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Pneumococcal Infections clinical trials

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NCT ID: NCT00488826 Completed - Clinical trials for Pneumococcal Infections

Study Evaluating 7-Valent Pneumococcal Conjugate Vaccine in Healthy Infants

Start date: October 2005
Phase: Phase 1
Study type: Interventional

This study is a combination of a Phase I and Phase III study design. The Phase I portion is an open-label, controlled study to evaluate the safety of 7vPnC in healthy Chinese infants. The Phase III portion is an open-label, controlled, randomized study to evaluate the safety and immunogenicity of 7-Valent Pneumococcal Conjugate Vaccine (7vPnC)in healthy Chinese infants. Both phases include a Primary Series which includes the primary 3 doses of 7vPnC and /or Diptheria and tetanus toxoids and accelular pertussis vaccine (DTaP) at about 3, 4, and 5 months of age; and a Booster Dose which includes the 4th dose of 7vPnC at 12-15 months of age.

NCT ID: NCT00488800 Completed - Clinical trials for Pneumococcal Infections

Safety and Local Tolerability of Prevenar in Indian Children

Start date: July 2006
Phase: Phase 4
Study type: Observational

This postmarketing surveillance study will evaluate the safety profile of Prevenar in Indian children. Prevenar is indicated for active immunization of infants and children from 6 weeks of age through 9 years of age against invasive disease (including meningitis, bacteraemic pneumonia, bacteraemia, sepsis) caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F. Prevenar has been marketed in India since June 2006. The Board of Health in India has given restricted permission to import and market Prevenar. The present study is a post-approval regulatory commitment to the Board of Health in India. This is an observational study and the protocol for the study has been approved by the Board of Health.

NCT ID: NCT00488371 Completed - Clinical trials for Pneumococcal Infections

Study Evaluating Streptococcus Pneumoniae Nasopharyngeal Carriage Rate in Children Receiving Prevnar®

Start date: November 2006
Phase: Phase 4
Study type: Observational

Primary Objective: To evaluate the impact of PCV7 vaccination on NP carriage rate of vaccine serotypes and serotype distribution Secondary Objective: To evaluate the impact of PCV7 vaccination on NP carriage of antibiotic resistant pneumococci and serotype distribution.

NCT ID: NCT00479323 Completed - Clinical trials for Pneumococcal Infections

Pneumococcal Reference Standard

Start date: June 2007
Phase: Phase 1
Study type: Interventional

Serum 89 SF is a supply of serum that was collected from people who were vaccinated with the pneumococcal vaccine in the late 1980s. The supply of this serum is running low. The purpose of this study is to give the pneumococcal vaccine to healthy volunteers and take serum blood samples in order to increase the reference serum supply. Study participants will include 250 healthy men and women, ages 18-45. Study procedures will include a physical exam, interviews, blood samples and blood testing. All volunteers will receive the pneumococcal vaccine in the deltoid muscle of the arm. Participants will be involved in the study for approximately 17 weeks.

NCT ID: NCT00471822 Completed - Clinical trials for Streptococcus Pneumoniae Infections

Nasopharyngeal Streptococcus Pneumoniae Carriage

Start date: July 2005
Phase: N/A
Study type: Observational

Primary Objective: Evaluation of the - Carriage rate of Streptococcus pneumoniae in the nasopharynx of children Secondary Objective: - Carriage rate and distribution of Streptococcus pneumoniae serotypes - Estimation of prevalence rate of antibiotic-resistant Streptococcus pneumoniae strains - Distribution of Staphylococcus aureus strain - The influence of risk factors in the Streptococcus pneumoniae carriage rate in children

NCT ID: NCT00452790 Completed - Clinical trials for Pneumococcal Infections

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in India

Start date: June 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in India.

NCT ID: NCT00452452 Completed - Clinical trials for Pneumococcal Infections

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine Catch-Up Regimens in Older Infants and Children

Start date: July 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent Pneumococcal conjugate vaccine (13vPnC) in older infants and children who have not previously been immunized with Pneumococcal vaccine.

NCT ID: NCT00427895 Completed - Clinical trials for Pneumococcal Infections

Study Comparing a 13-valent Pneumococcal Conjugate Vaccine With 23-valent Pneumococcal Polysaccharide Vaccine in Adults

Start date: February 27, 2007
Phase: Phase 3
Study type: Interventional

This study will assess the safety, tolerability and immune response of 13-valent pneumococcal conjugate vaccine (13vPnC) compared with 23-valent Pneumococcal Polysaccharide Vaccine (23vPS). Although the study started with only 1 population, amendments to the original protocol will now reflect three participant populations. Three age cohorts will be enrolled. The first cohort (age 60-64) will be blinded. Cohort 2 (age 50-59) and cohort 3 (age 18-49) are open label. Subjects in cohorts 1 and 2 will receive 2 vaccinations 3-4 years apart. Subjects in cohort 3 will receive 1 vaccination. All participants should be naïve of 23vPS. Comparisons of immune responses from the different cohorts will be done.

NCT ID: NCT00378417 Completed - Clinical trials for Pneumococcal Infections

Efficacy Trial of Two Pneumococcal Conjugate Vaccines (PncCRM and PncOMPC) for Prevention of Acute Otitis Media Due to Vaccine Serotypes

Start date: March 1995
Phase: Phase 3
Study type: Interventional

This was a randomized, double-blinded multicenter cohort study of Finnish children aged 2 to 24 months. The study was designed to evaluate the efficacy of two 7-valent pneumococcal conjugate vaccines (PncCRM and PncOMPC) parallelly, both vaccines compared with the same control vaccine (hepatitis B vaccine). The primary endpoint was culture-confirmed pneumococcal acute otitis media (AOM) episodes due to all serotypes included in the pneumococcal conjugate vaccine and the primary hypothesis was that, compared to the control vaccine group, the pneumococcal conjugate vaccine would protect infants from culture confirmed AOM caused by pneumococcal serotypes in the vaccine. The efficacy of the two vaccines against any pneumococcal AOM and any AOM was also evaluated. The children were vaccinated with the pneumococcal conjugate vaccine or the control vaccine at the age of 2, 4, 6 and 12 months and followed at study clinics established specifically for the purpose from 2 to 24 months of age. Whenever AOM was diagnosed during the follow-up, middle ear fluid was aspirated for bacterial culture.

NCT ID: NCT00368186 Terminated - Clinical trials for Pneumococcal Infections

Immunogenicity and Safety Study of Pneumococcal 7-Valent Conjugate Vaccine in Sickle Cell Disease Infants.

Start date: May 2001
Phase: Phase 4
Study type: Interventional

The primary objectives of this study were to assess the immunogenicity and the tolerance of the heptavalent pneumococcal conjugate vaccine (Prevenar) in young infants (2 months of age) with sickle cell disease when administred at 2,3, and 4 months of age.