- Trials with a EudraCT protocol (196)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (47)
Query did not match any clinical trials.
| These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006). | |
| Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records. | |
| Study title: Randomised, Open Trial of the lmmunogenicity and Safety of Diphtheria, Tetanus, Acellular Pertussis (DTacP) Vaccine Associated or Combined with PRP-T Vaccine Given at 2-4-6 or 3-4-5 Months in Healthy Infants |
| Active substance: Adorbed, inactivated diphteria, tetanus, acellular pertussis and poliomyelitis vaccine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47160 |
| Study title: Psychomotor recovery performance and postoperative attention scores in pediatric outpatient anesthesia: alfentanil-prpofol versus halothane-nitrous oxid. British Journal Anaesthesia 82 (suppl. 1): 11-12, 1999Psychomotor recovery performance and postoperative attention scores in pediatric outpatient anesthesia: alfentanil-prpofol versus halothane-nitrous oxid. British Journal Anaesthesia 82 (suppl. 1): 11-12, 1999 |
| Active substance: ALFENTANIL |
| Study summary document link (including results): isbir_alfentanil.pdf |
| View full study record |
| Document reference: 46370 |
| Study title: A phase II, double-blind, randomized study to compare the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepBlow thio/Hib2.5 Gödöllö to GSK Biologicals’ Tritanrix™-HepB/Hiberix™Gödöllö when administered as a three-dose primary vaccination course to healthy infants at 6, 10 and 14 weeks of age. A dose of unconjugated Hib vaccine (plain PRP booster) will be administered at the age of 10 months to 50% of the subjects. |
| Active substance: diphtheria, tetanus, pertussis (whole cell), hepatitis B (rdna) and haemophilus influenzae type B conjugate vaccine (absorbed) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 45716 |
| Study title: Randomised comparative assessment of the immunogenicity and reactogenicity of 3 different lots of SmithKline Beecham Biologicals' Haemophilus influenzae type b (PRP-TT) and the Pasteur/Mérieux Haemophilus type vaccine (PRP-T), administered to healthy infants as a primary vaccination course of three consecutive doses at 3, 4 and 5 months of age. |
| Active substance: Haemophilus influenzae type b capsular polysaccharide (PRP) conjugated to tetanus toxoid (TT) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41129 |
| Study title: Placebo controlled randomized study of haemophilus influenzae type b capsular polysaccharide tetanus conjugate vaccine (PRP-T) associated or combined with diphtheria- tetanus- pertussis vaccine (DTP) in two month old infants |
| Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 40998 |
| Study title: Assessment of the Immunogenicity and Safety of the Sanofi Pasteur DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™), Administered at 6, 10, and 14 Weeks of Age and Followed by a Booster Dose at 18-19 Months of Age in Healthy Infants Included in Two Study Groups Receiving the Hepatitis B Monovalent Vaccine Either at 0, 6, and 14 Weeks of Age or at 6, 10, and 14 Weeks of Age. |
| Active substance: Diphtheria, Tetanus, Acellular Pertussis and Inactivated Poliomyelitis Vaccine, Adsorbed and Haemophilus influenzae type b conjugate vaccine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47187 |
| Study title: Clinical Safety study of the DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) in Healthy Children and in Healthy Infants in the People’s Republic of China |
| Active substance: Diphtheria, Tetanus, Acellular Pertussis and Inactivated Poliomyelitis Vaccine, Adsorbed and Haemophilus influenzae type b conjugate vaccine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41322 |
| Study title: Immunogenicity and Safety of a Booster Dose of Aventis Pasteur’s DTacPIPV// PRP~T Combined Vaccine (Pentavac™/Pentaxim™) in 18-24 Months Old Children Primed with DTacP-HB-IPV-PRP~T Combined Vaccine (Hexavac™) in the Study A3R31 |
| Active substance: Diphtheria, Tetanus, Acellular Pertussis and Inactivated Poliomyelitis Vaccine, Adsorbed and Haemophilus influenzae type b conjugate vaccine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47188 |
| Study title: Immunogenicity and Safety of the Aventis Pasteur DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Given as a Three-Dose Primary Vaccination at 6, 10, and 14 Weeks of Age and Followed by a Booster Dose at 18-19 Months of Age in Healthy Infants in India |
| Active substance: Diphtheria, Tetanus, Acellular Pertussis and Inactivated Poliomyelitis Vaccine, Adsorbed and Haemophilus influenzae type b conjugate vaccine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41321 |
| Study title: Placebo controlled randomized study of haemophilus influenzae type b capsular polysaccharide tetanus conjugate vaccine (PRP-T) associated or combined with diphtheria- tetanus- pertussis vaccine (DTP) in two month old infants |
| Active substance: Diphtheria, Tetanus, Acellular Pertussis and Inactivated Poliomyelitis Vaccine, Adsorbed and Haemophilus influenzae type b conjugate vaccine |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47153 |
| Study title: Open clinical study to evaluate the reactogenicity of SmithKline Beecham Biologicals' Hib conjugate vaccine mixed with SmithKline Beecham Biologicals' DTPa vaccine when given as a booster dose to children at 15 to 18 months of age, previously primed with SB Bio's Hib tetanus conjugate and DTPa vaccines in study HIB-012. |
