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March 1990, Vol 144, No. 3 >
Article | March 1990

Protective Efficacy of Haemophilus influenzae Type b Polysaccharide-Diphtheria Toxoid-Conjugate Vaccine FREE

Wendy L. Nelson, RN, MPH; Dan M. Granoff, MD
[+] Author Affiliations

Accepted for publication September 11, 1989.

Presented in part at the Food and Drug Administration Vaccines and Related Biological Products Advisory Committee meeting. Washington, DC, January 30, 1989.

The opinions expressed in this article represent those of the authors and not necessarily those of the FDA.

Reprint requests to Washington University School of Medicine, 400 S Kingshighway Blvd, St Louis, MO 63110 (Dr Granoff).


Am J Dis Child. 1990;144(3):292-295. doi:10.1001/archpedi.1990.02150270042023.
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• We estimated the relative protective efficacy of Haemophilus influenzae type b polysaccharide (PRP) vaccine and PRP-diphtheria toxoid-conjugate (PRP-D) vaccine using data from reports of cases of invasive Haemophilus disease occurring in vaccinated children submitted to the Food and Drug Administration, Rockville, Md, and Washington University, St Louis, Mo. During the first 13 months following licensure of each of the vaccines, there were 127 cases reported in recipients of PRP vaccine vs 17 cases in recipients of PRP-D vaccine. The total number of reported cases for each vaccine is not necessarily comparable, since the extent of vaccine use in the population and the extent of reporting of cases may have been different during the two periods. However, the proportion of reported cases occurring equal to or 14 days or more after vaccination (a period considered sufficient to develop immunity) was significantly greater for PRP vaccine (106 [83%] of 127 cases) compared with PRP-D vaccine (7 [41%] of 17 cases). Based on the ratio of late-onset to early-onset cases observed for PRP vaccine, we would have expected 50 late-onset cases after PRP-D vaccination. Since only 7 late-onset PRP-D vaccine failures were reported (86% fewer than expected), the data suggest that PRP-D vaccine was more effective in preventing disease 14 days or more after vaccination than was PRP vaccine.

(AJDC. 1990;144:292-295)

