0
March 2, 1994, Vol 271, No. 9 >
ARTICLE | March 2, 1994

Efficacy of BCG Vaccine in the Prevention of Tuberculosis: Title and subTitle BreakMeta-analysis of the Published Literature FREE

Graham A. Colditz, MD, DrPH; Timothy F. Brewer, MD, MPH; Catherine S. Berkey, DSc, MA; Mary E. Wilson, MD; Elisabeth Burdick, MSc; Harvey V. Fineberg, MD, PhD; Frederick Mosteller, PhD
[+] Author Affiliations

Reprint requests to the Technology Assessment Group, Harvard School of Public Health, 677 Huntington Ave, Boston, MA 02115 (Dr Colditz).


JAMA. 1994;271(9):698-702. doi:10.1001/jama.1994.03510330076038
Text Size: A A A
Published online
Article
References

Objective.  —To quantify the efficacy of BCG vaccine against tuberculosis (TB).

Data Sources.  —MEDLINE with index terms BCG vaccine, tuberculosis, and human. Experts from the Centers for Disease Control and Prevention and the World Health Organization, among others, provided lists of all known studies.

Study Selection.  —A total of 1264 articles or abstracts were reviewed for details on BCG vaccination, concurrent vaccinated and unvaccinated groups, and TB outcome; 70 articles were reviewed in depth for method of vaccine allocation used to create comparable groups, equal surveillance and follow-up for recipient and concurrent control groups, and outcome measures of TB cases and/or deaths. Fourteen prospective trials and 12 case-control studies were included in the analysis.

Data Extraction.  —We recorded study design, age range of study population, number of patients enrolled, efficacy of vaccine, and items to assess the potential for bias in study design and diagnosis. At least two readers independently extracted data and evaluated validity.

Data Synthesis.  —The relative risk (RR) or odds ratio (OR) of TB provided the measure of vaccine efficacy that we analyzed. The protective effect was then computed by 1 —RR or 1 —OR. A random-effects model estimated a weighted average RR or OR from those provided by the trials or case-control studies. In the trials, the RR of TB was 0.49 (95% confidence interval [Cl], 0.34 to 0.70) for vaccine recipients compared with nonrecipients (protective effect of 51%). In the case-control studies, the OR for TB was 0.50 (95% CI, 0.39 to 0.64), or a 50% protective effect. Seven trials reporting tuberculous deaths showed a protective effect from BCG vaccine of 71% (RR, 0.29; 95% Cl, 0.16 to 0.53), and five studies reporting on meningitis showed a protective effect from BCG vaccine of 64% (OR, 0.36; 95% Cl, 0.18 to 0.70). Geographic latitude of the study site and study validity score explained 66% of the heterogeneity among trials in a random-effects regression model.

Conclusion.  —On average, BCG vaccine significantly reduces the risk of TB by 50%. Protection is observed across many populations, study designs, and forms of TB. Age at vaccination did not enhance predictiveness of BCG efficacy. Protection against tuberculous death, meningitis, and disseminated disease is higher than for total TB cases, although this result may reflect reduced error in disease classification rather than greater BCG efficacy.(JAMA. 1994;271:698-702)

