scholarly journals Comparison of the Immunogenicity and Safety of Three Enhanced Inactivated Poliovirus Vaccines from Different Manufacturers in Healthy Korean Infants: A Prospective Multicenter Study

Vaccines ◽  
2020 ◽  
Vol 8 (2) ◽  
pp. 200
Author(s):  
Byung Ok Kwak ◽  
Sang Hyuk Ma ◽  
Su Eun Park ◽  
Seon Hee Shin ◽  
Kyung Min Choi ◽  
...  
Keyword(s):  
Adverse Events ◽  
Prospective Study ◽  
Geometric Mean ◽  
Neutralizing Antibody ◽  
Primary Vaccination ◽  
Reliable Data ◽  
Prospective Multicenter Study ◽  
Serious Adverse Events ◽  
Healthy Infants ◽  
A Prospective Study

The enhanced inactivated poliovirus vaccine was first introduced in 2002, and several inactivated poliovirus vaccines are licensed in Korea. Reliable data by a prospective study on the immunogenicity and safety of the inactivated poliovirus vaccines in Korean infants are required. Normal healthy infants aged 6–12 weeks received three doses of the vaccine (IPVAX™, Imovax Polio™ or Poliorix™) in intervals of 2 months. Neutralizing antibody (NTAb) titers were measured before and 4–6 weeks after three-dose primary vaccination. Immunogenicity was evaluated by seroconversion rates and geometric mean titers obtained by analyzing NTAb titers. Local and systemic adverse events were recorded during 7 days after each vaccination. A total of 150 infants were included: 40 in IPVAX™, 52 in Imovax Polio™, and 58 in Poliorix™. The seroconversion rates for the group vaccinated with IPVAX™ were 100% in types 1, 2 and 3, while those of Imovax Polio™ were 98.1%, 96.2%, 96.2% and those of Poliorix™ were 98.3%, 100%, 100%, respectively. In all groups, injection site redness and irritability were the most common local and systemic adverse events. Neither serious adverse events nor adverse events above grade 2 were reported throughout the study. The currently used inactivated poliovirus vaccines was demonstrated to be safe and immunogenic in healthy Korean infants.

Postoperative serious adverse events in a teaching hospital: a prospective study

2002 ◽  
Vol 176 (5) ◽  
pp. 216-218 ◽  
Author(s):  
Rinaldo Bellomo ◽  
Donna Goldsmith ◽  
Sarah Russell ◽  
Shigehiko Uchino
Keyword(s):  
Adverse Events ◽  
Prospective Study ◽  
Teaching Hospital ◽  
Serious Adverse Events ◽  
A Prospective Study

scholarly journals Immunogenicity and Safety of Porcine Circovirus-Free Human Rotavirus Vaccine in Healthy Infants: A Phase 3 Randomized Trial

2020 ◽  
Author(s):  
Ignacio Salamanca de la Cueva ◽  
Barbara Pahud ◽  
Li-Min Huang ◽  
Michael Leonardi ◽  
José Garcia-Sicilia ◽  
...  
Keyword(s):  
Adverse Events ◽  
Limit Of Detection ◽  
Geometric Mean ◽  
Porcine Circovirus Type ◽  
Porcine Circovirus ◽  
Rotavirus Vaccine ◽  
Post Dose ◽  
Serious Adverse Events ◽  
Healthy Infants ◽  
Human Rotavirus

