Recombinant acellular pertussis vaccines containing genetically detoxified Pertussis Toxin (PTgen) have been used for booster immunisation in children, adolescents and adults including pregnant women in Thailand. Three vaccines have been licensed in Thailand, a monovalent (aPgen) and two vaccines combined with tetanus and reduced diphtheria dose vaccines (TdaPgen and Tdapgen). To address the need for improved vaccines in younger children, a new recombinant pediatric DTaP vaccine (DTaPgen) containing 5 µg genetically detoxified Pertussis Toxin (PTgen) and 10 µg Filamentous Hemagglutinin (FHA) was developed and found safe and immunogenic in a phase II trial in children aged 3 years onwards. The purpose of this study is to assess the immunogenicity and safety of this new pediatric formulation DTaPgen given as the first booster dose in healthy toddlers aged 15 to 36 months compared to a commercially available vaccine in Thailand.
This is a phase II/III randomized, observer-blind, active-controlled study conducted in Thailand, children aged 15-36-month-old with a history of DTwP (n=240) or DTaP (n=50) priming were randomized 2:1 to receive a dose of recombinant DTaPgen or licensed DTaP-IPV. The aim of this study is to evaluate the safety and non-inferior immunogenicity of DTaPgen versus DTaP-IPV vaccine given as the first booster dose in toddlers. Safety up to 1-year and vaccine antibody persistence will also be assessed for all children.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
290
A single dose of Acellular pertussis (DTaP) vaccine 0.5 ml will be given by intramuscularly at Day 0
A single dose of Acellular pertussis (DTaP) vaccine 0.5 ml. will be given by intramuscular as at Day 0
Vaccine Trial Centre (VTC), Faculty of Tropical Medicine, Mahidol University
Bangkok, Bangkok, Thailand
Kamphaengphet Hospital
Kamphaeng Phet, Changwat Kamphaeng Phet, Thailand
Phaholpolpayuhasena Hospital
Kanchanaburi, Kanchanaburi, Thailand
Seroconversion rates of PT
ELISA
Time frame: At 28 days following vaccination
Percentages of participants with solicited post-immunization local and systemic reactions
Self assessment by participant and data record from Diary Card
Time frame: During 7 days following vaccination
Percentages of participants with AEs
AEs reported by participant
Time frame: During 28 days following vaccination
Percentages of participants with SAEs
SAEs reported by participant
Time frame: During 28 days following vaccination
GMT antibody concentration to anti-PT neutralizing antibody
CHO
Time frame: Baseline and Day 28 after vaccination
GMT antibody concentration to DT, TT, PT and FHA
ELISA
Time frame: Baseline and Day 28 after vaccination
Seroprotection rates of Tetanus and Diphtheria
ELISA
Time frame: Day 28 after vaccination
Seroconversion rates of FHA and anti-PT neutralizing antibody
ELISA and CHO
Time frame: Day 28 after vaccination
Percentages of participants with SAEs
SAEs reported by participant
Time frame: Day 336 after vaccination
Seroconversion rates of FHA and anti-PT neutralizing antibody
ELISA and CHO
Time frame: Day 336 after vaccination
GMT antibody concentration to DT, TT, PT and FHA
ELISA
Time frame: Day 336 after vaccination
GMT antibody concentration to anti-PT neutralizing antibody
CHO
Time frame: Day 336 after vaccination
Seroprotection rates of Tetanus and Diphtheria
ELISA
Time frame: Day 336 after vaccination
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