix | Group 4: Rotarix, Rotarix | Group 5: Rotarix, RotaTeq, RotaTeq |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received RotaTeq® orally at 2, 4 and 6 months of age. | Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age. | Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age. | Participants received Rotarix® orally at 2 and 4 months of age. | Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age. |
| Period Title: Overall Study | |||||
| STARTED | 242 | 248 | 238 | 329 | 327 |
| Received Second Vaccine | 231 | 233 | 227 | 311 | 307 |
| Received Third Vaccine | 221 | 221 | 217 | 0 | 299 |
| COMPLETED | 212 | 212 | 214 | 301 | 297 |
| NOT COMPLETED | 30 | 36 | 24 | 28 | 30 |
Baseline Characteristics
| Arm/Group Title | Group 1: RotaTeq, RotaTeq, RotaTeq | Group 2: RotaTeq, Rotarix, Rotarix | Group 3: RotaTeq, RotaTeq, Rotarix | Group 4: Rotarix, Rotarix | Group 5: Rotarix, RotaTeq, RotaTeq | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Participants received 2-mL RotaTeq® orally at 2, 4 and 6 months of age. | Participants received 2-mL RotaTeq® orally at 2 months of age, followed by 1-mL Rotarix® orally at 4 and 6 months of age. | Participants received 2-mL RotaTeq® orally at 2 and 4 months of age, followed by 1-mL Rotarix® orally at 6 months of age. | Participants received 2-mL Rotarix® orally at 2 and 4 months of age. | Participants received 2-mL Rotarix® orally at 2 months of age, followed by 1-mL RotaTeq® orally at 4 and 6 months of age. | Total of all reporting groups |
| Overall Participants | 242 | 248 | 238 | 329 | 327 | 1384 |
| Age (weeks) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [weeks] |
9.2
(1.4)
|
9.1
(1.2)
|
9.2
(1.2)
|
9.1
(1.2)
|
9.2
(1.4)
|
9.2
(1.3)
|
| Age (Count of Participants) | ||||||
| <=18 years |
242
100%
|
248
100%
|
238
100%
|
329
100%
|
327
100%
|
1384
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
124
51.2%
|
112
45.2%
|
125
52.5%
|
176
53.5%
|
149
45.6%
|
686
49.6%
|
| Male |
118
48.8%
|
136
54.8%
|
113
47.5%
|
153
46.5%
|
178
54.4%
|
698
50.4%
|
| Race (NIH/OMB) (Count of Participants) | ||||||
| American Indian or Alaska Native |
1
0.4%
|
0
0%
|
1
0.4%
|
0
0%
|
1
0.3%
|
3
0.2%
|
| Asian |
5
2.1%
|
4
1.6%
|
4
1.7%
|
12
3.6%
|
8
2.4%
|
33
2.4%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
4
1.6%
|
1
0.4%
|
1
0.3%
|
0
0%
|
6
0.4%
|
| Black or African American |
60
24.8%
|
57
23%
|
52
21.8%
|
80
24.3%
|
81
24.8%
|
330
23.8%
|
| White |
143
59.1%
|
143
57.7%
|
139
58.4%
|
199
60.5%
|
195
59.6%
|
819
59.2%
|
| More than one race |
30
12.4%
|
35
14.1%
|
37
15.5%
|
33
10%
|
41
12.5%
|
176
12.7%
|
| Unknown or Not Reported |
3
1.2%
|
5
2%
|
4
1.7%
|
4
1.2%
|
1
0.3%
|
17
1.2%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||
| Hispanic or Latino |
41
16.9%
|
49
19.8%
|
45
18.9%
|
52
15.8%
|
67
20.5%
|
254
18.4%
|
| Not Hispanic or Latino |
201
83.1%
|
199
80.2%
|
193
81.1%
|
277
84.2%
|
260
79.5%
|
1130
81.6%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | ||||||
| United States |
242
100%
|
248
100%
|
238
100%
|
329
100%
|
327
100%
|
1384
100%
|
Outcome Measures
| Title | Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay |
|---|---|
| Description | Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the anti-rotavirus IgA antibody titer. A participant met the threshold of a positive response if the post vaccination anti-rotavirus IgA antibody titer was 20 or greater. |
| Time Frame | 3-6 weeks after the last vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported. |
| Arm/Group Title | Group 1: RotaTeq, RotaTeq, RotaTeq | Group 2: RotaTeq, Rotarix, Rotarix | Group 3: RotaTeq, RotaTeq, Rotarix | Group 4: Rotarix, Rotarix | Group 5: Rotarix, RotaTeq, RotaTeq |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received RotaTeq® orally at 2, 4 and 6 months of age. | Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age. | Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age. | Participants received Rotarix® orally at 2 and 4 months of age. | Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age. |
