Safety and Immunogenicity of Two Doses of Quadrivalent Meningococcal Conjugate Vaccine or One Dose of Meningococcal Group C Conjugate Vaccine, both Administered Concomitantly with Routine Immunization to 12‐ to 18‐Month‐Old Children

Abstract

OBJECTIVES:To describe the immunogenicity and safety of a two-dose series of a quadrivalent meningococcal (serogroups A, C, Y and W) polysaccharide diphtheria toxoid conjugate vaccine (MenACYW-D) administered to toddlers.METHODS:Children were randomly assigned (1:1) at study entry to receive MenACYW-D at 12 and 18 months of age (group 1; n=61) or meningococcal serogroup C conjugate vaccine (MCC) at 12 months of age (group 2; n=62). All received routine childhood immunizations. A, C, Y and W antibody titres were measured in group 1 before and one month after the 18-month MenACYW-D vaccination and were measured in group 2 at one and seven months post-MCC vaccination. Antibodies elicited by diphtheria and tetanus toxoids, and acellular pertussis vaccine adsorbed combined with inactivated poliomyelitis vaccine and Haemophilus influenzae b conjugate (DTaP-IPV-Hib) vaccine coadministered at the 18-month vaccination were measured one month later. Safety data were collected.RESULTS:At 19 months of age, ≥96% in group 1 achieved protective titres for the four meningococcal serogroups after dose 2; 67% in group 2 exhibited protective titres against serogroup C 28 days after MCC vaccination at 12 months of age, declining to 27% seven months later. DTaP-IPV-Hib elicited high antibody concentrations/titres in groups 1 and 2, consistent with historical values. The safety profiles after each dose generated no unexpected safety signals; no serious adverse events were related to vaccination.DISCUSSION:A two-dose series of MenACYW-D given concomitantly with a DTaP-IPV-Hib booster dose at 18 months of age demonstrated a good immunogenicity and safety profile. A two-dose series of MenACYW-D can be used as an alternative to one dose of MCC and provides protection against additional serogroups (NCT ID: NCT01359449).

Safety of a quadrivalent meningococcal conjugate vaccine in healthy subjects aged 9 months to 55 years in Vietnam

“…The study was not designed to detect vaccine-related AEs beyond 28 days post vaccination because they are less likely to occur after this time period. Similar to controlled trials conducted in other countries, 4,12,[14][15][16][17] these results show that…”

“…Mild‐to‐moderate injection site and systemic reactions (eg, fever, malaise) have often been reported in adults and children for MenACWY‐D in different countries, and are similar to those of other currently licensed, routinely administered vaccines . In infants, solicited systemic reactions such as appetite loss, irritability, and fever have also been frequently observed …”

“…The study was not designed to detect vaccine‐related AEs beyond 28 days post vaccination because they are less likely to occur after this time period. Similar to controlled trials conducted in other countries, these results show that MenACWY‐D has an acceptable safety profile in individuals from Vietnam aged 9 months to 55 years. No new clinically important findings were identified in this study.…”

“…12 In infants, solicited systemic reactions such as appetite loss, irritability, and fever have also been frequently observed. 12,17 Two 9 to 23-month-old infants experienced SAEs considered by and other meningococcal vaccines 19 in children, and this is also occasionally seen following several other childhood vaccinations. 20 Nevertheless, febrile seizures are usually benign, and vaccine-induced febrile seizures are rare compared with the frequency of fever from natural infection, particularly among young children.…”

Entirely Carbohydrate-Based Vaccines: An Emerging Field for Specific and Selective Immune Responses

“…The unconjugated capsular polysaccharide-based vaccine Menomune ® (Sanofi Pasteur, Pocono, PA, USA), which is useful for serotypes A/C/Y/W-135 can also induce short-term protection of approximately 2–3 years [ 33 ]. To achieve long-term protection, meningococcal groups A, C, Y and W-135 capsular polysaccharides are individually conjugated with either diphtheria toxoid or CRM 197 to achieve quadrivalent conjugate vaccines which are licensed as Menactra TM (Sanofi Pasteur) [ 48 ] or Menveo ® (Novartis Vaccines & Diagnostics s.r.I., Siena, Italy) [ 49 ] respectively.…”