Human Rotavirus Vaccine - two different formulations
BiologicalTwo oral doses
NCT Number: NCT00729001
This is a dose exploration study to assess the safety and immunogenicity of two doses of the candidate HRV vaccine at different virus concentrations in the target age group (infants approximately 2 months of age and previously uninfected with human rotavirus) and receiving concomitant administration of routine vaccinations. The study also aims at exploring the effect of unrestricted feeding on the immunogenicity of the vaccine.
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Notify Me6 week–12 week
All sexes
Interventional
Phase 2
All subjects enrolled from Eastern United States and Eastern Canada will continue their participation in the pilot efficacy follow-up (pilot efficacy subset).
The third dose of IPV vaccine (IPOL) may be given at visit 3, 4 or another time, at the investigator's discretion.
Comvax may be given in place of OmniHIB/ActHIB at Visit 1 and Visit 2 and the third dose of Comvax administered according to the prescribing information.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Two oral doses
Three-dose intramuscular injection (US subjects only)
Two-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
Three-dose intramuscular injection (US subjects only)
Other names: ActHIB
Three-dose intramuscular injection (Canada only)
Time frame: Two months after the second dose
Time frame: Within the 15-day solicited follow-up period after any dose of study vaccine.
Time frame: Within the 15-day solicited follow-up period after any dose of study vaccine
Time frame: Within 42 days after dose 1 and dose 2
Time frame: Throughout the entire study period
Time frame: At visits 1, 3 and 4 and at all Visits for pilot efficacy subset
Time frame: Before dose 1 and at the end of the study
Time frame: 2 months after dose 1
Time frame: Two months after dose 2 and at the end of the study.
Time frame: Two months after dose 2 and at the end of the study (only in a subset of U.S. subjects)
Time frame: Two months after dose 2 and at the end of the study.
Time frame: Two months after dose 2 and at the end of the study.
Time frame: Two months after dose 2.
Time frame: Two weeks after dose 2 until the end of the rotavirus season following vaccination.
GlaxoSmithKline
Industry
Phase II, Double-blind, Randomized, Placebo-controlled Study of 2 Doses of GSK Biologicals' Live Attenuated Human Rotavirus Vaccine at Different Virus Concentrations (10 5.2 and 10 6.4 Ffu) in Healthy Infants Following a 0, 2 Month Schedule and Previously Uninfected With Human Rotavirus.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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