ROTARIX (Rotavirus Vaccine, Live, Oral), for oral administration, is a live, attenuated rotavirus vaccine derived from the human 89-12 strain which belongs to G1P type. The rotavirus strain is propagated on Vero cells. After reconstitution, the final formulation (1 mL) contains at least 106.0 median Cell Culture Infective Dose (CCID50) of live, attenuated rotavirus. The lyophilized vaccine contains amino acids, dextran, Dulbecco's Modified Eagle Medium (DMEM), sorbitol, and sucrose. DMEM contains the following ingredients: sodium chloride, potassium chloride, magnesium sulfate, ferric (III) nitrate, sodium phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, sodium hydrogenocarbonate, and phenol red. 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 stomach and prevent its inactivation due to the acidic environment of the stomach. ROTARIX contains no preservatives. The tip cap and the rubber plunger of the oral applicator contain dry natural latex rubber. The vial stopper and transfer adapter are latex-free.
ROTARIX® is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series [see Clinical Studies]. ROTARIX is approved for use in infants 6 weeks to 24 weeks of age.
Published Studies Related to Rotarix (Rotavirus Vaccine)
Efficacy of human rotavirus vaccine against severe gastroenteritis in Malawian
children in the first two years of life: a randomized, double-blind, placebo
controlled trial. 
Rotavirus gastroenteritis is a major cause of morbidity and mortality among
African infants and young children. A phase III, placebo-controlled, multi-centre
clinical trial of a live, oral G1P human rotavirus vaccine (RIX4414)
undertaken in Malawi and South Africa significantly reduced the incidence of
severe rotavirus gastroenteritis in the first year of life...
Methodology and lessons-learned from the efficacy clinical trial of the
pentavalent rotavirus vaccine in Bangladesh. 
An efficacy clinical trial with pentavalent rotavirus vaccine (PRV), RotaTeq(Â®),
was conducted at Matlab field site of ICDDR,B, Bangladesh from March 2007 to
March 2009... The study was well accepted in the community
and was completed successfully.
Safety of the pentavalent rotavirus vaccine (PRV), RotaTeq(Â®), in Kenya,
including among HIV-infected and HIV-exposed infants. 
Two multicenter Phase III trials were conducted in five countries from March 2007
to March 2009 to evaluate the safety and efficacy of the pentavalent rotavirus
vaccine (PRV), RotaTeq(Â®), in Africa and Asia. In this report, we evaluate the
safety of this vaccine, including among HIV-infected and HIV-exposed infants, in
Immunogenicity and safety of an investigational hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-hepatitis B-Haemophilus influenzae B conjugate combined vaccine in healthy 2-, 4-, and 6-month-old Argentinean infants. [2011.06]
BACKGROUND AND AIMS: Assessment of a new, fully liquid, investigational hexavalent DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim, Sanofi Pasteur), containing the same active ingredients as Pentaxim (DTaP-IPV//PRT-T) and 10 mug Hansenula polymorpha-derived recombinant hepatitis B (Hep B) surface antigen, Sanofi Pasteur, in Argentinean infants... CONCLUSIONS: The new, fully liquid, investigational DTaP-IPV-Hep B-PRP-T vaccine (Hexaxim) is highly immunogenic and safe when compared with licensed comparators, warranting further development.
Results from a randomized clinical trial of coadministration of RotaTeq, a pentavalent rotavirus vaccine, and NeisVac-C, a meningococcal serogroup C conjugate vaccine. [2011.05]
RotaTeq (Merck & Co. Inc./Sanofi Pasteur MSD) is a three-dose, oral pentavalent rotavirus vaccine for the immunization of infants from 6 weeks of age for the prevention of rotavirus gastroenteritis...
Clinical Trials Related to Rotarix (Rotavirus Vaccine)
Introduction of an Oral Live Human Rotavirus (Rotarix) Vaccine in Matlab [Recruiting]
The study will be conducted in the Matlab Health and Demographic Surveillance System (HDSS)
field area of the International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B)
to determine the population effectiveness of Rotarix in Bangladeshi children. Villages in
both intervention and government comparison areas will be included in this evaluation. We
propose to introduce Rotarix into half of the villages of the Matlab HDSS. In villages
randomized to receive the vaccine, all eligible children will be offered Rotarix during
their first two Expanded Programme on Immunization (EPI) visits, as would routinely be done
if Rotarix were included in the Government EPI schedule. In villages randomized not to
receive Rotarix, children will receive their EPI vaccinations exactly as they would have in
the absence of this study. Administration of Rotarix will be conducted by regular EPI staff,
but ICDDR,B study staff will be present to document informed consent and collect
study-specific information. The Ministry of Health will be an active partner in this
evaluation since they will be the agency which may follow up with any subsequent vaccine
programme. Vaccination with Rotarix will be recorded on the infant's immunization card which
is normally used by the EPI programme, but also on a separate study-specific data collection
Vaccination with Rotarix will continue from study initiation through June 30, 2011.
Surveillance for rotavirus gastroenteritis will occur at Matlab Diarrhoeal Hospital and the
community treatment centres of the Matlab HDSS continuously throughout the study period.
Diarrheal illness information collected through surveillance will be linked to Rotarix
study-specific data through the subject's HDSS identification numbers. The primary study
endpoint will be the occurrence of an illness episode of acute diarrhoea, among infants and
children admitted to a medical facility, determined to be caused by wild-type rotavirus
found in a stool specimen. At the end of the surveillance period, rates of this primary
study endpoint among age-eligible infants will be compared for villages randomized to
receive Rotarix versus for villages randomized not to receive Rotarix. We expect that the
rates of rotavirus diarrhoea will be significantly lower among children from the vaccinated
The first participant was enrolled in the study on September 23, 2008. Till date (May 12,
2010) a total of 2,882 participants have been enrolled and received first dose. 2,684
participants received second dose of Rotarix. There were 1013 cases gastroentritis reported
to diarrhoeal treatment centres among <2 years old children from the vaccinated and
unvaccinated villages. There were six death cases among the children who received Rotarix
vaccine. These death cases were not related to the vaccines/study products.