| Measure Participants | 206 | 206 | 194 | 287 | 280 |
| Number [participants] |
186
76.9%
|
182
73.4%
|
175
73.5%
|
191
58.1%
|
261
79.8%
|
| Title | Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the 89-12 IgA Assay |
|---|---|
| Description | Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA 89-12 assay to determine the anti-rotavirus IgA antibody titer. A participant met the threshold of a positive response if the post vaccination anti-rotavirus IgA antibody titier was 20 or greater. |
| Time Frame | 3-6 weeks after the last vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported. |
| Arm/Group Title | Group 1: RotaTeq, RotaTeq, RotaTeq | Group 2: RotaTeq, Rotarix, Rotarix | Group 3: RotaTeq, RotaTeq, Rotarix | Group 4: Rotarix, Rotarix | Group 5: Rotarix, RotaTeq, RotaTeq |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received RotaTeq® orally at 2, 4 and 6 months of age. | Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age. | Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age. | Participants received Rotarix® orally at 2 and 4 months of age. | Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age. |
| Measure Participants | 206 | 207 | 193 | 287 | 280 |
| Number [participants] |
159
65.7%
|
184
74.2%
|
165
69.3%
|
219
66.6%
|
256
78.3%
|
| Title | GMT of Neutralizing Rotavirus Antibody to the Most Common Rotavirus Serotypes (G1-G4 and G9) |
|---|---|
| Description | Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the neutralizing antibody assay against the most common rotavirus serotypes, G1-G4 and G9. Antigen-specific geometric mean titers (GMT) for each group were calculated along with the 95% confidence intervals. |
| Time Frame | 3-6 weeks after the last dose of vaccine. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported. |
| Arm/Group Title | Group 1: RotaTeq, RotaTeq, RotaTeq | Group 2: RotaTeq, Rotarix, Rotarix | Group 3: RotaTeq, RotaTeq, Rotarix | Group 4: Rotarix, Rotarix | Group 5: Rotarix, RotaTeq, RotaTeq |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received RotaTeq® orally at 2, 4 and 6 months of age. | Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age. | Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age. | Participants received Rotarix® orally at 2 and 4 months of age. | Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age. |
| Measure Participants | 206 | 207 | 195 | 287 | 280 |
| G1P[8] Antigen |
84.5
|
93.6
|
112.0
|
45.3
|
96.6
|
| G2P[4] Antigen |
17.1
|
14.5
|
17.5
|
7.1
|
19.3
|
| G3,P[8] Antigen |
12.9
|
16.8
|
16.6
|
14.0
|
22.2
|
| G4P[6] Antigen |
18.6
|
17.7
|
21.3
|
7.0
|
19.0
|
| G4P[8] Antigen |
26.1
|
22.1
|
24.9
|
8.7
|
25.6
|
| G9P[6] Antigen |
13.1
|
13.5
|
16.1
|
6.8
|
14.5
|
| Title | Number of Participants Experiencing Solicited Systemic Reactions in the 8 Days After Vaccination |
|---|---|
| Description | The participants' parent/guardian was given a memory aid to record for 8 days the presence of solicited reactions of fever, diarrhea and vomiting. Fever was considered experienced if the participant was assessed with an axillary temperature of 100.4F or greater on any day in the 8-day period after any vaccination. Diarrhea was considered experienced if the participant had 3 or more looser than normal stools in a day. Vomiting was considered experienced if the participant vomited 2 or more times in a day. |
| Time Frame | Days 1-8 after each vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were vaccinated and had reactogenicity data reported are included in the analysis population. |
