human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: IMPORTANCE Maternal immunization with tetanus toxoid , reduced diphtheria toxoid , and acellular pertussis ( Tdap ) vaccine could prevent infant pertussis . OBJECTIVE To evaluate the safety and immunogenicity of Tdap immunization during pregnancy and its effect on infant responses to diphtheria and tetanus toxoids and acellular pertussis ( DTaP ) vaccine . DESIGN , SETTING , AND PARTICIPANTS Phase 1 - 2 , r and omized , double-blind , placebo-controlled , clinical trial conducted from 2008 to 2012 . Forty-eight pregnant women aged 18 to 45 years received Tdap  ( n = 33 ) or placebo ( n = 15 ) at 30 to 32 weeks ' gestation , with crossover immunization postpartum . INTERVENTIONS Tdap vaccination at 30 to 32 weeks ' gestation or postpartum . MAIN OUTCOMES AND MEASURES Primary outcomes were maternal and infant adverse events , pertussis illness , and infant growth and development until age 13 months . Secondary outcomes were antibody concentrations in  pregnant women before and 4 weeks after Tdap immunization or placebo , at delivery and 2 months ' postpartum , and in infants at birth , at 2 months , and after the third and fourth doses of DTaP. RESULTS No Tdap-associated serious adverse events occurred in women or infants . Injection site reactions after Tdap immunization were reported in 26 ( 78.8 % [ 95 % CI , 61.1%-91.0 % ] ) and 12 ( 80 % [ 95 % CI , 51.9%-95.7 % ] ) pregnant and postpartum women , respectively ( P > .99 ) . Systemic symptoms were reported in 12 ( 36.4 % [ 95 % CI , 20.4%-54.9 % ] ) and 11 ( 73.3 % [ 95 % CI , 44.9%-92.2 % ] ) pregnant and postpartum women , respectively ( P = .03 ) . Growth and development were similar in both infant groups . No cases of pertussis occurred . Significantly higher concentrations of pertussis antibodies were measured at delivery in women who received Tdap during pregnancy vs postpartum ( eg , pertussis toxin antibodies : 51.0 EU/mL [ 95 % CI , 37.1 - 70.1 ] and 9.1 EU/mL [ 95 % CI , 4.6 - 17.8 ] , respectively ; P < .001 ) and in their infants at birth ( 68.8 EU/mL [ 95 % CI , 52.1 - 90.8 ] and 14.0 EU/mL [ 95 % CI , 7.3 - 26.9 ] , respectively ; P < .001 ) and at age 2 months ( 20.6 EU/mL [ 95 % CI , 14.4 - 29.6 ] and 5.3 EU/mL [ 95 % CI , 3.0 - 9.4 ] , respectively ; P < .001 ) . Antibody responses in infants born to women receiving Tdap during pregnancy were not different following the fourth dose of DTaP. CONCLUSIONS AND RELEVANCE This preliminary assessment did not find an increased risk of adverse events among women who received Tdap vaccine during pregnancy or their infants . For secondary outcomes , maternal immunization with Tdap result ed in high concentrations of pertussis antibodies in infants during the first 2 months of life and did not substantially alter infant responses to DTaP. Further research is needed to provide definitive evidence of the safety and efficacy of Tdap immunization during pregnancy . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00707148 BACKGROUND Because adolescents and adults act as a primary source of pertussis infection for infants , vaccination of mothers immediately postpartum is a potential strategy to reduce transmission ( cocoon strategy ) . For this to be effective , high levels of antibodies must be achieved rapidly after vaccination . We sought to determine whether the antibody response to tetanus-diphtheria-acellular pertussis vaccine ( Tdap ) is sufficiently rapid to support the cocoon strategy . METHODS Two sequential studies were performed . The first was a nonr and omized , open study of a 5-pertussis-component Tdap vaccine ( tetanus toxoid , diphtheria toxoid , pertussis toxoid [ PT ] , filamentous hemagglutinin [ FHA ] , fimbriae types 2 and 3 [ FIM ] , and pertactin [ PRN ] ) given to women of childbearing age ; the second was a r and omized , open study of Tdap or no vaccine in postpartum women .  Serum levels of immunoglobin ( Ig ) G and IgA against pertussis antigens , serum levels of IgG against diphtheria and tetanus , and breast milk levels of IgA against pertussis antigens were measured at various times after vaccination . RESULTS In both studies , the antibody response was relatively rapid , with serum IgG and IgA levels beginning to increase noticeably by days 5 - 7 and approaching peak levels by day 14 . Greater than 68 % and 84.4 % of IgG and IgA responders , respectively , achieved ≥ 90 % of their maximum titer by day 14 . The diphtheria and tetanus antibody kinetics followed a similar time course . Breast milk levels of IgA against PT , FHA , and FIM were first detectable at day 7 , peaked by day 10 , and then slowly decreased through day 28 . Antibodies against PRN showed a similar response , although the peak occurred at day 14 . There were no significant antibody responses in the control group . CONCLUSIONS Although the antibody response to a dose of Tdap in healthy nonpregnant women of child-bearing age and postpartum women occurs by day 14 and