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1.
N Engl J Med ; 381(21): 2009-2019, 2019 11 21.
Artigo em Inglês | MEDLINE | ID: mdl-31693803

RESUMO

BACKGROUND: Dengue, a mosquito-borne viral disease, was designated a World Health Organization top 10 threat to global health in 2019. METHODS: We present primary efficacy data from part 1 of an ongoing phase 3 randomized trial of a tetravalent dengue vaccine candidate (TAK-003) in regions of Asia and Latin America in which the disease is endemic. Healthy children and adolescents 4 to 16 years of age were randomly assigned in a 2:1 ratio (stratified according to age category and region) to receive two doses of vaccine or placebo 3 months apart. Participants presenting with febrile illness were tested for virologically confirmed dengue by serotype-specific reverse-transcriptase polymerase chain reaction. The primary end point was overall vaccine efficacy in preventing virologically confirmed dengue caused by any dengue virus serotype. RESULTS: Of the 20,071 participants who were given at least one dose of vaccine or placebo (safety population), 19,021 (94.8%) received both injections and were included in the per-protocol analysis. The overall vaccine efficacy in the safety population was 80.9% (95% confidence interval [CI], 75.2 to 85.3; 78 cases per 13,380 [0.5 per 100 person-years] in the vaccine group vs. 199 cases per 6687 [2.5 per 100 person-years] in the placebo group). In the per-protocol analyses, vaccine efficacy was 80.2% (95% CI, 73.3 to 85.3; 61 cases of virologically confirmed dengue in the vaccine group vs. 149 cases in the placebo group), with 95.4% efficacy against dengue leading to hospitalization (95% CI, 88.4 to 98.2; 5 hospitalizations in the vaccine group vs. 53 hospitalizations in the placebo group). Planned exploratory analyses involving the 27.7% of the per-protocol population that was seronegative at baseline showed vaccine efficacy of 74.9% (95% CI, 57.0 to 85.4; 20 cases of virologically confirmed dengue in the vaccine group vs. 39 cases in the placebo group). Efficacy trends varied according to serotype. The incidence of serious adverse events was similar in the vaccine group and placebo group (3.1% and 3.8%, respectively). CONCLUSIONS: TAK-003 was efficacious against symptomatic dengue in countries in which the disease is endemic. (Funded by Takeda Vaccines; TIDES ClinicalTrials.gov number, NCT02747927.).


Assuntos
Vacinas contra Dengue/imunologia , Vírus da Dengue/imunologia , Dengue/prevenção & controle , Doenças Endêmicas/prevenção & controle , Adolescente , Américas/epidemiologia , Anticorpos Neutralizantes/sangue , Anticorpos Antivirais/sangue , Ásia/epidemiologia , Criança , Pré-Escolar , Dengue/epidemiologia , Dengue/imunologia , Vacinas contra Dengue/efeitos adversos , Vírus da Dengue/isolamento & purificação , Método Duplo-Cego , Feminino , Humanos , Incidência , Masculino , Sorogrupo , Resultado do Tratamento
2.
Vaccine ; 2019 Nov 05.
Artigo em Inglês | MEDLINE | ID: mdl-31703934

RESUMO

BACKGROUND: A dose-sparing inactivated polio vaccine (IPV-Al), obtained by adsorption of inactivated virus to an aluminium hydroxide adjuvant, can help mitigate global supply and the cost constraints of IPV. The objective of this trial was to demonstrate the non-inferiority of IPV-Al to standard IPV. METHODS: This phase 3, observer-blinded, randomised, controlled trial was conducted at 5 investigational sites in the Philippines. Infants not previously vaccinated with any polio vaccines were randomised to receive three IPV-Al (n = 502) or IPV vaccinations (n = 500) at 6, 10 and 14 weeks of age plus a booster vaccination at 9 months. The primary endpoint was type-specific seroconversion, defined as an antibody titre ≥4-fold higher than the estimated maternal antibody titre and a titre ≥8, one month after the primary vaccination series. RESULTS: Seroconversion rates following primary vaccination with IPV-Al (483 infants in the per-protocol analysis set) or IPV (478 infants) were: polio type 1, 97.1% versus 99.0%; type 2, 94.2% versus 99.0%; and type 3, 98.3% versus 99.6%. IPV-Al was non-inferior to IPV, as the lower 95% confidence limits of the treatment differences were above the predefined -10%-point limit: type 1, -1.85% (-3.85; -0.05); type 2, -4.75% (-7.28; -2.52); type 3, -1.24 (-2.84; 0.13). The booster effect (geometric mean titre (GMT) post-booster / GMT pre-booster) was: type 1, 63 versus 43; type 2, 54 versus 47; type 3, 112 versus 80. IPV-Al was well tolerated with a safety profile comparable to that of IPV. Serious adverse events were recorded for 29 infants (5.8%, 37 events) in the IPV-Al group compared to 28 (5.6%, 48 events) in the IPV group. CONCLUSION: Non-inferiority of IPV-Al to IPV with respect to seroconversion was confirmed and a robust booster response was demonstrated. Both vaccines had a similar safety profile. ClinicalTrials.gov identifier: NCT03032419.

