Blinded Retrospective Laboratory Evaluations to Assess the Serologic Response to Porcine Circovirus Type 1 (PCV-1) in Infants Following the Administration of GlaxoSmithKline (GSK) Biologicals' Human Rotavirus Vaccine (444563)

NCT02153333 COMPLETED

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.

Details

Lead sponsor	GlaxoSmithKline
Status	COMPLETED
Enrolment	1
Start date	2014-02
Completion	2014-12

Conditions

• Infections, Rotavirus

Interventions

• Serum sample

Primary outcomes

• Seropositivity rates for anti-PCV-1 antibodies. — At 1-2 months post dose 2 of HRV vaccine or placebo.
• Seroconversion rates for anti-PCV-1 antibodies. — At 1-2 months post dose 2 of HRV vaccine or placebo.