An observational study in Infections, Rotavirus, sponsored by GlaxoSmithKline. Completed. Open to participants aged 6 Weeks to 12 Weeks. Per ClinicalTrials.gov, last updated 2015-04-06.
Sponsored by GlaxoSmithKline · Observational
This study aims to evaluate the serologic response to PCV-1 in the serum samples previously collected during initiation of vaccination series of Human Rotavirus (HRV) vaccine studies (1-2 months post Dose 2 of HRV vaccine or placebo). Additionally, pre-vaccination sera samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time point will also be evaluated.
Serum samples collected from 6 clinical trials previously conducted for HRV vaccine (Rotarix™) are used in this study.
104 studies on the registry are indexed under Rotavirus Infections; 3 are open to participants now.
This study's enrollment of 1 is below the median of 643 across 33 observational studies indexed under Rotavirus Infections.
Browse Rotavirus Infections studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 120 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 240 (91%) have results posted.
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Infants aged 6 to 12 weeks from 6 previously completed clinical trials, who received 2 doses of either Rotarix™ or Placebo.
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Not applicable as no subjects will be actively enrolled in this study, only the sera samples of the subjects who were a part of previously conducted trials will be used for testing. However, the archived serum samples of only those subjects who satisfy the following criteria will be included in this study:
Exclusion Criteria:
Subjects who had received 2 doses of HRV vaccine in previous studies.
Procedure: Serum sample
Subjects who had received 2 doses of placebo in previous studies.
Procedure: Serum sample
Serum samples collected at pre-vaccination and at 1-2 months post Dose 2 in the previously conducted clinical trials will be assessed for anti-PCV-1 antibodies in this study. Additionally, pre-vaccination sera samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time point will also be evaluated.
Seropositivity rates for anti-PCV-1 antibodies.
Time frame: At 1-2 months post dose 2 of HRV vaccine or placebo.
Seroconversion rates for anti-PCV-1 antibodies.
Time frame: At 1-2 months post dose 2 of HRV vaccine or placebo.
No study locations are listed for this record.
The record gives a start of Feb 2014, a primary completion of Dec 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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