RotaTeq

RotaTeq

vaccine, rotavirus

Manufacturer:

Merck Sharp & Dohme
Full Prescribing Info
Contents
Live, oral pentavalent rotavirus vaccine.
Description
Each 2-mL dose contains the following human-bovine rotavirus reassortants: G1, G2, G3, G4 and P1[8]. The minimum dose levels of the reassortants are: G1 2.2 x 106 infectious units, G2 2.8 x 106 infectious units, G3 2.2 x 106 infectious units, G4 2 x 106 infectious units and P1[8] 2.3 x 106 infectious units.
The reassortants are propagated in Vero cells using standard tissue culture techniques in the absence of antifungal agents.
The reassortants are suspended in a buffered stabilizer solution. Each vaccine dose also contains the following inactive ingredients: Sucrose, sodium citrate, monobasic sodium phosphate monohydrate, sodium hydroxide, polysorbate 80 and also culture media. There are no preservatives or thimerosal present.
Action
Pharmacology: The human rotavirus serotypes (G1, G2, G3, G4 and P1[8]) have been selected for RotaTeq because these strains caused over 90% of rotavirus disease in North America, Europe and Australia over 88% of rotavirus disease worldwide between 1973 and 2003.
Efficacy: The efficacy of RotaTeq was evaluated in 2 studies among infants who received the vaccine (n=3484) or placebo (n=3499). The 3rd dose was administered to infants as old as 32 weeks of age. Efficacy evaluations included efficacy against any severity (mild, moderate and severe) of rotavirus gastroenteritis and efficacy against severe rotavirus gastroenteritis. The effect on healthcare contacts for rotavirus gastroenteritis, including hospitalizations and emergency department visits (n=68,038), routine visits to a physician (n=5673) and work loss (n=68,038) was also evaluated in the rotavirus safety and efficacy trial (REST). Concomitant administration of other licensed childhood vaccines except for oral poliovirus vaccine (OPV) was permitted in all phase III studies.
Efficacy against any severity of gastroenteritis caused by naturally occurring rotavirus of the composite of the G serotypes (G1-G4) included in RotaTeq was 73.8% and efficacy against severe rotavirus gastroenteritis was 98.2% through the 1st rotavirus season after completion of vaccination. RotaTeq also provided protection against non-vaccine G serotypes. Based on limited data, the efficacy against any severity of gastroenteritis caused by the non-vaccine G serotype (G9) was 74.1%. The efficacy of RotaTeq through 2 rotavirus seasons after completion of vaccination against any severity of rotavirus gastroenteritis was 71.3%.
RotaTeq reduced the rate of hospitalizations, emergency department visits, non-urgent care visits and parent/legal guardian work loss days. Hospitalizations and emergency department visits were evaluated among 68,038 infants and non-urgent care visits were evaluated among 5673 infants for a maximum of 2 years after vaccination. The rate reductions were as follows: 94.5% for hospitalizations and emergency department visits (95.8% for hospitalizations and 93.7% for emergency department visits), 86% for non-urgent care visits and 86.6% for parent/legal guardian work loss days.
Efficacy of RotaTeq against rotavirus gastroenteritis through the 1st full rotavirus season after completion of vaccination and reduction in hospitalizations/emergency department visits for rotavirus gastroenteritis for up to 2 years postvaccination by G-serotype are shown in Table 1.


