Last updated: 11/07/2018 14:24:48
To evaluate 2 doses of GSK Biologicals’ oral live attenuated human HRV vaccine co-administered with either OPV or IPV
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Reactogenicity & immunogenicity study of two doses of GSK Biologicals’ oral live attenuated HRV vaccine co-administered with either OPV or IPV in healthy infants (approximately 5-10 weeks old) in South Africa
Trial description: "The primary objective of this study was to demonstrate that co-administering HRV vaccine with OPV does not induce a significant decrease in poliovirus immune response one month after the third dose of combined vaccines.The primary objective was reached if one month after the third dose of polio vaccine, upper limit of the 95% CI for the difference in Seroprotection rate between the group B and C pooled and (minus) the group A was below 10% for each polio serotype."
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
450
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Steele AD et al. (2008) Co-administration study in South African infants of a live-attenuated oral human rotavirus vaccine (RIX4414) and poliovirus vaccines.Vaccine. 28(39): 6542-6548.
Steele AD et al. (2009) A review of rotavirus infection in and vaccination of human immunodeficiency virus-infected children. J Infect Dis. 1;200 Suppl 1:S57-62.
Medical condition
Rotavirus Infections
Product
Rotavirus Vaccine
Collaborators
Not applicable
Study date(s)
November 2001 to March 2003
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
5 - 10 weeks
Accepts healthy volunteers
Yes
- Healthy infants between 5 and 10 weeks of age at first study vaccination with (after the 2002 RV season) confirmed negative HIV status of the subject’s mother during pregnancy or thereafter.
- History of allergic disease, any confirmed or suspected immunosuppressive or immunodeficient condition, clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator or had not received treatment prohibited by the protocol.
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy infants between 5 and 10 weeks of age at first study vaccination with (after the 2002 RV season) confirmed negative HIV status of the subject’s mother during pregnancy or thereafter.
Exclusion criteria:
- History of allergic disease, any confirmed or suspected immunosuppressive or immunodeficient condition, clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator or had not received treatment prohibited by the protocol.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2003-31-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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