is suggestive of an anamnestic immune response , it may not be sufficiently rapid to protect infants in the first weeks of life BACKGROUND Neonatal tetanus is the cause of 23 to 73 % of neonatal deaths in developing countries and continues to be an important killer in many parts of India . METHODS In this nonr and omized cohort study in a rural area in India ,  tetanus toxoid immunization status was recorded for 1688 pregnant women . Liveborn children were followed up for 30 days for the occurrence of neonatal tetanus . Nonimmunized and partially immunized women were asked their reasons for not receiving tetanus toxoid vaccine . RESULTS Complete prenatal immunization with tetanus toxoid during pregnancy ( two doses 1 month apart ) was associated with an 88 % reduction in the risk of neonatal tetanus among the newborn children [ 95 % confidence interval ( CI ) 59 to 98 % ] . In multivariable analysis only complete immunization and the use of clean instruments for cutting the umbilical cord were independently associated with a reduction in risk of neonatal tetanus . Registration by the health care provider before 29 weeks of gestation , being 5 km or less from the vaccination facility , having two or more contacts with the health provider and having some school education were independently associated with complete immunization . CONCLUSIONS Immunization of pregnant women with tetanus toxoid was the single most effective intervention against neonatal tetanus independent of other interventions Maternal immunization with tetanus toxoid ( TT ) is the most effective was to prevent neonatal tetanus . In Duhok , Iraq data indicate low vaccination coverage . This study assessed  TT immunization  status among 600 r and omly selected pregnant women attending Azadi teaching hospital , Duhok for delivery , by both tetanus antibody seroprevalence and TT history . WHO criteria for protective levels were used for seroprevalence and vaccination history . Overall , 90 % of the women at delivery had protective tetanus antitoxin titres compared to only 55 % considered protected according to their vaccination history . Immunity rates for women who had received no TT vaccination , 1 dose , 2 doses and > or = 3 doses were 28.0 % , 92.6 % , 100.0 % and 99.0 % respectively . Groups with lower serological immunity levels were women aged less than 25 years , those reporting no history of vaccination and those living in Akre , Bardarash or Shekhan districts of Duhok .  Tetanus immunity determined by seroprevalence of tetanus antitoxin levels exceeded that estimated by vaccination history , and serological markers should be used instead of vaccination history in determining immunity status Objective The main purpose of this study was to identify possible associations between medicines used in pregnancy and preterm deliveries  using data mining as a screening tool . Setting s Prospect i ve cohort study . Methods We used data mining to identify possible correlates between preterm delivery and medicines used by 92,235 pregnant Danish women who took part in the Danish National Birth Cohort ( DNBC ) . We then evaluated the association between one of the identified exposures ( vaccination ) and the risk for preterm birth by using logistic regression . The women were classified into groups according to their exposure to vaccination . The regression analyses were adjusted for the following covariates : parity , infant ’s gender , maternal Body-Mass Index ( BMI ) , age , smoking , drinking , job , number of inhabitants in the place of residence , infections , diabetes , high blood pressure and preeclampsia . Main outcome measurePreterm birth , a delivery occurring before the 259th day of gestation ( i.e. , less than 37 full weeks ) . Results Data mining had indicated that maternal vaccination ( among other factors ) might be related to preterm birth . The following regression analysis showed that , the women who reported being vaccinated shortly before or during gestation had a slightly higher risk of giving preterm birth ( O.R. = 1.14 ; 95 % CI 1.04–1.25 ) as compared to the non-vaccinated group . Conclusion Whether the association between maternal vaccination and the risk for preterm birth found here is causal or not deserves further studies . Data mining , especially with additional refinements , may be a valuable and very efficient tool to screen large data bases for relevant information which can be used in clinical and public health research The antibody response in pregnant women vaccinated with either of two different adsorbed tetanus toxoids  has been studied . One vaccine ( A ) , prepared by toxoiding purified tetanus toxin followed by its adsorption onto calcium phosphate , exhibited a low titre expressed as international immunizing units , 69 IIU/0.5 ml . The other vaccine ( B ) , prepared by purifying formalinized crude tetanus toxin and adsorbing it onto aluminium phosphate showed a high titre , 212 IIU/0.5 ml . No significant differences between titres of