Pilar García-Corbeira

GlaxoSmithKline | GSK · Medical Department

Background Three hexavalent vaccines against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B virus (HBV), and Haemophilus influenzae type b (Hib) are licensed in Europe: Infanrix hexa (DT3aP-HBV-IPV/Hib), Hexyon (DT2aP-HBV-IPV-Hib) and Vaxelis (DT5aP-HBV-IPV-Hib). Methods A systematic literature search was performed in various electroni...

Background: Infants with history of prematurity (<37 weeks gestation) and low birth weight (LBW, <2500 g) are at high risk of infection due to functional immaturity of normal physical and immunological defense mechanisms. Despite current recommendations that infants with history of prematurity/LBW should receive routine immunization according to t...

Introduction This study was undertaken to estimate the burden of morbidity associated with laboratory-confirmed influenza in children below 15 years of age. Patients and methods Children presenting with acute respiratory infection and/or isolated fever at the Basurto University Hospital, Bilbao, Spain between November 2010 and May 2011 were includ...

In children, two AS03-adjuvanted A(H1N1)pdm09 vaccine doses given 21 days apart were previously shown to induce a high humoral immune response and to have an acceptable safety profile up to 42 days following the first vaccination. Here, we analysed the persistence data from two open-label studies, which assessed the safety, and humoral and cell-med...

This study assessed the immunogenicity and safety of a human rotavirus vaccine RIX4414; the effect of co-administration of childhood vaccines on the immune responses was also assessed. Healthy infants aged 6-14 weeks received two doses of RIX4414/placebo concomitantly with the primary childhood vaccination (Infanrix hexa, Infanrix quinta,Meningitec...

A range of schedules are recommended for hepatitis B vaccination of premature infants. This open-label study (217744/083) compared the immune response of premature (N = 94) and full-term infants (N = 92) to hepatitis B antigen following primary administration of hexavalent DTPa-HBV-IPV/Hib vaccine at 2-4-6 months and a booster dose at 18 months. An...

The development of vaccines against pandemic influenza viruses for use in children is a public health priority. In this phase II, randomized, open study, the immunogenicity and reactogenicity of H5N1 A/Vietnam/1194/2004 (NIBRG-14) (clade 1) prepandemic influenza vaccine were assessed in children aged 3 to 5 and 6 to 9 years. Children were randomize...

A booster dose of Haemophilus influenzae type b-Neisseria meningitidis serogroup C conjugate (Hib-MenC-TT) vaccine simultaneously administered with measles, mumps, and rubella (MMR) vaccine in 13- to 14-month-old Spanish toddlers, primed with 3 doses of a combined Diphteria-Tetanus-Acellular Pertusis DTPa-Hib-containing vaccine and a MenC-CRM197 co...

Background: Children suffer severe effects of influenza and play a major role in disease transmission. Prepandemic influenza vaccination of children can be a highly effective measure to contain the spread of pandemic influenza and to reduce its morbidity and mortality. The development of vaccines inducing broad immunity against drifted H5N1 strains...

A combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine (Hib-MenC-TT) may be a convenient alternative to separate Hib and MenC conjugate vaccines. Healthy infants randomized in a previous study for priming at 2, 4, and 6 months: Hib-MenC-TT primed group, 3 doses of Hib-MenC-TT + DTPa-HBV-IPV...

These studies assessed the immunogenicity and reactogenicity of booster vaccination with diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-adsorbed conjugated Haemophilus influenzae type b (DTaP-HBV-IPV/Hib) at 18-20 months, and with DTaP during the fifth year of life in children who had been born prematurely (<37 weeks gest...

This phase II study evaluated the immunogenicity and reactogenicity of primary vaccination with a novel Hib-MenC conjugate vaccine (GlaxoSmithKline [GSK] Biologicals) coadministered with DTPa-HBV-IPV (GSK Biologicals) at 2, 4 and 6 months. Healthy infants were randomized to receive Hib-MenC coadministered with DTPa-HBV-IPV (N = 117) or MenC-CRM (Wy...

