Drugs / Infanrix hexa
Infanrix hexa
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Infanrix Hexa | — | 2000-10-23 | europa.eu ↗ |
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial · 1 missed | ||||||
| Phase 1/2 | NCT05073003 | Oct 2021 → Jun 2025 | diarrheal disease | GlaxoSmithKline | Completed | Missed primary |
| Phase 23 trials | ||||||
| Phase 2 | NCT01453998 | Oct 2011 → Nov 2012 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, poliomyelitis +1 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00627458 | Feb → Aug 2008 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, poliomyelitis +1 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00376779 | Oct 2006 → May 2007 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, poliomyelitis +1 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 39 trials · 2 met primary | ||||||
| Phase 3 | NCT04031846 | Sep 2019 → Aug 2021 | pneumococcal infection | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT02096263 | Apr 2014 → Feb 2015 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, poliomyelitis +1 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01353703 | Apr 2012 → Feb 2013 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, poliomyelitis +1 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00533507 | Sep 2007 → Jun 2008 | Rotavirus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00508261 | Aug 2007 → May 2008 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00463437 | Apr 2007 → Jan 2008 | diphtheria, hepatitis B virus infection, pneumococcal infection, poliomyelitis +1 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00432042 | Jan 2007 → Mar 2008 | chickenpox, diphtheria, haemophilus infectious disease, hepatitis B virus infection +6 | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT00169728 | Sep 2003 → Jun 2006 | disease related to hematopoietic stem cell transplant | Heinrich-Heine University, Duesseldorf | Completed | No outcome recorded |
| Phase 3 | NCT00366366 | Sep 2001 → Sep 2002 | hepatitis B virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 48 trials · 1 missed | ||||||
| Phase 4 | NCT04294433 | Jun 2018 → Dec 2023 | hepatitis B virus infection | Laval University | Completed | No outcome recorded |
| Phase 4 | NCT02853929 | Sep 2016 → Mar 2019 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, poliomyelitis +1 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT02422264 | Jan 2016 → Mar 2018 | diphtheria, poliomyelitis, tetanus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT02408926 | Apr 2015 → Aug 2018 | pertussis | University of Antwerp | Completed | No outcome recorded |
| Phase 4 | NCT01392378 | Aug 2011 → Jan 2013 | — | Pfizer | Completed | Missed primary |
| Phase 4 | NCT00753649 | Sep 2008 → Mar 2013 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, poliomyelitis +1 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00611559 | Feb → Jun 2008 | diphtheria, hepatitis B virus infection, poliomyelitis, tetanus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT01457547 | Oct 2003 → May 2005 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, poliomyelitis +1 | GlaxoSmithKline | Completed | No outcome recorded |
| Comparator or background therapy38 trials | ||||||
| Phase 2 | NCT07320716 Comparator | Jan 2026 → Oct 2028 expected | diarrheal disease | GlaxoSmithKline | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06663436 Background | Nov 2024 → Oct 2025 | diarrheal disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01616459 Background | Jul 2012 → Apr 2013 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01248884 Comparator | Dec 2010 → Jan 2012 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, poliomyelitis +1 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01204658 Background | Sep 2010 → Nov 2011 | streptococcal infection | GlaxoSmithKline | Completed | Met primary |
| Phase 2 | NCT01171989 Comparator | Aug → Dec 2010 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, poliomyelitis +1 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01090453 Comparator | May 2010 → Oct 2011 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, meningococcal infection +2 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT01110044 Background | Apr 2010 → Aug 2012 | Rotavirus infection | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 2 | NCT00970307 Comparator | Aug 2009 → Jan 2010 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, poliomyelitis +1 | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00871741 Comparator | Apr → Jun 2009 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, meningococcal infection +2 | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 2 | NCT00513409 Background | Aug 2007 → Feb 2008 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00196976 Background | Mar 2005 → Mar 2006 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00129116 Comparator | Mar → Dec 2003 | haemophilus infectious disease, meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT07160244 Background | Aug 2025 → Nov 2028 expected | — | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT01983540 Background | Oct 2013 → Jun 2015 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, pertussis +2 | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT01480258 Comparator | Nov 2011 → Oct 2013 | bacterial infectious disease, viral infectious disease | MCM Vaccines B.V. | Completed | Met primary |
