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At least 19 recordsLinked to original sources
PubMed1997

Combination vaccines consisting of acellular pertussis vaccines.

Combination vaccines consisting of multiple vaccine antigens delivered in a single injection simplify vaccine administration. Combining multiple antigens into one injection, however, presupposes that the administration of multiple vaccines in combination will not reduce the safety and immunogenicity of the component vaccines. New generation vaccines seek to combine many more antigens from multiple, different pathogens, making them difficult to study in controlled, double blind, randomized clinical trials because of the number of study arms required for complete evaluation. Methods to simplify studies of combination vaccines include building on the framework of earlier studies to calculate sample size and reduce the number of control arms, standardizing serologic assays and assessment of adverse reactions and determining serologic correlates of protection to minimize the need for multiple efficacy studies and to facilitate evaluation of immunogenicity studies. Preliminary data indicate that immune responses to combination vaccines including diphtheria-tetanus-acellular pertussis, hepatitis B and inactivated poliovirus are comparable with those seen when the vaccines are administered separately. In contrast studies of combination vaccines that include Haemophilus influenzae type b Hib antigens show a diminished Hib antibody response, although the clinical relevance of this lowered antibody response has not yet been determined. Numerous small safety studies of combined vaccines have not found evidence of increased adverse reactions.

Clinical Trials as Topic↗
PubMed2005

Engineering the economic value of two pediatric combination vaccines.

Combination vaccines for pediatric immunization have become an effective means to reduce the number of separate injections required to immunize children according to the United States Recommended National Childhood Immunization Schedule. This paper reports the results of using operations research methodologies to analyze the price and value of two pentavalent combination vaccines for pediatric immunization: diphtheria-tetanus-acellular pertussis, hepatitis B, inactivated polio (DTPa-HBV-IPV) and diphtheria-tetanus-acellular pertussis, Haemophilus influenzae type B, inactivated polio (DTPa-HIB-IPV). These two combination vaccines are analyzed both individually and head-to-head, as a function of the cost of administering (or avoiding) an injection and the number of doses of the vaccine required to be in the lowest overall cost vaccine formulary. The main contribution of the paper is to provide a methodology for analyzing the impact of combination vaccines on pediatric vaccine formularies. This analysis shows that the DTPa-HBV-IPV vaccine may provide a good value at the current federally negotiated price of 32.75 dollars for a wide spectrum of health-care environments, though the actual number of injections that it reduces may be fewer than the optimistic numbers claimed by its manufacturer. The analysis also shows that if the DTPa-HIB-IPV vaccine is approved by the Food and Drug Administration (FDA), then under current market prices, it may need to be priced below the sum of its vaccine component prices to favorably compete with the DTPa-HBV-IPV vaccine.

Cost-Benefit Analysis↗
PubMed2001

Potency tests of combination vaccines.

Combination vaccines differ from single-component vaccines in composition and in how they are manufactured, which poses significant challenges to implementing effective quality-control tests, including measurement of potency. Because each combination vaccine is unique, existing guidelines often fail to provide sufficient information to overcome the inevitable problems encountered when developing and implementing potency tests. Success depends on careful consideration of scientific and regulatory issues. Significant problems may occur if potential interactions between different components in the vaccine are not taken into account during product and test development. Thorough analysis of critical assay parameters and attention to scientific and statistical justifications for the test increase the likelihood of its acceptance. Practical approaches based on experience include rational design of validation studies, complete evaluation and documentation of the potency tests under the conditions in which they are to be applied, and establishing the relationship between production lots of vaccine and lots used in clinical trials.

Antigens↗
PubMed1997

Systemic adverse reactions in young Simmental calves following administration of a combination vaccine.

Combination vaccines containing viral and bacterial antigens are commonly used in veterinary practice and have been associated with adverse reactions. A group of young Simmental calves developed fever and depression following administration of a mixed vaccine, and 1 died with pulmonary edema, suggesting that endotoxins or other bacterial components may interact synergistically with some adjuvants to cause an enhanced pathologic inflammatory response in some individuals.

Animals↗
PubMed1999

New acellular pertussis-containing paediatric combined vaccines.