circulating antibodies were obtained after the first injection of either vaccine , but titres after the second injection were much higher for vaccine A as compared with those obtained using vaccine B. The results showed that the  immune response in human beings is not correlated to titres expressed in IIU . These results confirm that other methods should be adopted for evaluating the potency of vaccines . A simplified technique based on the comparison of circulating antitoxin levels after vaccination of mice has recently been proposed 1 approach to the prevention of tetanus neonatorum ( a leading cause of infant death throughout the world ) is improving the quality of prenatal , obstetric , and postnatal maternal and child health services . Another complementary approach is the active immunization of women before or during pregnancy with tetanus toxoid .  Work in progress at the Matlab field station of the International Center for Diarrheal Disease Research in Bangladesh ( ICDDR , B ) provided a unique opportunity to study the effectiveness of certain aspects of these 2 strategies . In 1974 , during a field trial of cholera toxoid vaccine , 2 injections of an aluminum phosphate tetanus-diphtheria toxoid were provided as a control to a r and omly assigned group of nonpregnant women . Beginning in June 1978 , a program of immunizing women during pregnancy with aluminum phosphate-absorbed tetanus toxoid was initiated in conjunction with the implementation of a village based maternal and child health and family planning program in half of the same Matlab surveillance area . Throughout the period of these 2 programs , the ICDDR , B maintained an independent , longitudinal , vital registration system , identifying all births and deaths in the study area . In this analysis , all live births registered in the Maternal and Child Health-Family Planning and comparison areas during the September 1 , 1978 until December 31 , 1979 period were identified . These records were linked with any deaths recorded within 28 days of birth . The acceptance of tetanus vaccination  during the 1974 cholera vaccine trial , by the mothers of these live births , was ascertained from the 1974 vaccine registers . The acceptance of vaccination during the 1978 - 1979 program was obtained from the field registers . For infants whose mothers had received 2 tetanus injections 48 - 64 months prior to delivery , the neonatal mortality rate was 63.8/l000 live births compared with 78.3/1000 
    Output:
    
agent
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: IMPORTANCE Maternal immunization with tetanus toxoid , reduced diphtheria toxoid , and acellular pertussis ( Tdap ) vaccine could prevent infant pertussis . OBJECTIVE To evaluate the safety and immunogenicity of Tdap immunization during pregnancy and its effect on infant responses to diphtheria and tetanus toxoids and acellular pertussis ( DTaP ) vaccine . DESIGN , SETTING , AND PARTICIPANTS Phase 1 - 2 , r and omized , double-blind , placebo-controlled , clinical trial conducted from 2008 to 2012 . Forty-eight pregnant women aged 18 to 45 years received Tdap  ( n = 33 ) or placebo ( n = 15 ) at 30 to 32 weeks ' gestation , with crossover immunization postpartum . INTERVENTIONS Tdap vaccination at 30 to 32 weeks ' gestation or postpartum . MAIN OUTCOMES AND MEASURES Primary outcomes were maternal and infant adverse events , pertussis illness , and infant growth and development until age 13 months . Secondary outcomes were antibody concentrations in  pregnant women before and 4 weeks after Tdap immunization or placebo , at delivery and 2 months ' postpartum , and in infants at birth , at 2 months , and after the third and fourth doses of DTaP. RESULTS No Tdap-associated serious adverse events occurred in women or infants . Injection site reactions after Tdap immunization were reported in 26 ( 78.8 % [ 95 % CI , 61.1%-91.0 % ] ) and 12 ( 80 % [ 95 % CI , 51.9%-95.7 % ] ) pregnant and postpartum women , respectively ( P > .99 ) . Systemic symptoms were reported in 12 ( 36.4 % [ 95 % CI , 20.4%-54.9 % ] ) and 11 ( 73.3 % [ 95 % CI , 44.9%-92.2 % ] ) pregnant and postpartum women , respectively ( P = .03 ) . Growth and development were similar in both infant groups . No cases of pertussis occurred . Significantly higher concentrations of pertussis antibodies were measured at delivery in women who received Tdap during pregnancy vs postpartum ( eg , pertussis toxin antibodies : 51.0 EU/mL [ 95 % CI , 37.1 - 70.1 ] and 9.1 EU/mL [ 95 % CI , 4.6 - 17.8 ] , respectively ; P < .001 ) and in their infants at birth ( 68.8 EU/mL [ 95 % CI , 52.1 - 90.8 ] and 14.0 EU/mL [ 95 % CI , 7.3 - 26.9 ] , respectively ; P < .001 ) and at age 2 months ( 20.6 EU/mL [ 95 % CI , 14.4 - 29.6 ] and 5.3 EU/mL [ 95 % CI , 3.0 - 9.4 ] , respectively ; P < .001 ) . Antibody responses in infants born to women receiving Tdap during pregnancy were not different following the fourth dose of DTaP. CONCLUSIONS AND RELEVANCE This preliminary assessment did not find an increased risk of adverse events among women who received Tdap vaccine during pregnancy or their infants . For secondary outcomes , maternal immunization with Tdap result ed in high concentrations of pertussis antibodies in infants during the first 2 months of life and did not substantially alter infant responses to DTaP. Further research is needed to provide definitive evidence of the safety and efficacy of Tdap immunization during pregnancy . