Study design and participants
ICH, tetanus
TETANUS, HIB
This was a phase 3, randomized, observer-blind study conducted in 8 centers across India among 460 infants who were followed up for safety and immunogenicity for 28 days after administration of three doses of either investigational or licensed comparator DTwP-HepB-Hib formulations at 6–8, 10–12 and 14–16 weeks of age. The study was performed from December 2018 to July 2019. The study was approved by the Indian National Regulatory Authority (The Drugs Controller General of India [DCGI]) and appropriate independent ethics committees and institutional review boards prior to the start of the study. The study was registered in the Clinical Trials Registry—India (CTRI/2018/12/016692). The conduct of this study was consistent with the standards established by the Declaration of Helsinki and compliant with the ICH guidelines for good clinical practice as well as with all local and / or national regulations and directives. Written signed informed consent was obtained from the subject’s parent/ legally acceptable representative (LAR) before any study procedures were performed. The entire informed consent process was audio-visually recorded as per Indian regulations.The study population included infants aged 6–8 weeks, at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg, or medically stable prematurely born infants (born after a gestation period of 27–36 weeks), receiving the primary series of D, T, P, HepB and Hib vaccination as per the National Immunization schedule [Eligible subjects were randomized into two groups in 1:1 ratio to receive either the investigational DTwP-HepB-Hib vaccine formulation or the comparator (licensed) DTwP-HepB-Hib vaccine formulation. Randomization was performed using the permuted block method with stratification on centers and was managed with scratchable lists, available on site, which provided the vaccine to be administered for each enrolled participant. The study was conducted in an observer-blind manner, meaning that the subject’s parents / LAR, the study investigators and study staff, except the person in charge of the vaccination, were unaware of the group allocation throughout the study period.Each dose (0.5 mL) of both the investigational (batch number 2PLU005A18 expiring in Jan 2020) and the licensed comparator (batch number PLU015A17 expiring in Jun 2019) DTwP-HepB-Hib formulations, presented in 10-dose vials, contained diphtheria toxoid (≥ 30 IU), tetanus toxoid (≥ 60 IU), whole cell 