A field based evaluation of adverse events following MenAfriVac® vaccine delivered in a controlled temperature chain (CTC) approach in Benin

An estimated one hundred million African meningitis belt residents have received MenAfriVac(®)meningococcal serogroup A conjugate vaccine. Since October 2012 the vaccine has been licensed for use in a controlled temperature chain (CTC) approach, at temperatures of up to 40°C for up to four days. The Benin Ministry of Health conducted a pilot evaluation in one of its 34 health districts to assess whether the CTC approach was associated with increased adverse events following immunisation (AEFIs). We compared the occurrence of AEFIs during the 5 days following immunisation for 4 villages in the district using the CTC approach to 4 villages in another district using the traditional approach (vaccine kept at +2 to +8°C). Severe events resulting in hospitalisation or death of non-interviewed household members also were recorded. We included 1000 persons in the CTC and 999 in the non-CTC group. Only mild and transient AEFIs were noted in both groups, such as pain at injection site or fever. Compared to the non-CTC group, the CTC group had similar or lower rates of AEFIs and the occurrence of AEFIs in both groups was similar to that indicated in the vaccine package insert. No case of hospitalisation or death occurred among interviewed and non-interviewed household members. The CTC approach, as implemented in Benin, was not associated with an increased rate of adverse events in the five days following immunisation, either when compared to a concurrent non-CTC population or to previous studies.