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00707148 BACKGROUND Because adolescents and adults act as a primary source of pertussis infection for infants , vaccination of mothers immediately postpartum is a potential strategy to reduce transmission ( cocoon strategy ) . For this to be effective , high levels of antibodies must be achieved rapidly after vaccination . We sought to determine whether the antibody response to tetanus-diphtheria-acellular pertussis vaccine ( Tdap ) is sufficiently rapid to support the cocoon strategy . METHODS Two sequential studies were performed . The first was a nonr and omized , open study of a 5-pertussis-component Tdap vaccine ( tetanus toxoid , diphtheria toxoid , pertussis toxoid [ PT ] , filamentous hemagglutinin [ FHA ] , fimbriae types 2 and 3 [ FIM ] , and pertactin [ PRN ] ) given to women of childbearing age ; the second was a r and omized , open study of Tdap or no vaccine in postpartum women .  Serum levels of immunoglobin ( Ig ) G and IgA against pertussis antigens , serum levels of IgG against diphtheria and tetanus , and breast milk levels of IgA against pertussis antigens were measured at various times after vaccination . RESULTS In both studies , the antibody response was relatively rapid , with serum IgG and IgA levels beginning to increase noticeably by days 5 - 7 and approaching peak levels by day 14 . Greater than 68 % and 84.4 % of IgG and IgA responders , respectively , achieved ≥ 90 % of their maximum titer by day 14 . The diphtheria and tetanus antibody kinetics followed a similar time course . Breast milk levels of IgA against PT , FHA , and FIM were first detectable at day 7 , peaked by day 10 , and then slowly decreased through day 28 . Antibodies against PRN showed a similar response , although the peak occurred at day 14 . There were no significant antibody responses in the control group . CONCLUSIONS Although the antibody response to a dose of Tdap in healthy nonpregnant women of child-bearing age and postpartum women occurs by day 14 and is suggestive of an anamnestic immune response , it may not be sufficiently rapid to protect infants in the first weeks of life BACKGROUND Neonatal tetanus is the cause of 23 to 73 % of neonatal deaths in developing countries and continues to be an important killer in many parts of India . METHODS In this nonr and omized cohort study in a rural area in India ,  tetanus toxoid immunization status was recorded for 1688 pregnant women . Liveborn children were followed up for 30 days for the occurrence of neonatal tetanus . Nonimmunized and partially immunized women were asked their reasons for not receiving tetanus toxoid vaccine . RESULTS Complete prenatal immunization with tetanus toxoid during pregnancy ( two doses 1 month apart ) was associated with an 88 % reduction in the risk of neonatal tetanus among the newborn children [ 95 % confidence interval ( CI ) 59 to 98 % ] . In multivariable analysis only complete immunization and the use of clean instruments for cutting the umbilical cord were independently associated with a reduction in risk of neonatal tetanus . Registration by the health care provider before 29 weeks of gestation , being 5 km or less from the vaccination facility , having two or more contacts with the health provider and having some school education were independently associated with complete immunization . CONCLUSIONS Immunization of pregnant women with tetanus toxoid was the single most effective intervention against neonatal tetanus independent of other interventions Maternal immunization with tetanus toxoid ( TT ) is the most effective was to prevent neonatal tetanus . In Duhok , Iraq data indicate low vaccination coverage . This study assessed  TT immunization  status among 600 r and omly selected pregnant women attending Azadi teaching hospital , Duhok for delivery , by both tetanus antibody seroprevalence and TT history . WHO criteria for protective levels were used for seroprevalence and vaccination history . Overall , 90 % of the women at delivery had protective tetanus antitoxin titres compared to only 55 % considered protected according to their vaccination history . Immunity rates for women who had received no TT vaccination , 1 dose , 2 doses and > or = 3 doses were 28.0 % , 92.6 % , 100.0 % and 99.0 % respectively . Groups with lower serological immunity levels were women aged less than 25 years , those reporting no history of vaccination and those living in Akre , Bardarash or Shekhan districts of Duhok .  