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At least 55 records · Page 3Linked to original sources
PubMed1992

[Quality control of the vaccines and cold chain during the national vaccination campaigns].

During the two vaccination campaigns against rinderpest and contagious bovine pleuropneumonia (CBPP) in 1989 and 1990, 507 vaccine samples were collected for quality control at each step of the distribution chain from the Veterinary Pharmacy of Abidjan to the vaccinator on the field. Parallel to that, the quality of the cold chain was checked. A total of 463 titrations were performed. All the titration levels were above the OIE/FAO standards, i.e. 10(2.5) DICT50/ml for rinderpest Valence and 10(7) viable germs/ml for contagious bovine pleuropneumonia Valence.

Animals↗
PubMed1994

Are childhood immunization programmes in Australia at risk? Investigation of the cold chain in the Northern Territory.

Since vaccines may lose their potency if transported or stored outside the recommended temperature range (2-8 degrees C), we carried out a study in the Darwin area of the Northern Territory of Australia to determine the links in the cold chain, including the extent of vaccine monitoring, and whether the vaccines were being exposed to unsafe temperatures. Sabin oral poliomyelitis vaccine (OPV) and recombinant hepatitis-B (HB) vaccine were selected for special monitoring. A total of 127 vials of OPV and 144 vials of HB vaccine were dispatched during October, November and December 1990 to the government, independent health services and general practitioner surgeries which routinely administer these vaccines. We distributed the two vaccines with MonitorMark time/temperature and Coldside indicator tags attached to cards for recording the date, location and temperature exposures each time the vaccines were moved or used. A total of 65% of the OPV and 41% of the HB vaccine monitor cards were returned for analysis. The vaccines were transported and stored at one to four locations prior to being administered. Some 23% of tagged OPV was exposed for 48 hours or more to a temperature > 10 degrees C; 47.5% of tagged HB vaccines were exposed to -3 degrees C or less, the majority of them during storage in health facilities or clinics. Exposures were independent of distance from the distribution centre, mode of transport, or type of facility. Our results show that the vaccines were often exposed to temperatures outside the recommended range during transport and storage, putting them at risk of loss of potency.(ABSTRACT TRUNCATED AT 250 WORDS)

Child↗
PubMed2006

Overcoming the need for a cold chain with conjugated meningococcal Group C vaccine: A controlled, randomized, double-blind study in toddlers on the safety and immunogenicity of Menjugate, stored at room temperature for 6 months.

Millions of vaccine doses are wasted each year due to a lapse in recommended storage conditions. Maintaining the cold chain for vaccines is both expensive and difficult, especially in developing countries. The present study investigated the safety and immunogenicity of a single dose of the conjugated meningococcal Group C vaccine, Menjugate, stored for 6 months at room temperature (25+/-2 degrees C, N=250) or at 2-8 degrees C (N=250) when administered to 12-23 months toddlers. In the two respective groups, 87 and 88% of toddlers reached bactericidal antibodies titers of at least 1:8. The immunogenicity of Menjugate stored at room temperature was not inferior to that stored at 2-8 degrees C. The safety profile and immunogenicity of the vaccine was not influenced by the storage condition.

Antibodies, Bacterial↗
PubMed1996

Cold chain in a hot climate.

We monitored the temperatures of batches of vaccine during transport and storage from a national warehouse to five Northern Territory vaccination clinics. Electronic temperature monitors were placed with vaccines, and were programmed to record the temperature every 30 minutes for up to three months. A diary was attached to each vaccine batch to record each change in location. The temperature recordings covered 8369 hours. There were regular temperature deviations outside the recommended range. In the hot climate of the Northern Territory, freezing is the greatest threat to vaccine potency. Recommendations from the study include: routine use of cold chain indicators, increased vaccine turnover and storage of vaccines within an operational temperature range of 4 to 8 degrees C. Research is needed to investigate the efficacy of heat-stable vaccines when stored at ambient temperatures and in air-conditioned environments.

Climate↗
PubMed1999

A district survey of vaccine cold chain protection in general practitioners' surgeries.

Failure to ensure that vaccines are kept within a prescribed temperature range at all times can reduce their potency and cause primary vaccine failure. A postal survey of 103 general practices in a health district to assess vaccine handling and storage yielded 75 responses (73%). Poor practice was identified in receipt and storage of vaccines, temperature monitoring and control, management of vaccines during immunisation sessions, and disposal of partly used vaccines. The data suggest that the vaccine cold chain is not maintained with the degree of care necessary for safe practice. National guidelines need to be implemented conscientiously by all those involved with immunisation programmes if the effectiveness of vaccines is to be guaranteed.

Drug Storage↗
PubMed1992

Storage of vaccines in the community: weak link in the cold chain?

OBJECTIVE: To assess quality of storage of vaccines in the community. DESIGN: Questionnaire survey of general practices and child health clinics, and monitoring of storage temperatures of selected refrigerators. SETTING: Central Manchester and Bradford health districts. SUBJECTS: 45 general practices and five child health clinics, of which 40 (80%) responded. Eight practices were selected for refrigeration monitoring. MAIN OUTCOME MEASURES: Adherence to Department of Health guidelines for vaccine storage, temperature range to which vaccines were exposed over two weeks. RESULTS: Of the 40 respondents, only 16 were aware of the appropriate storage conditions for the vaccines; eight had minimum and maximum thermometers but only one of these was monitored daily. In six of the eight practices selected for monitoring of refrigeration temperatures the vaccines were exposed to either subzero temperatures (three fridges) or temperatures up to 16 degrees C (three). Two of these were specialised drug storage refrigerators with an incorporated thermostat and external temperature gauges. CONCLUSION: Vaccines were exposed to temperatures that may reduce their potency. Safe storage of vaccines in the clinics cannot be ensured without adhering to the recommended guidelines. Provision of adequate equipment and training for staff in maintaining the "cold chain" and the use and care of equipment are important components of a successful immunisation programme.

Child↗
PubMed2005

Maintaining the cold chain shipping environment for Phase I clinical trial distribution.

The study aimed to demonstrate satisfactory inter-UK transit of cold storage clinical trial material. The product environment had to be maintained between 0 and 8 degrees C throughout transit until delivery. Straightforward, low cost and simplified shipping arrangements were sought that would be appropriate for small-scale Phase I clinical trial activities. A laboratory test defined an optimal three frozen gel pack configuration to maintain refrigerated environmental conditions for dummy product packs in a single type and size of insulated shipper. The internal environment was temperature monitored at 30-min intervals in all tests. Twelve Glasgow to London transits were then studied over 2 years to include all seasonal temperature variations. A configuration using three frozen gel packs and 4 h pre-chill of the transit container maintained the internal environment at 0-8 degrees C for up to 48 h during autumn, winter and spring. A modified four frozen gel pack configuration was suitable for summer transit. Thus cold shipment verification was successfully carried out for a small-scale distribution operation. It was proven that refrigerated shipping conditions could be maintained using a straightforward and cost effective 'passive' type system consisting of frozen gel packs and insulated transit containers.

Clinical Trials, Phase I as Topic↗