Phase 3 N=1,992 A Phase III Clinical Trial of a Haemophilus Influenzae Type b (Hib) Conjugate Vaccine
Haemophilus Influenza
Primary: Number of Participants With Solicited Adverse Reactions — 507; 480 Count of Participants
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Phase 1 N=40 Evaluation of Non-typable Haemophilus Influenzae and Pneumococcal Protein Vaccine Formulations in Young Adults
Streptococcus Pneumoniae · Haemophilus Influenzae
Primary: Number of Subjects With Any Solicited Local and General Symptoms — 15; 16; 4; 10 Subjects
Phase 2 N=407 Dose Ranging Study of Combined Haemophilus Influenzae Type B-Meningococcal Serogroups CY (Hib-MenCY-TT) Vaccine
Haemophilus Influenzae Type b · Neisseria Meningitidis
Primary: Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 1 Milligram Per Milliliter — 72; 75; 65; 66 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 3 N=131 Study of Quinvaxem for Vaccination Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by Haemophilus Influenzae Type B
Diphtheria · Pertussis · Tetanus
Primary: Immunogenicity - Seroprotection (Seroconversion for Pertussis) to Each Vaccine Component — 93.1; 99.2; 98.5; 93.1 percentage of subjects
Phase 4 N=333 Immunogenicity of H. Influenzae Type b PRP-OMP Vaccines in American Indian and Alaska Native Children (the HibVax Study)
Haemophilus Influenzae Type B Infection
Primary: Anti-PRP IgG Geometric Mean Concentration (GMC) — 0.40; 0.41 μg/mL — p=0.85
N/A N=3,641 Prevalence of Nasopharyngeal Carriage of Streptococcus Pneumoniae in Healthy Children of 12-18 Months in 6 Cities, China
Streptococcus Pneumoniae Infections
Primary: Percentage of Participants With Nasopharyngeal Carriage of Streptococcus Pneumoniae — 12.5; 7.2; 16.6; 9.3 percentage of participants
Phase 3 N=4,180 Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine
Haemophilus Influenzae Type b · Neisseria Meningitidis
Primary: Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations — 10.170; 11.424; 11.438; 11.021 microgram per milliliter (µg/mL)
Phase 3 N=426 Persistency Study After Hib-CRM (Cross-Reacting Material)197 or Hib-TT (Tetanus Toxoid) Vaccines in Chinese Children
Meningitis, Epiglottitis, Pneumonia, Arthritis Caused by Haemophilus Influenzae Type b
Primary: Geometric Mean Anti-PRP (Polyribosyl Ribitol Phosphate) Concentrations at Day 1 (4 Years Post Booster Dose Administered in Study V37_07E1) — 2.66; 5.05 Concentration in…
Phase 3 N=41,181 Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease
Infections, Streptococcal · Streptococcus Pneumoniae
Primary: Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of…
Phase 2 N=378 Safety of and Immune Response to a Meningitis Vaccine in HIV-Infected Children and Youth
HIV Infections · Meningitis
Primary: Number of Immunogenic Responders, With Response Defined as a 4-fold or Greater Increase in Serum Bactericidal Antibody Titers From Study Entry to Week 28 After 2 Doses…
Phase 3 N=581 Persistence of Antibodies at 3, 4 and 6 Years of Age After Vaccination With Meningococcal, Pneumococcal and Hib Vaccines
Neisseria Meningitidis · Haemophilus Influenzae Type b
Primary: Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Titers Using Rabbit Complement (rSBA-MenC) Equal to or Above Cut-off Value — 120; 144; 127; 113…
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=70 Safety and Immunogenicity of Sequential Pneumococcal Immunization in Preschool Asthmatics
Asthma
Primary: Immunogenicity of Pneumococcal Vaccination — 0.05; 0.05 [µg/ml]
Phase 3 N=546 Study of Modified Process Hib/Hep B Vaccine in Infants (V121-019)(COMPLETED)
Haemophilus Influenzae Type B · Hepatitis B
Primary: The Number of Anti-HBs Seroprotected Participants 1 Month After the Third Dose. — 230; 226 Participants
