A phase IIIb open study to assess the long-term efficacy and safety of GlaxoSmithKline (GSK) Biologicals' oral live attenuated human rotavirus (HRV) vaccine approximately three years after vaccination in healthy infants aged 6-12 weeks at the time of first vaccination in the Rota-036 study (102247) in Finland. - ROTA-036 EXT Y3

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006552-36-FI

Enrollment

2601

Registered

2006-12-01

Start date

2007-01-18

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long-term efficacy and safety follow-up

Interventions

Trade Name: Rotarix Product Name: Live attenuated human rotavirus (HRV) vaccine, oral Product Code: RIX4414 Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: HRV vaccine (live) Curr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •A male or female who has completed the second year efficacy follow-up of the primary vaccination study (Rota-036, eTrack No.102247) in Finland. •Written informed consent obtained from the parent or guardian of the subject. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Not applicable as this study is a long-term efficacy and safety follow-up of subjects who have received the HRV vaccine or the placebo dose in the primary vaccination study (Rota-036).

Design outcomes

Primary

Measure	Time frame
Main Objective: •To assess the efficacy of GSK Biologicals’ HRV vaccine with respect to any RV GE episodes caused by the circulating wild-type RV strains during the follow-up period.;Secondary Objective: Secondary efficacy objectives, to assess: •efficacy of GSK's HRV vaccine with respect to severe RV GE caused by circulating wild-type RV strains •if administration of GSK's HRV vaccine can prevent any & severe RV GE caused by wild-type RV strain of G1 and non-G1 serotypes •if administration of GSK's HRV vaccine can prevent severe GE Secondary safety objectives: •safety of GSK's HRV vaccine in terms of mortality & occurrence of SAEs during the follow-up period •safety of GSK's HRV vaccine in terms of mortality & occurrence of IS during the period from end of the 2nd follow-up period up to the start of the study (retrospective follow-up);Primary end point(s): •Occurrence of any RV GE caused by the circulating wild-type RV strains during the study period for the long-term follow-up.	—

Measure

Time frame

Main Objective: •To assess the efficacy of GSK Biologicals’ HRV vaccine with respect to any RV GE episodes caused by the circulating wild-type RV strains during the follow-up period.;Secondary Objective: Secondary efficacy objectives, to assess: •efficacy of GSK's HRV vaccine with respect to severe RV GE caused by circulating wild-type RV strains •if administration of GSK's HRV vaccine can prevent any & severe RV GE caused by wild-type RV strain of G1 and non-G1 serotypes •if administration of GSK's HRV vaccine can prevent severe GE Secondary safety objectives: •safety of GSK's HRV vaccine in terms of mortality & occurrence of SAEs during the follow-up period •safety of GSK's HRV vaccine in terms of mortality & occurrence of IS during the period from end of the 2nd follow-up period up to the start of the study (retrospective follow-up);Primary end point(s): •Occurrence of any RV GE caused by the circulating wild-type RV strains during the study period for the long-term follow-up.

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Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026