What is the recommended administration schedule for Rotateq (rotavirus vaccine)?

RotaTeq Administration Schedule

RotaTeq (RV5) is administered as a 3-dose oral series at 2,4, and 6 months of age, with the first dose given between 6 weeks and 14 weeks 6 days of age, and all doses completed by 8 months of age. 1, 2

Dosing Schedule

Standard Timing:

• Dose 1: 2 months of age 1
• Dose 2: 4 months of age 1
• Dose 3: 6 months of age 1

Critical Age Restrictions

Minimum and Maximum Ages:

• Minimum age for first dose: 6 weeks 1, 3
• Maximum age for first dose: 14 weeks, 6 days (do NOT initiate after this age) 1, 3
• Maximum age for final dose: 8 months, 0 days 1
• Minimum interval between doses: 4 weeks 1

These age restrictions exist because safety and efficacy data are only available for infants vaccinated within these age windows. 1, 3 The FDA label specifies the third dose should not be given after 32 weeks of age, but the American Academy of Pediatrics recommends the more conservative cutoff of 8 months, 0 days. 1, 2

Administration Details

Route and Preparation:

• Administer orally only—never inject 2
• Supplied as ready-to-use liquid in squeezable plastic dosing tube (2 mL volume) 2
• No reconstitution or dilution needed 2
• Squeeze entire contents into infant's mouth toward inner cheek 2

Feeding Restrictions:

• No restrictions on food or liquid intake (including breast milk) before or after vaccination 2

Incomplete Doses:

• If infant spits out or regurgitates vaccine, do NOT give replacement dose 2
• Continue with remaining scheduled doses 2

Co-administration with Other Vaccines

RotaTeq may be given simultaneously with all routine infant vaccines including DTaP, Hib, IPV, hepatitis B, and pneumococcal conjugate vaccine. 1, 2 For infants ≥6 months, it can be co-administered with inactivated influenza vaccine. 1

Special Populations

Preterm Infants:

• Use chronological age (not corrected gestational age) for timing 1, 4
• Vaccinate on same schedule as term infants if clinically stable 1, 4
• If still hospitalized in NICU at 2 months, consider waiting until discharge to avoid theoretical transmission risk to other NICU infants, BUT do not delay beyond 14 weeks, 6 days or the infant becomes permanently ineligible 4

Product Interchangeability:

• Complete the series with RotaTeq whenever possible 1
• If prior vaccine product unknown or unavailable, give total of 3 doses to complete series 1

Common Pitfalls to Avoid

• Do not start the series in infants ≥15 weeks old—they have aged out of eligibility permanently 1, 3
• Do not delay first dose waiting for "perfect timing"—the narrow age window means delays can result in permanent ineligibility 3, 4
• Do not use corrected age for preterm infants—always use chronological age from birth 1, 4
• Do not give replacement dose if infant spits out vaccine—this was not studied in trials 2

Storage

Store refrigerated at 2°-8°C (36°-46°F), protect from light, and administer as soon as possible after removing from refrigeration. 1, 2