- Trials with a EudraCT protocol (168)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (15)
168 result(s) found for: Haemophilus influenzae type b vaccine.
Displaying page 1 of 9.
EudraCT Number: 2011-005032-26 | Sponsor Protocol Number: 106445, | Start Date*: 2015-06-25 | ||||||||||||||||||||||||||||||||||||
Sponsor Name:GlaxoSmithKline Biologicals | ||||||||||||||||||||||||||||||||||||||
Full Title: A phase III, open, randomized, controlled, multi-centre study to demonstrate the non-inferiority of the meningococcal serogroup C and the Haemophilus influenzae type b immune response of GlaxoSmith... | ||||||||||||||||||||||||||||||||||||||
Medical condition: Healthy volunteers (for primary immunization against meningococcal serogroup C and booster immunization against Haemophilus influenzae type b diseases of healthy children aged 12-18 months) | ||||||||||||||||||||||||||||||||||||||
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Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |||||||||||||||||||||||||||||||||||||
Trial protocol: Outside EU/EEA | ||||||||||||||||||||||||||||||||||||||
Trial results: View results |
EudraCT Number: 2006-002898-47 | Sponsor Protocol Number: 107737 | Start Date*: 2007-01-16 |
Sponsor Name:GlaxoSmithKline Biologicals | ||
Full Title: A phase IIIb open study to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with DTPa-HBV-IPV/Hib (Infanrix h... | ||
Medical condition: Three dose primary vaccination of preterm infants between 8-16 weeks (56-118 days) of age at the time of first vaccination against Streptococcus pneumoniae. | ||
Disease: | ||
Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
Trial protocol: GR (Completed) ES (Ongoing) | ||
Trial results: View results |
EudraCT Number: 2005-006066-34 | Sponsor Protocol Number: 105987,105988 | Start Date*: 2015-06-01 | |||||||||||||||||||||
Sponsor Name:GlaxoSmithKline Biologicals | |||||||||||||||||||||||
Full Title: A phase III, single-blind, randomized, controlled, multinational study for the evaluation of safety of GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-t... | |||||||||||||||||||||||
Medical condition: Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y | |||||||||||||||||||||||
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Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | ||||||||||||||||||||||
Trial protocol: Outside EU/EEA | |||||||||||||||||||||||
Trial results: View results |
EudraCT Number: 2012-002727-15 | Sponsor Protocol Number: 114174 | Start Date*: 2015-06-22 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Sponsor Name:GlaxoSmithKline Biologicals | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Full Title: A phase II, randomized, controlled, observer-blind study to evaluate the impact of two formulations of GlaxoSmithKline (GSK) Biologicals’ combined 10-valent pneumococcal polysaccharide and non-type... | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Medical condition: Healthy volunteers (for one-dose vaccination of healthy children between 2-4 years of age at the time of vaccination against Streptococcus pneumoniae (S. pneumoniae) and Haemophilus influenzae (H. ... | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Population Age: Infants and toddlers, Children, Under 18 | Gender: Male, Female | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Trial protocol: Outside EU/EEA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Trial results: View results |
EudraCT Number: 2014-005136-33 | Sponsor Protocol Number: V37_07 | Start Date*: 2014-11-28 |
Sponsor Name:Novartis Vaccines and Diagnostics | ||
Full Title: A Phase III Observer-Blind, Randomized, Controlled, Single-Coordinating Center Pediatric Study in China Comparing Vaxem Hib to HIBERIX® Using a Local Dosing Regimen in Infants | ||
Medical condition: Meningitis, epiglottitis, pneumonia, arthritis caused by Haemophilus influenzae type b. | ||
Disease: | ||
Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
Trial protocol: Outside EU/EEA | ||
Trial results: View results |
EudraCT Number: 2009-016579-31 | Sponsor Protocol Number: OVG2008/6 | Start Date*: 2010-01-14 | |||||||||||||||||||||||||||||||||||||||||||||||||||
Sponsor Name:University of Oxford | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Full Title: An open label randomised controlled study to evaluate the induction of immune memory following infant vaccination with a glyco-conjugate Neisseria meningitidis serogroup C vaccine and to assess the... | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Medical condition: Active immunisation of children for the prevention of invasive diseases caused by Neisseria meningitidis serogroup C, Streptococcus pneumoniae, diphtheria, tetanus, pertussis, poliomyelitis and inv... | |||||||||||||||||||||||||||||||||||||||||||||||||||||
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Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Trial protocol: GB (Completed) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
Trial results: View results |
