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Last update 21 Mar 2025
Haemophilus b conjugate vaccine(GSK Plc)
Last update 21 Mar 2025
Overview
Basic Info
Drug Type Prophylactic vaccine, Toxoid vaccine, Conjugated vaccine |
Synonyms Hib vaccine conjugate(GSK Plc), Hiberix, GSK 208108 |
Target- |
Action stimulants |
Mechanism Immunostimulants |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date United States (19 Aug 2009), |
Regulation- |
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Related
18
Clinical Trials associated with Haemophilus b conjugate vaccine(GSK Plc)NCT03893448
A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 4-dose Regimen of V114 in Healthy Infants (PNEU-PED)
NCT03620162
A Phase 3, Multicenter, Randomized, Double-blind Study to Evaluate the Interchangeability of V114 and Prevnar 13™ With Respect to Safety, Tolerability, and Immunogenicity in Healthy Infants (PNEU-DIRECTION)
NCT03621670
Safety and Immunogenicity of GSK Meningococcal Group B Vaccine and 13-valent Pneumococcal Vaccine Administered Concomitantly With Routine Infant Vaccines to Healthy Infants
100 Clinical Results associated with Haemophilus b conjugate vaccine(GSK Plc)
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100 Translational Medicine associated with Haemophilus b conjugate vaccine(GSK Plc)
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100 Patents (Medical) associated with Haemophilus b conjugate vaccine(GSK Plc)
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16
Literatures (Medical) associated with Haemophilus b conjugate vaccine(GSK Plc)01 Feb 2012VaccineQ3 · MEDICINE
Immunogenicity and safety of LBVH0101, a new Haemophilus influenzae type b tetanus toxoid conjugate vaccine, compared with Hiberix™ in Korean infants and children: A randomized trial
Q3 · MEDICINE
Article
Author: Hoan Jong Lee ; Sung Hee Chang ; Yun Kyung Kim ; Eun Ae Park ; Nam Hee Kim ; Su Eun Park ; Jina Lee ; Hyunju Lee ; Kyung Hyo Kim ; Byung Wook Eun
BACKGROUND:
The World Health Organization (WHO) recommends that all countries adopt Haemophilus influenzae type b (Hib) vaccine into routine child immunization programs to protect children from the significant burden of life-threatening pneumonia and meningitis.
METHODS:
In this blind, comparative, randomized, phase-III Korean multicenter study, we assessed immunogenicity and safety following primary vaccination of a new H. influenzae type b tetanus toxoid conjugate vaccine, LBVH0101 (LG Life Sciences, Ltd., Seoul, Korea) compared with Hiberix™ (GSK, Rixensart, Belgium) in Korean children at 2, 4 and 6 months of age followed by a booster vaccination at 12-15 months. Serum anti-PRP IgG concentration and bactericidal activity were determined. Local/systemic symptoms were assessed after vaccination. Serious adverse events were recorded throughout the study.
RESULTS:
A total of 185 infants were included in immunogenicity evaluations. After the second and third doses of LBVH0101, 90.32% and 100% of infants achieved an antibody level ≥1 μg/mL, respectively, compared with 78.26% and 96.74% of those who received Hiberix™. After the second vaccination, the geometric mean concentration (GMC) of LBVH0101 recipients was 7.34 μg/mL and was higher than that of Hiberix™ recipients (3.55 μg/mL). After the third vaccination, the GMCs were 14.59 μg/mL and 12.15 μg/mL in the LBVH0101 and Hiberix™ recipients, respectively. The booster dose produced higher antibody concentrations: 30.25 μg/mL and 71.64 μg/mL for LBVH0101 and Hiberix™ recipients, respectively. Bactericidal capacity and antibody potency of anti-PRP IgG induced by LBVH0101 was 35.05 and 116.27 after the second and third vaccinations, respectively, compared with 53.76 and 79.64 for Hiberix™. Anti-PRP IgG seroprotection rate and GMC were similar post-primary immunization between the groups; both showed functional maturation and similar booster responses. LBVH0101 had comparable safety results as the control vaccine, Hiberix™, as most of the solicited adverse events and unsolicited adverse events upon LBVH0101 administration were mild in severity. No serious vaccination-related adverse reactions were observed.
CONCLUSIONS:
LBVH0101 showed a good immunogenicity and safety profile in infants and children. The two-dose infant-priming schedule with a booster dose may suffice for Hib immunization in Korean infants (Clinical trial registration numbers: NCT01019772 and NCT01251133).