REFERENCES

1 +
Rieder HL, Cauthen GM, Comstock GW, Snider DE.  Epidemiology of tuberculosis in the United States. Epidemiol Rev . 1989;;11:79-98.
2 +
Centers for Disease Control and Prevention.  Tuberculosis mortality—United States, 1992. MMWR Morb Mortal Wkly Rep . 1992;;42:696-697,703-704.
3 +
Centers for Disease Control and Prevention.  Prevention and control of tuberculosis in US communities with at-risk minority populations. MMWR Morb Mortal Wkly Rep . 1992;;41( (RR-5) ):1-11.
4 +
Hamburg MA.  The challenge of controlling tuberculosis in New York City. N Y State J Med . 1992;;92:291-293.
5 +
Frieden TR, Sterling T, Pablos-Mendez A, Kilburn JD, Cauthen GM, Dooley SM.  The emergence of drug-resistant tuberculosis in New York City. N Engl J Med . 1993;;328:521-526.
6 +
Centers for Disease Control.  Nosocomial transmission of multidrug-resistant tuberculosis among HIV-infected persons—Florida and New York, 1988-1991. MMWR Morb Mortal Wkly Rep . 1991;; 40:585-591.
7 +
Edlin BR, Tokars JI, Grieco MH, et al.  An outbreak of multidrug resistant tuberculosis among hospitalized patients with the acquired immunodeficiency syndrome. N Engl J Med . 1992;;326:1514-1521.
8 +
Fischl MA, Uttamchandani RB, Daikos GL, et al.  An outbreak of tuberculosis caused by multiple-drug-resistant tubercle bacilli among patients with HIV infection. Ann Intern Med . 1992;;117:177-183.
9 +
Pearson, ML, Jereb JA, Frieden TR, et al.  Nosocomial transmission of multidrug-resistant mycobacterium tuberculosis. Ann Intern Med . 1992;;117: 191-196.
10 +
Centers for Disease Control and Prevention.  National action plan to combat multidrug-resistant tuberculosis. MMWR Morb Mortal Wkly Rep . 1992;; 41:5-8.
11 +
Centers for Disease Control.  Use of BCG vaccines in the control of tuberculosis: a joint statement by the ACIP and the Advisory Committee for Elimination of Tuberculosis. MMWR Morb Mortal Wkly Rep . 1988;;37:663-664,669-675.
12 +
 BCG: bad news from India. Lancet . 1980;;1:73-74. Editorial.
13 +
 BCG vaccination after the Madras study. Lancet . 1981;;1309-1310. Editorial.
14 +
Smith PG.  Case-control studies of the efficacy of BCG against tuberculosis.  In: International Union Against Tuberculosis, ed. Proceedings of the 26th IUAT World Conference on Tuberculosis and Respiratory Diseases . Singapore, Japan: Professional Postgraduate Services International; 1987;:73-79.
15 +
Tuberculosis Prevention Trial, Madras.  Trial of BCG vaccines in south India for tuberculosis prevention. Indian J Med Res . 1980;;72( (suppl) ):1-74.
16 +
ten Dam HG.  Research on BCG vaccination. Adv Tuberc Res . 1984;;21:79-106.
17 +
von Reyn CF, Clements CJ, Mann JM.  Human immunodeficiency virus infection and routine childhood immunization. Lancet . 1987;;2:669-672.
18 +
ten Dam HG, Toman K, Hitze KL, Guld J.  Present knowledge of immunization against tuberculosis. Bull World Health Organ . 1976;;54:255-269.
19 +
Comstock GW.  Identification of an effective vaccine against tuberculosis. Am Rev Respir Dis . 1988;;138:479-480.
20 +
Fine PEM, Rodrigues LC.  Modern vaccines: mycobacterial diseases. Lancet . 1990;;335:1016-1020.
21 +
L'Abbe HA, Detsky AS, O'Rourke K.  Meta-analysis in clinical research. Ann Intern Med . 1987;; 107:224-233.
22 +
Sacks HS, Berrier J, Reitman D, Ancona-Berk VA, Chalmers TC.  Meta-analysis of randomized controlled trials. N Engl J Med . 1987;;316:450-455.
23 +
Aronson JD.  Protective vaccination against tuberculosis with special reference to BCG vaccination. Am Rev Tuberc . 1948;;58:255-281.
24 +
Heimbeck J.  Tuberculosis in hospital nurses. Tubercle . 1936;;18:97-99.
25 +