3.
Artigo em Inglês | MEDLINE | ID: mdl-31765270

RESUMO

The 7th Asian Vaccine Conference (ASVAC 2019) was held in Yangon, Myanmar from 13-15, September, 2019. It brought together stakeholders in the field of vaccination to address challenges and issues relevant to clinical practice and immunization programmes in the region. The conference themed "Immunization: sustaining health security in Asia", included pre-conference workshops, a Vaccinology Masterclass, plenary lectures, symposia and poster presentations. There were over 700 participants ~ 400 local and 300 international from 31 countries ~ and 55 international and local speakers from 19 countries. An Asian EPI managers' meeting was also held on 11-12 September in Naypyidaw, the new capital of Myanmar, and was hosted by Ministry of Health and Sports, Myanmar with support from World Health Organization, UNICEF and other partners. This inter-regional meeting aimed to strengthen the cooperation and collaboration of EPI Managers and others involved in implementing immunization programmes in the region. The conference was organized by the Immunization Partners in Asia Pacific (IPAP) and hosted by Myanmar Pediatric Society and the Ministry of Health and Sports, Myanmar. Other partners included the Confederation of Meningitis Organization, Philippine Foundation of Vaccination, Pediatric Infection Disease Society of the Philippines, Asia Pacific Alliance for the Control of Influenza, PATH, ROTA Council, International Society of Tropical Pediatrics, Asian Society for Pediatric Infection Diseases and other partners. Previous conferences have be held in Siem Reap (2009), Manila (2010), Jakarta (2011), Cebu (2013), Hanoi (2015) and Singapore (2015). The 8th Asian Vaccine Conference will be held in Penang, Malaysia in 2021 to further IPAP's vision of a world where no one suffers from a vaccine preventable disease.

4.
Hum Vaccin Immunother ; : 1-3, 2019 Nov 26.
Artigo em Inglês | MEDLINE | ID: mdl-31769714
5.
Vaccine ; 37(13): 1876-1884, 2019 Mar 22.
Artigo em Inglês | MEDLINE | ID: mdl-30558818

RESUMO

BACKGROUND: A quadrivalent split-virion inactivated influenza vaccine (VaxigripTetra™, Sanofi Pasteur; IIV4) containing two A strains (H1N1 and H3N2) and B strains from both lineages (Victoria and Yamagata) was approved in Europe in 2016 for individuals aged ≥ 3 years. This study examined the efficacy and safety of IIV4 in children aged 6-35 months. METHODS: This was a phase III randomised controlled trial conducted in Latin America, Asia, Africa, and Europe during the Northern Hemisphere 2014/2015 and 2015/2016 and Southern Hemisphere 2014 and 2015 influenza seasons. Healthy children aged 6-35 months not previously vaccinated against influenza were randomised to receive two full doses 28 days apart of IIV4, placebo, the licensed trivalent split-virion inactivated vaccine (IIV3), an investigational IIV3 containing a B strain from the alternate lineage. The primary objective was to demonstrate efficacy against influenza illness caused by any strain or vaccine-similar strains. RESULTS: The study enrolled 5806 participants. Efficacy, assessed in 4980 participants completing the study according to protocol, was demonstrated for IIV4. Vaccine efficacy was 50.98% (97% CI, 37.36-61.86%) against influenza caused by any A or B type and 68.40% (97% CI, 47.07-81.92%) against influenza caused by vaccine-like strains. Safety profiles were similar for IIV4, placebo, and the IIV3s, although injection-site reactions were slightly more frequent for IIV4 than placebo. CONCLUSIONS: IIV4 was safe and effective for protecting children aged 6-35 months against influenza illness caused by vaccine-similar or any circulating strains. CLINICAL TRIAL REGISTRATION: EudraCT no. 2013-001231-51.