01 Dec 2011Malaria journalQ3 · MEDICINE
Anaemia in a phase 2 study of a blood stage falciparum malaria vaccine
Q3 · MEDICINE
ArticleOA
Author: Ruth D Ellis ; Dapa Diallo ; Issaka Sagara ; Mahamadou S Sissoko ; Kazutoyo Miura ; Ogobara K Doumbo ; Michael P Fay ; Alassane Dicko ; Aldiouma Guindo ; Merepen A Guindo
BACKGROUND:
A Phase 1-2b study of the blood stage malaria vaccine AMA1-C1/Alhydrogel was conducted in 336 children in Donéguébougou and Bancoumana, Mali. In the Phase 2 portion of the study (n = 300), no impact on parasite density or clinical malaria was seen; however, children who received the study vaccine had a higher frequency of anaemia (defined as haemoglobin < 8.5 g/dL) compared to those who received the comparator vaccine (Hiberix). This effect was one of many tested and was not significant after adjusting for multiple comparisons.
METHODS:
To further investigate the possible impact of vaccination on anaemia, additional analyses were conducted including patients from the Phase 1 portion of the study and controlling for baseline haemoglobin, haemoglobin types S or C, alpha-thalassaemia, G6PD deficiency, and age. A multiplicative intensity model was used, which generalizes Cox regression to allow for multiple events. Frailty effects for each subject were used to account for correlation of multiple anaemia events within the same subject. Intensity rates were calculated with reference to calendar time instead of time after randomization in order to account for staggered enrollment and seasonal effects of malaria incidence. Associations of anaemia with anti-AMA1 antibody were further explored using a similar analysis.
RESULTS:
A strong effect of vaccine on the incidence of anaemia (risk ratio [AMA1-C1 to comparator (Hiberix)]= 2.01, 95% confidence interval [1.26,3.20]) was demonstrated even after adjusting for baseline haemoglobin, haemoglobinopathies, and age, and using more sophisticated statistical models. Anti-AMA1 antibody levels were not associated with this effect.
CONCLUSIONS:
While these additional analyses show a robust effect of vaccination on anaemia, this is an intensive exploration of secondary results and should, therefore, be interpreted with caution. Possible mechanisms of the apparent adverse effect on haemoglobin of vaccination with AMA1-C1/Alhydrogel and implications for blood stage vaccine development are discussed. The potential impact on malaria-associated anaemia should be closely evaluated in clinical trials of AMA1 and other blood stage vaccines in malaria-exposed populations.
18 Sep 2009MMWR. Morbidity and mortality weekly reportQ1 · MEDICINE
Licensure of a Haemophilus influenzae type b (Hib) vaccine (Hiberix) and updated recommendations for use of Hib vaccine.
Q1 · MEDICINE
Article
On August 19, 2009, the Food and Drug Administration (FDA) licensed Hiberix (GlaxoSmithKline Biologicals, Rixensart, Belgium), a Haemophilus influenzae type b (Hib) conjugate vaccine composed of H. influenzae type b capsular polysaccharide (polyribosyl-ribitol-phosphate [PRP]) conjugated to inactivated tetanus toxoid (PRP-T). Hiberix is licensed for use as the booster (final) dose of the Hib vaccine series for children aged 15 months through 4 years (before the 5th birthday) who have received previously the primary series of Hib vaccination (consisting of 2 or 3 doses, depending on the formulation). The Advisory Committee on Immunization Practices (ACIP) recommends Hib booster vaccination for children at ages 12 through 15 months; however, because of the recent shortage of Hib vaccines, many children have deferred the booster dose and therefore require catch-up vaccination. This report summarizes the indications for Hiberix use and provides guidance on Hib booster dose administration based on increasing vaccine supplies. Vaccination recommendations in this report update the previous advisory on Hib booster administration (June 26, 2009), which advised that children with deferred booster doses receive it at the next regularly scheduled visit. Vaccination providers are now recommended to begin recall of children in need of the booster dose when feasible and monovalent Hib vaccine supply in the office is adequate.
