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Completed

NCT Number: NCT00420316

Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine.

To assess the long-term efficacy and safety of the subjects during the third year after priming with 2 doses of GSK Biologicals' oral live attenuated HRV vaccine (Rotarix) in the primary vaccination study (102247). The Rotarix vaccine was administered in the primary vaccination study. There was no vaccine/intervention in this long-term efficacy study.

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Key information

Conditions

Infections, Rotavirus Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Infections Intestinal Diseases Intestinal Obstruction Intussusception RNA Virus Infections Reoviridae Infections Rotavirus Infections Virus Diseases

Age range

32 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Espoo, Finland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A male or female who has completed the second year efficacy follow-up of the primary vaccination study in Finland.
  • Written informed consent obtained from the parent or guardian of the subject.

Treatment and study plan

Rotarix (primary vaccination study)

Biological

GlaxoSmithKline Biologicals' oral live attenuated human rotavirus vaccine.

Placebo (primary vaccination study)

Biological

Two liquid oral doses of placebo

Primary outcomes

  1. Number of Subjects With Any Rotavirus Gastroenteritis (RVGE)

    Time frame: During the study period for the long-term follow-up (i.e. 6 months)

    Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes.

Secondary outcomes

  1. Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE)

    Time frame: During the study period for the long-term follow-up (i.e. 6 months)

    Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.

  2. Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With G1 Serotype

    Time frame: During the study period for the long-term follow-up (i.e. 6 months)

    Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes. Only GE episodes in which wild-type RV strain of G1 serotype was identified in a stool specimen, were included in the efficacy analysis.

  3. Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With G1 Serotype

    Time frame: During the study period for the long-term follow-up (i.e. 6 months)

    Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain of serotype G1 and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.

  4. Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype

    Time frame: During the study period for the long-term follow-up (i.e. 6 months)

    Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain of non-G1 serotype was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes.

  5. Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype

    Time frame: During the study period for the long-term follow-up (i.e. 6 months)

    Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain of non-G1 serotype and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.

  6. Number of Subjects With Severe Gastroenteritis (GE)

    Time frame: During the study period for the long-term follow-up (i.e. 6 months)

    Severe GE was defined as a GE episode requiring hospitalization and/or re-hydration therapy in a medical facility.

  7. Number of Subjects Reporting Serious Adverse Events (SAEs)

    Time frame: During the study period for the long-term follow-up (i.e. 6 months)

    An SAE was any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.

  8. Number of Subjects Reporting Intussusception (IS)

    Time frame: During the period starting from the end of the second follow-up up to the start of the study (up to 6 months)

    Intussusception is defined as the telescoping of the intestine.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

To Assess Long-term Efficacy & Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine (Rotarix) in the Primary Vaccination Study (102247).

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jan 11, 2007
Registry last updated
Aug 28, 2018

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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