Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly...
Hepatitis BDiphtheria4 moreThis study will assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals' (formerly SmithKline Beecham Biologicals') DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine compared to the separate administration of DTPa-HBV-IPV (Infanrix™ penta) and Hib (Hiberix™) vaccines administered at 3 and 5 months of age.
Polio End-game Strategies - Poliovirus Type 2 Challenge Study
PoliomyelitisPoliomyelitis eradication has entered its last phase with only three remaining endemic countries, of which Pakistan is one. There hasn't been a case of wild type poliovirus 2 since 1999, and no case of wild type poliovirus 3 since November 2012. However, paralytic polio resulting from circulating strains of Sabin poliovirus type 2 have become a challenge, and reported from several areas with low population immunity to polio, including in Pakistan. This study will provide data to National Immunization Authorities in order to make strategic decisions about their polio vaccination schedules in anticipation of the global tOPV to bOPV switch and will provide data on the proposed responses to type 2 poliovirus outbreaks.
Treatment of Post-poliomyelitis Syndrome by Intravenous Immunoglobulin
Post-Poliomyélitis SyndromOur study evaluates the efficacy of IGIV treatment in PPS on clinical (walking and pain) and isokinetic (muscle strength) criteria, on patients with PS at Montpellier's Hospital
To Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to...
DiphtheriaTetanus2 moreThe study objective is to assess the immunogenicity and safety of DTaP-IPV combination vaccine administered as a boosting dose to healthy 4 to 6-year-old children who received three doses of primary immunization against diphtheria, tetanus, pertussis, and polio.
To Develop, Implement and Evaluate the Polio Demonstration Project Comprising of a Community Based...
PolioPolio Sero Conversion2 moreThe objective of the projects is to Develop and implement a Package of interventions that will comprise of an augmented communication and counseling strategy coupled with private sector involvement and a combined Oral Polio Vaccine and Inject able Polio Vaccine approach during the Polio campaigns followed by the evaluation of this project for acceptability, feasibility and effectiveness of the intervention Package.
Comparison of Immunity Following IPV Versus fIPV: a Community Based Randomized Controlled Trial...
Poliovirus VaccineInactivated2 moreThis study will be conducted in four low-income areas of Bin Qasim Town Karachi. This will be a community based randomized control trial of 21 months duration. The trial will include four arms; arm A and B will enroll children age 14-18 weeks and randomize them to either full dose IPV (0.5ml) or fractional IPV (0.1ml). Arms C and D will enroll children at 9 months of age and randomize them to either fractional or full dose IPV. Children aged 14 weeks for arms A and B and 9 months for arms C and D living in the selected communities of Bin qasim Town Karachi who have not received IPV vaccine during routine immunization for arms A and B and who have documentary evidence of receiving IPV vaccine at 14 weeks of age for arms C and D will be eligible for enrollment. The investigators will exclude children who are found acutely ill or those requiring emergent medical care/hospitalization at the time of enrollment. The investigators will use the Demographic Surveillance System (DSS) in the four study areas to identify the households with eligible children. The children of the parents who agree to participate in the study will be screened for eligibility by the trained research associates. After randomization into four different arms, the study trained research vaccinators will administer the IPV or fIPV as per randomization. Children will be observed in the center for 30 minutes after vaccination before leaving for home. Parents/guardians of all the participants will also be requested to immediately report any adverse effect occurring later. This study will be conducted in compliance with this protocol, GCP guidelines and all applicable international and local regulatory requirements. The study has approval by the Ethical Review Committee of the Aga Khan University (AKU), the National Bioethics Committee of Pakistan, and ethical approval at WHO/Headquarters in Geneva. All study procedures will be conducted in AKU's field research sites from where subjects will be recruited. The Clinical Trials Unit (CTU) of AKU will be engaged in providing support for specific study procedures conducted at CTU such as randomization, management of vaccines (storage, dispensing and incineration), and other responsibilities agreed in writing. Adverse events following vaccine administration will be monitored and all serius adverse events will be reported within 24 hours to WHO, DSMB and AKU IRB. All the vaccines used are licensed in Pakistan and in routine use.
Immunogenicity nOPV2 With and Without bOPV
PoliomyelitisThis is an open-label randomized clinical trial that will compare immune responses among infants who receive either novel monovalent oral poliovirus vaccine type 2 (nOPV2) alone, bivalent oral poliovirus vaccine (bOPV) alone, or co-administered nOPV2 and bOPV.
Post-marketing Surveillance to Assess the Safety of Infanrix-IPV Vaccine Among Infants and Children...
Acellular PertussisDiphtheria3 moreThe purpose of this study is to collect safety information following routine vaccination with Infanrix-IPV among infants and children in Korea.
Monovalent Oral Poliovirus Vaccine Type 1 Intestinal and Humoral Immunity Study
PoliomyelitisThis is an open-label phase IV randomized clinical trial that will assess intestinal and humoral immunity among infants who receive a combination of monovalent oral poliovirus vaccine type 1 and fractional dose of inactivated poliovirus vaccine, monovalent oral poliovirus vaccine type 1 only, and bivalent oral poliovirus vaccine only.
Effect of Ankle-foot Orthoses on Balance Confidence
Peripheral Nerve DiseasePeripheral Nerve Injury Lower Limb3 moreThe patients at our Prosthetics and Orthotics Outpatient Clinic who have had an ankle-foot orthosis for at least one year will fill in the Activities-Specific Balance Confidence Scale (ABC Scale) for wearing the orthosis and for not wearing the orthosis. They will also answer a mini survey about falls in order to determine whether they have fallen within the last 6 months.