Rotavin Vaccin

Each 1-dose (2ml) vial of rotavirus vaccine contains the following ingredients:

Oral solution.

Clear, yellow solution.

Rotavin vaccine is indicated for oral use to prevent acute gastroenteritis caused by rotavirus.

Suitable subjects for the first dose are children 6 weeks of age and older.

Oral route: Vaccine is for oral use only (do not inject).

Oral dose: 2ml/dose

Schedule:

Immunization schedule consists of 2 doses:

• First dose for children 6 weeks and older.
• Second dose 1-2 months after the first dose.

Children should complete the Rotavin vaccination course before 6 months of age.

Administration method:

• Shake well before use.
• Use a sterile syringe to draw 2ml of vaccine, discarding the needle.
• Administration: Place the child with their back against the mother's lap, insert the vaccine syringe into the inner cheek, and slowly administer the entire amount of vaccine.

Note: After use, syringes and vaccine vials must be collected into medical waste containers and disposed of according to medical waste regulations.

Do not use Rotavin vaccine for children with hypersensitivity after the first dose or hypersensitivity to any component of the vaccine.

Do not use Rotavin vaccine if the child has a severe, acute illness, high fever, diarrhea, or vomiting.

Do not use Rotavin vaccine for children with congenital gastrointestinal defects, intussusception, or severe immunodeficiency.

Caution is needed for individuals with a history of allergies or seizures.

Vaccines should not be administered when someone has a fever or is undergoing treatment that affects the immune system (such as taking medication, blood transfusions, or blood-derived products…). Children should only receive vaccines after been fever-free for at least 3 days and at least 4 weeks after the completion of any treatment.

If the child spits out most of the vaccine immediately after administration, a replacement dose should be given immediately. Note that the child should not be breastfed for 30 minutes before and after vaccination.

The vaccine is not intended for use in adults.

There are no data on the use of the vaccine in pregnant and breastfeeding women.

Breastfeeding does not reduce the protective efficacy of the vaccine, so breastfeeding can be continued when giving the vaccine to infants.

There is no evidence of the vaccine's effect on the ability to drive or operate machinery.

Rotavin vaccine can be used concurrently with other vaccines such as polio vaccine (IPV, OPV); combined vaccines (6-in-1, 5-in-1); hepatitis B vaccine; Hib vaccine... without affecting the safety and efficacy of these vaccines.

Clinical trial results from 2 research sites in Vietnam (Phu Tho and Thai Binh) involving nearly 1,000 children aged 6 to 12 weeks showed that:

• Symptoms that children may experience after vaccination include vomiting, fever, diarrhea, abdominal pain, coughing, fussiness... but these are very rare and show no statistically significant difference between the vaccine group and the placebo group.
• There were some cases of diarrhea, but there is no evidence linking them to Rotavin vaccine.
• There were no cases of serious reactions.

Report to your doctor/pharmacist any adverse effects encountered when using the vaccine.

Overdose: There are no data on vaccine overdose; do not exceed the specified vaccine dose.

Management of drug overdose: Actively monitor to have timely management measures.

Pharmacokinetics

Pharmacological Group: Live attenuated vaccine

Pharmacodynamics

ATC Code: J07BH01

Mechanism of Action:

Rotavin vaccine contains live attenuated rotavirus, strain G1P[8], which is the most common pathogenic strain in Vietnam and worldwide. The vaccine virus can replicate in the human intestine and create an immune response for the body.

Immunogenicity:

Clinical trial results show that Rotavin vaccine (dose 2×10⁶ PFU, 2 doses 2 months apart) produces the highest immune response.

*IgA Antibody:

The overall IgA antibody seroconversion rate in the vaccine group was 80.6% (76.6% in Phu Tho and 84.7% in Thai Binh). Meanwhile, in the placebo group, this rate was 13.9% (11.1% and 16.3% in Phu Tho and Thai Binh, respectively), corresponding to natural virus infection.

After 1 year, the antibody seroconversion rate in the vaccine group was 73% in Thai Binh and 76.5% in Phu Tho, with a statistically significant difference between the vaccine group and the placebo group (p < 0.00001).

*IgG Antibody:

The rate of children with IgG antibody response after vaccination reached 72.8 - 85.3%. The geometric mean titer of IgG (IgG-GMT) increased 1.4-fold compared to pre-vaccination at both study sites.

After 1 year of administration, the IgG-GMT of the placebo group decreased 7-fold while the IgG-GMT of the vaccine group remained unchanged. Clinical trial results prove that the disease prevention efficacy of Rotavin vaccine is equivalent to the control vaccine Rotarix (Belgium) currently in use in Vietnam.

Institutional standard.

Shelf life 24 months from production date under 2-8°C storage conditions.

Can be stored frozen.

Specification 1: One vaccine vial contains 1 dose (2ml) packed in a small box with an instruction leaflet.

Specification 2: 1 vaccine vial contains 1 dose (2ml), 10 vials are packed in 1 box with an instruction leaflet.