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Measles clinical trials

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NCT ID: NCT01681992 Completed - Measles Clinical Trials

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life

Start date: October 10, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate end of shelf-life potency in terms of the immunogenicity and safety of GSK Biologicals' trivalent MMR vaccine, by comparing it to Merck & Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).

NCT ID: NCT01668745 Recruiting - Measles Vaccine Clinical Trials

Trial of Additional Measles Vaccine to Reduce Child Mortality. Burkina Faso.

Start date: May 2013
Phase: Phase 4
Study type: Interventional

Background: All observational studies and a few randomised controlled trials (RCT) suggest that early measles vaccine (MV), in particular an early two-dose strategy, has a much better effect on overall mortality than later MV. These results suggest that MV has a non-measles related beneficial effect on child survival. Objective: To evaluate in a multi-center RCT the effect on child survival and other health indicators of a two-dose measles vaccination schedule by providing an additional dose of Edmonston-Zagreb (EZ) MV as soon as possible after 4 months of age as well as the standard measles vaccine at 9 months of age. Three trials are planned in Guinea-Bissau, Ghana and Burkina Faso. The investigators will test a 40-43% reduction of mortality at each site separately and a 32% reduction overall. Based on the results from the RCT, the investigators will assess the cost-effectiveness of the intervention. Design, Burkina Faso: Newborns are followed through the Health and Demographic Surveillance System (HDSS) of the Centre de Recherche en Sante de Nouna. Information on routine and campaign vaccinations will be collected regularly through home visits and health centre registers. Four weeks after having received the third dose of pentavalent vaccine (Penta3), the children will be eligible for enrollment in the trial if they are not severely ill. Eligible children will be invited to take part in the trial. Provided parental informed consent is given, the children will be randomised to MV at 4 and 9 months of age or only at 9 months. Cost estimates will be based on consumption of services and average cost per unit. The incremental cost effectiveness ratio will be calculated. Sample size, follow-up and analyses: To detect a 43% reduction in overall mortality at each site the investigators intend to enroll at least 4050 children in Burkina Faso. The children will be followed for survival and hospitalisations to 3 years of age or to the end of the study after three years. The investigators will analyse the effects by site and combined; by sex and season; possible interactions with other interventions like campaigns with drugs, vaccines or micronutrients will be explored. Antibody study: 450 children will be enrolled in a subgroup study to examine the effect of maternal antibody levels on subsequent antibody responses to MV. The children will be followed to 24 months of age and samples collected at 4, 9 and 24 months of age.

NCT ID: NCT01644721 Recruiting - Measles Vaccine Clinical Trials

Trial of Additional Measles Vaccine to Reduce Child Mortality

Start date: July 2012
Phase: Phase 4
Study type: Interventional

Background: All observational studies and a few randomised controlled trials (RCT) suggest that early measles vaccine (MV), in particular an early two-dose strategy, has a much better effect on overall mortality than later MV. These results suggest that MV has a non-measles related beneficial effect on child survival. Objective: To evaluate in a two-site RCT the effect on child survival and other health indicators of a two-dose measles vaccination schedule by providing an additional dose of Edmonston-Zagreb (EZ) MV as soon as possible after 4 months of age as well as the standard measles vaccine at 9 months of age. The trials are planned in Guinea-Bissau and Burkina Faso. The investigators will test a 40-43% reduction of mortality at each site separately and a 32% reduction overall. Based on the results from the RCT, the investigators will assess the cost-effectiveness of the intervention. Design, Guinea-Bissau: Newborns are followed through the Health and Demographic Surveillance System (HDSS) of the Bandim Health Project. Information on routine and campaign vaccinations will be collected regularly through home visits and health centre registers. Four weeks after having received the third dose of pentavalent vaccine (Penta3), the children will be eligible for enrollment in the trial if they are not severely ill. Eligible children will be invited to take part in the trial. Provided parental informed consent is given, the children will be randomised to MV at 4 and 9 months of age or only at 9 months. Cost estimates will be based on consumption of services and average cost per unit. The incremental cost effectiveness ratio will be calculated. Sample size, follow-up and analyses: To detect a 40% reduction in overall mortality at each site the investigators intend to enroll at least 3,750 children in Guinea-Bissau. The children will be followed for survival and hospitalisations to 3 years of age or to the end of the study after three years. The investigators will analyse the effects by site and combined; by sex and season; possible interactions with other interventions like campaigns with drugs, vaccines or micronutrients will be explored. Antibody study: 450 children will be enrolled in a subgroup study to examine the effect of maternal antibody levels on subsequent antibody responses to MV. The children will be followed to 24 months of age and samples collected at 4, 9 and 24 months of age.