Combined pediatric vaccines have the advantages of conferring protection against multiple common infectious diseases with a reduced number of injections. Their use should lead to better compliance to recommended vaccination schedules. Diphtheria (D), tetanus (T) and whole-cell pertussis vaccine (P) have been successfully combined, with or without inactivated poliovirus vaccine (IPV) in the same syringe for many years. Recently developed acellular pertussis (aP) Haemophilus influenzae type B (Hib), inactivated poliomyelitis virus and hepatitis B vaccines are ideal candidates for inclusion in current combined vaccines. Nevertheless, the development of new combinations has to face preclinical and clinical issues: the appropriate formulation of the new antigen(s) and other vaccine components needs to be determined to ensure compatibility and guard against potential additive or unexpected adverse reactions; potential immunological interference between antigens and the negative impact of other vaccine components on immunogenicity may occur, and these have to be examined also. Whole-cell pertussis vaccines are highly protective against whooping cough, but the severe adverse reactions that these vaccines sometimes produce have led to hesitation over their use, including the decision of some countries to stop pertussis immunization. To increase the acceptability of pertussis vaccination, Pasteur Mérieux Connaught has developed a combined D, T and a two-component acellular pertussis vaccine (DTaP), composed of purified pertussis toxoid (PT) and filamentous haemagglutinin (FHA), which has been shown to be effective in an efficacy trial conducted in Senegal. Acellular DTaP vaccines are immunogenic and have a better safety profile than DTP vaccines, when given either for the primary series, for the booster vaccination or for both. In order to meet worldwide demands, the combined DTaP-IPV or DTP-IPV has been developed for countries where IPV is recommended. Following the encouragement of the WHO, an H. influenzae type B tetanus-conjugated (Act-HIB) vaccine, has been combined in a full liquid formulation with the whole-cell DTP. This vaccine showed a good safety and immunogenicity profile in infants and in toddlers. A combined DTaP-IPV-PRP-T vaccine (where the Act-HIB vaccine is reconstituted by the full-liquid DTaP-IPV) also has been successfully developed both for the primary series and for booster vaccination; although, a reduced immunogenicity against PRP observed after the primary series, this did not affect vaccine priming. Hepatitis B immunization campaigns targeting high-risk groups have failed to control the disease in areas of low endemicity. In 1992, the WHO recommended that hepatitis B vaccination should be integrated into the EPI in all countries by 1997-1999. For that purpose, hepatitis B vaccine is currently evaluated in pediatric combined vaccines. Developing new combination vaccines is a difficult but essential process for maintaining high immunization rates worldwide against infectious diseases, provided that the costs are acceptable. New combined vaccines including pneumococcal and meningococcal component are under wide-scale development.

Hepatitis B Vaccines↗
PubMed1988

Interference between strains in live virus vaccines. II: Combined vaccination with varicella and measles-mumps-rubella vaccine.

A combined vaccine against varicella and measles-mumps-rubella made by mixing two commercially available products (Varilrix and Pluserix SK-RIT) has proved to be only partially successful in early trials. Although the seroconversion rates with the MMR components were comparable with those usually achieved, the varicella take was depressed to 77%. A new low dose measles-mumps-rubella vaccine was prepared in which the measles virus content was reduced to 1/5 and the mumps virus content to 1/8. Commercial varicella vaccine was added to the low dose MMR vaccine. The seroconversion rates for measles was 98.2%, for mumps 100%, for rubella 99.4% and for varicella 98%. This product seemed to be well balanced in respect of a possible interference between the four different virus vaccine strains.

Antibodies, Viral↗
PubMed1996

Analysis of Haemophilus influenzae type B conjugate and diphtheria-tetanus-pertussis combination vaccines.

Combined vaccines consisting of diphtheria (D), tetanus (T), whole cell pertussis (Pw), and Haemophilus influenzae type b (Hib) conjugates are safe and immunogenic; however, there has been a tendency toward lower antibody responses in persons receiving mixtures of DTPw and Hib vaccines. Possible explanations are physical or chemical incompatibilities or immunologic interference. Mixtures of DT-acellular pertussis (Pa) and Hib conjugates have been evaluated as booster vaccinations in children, and preliminary data indicate good safety and acceptable immunogenicity. A study evaluating the combined administration of DTPa, Hib conjugate, and inactivated polio vaccine in infants is ongoing in Finland. Preliminary data suggest that the combination is safe. When the first serum samples were assayed, no major differences in pertussis, diphtheria, and tetanus antibodies were found among children given the vaccines mixed or separately. Hib and polio antibody results are not yet available.

Bacterial Capsules↗
PubMed2001

Clinical relevance of lower Hib response in DTPa-based combination vaccines.

Combination vaccines are essential to enable administration of all the required antigens in routine infant immunisation schedules at any single visit. Some combinations of diphtheria-tetanus-acellular pertussis (DTPa) with Haemophilus influenzae type b (Hib) conjugate vaccines have been shown to result in lower Hib titres than when Hib is administered separately. While confirming that a primary series with a DTPa-HBV-IPV/Hib combination gives lower antibody levels than separate Hib conjugates, we show that the nature (isotype and IgG subclasses) and function (avidity and opsonic activity) of the antibodies are the same, and immunologic memory is induced. It is likely therefore that the DTPa-HBV-IPV/Hib combination will be efficacious against Hib disease.

Antibodies, Bacterial↗
PubMed2002

Safety and immunogenicity of TETRActHIB (a vaccine combining DTP vaccine and Haemophilus influenzae type B conjugate vaccine) administered to infants at 6, 10 and 14 weeks of age.