100 Deals associated with Haemophilus b conjugate vaccine(GSK Plc)
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External Link
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
R&D Status
Approved
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| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Haemophilus Infections | United States | 19 Aug 2009 |
Developing
10 top R&D records. to view more data
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| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Rotavirus Infections | Phase 3 | United States | 14 Sep 2017 | |
| Viral gastroenteritis due to Rotavirus | Phase 3 | United States | 14 Sep 2017 | |
| Streptococcal Infections | Phase 3 | United States | 10 Jun 2008 | |
| Diphtheria | Phase 3 | - | 01 Sep 2000 | |
| Hepatitis B | Phase 3 | - | 01 Sep 2000 | |
| Poliomyelitis | Phase 3 | - | 01 Sep 2000 | |
| Tetanus | Phase 3 | - | 01 Sep 2000 | |
| Whooping Cough | Phase 3 | - | 01 Sep 2000 | |
| Tuberculosis | Phase 2 | Gambia | 07 Jul 2010 |
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Clinical Result
Clinical Result
Indication
Phase
Evaluation
View All Results
Phase 3 | 1,280 | (HRV Porcine Circovirus (PCV)-Free Liquid Group) | mqexoonokw = iagxhglbsn jbhattkywd (kxlvpunkvx, xzzhmndadg - qdzqjnmjsr) View more | - | 31 Oct 2019 | ||
(HRV Lyophilized Group) | mqexoonokw = uzachzzokj jbhattkywd (kxlvpunkvx, ribgadwjme - swmpoifwul) View more | ||||||
Phase 2 | 301 | (SB692342 2 Dose Group) | susvcvctvc = adlfayicml ufrbqbvyme (dvfjfmvwep, uiqjeszblf - fmjfqrawzx) View more | - | 27 Nov 2018 | ||
(SB692342 1 Dose Group) | susvcvctvc = bvtrsgcnbf ufrbqbvyme (dvfjfmvwep, hjdjfnpywn - vdezfqfqbk) View more | ||||||
Phase 3 | 296 | (Tritanrix-HepB/Hib-MenAC +Mencevax ACWY Group) | lsekbpjszn = iftsurgwhz xbwobvvfwn (hjscqbzhlb, cmotenjfrv - sairuclpsn) View more | - | 03 Aug 2017 | ||
(Tritanrix-HepB/Hiberix+Mencevax ACWY Group) | lsekbpjszn = drepcwjjrg xbwobvvfwn (hjscqbzhlb, rhrjwvptvf - gsrxcytnls) View more | ||||||
Phase 3 | 168 | (Tritanrix-HepB/Hiberix Group) | npwyykwzvp = jakhwqwyfj ghbrfmgmjr (lxayxjajmz, odgqgxbbvi - svvfoykwpt) View more | - | 01 Mar 2017 | ||
Hiberix-Mencevax AC+Tritanrix-HepB (Tritanrix-HepB/Hiberix-Mencevax AC Group) | npwyykwzvp = vhupduqxmy ghbrfmgmjr (lxayxjajmz, hnrojbvjig - txjeogiqdq) View more | ||||||
Phase 4 | 2,590 | Hib+Infanrix-IPV | zzdxeoskqn = gakuhqkqti fuhcjgvywu (uvmjoejgvo, ojfuwgkorz - sofhjiqnng) View more | - | 07 Feb 2017 | ||
Phase 3 | 4,003 | ymgankyigj = dhjsnymhkk wlvzuoyjiz (vubwntwyao, iddroelfay - snxmdebnwb) View more | - | 19 Aug 2013 | |||
(ActHIB Group) | ymgankyigj = twsuslfdoj wlvzuoyjiz (vubwntwyao, wogmhxwaks - vsvbwwdzvs) View more | ||||||
Phase 3 | 450 | cmynxjuaux = qecdctezkm feiwraltql (eomeyaqzqz, flcmnyrdvp - jlsarucvkj) View more | - | 19 Jan 2011 | |||
Wyeth-Lederle's Prevenar™+GSK Biologicals' Hiberix™ (Prevenar Group) | cmynxjuaux = epxevmjcbc feiwraltql (eomeyaqzqz, filqesplqf - ckvyeovnrl) View more | ||||||
Phase 3 | 503 | (Synflorix Group) | lkauxhwcvb = rudbjexxvu dhigxumbxl (oxgkqsyhgd, vasvlbtmwm - qamsmuuapa) View more | - | 14 Jun 2010 | ||
(Prevenar Group) | lkauxhwcvb = smbzvdrryj dhigxumbxl (oxgkqsyhgd, atawvqenec - oxjrnvcvpl) View more | ||||||
Phase 3 | 467 | hoctgxfxxs(ahcveahjlm) = gobqaxbctc jsgodjvbkf (yayhqcqfsf, uliiiahppo - tqqsvjlgra) View more | - | 26 Aug 2009 | |||
hoctgxfxxs(ahcveahjlm) = judgnjoecx jsgodjvbkf (yayhqcqfsf, qmheelroof - epxzsnkbgr) View more |
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