REFERENCES

1 +
Immunization Practices Advisory Committee.  Update: prevention of Haemophilus influenzae type b disease . MMWR . 1988;;37:13-16.
2 +
American Academy of Pediatrics Committee on Infectious Diseases.  Haemophilus influenzae type b conjugate vaccine . Pediatrics . 1988;;81:908-910.
3 +
Weinberg GA, Granoff DM.  Polysaccharide-protein conjugate vaccines for the prevention of Haemophilus influenzae type b disease . J Pediatr . 1988;;113:621-631.
4 +
Granoff DM, Osterholm MT.  Safety and efficacy of Haemophilus influenzae type b polysaccharide vaccine . Pediatrics . 1987;;80:590-592.
5 +
Ward JI, Broome CV, Harrison LH, Shinefield H, Black S.  Haemophilus influenzae type b vaccines: lessons for the future . Pediatrics . 1988;;81:886-893.
6 +
Daum RS, Marcuse EK, Giebink GS, et al.  Haemophilus influenzae type b vaccines: lessons from the past . Pediatrics . 1988;;81:893-897.
7 +
Osterholm MT, Rambeck JH, White KE, et al.  Lack of efficacy of Haemophilus b polysaccharide vaccine in Minnesota . JAMA . 1988;;260:1423-1428.
8 +
Harrison LH, Broome CV, Hightower AW, et al.  A day care-based study of the efficacy of Haemophilus b polysaccharide vaccine . JAMA . 1988;; 260:1413-1418.
9 +
Black SB, Shinefield HR, Hiatt RA, Fireman BH.  Efficacy of Haemophilus influenzae type b capsular polysaccharide vaccine . Pediatr Infect Dis J . 1988;;7:149-156.
10 +
Shapiro ED, Murphy TV, Wald ER, Brady CA.  The protective efficacy of Haemophilus b polysaccharide vaccine . JAMA . 1988;;260:1419-1422.
11 +
Murphy TV, Osterholm MT, Pierson LM, et al.  Prospective surveillance of Haemophilus influenzae type b disease in Dallas County, Texas, and in Minnesota . Pediatrics . 1987;;79:173-180.
12 +
Eskola J, Peltola H, Takala AK, et al.  Efficacy of Haemophilus influenzae type b polysaccharide-diphtheria toxoid conjugate vaccine in infancy . N Engl J Med . 1987;;317:717-722.
13 +
Ward JI, Brenneman G, Letson G, Hayward W, Alaska Vaccine Efficacy Trial Study Group. Limited protective efficacy of an H influenzae type b conjugate vaccine (PRP-D) in Native Alaskan infants immunized at 2, 4 and 6 mo of age. In: Program and abstracts of the 28th Interscience Conference on Antimicrobial Agents and Chemotherapy; October 23-26, 1988; Los Angeles, Calif. Abstract 1127.
14 +
Orenstein WA, Bernier RH, Hinman AR.  Assessing vaccine efficacy in the field . Epidemiol Rev . 1988;;10:212-241.
15 +
Orenstein WA, Bernier RH, Dondero TJ, et al.  Field evaluation of vaccine efficacy . Bull WHO . 1985;;63:1055-1068.
16 +
Clemens JD, Shapiro ED.  Resolving the pneumococcal vaccine controversy: are there alternatives to randomized clinical trials . Rev Infect Dis . 1984;;6:589-600.
17 +
Daum, RS, Sood SK, Osterholm MT, et al.  Decline in serum antibody to the capsule of Haemophilus influenzae type b in the immediate postimmunization period . J Pediatr . 1989;;114:742-747.
18 +
Anderson P, Johnston RB Jr, Smith DH.  Human serum activities against Haemophilus influenzae type b . J Clin Invest . 1972;;51:31-38.
19 +
Band J, Binkin N.  Epidemic of meningococcal meningitis in Bamako, Mali: epidemiological features and analysis of vaccine efficacy . Lancet . 1982;;2:315-317.
20 +
Smit P, Oberholzer D, Hayden-Smith S, et al.  Protective efficacy of pneumococcal polysaccharide vaccines . JAMA . 1977;;238:2613-2616.
21 +
Gotschlich EC, Goldschneider I, Artenstein MS.  Human immunity to the meningococcus: immunogenicity of group A and group C meningococcal polysaccharides in human volunteers . J Exp Med . 1969;;129:1367-1384.
22 +
Marchant CD, Band E, Froeschle JE, McVerry PH.  Depression of anticapsular antibody after immunization with Haemophilus influenzae type b polysaccharide-diphtheria conjugate vaccine . Pediatr Infect Dis J . 1989;;8:508-511.
23 +
Faich GA.  Adverse drug reaction monitoring . N Engl J Med . 1986;;314:1589-1592.
24 +
Turner WM, Milstein JB, Faich GA, Armstrong GD.  The processing of adverse reaction reports at FDA . Drug Inform J . 1986;;20:147-150.
25 +
Granoff DM, Shackelford PG, Suarez BK, et al.  Haemophilus influenzae type b disease in children vaccinated with type b polysaccharide vaccine . N Engl J Med . 1986;;315:1584-1590.
26 +
Granoff DM, Sheetz KE, Nahm MH, et al.  Further immunologic evaluation of children who develop Haemophilus disease despite previous vaccination with type b polysaccharide vaccine . Monogr Allergy . 1988;;23:256-268.
27 +
Greenberg DP, Vadheim CM, Marcy SM, Ward JI.  Safety of H influenzae type b conjugate vaccine (PRP-D) in 15 713 children 18-60 months of age . Pediatr Res . 1989;;26:179. Abstract.
28 +
Spinola SM, Sheaffer CI, Philbrick KB, Gilligan PH.  Antigenuria after Haemophilus influenzae type b polysaccharide immunization: a prospective study . J Pediatr . 1986;;109:835-838.
29 +
Snedecor GW. Cochran WG. Statistical Methods . 7th ed. Ames, Iowa: Iowa State University Press; 1980;:124.
30 +
Sood SK, Schreiber JR, Siber GR, Daum RS.  Post-vaccination susceptibility to invasive Haemophilus influenzae type b disease in infant rats . J Pediatr . 1988;;113:814-819.
31 +
Rossi AC, Bosco J, Faich GA, et al.  The importance of adverse reaction reporting by physicians . JAMA . 1988;;259:1203-1204.
32 +
Weber JCP.  Epidemiology of adverse reactions to nonsteroidal anti-inflammatory drugs . In: Rainsford KD , Velo GP, eds. Advances in Inflammation Research, VI. New York, NY: Raven Press; 1984;.

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Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

