Clinical Trials associated with Diphtheria, tetanus, pertussis (acellular, component), hepatitis-B (rDNA) and poliomyelitis (inactivated) vaccine (GlaxoSmithKline Plc)

NCT07160244

/ RecruitingPhase 3

A Phase 3, Randomized, Placebo-Controlled, Double-Blinded Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Multivalent Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Infants

BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies.
This study is seeking healthy pregnant participants:
* aged 49 or younger who can join.
* between 24 and 36 weeks of gestation ("Gestational age" is a medical term used to describe how far along your pregnancy is)
* had a fetal ultrasound examination performed with no major fetal abnormalities observed
* documented negative for HIV, syphilis and Hepatitis B All participants in this study will receive only 1 shot in an arm. This could either be a group B streptococcus 6-valent polysaccharide conjugate vaccine (GBS6) or placebo. Placebo is an inactive substance used in the study for comparison purposes; in this study, the placebo injection will be saline (saltwater). The pregnant participants may take part in this study for a maximum of 14 months (6 months after delivery) , and their babies for about 12 months after they are born. The pregnant participants will need to visit the research site at least 3 to 4 times with some visits permitted to occur over the telephone.
A subset of infants will be asked to take part in the study for up to 19 months. The subset will receive diphtheria toxoid-containing vaccine and/or pneumococcal vaccine following each country's standard immunization plan and have blood drawn 1 month after completion of the primary and/or toddler (booster) doses.

Start Date25 Aug 2025

Sponsor / Collaborator

Pfizer Inc.

NCT03621670

/ CompletedPhase 3

Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants

The purpose of this study is to evaluate the safety and immunogenicity of Bexsero (meningococcal group B vaccine-rMenB+OMV NZ) in North American infants 6 weeks through 12 weeks of age, when administered concomitantly with Pneumococcal conjugate vaccine (PCV 13) and other recommended routine infant vaccinesv(RIV).

Start Date27 Jul 2018

Sponsor / Collaborator

GSK Plc

NCT03207750

/ CompletedPhase 3

Immunogenicity, Reactogenicity and Safety Study of Pediarix®, Hiberix® and Prevenar 13® Co-administered With Two Different Formulations of GSK Biologicals' HRV Vaccine (444563) in Healthy Infants 6-12 Weeks of Age

The purpose of this study is to assess if there is any immune interference between the Porcine circovirus free (PCV-free) liquid Human rotavirus (HRV) vaccine and routine infant vaccinations currently in use in the US, namely Pediarix®, Hiberix® and Prevenar 13® as compared to the currently licensed lyophilized formulation of the HRV vaccine when co-administered with the same routine vaccinations in healthy infants 6-12 weeks of age

Start Date14 Sep 2017

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with Diphtheria, tetanus, pertussis (acellular, component), hepatitis-B (rDNA) and poliomyelitis (inactivated) vaccine (GlaxoSmithKline Plc)

100 Translational Medicine associated with Diphtheria, tetanus, pertussis (acellular, component), hepatitis-B (rDNA) and poliomyelitis (inactivated) vaccine (GlaxoSmithKline Plc)

100 Patents (Medical) associated with Diphtheria, tetanus, pertussis (acellular, component), hepatitis-B (rDNA) and poliomyelitis (inactivated) vaccine (GlaxoSmithKline Plc)

Literatures (Medical) associated with Diphtheria, tetanus, pertussis (acellular, component), hepatitis-B (rDNA) and poliomyelitis (inactivated) vaccine (GlaxoSmithKline Plc)

02 Jan 2019·Human vaccines & immunotherapeuticsQ3 · MEDICINE

Long-term antibody persistence against hepatitis B in adolescents 14–15-years of age vaccinated with 4 doses of hexavalent DTPa-HBV-IPV/Hib vaccine in infancy

Q3 · MEDICINE

Article

Author: Panzer, Falko ; Suryakiran, Pemmaraju V. ; Donner, Matthias ; Adelt, Thomas ; Janssens, Winnie ; Mesaros, Narcisa ; Schwarz, Tino F. ; Behre, Ulrich