Rosenthal SR, Leppman M.  Tuberculosis control: BCG vaccination in a tuberculosis control program in infants, children and adults. Trans Natl Tuberc Assoc . 1953;;161-168.
26 +
Rosenthal SR.  Standardization and efficacy of BCG vaccination against tuberculosis. JAMA . 1955;; 157:801-807.
27 +
Ferguson RG.  BCG vaccination in hospitals and sanatoria of Saskatchewan. Am Rev Tuberc . 1946;; 54:325-339.
28 +
Rosenthal SR.  The use of BCG vaccination among medical and nursing students. Hospitals . 1943;;17:75-78.
29 +
Houghton HGH, Horne NW.  BCG vaccination of nurses and students in Edinburgh. Lancet . 1950;; 2:533-536.
30 +
DeFriez Al, Badger TL.  Tuberculosis in BCG-vaccinated nurses. N Engl J Med . 1957;;257:161-165.
31 +
Dickie HA.  Tuberculosis in student nurses and medical students at the University of Wisconsin. Ann Intern Med . 1950;;33:941-959.
32 +
Burrill D, Enarson DA, Allen EA, Grzyboski S.  Tuberculosis in female nurses in British Columbia: implications for control programs. Can Med Assoc J . 1985;;132:137-140.
33 +
Geiseler PJ, Nelson HE, Crispen RG, Moses VK.  Tuberculosis in physicians: a continuing problem. Am Rev Respir Dis . 1986;;133:773-778.
34 +
National Research Council. Combining Information: Statistical Issues and Opportunities for Research . Washington, DC: National Academy Press; 1992;.
35 +
DerSimonian R, Laird N.  Meta-analysis in clinical trials. Controlled Clin Trials . 1986;;7:177-188.
36 +
Berkey CS, Hoaglin DC, Mosteller F, Colditz GA.  A random-effects regression model for meta-analysis.  In: Colditz GA, Brewer T, Berkey CS, et al, eds. The Efficacy of BCG in the Prevention of Tuberculosis: Report to the CDC . Boston, Mass: Harvard University Press; June 1993;.
37 +
Morris CN.  Parametric empirical Bayes inference: theory and applications. J Am Stat Assoc . 1983;;78:47-55.
38 +
Hennekens CH, Buring JE. Epidemiology in Medicine . 1st ed. Boston, Mass: Little Brown & Co Inc; 1987;:79-82.
39 +
Coetzee AM, Berjak J.  BCG in the prevention of tuberculosis in an adult population. Proc Mine Med Officers Assoc . 1968;;48:41-53.
40 +
Ferguson RG, Simes AB.  BCG vaccination of Indian infants in Saskatchewan. Tubercle . 1949;;30: 5-11.
41 +
Hart PD, Sutherland I.  BCG and vole bacillus vaccines in the prevention of tuberculosis in adolescence and early adult life: final report to the Medical Research Council. BMJ . 1977;;2:293-295.
42 +
Rosenthal SR, Loewinsohn E, Graham ML, et al.  BCG vaccination in tuberculous households. Am Rev Respir Dis . 1960;;84:690-704.
43 +
Vandiviere HM, Dworski M, Melvin IG, Watson HA, Begley J.  Efficacy of bacillus Calmette-Guerin and isoniazid-resistant bacillus Calmette-Guerin with and without isoniazid chemoprophylaxis from day of vaccination, II: field trial in man. Am Rev Respir Dis . 1973;;108:301-313.
44 +
Stein SC, Aronson JD.  The occurrence of pulmonary lesions in BCG-vaccinated and unvaccinated persons. Am Rev Tuberc . 1953;;68:692-712.
45 +
Frimodt-Moller J, Acharyulu GS, Pillai KK.  Observations on the protective effect of BCG vaccination in a south Indian rural population. Bull Int Union Tuberc . 1973;;48:40-52.
46 +
Comstock GW, Woolpert SF, Livesay VT.  Tuberculosis studies in Muscogee County, Georgia: twenty-year evaluation of a community trial of BCG vaccination. Public Health Rep . 1976;;91:276-280.
47 +
Comstock GW, Livesay VT, Woolpert SF.  Evaluation of BCG vaccination among Puerto Rican children. Am J Public Health . 1974;;64:283-291.
48 +
Comstock GW, Webster RG.  Tuberculosis studies in Muscogee County, Georgia, VII: a twenty-year evaluation of BCG vaccination in a school population. Am Rev Respir Dis . 1969;;100:839-845.
49 +