Tetanus immunity determined by seroprevalence of tetanus antitoxin levels exceeded that estimated by vaccination history , and serological markers should be used instead of vaccination history in determining immunity status Objective The main purpose of this study was to identify possible associations between medicines used in pregnancy and preterm deliveries  using data mining as a screening tool . Setting s Prospect i ve cohort study . Methods We used data mining to identify possible correlates between preterm delivery and medicines used by 92,235 pregnant Danish women who took part in the Danish National Birth Cohort ( DNBC ) . We then evaluated the association between one of the identified exposures ( vaccination ) and the risk for preterm birth by using logistic regression . The women were classified into groups according to their exposure to vaccination . The regression analyses were adjusted for the following covariates : parity , infant ’s gender , maternal Body-Mass Index ( BMI ) , age , smoking , drinking , job , number of inhabitants in the place of residence , infections , diabetes , high blood pressure and preeclampsia . Main outcome measurePreterm birth , a delivery occurring before the 259th day of gestation ( i.e. , less than 37 full weeks ) . Results Data mining had indicated that maternal vaccination ( among other factors ) might be related to preterm birth . The following regression analysis showed that , the women who reported being vaccinated shortly before or during gestation had a slightly higher risk of giving preterm birth ( O.R. = 1.14 ; 95 % CI 1.04–1.25 ) as compared to the non-vaccinated group . Conclusion Whether the association between maternal vaccination and the risk for preterm birth found here is causal or not deserves further studies . Data mining , especially with additional refinements , may be a valuable and very efficient tool to screen large data bases for relevant information which can be used in clinical and public health research The antibody response in pregnant women vaccinated with either of two different adsorbed tetanus toxoids  has been studied . One vaccine ( A ) , prepared by toxoiding purified tetanus toxin followed by its adsorption onto calcium phosphate , exhibited a low titre expressed as international immunizing units , 69 IIU/0.5 ml . The other vaccine ( B ) , prepared by purifying formalinized crude tetanus toxin and adsorbing it onto aluminium phosphate showed a high titre , 212 IIU/0.5 ml . No significant differences between titres of circulating antibodies were obtained after the first injection of either vaccine , but titres after the second injection were much higher for vaccine A as compared with those obtained using vaccine B. The results showed that the  immune response in human beings is not correlated to titres expressed in IIU . These results confirm that other methods should be adopted for evaluating the potency of vaccines . A simplified technique based on the comparison of circulating antitoxin levels after vaccination of mice has recently been proposed 1 approach to the prevention of tetanus neonatorum ( a leading cause of infant death throughout the world ) is improving the quality of prenatal , obstetric , and postnatal maternal and child health services . Another complementary approach is the active immunization of women before or during pregnancy with tetanus toxoid .  Work in progress at the Matlab field station of the International Center for Diarrheal Disease Research in Bangladesh ( ICDDR , B ) provided a unique opportunity to study the effectiveness of certain aspects of these 2 strategies . In 1974 , during a field trial of cholera toxoid vaccine , 2 injections of an aluminum phosphate tetanus-diphtheria toxoid were provided as a control to a r and omly assigned group of nonpregnant women . Beginning in June 1978 , a program of immunizing women during pregnancy with aluminum phosphate-absorbed tetanus toxoid was initiated in conjunction with the implementation of a village based maternal and child health and family planning program in half of the same Matlab surveillance area . Throughout the period of these 2 programs , the ICDDR , B maintained an independent , longitudinal , vital registration system , identifying all births and deaths in the study area . In this analysis , all live births registered in the Maternal and Child Health-Family Planning and comparison areas during the September 1 , 1978 until December 31 , 1979 period were identified . These records were linked with any deaths recorded within 28 days of birth . The acceptance of tetanus vaccination  during the 1974 cholera vaccine trial , by the mothers of these live births , was ascertained from the 1974 vaccine registers . The acceptance of vaccination during the 1978 - 1979 program was obtained from the field registers . For infants whose mothers had received 2 tetanus injections 48 - 64 months prior to delivery , the neonatal mortality rate was 63.8/l000 live births compared with 78.3/1000 
    Output:
    