NCT ID: NCT01621802 Completed - Clinical trials for Measles-Mumps-Rubella

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age

Start date: June 21, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®) in the US by generating immunogenicity and safety data in contrast to the US standard of care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six years of age.

NCT ID: NCT01602094 Not yet recruiting - Measles Clinical Trials

Immunity to Measles Virus in the Thai Population Age 18-30 Years and Predictive Factors

Start date: July 2012
Phase: N/A
Study type: Observational

Prevalence of participants who have protective immunity to measles virus is less than ninety percent. Predictor of adequate measles antibody levels include the following : - History of measles infection - History of complete measles primary immunization( 2 doses with at least 1 month interval after age of 9 months) - History of measles exposure Predictor of inadequate measles antibody levels include the following : - Born outside Thailand - History of staying outside Thailand for long time in childhood - Living in the rural area for a long period in childhood - Fail to participate school system on time

NCT ID: NCT01557699 Completed - Clinical trials for Prophylaxis for the Measles Infection

A Clinical Trial to Assess the Safety of a Measles Vaccine (Dry Powder) Administered by Two Different Devices

PMV-001
Start date: March 2012
Phase: Phase 1
Study type: Interventional

This is a phase I, open-label, randomized study in healthy adults. Eligible subjects will be given single dose of either Dry Powdered Measles Vaccine (PMV) by Puffhaler® device, Dry PMV by SoloventTM device or licensed measles vaccine by subcutaneous route (SMV). Subjects will be followed for 180 days for safety.

NCT ID: NCT01536405 Completed - Measles Clinical Trials

Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)

Start date: June 5, 2012
Phase: Phase 3
Study type: Interventional

This study will compare the safety, tolerability, and immunogenicity of measles, mumps, rubella, and varicella (MMRV) vaccine made with an alternative manufacturing process with those of the 2006 process

NCT ID: NCT01506193 Completed - Measles Clinical Trials

Immunogenicity and Safety Study of PriorixTetraâ„¢ When Co-administered With Conjugated MenC Vaccine in Healthy Children

Start date: February 6, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' investigational measles, mumps, rubella and varicella (MMRV) vaccine (GSK208136, PriorixTetraâ„¢) when co-administered along with conjugated Meningococcal C (MenC) vaccine (Meningitec®, Nuron Biotechs' Vaccine) in healthy children.

NCT ID: NCT01486355 Recruiting - Measles Infection Clinical Trials

Additional Measles Vaccine at 4 Months of Age

Start date: August 2011
Phase: Phase 4
Study type: Interventional

Overall objective: To conduct a randomised controlled trial (RCT) to examine whether an early two-dose measles vaccination (MV) strategy at 4 and 9 months will reduce child mortality compared with the WHO strategy of one dose of MV at 9 months. Specific hypotheses Hypothesis I) Two doses of MV at 4 and 9 months compared with the standard dose of MV at 9 months will reduce mortality by 30% between 4 months and 5 years of age1. As in a previous trial it is expected that the beneficial effect is strongest for girls. Hypothesis II) Children receiving MV at 4 months in the presence of maternal measles antibodies (MatAb) will have 35% lower mortality between 4 months and 5 years of age than children receiving MV at 4 months with no detectable MatAb. Implications: These hypotheses are based on a previous RCT showing strong beneficial effects of providing an early measles vaccine, in particular among children with MatAb.

NCT ID: NCT01369394 Completed - Measles Clinical Trials

Making Decisions About the Measles-Mumps-Rubella Vaccine

Start date: June 2011
Phase: N/A
Study type: Interventional

The goal of this study is to determine whether a computer-based intervention that delivers individually-tailored educational messages about the MMR vaccine increases MMR vaccine-hesitant parents' intentions to have their children vaccinated.