We evaluated antibody persistence against hepatitis B virus (HBV) in adolescents previously vaccinated with a hexavalent diphtheria-tetanus-acellular pertussis-HBV-inactivated poliovirus-Haemophilus influenzae type b conjugate vaccine (DTPa-HBV-IPV/Hib), as part of the national newborn immunization program in Germany. We also assessed the anamnestic response to a challenge dose of a monovalent HBV vaccine. In this phase 4, open-label, non-randomized study (NCT02798952), 302 adolescents aged 14-15 years, primed in their first 2 years of life with 4 DTPa-HBV-IPV/Hib doses, received one challenge dose of monovalent HBV vaccine. Blood samples were taken before and one month post-vaccination and used to determine antibody levels against hepatitis B surface antigen (HBs). Reactogenicity and safety were also assessed post-challenge dose. Pre-challenge dose, 53.7% of 268 participants included in the according-to-protocol cohort for immunogenicity had anti-HBs antibody concentrations ≥10 mIU/mL (seroprotection cut-off) and 16.8% had anti-HBs antibody concentrations ≥100 mIU/mL. One month post-challenge dose, 93.3% of adolescents had anti-HBs antibody concentrations ≥10 mIU/mL and 87.3% had antibody concentrations ≥100 mIU/mL. An anamnestic response was mounted in 92.5% of adolescents. Injection site pain (in 33.6% of participants) and fatigue (30.2%) were the most frequently reported solicited local and general symptoms, respectively. Six of the 55 unsolicited adverse events reported were considered vaccination-related. Two vaccination-unrelated serious adverse events were reported during the study. Long-term antibody persistence against hepatitis B was observed in 14-15 years old adolescents previously primed in infancy with DTPa-HBV-IPV/Hib. A challenge dose of monovalent HBV vaccine induced strong anamnestic response, with no safety concerns.

01 Aug 2017·VaccineQ3 · MEDICINE

Safety, reactogenicity and immunogenicity of two investigational pneumococcal protein-based vaccines: Results from a randomized phase II study in infants

Q3 · MEDICINE

Article

Author: Prymula, Roman ; Borys, Dorota ; Song, Yue ; Silfverdal, Sven-Arne ; Gardev, Asparuh ; Wysocki, Jacek ; Szenborn, Leszek ; Albrecht, Piotr ; Traskine, Magali

INTRODUCTION:

Vaccination with formulations containing pneumococcal protein antigens such as pneumolysin toxoid (dPly) and histidine-triad protein D (PhtD) may extend serotype-related protection of pneumococcal conjugate vaccines (PCVs) against Streptococcus pneumoniae.

METHODS:

This phase II, multi-center, observer-blind trial conducted in Europe (NCT01204658) assessed 2 investigational vaccines containing 10 serotype-specific polysaccharide conjugates of PHiD-CV and either 10 or 30µg of dPly and PhtD each. Infants randomized 1:1:1:1 received 4 doses of PHiD-CV/dPly/PhtD-10, PHiD-CV/dPly/PhtD-30, PHiD-CV, or 13-valent PCV (PCV13), co-administered with DTPa-HBV-IPV/Hib, at ages ∼2, 3, 4 and 12-15months. Occurrences of fever >40.0°C following primary vaccination with PHiD-CV/dPly/PhtD vaccines compared to PHiD-CV (non-inferiority objective), dose superiority, safety and immunogenicity were assessed.

