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 vaccines(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 Aug 2020·Expert review of vaccinesQ2 · MEDICINE

Safety profile of Infanrix hexa – 17 years of GSK’s passive post-marketing surveillance

Q2 · MEDICINE

Article

Author: Hanssens, Linda ; Verheust, Céline ; Dolhain, Jan ; Puente Gómez, Ivonne

INTRODUCTION:

This paper reports 17 years of passive safety surveillance of routine use of the pediatric hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b-conjugate vaccine (DTPa-HBV-IPV/Hib, Infanrix hexa, GSK).

METHODS:

Global post-licensure passive surveillance data collected in GSK's central safety database since DTPa-HBV-IPV/Hib's launch (2000) are described.

RESULTS:

The most common spontaneously reported adverse events (AEs) after DTPa-HBV-IPV/Hib vaccination in children were fever (reporting rate: 7.74/100,000 doses distributed), crying (2.62/100,000), injection site erythema (1.87/100,000) and swelling (1.28/100,000). A review of extensive limb swelling did not reveal any safety concerns. An observed-to-expected analysis did not show an increased risk of sudden death after DTPa-HBV-IPV/Hib vaccination, in line with previous observations. The analyses confirmed that increases in spontaneous reporting proportions of convulsions with/without fever and hypotonic-hyporesponsive episodes after co-administration of DTPa-HBV-IPV/Hib and 13-valent pneumococcal conjugate vaccine remained small and their clinical significance unknown. The most common vaccination errors were mistakes in the vaccination schedule. Reporting of preparation errors (mostly reconstitution) was low and did not impact the vaccine's benefit-risk profile.

CONCLUSIONS:

Seventeen years of post-licensure experience confirm confidence in the safety profile of DTPa-HBV-IPV/Hib in routine use, with a favorable benefit-risk profile in infants and toddlers.

PLAIN LANGUAGE SUMMARY:

What is the context? The cornerstone of childhood vaccination in many countries worldwide is a vaccine that protects against several diseases: diphtheria, tetanus, whooping cough, hepatitis B, polio and Haemophilus influenzae type b infections (such as meningitis). One of these vaccines (the longest on the market) is called Infanrix hexa; it has been available for infants and toddlers since 2000. After a vaccine is included in a country's routine vaccination program, its safety is constantly checked; this is done in clinical trials and through spontaneous reporting of adverse events after vaccination. It is important to share up-to-date information on the safety of vaccines, particularly since concerns about vaccine safety in parents may lead to lower vaccination rates an disease outbreaks. Here we summarize 17 years of safety data for the Infanrix hexa vaccine. What is new? We analyzed spontaneously reported adverse events after Infanrix hexa vaccinations between 2000 and 2017 The most commonly reported adverse events were fever, crying and injection site redness and swelling An in-depth review of extensive limb swelling after Infanrix hexa vaccination revealed no safety concerns. There was no increased risk of sudden death after Infanrix hexa vaccination, consistent with what was shown in several other studies. As shown previously, seizures were more common when Infanrix hexa was given together with the pneumococcal conjugate vaccine, Prevnar 13, than when it was given alone. What is the take-home message? The large amount of safety data gathered from clinical trials and from spontaneous adverse event reporting during 17 years of routine vaccination with Infanrix hexa supports its continued use in young children.

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 Jul 2018·The Pediatric infectious disease journalQ4 · MEDICINE

Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib and PHiD-CV When Coadministered With MenACWY-TT in Infants

Q4 · MEDICINE

Article

Author: Marès Bermúdez, Josep ; Kolhe, Devayani ; Otero Reigada, Maria Del Carmen ; Baine, Yaela ; Fischbach, Thomas ; Carmona Martínez, Alfonso ; Mendez, Maria ; Miranda, Mariano ; Perez Porcuna, Xavier Maria ; Centeno Malfaz, Fernando ; Bleckmann, Gerhard ; Garcia Cabezas, Miguel Angel ; Merino Arribas, Jose Manuel ; Christoph, Wittermann ; Horn, Michael ; Van der Wielen, Marie

Background::

This study evaluated the immunogenicity and reactogenicity of a combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus virus-Haemophilus influenzae type b vaccine (DTPa-HBV-IPV/Hib) and a 10-valent pneumococcal conjugate vaccine (PHiD-CV) coadministered with a quadrivalent meningococcal conjugate vaccine (MenACWY-TT) in infants/toddlers.