Rosenthal SR, Loewinsohn E, Graham ML, et al.  BCG vaccination against tuberculosis in Chicago: a twenty-year study statistically analyzed. Pediatrics . 1961;;28:622-641.
50 +
Levine MI, Sackett MF.  Results of BCG immunization in New York City. Am Rev Tuberc . 1948;;53:517-532.
51 +
Aronson JD, Aronson CF, Taylor HC.  A twenty-year appraisal of BCG vaccination in the control of tuberculosis. Arch Intern Med . 1958;;101:881-893.
52 +
Houston S, Fanning A, Soskoine CL, Fraser N.  The effectiveness of bacillus Calmette-Guerin (BCG) vaccination against tuberculosis. Am J Epidemiol . 1990;;131:340-349.
53 +
Miceli I, De Kanto IN, Colaiacovo D, et al.  Evaluation of the effectiveness of BCG vaccination using the case-control method in Buenos Aires, Argentina. Int J Epidemiol . 1988;;17:629-634.
54 +
Myint TT, Win H, Aye HH, Kyaw-Myint TO.  Case-control study on evaluation of BCG vaccination of newborns in Rangoon, Burma. Ann Trop Paediatr . 1987;;7:159-166.
55 +
Packe GE, Innes JA.  Protective effect of BCG vaccination in infant Asians: a case-control study. Arch Dis Child . 1988;;63:277-281.
56 +
Putrali J, Sutrisna B, Rahayoe N, Gunardi AS.  A case-control study of effectiveness of vaccination in children in Jakarta, Indonesia.  In: Proceedings of the Eastern Regional Tuberculosis Conference of IUAT, 1983 . Jakarta, Indonesia; November 20-25, 1983;:194-200.
57 +
Rodrigues LC, Gill ON, Smith PG.  BCG vaccination in the first year of life protects children of Indian subcontinent ethnic origin against tuberculosis in England. Int J Epidemiol Community Health . 1991;;45:78-80.
58 +
Sirinavin S, Chotpitayasunondh T, Suwanjutha S, Sunalorn P, Chantarojanasiri T.  Protective efficacy of neonatal bacillus Calmette-Guerin vaccination against tuberculosis. Pediatr Infect Dis J . 1991;;10:350-365.
59 +
Young TK, Hershfield ES.  A case-control study to evaluate the effectiveness of mass neonatal BCG vaccination among Canadian Indians. Am J Public Health . 1986;;76:783-786.
60 +
Patel A, Schofield F, Siskind V, Abrahams E, Parker J.  Case-control evaluation of a school-age BCG vaccination programme in subtropical Australia. Bull World Health Organ . 1991;;69:425-433.
61 +
Shapiro C, Cook N, Evans D, et al.  A case-control study of BCG and childhood tuberculosis in Cali, Colombia. Int J Epidemiol . 1985;;14:441-446.
62 +
Camargos PAM, Guimaraes MDC, Antunes CMF.  Risk assessment for acquiring meningitis tuberculosis among children not vaccinated with BCG: a case-control study. Int J Epidemiol . 1988;; 17:193-197.
63 +
Wunsch-Filho V, Moncau JE, Nakao N.  Methodological considerations in case control studies to evaluate BCG vaccine effectiveness. Int J Epidemiol . 1993;;22:149-155.
64 +
Springett VH, Sutherland I.  Comparison of the efficacy of liquid and freeze-dried strains of BCG vaccine in preventing tuberculosis. BMJ . 1970;;4: 148-150.
65 +
Tuberculosis Prevention Trial.  Trial of BCG vaccines in south India for tuberculosis prevention: first report. Bull World Health Organ . 1979;;57:819-827.
66 +
Clemens JD, Chuong JH, Feinstein AR.  The BCG controversy: a methodological and statistical reappraisal. JAMA . 1983;;249:2362-2369.
67 +
ten Dam HG.  BCG vaccination.  In: Reichman LB, Hershfield ES, eds. Tuberculosis: A Comprehensive International Approach . New York, NY: Marcel Dekker Inc; 1993;:251-274.
68 +
Halvorsen KT, Burdick E, Colditz GA, Frazier HS, Mosteller F.  Combining results from independent investigations: meta-analysis in clinical research.  In: Bailar JC, Mosteller F, eds. Medical Uses of Statistics . 2nd ed. Boston, Mass: New England Journal of Medicine Books; 1992;:413-426.