| Arm/Group Title | Group 1: RotaTeq, RotaTeq, RotaTeq | Group 2: RotaTeq, Rotarix, Rotarix | Group 3: RotaTeq, RotaTeq, Rotarix | Group 4: Rotarix, Rotarix | Group 5: Rotarix, RotaTeq, RotaTeq |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received RotaTeq® orally at 2, 4 and 6 months of age. | Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age. | Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age. | Participants received Rotarix® orally at 2 and 4 months of age. | Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age. |
| Measure Participants | 241 | 245 | 236 | 326 | 325 |
| Fever |
37
15.3%
|
36
14.5%
|
31
13%
|
29
8.8%
|
49
15%
|
| Diarrhea |
22
9.1%
|
27
10.9%
|
17
7.1%
|
28
8.5%
|
32
9.8%
|
| Vomiting |
23
9.5%
|
22
8.9%
|
18
7.6%
|
17
5.2%
|
33
10.1%
|
| Title | Number of Participants Experiencing Hematochezia at Any Time During the Study |
|---|---|
| Description | Hematochezia was defined as any stools that are black and tarry; maroon in color; or frank red blood. At each visit, signs of hematochezia were assessed and the participant's parent/guardian was instructed to contact the clinical site at any time if the participant had evidence of hematochezia. |
| Time Frame | Day 1 through 6 months after the last vaccination |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants who were vaccinated are included in the analysis population. |
| Arm/Group Title | Group 1: RotaTeq, RotaTeq, RotaTeq | Group 2: RotaTeq, Rotarix, Rotarix | Group 3: RotaTeq, RotaTeq, Rotarix | Group 4: Rotarix, Rotarix | Group 5: Rotarix, RotaTeq, RotaTeq |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received RotaTeq® orally at 2, 4 and 6 months of age. | Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age. | Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age. | Participants received Rotarix® orally at 2 and 4 months of age. | Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age. |
| Measure Participants | 241 | 245 | 236 | 326 | 325 |
| Number [participants] |
5
2.1%
|
3
1.2%
|
5
2.1%
|
6
1.8%
|
13
4%
|
| Title | Geometric Mean Serum Anti-rotavirus IgA Titer |
|---|---|
| Description | Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the anti-rotavirus IgA antibody titers. The geometric mean titers (GMT) for each group were calculated along with the 95% confidence intervals. |
| Time Frame | 3-6 weeks after the last dose of vaccine |
Outcome Measure Data
| Analysis Population Description |
|---|
| The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported. |
| Arm/Group Title | Group 1: RotaTeq, RotaTeq, RotaTeq | Group 2: RotaTeq, Rotarix, Rotarix | Group 3: RotaTeq, RotaTeq, Rotarix | Group 4: Rotarix, Rotarix | Group 5: Rotarix, RotaTeq, RotaTeq |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received RotaTeq® orally at 2, 4 and 6 months of age. | Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age. | Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age. | Participants received Rotarix® orally at 2 and 4 months of age. | Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age. |
| Measure Participants | 206 | 207 | 195 | 287 | 280 |
| WC3 Assay |
294.03
|
215.81
|
305.89
|
38.06
|
256.90
|
| 89-12 Assay |
60.89
|
115.72
|
104.04
|
100.21
|
212.52
|
| Title | Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotypes G1, G2, G4P6 and G9 |
|---|---|
| Description | Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the antibody titers to rotavirus serotypes G1, G2, G4P6 and G9. A participant met the threshold of a positive response if the post vaccination antigen-specific antibody titer was 10 or greater. |
| Time Frame | 3-6 weeks after the last dose of vaccine. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported. |
| Arm/Group Title | Group 1: RotaTeq, RotaTeq, RotaTeq | Group 2: RotaTeq, Rotarix, Rotarix | Group 3: RotaTeq, RotaTeq, Rotarix | Group 4: Rotarix, Rotarix | Group 5: Rotarix, RotaTeq, RotaTeq |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received RotaTeq® orally at 2, 4 and 6 months of age. | Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age. | Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age. | Participants received Rotarix® orally at 2 and 4 months of age. | Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age. |
