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Indian Pediatrics

, Volume 55, Issue 12, pp 1050–1055 | Cite as

Safety and Immunogenicity of Two Doses of a Quadrivalent Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine in Indian and Russian Children Aged 9 to 17 Months

  • Bakul Javadekar
  • Apurba Ghosh
  • Rajeev Zachariah Kompithra
  • Shally Awasthi
  • Olga Perminova
  • Viktor Romanenko
  • Vera Rodnikova
  • Susanna Kharit
  • Yael Thollot
  • Valerie Bosch-Castells
  • Alexander Goldstein
  • Himanshu DubeyEmail author
Research Paper
  • 10 Downloads

Abstract

Objective

Evaluation of tolerability, safety and immunogenicity of a two-dose series of a quadrivalent meningococcal polysaccharide diptheria toxoid conjugate (ACYW-D) vaccine in Indian and Russian infants/toddlers.

Design

Open-label, single-arm, phase III multi-national trial.

Study participants

300 children aged 9–17 months, previously unvaccinated against meningococcal disease from four sites each in India (n=200) and the Russian Federation (n=100).

Intervention

Two 0.5 mL doses of ACYW-D by intramuscular injection, 3–6 months apart.

Main outcome measures

Meningococcal antibody titers to serogroups A, C, W-135 and Y, determined using a serum bactericidal assay in the presence of human complement before vaccination and 28 days after the second vaccination. Titers ≥1:8 against either/all of the A, C, W-135 or Y were considered seroprotective.

Results

After dose 2, 95.7–99.5% and 92.9–99.0% of infants/ toddlers achieved seroprotection across the four serogroups in India and the Russian Federation, respectively. No immediate adverse events were reported after any dose of ACYW-D. Solicited reactions were reported in 49.2% of participants, and were mainly of Grade 1 severity, and resolved within three days. Unsolicited adverse events were reported in 19.1% of infants: one event (Grade 3 diarrhea, resolving within one day) was considered related to study vaccine. No non-serious adverse events led to premature withdrawal from the study. Four serious adverse events were reported; none were considered related to study vaccine. No deaths occurred during the study.

Conclusions

A two-dose series of ACYW-D vaccine in Indian and Russian children (9-17 month) was well-tolerated with no safety concerns, and induced robust bactericidal antibody responses against the meningococcal serogroups contained in the vaccine.

Keywords

Bactericidal assay Immunization Meningococcus Prevention 

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Copyright information

© Indian Academy of Pediatrics 2018

Authors and Affiliations

  • Bakul Javadekar
    • 1
  • Apurba Ghosh
    • 2
  • Rajeev Zachariah Kompithra
    • 3
  • Shally Awasthi
    • 4
  • Olga Perminova
    • 5
  • Viktor Romanenko
    • 6
  • Vera Rodnikova
    • 7
  • Susanna Kharit
    • 8
  • Yael Thollot
    • 9
  • Valerie Bosch-Castells
    • 10
  • Alexander Goldstein
    • 11
  • Himanshu Dubey
    • 12
    • 13
  1. 1.Department of Pediatrics, Medical College and SSG Hospital, BarodaSSG Hospital Campus, Raopura, VadodaraGujaratIndia
  2. 2.Institute of Child HealthKolkataIndia
  3. 3.Well Baby Clinic, Department of Child HealthChristian Medical CollegeVelloreIndia
  4. 4.Department of PediatricsShahuji Maharaj Medical UniversityLucknowIndia
  5. 5.City Children’s Policlinic No 5PermRussia
  6. 6.Municipal City Children Hospital # 11EkaterinburgRussia
  7. 7.Murmansk Children’s City HospitalMurmanskRussia
  8. 8.Research Institute for Pediatric Infectious DiseasesSt. PetersburgRussia
  9. 9.Sanofi PasteurLyonFrance
  10. 10.Sanofi PasteurMarcy l’EtoileFrance
  11. 11.Sanofi PasteurMoscowRussia
  12. 12.Medical AffairsSanofi PasteurMumbaiIndia
  13. 13.House, CTS No. 117-B, L&T Business ParkSaki Vihar RoadPowaiIndia

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