Figures

Tables

Interactive Graphics

Video

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

Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal

1 +
Rieder HL, Cauthen GM, Comstock GW, Snider DE.  Epidemiology of tuberculosis in the United States. Epidemiol Rev . 1989;;11:79-98.
2 +
Centers for Disease Control and Prevention.  Tuberculosis mortality—United States, 1992. MMWR Morb Mortal Wkly Rep . 1992;;42:696-697,703-704.
3 +
Centers for Disease Control and Prevention.  Prevention and control of tuberculosis in US communities with at-risk minority populations. MMWR Morb Mortal Wkly Rep . 1992;;41( (RR-5) ):1-11.
4 +
Hamburg MA.  The challenge of controlling tuberculosis in New York City. N Y State J Med . 1992;;92:291-293.
5 +
Frieden TR, Sterling T, Pablos-Mendez A, Kilburn JD, Cauthen GM, Dooley SM.  The emergence of drug-resistant tuberculosis in New York City. N Engl J Med . 1993;;328:521-526.
6 +
Centers for Disease Control.  Nosocomial transmission of multidrug-resistant tuberculosis among HIV-infected persons—Florida and New York, 1988-1991. MMWR Morb Mortal Wkly Rep . 1991;; 40:585-591.
7 +
Edlin BR, Tokars JI, Grieco MH, et al.  An outbreak of multidrug resistant tuberculosis among hospitalized patients with the acquired immunodeficiency syndrome. N Engl J Med . 1992;;326:1514-1521.
8 +
Fischl MA, Uttamchandani RB, Daikos GL, et al.  An outbreak of tuberculosis caused by multiple-drug-resistant tubercle bacilli among patients with HIV infection. Ann Intern Med . 1992;;117:177-183.
9 +
Pearson, ML, Jereb JA, Frieden TR, et al.  Nosocomial transmission of multidrug-resistant mycobacterium tuberculosis. Ann Intern Med . 1992;;117: 191-196.
10 +
Centers for Disease Control and Prevention.  National action plan to combat multidrug-resistant tuberculosis. MMWR Morb Mortal Wkly Rep . 1992;; 41:5-8.
11 +
Centers for Disease Control.  Use of BCG vaccines in the control of tuberculosis: a joint statement by the ACIP and the Advisory Committee for Elimination of Tuberculosis. MMWR Morb Mortal Wkly Rep . 1988;;37:663-664,669-675.
12 +
 BCG: bad news from India. Lancet . 1980;;1:73-74. Editorial.
13 +
 BCG vaccination after the Madras study. Lancet . 1981;;1309-1310. Editorial.
14 +
Smith PG.  Case-control studies of the efficacy of BCG against tuberculosis.  In: International Union Against Tuberculosis, ed. Proceedings of the 26th IUAT World Conference on Tuberculosis and Respiratory Diseases . Singapore, Japan: Professional Postgraduate Services International; 1987;:73-79.
15 +
Tuberculosis Prevention Trial, Madras.  Trial of BCG vaccines in south India for tuberculosis prevention. Indian J Med Res . 1980;;72( (suppl) ):1-74.
16 +
ten Dam HG.  Research on BCG vaccination. Adv Tuberc Res . 1984;;21:79-106.
17 +
von Reyn CF, Clements CJ, Mann JM.  Human immunodeficiency virus infection and routine childhood immunization. Lancet . 1987;;2:669-672.
18 +
ten Dam HG, Toman K, Hitze KL, Guld J.  Present knowledge of immunization against tuberculosis. Bull World Health Organ . 1976;;54:255-269.
19 +
Comstock GW.  Identification of an effective vaccine against tuberculosis. Am Rev Respir Dis . 1988;;138:479-480.
20 +
Fine PEM, Rodrigues LC.  Modern vaccines: mycobacterial diseases. Lancet . 1990;;335:1016-1020.
21 +
L'Abbe HA, Detsky AS, O'Rourke K.  Meta-analysis in clinical research. Ann Intern Med . 1987;; 107:224-233.
22 +
Sacks HS, Berrier J, Reitman D, Ancona-Berk VA, Chalmers TC.  Meta-analysis of randomized controlled trials. N Engl J Med . 1987;;316:450-455.
23 +
Aronson JD.  Protective vaccination against tuberculosis with special reference to BCG vaccination. Am Rev Tuberc . 1948;;58:255-281.
24 +
Heimbeck J.  Tuberculosis in hospital nurses. Tubercle . 1936;;18:97-99.
25 +