Prematurity may be a risk factor for Haemophilus influenzae type b vaccine failure. This article evaluates the Haemophilus influenzae type b immunogenicity of a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus/Haemophilus influenzae type b vaccine in preterm infants (< 37 weeks' gestation). This was an open-label...

Children 17-20 months of age (N = 344) received a diphtheria-tetanus toxoids-acellular pertussis (DTPa)-inactivated poliovirus vaccine (IPV)/Haemophilus influenzae (Hib) booster after a 3-dose primary vaccination course with DTPa-hepatitis B vaccine-IPV/Hib plus conjugate meningococcal C vaccine-CRM. Seroprotection rates were >80% (diphtheria, teta...

This study evaluated the concurrent use of meningococcal C tetanus conjugate (MenC-TT) vaccine (NeisVac-C) with DTaP-based combinations, according to 2 vaccination schedules, one of which included hepatitis B vaccination at birth (Trial DTaP-HBV-IPV/Hib-097). Healthy infants were randomized to receive either DTaP-HBV-IPV/Hib (Infanrix hexa) at 2, 4...

Preterm infants are at increased risk from infections and should be vaccinated at the usual chronological age. The aim of the study was to evaluate the immunogenicity and reactogenicity of a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B virus-inactivated polio and Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine in preterm i...

A prospective observational naturalistic study was conducted to assess the reactogenicity of the combined hepatitis A and hepatitis B (HAB) vaccine in a real-life setting. All healthy candidates for HAB vaccination attending an adult vaccination centre between October 1998 and February 2000 were invited to participate in the study. A follow-up diar...

To evaluate the immunogenicity and safety of 3 doses of the combined diphtheria-tetanus toxoids-acellular pertussis-hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine (Infanrix hexa) when coadministered with a CRM197-conjugated meningococcal C vaccine (Meningitec) at different injection sites during th...

An open, randomised, multicentre trial was performed to compare the reactogenicity and safety profile of the administration of a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio (DTPa-HBV-IPV) vaccine administered in one injection mixed with Haemophilus influenzae type b (Hib) conjugate vaccine (Group 1) with that of...

The diphtheria-tetanus-whole-cell pertussis (DTPw) vaccine is being replaced in Western countries,and in several Spanish Autonomous Communities, by the diphtheria-tetanus-acellular pertussis (DTPa) vaccine. Although the administration of booster doses of DTPw or DTPa and Haemophilus influenzae type b conjugate (Hib) vaccines to toddlers is a curren...

An open, randomised, multicentre trial was performed to assess the reactogenicity and safety profile of the administration of a candidate Haemophilus influenzae type b (Hib) conjugate vaccine with a quadrivalent diphtheria-tetanus-acellular pertussis-hepatitis B (DTPa-HBV) vaccine as a single injection (Group 1) versus the simultaneous administrati...

Background: Only limited data on the seroprevalence of herpes simplex virus type 2 (HSV-2) are available from European countries. Until recently, serologic tests for HSV-2 serotyping have been hampered by cross-reactivity to type-common antigens. The present study aims at providing data on the prevalence of HSV-2 infection in a group of STD clinic...

Objective To compare the reactogenicity and safety of the administration of diphtheria-tetanus-acellular pertussis (DTPa) and Haemophilus influenzae type b conjugate (Hib) vaccines in one injection with those of the simultaneous administration of diphtheria-tetanus-whole cell pertussis (DTPw) and Hib vaccines in opposite limbs as booster doses to 1...

A prospective observational naturalistic study was conducted at a vaccination center to assess the reactogenicity of tetanus-diphtheria (adult-type) (Td) vaccine. In 1 year, 3072 adult subjects were invited to participate, of whom 1977 (62% women, mean age [+/- SD]: 39 [+/- 14.5] years [range: 18-85 years]) actively did so. A follow-up diary card w...

A seroepidemiological study was conducted to assess the seroprevalence of hepatitis A (HAV) antibodies in the Spanish general population in 1992-93. A total of 2744 subjects (1337 men and 1437 women) in the 5-59 years age range were stratified by gender and age (5-12, 13-19, 20-29, 30-39, 40-49, 50-59 years). The presence of total anti-HAV antibodi...