| Active substance: Haemophilus influenzae type b capsular polysaccharide (PRP) conjugated to tetanus toxoid (TT) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41133 |
| Study title: Open label, randomised comparative assessment of the immunogenicity and reactogenicity of SmithKline Beecham's (SB's) diphteria/tetanus/acellular pertussis (DTPa) vaccine and SB's Hib with commercially available diphtheria/tetanus/whole cell pertussis (DTPw) and SB's Hib. Vaccines to be combined in the same syringe and administered to healthy infants as three consecutive doses at 2, 3 and 4 months of age. |
| Active substance: Haemophilus influenzae type b capsular polysaccharide (PRP) conjugated to tetanus toxoid (TT) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41137 |
| Study title: Open randomised clinical study to evaluate the immunogenicity and reactogenicity of SB Biologicals' Hib tetanus conjugate vaccine, co-administered with SB Biologicals' DTPa vaccine either mixed in one syringe, or in two separate injections into opposite limbs, to healthy children around two years of age. |
| Active substance: Haemophilus influenzae type b capsular polysaccharide (PRP) conjugated to tetanus toxoid (TT) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41141 |
| Study title: Open study to assess the immunogenicity and reactogenicity of a three-dose primary vaccination course against Haemophilus influenzae type b, diphtheria, tetanus, pertussis and hepatitis B in healthy infants at 6, 10 and 14 weeks of age. |
| Active substance: Haemophilus influenzae type b capsular polysaccharide (PRP) conjugated to tetanus toxoid (TT) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41155 |
| Study title: Open, phase II clinical trial to assess long-term antibody persistence, before Td booster vaccination, in healthy children 5 to 6 years old, previously vaccinated with 4 doses of SB Biologicals¿ DTPa vaccine mixed with SB Biologicals¿ Hib conjugate vaccine in primary vaccination study Hib-006 (208108/005) and in booster vaccination study Hib-017 (208108/017). |
| Active substance: Haemophilus influenzae type b capsular polysaccharide (PRP) conjugated to tetanus toxoid (TT) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41156 |
| Study title: EUV07: A phase III, open, randomized, controlled, primary vaccination study to assess the immunogenicity and the safety of CP20/20/5/3DT-IPV-PRP~T and ACTAcel given concomitantly with OPV vaccine and TETRAct-Hib given concomitantly with OPV vaccine at 6, 10, 14 weeks of age. All infants receiving hepatitis B vaccine (Recomvax B) at 0, 6, 14 weeks of age EUV06: Safety and immunogenicity of hepatitis B vaccine distributed by Aventis Pasteur Korea administered at 0-1-6 months when given in association with three Aventis Pasteur pertussis combination (1 whole cell and 2 acellular) vaccines administered at 2, 4 and 6 months in Mexican infants |
| Active substance: Hepatitis B Surface Antigen |
| Study summary document link (including results): |
| View full study record |
| Document reference: 47181 |
| Study title: A phase IIb randomised, multi-site clinical study to assess the immunogenicity and reactogenicity of formulation B of SB Biologicals¿ Hib conjugate vaccine administered mixed as single injection with SB Biologicals¿ DTPa vaccine versus formulation A of SB Biologicals¿ Hib conjugate vaccine administered either mixed as single injection or separately into opposite thighs with SB Biologicals¿ DTPa vaccine as a three-dose primary vaccination course in healthy infants at 3, 4, and 5 months of age. |
| Active substance: Haemophilus influenzae type b capsular polysaccharide (PRP) conjugated to tetanus toxoid (TT) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41147 |
| Study title: A post-marketing surveillance study of GlaxoSmithKline Biologicals¿ Haemophilus influenzae type b (Hib) tetanus conjugate vaccine in 3,000 Filipino subjects. Phase IV single-blind randomised study to assess the feasibility of syringe mixing of combined diphtheria, tetanus, whole cell Bordetella pertussis (DTPw) vaccine and Haemophilus influenzae type b (Hib) conjugate vaccine as a three dose primary vaccination course in healthy infants. |
| Active substance: Haemophilus influenzae type b capsular polysaccharide (PRP) conjugated to tetanus toxoid (TT) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41151 |
| Study title: An open multicentric post marketing surveillance study of SmithKline Beecham haemophilus influenzae type B tetanus conjugate vaccine-Hiberix- administered according to local recommendations in infants and children up to the age of 5 years. Only Korean version-English title to be provided. |
| Active substance: Haemophilus influenzae type b capsular polysaccharide (PRP) conjugated to tetanus toxoid (TT) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41157 |
| Study title: An open, parallel, randomised clinical study to assess the reactogenicity of SB Biologicals¿ Hib conjugate vaccine mixed with SB Biologicals¿ DTPa vaccine in comparison to the Pasteur-Mérieux´s Hib conjugate vaccine mixed with Pasteur-Mérieux´s DTPw vaccine as a booster vaccination to healthy children at 15 to 20 months, previously primed with three doses of commercially available DTPw and Hib conjugate vaccines. |
| Active substance: Haemophilus influenzae type b capsular polysaccharide (PRP) conjugated to tetanus toxoid (TT) |
| Study summary document link (including results): |
| View full study record |
| Document reference: 41154 |