RESULTS:

575 children received primary vaccination, and 564 booster vaccination. The non-inferiority objective was met; no fever >40.0°C causally related to vaccination was reported during primary vaccination. Incidence of adverse events appeared similar between the 3 PHiD-CV groups. Serious adverse events were reported in 13, 9, 21 (1 related to vaccination), and 17 children in the PHiD-CV/dPly/PhtD-10, PHiD-CV/dPly/PhtD-30, PHiD-CV, and PCV13 groups, respectively. PHiD-CV/dPly/PhtD-30 was superior to PHiD-CV/dPly/PhtD-10 in terms of post-dose 3 anti-Ply and Anti-PhtD antibody levels. Anti-Ply and anti-PhtD antibody levels were higher in both PHiD-CV/dPly/PhtD groups than in controls and increased from post-primary to post-booster timepoint. Post-primary and booster vaccination, for each PHiD-CV serotype, ≥98.5% of participants in PHiD-CV/dPly/PhtD groups had antibody concentrations ≥ 0.2μg/mL, except for 6B (≥72.3%) and 23F (≥82.7%) post-primary vaccination. Similar results were observed in the PHiD-CV group. Immune responses to protein D and DTPa-HBV-IPV/Hib were within similar ranges for the 3 PHiD-CV groups.

CONCLUSION:

Both PHiD-CV/dPly/PhtD formulations co-administered with DTPa-HBV-IPV/Hib in infants were well-tolerated and immunogenic for dPly and PhtD antigens, while immune responses to serotype-specific, protein D and co-administered antigens did not appear altered in comparison to PHiD-CV group.

03 Jul 2017·Human vaccines & immunotherapeuticsQ3 · MEDICINE

Immunogenicity and safety of primary and booster vaccination with 2 investigational formulations of diphtheria, tetanus andHaemophilus influenzaetype b antigens in a hexavalent DTPa-HBV-IPV/Hib combination vaccine in comparison with the licensedInfanrix hexa

Q3 · MEDICINE

Article

Author: Cheuvart, Brigitte ; Janssens, Winnie ; Rivera, Luis ; Ahonen, Anitta ; Mesaros, Narcisa ; Korhonen, Tiina ; Vesikari, Timo ; Hezareh, Marjan

Safety and immunogenicity of 2 investigational formulations of diphtheria, tetanus and Haemophilus influenzae type b antigens of the combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliomyelitis-Hib vaccine (DTPa-HBV-IPV/Hib) were evaluated in a Primary (NCT01248884) and a Booster vaccination (NCT01453998) study. In the Primary study, 721 healthy infants (randomized 1:1:1) received 3 doses of DTPa-HBV-IPV/Hib formulation A (D_AT_APa-HBV-IPV/Hib), or B (D_BT_BPa-HBV-IPV/Hib) or the licensed DTPa-HBV-IPV/Hib vaccine (Infanrix hexa, GSK; control group) at 2, 3, 4 months of age. Infants were planned to receive a booster dose at 12-15 months of age with the same formulation received in the Primary study; however, following high incidence of fever associated with the investigational formulations in the Primary study, the Booster study protocol was amended and all infants yet to receive a booster dose (N = 385) received the licensed vaccine. In the Primary study, non-inferiority of 3-dose vaccination with investigational formulations compared with the licensed vaccine was not demonstrated due to anti-pertactin failing to meet the non-inferiority criterion. Post-primary vaccination, most infants had seroprotective levels of anti-diphtheria (100% of infants), anti-tetanus antigens (100%), against hepatitis B (≥ 97.5% across groups), polyribosyl-ribitol-phosphate (≥ 88.0%) and poliovirus types 1-3 (≥ 90.5%). Seropositivity rates for each pertussis antigen were 100% in all groups. Higher incidence of fever (> 38°C) was reported in infants receiving the investigational formulations (Primary study: 75.0% [A] and 72.1% [B] vs 58.8% [control]; Booster study, before amendment: 49.4% and 46.6% vs 37.4%, respectively). The development of the investigational formulations was not further pursued.

