NCT00779779

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

Completed Results posted Last updated 28 August 2018

What this trial tests

trial testing Rotarix™ in Infections, Rotavirus in 522 participants. Completed in 26 August 2009.

Timeline

22 November 2008

Primary endpoint
25 May 2009

26 August 2009

Quick facts

Lead sponsor	GlaxoSmithKline
Status	Completed
Study type	OBSERVATIONAL
Enrollment	522
Start date	22 November 2008
Primary completion	25 May 2009
Estimated completion	26 August 2009
Sites	1 location across Sri Lanka

Drugs / interventions tested

• Rotarix™

Conditions studied

• Infections, Rotavirus — all drugs for Infections, Rotavirus →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 6 Weeks to 19 Weeks, any sex, with Infections, Rotavirus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects With at Least One >= Grade "2" Fever, Vomiting or Diarrhoea Primary · During the 8-day solicited follow-up period

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.

Group	Value	95% CI
Rotarix Group	78

Number of Subjects Reporting Each Type of Solicited General Symptoms Secondary · During the 8-day follow-up period

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

Cough

Group	Value	95% CI
Rotarix Group	71

Diarrhoea

Group	Value	95% CI
Rotarix Group	24

Irritability

Group	Value	95% CI
Rotarix Group	124

Loss of appetite

Group	Value	95% CI
Rotarix Group	83

Fever

Group	Value	95% CI
Rotarix Group	152

Vomiting

Group	Value	95% CI
Rotarix Group	45

Number of Subjects Reporting Unsolicited Adverse Events (AEs) Secondary · During the 31-day follow-up period

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.

Group	Value	95% CI
Rotarix Group	25

Number of Subjects Reporting Serious Adverse Events (SAEs) Secondary · Throughout the study period (Day 0 to Month 3 or 4)

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

Group	Value	95% CI
Rotarix Group	1

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 4.6%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Rotarix Group

Serious: 1/522 (0%)

Deaths: —

Serious adverse events (1 terms)

Reaction	System	Rotarix Group
Crying	Nervous system disorders	—

Other adverse events (6 terms — click to expand)

Reaction	System	Rotarix Group
Fever	General disorders	—
Irritability	General disorders	—
Loss of appetite	General disorders	—
Cough	General disorders	—
Vomiting	General disorders	—
Diarrhoea	General disorders	—

Most-reported serious reactions: Crying.

Data from ClinicalTrials.gov NCT00779779 adverse events section.

Sponsor's own description

This Post Marketing Surveillance (PMS) will collect reactogenicity and safety data on the use of human rotavirus vaccine in healthy infants aged from 6 weeks (first dose) to not more than 24 weeks (second dose).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Reactogenicity and safety of the human rotavirus vaccine, Rotarix™ in The Philippines, Sri Lanka, and India: a post-marketing surveillance study.
   Bravo L, Chitraka A, Liu A, Choudhury J, et al · · 2014 · cited 7× · PMID 25424932 · DOI 10.4161/hv.29280