EudraCT Number: 2014-005036-33 | Sponsor Protocol Number: M37P1 | Start Date*: 2014-11-18 |
Sponsor Name:Novartis Vaccines and Diagnostics | ||
Full Title: A phase I study to investigate safety and reactogenicity of Vaxem Hib in healthy children aged 16 – 20 months and infants aged 2 - 4 months. | ||
Medical condition: Meningitis, epiglottitis, pneumonia, arthritis caused by Haemophilus influenzae type b. | ||
Disease: | ||
Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
Trial protocol: Outside EU/EEA | ||
Trial results: View results |
EudraCT Number: 2011-000943-26 | Sponsor Protocol Number: 115375 | Start Date*: 2011-05-12 | ||||||||||||||||||||||||||||||||||||
Sponsor Name:GlaxoSmithKline Biologicals | ||||||||||||||||||||||||||||||||||||||
Full Title: A phase IV, open-label, study to assess the antibody persistence in healthy 5-year-old children, previously vaccinated at 3, 5 and 11months of age with GSK Biologicals’ DTPa-HBV-IPV/Hib or DTPa-IPV... | ||||||||||||||||||||||||||||||||||||||
Medical condition: Healthy volunteers (Immunogenicity of the DTPa-HBV-IPV/Hib and DTPa-IPV/Hib vaccines in terms of persistence of antibodies to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and Hib vacc... | ||||||||||||||||||||||||||||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | |||||||||||||||||||||||||||||||||||||
Trial protocol: SE (Completed) NO (Completed) | ||||||||||||||||||||||||||||||||||||||
Trial results: View results |
EudraCT Number: 2015-001453-32 | Sponsor Protocol Number: V37_07E2 | Start Date*: 2015-04-29 |
Sponsor Name:Novartis Vaccines and Diagnostics Srl | ||
Full Title: A Phase IIIb, Controlled, Open Label, Single-Center, Persistency, Extension study in Chinese children after a 2 + 1 dose series of either CRM197- conjugate Haemophilus influenzae type b vaccine or ... | ||
Medical condition: Meningitis, epiglottitis, pneumonia, arthritis caused by Haemophilus influenzae type b. | ||
Disease: | ||
Population Age: Children, Under 18 | Gender: Male, Female | |
Trial protocol: Outside EU/EEA | ||
Trial results: View results |
EudraCT Number: 2014-000750-11 | Sponsor Protocol Number: 200799 | Start Date*: 2015-05-05 |
Sponsor Name:GlaxoSmithKline Biologicals | ||
Full Title: Study to compare immunogenicity of GSK Biologicals' 10Pn-PD-DiT 4-dose presentation to the licensed Synflorix™ (10Pn-PD-DiT) vaccine when co-administered with DTPw-combination vaccine in healthy in... | ||
Medical condition: Infections, Pneumococcal | ||
Disease: | ||
Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
Trial protocol: Outside EU/EEA | ||
Trial results: View results |
EudraCT Number: 2011-002076-16 | Sponsor Protocol Number: 109563 | Start Date*: 2012-04-12 | ||||||||||||||||
Sponsor Name:GlaxoSmithKline Biologicals | ||||||||||||||||||
Full Title: Clinical Otitis Media and Pneumonia Study (COMPAS): a phase III , double-blind, randomized, controlled, multicentre study to demonstrate the efficacy of GlaxoSmithKline (GSK) Biologicals’ 10-valent... | ||||||||||||||||||
Medical condition: Three dose primary vaccination of healthy infants between 6-16 weeks of age at the time of the first vaccination, followed by a booster dose at 15-18 months. | ||||||||||||||||||
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Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |||||||||||||||||
Trial protocol: Outside EU/EEA | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2014-005135-13 | Sponsor Protocol Number: V37_07E1 | Start Date*: 2014-11-28 |
Sponsor Name:Novartis Vaccines and Diagnostics | ||
Full Title: A Phase III Observer blind Single-Coordinating Center Pediatric Study in China Comparing a Booster Dose of Vaxem™ Hib to HIBERIX® When Given as Part of a Local Dosing Regimen in Infants | ||
Medical condition: Meningitis, epiglottitis, pneumonia, arthritis caused by Haemophilus influenzae type b. | ||
Disease: | ||
Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
Trial protocol: Outside EU/EEA | ||
Trial results: View results |
EudraCT Number: 2014-005159-24 | Sponsor Protocol Number: M37P2 | Start Date*: 2014-12-23 |
Sponsor Name:Novartis Vaccines and Diagnostics | ||
Full Title: A Phase III, observer-blind, randomized, controlled, multi-center study to inventigate the immunogenicity and safety of the Vaxem Hib™ in 2-4 months old healthy infants in China, according to the r... | ||
Medical condition: Invasive Haemophilus influenzae type b disease | ||
Disease: | ||
Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
Trial protocol: Outside EU/EEA | ||
Trial results: View results |
EudraCT Number: 2014-005203-24 | Sponsor Protocol Number: V37_11 | Start Date*: 2014-12-10 |
Sponsor Name:Novartis Vaccines and Diagnostics | ||
Full Title: A Post Marketing Surveillance Study to monitor the reactogenicity and safety of Vaxem™Hib when administered according to the prescribing information in Korea | ||
Medical condition: Meningitis, epiglottitis, pneumonia, arthritis caused by Haemophilus influenzae type b. | ||
Disease: | ||
Population Age: Infants and toddlers, Children, Under 18 | Gender: Male, Female | |