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References

1 +
Immunization Practices Advisory Committee.  Update: prevention of Haemophilus influenzae type b disease . MMWR . 1988;;37:13-16.
2 +
American Academy of Pediatrics Committee on Infectious Diseases.  Haemophilus influenzae type b conjugate vaccine . Pediatrics . 1988;;81:908-910.
3 +
Weinberg GA, Granoff DM.  Polysaccharide-protein conjugate vaccines for the prevention of Haemophilus influenzae type b disease . J Pediatr . 1988;;113:621-631.
4 +
Granoff DM, Osterholm MT.  Safety and efficacy of Haemophilus influenzae type b polysaccharide vaccine . Pediatrics . 1987;;80:590-592.
5 +
Ward JI, Broome CV, Harrison LH, Shinefield H, Black S.  Haemophilus influenzae type b vaccines: lessons for the future . Pediatrics . 1988;;81:886-893.
6 +
Daum RS, Marcuse EK, Giebink GS, et al.  Haemophilus influenzae type b vaccines: lessons from the past . Pediatrics . 1988;;81:893-897.
7 +
Osterholm MT, Rambeck JH, White KE, et al.  Lack of efficacy of Haemophilus b polysaccharide vaccine in Minnesota . JAMA . 1988;;260:1423-1428.
8 +
Harrison LH, Broome CV, Hightower AW, et al.  A day care-based study of the efficacy of Haemophilus b polysaccharide vaccine . JAMA . 1988;; 260:1413-1418.
9 +
Black SB, Shinefield HR, Hiatt RA, Fireman BH.  Efficacy of Haemophilus influenzae type b capsular polysaccharide vaccine . Pediatr Infect Dis J . 1988;;7:149-156.
10 +
Shapiro ED, Murphy TV, Wald ER, Brady CA.  The protective efficacy of Haemophilus b polysaccharide vaccine . JAMA . 1988;;260:1419-1422.
11 +
Murphy TV, Osterholm MT, Pierson LM, et al.  Prospective surveillance of Haemophilus influenzae type b disease in Dallas County, Texas, and in Minnesota . Pediatrics . 1987;;79:173-180.
12 +
Eskola J, Peltola H, Takala AK, et al.  Efficacy of Haemophilus influenzae type b polysaccharide-diphtheria toxoid conjugate vaccine in infancy . N Engl J Med . 1987;;317:717-722.
13 +
Ward JI, Brenneman G, Letson G, Hayward W, Alaska Vaccine Efficacy Trial Study Group. Limited protective efficacy of an H influenzae type b conjugate vaccine (PRP-D) in Native Alaskan infants immunized at 2, 4 and 6 mo of age. In: Program and abstracts of the 28th Interscience Conference on Antimicrobial Agents and Chemotherapy; October 23-26, 1988; Los Angeles, Calif. Abstract 1127.
14 +
Orenstein WA, Bernier RH, Hinman AR.  Assessing vaccine efficacy in the field . Epidemiol Rev . 1988;;10:212-241.
15 +
Orenstein WA, Bernier RH, Dondero TJ, et al.  Field evaluation of vaccine efficacy . Bull WHO . 1985;;63:1055-1068.
16 +
Clemens JD, Shapiro ED.  Resolving the pneumococcal vaccine controversy: are there alternatives to randomized clinical trials . Rev Infect Dis . 1984;;6:589-600.
17 +
Daum, RS, Sood SK, Osterholm MT, et al.  Decline in serum antibody to the capsule of Haemophilus influenzae type b in the immediate postimmunization period . J Pediatr . 1989;;114:742-747.
18 +
Anderson P, Johnston RB Jr, Smith DH.  Human serum activities against Haemophilus influenzae type b . J Clin Invest . 1972;;51:31-38.
19 +
Band J, Binkin N.  Epidemic of meningococcal meningitis in Bamako, Mali: epidemiological features and analysis of vaccine efficacy . Lancet . 1982;;2:315-317.
20 +
Smit P, Oberholzer D, Hayden-Smith S, et al.  Protective efficacy of pneumococcal polysaccharide vaccines . JAMA . 1977;;238:2613-2616.
21 +
Gotschlich EC, Goldschneider I, Artenstein MS.  Human immunity to the meningococcus: immunogenicity of group A and group C meningococcal polysaccharides in human volunteers . J Exp Med . 1969;;129:1367-1384.
22 +
Marchant CD, Band E, Froeschle JE, McVerry PH.  Depression of anticapsular antibody after immunization with Haemophilus influenzae type b polysaccharide-diphtheria conjugate vaccine . Pediatr Infect Dis J . 1989;;8:508-511.
23 +
Faich GA.  Adverse drug reaction monitoring . N Engl J Med . 1986;;314:1589-1592.
24 +
Turner WM, Milstein JB, Faich GA, Armstrong GD.  The processing of adverse reaction reports at FDA . Drug Inform J . 1986;;20:147-150.
25 +
Granoff DM, Shackelford PG, Suarez BK, et al.  Haemophilus influenzae type b disease in children vaccinated with type b polysaccharide vaccine . N Engl J Med . 1986;;315:1584-1590.
26 +
Granoff DM, Sheetz KE, Nahm MH, et al.  Further immunologic evaluation of children who develop Haemophilus disease despite previous vaccination with type b polysaccharide vaccine . Monogr Allergy . 1988;;23:256-268.
27 +
Greenberg DP, Vadheim CM, Marcy SM, Ward JI.  Safety of H influenzae type b conjugate vaccine (PRP-D) in 15 713 children 18-60 months of age . Pediatr Res . 1989;;26:179. Abstract.
28 +
Spinola SM, Sheaffer CI, Philbrick KB, Gilligan PH.  Antigenuria after Haemophilus influenzae type b polysaccharide immunization: a prospective study . J Pediatr . 1986;;109:835-838.
29 +
Snedecor GW. Cochran WG. Statistical Methods . 7th ed. Ames, Iowa: Iowa State University Press; 1980;:124.
30 +
Sood SK, Schreiber JR, Siber GR, Daum RS.  Post-vaccination susceptibility to invasive Haemophilus influenzae type b disease in infant rats . J Pediatr . 1988;;113:814-819.
31 +
Rossi AC, Bosco J, Faich GA, et al.  The importance of adverse reaction reporting by physicians . JAMA . 1988;;259:1203-1204.
32 +
Weber JCP.  Epidemiology of adverse reactions to nonsteroidal anti-inflammatory drugs . In: Rainsford KD , Velo GP, eds. Advances in Inflammation Research, VI. New York, NY: Raven Press; 1984;.

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