2 months of age: Rotarix®; 4 and 6 months of age: RotaTeq®

2 months of age: RotaTeq®; 4 and 6 months of age: Rotarix®

2 and 4 months of age: RotaTeq®; 6 months of age: Rotarix®

Participants received 2-mL RotaTeq® orally at 2, 4 and 6 months of age.

Group 1: RotaTeq, RotaTeq, RotaTeq

Participants received 2-mL RotaTeq® orally at 2 months of age, followed by 1-mL Rotarix® orally at 4 and 6 months of age.

Group 2: RotaTeq, Rotarix, Rotarix

Participants received 2-mL RotaTeq® orally at 2 and 4 months of age, followed by 1-mL Rotarix® orally at 6 months of age.

Group 3: RotaTeq, RotaTeq, Rotarix

Participants received 2-mL Rotarix® orally at 2 and 4 months of age.

Group 4: Rotarix, Rotarix

Participants received 2-mL Rotarix® orally at 2 months of age, followed by 1-mL RotaTeq® orally at 4 and 6 months of age.

Group 5: Rotarix, RotaTeq, RotaTeq

Total

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

Region of Enrollment

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.

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.

Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the WC3 IgA Assay

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.

Number of Participants Developing a Serum Anti-rotavirus Immunoglobulin (Ig) A Titer of 20 or Greater in the 89-12 IgA Assay

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.

GMT of Neutralizing Rotavirus Antibody to the Most Common Rotavirus Serotypes (G1-G4 and G9)

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 Solicited Systemic Reactions in the 8 Days After 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 Experiencing Hematochezia at Any Time During the Study

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.

Geometric Mean Serum Anti-rotavirus IgA Titer

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 Serotypes G1, G2, G4P6 and G9

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 Serotype G3

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.

Number of Participants Developing Neutralizing Rotavirus Antibody to Rotavirus Serotypes G4P8

Overall Study

Kathryn M. Edwards, MD

Rotavirus Infection

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.

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.

RotaTeq®

Kaiser Permanente Vaccine Study Center

Children's Hospital & Research Center Oakland - Primary Care Clinic

Emory Children's Center - Pediatric Infectious Diseases

University of Iowa - Vaccine Research & Education Unit

University of Maryland School of Medicine - Center for Vaccine Development - Baltimore

Children's Mercy Hospital and Clinics - Infectious Diseases

Duke Translational Medicine Institute - Clinical Vaccine Unit

Primary Physicians Research Inc. - Pittsburgh

Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center

The University of Texas Medical Branch - Sealy Center for Vaccine Development (SCVD)

Baylor College of Medicine - Molecular Virology and Microbiology

Group Health Research Institute - Seattle

Seattle Children's Hospital - Infectious Diseases

Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules

Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules With RotaTeq® and Rotarix®

National Institute of Allergy and Infectious Diseases (NIAID)

Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).

Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).

Infants with bowel resection who will receive the oral rotavirus vaccine, RotaTeq(R).
Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series

Infants With Bowel Resection

Healthy infants that are gest. age and age-matched controls within 14 days will be given the oral rotavirus vaccine, RotaTeq(R).
Oral, live, pentavalent rotavirus vaccine; RotaTeq(R): Oral vaccine for prevention of rotavirus infection, 3 dose series

Healthy Infants

Age, Customized

Pre-vaccination serum IgA antirotavirus titer

Rotavirus Anti-Immunoglobulin A (IgA) serum antibody level

Adverse events and patient tolerance of vaccine doses 1 - 3 for all infants participating in the study were recorded.

Safety and Tolerability of the Oral RotaTeq® Vaccine

Serum anti-rotavirus IgA level was measured post-vaccination in all subjects

Serum Anti-rotavirus IgA Level Post-vaccination

Eric McGrath, MD

Short Bowel Syndrome

Oral vaccine for prevention of rotavirus infection, 3 dose series

intussusception/buinneach

Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules

Safety and Immunogenicity of Rotavirus Vaccine (RotaTeq(R)) in Infants With Short Bowel Syndrome

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