News (Medical) associated with Diphtheria, tetanus, pertussis (acellular, component), hepatitis-B (rDNA) and poliomyelitis (inactivated) vaccine (GlaxoSmithKline Plc)

28 Jun 2022

·www.prnewswire.com

United States Human Vaccines Markets, 2018-2021 & Forecast to 2028: Approval/launches of the New Vaccines / Rising Focus on Immunization Programs / Increasing Investments and Government Support

DUBLIN, June 28, 2022 /PRNewswire/ -- The "United States Human Vaccines Market Size, Share, Top 45 Human Vaccines Brand In-depth Analysis, Emerging Trends, Current Analysis, Growth, Demand, Opportunity, and Forecast 2022 - 2028" report has been added to ResearchAndMarkets.com's offering. Amid the COVID-19 crisis, the United States human vaccines market is poised to grow by US$ 31,517 million by 2028, accelerating at a CAGR of 7% during the forecast period. The prominent factors that are expected to contribute to the growth of the United States human vaccines market: Increased Disease Awareness Approval/launches of the New Vaccines Rising Focus on Immunization Programs Increasing Investments and Government Support for the Vaccines Development The report contains a deep analysis of the United States human vaccines market size in terms of value. The report provides a clear insight into current and future developments of the United States vaccines market. The report also explores the detailed analysis, insights of the top 45 vaccines market assessment in the United States from 2018 to 2021, and forecasts to 2028. The report also details the latest information about the vaccine's pricing analysis, insights, and trends, and the regulatory framework of the United States human vaccines market. After conducting thorough research on the historical and current growth parameters, the growth prospects of the United States human vaccines market are obtained with maximum precision. This new 2022 market report provides a holistic analysis of the entire United States human vaccines market. The report offers the most up-to-date industry data on the actual market situation and future outlook for the United States' human vaccines market. The report also tracks and analyses competitive developments, including collaboration, partnership deals, distribution, exclusive and licensing agreements, new vaccine developments, and R&D activities in the market. The report also delivers an in-depth analysis of evolving market trends, drivers, and restraining forces that influence the growth of the market. The report also analyses detailed profiles of innovative and leading players with information on business overview, companies' vaccines portfolio, promising vaccines in the clinical development, and the newest developments The report will serve as a source for a 360-degree analysis, thoroughly integrating different models. This Newest and Comprehensive the United States Human Vaccines Market Research Report 2022 Delivers: Comprehensive Research Methodology of the United States Human Vaccines Market Detailed and Extensive Market Overview with Key Analyst Insights Insights about Market Determinants that are Stimulating the United States Human Vaccines Market To Analyze the Historical Growth in the Market Size of the United States Human Vaccines Market from 2018 to 2021 To Estimate and Forecast the Market Size of the United States Human Vaccines Market from 2022 to 2028 and Growth Rate until 2028 Detailed Insights of the Top 45 Human Vaccines Market Value Used in the U.S. with Six Years Forecast An Insightful Analysis of the Top 45 Vaccines Brand Market Share and Y-o-Y Growth Rate Delivers All-inclusive Insights on the Latest Pricing Analysis, Insights, and Trends Delivers an In-Depth