Testing and Licensure of Combination Vaccines for the Prevention of Infectious Diseases

Falk, Lydia A.; Midthun, Karen; McVittie, Loris D.; Goldenthal, Karen L.

doi:10.1007/978-1-59259-265-4_11

Cited by 5 publications

(13 citation statements)

References 19 publications

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“…For example, potency tests may represent a serological evaluation or challenge test after vaccination of animals or may rely on physiochemical characterization, such as composition and molecular weight (e.g., certain polysaccharide vaccines). Identity testing on the labeled final container may include immunological assays for vaccine antigens and serotyping of vaccine organism strains [6]. In addition, results of tests for product sterility and the absence of toxicity from extraneous contaminants (i.e., General Safety Test) should be provided.…”

Section: Products and Manufacturingmentioning

confidence: 99%

“…Clinical studies to evaluate the safety, immunogenicity, and (clinical end point) efficacy of combination vaccines should be randomized and well controlled, in most cases [6,7,[33][34][35].…”

Section: Clinical Evaluationmentioning

confidence: 99%

“…One of the more problematic recent examples has been the decreased response to Haemophilus influenzae type b (Hib) conjugate vaccines in some diphtheria and tetanus toxoids and acellular pertussis (DTaP) and Hib combination vaccines [8][9][10][11][12]. Such problems highlight the need for safety, immunogenicity, and (if applicable) clinical end point efficacy, as well as for relevant animal and laboratory studies, even if the component vaccines are licensed [3,6,7].…”

mentioning

confidence: 99%

“…The mixing can occur as a manufacturing step or be performed by a health care professional following package insert instructions [3,6,7]. However, there have been a number of important examples where unexpected decreases in immune responses have been observed when antigens are combined [8][9][10][11][12][13][14][15][16][17][18].…”

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confidence: 99%

“…There is considerable public health interest in developing and licensing safe and effective combination vaccines [1][2][3][4][5][6]. Because of the increasing importance of combination vaccines, the US Food and Drug Administration (FDA) has cosponsored 2 workshops and prepared a guidance document for industry on this topic.…”

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Prelicensure Evaluation of Combination Vaccines

et al. 2001

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There is considerable public health interest in licensing safe and effective combination vaccines. Because combination vaccines may progress rapidly from phase 1 to a pivotal phase 2 immunogenicity trial, a rigorous approach to address product issues early in development is warranted. Clinical studies to evaluate the safety, immunogenicity, and (when necessary) clinical end point efficacy of combination vaccines should be randomized and well controlled in most cases. A large phase 3 safety study (i.e., a study that enrolls thousands of vaccinees) should be included in the development plan if a phase 3 (clinical end point) efficacy trial will not be conducted. Often, the new combination vaccine under development contains immunogens that have all been previously licensed, have demonstrated efficacy in earlier clinical trials, or both. For such products, comparative immunogenicity data may be sufficient to support efficacy. When applicable, clinical data to support simultaneous administration with other relevant vaccines should be obtained. Given the complexity of combination vaccine development, early consultation with United States Food and Drug Administration can be invaluable.

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Section: Products and Manufacturingmentioning

confidence: 99%

Section: Clinical Evaluationmentioning

confidence: 99%

mentioning

confidence: 99%

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confidence: 99%

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confidence: 99%

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Prelicensure Evaluation of Combination Vaccines

et al. 2001

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Analysis of Studies to Evaluate Immune Response to Combination Vaccines

Horne¹,

Lachenbruch

Getson³

et al. 2001

CLIN INFECT DIS

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The development and evaluation of new combination vaccines is an important public health endeavor. Trials to evaluate these vaccines are customarily designed and analyzed as noninferiority studies. We explain the concept of noninferiority and highlight important issues that can be challenging in the statistical evaluation of these vaccines. Topics covered include end points, hypotheses, and analyses for comparing geometric mean concentrations (or titers) of antibody and proportion of vaccine recipients responding; covariate adjustment; the problem of multiplicity and its impact on sample size; and choice of a meaningful difference to rule out.

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Evaluating the Safety of Combination Vaccines

Ellenberg

2001

CLIN INFECT DIS

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The development of combination vaccines is important to facilitate protection of people from potentially life-threatening infectious diseases. As with all vaccines, the safety of these products is of critical importance. Although combination vaccines generally include components that have been studied and used previously, the possibility of new or more severe reactions arising from combining components cannot be dismissed. Controlled safety studies are needed for new combination vaccines to determine reliably whether risks are increased compared with administration of individual components. Such studies will generally be smaller than studies of vaccines with new immunogens, but the size of the study will depend on the types and rates of the reactions expected, given the vaccine's components, and on the level of increased risk that would be important to detect.

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Testing and Licensure of Combination Vaccines for the Prevention of Infectious Diseases

Cited by 5 publications

References 19 publications

Prelicensure Evaluation of Combination Vaccines

Prelicensure Evaluation of Combination Vaccines

Analysis of Studies to Evaluate Immune Response to Combination Vaccines

Evaluating the Safety of Combination Vaccines

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