Abstract Background Porcine circovirus type 1 (PCV-1) material was detected in the human rotavirus vaccine (HRV) in 2010. In this study we compared immunogenicity and safety of the PCV-free HRV vaccine (PCV-free HRV) with HRV. PCV-free HRV is an HRV with no detectable PCV-1 and PCV-2 according to the limit of detection of the tests used. Methods Healthy infants 6–12 weeks of age were randomized (1:1:1:1) to receive 2 doses of 1 of the 3 lots of PCV-free HRV or HRV. The study objectives were to demonstrate lot-to-lot consistency of the PCV-free HRV and noninferiority of PCV-free HRV as compared to HRV in terms of immunogenicity, 1–2 months post dose 2. Reactogenicity and safety were also assessed. Results Overall, 1612 infants were enrolled and 1545 completed the study. Study objectives were demonstrated because the predefined criteria were met. Among participants receiving PCV-free HRV and HRV, 79.27% and 81.76% seroconverted and geometric mean concentrations were 159.5 and 152.8 U/mL, respectively. The incidences of adverse events and serious adverse events were similar between the pooled PCV-free HRV and HRV groups. Conclusions The 3 PCV-free HRV lots demonstrated consistency and PCV-free HRV was noninferior compared to HRV in terms of immunogenicity. Clinical trials registration NCT02914184.

scholarly journals First, do no harm: the risks of overtreating children with epilepsy

2007 ◽  
Vol 65 (1) ◽  
pp. 1-4 ◽  
Author(s):  
Eunice Chuang ◽  
Marilisa M. Guerreiro ◽  
Sara Y. Tsuchie ◽  
Angelica Santucci ◽  
Carlos A. M. Guerreiro ◽  
...  
Keyword(s):  
Adverse Events ◽  
Prospective Study ◽  
Antiepileptic Drug ◽  
Antiepileptic Drugs ◽  
Seizure Frequency ◽  
Seizure Control ◽  
Control Method ◽  
Refractory Epilepsy ◽  
Do No Harm ◽  
A Prospective Study

BACKGROUND: Although overtreatment with antiepileptic drugs contributes to the morbidity associated with epilepsy, many children still are overtreated. OBJECTIVE: To evaluate if the withdrawal of at least one antiepileptic drug (AED) in children with refractory epilepsy using polytherapy enable a better seizure control. METHOD: This was a prospective study. Children with refractory epilepsy using at least two AEDs were included. Once the patient, or guardian, agreed to participate in the study, one or more AED were slowly tapered off. The remaining AEDs dosages could be adjusted as needed, but a new AED could not be introduced. RESULTS: Fifteen patients were evaluated, three girls; ages ranging from 3 to 18 (mean=8.7 years). After at least one AED withdrawal, two (13.5%) patients became seizure free, seizures improved >50% in 5 (33.5%) patients, did not change in 5 (33.5%), and seizure frequency became worse in 3 (20%). Adverse events improved in 12 patients (80%). CONCLUSION: The withdrawal of at least one AED is a valuable option in the treatment of selected children with refractory epilepsy.

scholarly journals Dual Modal Ultrasound Elastography of the Sternocleidomastoid Muscle in Healthy Infants: A Prospective Study

2019 ◽  
Vol 3 (4) ◽  
pp. 182
Author(s):  
Xu, MD Na ◽  
Xia, MD Bei ◽  
Shi, MD Wei ◽  
Tang, MD Ningning ◽  
Wu, MD ZhiXia ◽  
...  
Keyword(s):  
Prospective Study ◽  
Sternocleidomastoid Muscle ◽  
Ultrasound Elastography ◽  
Healthy Infants ◽  
A Prospective Study

scholarly journals DETECTION OF IgM ANTIBODIES TO Schistosoma mansoni GUT-ASSOCIATED ANTIGENS FOR THE STUDY OF THE DYNAMICS OF SCHISTOSOMIASIS TRANSMISSION IN AN ENDEMIC AREA WITH LOW WORM BURDEN

1998 ◽  
Vol 40 (4) ◽  
pp. 225-231 ◽  
Author(s):  
Herminia Y. KANAMURA ◽  
Luiz Candido S. DIAS ◽  
Carmem M. GLASSER ◽  
Rita Maria da SILVA ◽  
Rosa Maria J. PATUCCI ◽  
...  
Keyword(s):  
Prospective Study ◽  
Worm Burden ◽  
Endemic Area ◽  
Geometric Mean ◽  
Incidence Rates ◽  
Immunofluorescence Test ◽  
Blood Samples ◽  
Serological Data ◽  
A Prospective Study