Rosenthal SR, Leppman M.  Tuberculosis control: BCG vaccination in a tuberculosis control program in infants, children and adults. Trans Natl Tuberc Assoc . 1953;;161-168.
26 +
Rosenthal SR.  Standardization and efficacy of BCG vaccination against tuberculosis. JAMA . 1955;; 157:801-807.
27 +
Ferguson RG.  BCG vaccination in hospitals and sanatoria of Saskatchewan. Am Rev Tuberc . 1946;; 54:325-339.
28 +
Rosenthal SR.  The use of BCG vaccination among medical and nursing students. Hospitals . 1943;;17:75-78.
29 +
Houghton HGH, Horne NW.  BCG vaccination of nurses and students in Edinburgh. Lancet . 1950;; 2:533-536.
30 +
DeFriez Al, Badger TL.  Tuberculosis in BCG-vaccinated nurses. N Engl J Med . 1957;;257:161-165.
31 +
Dickie HA.  Tuberculosis in student nurses and medical students at the University of Wisconsin. Ann Intern Med . 1950;;33:941-959.
32 +
Burrill D, Enarson DA, Allen EA, Grzyboski S.  Tuberculosis in female nurses in British Columbia: implications for control programs. Can Med Assoc J . 1985;;132:137-140.
33 +
Geiseler PJ, Nelson HE, Crispen RG, Moses VK.  Tuberculosis in physicians: a continuing problem. Am Rev Respir Dis . 1986;;133:773-778.
34 +
National Research Council. Combining Information: Statistical Issues and Opportunities for Research . Washington, DC: National Academy Press; 1992;.
35 +
DerSimonian R, Laird N.  Meta-analysis in clinical trials. Controlled Clin Trials . 1986;;7:177-188.
36 +
Berkey CS, Hoaglin DC, Mosteller F, Colditz GA.  A random-effects regression model for meta-analysis.  In: Colditz GA, Brewer T, Berkey CS, et al, eds. The Efficacy of BCG in the Prevention of Tuberculosis: Report to the CDC . Boston, Mass: Harvard University Press; June 1993;.
37 +
Morris CN.  Parametric empirical Bayes inference: theory and applications. J Am Stat Assoc . 1983;;78:47-55.
38 +
Hennekens CH, Buring JE. Epidemiology in Medicine . 1st ed. Boston, Mass: Little Brown & Co Inc; 1987;:79-82.
39 +
Coetzee AM, Berjak J.  BCG in the prevention of tuberculosis in an adult population. Proc Mine Med Officers Assoc . 1968;;48:41-53.
40 +
Ferguson RG, Simes AB.  BCG vaccination of Indian infants in Saskatchewan. Tubercle . 1949;;30: 5-11.
41 +
Hart PD, Sutherland I.  BCG and vole bacillus vaccines in the prevention of tuberculosis in adolescence and early adult life: final report to the Medical Research Council. BMJ . 1977;;2:293-295.
42 +
Rosenthal SR, Loewinsohn E, Graham ML, et al.  BCG vaccination in tuberculous households. Am Rev Respir Dis . 1960;;84:690-704.
43 +
Vandiviere HM, Dworski M, Melvin IG, Watson HA, Begley J.  Efficacy of bacillus Calmette-Guerin and isoniazid-resistant bacillus Calmette-Guerin with and without isoniazid chemoprophylaxis from day of vaccination, II: field trial in man. Am Rev Respir Dis . 1973;;108:301-313.
44 +
Stein SC, Aronson JD.  The occurrence of pulmonary lesions in BCG-vaccinated and unvaccinated persons. Am Rev Tuberc . 1953;;68:692-712.
45 +
Frimodt-Moller J, Acharyulu GS, Pillai KK.  Observations on the protective effect of BCG vaccination in a south Indian rural population. Bull Int Union Tuberc . 1973;;48:40-52.
46 +
Comstock GW, Woolpert SF, Livesay VT.  Tuberculosis studies in Muscogee County, Georgia: twenty-year evaluation of a community trial of BCG vaccination. Public Health Rep . 1976;;91:276-280.
47 +
Comstock GW, Livesay VT, Woolpert SF.  Evaluation of BCG vaccination among Puerto Rican children. Am J Public Health . 1974;;64:283-291.
48 +
Comstock GW, Webster RG.  Tuberculosis studies in Muscogee County, Georgia, VII: a twenty-year evaluation of BCG vaccination in a school population. Am Rev Respir Dis . 1969;;100:839-845.
49 +
Rosenthal SR, Loewinsohn E, Graham ML, et al.  BCG vaccination against tuberculosis in Chicago: a twenty-year study statistically analyzed. Pediatrics . 1961;;28:622-641.
