Post-marketing Evaluation of Reactions Following Receipt of Recommended Adolescent Pertussis Vaccine...
PertussisDiphtheria2 morePost-marketing evaluation of reactions following receipt of recommended adolescent pertussis vaccine among persons with prior vaccination with acellular vs whole-cell pertussis vaccine. To describe and characterize adverse events occurring after vaccination with REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine among two groups: Group 1 - adolescents 10-14 years of age who participated in study 371-03/01 (and thus received a 5th dose of TRIPEDIA® vaccine) and Group 2 - controls 10-14 years of age who were vaccinated with at least three doses of a whole-cell pertussis vaccine in infancy plus at least one subsequent dose of pertussis vaccine in their 2nd through 7th year of life.
Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose...
Meningococcal MeningitisTetanus3 moreThe purpose of this study is to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and DAPTACEL® vaccine. The main objectives are: Immunogenicity: To evaluate the antibody responses to both vaccines when Menactra vaccine is given concomitantly with DAPTACEL® compared to when either vaccine is given alone. Safety: To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are administered concomitantly compared to when each vaccine is given alone.
Study to Evaluate the Immune Response After Booster Vaccination With Tdap-IPV Vaccine (Against Tetanus,...
Pertussis ImmunisationDiphtheria Immunisation2 morePrimary Objectives : To describe the long-term humoral immune responses to pertussis, diphtheria, and tetanus after homologous and heterologous pertussis vaccine priming regimens To determine the effects of the priming regimen on humoral responses to booster vaccination with Tdap-IPV vaccine To describe the long-term cell-mediated immune responses to pertussis after homologous and heterologous pertussis vaccine priming regimens To determine the effects of the priming regimen on cell-mediated immune response to booster vaccination with Tdap-IPV vaccine Secondary Objective: To describe the safety profile of Tdap-IPV vaccine in each group
Study to Compare the Anti-tetanus Neutralizing Antibody Titers and Safety of TNM002 Injection With...
TetanusThe primary objective is to compare the anti-tetanus neutralizing antibody titers of TNM002 Injection with human tetanus immunoglobulin (HTIG) following a single intramuscular (IM) injection in Chinese adult volunteers.
A Study to Assess the Immunogenicity and Safety of GSK Biologicals' Infanrix-IPV/Hib Vaccine Administered...
DiphtheriaTetanus3 moreThe purpose of this study is to evaluate the immune response, safety and reactogenicity after receiving combined DTPa-IPV/Hib vaccine when administered as a three-dose primary vaccination course at 3, 4.5 and 6 months of age and as a booster dose at 18 months of age in Russian healthy children according to the Russian immunisation schedule
Immunogenicity and Safety of Sanofi Pasteur's Combined Vaccine Given as a Three-Dose Primary Series...
DiphtheriaTetanus4 moreThe purpose of this study is to describe the immunogenicity and safety of Sanofi Pasteur's DTaP-IPV-Hep B-PRP-T fully liquid combined hexavalent vaccine (Hexaxim®) administered at 2, 3, and 4 months of age and at 16 to 17 months of age in infants and toddlers who received a dose of Hep B vaccine at birth or within 1 week after birth. Primary Objective: To describe the safety profile after each and all doses of Sanofi-Pasteur's DTaP-IPV-Hep B-PRP-T combined vaccine in Vietnamese infants and toddlers. Secondary Objective: To demonstrate the non-inferiority of the immune response to all antigens induced by the study vaccine in Vietnamese infants one month after the third dose in a 3-dose primary series with the immune response to all antigens induced by the same study vaccine outside Vietnam. To evaluate the immunogenicity of the study vaccine one month after the 3-dose primary series. To describe the persistence of all antibodies before receipt of the booster vaccination. To evaluate the immunogenicity of the study vaccine one month after the booster.
Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine Administered...
TetanusDiphtheria5 moreThe current trial will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine when administered as a booster dose following priming in the first year of life with the same vaccine. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00970307).
Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants....
DiphtheriaTetanus3 moreThis study is designed to assess the immunogenicity and safety of PENTAXIM™ combined vaccine versus TETRAXIM™ vaccine to support registration of PENTAXIM™ in South Korea. Primary Objective: To demonstrate the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3, Polyribosyl Ribitol Phosphate [PRP]) and vaccine response rates to acellular Pertussis antigens of sanofi pasteur's PENTAXIM™ vaccine versus sanofi pasteur's TETRAXIM™ and Act (Haemophilus influenzae type b) HIB™ vaccines, one month after the three-dose primary vaccination.
A Study of DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Act-HIB Monovalent Vaccine...
DiphtheriaTetanus2 moreThe purpose of this study is to assess the immunogenicity and safety of ACTACEL combined vaccine in support of registration of this product in China Primary Objectives: To demonstrate that ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age is not inferior, in terms of seroprotection, to Wuhan's Diphtheria, Tetanus, acellular Pertussis (DTaP) and Haemophilus influenzae type b (Act-HIB) vaccine given concomitantly, for diphtheria, tetanus, and Polyribosyl Ribitol Phosphate (PRP) antigens, one month after the three-dose primary vaccination. To demonstrate the superiority, in terms of seroconversion, of ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age for Pertussis Toxoid (PT), Fimbriae types 2 and 3 (FIM2) and (FIM3) pertussis antigens, compared with Wuhan's DTaP and Act-HIB vaccines given concomitantly, one month after the three-dose primary vaccination. Secondary Objectives: To describe the safety after administration of the study vaccines. To describe in each group the immunogenicity of the study vaccines one month after the primary vaccination and before and one month after the booster vaccination.
Study in Infants (6-12 Months) Comparing Two Doses of a Monovalent Glycoprotein-Conjugated (Diptheria...
Haemophilus Influenzae Type b (Hib) InfectionThis study will evaluate the safety and efficacy of two doses of two commercially available vaccines used to prevent Haemophilus influenzae type b infections in children 6-12 months of age.