The safety and immunogenicity of TETRActHIB (a vaccine combining diphtheria and tetanus toxoids-pertussis vaccine (DTP) with Haemophilus influenzae type b (Hib) conjugate vaccine (polyribosyl ribitol phosphate conjugated to tetanus protein) (PRP-T)) was assessed in 131 Cape Town infants immunized at 6, 10 and 14 weeks of age. Serological responses to all component antigens were measured before the first dose and at 18 weeks of age. In addition, anti-PRP antibodies were measured at 9 and 18 months of age to determine long-term immunogenicity. The vaccine was well tolerated by infants and no significant side-effects were reported. Responses to Hib at 18 weeks of age were good in that most infants achieved a level of anti-PRP antibodies > or = 0.15 microgram/ml, indicative of short-term protection, and 70% achieved a level > or = 1 microgram/ml, indicative of long-term protection. The proportions of children with protective levels > or = 0.15 microgram/ml and > or = 1 microgram/ml were similar at 9 and 18 months of age, i.e. approximately 75% and 45%, respectively. Responses to tetanus and diphtheria toxoids were excellent and all infants achieved protective serological levels. Responses to pertussis were moderate in that approximately 65% achieved 'protective' serum levels of pertussis agglutinins, i.e. titres > or = 320. In conclusion, this study has shown that the DTP/PRP-T vaccine is safe, immunogenic and well tolerated in infants immunised at 6, 10 and 14 weeks of age. TETRActHIB is therefore suitable for inclusion in the World Health Organisation Expanded Programme on Immunisation (WHO EPI) schedule.

Age Factors↗
PubMed2003

Considerations for implementing a new combination vaccine into managed care.

BACKGROUND: The control and elimination of several deadly childhood diseases are a result of extensive vaccination efforts made by pediatricians, family practitioners, public health providers, and health outreach systems. Managed care can assist this effort through facilitating the delivery of affordable quality healthcare to patients. OBJECTIVE: To describe the considerations made by managed care when implementing a new vaccine into practice. RESULTS: Managed care plans often assess the medical necessity, consumer acceptance, and pharmacoeconomic benefits of a vaccine when considering whether it can be implemented into practice. DTaP-HepB-IPV (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B [Recombinant] and Inactivated Poliovirus Vaccine [Combined]), a new combination vaccine, has demonstrated similar immunogenicity and safety when compared with separately administered component vaccines. Use of this combination vaccine will help to simplify the current immunization schedule, and therefore decrease the number of injections infants receive in the first year of life, favorably influencing consumer perception of this new vaccine. A reduction in the number of office visits as a result of fewer injections and improved vaccine compliance may result in a positive pharmacoeconomic impact on parents, physicians, and payers. Reduced administration fees, fewer needed syringes, and decreased risk of needlestick injury resulting from the use of combination vaccines all may have a positive impact on acceptance of these vaccines by managed care organizations. CONCLUSION: DTaP-HepB-IPV is expected to meet the tests of medical appropriateness, consumer acceptance, and pharmacoeconomic reasonableness, thereby fulfilling the value proposition of a new combination vaccine for managed healthcare plans.

Diphtheria-Tetanus-acellular Pertussis Vaccines↗
PubMed1994

Combined vaccines--the European contribution.

Efforts to develop new vaccine combining as many immunogens as possible have stimulated researchers of most European vaccine manufacturers to contribute with new vaccine designs. Besides the conventional combinations the following approaches are under development: new carrier systems for inactivated antigens; new adjuvants for subunit antigens; live attenuated combined vaccines; vector combined vaccines; synthetic polypeptide combined vaccines. The availability of new combined vaccines will greatly facilitate immunization programmes for the control of many diseases around the world. The whole of modern society in general is moving towards prevention--for example on safety issues--as well as in medicine, where prophylactic approaches are medically, scientifically, ethically, and mortally more justifiable as well as being more cost-effective. Besides improving the health and overall quality of life of the world's population, the use of combined vaccines will further reduce already overstretched health care budgets.

Adjuvants, Immunologic↗
PubMed2000

Hepatitis A and hepatitis B vaccinations: immunogenicity of combined vaccine and of simultaneously or separately applied single vaccines.

The vaccination success and side effects of hepatitis A and hepatitis B immunisation of health care employees when using a combined vaccine were compared to those observed with simultaneous or single immunisations. The immunological response of two groups of healthy participants (75 each) receiving either single HAV or HBV vaccination was compared with that of two groups (75 each) vaccinated either simultaneously with both vaccines or with the combined vaccine. There were no non or low responders with respect to hepatitis A vaccination. Only one participant failed to build up an anti-HBs titer after combined vaccination. The good tolerance of separate, simultaneous and combined vaccinations was confirmed. Both combined and simultaneous vaccination led to significantly higher anti-HAV titers than single immunisation, while markedly but not significantly higher anti-HBs titers were found only with simultaneous vaccination. Considering the additional advantage of the higher acceptance of only one injection with the combined vaccine, this vaccination should be recommended for employees at risk for both hepatitis A and hepatitis B.

Adolescent↗