7.
Curr Drug Saf ; 10(1): 80-6, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-25859680

RESUMO

Vaccines are among the most effective measures to control and prevent infectious diseases. Yet, the topic of vaccination is difficult to communicate, as it bears upon individual versus common good. The efficacy and safety of vaccines can only be shown by the absence of undesired events, such as vaccine-preventable diseases or adverse events following immunization. The authors of this paper view accurate, transparent and timely vaccine-safety communication to the media and general public as a core responsibility of healthcare providers. The authors wish to explore potential difficulties faced by immunization specialists when talking to the media, and suggest how to successfully convey vaccination messages to the general public.


Assuntos
Comunicação em Saúde/métodos , Disseminação de Informação , Meios de Comunicação de Massa , Opinião Pública , Vacinação , Vacinas/uso terapêutico , Acesso à Informação , Atitude do Pessoal de Saúde , Informação de Saúde ao Consumidor , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Programas de Imunização , Aceitação pelo Paciente de Cuidados de Saúde , Educação de Pacientes como Assunto , Segurança do Paciente , Percepção , Papel do Médico , Fatores de Proteção , Medição de Risco , Fatores de Risco , Vacinação/efeitos adversos , Vacinação/economia , Vacinas/efeitos adversos
8.
Hum Vaccin Immunother ; 10(8): 2276-83, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-25424932

RESUMO

Regulatory bodies in The Philippines, Sri Lanka, and India require post-marketing surveillance to provide additional safety data on Rotarix™ in real-life settings. In such studies conducted in The Philippines (November 2006 to July 2012; NCT00353366), Sri Lanka (November 2008 to August 2009; NCT00779779), and India (August 2009 to April 2010; NCT00938327), 2 doses of Rotarix™ were administered according to the local prescribing information (PI). The occurrence of at least Grade "2"/"3" solicited adverse event (AE) (fever, vomiting, or diarrhea), within 15 days in The Philippines or 8 days in Sri Lanka and India; unsolicited AEs within 31 days and serious adverse events (SAEs) throughout the study were recorded. Of the 1494, 522, and 332 infants enrolled in The Philippines, Sri Lanka, and India, 14.7% 14.9% and 12.7% infants, respectively recorded at least Grade "2"/"3" solicited AEs. The most commonly reported solicited AEs were irritability in The Philippines (32.2% post-Dose-1; 23.5% post-Dose-2) and India (23.0% post-Dose-1; 13.2% post-Dose-2), and fever (18.0% post-Dose-1; 20.2% post-Dose-2) in Sri Lanka. Unsolicited AEs were recorded in 24.5% (The Philippines), 4.8% (Sri Lanka), and 6.9% (India) of infants. Forty-one SAEs were recorded in the Philippines of which 6 (decreased oral intake with increased sleeping time and constipation; pneumonia, urinary tract infection, and intussusception) were considered by the investigators as causally related to vaccination. One vaccine-unrelated SAE occurred in a Sri Lankan infant. All SAEs resolved and the infants recovered. Two doses of Rotarix™, administered to healthy infants according to local PI, were well tolerated in The Philippines, Sri Lanka, and India.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Vigilância de Produtos Comercializados , Infecções por Rotavirus/prevenção & controle , Vacinas contra Rotavirus/efeitos adversos , Humanos , Índia/epidemiologia , Lactente , Recém-Nascido , Masculino , Filipinas/epidemiologia , Prevalência , Vacinas contra Rotavirus/administração & dosagem , Sri Lanka/epidemiologia , Vacinas Atenuadas/administração & dosagem , Vacinas Atenuadas/efeitos adversos
9.
PLoS Negl Trop Dis ; 8(11): e3027, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-25375119

RESUMO

This literature analysis describes the available dengue epidemiology data in the Philippines between 2000 and 2011. Of 253 relevant data sources identified, 34, including additional epidemiology data provided by the National Epidemiology Center, Department of Health, Philippines, were reviewed. There were 14 publications in peer reviewed journals, and 17 surveillance reports/sources, which provided variable information from the passive reporting system and show broad trends in dengue incidence, including age group predominance and disease severity. The peer reviewed studies focused on clinical severity of cases, some revealed data on circulating serotypes and genotypes and on the seroepidemiology of dengue including incidence rates for infection and apparent disease. Gaps in the data were identified, and include the absence incidence rates stratified by age, dengue serotype and genotype distribution, disease severity data, sex distribution data, and seroprevalence data.