Analysis of Evolving Market Trends, Drivers, and Restraints of the United States Human Vaccines Market An Insightful Investigation has been done on Promising Human Vaccines in the Clinical Development Delivers Comprehensive Insights into the Regulatory Framework of the United States Human Vaccines Market Tracks Competitive Developments, Approaches, Recent Industry Developments, Partnership, Collaboration Deals, Distribution, Exclusive, and Licensing Agreement A Comprehensive List of the Leading Companies along with the Analysis of their Current Vaccines Portfolio, Promising Human Vaccines in the Clinical Development, and Present Development The Report Helps Answer the Following Questions: What is the current scenario of the United States human vaccines market? What is the total market size and forecast (until 2028) of the United States human vaccines market? How big is the United States human vaccines market? At what CAGR is the U.S. human vaccines market projected to grow in the forecast period (2022-2028)? What are the leading human vaccines? What are their revenue potentials to 2028? Which human vaccine brand provides the highest market share? What is the regulatory framework in the United States vaccines market? What are the key factors driving the United States human vaccines market? What are the key challenges of the United States human vaccines market? What are the major deals and agreement happenings in the United States human vaccines market? What are the United States human vaccines pricing trends and analysis? What are the various human vaccines available in the United States? Who are the topmost market players? What are their happenings, current developments, and scenarios? How is the market predicted to develop in the future? Key Topics Covered: 1. Executive Summary 2. United States Human Vaccines Market Size and Forecast (2018 - 2028) 3. United States Human Vaccines Brand Market Share and Y-o-Y Growth (%), 2018 - 2028 4. Key Market Growth Drivers and Challenges in the United States Human Vaccines Market 4.1 Key Market Growth Drivers 4.2 Key Market Challenges 5. United States Top 45 Human Vaccines Market Value Analysis, Insights and Forecasts, 2018 - 2028 5.1 Daptacel 5.2 Quadracel 5.3 Kinrix 5.4 Vaxelis 5.5 IPOL 5.6 Vaqta 5.7 Havrix 5.8 Twinrix 5.9 Engerix B 5.10 PedvaxHIB 5.11 ActHIB 5.12 Hiberix 5.13 MenQuadfi 5.14 Tenivac 5.15 Imovax 5.16 FluMist Quadrivalent 5.17 Prevnar 13 5.18 Gardasil 9 5.19 Fluzone Quadrivalent 5.20 Flublok 5.21 Flucelvax Quadrivalent 5.22 Afluria Quadrivalent 5.23 Fluad 5.24 Varivax 5.25 Menactra 5.26 Proquad 5.27 Pneumovax 23 5.28 Fluarix 5.29 FluLaval 5.30 M-M-R II 5.31 Adacel 5.32 Boostrix 5.33 Bexsero 5.34 Menveo 5.35 Trumenba 5.36 Shingrix 5.37 Pentacel 5.38 Recombivax HB 5.39 Rotateq 5.40 Rotarix 5.41 Pediarix 5.42 Infanrix 5.43 Heplisav-B 5.44 TDVAX 5.45 BioThrax 5.46 Other Vaccines 6. United States Human Vaccines Pricing Analysis, Insights and Trends 7. Regulatory Framework of the United States Human Vaccines Market 8. Major Deals and Agreement Happenings in the Human Vaccines Market 8.1 Merger & Acquisitions 8.2 Collaboration Deals 8.3 Licensing Agreement 8.4 Exclusive Agreement 8.5 Distribution Agreement 8.6 Partnership Deals 9. Leading Companies in the United States Human Vaccines Market 9.1 Sanofi Pasteur 9.1.1 Business Overview 9.1.2 Human Vaccines Portfolio 9.1.3 Promising Human Vaccines in the Clinical Development 9.1.4 Recent Development 9.3 Merck 9.4 Pfizer 9.5 Seqirus (CSL Limited) 9.6 AstraZeneca 9.7 Dynavax Technologies Corporation 9.8 Emergent BioSolutions Inc. For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1904 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