Trial protocol: Outside EU/EEA | ||
Trial results: View results |
EudraCT Number: 2012-000254-64 | Sponsor Protocol Number: 114056 | Start Date*: 2012-04-12 | ||||||||||||||||
Sponsor Name:GlaxoSmithKline Biologicals | ||||||||||||||||||
Full Title: A phase III, open, controlled study to evaluate the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10- valent pneumococcal conjugate vaccine administered to children with sickle cell... | ||||||||||||||||||
Medical condition: Active immunization against disease caused by Streptococcus pneumoniae in children from 8 weeks up to 2 years of age. | ||||||||||||||||||
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Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |||||||||||||||||
Trial protocol: Outside EU/EEA | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2021-006686-37 | Sponsor Protocol Number: SH600009 | Start Date*: 2022-02-18 | ||||||||||||||||||||||||||||||||||||||||||||||
Sponsor Name:Sanofi Pasteur | ||||||||||||||||||||||||||||||||||||||||||||||||
Full Title: Immunogenicity and Safety of a DTwP-HepB-Hib-IPV (SHAN6™) Vaccine when Administered Concomitantly with Routine Pediatric Vaccines in Healthy Infants and Toddlers in Thailand | ||||||||||||||||||||||||||||||||||||||||||||||||
Medical condition: Diphtheria, Tetanus, Pertussis, Hepatitis-B, invasive Haemophilus influenzae type b and Poliomyelitis diseases | ||||||||||||||||||||||||||||||||||||||||||||||||
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Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |||||||||||||||||||||||||||||||||||||||||||||||
Trial protocol: Outside EU/EEA | ||||||||||||||||||||||||||||||||||||||||||||||||
Trial results: View results |
EudraCT Number: 2011-002077-35 | Sponsor Protocol Number: 111634 | Start Date*: 2012-04-12 | ||||||||||||||||
Sponsor Name:GlaxoSmithKline Biologicals | ||||||||||||||||||
Full Title: A phase III, open, controlled study in South Africa to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine administered as a 3-dose (6,... | ||||||||||||||||||
Medical condition: 3- or 2-dose primary vaccination against Streptococcus pneumoniae together with a 3-dose primary vaccination against diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b di... | ||||||||||||||||||
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Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |||||||||||||||||
Trial protocol: Outside EU/EEA | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2010-019730-27 | Sponsor Protocol Number: 113994 | Start Date*: 2010-09-07 | ||||||||||||||||
Sponsor Name:GlaxoSmithKline Biologicals | ||||||||||||||||||
Full Title: A phase II, randomized, controlled, observer-blind study to assess the safety, reactogenicity and immunogenicity of two formulations of GlaxoSmithKline (GSK) Biologicals’ Streptococcus pneumoniae p... | ||||||||||||||||||
Medical condition: Three-dose primary vaccination against Streptococcus pneumoniae (S pneumoniae) and Haemophilus influenzae (H influenzae) in healthy infants between 6-14 weeks (42-104 days) of age at the time of th... | ||||||||||||||||||
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Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |||||||||||||||||
Trial protocol: CZ (Completed) PL (Completed) SE (Completed) DE (Completed) | ||||||||||||||||||
Trial results: View results |
EudraCT Number: 2012-004137-16 | Sponsor Protocol Number: 114260 | Start Date*: 2015-05-27 |
Sponsor Name:GlaxoSmithKline Biologicals | ||
Full Title: A phase III, randomized, open-label, multicentre study to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals’ combined DTPa-IPV/Hib vaccine administered as a three-... | ||
Medical condition: Primary immunization of healthy infants in the first year of life against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b (Hib) diseases. | ||
Disease: | ||
Population Age: Infants and toddlers, Under 18 | Gender: Male, Female | |
Trial protocol: Outside EU/EEA | ||
Trial results: View results |
EudraCT Number: 2016-000274-37 | Sponsor Protocol Number: PRI03C | Start Date*: 2016-03-21 | ||||||||||||||||||||||||||||||||||||
Sponsor Name:MCM Vaccine B.V. | ||||||||||||||||||||||||||||||||||||||
Full Title: Long-term Persistence of Hepatitis B and Pertussis Antibody Responses in Healthy 4- to 5 year old Children Previously Vaccinated with a 2-dose or 3-dose Infants series and Toddler dose with VAXELIS... | ||||||||||||||||||||||||||||||||||||||
Medical condition: Vaxelis is indicated for primary and booster vaccination in infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B (HB), poliomyelitis and invasive diseases caused by Haemophilus ... | ||||||||||||||||||||||||||||||||||||||
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Population Age: Children, Under 18 | Gender: Male, Female | |||||||||||||||||||||||||||||||||||||
Trial protocol: FI (Completed) | ||||||||||||||||||||||||||||||||||||||
Trial results: View results |
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