Impact Factor 2021: 3.041 (@Clarivate Analytics)
5-Year Impact Factor: 2.776 (@Clarivate Analytics)
Impact Factor Rank: 10/24, Q2 (Tropical Medicine)
  • Users Online: 799
  • Print this page
  • Email this page
Year : 2019  |  Volume : 12  |  Issue : 9  |  Page : 396-403

Long-term safety follow-up of children from a randomized—controlled phase II b proof—of—concept efficacy study of the live, attenuated, tetravalent dengue vaccine (CYD—TDV) in Thailand

1 Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University, 420/6 Ratchawithi Road, Bangkok, 10400, Thailand
2 Sanofi Pasteur Clinical Sciences, 87/2 CRC Tower 23rd Floor, All Seasons Place, Wireless Road, Lumpini, Pathumwan, Bangkok, Thailand
3 Ratchaburi Hospital, 77/4, Kathatorn Road, Tambon Na Muang, Amphoe Muang Ratchaburi, Thailand
4 Sanofi Pasteur Clinical Sciences, 38 Beach Road #18-11 South Beach Tower, Singapore 189767, Singapore
5 Sanofi Pasteur Clinical Programs, Marcy L’Etoile, France
6 Sanofi Pasteur Global Pharmacovigilance, Lyon, France

Correspondence Address:
Danaya Chansinghakul
Sanofi Pasteur Clinical Sciences, 87/2 CRC Tower 23rd Floor, All Seasons Place, Wireless Road, Lumpini, Pathumwan, Bangkok 10330
Login to access the Email id

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/1995-7645.267582

Rights and Permissions

Objective: To investigate the long-term safety of a tetravalent dengue vaccine (CYD-TDV) in children in a phase Π b follow-up study in Thailand. Methods: In the phase Π b study, children aged 4-11 years were randomized (2:1) to receive three injections of CYD-TDV or serve as control at 6-month intervals, with 25 months’ active follow-up (active phase). This study was an additional four-year passive surveillance for hospitalized virologically-confirmed dengue (VCD; hospital phase). Cases of hospitalized VCD, severe hospitalized VCD, vaccine-related serious adverse events, and deaths were reported for the total population, with post-hoc analyses by enrollment age (<9 and years). Results: Of 3 997 participants receiving injection, 80.1% were recruited to the hospital phase [2 131 (CYD-TDV); 1 072 (control)]. Eighty-five hospitalized VCD cases were reported in the CYD-TDV group and 46 in the control group during the four-year hospital phase [relative risk (RR): 0.93, 95% confidence interval (CI): 0.64-1.36]. The RR over six years of follow-up was 0.77 (95% CI: 0.57-1.05). In those aged ≥9 years, the cumulative RRs in the active phase, hospital phase, and entire six years were 0.28 (95% CI: 0.08-0.81), 0.51 (95% CI: 0.25-1.05), and 0.42 (95% CI: 0.24-0.75), respectively. In the overall population, there were ten severe hospitalized VCD cases in the CYD-TDV group and five in the control group over six years (RR: 1.00, 95% CI: 0.31-3.75). Conclusions: Over six years of follow-up, in children aged ≥9 years, CYD-TDV administration is associated with a reduced risk of hospitalized VCD.

Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)

 Article Access Statistics
    PDF Downloaded324    
    Comments [Add]    
    Cited by others 3    

Recommend this journal