Methods::

In this open, controlled, phase III study (NCT01144663), 2095 healthy infants were randomized (1:1:1:1) into 4 groups to receive MenACWY-TT at 2, 3, 4 and 12 months of age or MenACWY-TT, MenC-CRM197, or MenC-TT at 2, 4 and 12 months of age. All participants received PHiD-CV and DTPa-HBV-IPV/Hib at 2, 3, 4 and 12 months of age. Immunogenicity of DTPa-HBV-IPV/Hib was evaluated in exclusive randomized subsets of 25% of participants from each group postprimary, prebooster and postbooster vaccination, whereas immunogenicity of PHiD-CV was evaluated at all time points. Reactogenicity was evaluated on the total vaccinated cohorts during 8 days after each vaccination.

Results::

For each DTPa-HBV-IPV/Hib antigen, ≥97.2%, ≥76.5% and ≥97.9% of participants had seropositive/seroprotective levels 1 month postprimary vaccination, before the booster dose and 1 month postbooster, respectively. For each vaccine pneumococcal serotype, ≥74.0% of infants had antibody concentrations ≥0.35 μg/mL at 1 month postprimary vaccination, and robust increases in antibody geometric mean concentrations were observed from prebooster to postbooster. Redness was the most frequent solicited local symptom at the DTPa-HBV-IPV/Hib and PHiD-CV injection sites, reported after up to 47.7% and 57.0% of doses postprimary and postbooster vaccination, respectively.

Conclusions::

Primary and booster vaccinations of infants/toddlers with DTPa-HBV-IPV/Hib and PHiD-CV coadministered with MenACWY-TT were immunogenic with clinically acceptable reactogenicity profiles. These results support the coadministration of MenACWY-TT with routine childhood vaccines.

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)

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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

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03207750 (CTgov)	Phase 3	Rotavirus Infections \| Viral gastroenteritis due to Rotavirus	1,280	Hiberix+human rotavirus (HRV) vaccine+PCV+Prevnar-13+Pediarix (HRV Porcine Circovirus (PCV)-Free Liquid Group)	sjlrdmoceh = lbebgjrpoo dzmipggbqa (hivmbsegrz, lhziinnzfo - nkktntiesk) View more	-	31 Oct 2019
				Hiberix+human rotavirus (HRV) vaccine+Prevnar-13+Pediarix (HRV Lyophilized Group)	sjlrdmoceh = dcklidvecs dzmipggbqa (hivmbsegrz, divyiowfwd - khphcmywbq) View more
NCT00129116 (CTgov)	Phase 2	Hemophilus influenza infection \| Meningitis	388	Hib-MenCY-TT vaccine+Infanrix penta ® (Menhibrix F1/Infanrix-penta Group)	fyhtvpykeh = qpgdrekzyk eggqmsnkkg (isfhcwtalx, ccnwkqjvxj - ymenlyxhwb) View more	-	23 Jul 2012
				Hib-MenCY-TT vaccine+Infanrix penta ® (Menhibrix F2/Infanrix-penta Group)	fyhtvpykeh = tscjuibiaw eggqmsnkkg (isfhcwtalx, zjnwfjazmk - saslahknzk) View more
NCT00891176 (CTgov)	Phase 3	Hemophilus influenza infection \| Meningitis	582	Pneumococcal conjugate vaccine GSK1024850A+InfanrixTM IPV/Hib+InfanrixTM hexa+MeningitecTM (Synflorix-Meningitec Group)	lneihryloo = oqxqykoqar obhxbfxukz (qtruqsqiah, dpqbajfaua - xuyejubiqx) View more	-	23 Dec 2010
				Pneumococcal conjugate vaccine GSK1024850A+InfanrixTM IPV/Hib+InfanrixTM hexa+NeisVac-CTM (Synflorix-NeisVac-C Group)	lneihryloo = poqqupemqy obhxbfxukz (qtruqsqiah, iitpkuxiik - glbnlsnxjf) View more
NCT00586612 (CTgov)	Phase 3	Meningitis \| Haemophilus Infections	313	Menitorix™+Infanrix™ IPV+Prevenar™+Infanrix™ penta (Preterm Group)	euwlhmpclc = ipyxnhlfzi mvijgybfsd (tavppmruon, qrcivjcofe - rstazzulnx) View more	-	22 Jan 2010
				Menitorix™+Infanrix™ IPV+Prevenar™+Infanrix™ penta (Full-term Group)	euwlhmpclc = sogydsopnc mvijgybfsd (tavppmruon, tfmaxcobgd - ncleekqpbm) 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™)	cxbimuvynv = ureborzylv mexfbarqrt (ylsnmxcqld, yvusieuyby - wrkbieesrj) 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™)	cxbimuvynv = nooqpbneni mexfbarqrt (ylsnmxcqld, ixqqhjcnew - zwistypyvh) View more

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

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