| Phase 3 | NCT01444781 Comparator | Sep 2011 → Apr 2013 | diphtheria, hepatitis B virus infection, pertussis, poliomyelitis +1 | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT01341639 Comparator | May 2011 → Mar 2013 | bacterial infectious disease, viral infectious disease | MCM Vaccines B.V. | Completed | Met primary |
| Phase 3 | NCT01153841 Background | Feb → Jul 2011 | streptococcal pneumonia | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01218451 Background | Sep 2010 → Jan 2012 | meningococcal infection | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01144663 Background | Jul 2010 → Jun 2012 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00808444 Background | Jan → Nov 2009 | streptococcal infection | GlaxoSmithKline | Completed | Met primary |
| Phase 3 | NCT00652951 Comparator | Apr 2008 → May 2009 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00624819 Background | Mar → Jun 2008 | pneumococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00657709 Comparator | Mar 2008 → Jan 2010 | meningococcal meningitis | Novartis Vaccines | Completed | Met primary |
| Phase 3 | NCT00654901 Comparator | Mar 2008 → May 2009 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, pertussis +2 | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT00489554 Background | Jul 2007 → Mar 2008 | pneumococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00496015 Background | Jul 2007 → Mar 2008 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00466947 Background | Jun 2007 → Aug 2010 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00390910 Background | Oct 2006 → Jul 2007 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00401531 Comparator | Oct 2006 → Nov 2007 | diphtheria, haemophilus infectious disease, hepatitis B virus infection, pertussis +1 | Sanofi Pasteur, a Sanofi Company | Completed | Met primary |
| Phase 3 | NCT00370396 Background | Sep 2006 → Jun 2007 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00370318 Background | Sep 2006 → Apr 2007 | Rotavirus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00322335 Comparator | May → Jul 2006 | haemophilus infectious disease, meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00327184 Comparator | Apr → Nov 2006 | haemophilus infectious disease, meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00307034 Background | Jan 2006 → Jan 2007 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT01235949 Background | Nov 2010 → Mar 2012 | streptococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 4 | NCT00294294 Background | May 2005 → Dec 2006 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 61 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Infanrix-hexa | “Subjects received 3 doses of SynflorixTM vaccine co-administered with Infanrix hexaTM at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each...” NCT00652951 ↗64“Evaluation of Antibody Persistence at 3.5 and 4.5 Years of Age in Healthy Children After Primary Series and Booster Vaccination With Investigational (DTaP-IPV-Hep B-PRP~T) or...” NCT01983540 ↗ “The DTaP5-HB-IPV-Hib group received the investigational hexavalent vaccine (DTaP-HB-IPV-Hib) and the Control group received Infanrix-hexa (DTPa3-HBV-IPV/Hib) at 2, 3, 4 and 12...” PMID 27846055 ↗ Feb 2017 “Subjects receive 2 primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age of NeisVac-C™ + Infanrix™ hexa vaccines.” NCT00327184 ↗ “Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants” NCT00401531 ↗ “Concomitant vaccinations of Infanrix hexa (0.5 mL) and Prevenar 13 (0.5 mL) at 2, 4 and 6 months of age” NCT01218451 ↗ “safety and immunogenicity of the booster dose of either DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ vaccine.” NCT01444781 ↗ “the Control Group received Infanrix-hexa (DTPa3-HBV-IPV/Hib) at 2, 4 and 11-12months of age.” PMID 27288217 ↗ Jun 2016 “Infanrix Hexa (DTPa-HBV-IPV/Hib)” NCT01204658 ↗ “Infanrix hexa™” NCT01144663 ↗ |
| Known as | DTPa-HBV-IPV/Hib | “licensed GSK Biologicals DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine” NCT01616459 ↗1“Infanrix Hexa (DTPa-HBV-IPV/Hib)” NCT01204658 ↗ |
| Known as | DTPa-HBV-IPV/Hib vaccine | “DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™)” NCT00196976 ↗1“DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA)” NCT01457547 ↗ |
| Known as | DTPa3-HBV-IPV/Hib | “The DTaP5-HB-IPV-Hib group received the investigational hexavalent vaccine (DTaP-HB-IPV-Hib) and the Control group received Infanrix-hexa (DTPa3-HBV-IPV/Hib) at 2, 3, 4 and 12...” PMID 27846055 ↗ Feb 20171“the Control Group received Infanrix-hexa (DTPa3-HBV-IPV/Hib) at 2, 4 and 11-12months of age.” PMID 27288217 ↗ Jun 2016 |
| Known as | Infanrix Hexa TM | “Compared to the Currently Licensed GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (Infanrix Hexa TM) When Administered to Healthy Infants at 2, 3 and 4 Months of Age.” NCT00376779 ↗ |
| Modality | Vaccine | “DTaP-IPV-HBV/Hib combination vaccine, Infanrix hexa” NCT00169728 ↗ |
| Route | Intramuscular | “One intramuscular dose during the primary vaccination study” NCT00196976 ↗ |