Phase 2 N=388 3 Formulations of Hib-MenCY-TT Vaccine & 1 Formulation of Hib-MenC-TT Vaccine Compared to Licensed Meningococcal Serogroup C Conjugate Vaccine, Each Administered at 2,3,4 Mths of Age
Haemophilus Influenzae Type b · Neisseria Meningitidis
Primary: Number of Subjects With Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentration Equal to or Above 1 Microgram Per Millilitre (µg/mL). — 66; 66; 69; 73…
Phase 2 N=1,103 Hib-MenCY-TT Vaccine Study Compared to Licensed Hib and Meningococcal Serogroup C Conjugate Vaccines
Neisseria Meningitidis · Haemophilus Influenzae Type b
Primary: Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Concentration Greater Than or Equal to 1.0 Microgram Per Milliliter (µg/mL) — 255; 76 Participants
Phase 3 N=394 Immunogenicity and Safety of Havrix™ Co-Administered With a Diphtheria, Tetanus and Pertussis and a Haemophilus b Vaccine in Children Aged 15 Months
Hepatitis A
Primary: Number of Seropositive Subjects for Anti-hepatitis A Virus (HAV) Antibodies Following the Second Dose of Havrix — 88; 84; 77 Participants
Phase 3 N=4,391 Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age
Haemophilus Influenzae Type b · Neisseria Meningitidis
Primary: Number of Subjects Reporting Serious Adverse Events (SAEs) — 109; 33 Subjects
Phase 3 N=4,003 Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants
Haemophilus Influenzae Type b
Primary: Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to (≥) 0.15 Microgram Per Milliliter (µg/mL) and ≥ 1.0…
N/A N=411 Evaluation of Moderate to Severe Influenza Outcomes in Children
Influenza · Otitis Media · Lower Resp Tract Infection
Primary: Hospitalization — 26; 2 Participants
Phase 2 N=575 Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants
Infections, Streptococcal
Primary: Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study — 82; 76; 72…
Phase 2 N=756 Comparison of GSKBiologicals' Hib-MenCY-TT Vaccine vs Licensed Hib Conjugate or Meningococcal Vaccine
Haemophilus Influenzae Type b · Neisseria Meningitidis
Primary: Number of Subjects With Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibody Concentration Equal to or Above (≥) Cut-off Value. — 186; 181 Participants
Phase 3 N=6,177 Impact on Carriage, Acute Otitis Media, Immuno & Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A
Infections, Streptococcal · Streptococcus Pneumoniae
Primary: Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of…
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=433 Study in Toddlers to Demonstrate Non-inferiority of GSK Biologicals' Hib-MenC & to Evaluate Persistence up to 5 Years.
Haemophilus Influenzae Type b · Neisseria Meningitidis
Primary: Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL) — 292; 100…
Phase 3 N=270 Long-Term Antibody Persistence at 1, 3 and 5 Years After a Fourth Dose of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to ActHIB
Neisseria Meningitidis · Haemophilus Influenzae Type b
Primary: Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter — 116; 49; 46; 60…
Phase 3 N=379 Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine
Diphtheria · Tetanus · Pertussis
Primary: Number of Participants With Seroprotection to Hepatitis H Antigen After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or…
Phase 3 N=177 Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth
Diphtheria · Tetanus · Whooping Cough
Primary: Percentage of Participants With Seroprotection After Vaccinations With Sanofi Pasteur's DTaP-IPV-HB-PRP-T Combined Vaccine Following a Documented Dose of a Commercial…
Phase 3 N=30 Phase 3 Study of BK1310 in Healthy Infants
Immunization; Infection
Primary: Antibody Prevalence Rate Against Anti-PRP With 1 μg/mL or Higher, Diphtheria Toxin, Pertussis, Tetanus Toxin, and Polio Virus, Defined as the Percentage of Participants…