N/A N=67 Influence of IPV on GOR in Infants From 0 to 12 Months.
Gastro-oesophageal Reflux
Primary: Number of Refluxes — 0.48; 0.97 number of refluxes
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=392 A Study on the Immune Response and Safety of Inactivated Poliovirus Vaccine (IPV) When Co-administered With Human Rotavirus (HRV) Porcine Circovirus (PCV)-Free Vaccine in Healthy Chinese Infants
Gastroenteritis
Primary: Percentage of Participants With Seroconversion for Anti-poliovirus Types 1, 2 and 3 Neutralizing Antibody (Ab) — 99.2; 99.3; 100; 99.3 Percentage of participants
Phase 1 N=87 Inactivated Poliovirus Vaccine (IPV) With or Without E.Coli Double Mutant Heat-Labile Toxin (dmLT) Challenge Study in Healthy Adults
Polio
Primary: Number of Participants With Serious Adverse Events Over the Course of the Study — 0; 0; 0 Participants
Phase 3 N=452 Evaluation of the Immunogenicity, Safety and Reactogenicity of the Combined DTPa-IPV Vaccine in Healthy Infants
Tetanus · Acellular Pertussis · Diphtheria
Primary: Number of Seroprotected Subjects Against Diphtheria (Anti-D) and Tetanus (Anti-T) — 204; 211; 204; 211 Subjects
Phase 3 N=773 A Study to Evaluate Immunogenicity of Intramuscular Full-Dose and Intradermal Fractional Dose of IPV
Poliomyelitis
Primary: Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 2 Doses IPV IM — 98.1; 95.9; 98.7; 97.9 percentage of seroconversion — p=0.05
Phase 3 N=3,372 Study of DTap-IPV Compared to DAPTACEL® and IPOL® as the 5th Dose in Children 4 to 6 Years of Age
Tetanus · Diphtheria · Pertussis
Primary: Number of Participants With Booster Response to the Pertussis Antigens Following Vaccination With Either DTaP-IPV or DAPTACEL® + IPOL® Vaccine — 240; 222; 242; 217…
N/A N=103 The Effectiveness of AAD and IPV to Treat Hospitalized Infants (<2years) With Acute Viral Bronchiolitis.
Bronchiolitis
Primary: Length of Hospital Stay — 3.5; 3.6; 4.5 days
Phase 3 N=400 Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of RotaTeq® (V260) and Inactivated Poliomyelitis Vaccine in Healthy Chinese Infants (V260-074)
Prevention of Rotavirus Gastroenteritis in Infants and Children Caused by Serotypes G1, G2, G3, G4, and G9
Primary: Percentage of Participants Achieving Neutralizing Antibody Seroconversion to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV — 98.9; 100.0; 98.3; 99.5…
Phase 2 N=231 Intradermal Versus Intramuscular Polio Vaccine Booster in HIV-Infected Subjects
Polio Immunity
Primary: Post Booster Polio Neutralizing Antibody Titers — 1715; 976; 1249; 1328 antibody titers
Phase 1 N=30 Phase 1 Novel Live Attenuated Serotype 2 Oral Polio Vaccine Study in Inactivated Polio Vaccine (IPV) Primed Adults
Poliomyelitis
Primary: Number of Participants With Serious Adverse Events and Severe Adverse Events Throughout the Study — 0; 0; 6; 9 Participants
Phase 3 N=1,796 Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age
Pneumococcal Disease
Primary: Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC — 6.3; 7.4; 4.0; 3.3 Percentage of participants
Phase 3 N=303 Immunogenicity and Safety of Boostrix Polio Vaccine as a Booster Dose in 5 to 6-year-old Children.