Immunogenicity of Rotavirus Vaccine [Recruiting]
Rotavirus is one of the most common causes of severe diarrhea, responsible for 40% of all
diarrhea related deaths in children worldwide. Two vaccines against Rotavirus, Rotarix® and
Rotateq® were licensed in many high and middle income countries in 2006, but lack of
efficacy data in low income countries had prevented WHO from making a universal
recommendation of their use until recently. This study will be conducted in Pakistan and
will look at two objectives:
1. To compare the immunogenicity of Rotarix® vaccine when administered at 6 and 10 weeks
of life and at 6, 10 and 14 weeks of life.
2. To compare the immunogenicity of Rotarix® vaccine in infants breast fed at the time of
vaccine administration with infants whose breast feeding is withheld for one hour
before and after vaccine administration.
Safety and Immunogenicity of Rotavirus Vaccine (RotaTeq(R)) in Infants With Short Bowel Syndrome [Recruiting]
Rotavirus infection is a common pediatric illness and is the leading cause of severe acute
gastroenteritis (vomiting and diarrhea) in infants and young children. Since February of
2006, an oral vaccine to prevent rotavirus has been approved by the Food and Drug
Administration (FDA). The company that makes the oral vaccine is Merck and Company. Since
the FDA approval, the American Academy of Pediatrics (AAP) and that Advisory Committee on
Immunization Practices (ACIP) has recommended the use of this oral vaccine in infants. A
previous rotavirus oral vaccine, Rotashield, was removed from the market for concerns that
it was causing an increase in a gastrointestinal (GI) disease called intussusception.
However, the new rotavirus vaccine was studied by the manufacturer and was not found to
cause an increase in the cases of intussusception. Intussusception is a disease in which a
portion of the GI tract folds back on itself leading to GI tract obstruction or back-up.
The manufacturer of the vaccine noted on package insert information that the vaccine was not
studied, originally, in infants with a history of GI disorders or in infants who have had
surgery on their abdomen. Currently, there is no information available in the scientific
literature about the use of the oral rotavirus vaccine in infants with GI diseases or those
who have had GI surgeries.
The objective of the study is the assessment of safety and tolerability of the oral RotaTeqÂ®
vaccine for all infants participating in the study. All infants will be followed for
clinical adverse events with active safety surveillance for the first 42 days after each
dose and also monthly afterward for a total of 12 months from the first vaccination date.
The secondary objective of the study is to quantify the immunologic response will occur in
all of the infants in the study. Assessment of percentage of the number of infants who have
a good immune response (three-fold rise in IgA titer or greater) to the complete rotavirus
vaccine series (three oral vaccines in total) by a blood test to check the rotavirus
immunoglobulin A (IgA) level in infants with short bowel syndrome compared to normal infants
Infants, meeting eligibility criteria and whose parents have signed informed consent will
have their study information collected. These infants will be tested for the presence of
pre-vaccine anti-rotavirus antibody, IgA levels, as mentioned above. After the blood is
obtained, participants will receive their first oral rotavirus vaccine dose between the ages
of 6 weeks to 12 weeks of life per package insert information. This oral rotavirus vaccine
may be administered with other routine pediatric vaccines at the participant primary care
provider's office. The date of the rotavirus vaccine and lot number would be recorded on
vaccine administration date cards. Most participants will have their vaccines given through
the Infectious Disease clinic staff at the Children's Hospital of Michigan.
Subsequent doses of the oral rotavirus vaccine will be given at a minimal interval between
vaccines of four weeks. The third, and final vaccine dose must be given by 32 weeks of
life. Any adverse reactions to the vaccine will be reported on the National Vaccine Adverse
Event Reporting System and MedWatch forms.
Finally, two weeks after the participants have had all three oral rotavirus vaccine doses,
the second and final blood draw will take place for measuring the post-vaccine level of
anti-rotavirus antibody, IgA.
Participants in the study will be monitored by telephone contacts on days 7, 14, and 42
after each dose and within 48 to 72 hours of each dose of the rotavirus vaccine regarding
any serious adverse events. Each infant will also be assessed in the clinical setting each
week after a vaccine dose has been given. As above, parents of participants will be asked
to fill out the vaccine report card and record the child's temperature, and any episodes of
vomiting, diarrhea, blood in the stools or fussiness for the first seven days. The parents
will also be asked to record any other events from day 8 through 42 after each vaccine is
administered such as fever, ear infection, runny nose, etc. Afterward, parents will also
have monthly phone call safety follow-ups during the 12 month period following the first
vaccination. A Data Safety and Monitoring Board will oversee the study and it's progress
and will have the ability to vote to stop the study should any safety concerns arise.
Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules [Recruiting]
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
Safety and Immune Response of a Rotavirus Vaccine in HIV-infected and Uninfected Children Born to HIV-infected Mothers [Recruiting]
Rotavirus is the leading cause of severe diarrhea in infants and young children, accounting
for 45% of severe diarrhea disease in both developed and developing countries. Although
rotavirus infection is not more common in HIV-infected children, it complicates their care
and interferes with their nutrition. Chances of death by these infections can be greater in
HIV-infected children when they also suffer from wasting, malnutrition, and/or opportunistic
infections. The primary purpose of this study is to evaluate the safety and immunogenicity
of the Rotavirus vaccine candidate, RotaTeq, in HIV-infected and uninfected children born to
Page last updated: 2013-02-10