Assuntos
Vírus da Dengue/classificação , Dengue/epidemiologia , Distribuição por Idade , Vírus da Dengue/genética , Vírus da Dengue/imunologia , Meio Ambiente , Genótipo , Humanos , Incidência , Filipinas/epidemiologia , Estações do Ano , Estudos Soroepidemiológicos , Sorogrupo , Distribuição por Sexo
10.
Vaccine ; 32(46): 6146-56, 2014 Oct 21.
Artigo em Inglês | MEDLINE | ID: mdl-25223266

RESUMO

BACKGROUND: Non-adjuvanted seasonal influenza vaccines show only modest efficacy in young children. This study compared the immunogenicity, reactogenicity and safety of the MF59-adjuvanted trivalent subunit vaccine (aTIV) with two non-adjuvanted trivalent vaccines, TIV-1, the non-adjuvanted version of aTIV, and TIV-2, a split virion vaccine. METHODS: 6078 children received two doses of aTIV (n=3125), TIV-1 (n=1479), or TIV-2 (n=1474) four weeks apart (Days 1 and 29). Children aged 6 to <36 months and 36 to <72 months received 0.25 mL and 0.50 mL doses, respectively. Immunogenicity was assessed by hemagglutination inhibition (HI) assay (n=2435) on Days 1, 29, 50 and 209. Safety was assessed up to Day 394. RESULTS: After the second vaccination (Day 50), the aTIV group showed significantly higher geometric mean HI titers and seroconversion rates than the TIV-1 or TIV-2 groups against all homologous and heterologous strains. The difference was enhanced at HI titers ≥110. aTIV elicited a faster, more persistent antibody response, with significantly higher titers in the aTIV group after one vaccination (Day 29) and after six months (Day 209) than in either TIV group. aTIV was more reactogenic than were TIV-1 and TIV-2 but rates of severe adverse events were very low for all three vaccines. CONCLUSION: In infants and young children, the MF59-adjuvanted vaccine induced substantially faster (after one dose), higher, persistent HI titers than the non-adjuvanted vaccines, with consistently higher seroprotection rates at increased threshold HI titers. This trial is registered at clinicaltrials.gov: NCT01346592.


Assuntos
Formação de Anticorpos , Vacinas contra Influenza/uso terapêutico , Influenza Humana/prevenção & controle , Adjuvantes Imunológicos/administração & dosagem , Anticorpos Antivirais/sangue , Pré-Escolar , Feminino , Testes de Inibição da Hemaglutinação , Humanos , Lactente , Vírus da Influenza A Subtipo H1N1 , Vírus da Influenza A Subtipo H3N2 , Vírus da Influenza B , Vacinas contra Influenza/administração & dosagem , Masculino , Polissorbatos/administração & dosagem , Método Simples-Cego , Esqualeno/administração & dosagem , Vacinas de Subunidades/administração & dosagem , Vacinas de Subunidades/uso terapêutico
11.
Pediatr Infect Dis J ; 32(10): e383-9, 2013 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-23629024

RESUMO

BACKGROUND: Worldwide, invasive pneumococcal disease (IPD) causes considerable morbidity and mortality among children, but incidence data in Asia are lacking. This 2-year hospital-based, prospective, surveillance study was conducted at 3 study sites in urban areas of the Philippines to estimate IPD and pneumonia incidence in children and describe the serotype distribution of invasive Streptococcus pneumoniae isolates. METHODS: Children aged 28 days to <60 months residing within the 3 surveillance areas presenting with possible IPD were enrolled. Initial diagnosis, history of pneumococcal vaccine receipt and previous antimicrobial treatment were recorded. Blood specimens were collected for S. pneumoniae identification and serotyping. Final diagnosis was determined for hospitalized subjects, subjects whose culture yielded S. pneumoniae and subjects with clinically suspected meningitis. RESULTS: A total of 5940 subjects were enrolled, 47 IPD cases identified. IPD site rates were 33.49 per 100,000, 25.38 per 100,000 and 25.85 per 100,000. Chest radiograph-confirmed pneumonia incidence ranged from 633.74 to 1683.59 per 100,000. Highest chest radiograph-confirmed pneumonia incidence occurred in those 28 days to <6 months of age at 2 sites (2166.16 and 3891.94 per 100,000) and those 6-12 months of age at the third site (3847.52 per 100,000). Thirty-five S. pneumoniae isolates were serotyped; most commonly identified were serotypes 1, 2, 5, 6B, 14 and 18F. One serotype 14 isolate was erythromycin resistant. Previous antibiotic therapy was documented in 17-53% of subjects; 2 subjects had received pneumococcal vaccine. At 2 sites, one-third of IPD subjects died. CONCLUSIONS: IPD is an important cause of morbidity and mortality among urban children in the Philippines. Our data support the expectation that widespread immunization would decrease IPD disease burden.