Seroepidemiology studies of herpes simplex virus type 2 (HSV-2) infections have been difficult to carry out because antibodies to HSV type 1 (HSV-1) show an extensive cross-reactivity with HSV-2 antigens. Many kits available currently are not entirely type specific for serodiagnosis of HSV-2 infections and therefore do not allow reliable discrimina...

Herpes simplex type 2 (HSV-2) seroprevalence within a community is determined by sexual and perinatal transmission from mother to baby, the two main sources of virus shedding. A seroepidemiological study of HSV-2 was undertaken on a representative sample (n = 3974) of the Spanish population to assess indirectly the relative relevance of these two t...

A seroepidemiological study was conducted on a representative sample (n = 3944) of the Spanish population to assess the immune status to diphtheria. A total of 1907 men and 2037 women in the 5-59 years age range were stratified by sex and age (5-12, 13-19, 20-29, 30-39, 40-49, 50-59 years). Concentrations of toxin antibodies were measured using a c...

The MIC is the main microbiologic parameter used to predict the efficacies of antibiotics. However, it is well known that MICs may vary according to the inoculum size used (inoculum effect), especially with some beta-lactam antibiotics. In order to correlate the pharmacologic and microbiologic properties of some beta-lactams, an experimental model...

HSV-2 seroepidemiological studies may be difficult to perform since antibodies to HSV-1 show an extensive crossreactivity with HSV-2 antigens. A panel of 306 specimens, obtained from Spanish universitary healthy students (age range: 18-25) were evaluated for HSV-2 Ig G antibodies by a non-recombmant enzyme immunoassay (Flatest HSV-2 IgG). Positive...

The inoculum effect on minimum inhibitory and minimum bactericidal concentrations of cefditoren, benzylpenicillin, ampicillin, cefotaxime, ceftriaxone, and meropenem against six clinical isolates each of Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria meningitidis was studied using inocula of approximately 10(4) to 10(5) and 10(7) t...

We performed a retrospective analysis of 28 cases of bacteriuria due to nontyphoidal Salmonella (NTS). Twenty-onepatients (75%) had symptoms of urinary tract infection (16, cystitis; 3, pyelonephritis; and 2, renal abscess), and 7 remained asymptomatic. In 24 casesNTS was the sole pathogen isolated from urine. Salmonella enteritidis (a Salmonella s...

Non-typhoid Salmonella infection in man has been divided into five clinical groups: gastroenteritis, enteric fever, bacteraemia, chronic carrier state and localized infection. This classification has neither pathogenic nor prognostic significance. We retrospectively reviewed the charts of 183 patients with extraintestinal salmonellosis who presente...

The aim of this study was to know the clinical characteristics of osteoarticular infection by Salmonella non typhi (SNT) in Spain. The medical records of 14 patients with osteoarticular infection by SNT from January 1970 to December 1992 were reviewed. Over the above mentioned 23 years, 1334 patients had been diagnosed with one or more SNT isolatio...

We retrospectively reviewed the charts of 51 patients with primary nontyphoid salmonella (NTS) bacteremia who did not have AIDS and who had no history of gastroenteritis and no other identified source of infection. We compared these patients with 58 patients who developed secondary NTS bacteremia following an episode of gastroenteritis. The followi...

The aim of this study was to analyze the manifestations of the syndromes which constitute focal infection by Salmonella no typhi (SNT). Ninety-one episodes of SNT infections studied over a period of 32 years in the Fundación Jiménez Díaz (Madrid, Spain) were retrospectively analyzed. Of the 1,892 patients with SNT infection studied during this peri...

Despite the efficacy of modern antimicrobials bacteremia by anaerobes (AB) continues to present a high mortality rate. The aim of this study was to determine the relative frequency and clinical significance of isolations of anaerobic bacteria in blood cultures and to know the prognostic factors of AB. From total of 231 patients observed over a peri...

To know the incidence of Mycobacterium tuberculosis resistant to anti-tuberculin drugs in addition to the clinical features, treatment and evolution of the patients. This was a retrospective study of the clinical histories of patients with isolation of Mycobacterium tuberculosis with some type of resistance studied from January 1980 to April 1992....