Reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals Rotarix (human rotavirus vaccine) in Indian infants

An open, single group, multi-centric, post marketing surveillance (PMS) to monitor the reactogenicity and safety of oral live attenuated human rotavirus (HRV) vaccine, Rotarix when administered according to the Prescribing Information to Indian infants

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2009/091/000570

Enrollment

328

Registered

2009-10-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Rotarix: Two doses of oral vaccine Control Intervention1: Nil: Single group study

Eligibility

Inclusion criteria

Inclusion criteria: • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in this PMS. • A male or female infant, from the age of 6 weeks at the time of the first vaccination and less than 24 weeks of age at the time of second vaccination. • Written informed consent obtained from the parent or guardian of the subject.

Exclusion criteria

Exclusion criteria: ? History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. ? Concurrently participating in another clinical study, at any time during the surveillance period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). ? Acute disease at the time of enrolment. ? Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose the subject for intussusception. ? Known hypersensitivity after previous administration of rotavirus vaccine or to any component of the vaccine. ? Gastroenteritis within 7 days preceding vaccination.

Design outcomes

Primary

Measure	Time frame
Occurrence of at least one grade 2 or grade 3 fever, vomiting or diarrhoea.Timepoint: During the 8-day (Day 0 to Day 7) follow-up period after any Rotarix vaccination.	—

Secondary

Measure	Time frame
For each type of solicited symptom, occurrence of the symptom.Timepoint: Within the 8-day (Day 0 to Day 7) follow-up period after each dose of the vaccination.;Occurrence of Serious adverse events (SAEs)Timepoint: Throughout the surveillance period following the first dose administered in the study;Occurrence of unsolicited symptoms according to MedDRA classification.Timepoint: During the 31-day (Day 0 ? Day 30) follow-up period after any vaccination.	—

Measure

Time frame

For each type of solicited symptom, occurrence of the symptom.Timepoint: Within the 8-day (Day 0 to Day 7) follow-up period after each dose of the vaccination.;Occurrence of Serious adverse events (SAEs)Timepoint: Throughout the surveillance period following the first dose administered in the study;Occurrence of unsolicited symptoms according to MedDRA classification.Timepoint: During the 31-day (Day 0 ? Day 30) follow-up period after any vaccination.

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Countries

India

Contacts

Public ContactDr Shailesh Mehta

GlaxoSmithKline

shailesh.i.mehta@gsk.com00912224959611

Outcome results