- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01266850
Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules
Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules With RotaTeq® and Rotarix®
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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California
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Oakland, California, United States, 94612-3610
- Kaiser Permanente Vaccine Study Center
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Oakland, California, United States, 94618-1033
- Children's Hospital & Research Center Oakland - Primary Care Clinic
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Georgia
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Atlanta, Georgia, United States, 30322-1014
- Emory Children's Center - Pediatric Infectious Diseases
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Iowa
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Iowa City, Iowa, United States, 52242-2600
- University of Iowa - Vaccine Research & Education Unit
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Maryland
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Baltimore, Maryland, United States, 21201-1509
- University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
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Missouri
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Kansas City, Missouri, United States, 64108-4619
- Children's Mercy Hospital and Clinics - Infectious Diseases
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North Carolina
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Durham, North Carolina, United States, 27704-2120
- Duke Translational Medicine Institute - Clinical Vaccine Unit
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15241-3100
- Primary Physicians Research Inc. - Pittsburgh
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Tennessee
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Nashville, Tennessee, United States, 37232-2573
- Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center
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Texas
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Galveston, Texas, United States, 77555-1121
- The University of Texas Medical Branch - Sealy Center for Vaccine Development (SCVD)
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Houston, Texas, United States, 77030-3411
- Baylor College of Medicine - Molecular Virology and Microbiology
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Washington
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Seattle, Washington, United States, 98101-1466
- Group Health Research Institute - Seattle
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Seattle, Washington, United States, 98105-3901
- Seattle Children's Hospital - Infectious Diseases
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 1, RotaTeq® x 3
2, 4 and 6 months of age: 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®
|
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.
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.
|
Active Comparator: Group 4, Rotarix® x 2
2 and 4 months of age: 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®
|
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.
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 3, RotaTeq® x 2, Rotarix®
2 and 4 months of age: RotaTeq®; 6 months of age: Rotarix®
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay
Time Frame: 3-6 weeks after the last vaccination
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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.
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3-6 weeks after the last vaccination
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Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the 89-12 IgA Assay
Time Frame: 3-6 weeks after the last vaccination
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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.
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3-6 weeks after the last vaccination
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Geometric Mean Serum Anti-rotavirus IgA Titer
Time Frame: 3-6 weeks after the last dose of vaccine
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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.
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3-6 weeks after the last dose of vaccine
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GMT of Neutralizing Rotavirus Antibody to the Most Common Rotavirus Serotypes (G1-G4 and G9)
Time Frame: 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.
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3-6 weeks after the last dose of vaccine.
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Number of Participants Experiencing Solicited Systemic Reactions in the 8 Days After Vaccination
Time Frame: Days 1-8 after each vaccination
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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.
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Days 1-8 after each vaccination
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Number of Participants Experiencing Hematochezia at Any Time During the Study
Time Frame: Day 1 through 6 months after the last vaccination
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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.
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Day 1 through 6 months after the last vaccination
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Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotypes G1, G2, G4P6 and G9
Time Frame: 3-6 weeks after the last dose of vaccine.
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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.
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3-6 weeks after the last dose of vaccine.
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Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotype G3
Time Frame: 3-6 weeks after the last dose of vaccine.
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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.
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3-6 weeks after the last dose of vaccine.
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Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotypes G4P8
Time Frame: 3-6 weeks after the last dose of vaccine.
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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.
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3-6 weeks after the last dose of vaccine.
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-0017
- N01AI80006C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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