Safety, immunogenicity and lot-to-lot consistency of a new Bivalent Oral Polio Vaccine (bOPV) in healthy Infants: Results of a Phase III, observer blind, randomized, controlled clinical study

Zaman, Khalequ; Kingma, Robert; Yunus, Muhammad; Straaten, Ineke van; Mekkes, D. R.; Bouwstra, Xandra; Gunale, Bhagwat; Kulkarni, Prasad S.

doi:10.1016/j.vaccine.2019.06.048

Cited by 3 publications

(1 citation statement)

References 8 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…IPV and OPV are both effective in preventing polio disease. However, the use of OPV can cause rare cases of vaccine-associated paralytic poliomyelitis, as well as a significant resurgence of poliomyelitis cases due to circulating vaccine-derived poliovirus [ 8 , 9 ] and low vaccination coverage in some countries [ 10 , 11 ]. For this reason, the core of the Polio Eradication and Endgame Strategic Plan implemented by the Global Polio Eradication Initiative is to introduce IPV into routine immunization programs worldwide, as a replacement for OPV [ 2 , 12 , 13 ].…”

mentioning

confidence: 99%

Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains: A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Seamless Study

Capeding

Gomez-Go²,

Oberdorfer

et al. 2020

The Journal of Infectious Diseases

View full text Add to dashboard Cite

Background A new inactivated polio vaccine made from Sabin strains (sIPV) was developed as part of the global polio eradication initiative. Methods This randomized, double-blind, active-controlled, phase 2/3 seamless study was conducted in 2 stages. Healthy infants aged 6 weeks were randomly assigned to receive 3 doses of 1 of 4 study vaccines at 6, 10, and 14 weeks of age (336 received low-, middle-, or high-dose sIPV, or conventional IPV [cIPV] in stage I, and 1086 received lot A, B, or C of the selected sIPV dose, or cIPV in stage II). The primary outcome was the seroconversion rate 4 weeks after the third vaccination. Results In stage I, low-dose sIPV was selected as the optimal dose. In stage II, consistency among the 3 manufacturing lots of sIPV was demonstrated. The seroconversion rates for Sabin and wild strains of the 3 serotypes after the 3-dose primary series were 95.8% to 99.2% in the lot-combined sIPV group and 94.8% to 100% in the cIPV group, proving the noninferiority of sIPV compared to cIPV. No notable safety risks associated with sIPV were observed. Conclusions Low-dose sIPV administered as a 3-dose vaccination was safe and immunogenic compared to cIPV. Clinical Trials Registration NCT03169725.

show abstract

mentioning

confidence: 99%