Assuntos
Infecções Pneumocócicas/epidemiologia , Streptococcus pneumoniae/isolamento & purificação , Pré-Escolar , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Filipinas/epidemiologia , Infecções Pneumocócicas/microbiologia , Infecções Pneumocócicas/mortalidade , Infecções Pneumocócicas/prevenção & controle , Vacinas Pneumocócicas/administração & dosagem , Estudos Prospectivos , Streptococcus pneumoniae/classificação , Streptococcus pneumoniae/imunologia , População Urbana/estatística & dados numéricos , Vacinação/estatística & dados numéricos
12.
Artigo em Inglês | MEDLINE | ID: mdl-23077857

RESUMO

Data on the epidemiology of acute hepatic failure (AHF) among pediatric Filipinos is limited. This study investigated the etiology, outcomes and incidence of AHF among 0-18 year old Filipino children. A hospital-based retrospective and prospective surveillance study was conducted at Philippine General Hospital between January 2000 and December 2006. AHF was defined as onset of coagulopathy and/or encephalopathy < or = 28 days after the onset of symptoms, a patient/ laboratory prothrombin time >2, an elevated bilirubin level and evidence of liver failure complicated by encephalopathy. Blood samples were tested for viral hepatitis antibodies using ELISA (Abbott Lab). AHF incidence rates were calculated with 95% confidence intervals (CI). Twenty-seven subjects were recruited and 26 included in the analysis. The mean age of AHF subjects at the time of hospital admission was 6.9 years (SD:6.09 years). The most frequent etiological agents for AHF were hepatitis A virus (HAV) (19.2%; 5/26) and hepatitis B virus (3.8%; 1/26). Incidence of AHF was 11.05 per 100,000 subject years (95% CI 6.81-15.30). Jaundice was observed in 84.6% (22/26) of subjects and encephalopathy on admission (any grade) was reported in 72.0% of subjects: AHF was fatal in 84.6% (22/26) of subjects. HAV was the most common etiological agent for AHF. Indeterminate causes for AHF indicate the need for further investigation.


Assuntos
Falência Hepática Aguda/complicações , Falência Hepática Aguda/epidemiologia , Adolescente , Criança , Pré-Escolar , Ensaio de Imunoadsorção Enzimática , Feminino , Hepacivirus , Encefalopatia Hepática/etiologia , Vírus da Hepatite A , Anticorpos Anti-Hepatite , Humanos , Incidência , Lactente , Recém-Nascido , Icterícia/etiologia , Falência Hepática Aguda/etiologia , Falência Hepática Aguda/virologia , Masculino , Filipinas/epidemiologia , Estudos Prospectivos , Estudos Retrospectivos
13.
Int J Infect Dis ; 14(8): e649-58, 2010 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-20181506

RESUMO

BACKGROUND: Diphtheria (D), tetanus (T), pertussis (P), hepatitis B (HepB), invasive Haemophilus influenzae type b (Hib) disease, and measles cause substantial global morbidity and mortality. METHODS: This unique review highlights geographic differences in disease burden across certain countries in the African, Americas, Mediterranean, South-East Asian, and Western Pacific World Health Organization (WHO) regions, and relates this to vaccination coverage and local vaccine recommendations using the authors' countries as illustrations. RESULTS: Substantial differences were observed in the incidence of these diseases and in vaccination coverage between the countries studied. Disease incidence often reflected inadequate surveillance, but also variable or poor vaccination coverage. Vaccination coverage against HepB was particularly low in the African and South-East Asian WHO regions; vaccination coverage against invasive Hib disease was low in these regions and in the Eastern Mediterranean and Western Pacific WHO regions. Vaccination schedules within some countries in these regions do not include, or have only recently included, vaccinations against HepB and Hib disease. The use of DTwP-HepB-Hib (diphtheria, tetanus, whole-cell pertussis, HepB, Hib) combination vaccines has now been adopted by some countries to help increase vaccination coverage. CONCLUSIONS: Vaccination coverage and vaccination schedules vary markedly between the countries studied, often according to the resources available. DTwP-HepB-Hib combination vaccines represent a cost-effective option, with the potential to substantially reduce the burden associated with these diseases by increasing coverage and compliance.