Acellular Pertussis · Tetanus · Diphtheria
Primary: Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibody Concentrations — 9.207; 21.393; 12.527; 11.07 IU/mL
N/A N=17,446 Presumptively Initiating Vaccines and Optimizing Talk With Motivational Interviewing (PIVOT With MI)
Preventive Health Services (PREV HEALTH SERV)
Primary: Child Immunization Status at 19 Months, 0 Days of Age Characterized as Percent Days Under-immunized (DUI) — 32; 24 percentage of days under-immunized — p=0.9
Phase 3 N=702 Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received Hepatitis B Vaccine
Haemophilus Influenzae Type b · Diphtheria · Tetanus
Primary: Number of Subjects Reporting Any Solicited Local Symptoms — 130; 120; 89; 134 Participants
Phase 3 N=25 Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' IPV Vaccine (PoliorixTM) in Toddlers
Poliomyelitis
Primary: Number of Subjects With Any and Grade 3 Solicited Local Symptoms — 4; 0; 5; 0 Subjects
Phase 4 N=22 Special Access Program IMVAMUNE®
Vaccination
Primary: ELISA Seropositivity Rate — 40.9; 100.0 percentage of subjects
Phase 3 N=4,209 Immune Response and Safety Comparison of 3 Lots of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP + IPV Vaccines
Tetanus · Acellular Pertussis · Diphtheria
Primary: Geometric Mean Concentrations (GMCs) for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies in a Subset of Subjects — 16.704; 18.658; 18.437; 18.112 IU/mL
Phase 2 N=624 Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® PEDIATRICO in Argentinean Infants
Diphtheria · Tetanus · Pertussis
Primary: Percentage of Participants With Seroconversion for Anti-pertussis Toxoid and Anti-filamentous Hemagglutinin Antibodies Post-vaccination With Either DTaP-IPV-Hep B-PRP~T…
Phase 3 N=957 Immunogenicity and Safety of Booster Dose of PoliorixTM Vaccine in Previously Vaccinated Toddlers
Poliomyelitis
Primary: Number of Subjects Seroprotected for Poliovirus Types 1, 2 and 3 Antibodies Above the Cut-off Value — 456; 456; 456 Participants
Phase 1 N=60 Seasonal Trivalent Inactivated Split Virion Influenza Vaccine Clinical Trial (IVACFLU-S)
Influenza, Human
Primary: Number of Participants With Immediate Adverse Events — 0; 0 participants
N/A N=53 Intervention for IPV Perinatal Women- RCT
Intimate Partner Violence
Primary: Composite Abuse Scale (CAS)-CAS Victimization Total Score — 26.36; 16.56; 12.38; 16.52 units on a scale — p=0.4016
Phase 3 N=780 Co-administration of Pneumococcal Conjugate Vaccine With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib
Infections, Streptococcal
Primary: Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary…
Phase 4 N=192 Immunogenicity and Safety of Concomitant Administration of RotaTeq™ (V260) and the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Healthy Japanese Infants (V260-060)
Rotavirus Disease
Primary: Percentage of Participants Achieving Seroresponse for Diphtheria Toxin, Tetanus Toxin, Pertussis Filamentous Hemagglutinin (FHA), and Poliovirus Type 1, 2, and 3 — 100…
Phase 3 N=263 Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants
Diphtheria · Tetanus · Pertussis
Primary: Number of Participants Achieving Seroprotection for Anti Hep-B After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ — 131; 130…
N/A N=60 Recovering From Intimate Partner Violence Through Strengths and Empowerment (RISE)
Intimate Partner Violence · Self-efficacy
Primary: Empowerment Via the Personal Progress Scale Revised — 129.82; 132.25; 146.13; 137.24 score on a scale — p=<.05
Phase 4 N=2,590 Assess the Safety & Reactogenicity of DTPa-IPV/Hib Vaccine Administered at 3, 4, 5 & 18 Mths of Age, in Healthy Infants
Diphtheria · Tetanus · Poliomyelitis
Primary: Number of Subjects Reporting Any Solicited Local and General Symptoms — 855; 907; 706; 929 Subjects
Phase 4 N=1,271 Concomitant Use of Hepatitis A Vaccine, Inactivated With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Given to Healthy Children 15 Months of Age (V251-068)
Hepatitis A Virus
Primary: Seropositivity Rate (SPR) to Hepatitis A — 100; 100; 100; 100 Percentage of participants
Phase 4 N=100 A Study to Evaluate the Safety and Immunogenicity of Monovalent OPV2 in Children Aged 1 to 5 Years in Lithuania
Poliomyelitis
Primary: SAEs and Severe AEs — 0; 0 Participants — p=0.05
Phase 3 N=825 Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine
Acellular Pertussis · Tetanus · Diphtheria
Primary: Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids — 241; 250; 234; 269 Participants
Phase 3 N=451 Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine
Poliomyelitis · Tetanus · Acellular Pertussis
Primary: Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. — 213; 217; 213; 217 Participants