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Efficacy and Safety in Pre-Term Infants: RotaTeq or placebo was administered to 2070 pre-term infants (25-36 weeks gestational age), including 1007 recipients of RotaTeq, according to their chronological age in a placebo-controlled study. Among a subset of 308 pre-term infants who were followed for all adverse experiences, the safety profile was generally similar among those infants receiving RotaTeq as compared with those receiving placebo. The incidence of fever, vomiting, diarrhea or irritability was generally similar among vaccine and placebo recipients. Efficacy (70.3%) in a subset of 204 pre-term infants (153 evaluable) was generally similar in the overall population.
Studies with Other Vaccines: The immunogenicity of RotaTeq, and diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine, inactivated poliovirus vaccine (IPV), Haemophilus influenzae type b conjugate vaccine (HIB), hepatitis B vaccine and pneumococcal conjugate vaccine was evaluated among 1358 infants. The immune responses to the specified vaccines were largely unaffected by RotaTeq. Of the 17 antigens studied, the antibody responses were similar among vaccine and placebo recipients except for a slightly diminished response to 1 of the 3 antigens tested for pertussis (pertactin). In addition, the studies demonstrated the efficacy of RotaTeq (89.5%) when administered with these vaccines.
Concomitant administration of RotaTeq and OPV did not affect the immune response to the polio antigens in a controlled study of 735 vaccinated infants. Although concomitant administration of OPV reduced some immune responses to RotaTeq, the seroconversion rates (greater than or equal to 3-fold rise from baseline) for serum IgA were >93%. There is evidence that a high level of efficacy against severe rotavirus gastroenteritis is maintained. The immune responses to RotaTeq are unaffected when OPV is administered 2 weeks after RotaTeq.
The safety profile, including the incidences of fever, vomiting, diarrhea and irritability was generally similar among subjects receiving the specified concomitant vaccines with RotaTeq and subjects receiving the specified concomitant vaccines with placebo.
In 1 study, 7367 infants received a hexavalent (DTaP, IPV, HIB and hepatitis B) vaccine concomitantly with RotaTeq. The frequency of overall serious adverse experiences (SAEs), regardless of causal relationship, was 2.9% in recipients of RotaTeq and 3.2% in placebo recipients. More detailed safety information was evaluated among a subset of 638 infants receiving RotaTeq with a hexavalent vaccine. The safety profile, including the incidences of fever, vomiting, diarrhea and irritability was generally similar among subjects receiving a hexavalent vaccine with RotaTeq and subjects receiving a hexavalent vaccine with placebo.
Immunogenicity: The immunologic mechanism by which RotaTeq protects against rotavirus gastroenteritis is unknown. A relationship between antibody responses to RotaTeq and protection against rotavirus gastroenteritis has not been established. However, RotaTeq induces antibodies that neutralize serotypes G1, G2, G3, G4 and P1[8]. In phase III studies, 92.9-100% of recipients of RotaTeq achieved a significant rise in serum anti-rotavirus IgA after a 3-dose regimen.
Toxicology: Animal Toxicology: A single and repeated dose oral toxicity study in mice suggests no special hazard to humans. The dose administered to mice was approximately 2.79 x 108 infectious units per kg (about 14-fold the projected infant dose).
Indications/Uses
Prevention of rotavirus gastroenteritis in infants caused by the serotypes G1, G2, G3 and G4 and G-serotypes that contain P1A[8] (eg, G9). RotaTeq may be administered as early as 6 weeks of age.
Dosage/Direction for Use
For oral use only. Not for injection.
Dosage: The vaccination series consists of 3 ready-to-use liquid doses of RotaTeq administered orally to infants.
The 1st dose of RotaTeq should be administered at 6-12 weeks of age; the subsequent doses should be administered at a minimum interval of 4 weeks between each dose.
There are no restrictions on the infant's consumption of food or liquid, including breast milk, either before or after vaccination with RotaTeq.
RotaTeq may be given to pre-term infants according to their chronological age.
If for any reason an incomplete dose is administered (eg, infant spits or regurgitates RotaTeq vaccine), a replacement dose is not recommended, since such dosing was not studied in the clinical trials. The infant should continue to receive any remaining doses in the recommended series.
Administration: RotaTeq is to be administered orally without mixing with any other vaccines or solutions. Do not reconstitute or dilute.
Each dose is supplied in a container consisting of a squeezable plastic, latex-free dosing tube with a twist-off cap, allowing for direct oral administration. The dosing tube is contained in a pouch.
To administer the vaccine, tear open the pouch and remove the dosing tube. Clear the fluid from the dispensing tip by holding the tube vertically and tapping the cap. Open the dosing tube in 2 easy motions: Puncture the dispensing tip by screwing cap clockwise until it becomes tight; remove cap by turning it counterclockwise.
Administer dose by gently squeezing liquid into infant's mouth toward the inner cheek until dosing tube is empty. (A residual drop may remain in the tip of the tube.)
Discard the empty tube and cap in approved biological waste containers according to local regulations.