Assuntos
Vacinas Bacterianas/administração & dosagem , Difteria/epidemiologia , Infecções por Haemophilus/epidemiologia , Diretrizes para o Planejamento em Saúde , Hepatite B/epidemiologia , Sarampo/epidemiologia , Tétano/epidemiologia , Vacinas Virais/administração & dosagem , Coqueluche/epidemiologia , Criança , Difteria/prevenção & controle , Saúde Global , Infecções por Haemophilus/prevenção & controle , Haemophilus influenzae tipo b/imunologia , Hepatite B/prevenção & controle , Humanos , Esquemas de Imunização , Incidência , Sarampo/prevenção & controle , Tétano/prevenção & controle , Vacinação/métodos , Vacinação/estatística & dados numéricos , Vacinas Combinadas/administração & dosagem , Coqueluche/prevenção & controle , Organização Mundial da Saúde
14.
Artigo em Inglês | MEDLINE | ID: mdl-19842381

RESUMO

The Philippines annual birth cohort of over 2 million is the second largest in the Western Pacific Region; 44% of births occur outside health facilities. With third dose infant hepatitis B (HB) vaccine coverage of 43% in 2006, erratic vaccine supply, and lack of policies or processes for universal HB vaccine birth dose delivery, a substantial burden of preventable chronic HB infection continues to occur. Funding, policy, technical and immunization delivery developments now make substantial progress in HB control in the Philippines possible. These developments can help expand access to trained birth care and essential postnatal care for mothers and their newborn.


Assuntos
Controle de Doenças Transmissíveis/organização & administração , Vacinas contra Hepatite B/administração & dosagem , Hepatite B/prevenção & controle , Programas de Imunização/organização & administração , Esquemas de Imunização , Vacina BCG/administração & dosagem , Feminino , Prioridades em Saúde , Hepatite B/epidemiologia , Hepatite B/transmissão , Vacinas contra Hepatite B/provisão & distribução , Humanos , Recém-Nascido , Transmissão Vertical de Doença Infecciosa/prevenção & controle , Filipinas/epidemiologia , Gravidez , Complicações Infecciosas na Gravidez/prevenção & controle
15.
Vaccine ; 25(50): 8432-40, 2007 Dec 05.
Artigo em Inglês | MEDLINE | ID: mdl-17961876

RESUMO

This paper presents the results of four separate phase III trials, which assessed the immunogenicity and reactogenicity of DTPw-HBV/Hib 2.5 in comparison with licensed Tritanrix-Hep B (GlaxoSmithKline Biologicals) and Hiberix (10 microg PRP), given as separate or mixed injections (3 trials) or with or without hepatitis B vaccine at birth (1 trial). The immunogenicity of DTPw-HBV/Hib 2.5 was non-inferior to the reference vaccine regimen in terms of seropositivity rates. The overall reactogenicity profile of DTPw-HBV/Hib 2.5 was also similar to that of the reference vaccine regimen. These results confirm the previously established immunogenicity and safety of reduced dose PRP conjugated vaccine regimens.


Assuntos
Anticorpos Antibacterianos/sangue , Vacina contra Difteria, Tétano e Coqueluche/efeitos adversos , Vacina contra Difteria, Tétano e Coqueluche/imunologia , Vacinas Anti-Haemophilus/efeitos adversos , Vacinas Anti-Haemophilus/imunologia , Anticorpos Anti-Hepatite B/sangue , Vacinas contra Hepatite B/efeitos adversos , Vacinas contra Hepatite B/imunologia , Vacinas Combinadas/efeitos adversos , Vacinas Combinadas/imunologia , Vacina contra Difteria, Tétano e Coqueluche/administração & dosagem , Método Duplo-Cego , Feminino , Vacinas Anti-Haemophilus/administração & dosagem , Antígenos de Superfície da Hepatite B/imunologia , Vacinas contra Hepatite B/administração & dosagem , Humanos , Esquemas de Imunização , Lactente , Masculino , Polissacarídeos/imunologia , Resultado do Tratamento , Vacinação , Vacinas Combinadas/administração & dosagem , Vacinas Conjugadas/administração & dosagem , Vacinas Conjugadas/efeitos adversos , Vacinas Conjugadas/imunologia
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