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Vaccines

Bioresearch Monitoring Inspection Results - Rotarix

MEMORANDUM

DATEMarch 3, 2008
FROMAnthony Hawkins, Bioresearch Monitoring, HFM-664
Division of Inspections and Surveillance
Office of Compliance and Biologics Quality
THROUGHPatricia Holobaugh, Bioresearch Monitoring Branch Chief, HFM-664
TOLaraine Henchal, Chair, BLA Committee, HFM-478
SUBJECTBioresearch Monitoring Inspection Results
STN: 125265/0
Product: Human Rotavirus (strain 89-12; RIX4414; Vero Cells) Vaccine, Live, Attenuated, Oral
Sponsor: GlaxoSmithKline Biologicals, SA

SUMMARY STATEMENT

The bioresearch monitoring inspections of six clinical sites did not reveal problems that impact the data submitted in the application.

BACKGROUND

Six clinical investigator inspections were performed in support of this Biologics License Application (BLA). Study subject population, geographic distribution, and field resource considerations were among the factors used to select the inspected sites. Information from the BLA was compared to source documents, during the inspections.

CLINICAL INVESTIGATORS
Site ##Subjects483Inspection Classification
Dr. Alexandre Linhares
Instituto Evandro Chagas
Belém - Pará, Brazil
050
3,218
No
NAI
Dra. Maribel Rivera
Hospital Escuela
Tegucigalpa, Honduras
250
4,195
Yes
VAI
Dra. Mercedes Macias-Parra
Instituto Nacional de Pediatria
Mexico City, Mexico
450
3,247
Yes
VAI

STUDY TITLE

A phase III, double-blind, randomized, placebo-controlled, multi-country and multi-center study to assess the efficacy, safety and immunogenicity of two doses of GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine in healthy infants. (Study Rota-023)

CLINICAL INVESTIGATORS, continued:

 Site ##Subjects483Inspection Classification
Dr. Tiina Korhonen
Tampere rokotusklinikka
Tampere, Finland
7915
296
No
NAI
Dr. Niklas Lindblad
Turku Rokotetutkimukset
Turku, Finland
7975
293
No
NAI
Dr. Anna-Maija Hanni
Oulun Rokotetutkimusklinikka
Oulu, Finland
7991
260
No
NAI

STUDY TITLE

A phase IIIb, double-blind, randomized, placebo-controlled, multi- country and multi-center study to assess the efficacy, safety and immunogenicity of two doses of GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine in healthy infants in co-administration with specific childhood vaccines. (Study Rota-036)

SPONSOR ISSUES

No sponsor or monitoring issues were noted.

NOTEWORTHY INSPECTIONAL FINDINGS

Part of one subject's electronic case report form (CRF) was deleted to include a serious adverse event (SAE), intussuseption, which occurred after the study subject was enrolled but before treatment with the study vaccine. The sponsor acknowledged that, at the time of the study, there was no clear instruction for completion of a CRF in case a subject was enrolled and randomized but did not receive the study vaccine (Dra. Rivera).

BIMO ADMINISTRATIVE FOLLOW-UP

We issued closeout letters to Drs. Linhares, Rivera, Macias-Parra, Korhonen, Lindblad and Hanni. If you have any questions or comments about this memo or any aspect of Bioresearch Monitoring, please contact me at (301) 827-6338.

_________________
Anthony Hawkins
Consumer Safety Officer

 

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