| Measure Participants | 206 | 207 | 194 | 287 | 280 |
| G1P[8] Antigen |
187
77.3%
|
192
77.4%
|
176
73.9%
|
260
79%
|
260
79.5%
|
| G2P[4] Antigen |
127
52.5%
|
112
45.2%
|
116
48.7%
|
61
18.5%
|
165
50.5%
|
| G4P[6] Antigen |
146
60.3%
|
136
54.8%
|
145
60.9%
|
68
20.7%
|
195
59.6%
|
| G9P[6] Antigen |
110
45.5%
|
109
44%
|
112
47.1%
|
71
21.6%
|
154
47.1%
|
| Title | Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotype G3 |
|---|---|
| Description | Blood was collected from all participants prior to vaccination and at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the antibody titers to rotavirus serotype G3. A participant met the threshold of a positive response if the post vaccination antibody titer was 10 or greater. |
| Time Frame | 3-6 weeks after the last dose of vaccine. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported. |
| Arm/Group Title | Group 1: RotaTeq, RotaTeq, RotaTeq | Group 2: RotaTeq, Rotarix, Rotarix | Group 3: RotaTeq, RotaTeq, Rotarix | Group 4: Rotarix, Rotarix | Group 5: Rotarix, RotaTeq, RotaTeq |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received RotaTeq® orally at 2, 4 and 6 months of age. | Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age. | Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age. | Participants received Rotarix® orally at 2 and 4 months of age. | Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age. |
| Measure Participants | 205 | 207 | 194 | 287 | 280 |
| Number [participants] |
108
44.6%
|
134
54%
|
111
46.6%
|
179
54.4%
|
189
57.8%
|
| Title | Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotypes G4P8 |
|---|---|
| Description | Blood was collected from all participants at the follow up visit 3-6 weeks after the last vaccination for testing in the ELISA assay to determine the antibody titers to rotavirus serotype G4P8. A participant met the threshold of a positive response if the post vaccination antibody titer was 10 or greater. |
| Time Frame | 3-6 weeks after the last dose of vaccine. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The per protocol analysis population includes participants who met all inclusion and exclusion criteria, received all scheduled study vaccinations, and who contributed post-vaccination blood samples for testing for which valid results were reported. |
| Arm/Group Title | Group 1: RotaTeq, RotaTeq, RotaTeq | Group 2: RotaTeq, Rotarix, Rotarix | Group 3: RotaTeq, RotaTeq, Rotarix | Group 4: Rotarix, Rotarix | Group 5: Rotarix, RotaTeq, RotaTeq |
|---|---|---|---|---|---|
| Arm/Group Description | Participants received RotaTeq® orally at 2, 4 and 6 months of age. | Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age. | Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age. | Participants received Rotarix® orally at 2 and 4 months of age. | Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age. |
| Measure Participants | 206 | 206 | 190 | 287 | 279 |
| Number [participants] |
161
66.5%
|
152
61.3%
|
150
63%
|
114
34.7%
|
216
66.1%
|
Adverse Events
| Time Frame | Solicited and unsolicited adverse events were collected for 8 days after each vaccination. Serious adverse events were collected from the first vaccination through the last follow-up visit at 6 months after the last vaccination. | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | For events solicited on the memory aid in the 8 days after each vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8-day period. Each 8-day period was considered a separate event. | |||||||||
