Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Infants

Browse trials for

• Rotavirus Infections 104
• Gastroenteritis 244

Keywords

• Gastroenteritis

Rotavirus Infections

104 studies on the registry are indexed under Rotavirus Infections; 3 are open to participants now.

This study's enrollment of 522 is below the median of 643 across 33 observational studies indexed under Rotavirus Infections.

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.

Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.

Groups and cohorts

• Rotarix Group

  Subjects received 2 oral doses of Rotarix vaccine at an interval of at least 4 weeks between doses. The first dose was given from the age of 6 weeks and vaccination with both doses was to be completed by 24 weeks of age.

  Biological: Rotarix™

Interventions

• BiologicalRotarix™

  Two oral doses, with at least 4 weeks interval in-between

Primary outcomes

1. Number of Subjects With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea

   Grade 2 fever was defined as axillary temperature \> 38.0 to \<= 39.0 degrees Celsius and grade 3 fever as axillary temperature \> 39.0 degrees Celsius. Grade 2 vomiting was defined as 2 episodes of vomiting per day and grade 3 as 3 or more episodes of vomiting per day. Grade 2 diarrhoea was defined as 4-5 looser than normal stools per day and grade 3 as 6 or more looser than normal stools a day.

   Time frame: During the 8-day solicited follow-up period

Secondary outcomes

1. Number of Subjects Reporting Each Type of Solicited General Symptoms

   Solicited symptoms included cough, diarrhoea, irritability, loss of appetite, fever (degrees Celsius) and vomiting.

   Time frame: During the 8-day follow-up period

2. Number of Subjects Reporting Unsolicited Adverse Events (AEs)

   Unsolicited AEs cover any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

   Time frame: During the 31-day follow-up period

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

   SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject

   Time frame: Throughout the study period (Day 0 to Month 3 or 4)

Baseline characteristics

Publications

• Ruberu D et al. Post-marketing surveillance of a live-attenuated human rotavirus vaccine (Rotarix™) in India and Sri Lanka. Abstract presented at the 9th International Congress of Tropical Pediatrics (ICTP). Bangkok, Thailand, 18-20 October 2011.
• Bravo L, Chitraka A, Liu A, Choudhury J, Kumar K, Berezo L, Cimafranca L, Chatterjee P, Garg P, Siriwardene P, Bernardo R, Mehta S, Balasubramanian S, Karkada N, Htay Han H. Reactogenicity and safety of the human rotavirus vaccine, Rotarix in The Philippines, Sri Lanka, and India: a post-marketing surveillance study. Hum Vaccin Immunother. 2014;10(8):2276-83. doi: 10.4161/hv.29280. PubMed 25424932 ↗