VaccineAcquisition

02 Jun 2021

·www.biospace.com

First Six-In-One Pediatric Combination Vaccine Now Available in the United States

With a new combination vaccination available in the United States, taking your child to the doctor to get vaccines might become a little less of a hassle. Or at the very least, less frequent. On Tuesday, it was announced that a new pediatric combination vaccine is now available in the U.S. The new vaccination, dubbed VAXELIS, is indicated for active immunization to help prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b. It is the first and only six-in-one pediatric combination vaccine available in the United States. The vaccine was developed by Merck and Sanofi Pasteur and is approved to be used as a 3-dose series in children six weeks through four years of age. “Given the potential to reduce the number of shots by as many as three in the first six months of life, as compared to pentavalent vaccines plus hepatitis B or Haemophilus influenzae type b vaccines, VAXELIS represents an important option for healthcare professionals and parents,” said Joanne Monahan, senior vice president, U.S. Vaccines, Merck. “Merck and Sanofi have been in contact with the major insurers and the appropriate pricing publications to notify them of the availability of VAXELIS, and we look forward to working with payers and providers to deliver this novel hexavalent vaccine to age-appropriate children.” While VAXELIS is the first six-in-one vaccine in the United States, combination vaccines in general have been around for a while (since the mid-1940s). In fact, some of them are so common, some people might not even realize they fall under this category. A combination vaccine is when two or more vaccines that could be given individually are put together into one shot. Some common combination shots include MMR (measles, mumps and rubella) and DTaP (diphtheria, tetanus and pertussis), although they could not be considered true combo vaccines because they aren't available as separate vaccines in the United States. Other common pediatric combination vaccines include Pediarix, ProQuad, Kinrix and Pentacel. Some of the benefits of combination vaccines include fewer shots, on-time protection, fewer visits to the doctor and less hassle overall. The U.S.-based partnership between Merck and Sanofi Pasteur under which VAXELIS was developed was established in 1991, and utilizes the companies' development, manufacturing and marketing experience for individual and combination vaccines.

Vaccine

02 Jun 2021

·www.biospace.com

First Six-In-One Pediatric Combination Vaccine VAXELIS Now Available in the United States

The new vaccination, dubbed VAXELIS, is indicated for active immunization to help prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b. VAXELIS is open for sale in US. With a new combination vaccination available in the United States, taking your child to the doctor to get vaccines might become a little less of a hassle. Or at the very least, less frequent. On Tuesday, it was announced that a new pediatric combination vaccine is now available in the U.S. The new vaccination, dubbed VAXELIS, is indicated for active immunization to help prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b. It is the first and only six-in-one pediatric combination vaccine available in the United States. The vaccine was developed by Merck and Sanofi Pasteur and is approved to be used as a 3-dose series in children six weeks through four years of age. “Given the potential to reduce the number of shots by as many as three in the first six months of life, as compared to pentavalent vaccines plus hepatitis B or Haemophilus influenzae type b vaccines, VAXELIS represents an important option for healthcare professionals and parents,” said Joanne Monahan, senior vice president, U.S. Vaccines, Merck. “Merck and Sanofi have been in contact with the major insurers and the appropriate pricing publications to notify them of the availability of VAXELIS, and we look forward to working with payers and providers to deliver this novel hexavalent vaccine to age-appropriate children.” While VAXELIS is the first six-in-one vaccine in the United States, combination vaccines in general have been around for a while (since the mid-1940s). In fact, some of them are so common, some people might not even realize they fall under this category. A combination vaccine is when two or more vaccines that could be given individually are put together into one shot. Some common combination shots include MMR (measles, mumps and rubella) and DTaP (diphtheria, tetanus and pertussis), although they could not be considered true combo vaccines because they aren’t available as separate vaccines in the United States. Other common pediatric combination vaccines include Pediarix, ProQuad, Kinrix and Pentacel. Some of the benefits of combination vaccines include fewer shots, on-time protection, fewer visits to the doctor and less hassle overall. The U.S.-based partnership between Merck and Sanofi Pasteur under which VAXELIS was developed was established in 1991, and utilizes the companies’ development, manufacturing and marketing experience for individual and combination vaccines.

VaccineDrug Approval

100 Deals associated with Diphtheria, tetanus, pertussis (acellular, component), hepatitis-B (rDNA) and poliomyelitis (inactivated) vaccine (GlaxoSmithKline Plc)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	J07CA12	-