For a period of 2 years, five follow-up measures of prevalence and incidence rates were estimated in a prospective study of S. mansoni infection in a group of schoolchildren who were living in a rural area of the Municipality of Itariri (São Paulo, Brazil), where schistosomiasis is transmitted by Biomphalaria tenagophila. Infection was determined by the examination of three Kato-Katz stool slides, and the parasitological findings were analyzed in comparison to serological data. In the five surveys, carried out at 6-month intervals (March-April and September-October), the prevalences were, respectively, 8.6, 6.8, 9.9, 5.8 and 17.2% by the Kato-Katz, and 56.5, 52.6, 60.8, 53.5 and 70.1% by the immunofluorescence test (IFT). Geometric mean egg counts were low: 57.8, 33.0, 35.6, 47.3 and 40.9 eggs per gram of feces, respectively. Of the total of 299 schoolchildren, who submitted five blood samples at 6-month intervals, one for each survey, 40% were IFT-positive throughout the study, and 22% were IFT-negative in all five surveys. Seroconversion from IFT negative to positive, indicating newly acquired S. mansoni infection, was observed more frequently in surveys carried out during March-April (after Summer holidays), than during September-October. Seasonal trends were not statistically significant for detection of S. mansoni eggs in stool. The results indicate that the use of IgM-IFT is superior to parasitological methods for detection of incidence of S. mansoni infection in areas with low worm burden.

scholarly journals Immunogenicity and Safety of 3 Formulations of a Respiratory Syncytial Virus Candidate Vaccine in Nonpregnant Women: A Phase 2, Randomized Trial

2019 ◽  
Vol 220 (11) ◽  
pp. 1816-1825 ◽  
Author(s):  
Tino F Schwarz ◽  
Roderick A McPhee ◽  
Odile Launay ◽  
Geert Leroux-Roels ◽  
Jaak Talli ◽  
...  
Keyword(s):  
Respiratory Syncytial Virus ◽  
Neutralizing Antibodies ◽  
Geometric Mean ◽  
Neutralizing Antibody ◽  
Candidate Vaccine ◽  
Phase 2 ◽  
Serious Adverse Events ◽  
Intramuscular Dose ◽  
Syncytial Virus ◽  
Neonates And Infants

Abstract Background Respiratory syncytial virus (RSV) is a common cause of respiratory tract illness and hospitalization in neonates and infants. RSV vaccination during pregnancy may protect offspring in their first months of life. Methods This randomized, observer-blind, multicenter, phase 2 study evaluated the immunogenicity and safety of an RSV candidate vaccine in healthy nonpregnant women aged 18–45 years. Four hundred participants were randomized (1:1:1:1) to receive a single intramuscular dose of vaccine containing 30 µg, 60 µg, or 120 µg of RSV fusion protein engineered to preferentially maintain a prefusion conformation (RSV-PreF vaccine) or placebo. Results Thirty days postvaccination, RSV-A neutralizing antibody geometric mean titers (GMTs) increased 3.75-, 4.42- and 4.36-fold; RSV-B neutralizing antibody GMTs 2.36-, 2.54- and 2.76-fold; and palivizumab competing antibody (PCA) concentrations 11.69-, 14.38- and 14.24-fold compared with baseline levels in the 30 µg, 60 µg, and 120 µg RSV-PreF groups, respectively. Antibody titers and PCA concentrations at day 30 were significantly higher with the 120 µg compared to the 30 µg RSV-PreF vaccine. All RSV-PreF vaccine formulations and the placebo had similar reactogenicity profiles. No serious adverse events were considered to be related to the RSV-PreF vaccine. Conclusions The 3 formulations of the investigational RSV-PreF vaccine were well-tolerated and induced RSV-A and RSV-B neutralizing antibodies and PCAs in healthy, nonpregnant women. Clinical Trials Registration NCT02956837.

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