Use With Other Vaccines: RotaTeq can be administered with diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine, inactivated or oral poliovirus vaccine (IPV or OPV), Haemophilus influenzae type b conjugate vaccine, hepatitis B vaccine and pneumococcal conjugate vaccine, meningococcal group C conjugate vaccine and hexavalent vaccines.
Concomitant administration of RotaTeq and OPV does not affect the immune response to the poliovirus antigens. Although concomitant administration of OPV may reduce some immune responses to rotavirus vaccine, there is evidence that a high level of efficacy against severe rotavirus gastroenteritis is maintained. The immune responses to RotaTeq are unaffected when OPV is administered 2 weeks after RotaTeq.
Overdosage
There are no data with regards to overdosage.
Contraindications
Hypersensitivity to any component of RotaTeq vaccine.
Individuals who develop symptoms suggestive of hypersensitivity after receiving a dose of RotaTeq should not receive further doses of RotaTeq.
Previous history of intussuception.
Special Precautions
No safety or efficacy data are available from clinical trials regarding the administration of RotaTeq to: Immunocompromised patients eg, individuals with malignancies or who are otherwise immunocompromised; individuals receiving immunosuppressive therapy; or individuals infected with HIV; or individuals who have received a blood transfusion or blood products, including immunoglobulins within 42 days.
In clinical trials, RotaTeq was not administered to infants known to have immunodeficient household members. In these trials, RotaTeq was shed in the stools of 8.9% of vaccine recipients almost exclusively in the week after dose 1 and in only 1 vaccine recipient (0.3%) after dose 3. There is a theoretical risk that the live virus vaccine can be transmitted to non-vaccinated contacts. Therefore, RotaTeq should be administered with caution to individuals with immunodeficient close contacts eg, individuals with malignancies or who are otherwise immunocompromised; or individuals receiving immunosuppressive therapy.
However, because nearly all children are infected with naturally occurring rotavirus by the age of 5 years, vaccination of infants may decrease the risk of exposure of immunodeficient household contacts to naturally occurring rotavirus. The healthcare provider should assess the potential risks and benefits of administering RotaTeq to infants known to have immunodeficient close contacts.
Infants with active gastrointestinal illness, chronic diarrhea or growth retardation, or a history of congenital abdominal disorders or intussusception were not to be included in the clinical studies. Administration of RotaTeq may be considered with caution in such infants when, in the opinion of the physician, withholding the vaccine entails a greater risk.
Any acute infection or febrile illness may be a reason for delaying use of RotaTeq except when, in the opinion of the physician, withholding the vaccine entails a greater risk. Low-grade fever itself and mild upper respiratory infection are not contraindications to vaccination with RotaTeq.
As with any vaccine, vaccination with RotaTeq may not result in complete protection in all recipients.
The level of protection provided by only 1 or 2 doses of RotaTeq was not studied in clinical trials.
No clinical data are available for RotaTeq when administered after exposure to rotavirus.
Effects on the Ability to Drive or Operate Machinery: Not applicable.
Carcinogenicity, Mutagenicity & Impairment of Fertility: RotaTeq has not been evaluated for its carcinogenic or mutagenic potential or its potential to impair fertility.
Use in pregnancy: RotaTeq is a pediatric vaccine and is not indicated for use in adults. There have been no adequate, well-controlled studies in women or animals.
Use in lactation: As RotaTeq is a pediatric vaccine and is not indicated for use in adults, information on the safety of RotaTeq vaccine when used during lactation is not available.
Use in children: RotaTeq has been shown to be generally well tolerated and highly efficacious in preventing rotavirus gastroenteritis when administered to infants 6-32 weeks of age. (For the recommended dosage schedule, see Dosage & Administration.)
Safety and efficacy have not been established in infants <6 weeks of age.
Use in the elderly: RotaTeq is not indicated for use in adult populations.
Use In Pregnancy & Lactation
Use in pregnancy: RotaTeq is a pediatric vaccine and is not indicated for use in adults. There have been no adequate, well-controlled studies in women or animals.
Use in lactation: As RotaTeq is a pediatric vaccine and is not indicated for use in adults, information on the safety of RotaTeq vaccine when used during lactation is not available.
Adverse Reactions
71,725 infants were evaluated in 3 placebo-controlled clinical trials including 36,165 infants who received RotaTeq and 35,560 infants who received placebo. Parents/guardians were contacted on days 7, 14 and 42 after each dose regarding intussusception and any other serious adverse event.
RotaTeq is generally well tolerated.
In the large-scale (34,837 vaccine recipients and 34,788 placebo recipients), placebo-controlled rotavirus efficacy and safety trial (REST), RotaTeq did not increase the risk of intussusception relative to placebo (see Table 2). Active surveillance was employed to identify potential cases of intussusception at days 7, 14 and 42 after each dose and every 6 weeks thereafter for 1 year after dose 1. There were no confirmed cases of intussusception during the 42-day period after dose 1 and there was no clustering of cases among vaccine recipients at any time period after any dose. Following the 1-year safety follow-up period, 4 cases of intussusception were reported in children who had received placebo during the study. (See Table 2.)


