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GSK Biologicals' liquid human rotavirus vaccine 444563 · 1 trial · 1 indication
A gastroenteritis episode was classified positive for rotavirus (RV) and caused by the circulating wild-type (WT) RV strains if RV other than the vaccine strain was identified in a stool sample collected during the episode. Severe RVGE was defined as an episode of RV GE with score equal to or higher than (\>=) 11 on a 20-point Vesikari scoring system.
| Arm | Type | Description |
|---|---|---|
| Rotarix Group | EXPERIMENTAL | Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh. |
| Placebo Group | PLACEBO_COMPARATOR | Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh. |
| Name | Type | Description |
|---|---|---|
| GSK Biologicals' liquid human rotavirus vaccine 444563 | BIOLOGICAL | Oral administration |
| Placebo | BIOLOGICAL | Oral administration |
| Infanrix™ | BIOLOGICAL | Intramuscular administration |
| Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV) | BIOLOGICAL | Oral administration |
Inclusion Criteria: * Subjects who the investigator believes that their parents/Legally Acceptable Representatives can and will comply with the requirements of the protocol. * A male or female infant of Chinese origin between, and including, 6 and 16 weeks of age at the time of the first vaccinatio...
It is an investigational vaccine developed by GSK plc for the prevention of rotavirus infections. It is a liquid formulation given to infants, and it is being studied in a Phase 3 clinical program. Rotavirus is a leading cause of severe diarrhea in young children.
It is being developed to protect against rotavirus infections in infants. The Phase 3 study enrolled healthy Chinese infants starting at 6 weeks of age. The vaccine is intended for prevention rather than treatment of an existing rotavirus infection.
The vaccine is developed by GSK plc, which trades on the New York Stock Exchange under the ticker GSK. GSK Biologicals is the company's vaccine division. The candidate is an investigational liquid formulation of a human rotavirus vaccine.
It is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The completed study was randomized, double blind, and placebo controlled, and it enrolled 3,340 healthy infants in China.
The vaccine has been evaluated in one completed Phase 3 trial, NCT01171963, titled Study to Assess the Efficacy, Immunogenicity and Safety of Liquid Human Rotavirus Vaccine, in Healthy Chinese Infants. It enrolled 3,340 healthy infants aged 6 weeks and older in China and was placebo controlled.