| Arm/Group Title | Group 1: RotaTeq, RotaTeq, RotaTeq | Group 2: RotaTeq, Rotarix, Rotarix | Group 3: RotaTeq, RotaTeq, Rotarix | Group 4: Rotarix, Rotarix | Group 5: Rotarix, RotaTeq, RotaTeq | |||||
| Arm/Group Description | Participants received RotaTeq® orally at 2, 4 and 6 months of age. | Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age. | Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age. | Participants received Rotarix® orally at 2 and 4 months of age. | Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age. | |||||
All Cause Mortality |
||||||||||
| Group 1: RotaTeq, RotaTeq, RotaTeq | Group 2: RotaTeq, Rotarix, Rotarix | Group 3: RotaTeq, RotaTeq, Rotarix | Group 4: Rotarix, Rotarix | Group 5: Rotarix, RotaTeq, RotaTeq | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| Group 1: RotaTeq, RotaTeq, RotaTeq | Group 2: RotaTeq, Rotarix, Rotarix | Group 3: RotaTeq, RotaTeq, Rotarix | Group 4: Rotarix, Rotarix | Group 5: Rotarix, RotaTeq, RotaTeq | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 11/242 (4.5%) | 7/248 (2.8%) | 13/238 (5.5%) | 11/329 (3.3%) | 21/327 (6.4%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Lymphadenitis | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 1/238 (0.4%) | 1 | 0/329 (0%) | 0 | 0/327 (0%) | 0 |
| Congenital, familial and genetic disorders | ||||||||||
| Craniosynostosis | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 0/329 (0%) | 0 | 1/327 (0.3%) | 1 |
| Gastrointestinal disorders | ||||||||||
| Intussusception | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 1/238 (0.4%) | 1 | 0/329 (0%) | 0 | 0/327 (0%) | 0 |
| Vomiting | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 0/329 (0%) | 0 | 1/327 (0.3%) | 1 |
| General disorders | ||||||||||
| Pyrexia | 0/242 (0%) | 0 | 1/248 (0.4%) | 1 | 1/238 (0.4%) | 1 | 0/329 (0%) | 0 | 0/327 (0%) | 0 |
| Immune system disorders | ||||||||||
| Food allergy | 1/242 (0.4%) | 1 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 0/329 (0%) | 0 | 0/327 (0%) | 0 |
| Infections and infestations | ||||||||||
| Abscess | 0/242 (0%) | 0 | 1/248 (0.4%) | 1 | 0/238 (0%) | 0 | 0/329 (0%) | 0 | 0/327 (0%) | 0 |
| Abscess neck | 1/242 (0.4%) | 1 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 0/329 (0%) | 0 | 1/327 (0.3%) | 1 |
| Bacteraemia | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 0/329 (0%) | 0 | 1/327 (0.3%) | 1 |
| Bronchiolitis | 1/242 (0.4%) | 1 | 2/248 (0.8%) | 2 | 3/238 (1.3%) | 5 | 0/329 (0%) | 0 | 2/327 (0.6%) | 2 |
| Cellulitis of male external genital organ | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 0/329 (0%) | 0 | 1/327 (0.3%) | 1 |
| Croup infectious | 1/242 (0.4%) | 1 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 0/329 (0%) | 0 | 0/327 (0%) | 0 |
| Eczema herpeticum | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 0/329 (0%) | 0 | 1/327 (0.3%) | 1 |
| Gastroenteritis | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 1/238 (0.4%) | 1 | 0/329 (0%) | 0 | 1/327 (0.3%) | 1 |
| Meningitis aseptic | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 0/329 (0%) | 0 | 1/327 (0.3%) | 1 |
| Pneumonia | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 0/329 (0%) | 0 | 2/327 (0.6%) | 2 |
| Pneumonia bacterial | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 0/329 (0%) | 0 | 1/327 (0.3%) | 1 |
| Pneumonia respiratory syncytial viral | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 1/238 (0.4%) | 1 | 0/329 (0%) | 0 | 0/327 (0%) | 0 |
| Pyelonephritis | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 1/329 (0.3%) | 1 | 0/327 (0%) | 0 |
| Respiratory syncytial virus bronchiolitis | 1/242 (0.4%) | 1 | 1/248 (0.4%) | 1 | 3/238 (1.3%) | 3 | 2/329 (0.6%) | 2 | 2/327 (0.6%) | 2 |
| Respiratory tract infection | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 0/329 (0%) | 0 | 1/327 (0.3%) | 1 |
| Staphylococcal infection | 1/242 (0.4%) | 1 | 0/248 (0%) | 0 | 1/238 (0.4%) | 1 | 0/329 (0%) | 0 | 0/327 (0%) | 0 |