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Kawasaki's disease was reported in the phase III clinical trials in <0.1% (5/36,150) of vaccine recipients and <0.1% (1/35,536) of placebo recipients within 42 days of any dose (not statistically significant).
In 11,711 infants (6138 recipients of RotaTeq) from the 3 studies, a Vaccination Report Card was used by parents/guardians to record the child's temperature and any episodes of diarrhea and vomiting on a daily basis during the 1st week following each vaccination. Table 2 summarizes the frequencies of these adverse events, regardless of cause. (See Table 3.)


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Parents/guardians of the 11,711 infants were also asked to report the presence of other events on the vaccination report card for 42 days after each dose. The following vaccine-related adverse experiences were observed among recipients of RotaTeq at a frequency of at least 0.3% greater than that was observed among placebo recipients.
Very Common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1000); very rare (<1/10,000).
Infections and Infestations: Uncommon: Nasopharyngitis (0.6% vaccine recipients, 0.3% placebo recipients).
Gastrointestinal Disorders: Very Common: Diarrhea (17.6% vaccine recipients, 15.1% placebo recipients), vomiting (10.1% vaccine recipients, 8.2% placebo recipients).
General Disorders and Administration Site Conditions: Very Common: Pyrexia (20.9% vaccine recipients, 18.7% placebo recipients).
Other Adverse Events: Otitis media and bronchospasm occurred in more vaccine recipients than placebo recipients (14.5% vs 13% and 1.1% vs 0.7%, respectively) overall; however, among cases that were considered to be vaccine-related in the opinion of the study investigator, the incidence was the same for vaccine and placebo recipients for otitis media (0.3%) and bronchospasm (<0.1%).
Administration of other licensed vaccines was permitted in all studies. The safety of RotaTeq when administered concomitantly with prespecified licensed vaccines including Haemophilus influenzae type b and hepatitis B vaccine, diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine, inactivated poliovirus vaccine (IPV), pneumococcal conjugate vaccine and hexavalent vaccines was evaluated in a phase III placebo-controlled study. In a subsequent controlled study, the safety of RotaTeq was well tolerated; the frequency of adverse experiences observed was generally similar to that seen in the control group.
Post-Marketing Reports: The following adverse experiences have been spontaneously reported during post-approval use of RotaTeq. Because these experiences were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish a causal relationship to vaccine exposure.
Skin and Subcutaneous Tissue Disorders: Urticaria.
Drug Interactions
There are no known drug interactions. (See Use with Other Vaccines under Dosage & Administration.)
Caution For Usage
Instructions to Healthcare Provider: The healthcare provider should determine the current health status and previous vaccination history of the vaccine recipient.
The healthcare provider should question the parent or guardian about reactions to a previous dose of RotaTeq or other rotavirus vaccine.
Information for Parents/Guardians: The healthcare provider should provide the vaccine information required to be given with each vaccination to the parent or guardian.
The healthcare provider should inform the parent or guardian of the benefits and risks associated with vaccination, as well as the importance of completing the immunization series. For risks associated with vaccination, see Precautions and Adverse Reactions.
Parents or guardians should be instructed to report any adverse reactions to their healthcare provider.
Storage
Store and transport refrigerated at 2°-8°C. Protect from light.
RotaTeq should be administered as soon as possible after being removed from refrigeration. When out of refrigeration at room temperature at or below 25°C, administration may be delayed for up to 48 hrs. After this time, RotaTeq should be discarded in approved biological waste containers according to local regulations.
ATC Classification
J07BH01 - rota virus, live attenuated ; Belongs to the class of rota virus diarrhea viral vaccines.
Presentation/Packing
Vaccine (oral) 2 mL (pre-filled dosing tube, single-dose) x 1's, 10's.
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