50 +
Levine MI, Sackett MF.  Results of BCG immunization in New York City. Am Rev Tuberc . 1948;;53:517-532.
51 +
Aronson JD, Aronson CF, Taylor HC.  A twenty-year appraisal of BCG vaccination in the control of tuberculosis. Arch Intern Med . 1958;;101:881-893.
52 +
Houston S, Fanning A, Soskoine CL, Fraser N.  The effectiveness of bacillus Calmette-Guerin (BCG) vaccination against tuberculosis. Am J Epidemiol . 1990;;131:340-349.
53 +
Miceli I, De Kanto IN, Colaiacovo D, et al.  Evaluation of the effectiveness of BCG vaccination using the case-control method in Buenos Aires, Argentina. Int J Epidemiol . 1988;;17:629-634.
54 +
Myint TT, Win H, Aye HH, Kyaw-Myint TO.  Case-control study on evaluation of BCG vaccination of newborns in Rangoon, Burma. Ann Trop Paediatr . 1987;;7:159-166.
55 +
Packe GE, Innes JA.  Protective effect of BCG vaccination in infant Asians: a case-control study. Arch Dis Child . 1988;;63:277-281.
56 +
Putrali J, Sutrisna B, Rahayoe N, Gunardi AS.  A case-control study of effectiveness of vaccination in children in Jakarta, Indonesia.  In: Proceedings of the Eastern Regional Tuberculosis Conference of IUAT, 1983 . Jakarta, Indonesia; November 20-25, 1983;:194-200.
57 +
Rodrigues LC, Gill ON, Smith PG.  BCG vaccination in the first year of life protects children of Indian subcontinent ethnic origin against tuberculosis in England. Int J Epidemiol Community Health . 1991;;45:78-80.
58 +
Sirinavin S, Chotpitayasunondh T, Suwanjutha S, Sunalorn P, Chantarojanasiri T.  Protective efficacy of neonatal bacillus Calmette-Guerin vaccination against tuberculosis. Pediatr Infect Dis J . 1991;;10:350-365.
59 +
Young TK, Hershfield ES.  A case-control study to evaluate the effectiveness of mass neonatal BCG vaccination among Canadian Indians. Am J Public Health . 1986;;76:783-786.
60 +
Patel A, Schofield F, Siskind V, Abrahams E, Parker J.  Case-control evaluation of a school-age BCG vaccination programme in subtropical Australia. Bull World Health Organ . 1991;;69:425-433.
61 +
Shapiro C, Cook N, Evans D, et al.  A case-control study of BCG and childhood tuberculosis in Cali, Colombia. Int J Epidemiol . 1985;;14:441-446.
62 +
Camargos PAM, Guimaraes MDC, Antunes CMF.  Risk assessment for acquiring meningitis tuberculosis among children not vaccinated with BCG: a case-control study. Int J Epidemiol . 1988;; 17:193-197.
63 +
Wunsch-Filho V, Moncau JE, Nakao N.  Methodological considerations in case control studies to evaluate BCG vaccine effectiveness. Int J Epidemiol . 1993;;22:149-155.
64 +
Springett VH, Sutherland I.  Comparison of the efficacy of liquid and freeze-dried strains of BCG vaccine in preventing tuberculosis. BMJ . 1970;;4: 148-150.
65 +
Tuberculosis Prevention Trial.  Trial of BCG vaccines in south India for tuberculosis prevention: first report. Bull World Health Organ . 1979;;57:819-827.
66 +
Clemens JD, Chuong JH, Feinstein AR.  The BCG controversy: a methodological and statistical reappraisal. JAMA . 1983;;249:2362-2369.
67 +
ten Dam HG.  BCG vaccination.  In: Reichman LB, Hershfield ES, eds. Tuberculosis: A Comprehensive International Approach . New York, NY: Marcel Dekker Inc; 1993;:251-274.
68 +
Halvorsen KT, Burdick E, Colditz GA, Frazier HS, Mosteller F.  Combining results from independent investigations: meta-analysis in clinical research.  In: Bailar JC, Mosteller F, eds. Medical Uses of Statistics . 2nd ed. Boston, Mass: New England Journal of Medicine Books; 1992;:413-426.

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AAM 2010;304:1493-1495.
All you need to read in the other general journals
BMJ 2010;341:c5893-c1494.
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