| Streptococcal infection | 1/242 (0.4%) | 1 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 0/329 (0%) | 0 | 0/327 (0%) | 0 |
| Subcutaneous abscess | 0/242 (0%) | 0 | 1/248 (0.4%) | 1 | 1/238 (0.4%) | 1 | 0/329 (0%) | 0 | 0/327 (0%) | 0 |
| Urosepsis | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 1/329 (0.3%) | 1 | 0/327 (0%) | 0 |
| Vulval cellulitis | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 1/329 (0.3%) | 1 | 0/327 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||||||
| Injury | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 1/329 (0.3%) | 1 | 0/327 (0%) | 0 |
| Multiple fractures | 0/242 (0%) | 0 | 1/248 (0.4%) | 1 | 0/238 (0%) | 0 | 0/329 (0%) | 0 | 0/327 (0%) | 0 |
| Skull fracture | 1/242 (0.4%) | 1 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 0/329 (0%) | 0 | 1/327 (0.3%) | 1 |
| Toxicity to various agents | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 1/238 (0.4%) | 1 | 0/329 (0%) | 0 | 0/327 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||
| Dehydration | 1/242 (0.4%) | 1 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 0/329 (0%) | 0 | 1/327 (0.3%) | 1 |
| Failure to thrive | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 1/329 (0.3%) | 1 | 0/327 (0%) | 0 |
| Nervous system disorders | ||||||||||
| Gross motor delay | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 0/329 (0%) | 0 | 1/327 (0.3%) | 1 |
| Hemiparesis | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 0/329 (0%) | 0 | 1/327 (0.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Apparent life threatening event | 1/242 (0.4%) | 1 | 0/248 (0%) | 0 | 1/238 (0.4%) | 1 | 0/329 (0%) | 0 | 1/327 (0.3%) | 1 |
| Asthma | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 2/329 (0.6%) | 2 | 0/327 (0%) | 0 |
| Bronchial hyperreactivity | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 1/329 (0.3%) | 1 | 0/327 (0%) | 0 |
| Dyspnoea | 1/242 (0.4%) | 1 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 0/329 (0%) | 0 | 0/327 (0%) | 0 |
| Hypoxia | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 1/329 (0.3%) | 1 | 0/327 (0%) | 0 |
| Pneumonitis | 0/242 (0%) | 0 | 1/248 (0.4%) | 1 | 0/238 (0%) | 0 | 0/329 (0%) | 0 | 0/327 (0%) | 0 |
| Respiratory distress | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 0/329 (0%) | 0 | 1/327 (0.3%) | 1 |
| Status asthmaticus | 0/242 (0%) | 0 | 0/248 (0%) | 0 | 0/238 (0%) | 0 | 0/329 (0%) | 0 | 1/327 (0.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||||
| Group 1: RotaTeq, RotaTeq, RotaTeq | Group 2: RotaTeq, Rotarix, Rotarix | Group 3: RotaTeq, RotaTeq, Rotarix | Group 4: Rotarix, Rotarix | Group 5: Rotarix, RotaTeq, RotaTeq | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 75/242 (31%) | 95/248 (38.3%) | 98/238 (41.2%) | 85/329 (25.8%) | 135/327 (41.3%) | |||||
| General disorders | ||||||||||
| Irritability | 35/242 (14.5%) | 44 | 38/248 (15.3%) | 54 | 40/238 (16.8%) | 51 | 53/329 (16.1%) | 70 | 61/327 (18.7%) | 90 |
| Pyrexia | 5/242 (2.1%) | 5 | 9/248 (3.6%) | 11 | 15/238 (6.3%) | 15 | 6/329 (1.8%) | 8 | 12/327 (3.7%) | 13 |
| Infections and infestations | ||||||||||
| Bronchiolitis | 6/242 (2.5%) | 6 | 11/248 (4.4%) | 11 | 12/238 (5%) | 14 | 3/329 (0.9%) | 3 | 13/327 (4%) | 15 |
| Otitis media | 15/242 (6.2%) | 17 | 14/248 (5.6%) | 15 | 9/238 (3.8%) | 11 | 4/329 (1.2%) | 4 | 27/327 (8.3%) | 29 |
| Upper respiratory tract infection | 27/242 (11.2%) | 29 | 38/248 (15.3%) | 44 | 31/238 (13%) | 34 | 24/329 (7.3%) | 24 | 50/327 (15.3%) | 61 |
| Skin and subcutaneous tissue disorders | ||||||||||
| Rash | 8/242 (3.3%) | 8 | 13/248 (5.2%) | 14 | 18/238 (7.6%) | 18 | 7/329 (2.1%) | 7 | 9/327 (2.8%) | 9 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Kathryn M. Edwards, MD |
|---|---|
| Organization | Vanderbilt University Medical Center |
| Phone | 615-322-3078 |
| kathryn.edwards@vanderbilt.edu |
- 08-0017
- N01AI80006C