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Diphtheria	European Union	GlaxoSmithKline Biologicals SA	23 Oct 2000
Diphtheria	Iceland	GlaxoSmithKline Biologicals SA	23 Oct 2000
Diphtheria	Liechtenstein	GlaxoSmithKline Biologicals SA	23 Oct 2000
Diphtheria	Norway	GlaxoSmithKline Biologicals SA	23 Oct 2000
Hepatitis B	European Union	GlaxoSmithKline Biologicals SA	23 Oct 2000
Hepatitis B	Iceland	GlaxoSmithKline Biologicals SA	23 Oct 2000
Hepatitis B	Liechtenstein	GlaxoSmithKline Biologicals SA	23 Oct 2000
Hepatitis B	Norway	GlaxoSmithKline Biologicals SA	23 Oct 2000
Poliomyelitis	European Union	GlaxoSmithKline Biologicals SA	23 Oct 2000
Poliomyelitis	Iceland	GlaxoSmithKline Biologicals SA	23 Oct 2000
Poliomyelitis	Liechtenstein	GlaxoSmithKline Biologicals SA	23 Oct 2000
Poliomyelitis	Norway	GlaxoSmithKline Biologicals SA	23 Oct 2000
Tetanus	European Union	GlaxoSmithKline Biologicals SA	23 Oct 2000
Tetanus	Iceland	GlaxoSmithKline Biologicals SA	23 Oct 2000
Tetanus	Liechtenstein	GlaxoSmithKline Biologicals SA	23 Oct 2000
Tetanus	Norway	GlaxoSmithKline Biologicals SA	23 Oct 2000
Whooping Cough	European Union	GlaxoSmithKline Biologicals SA	23 Oct 2000
Whooping Cough	Iceland	GlaxoSmithKline Biologicals SA	23 Oct 2000
Whooping Cough	Liechtenstein	GlaxoSmithKline Biologicals SA	23 Oct 2000
Whooping Cough	Norway	GlaxoSmithKline Biologicals SA	23 Oct 2000

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Haemophilus Infections	Phase 3	Finland	GlaxoSmithKline Biologicals (Shanghai) Ltd.	13 Mar 2006

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00891176 (CTgov)	Phase 3	Hemophilus influenza infection \| Meningitis	582	Pneumococcal conjugate vaccine GSK1024850A+InfanrixTM IPV/Hib+InfanrixTM hexa+MeningitecTM (Synflorix-Meningitec Group)	qefechkraa = oimtljivlx zazyfprtan (xnubglipjz, uxixqfctme - wgkpffuaca) View more	-	23 Dec 2010
				Pneumococcal conjugate vaccine GSK1024850A+InfanrixTM IPV/Hib+InfanrixTM hexa+NeisVac-CTM (Synflorix-NeisVac-C Group)	qefechkraa = joiqnrisxu zazyfprtan (xnubglipjz, kdfipkqlyl - nmanmfzcgb) View more
NCT00586612 (CTgov)	Phase 3	Hemophilus influenza infection \| Meningitis	313	Menitorix™+Infanrix™ IPV+Prevenar™+Infanrix™ penta (Preterm Group)	qfsxbrzbta = ciigonmomy agstkvwnwd (rpicjdkpwj, abtpwffapv - ycumlvejig) View more	-	22 Jan 2010
				Menitorix™+Infanrix™ IPV+Prevenar™+Infanrix™ penta (Full-term Group)	qfsxbrzbta = sfzkjvvywj agstkvwnwd (rpicjdkpwj, wrkrypjblk - qjgypvujsa) View more
NCT00463437 (CTgov)	Phase 3	Diphtheria \| Pneumonia, Pneumococcal \| Hepatitis B ... View more	1,437	Pneumococcal conjugate vaccine GSK1024850A+Infanrix IPV Hib+Infanrix hexa+Meningitec (GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™)	ayxcfdgljh = rbjhrujjqo yshrrilexh (iatoozusod, ygvxbotcrr - oybwnyldia) View more	-	03 Aug 2009
				Pneumococcal conjugate vaccine GSK1024850A+Infanrix IPV Hib+Infanrix hexa+NeisVac-C (GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™)	ayxcfdgljh = pgpcmkbezk yshrrilexh (iatoozusod, ilvodnvlnw - wcajavwgkd) View more

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Diphtheria, tetanus, pertussis (acellular, component), hepatitis-B (rDNA) and poliomyelitis (inactivated) vaccine (GlaxoSmithKline Plc)

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