Bexsero Booster at 14 Months in High-Risk Infants
Yes, a 14-month-old high-risk infant can receive a booster dose of Bexsero (MenB-4C), as this falls within the recommended 12-15 month booster window established in clinical trials and real-world implementation.
Vaccination Schedule for High-Risk Infants
The evidence for Bexsero in infants comes primarily from clinical trial data and the UK's national immunization program, though current U.S. ACIP guidelines do not recommend MenB vaccines for children under 10 years of age 1. However, the vaccine has been extensively studied and used in younger populations internationally.
Primary Series Completion
- Standard infant schedule: Bexsero is administered at 2,4, and 6 months of age, followed by a booster at 12 months 2, 3
- The UK implemented a reduced two-dose primary schedule at 2 and 4 months with a 12-month booster, which demonstrated 75% reduction in disease incidence 4
- At 14 months, this infant would be receiving the booster dose, which is within the acceptable timeframe used in clinical trials (12-15 months) 3
Vaccine Effectiveness Data
- After the two-dose infant priming schedule plus booster at 12 months, vaccine effectiveness was 59.1% (95% CI, -31.1 to 87.2) against meningococcal group B disease 4
- The booster dose at 12 months elicited robust anamnestic responses, confirming establishment of immunologic memory from the primary series 5, 3
- Protection was sustained for at least 2 years after the three-dose schedule 4
High-Risk Considerations
Important Caveat for U.S. Practice
The major limitation is that ACIP guidelines explicitly state "No recommendations for use of MenB vaccines in this population" for children 2-23 months of age 1. This creates a regulatory and reimbursement challenge in the United States, even though:
- The vaccine is licensed and has extensive safety and efficacy data in this age group internationally 2, 3, 6
- High-risk infants with complement deficiencies or asplenia face substantial mortality risk from meningococcal disease 1
For High-Risk Infants Specifically
If this infant has completed a primary Bexsero series (typically 2-3 doses) and has high-risk conditions such as:
- Complement component deficiencies
- Functional or anatomic asplenia
- Exposure during an outbreak
The booster at 14 months would be appropriate based on the clinical trial schedules 3, though this would be considered off-label use in the U.S. context 1.
Safety Profile
- Bexsero is associated with higher rates of fever when co-administered with routine infant vaccines 2, 3
- The UK program recommends prophylactic paracetamol (three doses) with primary vaccinations to reduce fever risk 2
- At 14 months as a standalone booster, fever rates are lower than with primary series doses 3
- Overall reactogenicity is acceptable, with no new safety concerns identified after >1,000 doses distributed worldwide 6
Practical Implementation
- If the infant completed a primary series at 2,4, and 6 months, the 14-month dose represents the standard booster 3
- Any delay from the ideal 12-month timing is acceptable; the 14-month administration still falls within the studied timeframe 3
- Document the high-risk indication clearly, as this justifies off-label use in the U.S. 1
- Counsel parents about expected local reactions and fever, though these are typically milder with booster doses than primary series 3